20080102-IR-260070253FRA Adds 260 IAC 1.1-0.5 regarding definitions related to breath test operators and instruments. Amends 260 IAC 1.1-1-3 to change the practical exam requirement for breath test operator recertification. ...

TITLE 260 STATE DEPARTMENT OF TOXICOLOGY

Final Rule

LSA Document #07-253(F)

DIGEST

Adds 260 IAC 1.1-0.5 regarding definitions related to breath test operators and instruments. Amends 260 IAC 1.1-1-3 to change the practical exam requirement for breath test operator recertification. Readopts 260 IAC 1.1-2-3. Makes numerous other changes in the rules concerning certification of breath test operators and instruments. Effective 30 days after filing with the Publisher.

260 IAC 1.1-0.5; 260 IAC 1.1-1-1; 260 IAC 1.1-1-2; 260 IAC 1.1-1-3; 260 IAC 1.1-2-1; 260 IAC 1.1-2-2; 260 IAC 1.1-2-3; 260 IAC 1.1-3-1; 260 IAC 1.1-4-8; 260 IAC 1.1-5-1

SECTION 1. 260 IAC 1.1-0.5 IS ADDED TO READ AS FOLLOWS:

ARTICLE 1.1. BREATH TEST OPERATORS AND INSTRUMENTS

Rule 0.5. Definitions

260 IAC 1.1-0.5-1 Applicability

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 1. The definitions in this rule apply throughout this article.

(State Department of Toxicology; 260 IAC 1.1-0.5-1; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

260 IAC 1.1-0.5-2 "Breath test instrument" defined

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 2. "Breath test instrument" means an instrument for performing evidentiary breath tests for ethanol, selected and certified by the department.

(State Department of Toxicology; 260 IAC 1.1-0.5-2; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

260 IAC 1.1-0.5-3 "Breath test operator" defined

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 3. "Breath test operator" means a person certified by the department under this article to perform evidentiary breath tests for ethanol.

(State Department of Toxicology; 260 IAC 1.1-0.5-3; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

260 IAC 1.1-0.5-4 "Department" defined

Authority: IC 9-30-6-5

Affected: IC 21-45-3

Sec. 4. "Department" means the state department of toxicology established within the Indiana University School of Medicine by IC 21-45-3.

(State Department of Toxicology; 260 IAC 1.1-0.5-4; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

260 IAC 1.1-0.5-5 "Director" defined

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 5. "Director" means the director of the department.

(State Department of Toxicology; 260 IAC 1.1-0.5-5; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 2. 260 IAC 1.1-1-1 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-1-1 Screening of applicants for training

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 1. (a) An examination shall be authorized by the director of the state department of toxicology of Indiana University School of Medicine for the screening of applicants prior to acceptance in a course for training as breath test operators. to analyze breath for ethanol.

(b) Such The screening examination shall include problems involving mathematics and such other subjects as are deemed relevant by the director.

(c) Any person selected to attend the training course for breath test operators must have demonstrated his or her qualifications eligibility to the director by taking and passing the screening examination.

(d) Any eligible person having passed the screening examination and having failed the school may be admitted to a subsequent school without repeating the screening examination.

(State Department of Toxicology; 260 IAC 1.1-1-1; filed Dec 13, 1983, 10:56 a.m.: 7 IR 335; filed Dec 6, 1998, 1:50 p.m.: 22 IR 973; readopted filed Nov 7, 2005, 2:35 p.m.: 29 IR 896; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 3. 260 IAC 1.1-1-2 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-1-2 Training courses

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 2. (a) Any person to be certified as a breath test operator analyzing breath for ethanol must attend and complete a course in the theory and operation of test devices approved by the director. of the state department of toxicology.

(b) Such a The course shall include a minimum of twelve (12) hours of instruction.

(c) Such The instruction shall be devoted to include lectures, laboratory training, and demonstrations in accordance with the following:

(1) The pharmacology and toxicology of alcohol. ethanol.

(2) The theory, operation, and care of the breath test equipment. instruments.

(3) The legal aspects of breath testing for ethanol.

(4) The interpretation of breath test for ethanol results.

(5) Laboratory training using an approved device instrument to analyze breath for alcohol: ethanol:

(A) using known ethanol-water or ethanol-gas solutions; and/or or

(B) on a human who has consumed a test dose of ethanol;

or both.

(d) Examinations shall be as follows:

(1) An A written examination shall be given after six (6) to eight (8) hours of instruction.

(2) A laboratory examination shall be given consisting of, at a minimum, demonstration of proper technique in giving a breath test using a breath test instrument.

(2) (3) A written final examination shall be given at the completion of the school. The final examination shall be prepared, administered, and graded under the direction of the director. of the state department of toxicology of Indiana University School of Medicine.

(e) To successfully complete the approved course, a candidate must have performed satisfactorily in the laboratory and demonstrated his or her qualifications to the satisfaction of the director of the state department of toxicology of Indiana University School of Medicine in all written examinations.

(State Department of Toxicology; 260 IAC 1.1-1-2; filed Dec 13, 1983, 10:56 a.m.: 7 IR 336; filed Dec 19, 1985, 3:37 p.m.: 9 IR 1292; errata, 9 IR 2063; filed Dec 6, 1998, 1:50 p.m.: 22 IR 973; filed Apr 24, 2000, 12:51 p.m.: 23 IR 2222; readopted filed Nov 3, 2006, 1:46 p.m.: 20061122-IR-260060047RFA; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 4. 260 IAC 1.1-1-3 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-1-3 Certification and recertification of breath test operators

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 3. (a) Any person who has successfully completed an approved course in the theory and operation of approved breath test equipment may be certified as a breath test operator by the director of the state department of toxicology of Indiana University School of Medicine.

(b) (a) The director of the state department of toxicology of Indiana University School of Medicine will issue a certificate bearing an expiration date to certify persons who:

(1) have successfully passed completed a breath test for intoxication school approved by the director of the state department of toxicology and meeting the minimum requirements course, as set out described in section 2 of this rule; and found to be duly qualified.

(2) are employed by a law enforcement agency. As used in this section, "law enforcement agency" means an agency or a department of any level of government whose principal function is the apprehension of criminal offenders.

(c) (b) Any person certified as a breath test operator by the director of the state department of toxicology of Indiana University School of Medicine must be recertified by examination at least every two (2) years from the month of certification or recertification. Reasonable deviations from this schedule may be approved by the director. The director will issue a certificate bearing the expiration date to the persons who are successfully recertified.

(d) (c) The recertification procedure shall be determined established by the director. of the state department of toxicology of Indiana University School of Medicine.

(e) (d) Any person seeking recertification must demonstrate his or her qualifications to the satisfaction of the director by doing the following:

(1) Taking a written examination similar in content to the final examination given at the completion of the school course for training breath test operators. and

(2) Demonstrating his or her competence in performing an evidentiary breath test by one (1) of the following methods as prescribed by the director:

(A) Successfully performing one (1) or more breath tests during the certification period prior to recertification. The director shall determine the:

(i) number of breath tests required to demonstrate competence; and

(ii) method of documentation of performance of breath tests.

(B) Successfully completing a practical examination at the time of recertification, in circumstances to be defined by the director.

(f) (e) Any person:

(1) failing the first recertification examination; or

(2) not appearing to take this examination;

may be given a second recertification examination within sixty (60) days of the first examination. During this time period, the individual is not certified to operate approved evidentiary breath test instruments. If this second examination is failed or missed, the operator individual will not be certified again until he or she has successfully completed an approved breath test school (see course as described in section 2 of this rule, held after this second recertification examination.

(g) Nothing in this rule shall prevent the director of the state department of toxicology of Indiana University School of Medicine from suspending or revoking the certification of any operator at any time he determines such suspension or revocation to be in the best interest of the breath test for ethanol program.

(h) Any certificate issued under this section shall be valid from the date on the certificate until the expiration date two (2) years from the last day of the month the certificate was dated.

(i) (f) The director of the state department of toxicology shall issue to all certified and recertified breath test operators a wallet identification certificate, which certificate shall be valid from the date of issuance to an operator to the last day of the expiration month stated date printed on the certificate.

(g) Nothing in this rule shall prevent the director from suspending or revoking the certification of any operator at any time the director determines such suspension or revocation to be in the best interest of the breath test for ethanol program.

(State Department of Toxicology; 260 IAC 1.1-1-3; filed Dec 13, 1983, 10:56 a.m.: 7 IR 336; filed Dec 19, 1985, 3:37 p.m.: 9 IR 1293; filed Dec 6, 1998, 1:50 p.m.: 22 IR 973; filed Apr 24, 2000, 12:51 p.m.: 23 IR 2222; readopted filed Nov 3, 2006, 1:46 p.m.: 20061122-IR-260060047RFA; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 5. 260 IAC 1.1-2-1 IS AMENDED TO READ AS FOLLOWS:

Rule 2. Inspection and Certification of Breath Test Instruments

260 IAC 1.1-2-1 Inspection of breath test instruments

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 1. (a) All Each breath test equipment instrument approved by the director of the state department of toxicology of Indiana University School of Medicine shall be inspected at least once each on every one hundred eighty (180) days at their usual its established location, which must be in a building. If such the location (building) of the instrument is changed, the equipment instrument must be reinspected before it can be certified for use.

(b) Such The inspection shall include verification at least one (1) test demonstrating that the equipment instrument:

(1) is in good operating condition; and

(2) satisfies the accuracy requirements set out in subsection (e)(2).

(c) Only persons authorized by the director of the state department of toxicology of Indiana University School of Medicine shall inspect approved breath test equipment. instruments.

(d) All such authorized inspectors shall report their findings to the director.

(e) All breath test equipment instruments shall meet the following standards:

(1) Certification tests shall be made using known ethanol-water or ethanol-gas solutions, approved by the director, of the state department of toxicology of Indiana University School of Medicine, to simulate an ethanol a breath solution. sample.

(2) Such The test results shall not deviate more than minus eight percent (-8%) from the known alcohol ethanol content of the ethanol-water or ethanol-gas solution, vapor. No test result for the purpose of certification shall exceed the known ethanol content of the test vapor. For example, 0.10% w/v a solution of ethanol in water that produces a vapor having eight-hundredths (0.08) grams of ethanol per two hundred ten (210) liters shall test within the range of 0.092% seventy-four thousandths (0.074) to 0.100%. No test result for the purpose of certification shall exceed the known ethanol content of the test solution. eighty-thousandths (0.080) grams per two hundred ten (210) liters.

(3) For the purpose of inspecting the breath test equipment, instrument, the analytical result shall be expressed to the third decimal place.

(4) Other tests that are not part of the inspection may be performed at the time of the inspection.

(f) Chemicals, if required, shall be of sufficient strength and quality to allow the breath test device instrument to operate in the manner specified in subsection (e)(2).

(State Department of Toxicology; 260 IAC 1.1-2-1; filed Dec 13, 1983, 10:56 a.m.: 7 IR 337; filed Dec 19, 1985, 3:37 p.m.: 9 IR 1293; filed Dec 6, 1998, 1:50 p.m.: 22 IR 974; filed Apr 24, 2000, 12:51 p.m.: 23 IR 2223; readopted filed Nov 3, 2006, 1:46 p.m.: 20061122-IR-260060047RFA; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 6. 260 IAC 1.1-2-2 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-2-2 Certification of instruments and chemicals

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 2. (a) All breath test equipment instruments shall be certified as to compliance with standards specified in section 1(e) and 1(f) of this rule at least once each one hundred eighty (180) days.

(b) The certification of inspection and compliance of breath test equipment instruments shall be in writing by the director. of the state department of toxicology of Indiana University School of Medicine.

(c) Such The certification shall be based on information provided by authorized inspectors and any other evidence the director, of the state department of toxicology of Indiana University School of Medicine, at his or her discretion, may require.

(d) The current certificate of inspection and compliance shall be sent to the clerk of the circuit court in the county in which the instrument is used. All certifications of inspection shall:

(1) remain on file in the Indiana University School of Medicine department; and shall

(2) be made available to anyone for viewing only during regular office hours.

(State Department of Toxicology; 260 IAC 1.1-2-2; filed Dec 13, 1983, 10:56 a.m.: 7 IR 337; filed Dec 19, 1985, 3:37 p.m.: 9 IR 1294; filed Dec 6, 1998, 1:50 p.m.: 22 IR 975; readopted filed Nov 7, 2005, 2:35 p.m.: 29 IR 896; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 7. 260 IAC 1.1-2-3 IS READOPTED TO READ AS FOLLOWS:

260 IAC 1.1-2-3 Repair and maintenance

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 3. A certified breath test operator is authorized to make replacements and adjustments not related to the calibration of the instrument.

(State Department of Toxicology; 260 IAC 1.1-2-3; filed Dec 13, 1983, 10:56 a.m.: 7 IR 337; readopted filed Aug 6, 2002, 4:55 p.m.: 25 IR 4221; readopted filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 8. 260 IAC 1.1-3-1 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-3-1 Approval of methods; checklists

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 1. (a) The director shall approve a method for the administration of a test to analyze breath for ethanol for each approved type of equipment instrument in use. Such approved method shall be kept on file in the state department of toxicology of Indiana University School of Medicine.

(b) Such The approved method shall be followed in making an analysis of breath for ethanol.

(c) The director may approve and distribute a checklist that sets forth in abbreviated form the approved method for the administration of a test to analyze breath for ethanol for each approved type of equipment instrument in use.

(d) A method approved by the director for use with an approved equipment instrument shall remain in effect from the date of approval until such time as the department shall adopt a rule changing such the approved method.

(State Department of Toxicology; 260 IAC 1.1-3-1; filed Dec 13, 1983, 10:56 a.m.: 7 IR 338; readopted filed Aug 6, 2002, 4:55 p.m.: 25 IR 4221; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 9. 260 IAC 1.1-4-8 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-4-8 B.A.C. Datamaster with keyboard breath analysis method

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 8. The following is the approved method to conduct a B.A.C. Datamaster with keyboard test for alcohol ethanol intoxication:

(1) The person to be tested must:

(A) have had nothing to eat or drink; must

(B) not have put any foreign substance in into his or her mouth or respiratory tract; and must

(C) not smoke;

within twenty (20) minutes prior to before the time a breath sample is taken.

(2) The green LED on the instrument display must be lighted. glowing.

(3) Depress the run button, enter the password, and insert the evidence ticket or verify that the external printer is ready to use.

(4) Follow the displayed request for information, and enter the information by the keyboard.

(5) When the "please blow" appears on the display, place a new mouthpiece in the breath tube. The subject must deliver a breath sample.

(6) When the printer stops, remove the evidence ticket or report sheet from the instrument printer and check the report printed on the evidence ticket or report sheet for the numerical alcohol ethanol subject sample and correct date and time.

(7) If the EVIDENCE TICKET report displays one (1) of the following messages, the test is not valid; proceed as instructed:

(A) If "subject sample interferent" is printed on the EVIDENCE TICKET, report, return to step 1 described in subdivision (1) and perform a second breath test beginning with a twenty (20) minute period. If "subject sample interferent" is printed on the EVIDENCE TICKET report of this second breath test:

(i) obtain an alternate chemical test for ethanol; or

(ii) perform the breath test on another evidentiary breath test instrument.

(B) If "subject sample invalid" is printed on the EVIDENCE TICKET, report, return to step 1 described in subdivision (1) and perform a second breath test beginning with a twenty (20) minute period. If "subject sample invalid" is printed on the EVIDENCE TICKET report of this second breath test:

(i) obtain an alternate chemical test for ethanol; or

(ii) perform the breath test on another evidentiary breath test instrument.

(C) If "radio interference" is printed on the EVIDENCE TICKET, report, locate and remove the source of RFI the radio interference and return to step 2 described in subdivision (2) and perform a second breath test. If "radio interference" is printed on the EVIDENCE TICKET report of this second breath test:

(i) obtain an alternate chemical test for ethanol; or

(ii) perform the breath test on another evidentiary breath test instrument.

(D) If "subject sample incomplete" is printed on the EVIDENCE TICKET, report, return to step 2 described in subdivision (2) and perform a second breath test. If "subject sample incomplete" is printed on the EVIDENCE TICKET report of this second breath test:

(i) obtain an alternate chemical test for ethanol; or

(ii) perform the breath test on another evidentiary breath test instrument.

However, if the "subject sample incomplete" was caused by the lack of cooperation by the subject, the breath test operator should record that the test was refused.

(State Department of Toxicology; 260 IAC 1.1-4-8; filed Sep 6, 1991, 5:00 p.m.: 15 IR 6; filed Dec 6, 1998, 1:50 p.m.: 22 IR 975; filed Apr 24, 2000, 12:51 p.m.: 23 IR 2223; readopted filed Nov 3, 2006, 1:46 p.m.: 20061122-IR-260060047RFA; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

SECTION 10. 260 IAC 1.1-5-1 IS AMENDED TO READ AS FOLLOWS:

260 IAC 1.1-5-1 Breath test instruments

Authority: IC 9-30-6-5

Affected: IC 9-30-6-5

Sec. 1. (a) All breath test instrument models must be selected by the director of the state department of toxicology (department) of the Indiana University School of Medicine prior to their evidentiary use in Indiana. The testing of such the instruments must be performed in the department's laboratory. facility. The procedure for evaluation of the instruments must be established by the department and designed to ensure the accurate analysis of breath specimens for the determination of breath or blood alcohol ethanol concentrations, or both, relative to traffic law enforcement. To achieve selection under IC 9-30-6-5, a breath test instrument must meet, at a minimum, the following criteria:

(1) The:

(A) instrument must analyze breath samples; and the

(B) numerical value it reports reported shall be expressed as grams of alcohol ethanol per (A) one hundred (100) milliliters of the person's blood; or (B) two hundred ten (210) liters of the person's breath.

(2) The instrument must be as follows:

(A) Capable of calibration for the purpose of certification with a known alcohol ethanol standard in accord with 260 IAC 1.1-2-1(e) and maintain this calibration during routine breath alcohol ethanol testing.

(3) The instrument must be (B) Able to analyze a known alcohol ethanol reference sample within the limits specified by 260 IAC 1.1-2-(e), 260 IAC 1.1-2-1(e) separate from calibrate calibration for certification.

(4) The instrument must be (C) Equipped with sufficient features to prevent unauthorized alteration, tampering, or manipulation in order to safeguard the breath sampling process and alcohol ethanol concentration analysis.

(b) A The instruments for which approved methods are provided in 260 IAC 1.1-4 shall constitute the list of approved models of breath test instruments shall be distributed as provided required by IC 9-30-6-5(b). IC 9-30-6-5.

(State Department of Toxicology; 260 IAC 1.1-5-1; filed Aug 30, 1994, 1:10 p.m.: 18 IR 11; filed Dec 6, 1998, 1:50 p.m.: 22 IR 976; filed Jan 26, 2001, 9:31 a.m.: 24 IR 1608; readopted filed Oct 9, 2007, 2:37 p.m.: 20071031-IR-260070544RFA; filed Dec 3, 2007, 3:37 p.m.: 20080102-IR-260070253FRA)

LSA Document #07-253(F)

Notice of Intent: 20070516-IR-260070253NIA

Proposed Rule: 20070912-IR-260070253PRA

Hearing Held: October 9, 2007

Approved by Attorney General: November 19, 2007

Approved by Governor: December 3, 2007

Filed with Publisher: December 3, 2007, 3:37 p.m.

Documents Incorporated by Reference: None Received by Publisher

Small Business Regulatory Coordinator: Peter F. Method, Ph.D., Acting Director, Indiana State Department of Toxicology, 550 West 16th Street, Indianapolis, Indiana 46202, [phone], [e-mail]

Posted: 01/02/2008 by Legislative Services Agency

DIN: 20080102-IR-260070253FRA

Composed: Nov 01,2016 12:19:11AM EDT

A PDF version of this document.