22 Minimum levels of controlled substances or their metabolites in blood to establish presence of controlled substance

Minimum Levels of Controlled Substances or Their Metabolites in Blood to Establish Presence of Controlled Substance

[42 Pa.B. 110]
[Saturday, January 7, 2012]

 Under 75 Pa.C.S. § 1547(c)(4) (relating to chemical testing to determine amount of alcohol or controlled substance), as amended by the act of September 30, 2003 (P. L. 120, No. 24), the Department of Health (Department) is publishing a notice of the minimum levels of Schedule I, nonprescribed Schedule II and nonprescribed Schedule III controlled substances or their metabolites that must be present in a person's blood for the test results to be admissible in a prosecution for a violation of 75 Pa.C.S. § 1543(b)(1.1), § 3802(d)(1), (2) or (3) or § 3808(a)(2) (relating to driving while operating privilege is suspended or revoked; driving under influence of alcohol or controlled substance; and illegally operating a motor vehicle not equipped with ignition interlock).

 Although there are hundreds of controlled substances in Schedules I, II and III, quantitation limits are listed only for commonly abused controlled substances for which testing procedures are readily available. The minimum quantitation limits listed for each controlled substance or metabolite are the lowest concentrations that one or more of the laboratories with the least sensitive procedures in the Department's approval program for facilities offering these testing services specified they can reliably determine.

 For this reason, the controlled substances and metabolites listed in this notice are not meant to be all inclusive. The Department recognizes there are other controlled substances and metabolites not listed where testing will be required. When that situation occurs, interested parties should contact the laboratory performing the test to inquire as to that laboratory's specific method of testing, the equipment used, and any policies or procedures employed by that laboratory to ensure that the test results are valid.

 The limit of quantitation (LOQ) for any laboratory will depend on the equipment and procedures employed for confirmatory testing. Laboratories approved by the Department to test blood for controlled substances or their metabolites will have LOQs at or below the minimum quantitation limits listed in this notice.

 For the first time, the Department's notice contains multiple listings for cannabinoids. There are now three cannabinoids listed: the parent drug, Delta-9-Tetrahydrocannabinol (THC) and two metabolites of THC: 11-Hydroxy-Delta-9-Tetrahydrocannabinol (THC-OH) and 11-Nor-9-Carboxy-Delta-9-Tetrahydrocannabinol (THC-COOH). Multiple listings are being published because approved laboratories may test for the parent drug, one of its metabolites or a combination of the three cannabinoids. The multiple listings for cannabinoids do not require a laboratory to obtain a test result for the parent drug and the two metabolites for the test result to be admissible into evidence. A laboratory only needs to test for at least one of the cannabinoids listed and meet the minimum detection level for that cannabinoid. In addition, the Department has listed Methylenedioxyam- phetamine (MDA) and Methylenedioxymethamphetamine (MDMA, Ecstasy) under the classification of amphetamines.

 Clinical laboratories that operate in this Commonwealth and that perform analyses of blood to determine controlled substance content must be approved by the Department in accordance with 28 Pa. Code § 5.50 (relating to approval to provide special analytical services) and be listed in notices published twice annually in the Pennsylvania Bulletin. The approval process requires laboratories to demonstrate an acceptable level of proficiency in determining the presence of controlled substances or their metabolites in their blood.

 This testing is a two-step process. The first step involves the screening of blood using a relatively rapid and inexpensive technique to presumptively determine which specimens may contain the substance or a metabolite of the substance for which the blood is screened. The second step utilizes a more sensitive and specific procedure to substantiate the presence and concentration of the substance or its metabolite that was presumptively detected in the initial screening procedure.

 Confirmatory analyses employed to substantiate the presence of a drug or drug metabolite generally focus on identifying and quantitatively determining the concentration of the parent drug or a primary metabolite if extensive biotransformation occurs. The detection limits listed were developed by reviewing the minimum reportable concentrations for confirmatory analyses that laboratories in the Department's approval program specified they could measure. The concentrations listed are the highest LOQs that any of the laboratories approved by the Department to test blood for controlled substance content specify they can reliably determine.

 In publishing subsequent notices, the Department will revise, as needed, minimum quantitation limits of those controlled substances or their metabolites already listed and add new controlled substances or their metabolites when the data received from approved laboratories warrants their inclusion.

 Persons with a disability who require an alternative format for this notice (for example, large print, audiotape or Braille) should contact Dr. M. Jeffery Shoemaker, Director, Division of Chemistry and Toxicology, Bureau of Laboratories, at [phone], for speech and/or hearing impaired persons V/TT [phone], or by using the Pennsylvania AT&T Relay Service at [phone] (TT).

Class	Substance	Schedule	Minimum Quantitation Limits (nanograms/milliliter)
Amphetamines
	Amphetamine Methamphetamine Methylenedioxyamphetamine (MDA) Methylenedioxymethamphetamine (MDMA,  Ecstasy)	II II I I	5 5 50 50
Analgesics
	Methadone	II	20
Cannabinoids
	Delta-9-THC (THC)* 11-Hydroxy-Delta-9-THC (THC-OH) 11-Nor-9-Carboxy-Delta-9-THC  (THC-COOH)	I I I	2 5 5
Cocaine
	Cocaine Benzoylecgonine	II II	5 5
Hallucinogens
	Phencyclidine	II	1
Opiates
	Codeine Hydrocodone Hydromorphone 6-Monoacetylmorphine Morphine Oxycodone	II II II II II II	5 5 2.5 2.5 5 5
Sedatives/Hypnotics
	Amobarbital Pentobarbital Secobarbital	II II II	40 40 40

* THC = tetrahydrocannabinol

ELI N. AVILA, MD, JD, MPH, FCLM, 
Secretary

[Pa.B. Doc. No. 12-22. Filed for public inspection January 6, 2012, 9:00 a.m.]