Christine A. Sannerud, Chief
Drug and Chemical Evaluation Section (ODE) U.S. Drug Enforcement Administration (202) 307-7183
Office of Diversion Control, ODE 1 Drug and Chemical Evaluation Section (ODE) Chemical Role includes:
• Determination of chemicals used in the manufacture of controlled substances. • Use of existing regulatory mechanisms to control compounds used in this manufacture.
Office of Diversion Control, ODE 2 Current Activities
• Iodine Regulations (NPRM) • Sodium Permanganate • Elimination of Ephedrine/Pseudoephedrine Chemical Mixture Exemptions • Control of Precursors to Fentanyl • Positional Isomers Definition
Office of Diversion Control, ODE 3 Methamphetamine Production
Office of Diversion Control, ODE 4 Iodine Control
• Iodine used as reagent in Methamphetamine production • Number one U.S. clandestinely produced drug
Office of Diversion Control, ODE 5 U.S. Department of Justice Drug Enforcement Administration Office of Diversion Control Chemical Investigations Section Methamphetamine Clandestine Laboratory Seizures With DEA participation
WASH MONTANA N DAKOTA WASH MONTANA N DAKOTA WASH MONTANA N DAKOTA MN 1993 -218 MN 1994 -263 MN 1995 -327
ME ME WI ME S DAKOTA WI S DAKOTA WI OREGON S DAKOTA OREGON VT OREGON VT 10 VT WYOMING IDAHO WYOMING WYOMING MI IDAHO MI MI IDAHO NH NH NH IOWA NY NY NY MA IOWA MA IOWA MA NEBRASKA ILL NEBRASKA ILL NEBRASKA ILL NEVADA NEVADA IN NEVADA IN PA RI OHIO PA RI OHIO PA RI IN OHIO CT CT CT UTAH UTAH COLORADO UTAH COLORADO NJ 14 NJ KANSAS NJ CA 10 COLORADO W CA W CA W KANSAS V DE 25 KANSAS 12 V VA DE V DE VA 14 MD MD 23 29 13 16 37 MD KY MISSOURI KY KY VA MISSOURI DC DC MISSOURI DC 110 NEW NEW OKLA TN NC OKLA TN NC 108 OKLA TN NC ARIZONA NEW ARK 115 ARIZONA MEXICO ARK ARIZONA MEXICO ARK MEXICO 10 SC 15 11 SC 19 SC 12 MS AL 16 MS AL GA TEXAS GA TEXAS MS AL GA TEXAS LA LA LA 11 21 10
FL FL FL
1996 -879 1997 -1431 1998 -1623 WASH MONTANA N DAKOTA 1 MN 5 3 1 13 5 3 1 14 14 41 WI ME OREGON S DAKOTA VT 2 2 IDAHO WYOMING 2 MI 10 30 8 NH 3 IOWA NY 3 1 2 MA 4 8 5 NEBRASKA ILL NEVADA 10 IN PA 1 22 7 19 OHIO RI 7 UTAH CT 191 19 164 27 5 COLORADO 5 1 12 14 4 8 3 50 1 12 DE--1 CA KANSAS W NJ 1 115 111 V DE 26 46 DE--1 51 29 MA--2 37 63 43 K 4 17 235 VA MD 421 DC--1 366 ME--1 3 Y DC 2 1 MISSOURI 1 13 NH--1 NEW 155 OKLA TN NC 107 106 NJ--1 ARIZONA MEXICO ARK 2 23 2 43 3 71 169 149 83 7 74 SC 139 20 226 29 MS AL GA 1 5 1 4 12 3 18 TEXAS LA 1 5 4 2 1 4 12 1 25 38 18 1 FL 5
1 1
Office of Diversion Control, ODE 6 10/2/2006 1 2 - 4 5 - 9 10> DEA and State and Local Law Enforcement Methamphetamine Seizures (Includes Labs, dump sites, glassware and equipment seizures) Calendar Years 1999 – 2005 (Reported through June 2006)
20000 17356 17170 18000 16212 16000 13537 14000 12139 12000 10000 9092 8000 7438 6000 4000 2000 0 1999 2000 2001 2002 2003 2004 2005
Office of Diversion Control, ODE 7 Methamphetamine Production
• P2P + Methylamine d,l-methamphetamine
• Ephedrine + Hydriodic Acid + Red-P d-methamphetamine
•
Office of Diversion Control, ODE 8 Methamphetamine Production
• Ephedrine + Hydriodic Acid + Red-P d-methamphetamine •
• Pseudoephedrine + Iodine + Red-P d-methamphetamine • or Ephedrine Crystals • • Pseudoephedrine + Iodine + Red-P d-methamphetamine • or Ephedrine Tincture*
• * Hydrogen Peroxide used to precipitate out crystals Office of Diversion Control, ODE 9 Office of Diversion Control, ODE 10 “Mexican Crime Group Methamphetamine ‘SUPER LAB’ Seizure in California.”
Office of Diversion Control, ODE 11 “Two Large Capacity Methamphetamine Clan Labs.”
Office of Diversion Control, ODE 12 Existing Iodine Controls
• List II Chemical • Threshold 0.4 kilograms • Only domestic transactions regulated • Import/Export transactions exempted • Iodine tinctures (considered chemical mixtures) are exempt
Office of Diversion Control, ODE 13 Iodine Problem
• Widely used in clandestine laboratories • Since tinctures are exempt, lab operators have discovered they can acquire unregulated 7% tincture, add hydrogen peroxide and precipitate out iodine crystals for clan lab use • Scope of diversion is an international problem
Office of Diversion Control, ODE 14 Proposed Changes to Iodine Regulations • NPRM Published August 11, 2006 with 60-day comment period • Move from List II to List I – Impose registration requirement • Add Import/Export Controls • Remove threshold so that all transactions regulated regardless of size • Control chemical mixtures at concentration level which will regulate 7% iodine tincture – Used primarily in livestock/horse industry – No household use
Office of Diversion Control, ODE 15 Iodine Control
• Will not adversely impact any of the iodine products sold in retail drug store setting • Will exempt iodine-povidone complexes (all concentrations) • Will not regulate iodine 2% tincture • Will not control any of the iodide compounds sold via prescription or radiolabeled for diagnostic purposes. • Currently reviewing comments and considering further exemptions where appropriate
Office of Diversion Control, ODE 16 Sodium Permanganate
Office of Diversion Control, ODE 17 Sodium Permanganate
• Direct Substitute for Potassium Permanganate in cocaine processing • NPRM to control as a List II chemical published March 1, 2005 • Final Rule published October 17, 2006
Office of Diversion Control, ODE 18 Cocaine Production
Office of Diversion Control, ODE 19 TYPES OF CHEMICALS HISTORICALLY USED IN THE PRODUCTION OF COCAINE
SOLVENTS -Methyl Ethyl Ketone (MEK), Methyl isobutyl Ketone (MIBK), Acetone, Ethyl ether, Toluene, Kerosene
ACIDS - Sulfuric Acid Hydrochloric Acid
BASES - Calcium, Sodium or Potassium Carbonate, Calcium Oxide Ammonia Water
OXIDANTS - Potassium Permanganate
Office of Diversion Control, ODE 20 Office of Diversion Control, ODE 21 PRODUCTION OF ILLICIT COCAINE FOUR STEPS
COLLECTION OF COCA LEAVES
PRODUCTION OF COCA PASTE BY SOLVENT PROCESS OR ACID PROCESS
PRODUCTION OF COCAINE BASE
PRODUCTION OF COCAINE HYDROCHLORIDE
Office of Diversion Control, ODE 22 Production of Coca Base
COCA PASTE
ADD DILUTE SULFURIC ACID; ADD POTASSIUM PERMANGANATE; MIX AND FILTER Solids SOLUTION OF ACID WITH COCAINE
ADD AMMONIA WATER; MIX; FILTER
Liquid COCAINE BASE
Office of Diversion Control, ODE 23 Office of Diversion Control, ODE 24 Sodium Permanganate
• Direct Substitute for Potassium Permanganate • Potassium permanganate one of the most important chemicals for cocaine production • U.S. producers changing production toward increase production of Sodium Permanganate • Sodium Permanganate available as a 40% solution has advantage of being miscible with water in all proportions (Potassium Permanganate has only 6.38% solubility in water)
Office of Diversion Control, ODE 25 Proposed Controls for Sodium Permanganate • Since directly substitutable for Potassium Permanganate • Propose Same level of Control • List II – No Registration • Thresholds: 55 kgs domestic, 500 kgs import/export • Chemical Mixtures <= 15 percent exempt
Office of Diversion Control, ODE 26 Ephedrine/ Pseudoephedrine Exemptions
Office of Diversion Control, ODE 27 Ephedrine/ Pseudoephedrine Exemptions This Interim Rule announces the removal of the CSA exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine.
• In a Final Rulemaking [68 FR 23195] published on May 1, 2003, DEA initially created an exemption from CSA chemical regulations for all chemical mixtures containing five percent or less total ephedrine/pseudoephedrine.
• Additionally, that rulemaking created an exemption for chemical mixtures consisting of unaltered harvested plant material containing ephedrine alkaloids (e.g. ephedra).
• This Interim Rule, however, removes these two exemptions. Therefore, these materials shall now be subject to all CSA provisions.
Office of Diversion Control, ODE 28 • The Combat Methamphetamine Epidemic Act of 2005 (CMEA) added additional controls on ephedrine and pseudoephedrine and mandated that DEA limit the domestic production and importation of materials containing ephedrine and pseudoephedrine to quantities necessary for medical, scientific and other legitimate purposes.
• DEA has growing concerns regarding ephedra and dietary supplements containing ephedra, and their use as the source of the precursor material for use in the illicit production of methamphetamine.
• While the FDA has taken action to eliminate ephedra dietary supplements from the U.S. market, DEA has seen increases in number of import requests for ephedra, leading to a concern that these products are being diverted for use in illicit manufacture of methamphetamine. Office of Diversion Control, ODE 29 • Given these concerns, and Congressional direction to limit the importation of materials containing ephedrine/ pseudoephedrine, DEA is eliminating the exemptions for this material.
Office of Diversion Control, ODE 30 Clandestine Fentanyl
Office of Diversion Control, ODE 31 Pharmacology
• Synthetic opioid • Schedule II narcotic • Low therapeutic index Euphoria vs respiratory depression
• Effects are similar to morphine and heroin, but with two principle differences: 1) Duration of action (rapid onset, shorter acting)
2) Potency (much greater potency) 50 -100x more potent analgesic than Morphine 30 - 50 x more potent analgesic than Heroin Potency depends on route of administration and the effect being measured
Office of Diversion Control, ODE 32 History of Fentanyl Abuse
• 1970’s to present – Abuse of injectables Medical professionals (doctors/nurses/pharmacists) often in a hospital setting
• 1990’s to present– Abuse of transdermal patch & Troche
• 2000’s – Clan labs making fentanyl 6 Fentanyl clan labs since 2000 5 of which are known or suspect to have used Siegfried Method DEA preparing regulations to control precursor chemicals 499 Confirmed Death + 288 Suspected deaths in U.S.
Office of Diversion Control, ODE 33 Illicitly Manufactured Fentanyl-Related Deaths by Location Since 3/4/2005 (DEA Compiled: 10/12/06)
Location Confirmed Suspected (City/area and surrounding counties) Deaths Deaths Chicago, Illinois 214 2 Detroit, Michigan 150 62 Philadelphia, PA/Camden, NJ/Wilmington, DE 215 14 Rest of PA 57 New York State 45 St. Louis, Missouri 27 14 Other areas 13 Total Deaths => 606 207
Office of Diversion Control, ODE 34 Illicitly Manufactured Fentanyl-Related Deaths/Week in U.S. From March 4, 2005 – August 5, 2006 (Total DEA Confirmed Deaths Graphed: 606)
40 35 30 25 20 15 10 Number of Deaths of Number 5 0 5/8/05 6/5/05 7/3/05 4/9/06 5/7/06 6/4/06 7/2/06 4/10/05 7/31/05 8/28/05 9/25/05 1/15/06 2/12/06 3/12/06 7/30/06 10/23/05 11/20/05 12/18/05 Week (Sun. to Sat.) Compiled 10/12/2006
Office of Diversion Control, ODE 35 Clandestine Lab in Toluca, Mexico
Sunday, May 21, 2006 PGR/SIEDO and AFI
Fentanyl Production Office of Diversion Control, ODE 36 Drug and Chemical Evaluation, Drug Enforcement Administration, Department of Justice Siegfried Method
Imine
Office of Diversion Control, ODE 37 Control of Precursors
• DEA is moving to control precursors: – NPP (N-phenethyl-4-piperidone) as a listed chemical in List I – ANPP (4-anilino-N-phenethyl-4-piperidine) as an immediate precursor in Schedule II
Office of Diversion Control, ODE 38 Legitimate Uses Of NPP
• Legitimate uses of NPP: Pharmaceutical Industry Pharmaceutical R&D to synthesis experimental compounds Analytical Reference Standards • Drugs prepared from NPP: Fentanyl Carfentanyl Cinitapride – gastrointestinal motility agent Fenspiride – nonsteroidal anti-flammatory agent Specialty Chemical Low volume Only 6 domestic chemical suppliers of NPP Only 24 domestic purchases since January 1, 2004
Office of Diversion Control, ODE 39 Fentanyl Synthesis: Siegfried Method
NPP ANPP Fentanyl
Office of Diversion Control, ODE 40 Siegfried Method: Making ANPP
NPP Isolate ANPP Add Aniline/Molecular Sieves crystals
Stir 24 hrs at room temp Extraction Dry
NaBH4 Imine Stir for 3 hrs at room temp NaOH Clean up stage Add H2O & HCl Aqueous Phase
Office of Diversion Control, ODE 41 Siegfried Method: Making Fentanyl
ANPP
Add propionyl chloride slowly
Stir 1hr at room temp
Extract & Dry Fentanyl
Office of Diversion Control, ODE 42 LA Area Fentanyl / MDA Lab
¾ November 2005, law enforcement seized a lab in the LA area suspected to be Fentanyl lab.
¾ Chemists analyzed the samples submitted and confirmed fentanyl and MDA present.
¾ A 5 kilogram bag of “NPP” (1-phenethyl-4 piperidone) precursor was seized.
Office of Diversion Control, ODE 43 Definition of Positional Isomers
• This Rulemaking establishes a specific, technical definition for the term “positional isomer” as it relates to Schedule I hallucinogens.
Office of Diversion Control, ODE 44 Background: Positional Isomers • The CSA (21 U.S.C. 802(14) and 21 U.S.C. 812(c)(I)(c)) specify which hallucinogenic compounds are considered Schedule I Controlled Substances. The CSA states that all salts, isomers and salts of isomers of these compounds are also Schedule I Controlled Substances.
• Under 21 CFR 1308.11(d), the CSA states that the term isomers shall include “optical, positional and geometric isomers”.
• Optical and geometric isomerism easily determined.
• The definition will include precise language that will allow for an unambiguous determination of which isomers of Schedule I hallucinogenic substances are considered to be “positional”, and therefore subject to Schedule I control. Office of Diversion Control, ODE 45 • The addition of a definition for the term “positional isomer” will assist legitimate research and industry in determining the control status of materials that are isomers of Schedule I hallucinogens.
• While DEA will remain the authority on ultimately determining the control status of a given material, providing a specific definition for “positional isomer” will ensure consistent criteria are utilized in making these determinations.
• The addition of a definition for the term “positional isomer” will not result in the control of additional substances or have a negative impact on legitimate researchers or industry working with isomers of Schedule I hallucinogenic substances.
Office of Diversion Control, ODE 46 Status: Positional Isomers
• A Notice of Proposed Rulemaking (NPRM) was Published in Federal Register on May 25, 2006
• A final rule is being circulated for signature.
Office of Diversion Control, ODE 47 Christine A. Sannerud, Chief
Drug and Chemical Evaluation Section (ODE) U.S. Drug Enforcement Administration (202) 307-7183
Office of Diversion Control, ODE 48