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Published by the Drug Enforcement Administration Office of Forensic Sciences Washington, D.C. 20537 The U. S. Attorney General has determined that the publication of this periodical is necessary in the transaction of the public business required by the Department of Justice. Information, instructions, and disclaimers are published in the January issues.
- INTELLIGENCE ALERT - "HOMEMADE" CHOCOLATES CONTAINING PSILOCYBIN
MUSHROOMS - RESPONSES REQUESTED - Editor's Preface: In April and May 2003, the DEA Office of Forensic Sciences received multiple reports of homemade chocolates containing ground-up psilocybin mushroom parts. Three of the reports were from State and Local forensic laboratories and/or police departments in Ohio, Oregon, and Rhode Island. The fourth was reported by the DEA Mid-Atlantic Laboratory (Largo, Maryland), and was seized in Virginia. Additionally, a similar report concerning a seizure in Vail, Colorado was published in the National Drug Intelligence Center's (NDIC's) April 29, 2003 issue of the Narcotics Digest Weekly. The NDIC report also included a summary brief of a number of similar seizures dating back as far as two years. In several cases, the seizures were multi-kilo. There were two common elements among most of the seizures: First, the chocolates all appeared to have been made from molds - in several cases, using candy molds, and in other cases apparently using ice-cube trays (and the seizure in Virginia was received in an ice-cube tray). In addition, in several cases, the chocolates were wrapped in colored foil. These reports are the first seen by the Office of Forensic Sciences. As noted above, however, the NDIC report indicates that similar exhibits were seized in the Vail, Colorado area as long as two years ago, and furthermore refers to additional seizures made in Colorado, Georgia, North Carolina, Oregon, West Virginia, and Wisconsin since the initial seizure in Vail. The NDIC brief also indicates that the source may be "psilocybin mushroom cultivators in Oregon and Washington who transport the drug via package delivery services", and reported the seizures of over 250 pounds of material in nine incidents by an airport interdiction team in Portland, Oregon. The above referenced report from the Oregon State Police Forensic Laboratory in Portland confirmed five such seizures since October 2002 (probably included in the NDIC total).The first report of these chocolates (from North Ridgefield, Ohio) in Microgram Bulletin was reported in the May 2003 issue. The other three referenced seizures (or sets of seizures) are reported below. The above referenced intelligence brief from the Narcotics Digest Weekly is also reproduced below. RESPONSES REQUESTED: The widespread appearances, seizure amounts, and similarities of preparation (candy molds or ice cube trays) and sales packaging (wrapping in colored foil), suggest the possibility of a common source (or a loose confederation of sources) and a nationwide distribution network. The DEA Dangerous Drugs Strategic Intelligence Unit (NTSG) and the National Drug Intelligence Center (NDIC) are both interested in this issue. Subscribers are asked to forward details to NTSG by FAX to 202/307-7916, Attn: J. Hines; and to NDIC by email to < ronald.strong2@usdoj.gov >. * * * * * IN PORTLAND, OREGON
[Summary Report] Beginning in October 2002, the Oregon State Police Forensic Lab in Portland, Oregon received four separate submissions of chocolate candies containing ground psilocybin mushrooms from the Portland Airport Interagency Narcotics Team (PAINT). The candies were molded into various shapes, including eggs, butterflies, bugs, Halloween-theme designs, and Reese's-type cups, and arrived wrapped in metallic foils of assorted colors (see Photos 1 - 2). In all four cases, the concoctions were being shipped via Federal Express to locations nationwide. In the largest case, the total net weight of the concoctions exceeded 11 kilograms. A later submission contained nearly 5 kilograms of finely ground mushroom material (see Photo 3), and also included the food processor used for grinding the mushrooms. Under magnification, grey flakes were visible throughout the chocolate matrix on all exhibits. Samples were analyzed as follows: The concoctions were crushed, soaked in dilute sulfuric acid, and washed with chloroform (to remove some of the fatty components). The acidic layer was isolated, basified with aqueous NaOH to pH 10, and extracted with chloroform. Analysis of the extract by GC/MS indicated caffeine (from the chocolate) and confirmed psilocin. UV spectrophotometry on the final chloroform extract displayed a broad absorption in the region consistent with psilocin/psilocybin, but it was too similar to the UV from a blank chocolate extract to be considered conclusive. A second analysis was conducted by particle-picking specks of the mushroom material from the concoctions (see Photo 4), adding fresh Weber's color test reagent to them, and noting a color change from red to blue upon addition of a drop of concentrated HCl (positive for psilocin). Quantitation was not performed on any of the exhibits. [Editor's Notes: According to the submitter, the relative percentage of mushrooms varied significantly between seizures; this indicates poor "quality control" and the potential for overdosing. Additionally, the submitter indicated that a subsequent (fifth) case was seized from a UPS package; this confirms that any parcel delivery service may be utilized for shipment. The latter case was handled by the Portland Police Department (no further information).] * * * * * IN SOUTH KINGSTOWN, RHODE ISLAND The Drug Chemistry
Section of the Rhode Island State Forensic Laboratory (Providence, Rhode
Island) recently received a submission of two pieces of chocolate "candy"
reported to contain psilocin (See Photos 5 and 6).
The exhibits were seized in South Kingstown by the South Kingstown Police
Department from an individual who was trying to sell them to students
at a local public school. The chocolates weighed 16 grams each, and were
individually wrapped in colored foil (see upper right quadrant of Photo
5). After cutting the pieces in half, visual inspection confirmed
that small pieces of (presumed) mushroom pieces were mixed into the chocolate
(see Photo 6). The mixtures were otherwise homogenous,
suggesting that the mushroom pieces had been mixed with hot, liquified
chocolate, and the resulting concoction allowed to harden in some type
of mold (possibly an ice cube tray). Analysis of a 6% acetic acid/chloroform
extract by GC/MS and UV confirmed psilocin (quantitation was not performed).
This is the first time the laboratory has received a submission of this
type.
* * * * * IN RICHMOND, VIRGINIA
The DEA Mid-Atlantic Laboratory (Largo, Maryland) recently received an unusual exhibit consisting of one 14-section plastic ice cube tray with each compartment containing a cube of hardened mixture of chocolate and plant material, suspected containing psilocybin mushrooms (see Photo 7). The exhibit (total net mass 354.2 grams) was seized from a residence in Richmond, Virginia by agents from the DEA Richmond District Office, and was ancillary to an MDMA seizure. Analysis by GC/MS confirmed psilocin (quantitation was not performed). The exhibit was unusual in that the relative percentage of mushroom material to chocolate was quite high, varying between 10 and 20 percent by volume, and the mushrooms were also "sandwiched" between two layers of chocolate, not evenly distributed. In addition, the chocolate was a much lighter color than "normal" chocolate (see Photo); it was unclear whether this was due to the method of preparation, or if a lighter colored variety of chocolate was used. This was the first submission of a chocolate/psilocybin mushroom concoction to the Mid-Atlantic Laboratory. [Editor's Notes: According to the Case Agent, the perpetrators in this case were making the concoction themselves, not receiving it from an outside source. The mushrooms were allegedly provided by a relative in New England.]
* * * * * IN VAIL, COLORADO From the April 29, 2003 issue of the Narcotics Digest
Weekly Colorado: The Vail Police Department reports that local independent dealers increasingly are distributing chocolate-coated psilocybin mushrooms wrapped in multicolored foil--a practice that was first reported in the Vail area approximately 18 to 24 months ago. The chocolate-coated psilocybin mushrooms typically are distributed at area concerts and private parties for $10 per 1-inch cube. Police officials believe that distributors are supplied by psilocybin mushroom cultivators in Oregon and Washington who transport the drug via package delivery services. NDIC Comment: Coating psilocybin mushrooms in chocolate provides traffickers with an effective method of concealment and enables abusers to ingest the drug in public settings. Law enforcement reporting indicates that chocolate-coated psilocybin mushroom distribution has recently increased in several areas of the United States, including Colorado, Georgia, North Carolina, Oregon, West Virginia, and Wisconsin. Moreover, law enforcement reporting indicates that Portland, Oregon, is one of the primary source areas for chocolate-coated psilocybin mushrooms. From September 2002 to April 2003, law enforcement authorities with the Portland Police Bureau, DEA, and the Portland Airport Interagency Narcotics Team (PAINT) seized over 250 pounds of chocolate-coated psilocybin mushrooms in nine incidents. The psilocybin mushrooms were being transported from Oregon to markets throughout the United States via package delivery services. * * * * *
- INTELLIGENCE BRIEF- VERY LARGE ECSTASY LABORATORY SEIZED In early December 2002, agents from the Pennsylvania Office of Attorney General, Bureau of Narcotics Investigation (BNI), seized a very large MDMA production laboratory in Bangor, Pennsylvania (located about 90 miles north of Philadelphia). A supply and storage warehouse in nearby Roseto was also seized; this latter facility was acting as a front company to purchase precursor and essential chemicals - the nominal purpose of which was to create flavoring ingredients for fruit juices. Unusually, the laboratory was located within a 30,000 gallon steel drum that had been mostly buried underneath the very long driveway of the operator's rather isolated residence, and was further obscured from view and camouflaged with large boulders (see Photos 8 and 9).
Safrole and sassafras oil were both recovered. Based on the various chemicals found at the site, the operator was apparently converting safrole to isosafrole, oxidizing isosafrole to the corresponding phenylacetone, and using methylamine (probably produced from acetamide) to produce MDMA via an aluminum amalgam reduction. A tableting press was also recovered (see Photo 10). Tablets purchased during the investigation and recovered at the laboratory site (approximately 4,000) weighed 290 - 295 milligrams each, and were brownish-white, plain (no logo), and unscored (see Photo 11; closeup photo not available). Analysis confirmed MDMA (quantitation not reported). Agents on-site estimated that the laboratory had been in operation for at least two years, and was capable of producing more than one million Ecstasy tablets per year - making it likely the largest MDMA laboratory ever seized in the eastern United States. The tablets were distributed throughout the (local) Lehigh Valley and also in several nearby states.
* * * * *
- INTELLIGENCE BRIEF- POLYDRUG SEIZURES, INCLUDING "ICE" METHAMPHETAMINE,
The Broward Sheriff's Office Crime Laboratory (Fort Lauderdale, Florida) recently received a number of interesting exhibits from the Fort Lauderdale Police Department. Seized at a local residence were three bags of suspected "Ice" methamphetamine, total net mass 19.7 grams (see Photo 12). Analysis by GC/MSD and by chemical derivatization confirmed methamphetamine (not quantitated). Also seized at the location were 57 orange colored tablets with a "ying/yang" logo, total net mass 19.8 grams, suspected Ecstasy (see photo 13). Analysis, however, indicated not MDMA but rather 3,4-methylenedioxy-amphetamine (MDA) (not quantitated). Finally, 10 green tablets with an unidentified logo (possibly an animal head), were also seized, net mass not reported, suspected Ecstasy (see Photo 14). Analysis confirmed MDMA (not quantitated). Also submitted as a result of an (unrelated) vehicle stop was a FedEx box containing three exhibits. The first was a bag of white crystalline material, net mass 672.7 grams, suspected "Ice" methamphetamine (photo not available). Analysis by GC/MSD and by chemical derivatization confirmed methamphetamine (not quantitated). The second was 48 boxes of 10 mL injectable vials, each labelled "Ketaphorte 1000 mg Anasthesia Injectable, Cosulte al Medico Veternario, ketamina base 100 mg" (photo not available). Analysis by GC/MSD and UV confirmed ketamine (not quantitated). The third was a red tablet with a "TP" logo, suspected Ecstasy (photo not available; net mass not reported). Analysis by GC/MSD and chemical derivatization indicated a mixture of methamphetamine, MDMA, and caffeine. This second set of seizures was notable because the "Ice" methamphetamine exhibit was the largest ever submitted to the Broward Sheriff's Office Crime Laboratory.
* * * * *
- INTELLIGENCE BRIEF - MDMA TABLETS WITH A "DOVE" LOGO IN REDDING, CALIFORNIA
The California Department of Justice, Bureau of Forensic Services, Redding Criminalistics Laboratory (Redding, California - approximately 150 miles north of Sacramento) recently received six light green pills (approximately 7 mm x 4-5 mm) with a dove logo, submitted as an unknown (see Photo 15). The pills were obtained in Redding by the Redding Police Department, as a result of a traffic stop; two baggies of cocaine were also seized. Analysis of the tablets by color testing and GC/MS confirmed MDMA (not quantitated). A tablet similar to this submission was found on the Internet (www.dancesafe.org/labtesting/), but this was the first time these type of pills have been submitted to the Redding Laboratory.
* * * * *
- INTELLIGENCE BRIEF - TABLETS CONTAINING MIXED PIPERAZINES IN ALGONA, IOWA
The Iowa Division of Criminal Investigation Criminalistics Laboratory (Des Moines, Iowa) recently received three pink tablets, composition unknown, total net mass 450 milligrams. The tablets measured 10 mm x 4 mm and had an indistinct logo (see Photo 16). The exhibits were seized in Algona by the Algona Police Department as a result of a vehicle stop to serve an arrest warrant for methamphetamine manufacture. Analysis by TLC and GC/MS indicated a mixture of benzylpiperazine (BZP), trifluromethylphenylpiperazine (TFMPP), and ortho-methoxyphenylpiperazine (OMPP) (quantitation not performed, but all three compounds showed strong peaks in the GC/MS run). The tablets appear to be quite similar in color and composition to mixed piperazine tablets previously reported in Microgram Bulletin. This is the first encounter of these federally controlled Schedule I substances in Iowa. BZP, TFMPP, and OMPP are not yet scheduled in Iowa; however, it is anticipated they will become Schedule I (Iowa) by next year.
* * * * * - INTELLIGENCE BRIEF - COCAINE IN PLASTIC PLANTAINS IN STATEN ISLAND, NEW YORK The DEA Northeast Laboratory (New York, New York) recently received an unusual submission of green plastic plantains containing suspected cocaine (see Photo 17). The plantains were seized by U.S. Coast Guard and the DEA-NY Task Force from a shipping container that was destined for New York City. Each plantain measured approximated 12.5 x 2.5 inches, and contained a cylinder of compressed powder within a balloon (see Photo 18). Analysis by GC/MS, FTIR, and GC confirmed 75 percent cocaine hydrochloride. In all, 702 plantains contained a total net mass of 90.05 kilograms. Although this laboratory has analyzed many cocaine samples from variety of smuggling techniques, this was the first encounter of this particular method of concealment.
- INTELLIGENCE BRIEF - "LIQUID HEROIN" IN RUM BOTTLES AT JFK AIRPORT, NEW YORK
The
DEA Northeast Laboratory (New York, New York) recently received
three "Havana Club" rum bottles containing a brown-colored
liquid, that field-testing indicated contained heroin (see Photo
19). The bottles were seized by U.S. Customs at JFK International
Airport in Queens, New York, from a passenger arriving from Cali,
Colombia. Analysis by GC/MS, FTIR, and GC confirmed 319 milligrams
heroin hydrochloride per milliliter. A total net mass of 702 grams
of heroin hydrochloride was recovered from about 2.2 liters of
liquid (suspected alcohol based, not further identified). Although
this laboratory has analyzed many liquid cocaine samples, liquid
heroin is very unusual. However, field intelligence suggests that
this method of smuggling heroin may be encountered more frequently
in the near future.
* * * * *
- INTELLIGENCE BRIEF - COCAINE BRICK PRESS SEIZED IN MIAMI, FLORIDA
The DEA Southeast Laboratory (Miami, Florida) recently received a cocaine brick mold contaminated with white powder, plus two additional exhibits of white powder, one of which was recovered from the mold, suspected to be cocaine or a cocaine adulterant/diluent. The exhibit was seized from a private residence in Miami by personnel from the DEA Miami Field Division. A hydraulic press was also found at the residence, but was not submitted to the laboratory. At the time of seizure, the powder was being compressed into a brick. The mold inside dimensions were approximately 8 x 6 x 3 inches (see Photo 20). Analysis of the powder being pressed in the mold (total net mass 665.9 grams) by GC/FID and GC/MS confirmed 15 percent cocaine hydrochloride, cut with tetracaine and caffeine. Analysis of the second powder exhibit (total net mass 277.0 grams) identified it to be a mixture of tetracaine and caffeine. This was the first seizure of a cocaine brick mold to the Southeast Laboratory. [Editor's Notes: According to the analyst, the evidence and related intelligence confirmed that the perpetrators were cutting higher purity cocaine and repressing it for sale. This would mimic analogous cocaine and heroin "pelleting" operations previously reported in Microgram Bulletin.] * * * * *
- INTELLIGENCE BRIEF - RED "CRACK" IN NAPOLEONVILLE, LOUISIANA
The DEA South Central Laboratory (Dallas, Texas) recently received a submission of eight plastic, knotted baggies, each containing a red, hard chunky material, suspected cocaine base, total net mass 48.1 grams (see Photo 21). The exhibit was purchased by DEA New Orleans in Napoleanville, Lousisiana (south of Baton Rouge and west of New Orleans). Analysis by color testing, FTIR, ATR, GC/MS, and HPLC confirmed 54 percent cocaine base. The red color was apparently due to food coloring or a similar dye (not further investigated). Of note, the red color gave some interference with typical color tests. Cocaine base is routinely analyzed by the South Central Laboratory, but it is usually seen as an off-white or beige color. [Editor's
Note: According to the Case Agent, the red coloring was not a marketing
ploy, but rather an effort to pass the cocaine off as candy or cookie
parts in case of approach by law enforcement personnel.]
* * * * *
- INTELLIGENCE BRIEF - PSILOCIN/TETRAHYDROCANNABINOL MIXTURE IN VISTA, CALIFORNIA The DEA Southwest Laboratory (San Diego, California) recently received an unusual sample consisting of a ziploc bag containing a brown/gray substance suspected to be psilocin, net mass 11.5 grams (photo not available). The exhibit was seized by DEA personnel in Vista, California. After extraction from a sodium bicarbonate triturate into ether, however, analysis by GC/MS indicated not just psilocin but rather a mixture of psilocin and delta-9-tetrahydrocannabinol (THC), cannabinol, and cannabidiol. Further investigation using a microscope (under 10x magnification) determined that no marijuana was present; however, the microscopic examination revealed that vermiculite was mixed into the sample. Vermiculite is an absorptive substance used as a packing material and also as a support media for growing plants. It is speculated that the vermiculite present in the sample had been previously used in a marijuana grow operation, and thereby absorbed the cannabinoids that were identified in the extract. Of note, the other psilocin samples submitted in this case contained no vermiculite or cannabinoids. * * * * * Selected Intelligence Brief Information Bulletin: Salvia Divinorum. National Drug Intelligence Center [Unclassified; Reprinted With Permission]
* * * * * The distribution and abuse of Salvia divinorum or S. divinorum, a plant that contains the hallucinogen Salvinorin A, are becoming an increasing concern for law enforcement officials in the Northeast, Midwest, and Pacific regions of the country. Neither Salvia divinorum nor Salvinorin A is federally regulated in the United States or controlled in any other country except Australia, which adopted controlling legislation in 2002. Thus, Salvia divinorum is openly distributed via Internet sites and "head shops" located in California, Hawaii, Missouri, New York, Washington, and Wisconsin. Background Salvia divinorum (pronounced SAL-vee-ah dee-vin-OR-um)--frequently referred to as "Ska Maria Pastora" and "Diviner's Sage"--is a perennial herb in the mint family that resembles sage. The plant is native to certain areas of the Sierra Mazateca region of Oaxaca, Mexico, but can be grown in any humid, semitropical climate as well as indoors. Within the United States, the plant primarily is cultivated in California and Hawaii. It grows in large clusters and reaches over 3 feet in height. Salvinorin A is the active component of Salvia divinorum. Other plants with similar properties include Cannabis sativa, which contains tetrahydrocannabinol, the primary psychoactive compound in marijuana and Artemisia absinthium, known as wormwood and used to make absinthe. At this time there is no accepted medical use for Salvia divinorum; however, Mazatec Indians in Mexico use the plant in traditional healing ceremonies and to induce visions. The manner in which Salvia divinorum interacts with the brain to produce its hallucinogenic effect remains unclear. Abuse Abusers
ingest Salvia divinorum using various methods of administration. Like
tobacco, Salvia divinorum can be smoked or chewed. It also can be brewed
and ingested as a tea. When converted into a liquid extract, Salvia
divinorum also can be vaporized and inhaled. Immediately after ingesting
the drug, abusers typically experience vivid hallucinations--including
out-of-body experiences, sensations of traveling through time and space,
and feelings of merging with inanimate objects. Some abusers experience
intense synesthesia, an effect that causes the abusers' senses to become
confused. For example, abusers may describe hearing colors or smelling
sounds. The hallucinogenic effects generally last 1 hour or less unlike
other hallucinogens like LSD and PCP. High doses of the drug can cause
unconsciousness and short-term memory loss.
The long-term effects of Salvia divinorum abuse are unknown, as medical studies undertaken to examine the drug's physiological effects have focused only on short-term effects. However, information provided by abusers indicates that the negative long-term effects of Salvia divinorum may be similar to those produced by other hallucinogens such as LSD (lysergic acid diethylamide) including depression and schizophrenia. Some abusers also indicate that long-term abuse can cause hallucinogen persisting perception disorder, or "flashbacks". Numerous individuals report experiencing negative effects during their first experience with Salvia divinorum and indicate that they would not use it a second time. Some others report that the drug caused them to become introverted and sometimes unable to communicate clearly. National surveys conducted to estimate rates of drug abuse do not include questions regarding abuse of Salvia divinorum. Thus, current levels of abuse are difficult to determine. Most likely, the abuser population is limited and primarily consists of young adults and adolescents who frequent "head shops" or have been influenced by Internet sites promoting the drug. The percentage of first-time users who become regular abusers of the substance also is difficult to determine; however, one Internet distributor indicated that only 1 in 10 customers places a repeat order for the drug.
Availability Salvia
divinorum most often is distributed via the Internet and at some "head
shops" in California, Hawaii, Missouri, New York, Washington, and
Wisconsin. Prices for Salvia divinorum vary widely but are generally
higher for plants grown in Hawaii and Sierra Mazateca (Central Mexico).
An ounce of Salvia divinorum leaves sells for $15 to $120 while Salvia
divinorum plants generally sell for $20 to $45 each. Liquid extract
of Salvia divinorum--produced by crushing the leaves of the plants and
using solvents to extract Salvinorin A--sells for $110 to $300 per ounce.
Purchased primarily via the Internet, Salvia divinorum is transported
to customers via package delivery services.
The production, distribution, and abuse of Salvia divinorum or Salvinorin A currently are not federally regulated as the drug is not listed under Title 21 U.S. Code §812 of the Controlled Substances Act. However, HR 5607 (the Hallucinogen Control Act of 2002)--introduced in Congress on October 10, 2002--contains provisions to regulate Salvia divinorum and Salvinorin A. This bill was not acted upon when the 107th Congress adjourned, but is expected to be reintroduced during the current session. In response to the introduction of legislation on Salvia divinorum, a group has formed to lobby Congress to fight any attempts to regulate the use or availability of Salvia divinorum and Salvinorin A in the United States.
Increasing numbers of young adults and adolescents most likely will experiment with Salvia divinorum as the drug currently is unregulated and readily available via the Internet and "head shops". Salvia divinorum most likely will not become widely abused at social events such as raves and dance parties. The drug often causes some individuals to become introverted, and abusers at such events tend to seek drugs that enhance social interaction such as MDMA (3,4-methylenedioxymethamphetamine, also known as ecstasy). Proposed federal legislation to control Salvia divinorum and Salvinorin A may impact its availability, as distributors may be hesitant to sell the drug openly. Sources
* * * * * CLARIFICATION OF LISTING OF "TETRAHYDROCANNABINOLS" IN SCHEDULE I AND EXEMPTION FROM CONTROL OF CERTAIN INDUSTRIAL PRODUCTS AND MATERIALS DERIVED FROM THE CANNABIS PLANT; FINAL RULES [Reprinted from the Code of Federal Regulations, Friday, March 21, 2003, pps. 14114 - 14126] [Note: Slightly Edited to Fit Microgram Bulletin Format] DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [DEA-205F] RIN 1117-AA55 Clarification of Listing of "Tetrahydrocannabinols" in Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. SUMMARY: The Drug Enforcement Administration (DEA) is revising the wording of the DEA regulations to clarify that the listing of "Tetrahydrocannabinols" (THC) in schedule I of the Controlled Substances Act (CSA) and DEA regulations refers to both natural and synthetic THC. DATES: This final rule becomes effective on April 21, 2003. FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537; Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: What Does This Rule Accomplish and by What Authority Is It Being Issued? This final rule
clarifies that, under the CSA and DEA regulations, the listing of "Tetrahydrocannabinols"
in schedule I refers to both natural and synthetic THC. Why Is There A Need To Clarify The Meaning of "Tetrahydrocannabinols"? As DEA explained in its October 9, 2001 interpretive rule (66 FR 51530; hereafter "interpretive rule"), it is DEA's interpretation of the plain language of the CSA and DEA regulations that the listing of "Tetrahydrocannabinols" in schedule I refers to both natural and synthetic THC. Despite the wording of the statute, some members of the public were under the impression (prior to the publication of the interpretive rule) that the listing of "Tetrahydrocannabinols" in schedule I includes only synthetic THC--not natural THC. To eliminate any uncertainty, DEA is hereby revising the wording of its regulations to refer expressly to both natural and synthetic THC. Why Should Natural THC Be Considered a Controlled Substance? There are several reasons why natural THC should be considered a controlled substance. First, as explained in the interpretive rule, it is evident from the plain language of the CSA that Congress intended all THC--natural or synthetic--to be a schedule I controlled substance. Congress did so by listing "Tetrahydrocannabinols" in schedule I of the CSA--without limiting "Tetrahydrocannabinols" to either natural or synthetic form. 21 U.S.C. 812(c), Schedule I(c)(17). The basic dictionary definition of the word "tetrahydrocannabinols" refers collectively to a category of chemicals--regardless of whether such chemicals occur in nature or are synthesized in the laboratory.\1\ [\1\ For example, Merriam - Webster's Collegiate Dictionary (10th ed. 1999) defines "THC" as "a physiologically active chemical C21H30O2 from hemp plant resin that is the chief intoxicant in marijuana--called also tetrahydrocannabinol;" this definition does not mention synthetic THC.] Second, every molecule of THC has identical physical and chemical properties and produces identical psychoactive effects, regardless of whether it was formed in nature or by laboratory synthesis.\2\ Likewise, a product that contains THC in a given formulation will cause the same reaction to the human who ingests it regardless of whether the THC is natural or synthetic. Indeed, some researchers are currently investigating the possibility of using natural THC (extracted from cannabis plants) in drug products.\3\ [\2\ In this context,
"every molecule of THC" refers to every molecule of the same
isomer of THC. For example, all molecules of \9\-(trans)-THC are identical,
regardless of whether they are natural or synthetic. \3\ At present, Marinol[reg] is the only THC-containing drug product that has been approved for marketing by FDA. Marinol[reg] contains synthetic dronabinol (an isomer of THC) in sesame oil and encapsulated in soft gelatin capsules. This product has been approved for the treatment of nausea and vomiting associated with cancer chemotherapy as well as the treatment of anorexia associated with weight loss in patients with AIDS. See 64 FR 35928 (1999) (DEA final order transferring Marinol[reg] from schedule II to schedule III).] Third, regardless of its source, THC meets the criteria for classification in schedule I of the CSA. It is an hallucinogenic substance with a high potential for abuse and no currently accepted medical use.\4\ See 21 U.S.C. 812(b)(1). Thus, for purposes of CSA scheduling, there is no basis for distinguishing natural THC from synthetic THC. [\4\ There are no FDA-approved drug products that consist solely of THC. However, as stated in the preceding footnote, the FDA has approved a drug product (Marinol[reg]), which contains synthetic THC with other ingredients in a specified product formulation.] Fourth, to ignore the foregoing considerations and to treat natural THC as a noncontrolled substance would provide a loophole in the law that might be exploited by drug traffickers. If natural THC were a noncontrolled substance, those portions of the cannabis plant that are excluded from the CSA definition of marijuana (the stalks and sterilized seeds of the plant) would be legal, noncontrolled substances--regardless of their THC content. As a result, it would be legal to import into the United States, and to possess, unlimited quantities of cannabis stalks and sterilized seeds--again, regardless of their THC content. Anyone could then obtain this raw cannabis plant material to produce an extract of THC--all without legal consequence. This would give drug traffickers an essentially limitless supply of raw plant material from which they could produce large quantities of a highly potent extract that would be considered a noncontrolled substance and, therefore, entirely beyond the reach of law enforcement. To provide such a safe harbor to drug traffickers would be plainly at odds with the purpose and structure of the CSA.\5\ [\5\ As one United States Court of Appeals has stated, "a reading of the [CSA] and its legislative history makes it apparent that Congress, in legislating against drug use, intended to encompass every act and activity which could lead to proliferation of drug traffic. Nothing in the statute indicates any congressional intent to limit the reach of this legislation, which is described in its title as ‘Comprehensive.'" United States v. Everett, 700 F.2d 900, 907 (3d Cir. 1983) (internal citations omitted).] Does This Rule Change the Legal Status of "Hemp" Products? This rule does not
change the legal status of so-called "hemp" products (products
made from portions of the cannabis plant that are excluded from the CSA
definition of marijuana). Rather, this rule clarifies provisions of the
law and regulations that have been in effect since 1971. For the reasons
provided in the interpretive rule, it is DEA's view that the CSA and DEA
regulations have always (since their enactment more than 30 years ago)
declared any product that contains any amount of tetrahydrocannabinols
to be a schedule I controlled substance. This interpretation holds regardless
of whether the product in question is made from "hemp" or any
other material. What Is the Difference Between This Final Rule and the Previously-Issued Interpretive Rule? This final rule
is a legislative rule. It is important to understand the difference between
a legislative rule and an interpretive rule, such as the interpretive
rule on THC that DEA issued on October 9, 2001. The following is a brief
explanation of the difference between legislative rules and interpretive
rules. [\6\ See Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, 99 (1995).] Legislative rules, on the other hand, have the full force of law and are binding on all persons, and on the courts, to the same extent as a congressional statute.\7\ Because of this crucial difference, the APA requires agencies to engage in notice-and-comment proceedings before a legislative rule takes effect.\8\ By the same reasoning, since interpretive rules do not have the full force of law and are not binding on the courts, the APA expressly allows agencies to issue interpretive rules without engaging in notice-and-comment. 5 U.S.C. 553(b)(A), (d)(2). [\7\ National Latino Media Coalition v. F.C.C., 816 F.2d 785, 788 (D.C. Cir. 1987). \8\ Syncor Int'l Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 1997) ("it is because the agency is engaged in lawmaking [when it issues a legislative rule] that the APA requires it to comply with notice and comment").] Consistent with these APA principles, DEA published the interpretive rule in October 2001 without notice and comment, whereas the legislative rule that is being finalized in this document has gone through notice and comment. As a result, this final rule will have the full force of law and be binding on the courts--just as with all the other DEA regulations that have gone through notice and comment.\9\ In contrast, the interpretive rule was not binding on the courts. The practical effect of this distinction can be seen by considering the following hypothetical scenarios. If, prior to the publication of this final rule, a federal prosecution was commenced based solely on DEA's interpretive rule, the presiding court would have been free to choose between applying DEA's interpretation or its own interpretation of the law. But once this rule becomes final, if a person were to refuse to abide by the regulation and a federal prosecution were commenced, the court would be required to apply the new regulation.\10\ [\9\ The DEA regulations
are published in Title 21 of the Code of Federal Regulations, Part 1300. Comments That DEA Received in Response to the Proposed Rule Following publication
of the proposed rule, DEA received comments from thousands of individuals
and groups. The comments were in the form of original letters, form letters,
petitions, and a cookbook. Those who submitted comments included companies
that manufacture and distribute various "hemp" products, associations
that represent such manufacturers and distributors, domestic and Canadian
government officials, and individuals. These commenters expressed criticisms
on a variety of issues. In accordance with the APA, DEA carefully considered
all of the comments it received. Most of the comments
that DEA received relate to both the proposed rule (DEA 205; 66 FR 51535)
and the interim rule (DEA 206; 66 FR 51539), which were published together
(along with the interpretive rule) in the October 9, 2001 Federal Register.
Those comments that pertain primarily to DEA 205 are addressed in this
final rule. Those comments that pertain primarily to DEA 206 are addressed
in the final DEA 206 rule, which appears in a separate Federal Register
document that immediately follows this document. Both DEA 205 and DEA
206 contain a summary of the pertinent comments, along with an explanation
of how DEA considered them in deciding to finalize the rules. The number of individuals and groups that participated in the comment process far exceeded the number of different issues raised. Many of the comments were similar to one another, partly because many persons submitted form letters or signed petitions written by groups which themselves submitted lengthy comments. In this document, together with the final rule finalizing the DEA 206 interim rule, DEA has addressed the major issues raised by the commenters. Some of these issues have already been addressed in the text that precedes this section. The remaining issues are addressed below and in the DEA 206 final rule. Comments Expressing Legal Disagreement With the Proposed Rule Many commenters disagreed with DEA's legal interpretation of those provisions of the CSA and DEA regulations that are relevant to the proposed rule. Specifically, these commenters disagreed with DEA's view that, under the plain language of the CSA, "any material, compound, mixture, or preparation, which contains any quantity of * * * Tetrahydrocannabinols (THC)" is a schedule I controlled substance. 21 U.S.C. 812(c), schedule I(c)(17); 21 CFR 1308.11(d)(27). These commenters asserted that THC content is irrelevant when it comes to products made from portions of the cannabis plant that are excluded from the definition of marijuana. According to these commenters, DEA should allow the CSA definition of marijuana to dictate which portions of the cannabis plant are controlled substances. DEA addressed this issue in detail in the legal analysis contained in the interpretive rule. Nonetheless, many commenters asserted that their point of view is the correct reading of the law and should be substituted for that of DEA. DEA reexamined this issue in view of the comments. While recognizing that many proponents of "hemp" products are steadfast in their view that natural THC content is irrelevant in deciding what is a controlled substance, DEA continues to believe that its interpretation follows directly from the plain language of the CSA and the DEA regulations and is consistent with the legislative history of the statute and regulations. Moreover, DEA believes that the analysis contained in the interpretive rule refutes all of the contrary legal arguments expressed in the comments. As the agency responsible for administering the CSA, it is DEA's obligation to ensure that the regulations clearly reflect what the agency believes are the purpose and intent of the Act. Comments as to Whether This Rule Constitutes a Rescheduling Action Some commenters expressed the view that this rule is a rescheduling action within the meaning of 21 U.S.C. 811 and that DEA should have gone through the procedures set forth in that section prior to issuing this rule.\11\ These comments appear to be based on a misunderstanding of the nature of the procedures under section 811. By its express terms, section 811 applies only where DEA seeks to add a substance to a schedule or remove one from a schedule. For example, if DEA were seeking to move a controlled substance from schedule II to schedule III, the agency would be required to follow the procedures set forth in section 811. The final rule being published today, however, does not change the schedule of THC or any other controlled substance. To the contrary, when this final rule becomes effective, on April 21, 2003, THC will remain in the same schedule in which it has been since the enactment of the CSA in 1970: Schedule I. [\11\ Under 21 U.S.C. 811, to change the schedule of a controlled substance, DEA must first request from the Secretary of Health and Human Services a scientific and medical evaluation and scheduling recommendation and follow additional procedures set forth in section 811. However, as discussed above, section 811 is inapplicable where, as in this final rule, DEA is not changing the schedule of a controlled substance.] Nor would engaging in the rescheduling procedures set forth in section 811 be consistent with the purpose of this rule. Section 811 sets forth the procedures to determine whether a particular substance meets the criteria for placement in a particular schedule. The purpose of this rule is not to determine whether THC meets the criteria for classification in schedule I; rather, this rule serves to clarify that the longstanding placement of THC in schedule I includes both natural and synthetic THC. There is no question about whether THC meets the criteria for placement in schedule I.\12\ Even those commenters who suggested that this rule should be issued under section 811 do not dispute that all THC (natural or synthetic) meets the criteria for placement in schedule I. As discussed above, the chemical THC has the identical physical and chemical properties, and produces the same psychoactive effects, regardless of whether it is natural or synthetic. For these reasons, section 811 is inapplicable to this rule. [\12\ The criteria for placement in schedule I are: "no currently accepted medical use in treatment in the United States," "a lack of accepted safety for use * * * under medical supervision," and "a high potential for abuse." 21 U.S.C. 812(b)(1).] Comments Regarding Poppy Seeds Some of the commenters asserted that DEA should not take literally the plain language of the CSA: that "any material, compound, mixture, or preparation, which contains any quantity of * * * Tetrahydrocannabinols [THC]" is a schedule I controlled substance. To read this provision literally, some commenters said, would mean that poppy seeds must be considered controlled substances if they contain trace amounts of opiates (such as morphine, codeine, or thebaine). This concern is unfounded because, under the CSA and DEA regulations, substances that contain opiates are controlled differently than substances that contain schedule I hallucinogens (such as THC). It is true that poppy seeds are excluded from the definition of opium poppy (21 U.S.C. 802(19)) just as sterilized cannabis seeds are excluded from the definition of marijuana. However, while it is the case that "any material, compound, mixture, or preparation, which contains any quantity of" an hallucinogenic controlled substance is a controlled substance (21 U.S.C. 812(c), schedule I (c); 21 CFR 1308.11(d)), it is not the case that any material, compound, mixture, or preparation which contains any quantity of an opiate is a controlled substance. Rather, naturally-occurring opiates found in substances of vegetable origin are subject to control under the CSA only if they are extracted from the substances of vegetable origin. 21 U.S.C. 812(c), schedule II(a); 21 CFR 1308.12(b)).\13\ [\13\ Plant materials that are the source of narcotics, such as opium poppy, poppy straw, and opium, are specifically listed in schedule II. However, as stated above, the listing of opium poppy does not include poppy seeds, since the seeds are excluded from the definition of opium poppy.] Comments Regarding the Single Convention on Narcotic Drugs Several commenters asserted that the proposed rule is impermissible in view of a certain provision of the Single Convention on Narcotic Drugs, 1961 ("Single Convention"). The Single Convention, which the United States ratified in 1967, was designed to establish effective control over international and domestic traffic in controlled substances, and parties to the Convention are required to implement certain minimum measures. Article 28 of the Single Convention imposes on parties certain restrictions on the cultivation of the cannabis plant. However, paragraph 2 of Article 28 states that the Single Convention does not apply "to the cultivation of the cannabis plant exclusively for industrial purposes (fibre [sic] and seed) or horticultural purposes." Several commenters asserted that this provision means that the United States is prohibited from imposing any restrictions on "hemp." This assertion is incorrect. The Single Convention sets minimum standards of drug control measures that the parties must apply--not maximum measures. Parties are free to impose whatever additional measures they believe are necessary to prevent the misuse, and illicit traffic in, controlled substances. Indeed, various provisions of the CSA go beyond the minimum measures required by the Single Convention. Congress's decision under the CSA to control anything that contains "any quantity" of THC is the decisive factor for purposes of this rule, regardless of whether a less restrictive rule would be permissible under the Single Convention.\14\ [\14\ To fully address
the distinctions between the control of cannabis under the Single Convention
and the control of marijuana and THC under CSA would require a lengthy
discussion. Such a discussion is unnecessary here because this rule is
based on how THC is controlled under the CSA. Thus, there is no need to
address here whether the reference in the Single Convention (Article 28,
paragraph 2) to cannabis grown for "industrial" or "horticultural"
purposes includes cannabis grown to make foods or beverages, or whether
such reference is limited to non-human-consumption items such as rope,
paper, textiles, industrial solvents, and birdseed. Comments Regarding Trade Agreements Some commenters
expressed the view that the proposed rule violates certain obligations
of the North American Free Trade Agreement (NAFTA) and the World Trade
Organization (WTO) agreements. Many of these same commenters expressed
these assertions to DEA before the proposed rule was published in October
2001. As a result, both before and after publication of the proposed rule,
DEA sought the input of the Department of State and other components of
the Executive Branch with the relevant expertise and responsibility for
such matters and concluded that the proposed rule--which simply clarifies
longstanding federal law with respect to schedule I hallucinogenic controlled
substances--does not violate NAFTA or the WTO agreements. Comments Requesting an Extension of the Comment Period Some commenters
asked DEA to extend the comment period. DEA did not do so for the following
reasons. In the notice of the proposed rule, DEA provided a 60-day comment
period from the date of the publication in the Federal Register,
which allowed ample time for any interested persons to express their opinions. [\15\ At the time the comment period closed, postal deliveries to DEA and other agencies were delayed after the widely-reported incidents of anthrax being sent through the mail. Because of this, although the proposed rule indicated that DEA would only consider comments received on or before December 10, 2001, the agency considered all comments postmarked by that date, even if they arrived late.] DEA provided the public with advance notice of the rules. In the year preceding the October 9, 2001 publication of the rules, DEA announced twice in the Federal Register that the agency would be issuing the proposed rule, along with the interpretive rule and the interim rule, and described the nature of the rules. See Department of Justice Unified Agenda, 66 FR 25624 (May 14, 2001), 65 FR 74024 (November 30, 2000). It is evident from the comments submitted on the proposed rule that the advance notice gave interested persons ample time to assemble and articulate their thoughts and opinions. Some of those persons who requested an extension of the comment period themselves submitted lengthy comments, indicating that they have already fully expressed their views. In light of these considerations, extending the comment period was unnecessary. Comments Regarding Economic Impact of the Proposed Rule Many commenters expressed concern about how the proposed rule might impact economically various businesses that deal in "hemp" products. These economic considerations are addressed in the next section of this document (regulatory certifications). Regulatory Certifications Certain provisions
of Federal law and executive orders (specified below) require agencies
to assess how their rules might impact the economy, small businesses,
and the states. (Hereafter in this document, these provisions will be
referred to collectively as the "certification provisions.")
DEA has conducted these certifications. However, before discussing the
economics, the nature of this rule should be reiterated. This rule revises
the wording of the DEA regulations to clarify for the public the agency's
understanding of longstanding federal law. In other words, through this
rule, DEA is implementing what it believes to be the mandate of Congress
under the CSA. (This mandate is that every substance containing THC be
listed in schedule I, unless the substance is specifically exempted from
control or listed in another schedule.) Regardless of how this rule might
impact the economy, small businesses, or the states, DEA must carry out
the mandate. [\16\ See 21 U.S.C. 801(2).] Moreover, one of
the chief aims of the certification provisions is to ensure that agencies
consider the potential economic ramifications of imposing new regulations.
This rule, however, does not create any new category of regulation governing
the handling of controlled substances. Rather, the rule merely helps to
clarify what products are, or are not, subject to what DEA believes are
preexisting CSA requirements. [\17\ On January
28, 2002, a company that sells "hemp" food products issued the
following statement on its website (http://www.thehempnut.com): It is
the position of HempNut, Inc. and the Hemp Food Association (HFA) that
this Rule [published by DEA on October 9, 2001] is merely a clarification
and confirmation of the basis under which DEA, US Customs, and all responsible
hempseed importers have already been operating under for quite some time,
namely, that hempseed products may not contain tetrahydrocannabinol (THC).
A survey of hempseed importers revealed that all were in full compliance
with the Rule, and have The one other category of products that might be impacted economically by this rule is that in which pure cannabis seeds are sold as birdseed. (As set forth in the interim rule, which is being finalized today, DEA is exempting animal feed mixtures containing sterilized cannabis seeds with other ingredients, but not pure sterilized cannabis seeds.) In the regulatory certifications attached to the proposed rule, DEA estimated that no more than $77,000 worth of birdseed that contains cannabis seeds is imported into the United States for sale in this country. It appears likely that most of this birdseed is sold in a mixture that is exempted under the interim rule. Accordingly, the total amount of pure "hempseeds" sold as birdseed in this country is probably much less than $77,000. Regulatory Flexibility Act For the reasons provided above, the Acting Administrator hereby certifies that this rule will not have a significant impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 605(b)). The economic activity that would be disallowed under this rule is already illegal under DEA's interpretation of existing law. Even if one were to assume that such economic activity were legal under current law, the prohibition on such activity resulting from this rule (summarized above) would not constitute significant impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act. Therefore, a final regulatory flexibility analysis is not required for this rule. Executive Order 12866 This rule has been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, 1(b), Principles of Regulation. This rule has been determined to be a "significant regulatory action" under Executive Order 12866, 3(f). Accordingly, this rule has been reviewed by the Office of Management and Budget for purposes of Executive Order 12866. Executive Order 13132 This rule does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rule does not have federalism implications warranting the application of Executive Order 13132. Executive Order 12988--Civil Justice Reform This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year. Therefore, no actions are necessary under the Unfunded Mandates Reform Act of 1995. Small Business Regulatory Enforcement Fairness Act of 1996 For the reasons provided above, this rule is not likely to result in any of the following: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. The economic activity disallowed under this rule is already illegal under DEA's interpretation of existing law. Even if one were to assume that such economic activity were legal under current law, the prohibition on such activity resulting from this rule would not render the rule a major rule under the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 804. Therefore, the provisions of SBREFA relating to major rules are inapplicable to this rule. However, a copy of this rule has been sent to the Office of Advocacy, Small Business Administration. Further, a copy of this final rule will be submitted to each House of the Congress and to the Comptroller General in accordance with SBREFA (5 U.S.C. 801). Paperwork Reduction Act of 1995 This rule does not involve collection of information within the meaning of the Paperwork Reduction Act of 1995. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Final Rule Pursuant to the authority vested in the Attorney General under sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)), delegated to the Administrator and Deputy Administrator pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, appendix to subpart R, sec. 12, the Acting Administrator hereby orders that Title 21 of the Code of Federal Regulations, part 1308, be amended as follows: PART 1308--[AMENDED] 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Section 1308.11(d)(27) is revised to read as follows: Sec. 1308.11 Schedule I. * * * * * (Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.) * * * * * Dated: March 18,
2003. BILLING CODE 4410-09-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [DEA-206F] RIN 1117-AA55 Exemption From Control of Certain Industrial Products and Materials Derived From the Cannabis Plant AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. SUMMARY: The Drug Enforcement Administration (DEA) is adopting as final an interim rule exempting from control (i.e., exempting from all provisions of the Controlled Substances Act (CSA)) certain items derived from the cannabis plant and containing tetrahydrocannabinols (THC). Specifically, the interim rule exempted THC-containing industrial products, processed plant materials used to make such products, and animal feed mixtures, provided they are not used, or intended for use, for human consumption (and therefore cannot cause THC to enter the human body). DATES: This final rule becomes effective on April 21, 2003. FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, D.C. 20537; Telephone: (202) 307-7183. SUPPLEMENTARY INFORMATION: What Does This Rule Accomplish and by What Authority Is It Being Issued? This final rule
revises the DEA regulations to add a provision exempting from CSA control
certain THC-containing industrial products, processed plant materials
used to make such products, and animal feed mixtures, provided such products,
materials, and feed mixtures are made from those portions of the cannabis
plant that are excluded from the definition of marijuana and are not used,
or intended for use, for human consumption. Among the types of industrial
products that are exempted as a result of this final rule are: (i) Paper,
rope, and clothing made from cannabis stalks; (ii) processed cannabis
plant materials used for industrial purposes, such as fiber retted from
cannabis stalks for use in manufacturing textiles or rope; (iii) animal
feed mixtures that contain sterilized cannabis seeds and other ingredients
(not derived from the cannabis plant) in a formulation designed, marketed,
and distributed for animal (nonhuman) consumption; and (iv) personal care
products that contain oil from sterilized cannabis seeds, such as shampoos,
soaps, and body lotions (provided that using such personal care products
does not cause THC to enter the human body). Why Is DEA Exempting From Control Certain THC-Containing Substances Not Intended for Human Consumption? Without the exemptions made by the interim rule, which are adopted as final in this rule, a wide variety of legitimate industrial products derived from portions of the cannabis plant would be considered schedule I controlled substances. For example, paper, rope, and clothing (made using fiber from cannabis stalks) and industrial solvents, lubricants, and bird seed mixtures (made using sterilized cannabis seeds or oil from such seeds) would, in the absence of the interim rule, be considered schedule I controlled substances if they contained THC. If such products were considered schedule I controlled substances, their use would be severely restricted.\1\ Under the interim rule, however, which DEA is adopting as final here, DEA exempted such legitimate industrial products from control, provided they are not used, or intended for use, for human consumption. As explained below, DEA believes this approach protects the public welfare within the meaning of the CSA while striking a fair balance between the plain language of the Act and the intent of Congress under prior marijuana legislation. [\1\ The CSA and DEA regulations permit industrial use of schedule I controlled substances, but only under strictly regulated conditions.] THC is an hallucinogenic substance with a high potential for abuse. Congress recognized this fact by placing it in schedule I of the CSA. Because of this, there are only two ways that THC may lawfully enter a person's body: (1) If the THC is contained in a drug product that has been approved by the Food and Drug Administration (FDA) as being safe and effective for human use; \2\ or (2) if an experimental drug containing THC is provided to a research subject in clinical research that has been approved by FDA and conducted by a researcher registered with DEA.\3\ Disallowing human consumption of schedule I controlled substances except in the foregoing limited circumstances is an absolute necessity to conform with the CSA and protect the public welfare within the meaning of the Act.\4\ [\2\ 21 U.S.C. 331, 355, 811(b), 812(b). At present, Marinol[reg] is the only THC-containing drug product that has been approved for marketing by FDA. Marinol[reg] is the brand name of a product containing synthetic dronabinol (a form of THC) in sesame oil and encapsulated in soft gelatin capsules that has been approved for the treatment of nausea and vomiting associated with cancer chemotherapy as well as the treatment of anorexia associated with weight loss in patients with AIDS. Because Marinol[reg] is the only THC-containing drug approved by FDA, it is the only THC-containing substance listed in a schedule other than schedule I. DEA recently transferred Marinol[reg] from schedule II to schedule III, thereby lessening the CSA regulatory requirements governing its use as medicine. See 64 FR 35928 (1999). \3\ 21 U.S.C. 823(f); 21 CFR 5.10(a)(9), 1301.18, 1301.32. \4\ In enacting the CSA, Congress stated: "The illegal importation, manufacture, distribution, and possession and improper use of controlled substances have a substantial and detrimental effect on the health and general welfare of the American people." 21 U.S.C. 801(2).] Where, however, a schedule I controlled substance is contained in a product not used for human consumption, the CSA provides DEA with discretionary authority to issue regulations exempting such product from control.\5\ DEA has carefully considered whether it is appropriate to exercise this discretionary authority when it comes to industrial "hemp" products (i.e., products made from portions of the cannabis plant excluded from the CSA definition of marijuana). The text of the CSA and its legislative history make no mention of industrial uses of the cannabis plant. However, DEA has taken into account that, under prior legislation (the Marihuana Tax Act of 1937), Congress intended to permit the use of certain cannabis-derived industrial products. The Senate Report accompanying the 1937 Act stated: [\5\ See 21 U.S.C. 811(g)(3); see also 21 U.S.C. 871(b) (providing discretionary authority to DEA Administrator to "promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under [the CSA].").] The [cannabis] plant
* * * has many industrial uses. From the mature stalks, fiber is produced
which in turn is manufactured into twine, and other fiber products. From
the seeds, oil is extracted which is used in the manufacture of such products
as paint, varnish, linoleum, and soap. From hempseed cake, the residue
of the seed after the oil has been extracted, cattle feed and fertilizer
are manufactured. In addition, the seed is used as a special feed for
pigeons. [\6\ A detailed comparison of the 1937 Marihuana Tax Act and the CSA is provided in the October 9, 2001 interpretive rule. 66 FR at 51530-51531.] DEA may not arbitrarily
exempt a controlled substance from application of the CSA. Rather, such
an exemption must be based on a provision of the CSA. As cited above,
the exemption of certain "hemp" products under this final rule
is issued pursuant to two CSA provisions: 21 U.S.C. 811(g)(3)(B) and 871(b). [\7\ Unless otherwise indicated, all references in this document to "cannabis seeds" or " `hemp' seeds" refer to sterilized seeds (incapable of germination). In contrast to sterilized cannabis seeds, unsterilized cannabis seeds fit within the CSA definition of marijuana and are not exempted from control under this interim rule. \8\ If, however, the "hemp" seeds used in animal feed are sterilized cannabis seeds that contain no THC, such seeds are not a controlled substance. Under such circumstances, there is no need to exempt such seeds from control.] As stated above
and in the interpretive rule, the legislative history of the 1937 Marihuana
Tax Act reveals that Congress expressly contemplated allowing "hemp"
animal feed. The 1937 Congress categorized such use of "hemp"
as a legitimate "industrial" use. It is true that the intent
of the 1937 Congress is no longer controlling since the CSA repealed the
1937 Act and declared anything containing THC to be a schedule I controlled
substance. However, because neither the text nor the legislative history
of the CSA addresses the legality of using sterilized cannabis seeds in
animal feed, or the possibility that such seeds might contain THC, what
was viewed under the 1937 Act as "legitimate industrial use"
of such seeds in animal feed continued uninterrupted following the enactment
of the CSA in 1970. How Is "Human Consumption" Defined Under This Rule? Under this final
rule, a material, compound, mixture, or preparation containing THC will
be considered "used for human consumption" (and therefore not
exempted from control) if it is: (I) Ingested orally or (ii) applied by
any means such that THC enters the human body. A material, compound, mixture,
or preparation containing THC will be considered "intended for use
for human consumption" and, therefore, not exempted from control
if it is: (i) Designed by the manufacturer for human consumption; (ii)
marketed for human consumption; or (iii) distributed, exported, or imported
with the intent that it be used for human consumption. How Are "Processed Plant Material" and "Animal Feed Mixture" Defined Under This Rule? Under this final rule, any portion of the cannabis plant excluded from the CSA definition of marijuana will be considered "processed plant material" if it has been subject to industrial processes, or mixed with other ingredients, such that it cannot readily be converted into an |
