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                   UNITED STATES DEPARTMENT OF JUSTICE 
                      Drug Enforcement Administration 

_______________________________________ 
                                       ) 
  In The Matter Of                     ) 
                                       )              Docket No. 86-22 
     MARIJUANA RESCHEDULING PETITION   ) 
_______________________________________) 


                OPINION AND RECOMMENDED RULING, FINDINGS OF 
                  FACT, CONCLUSIONS OF LAW AND DECISION OF 
                       Administrative LAW JUDGE. 


FRANCIS L. YOUNG, Administrative Law Judge 


DATED: SEP 6  1988 

                   UNITED STATES DEPARTMENT OF JUSTICE 
                      Drug Enforcement Administration 

_______________________________________ 
                                       ) 
  In The Matter Of                     ) 
                                       )              Docket No. 86-22 
     MARIJUANA RESCHEDULING PETITION   ) 
_______________________________________) 


                 OPINION AND RECOMMENDED RULING, FINDINGS OF 
                   FACT, CONCLUSIONS OF LAW AND DECISION OF 
                        ADMINISTRATIVE LAW JUDGE. 


FRANCIS L. YOUNG, Administrative Law Judge 


APPEARANCES: 


 KEVIN B. ZEESE, Esq. 
 ARNOLD S. TREBACH, Esq. 
  for National Organization For The Reform of 
  Marijuana Laws 

 FRANK B. STILWELL, III, Esq. 
  for Alliance for Cannabis Therapeutics 

 DAVID C. BECK, Esq. 
  for Cannabis Corporation of America 

 CARL ERIC OLSEN, Pro Se 

 CHARLOTTE J. MAPES, Esq. 
 MADELEINE R. SHIRLEY, Esq. 
  for the Government 

 KARL BERNSTEIN 
  for National Federation of Parents for Drug-Free Youth 

 VIRGINIA PELTIER, Esq. 
  for the International Association of Chiefs of Police 


DATED: SEP 6 1988 

                                 CONTENTS 

               I.     INTRODUCTION                            1 

               II.    RECOMMENDED RULING                      7 

               III.   ISSUES                                  7 

               IV.    STATUTORY REQUIREMENTS FOR SCHEDULING   8 

               V.     ACCEPTED MEDICAL USE IN TREATMENT 
                       - CHEMOTHERAPY                         10 

                         Findings of Fact                     10 

                         Discussion                           26 

               VI.    ACCEPTED MEDICAL USE IN TREATMENT 
                       - GLAUCOMA                             35 

                         Findings of Fact                     35 

                         Discussion                           38 

               VII.   ACCEPTED MEDICAL USE IN TREATMENT 
                       - MULTIPLE SCLEROSIS, SPASTICITY & 
                         HYPERPARATHYROIDISM                  40 

                         Findings of Fact                     40 

                         Discussion                           54 

               VIII.  ACCEPTED SAFETY FOR USE UNDER MEDICAL 
                       SUPERVISION                            56 

                         Findings of Fact                     56 

                         Discussion                           65 

               IX.    CONCLUSIONS AND RECOMMENDED DECISION    67 

                      CERTIFICATION OF SERVICE                69 

                                   - i - 

                   UNITED STATES DEPARTMENT OF JUSTICE 
                      Drug Enforcement Administration 

_______________________________________ 
                                       ) 
  In The Matter Of                     ) 
                                       )              Docket No. 86-22 
     MARIJUANA RESCHEDULING PETITION   ) 
_______________________________________) 


                 OPINION AND RECOMMENDED RULING, FINDINGS OF 
                   FACT, CONCLUSIONS OF LAW AND DECISION OF 
                        ADMINISTRATIVE LAW JUDGE. 


                                     1. 

                                INTRODUCTION 


     This is a rulemaking pursuant to the Administrative Procedure Act, 5 
U.S.C.  551, et seq., to determine whether the marijuana plant (Cannabis 
sativa L) considered as a whole may lawfully be transferred from Schedule  
I to Schedule II of the schedules established by the Controlled  
Substances Act (the Act), 21 U.S.C.  801, et seq.  None of the parties  
is seeking to "legalize" marijuana generally or for recreational  
purposes.  Placement in Schedule II would mean, essentially, that  
physicians in the United States would not violate Federal law by  
prescribing marijuana for their patients for legitimate therapeutic  
purposes.  It is contrary to Federal law for physicians to do this as  
long as marijuana remains in Schedule I.  This proceeding had its origins  
on May 18, 1972 when the National Organization for the Reform of  
Marijuana Laws (NORML) and two other groups submitted a petition to the  
Bureau of Narcotics and Dangerous Drugs (BNDD) [footnote 1], predecessor 
______________________ 
1    The powers and authority granted by the Act to the Attorney General 
     were delegated to the Director of BNDD and subsequently to the 
     Administrator of DEA.  28 C.F.R.  0.100, et seq. 

agency to the Drug Enforcement Administration (DEA or the Agency), asking 
that marijuana be removed from Schedule I and freed of all controls 
entirely, or be transferred from Schedule I to Schedule V where it would  
be subject to only minimal controls.  The Act by its terms had placed 
marijuana in Schedule I thereby declaring, as a matter of law that it had 
no legitimate use in therapy in the United States and subjecting the 
substance to the strictest level of controls.  The Act had been in effect 
for just over one year when NORML submitted its 1972 petition. 

     On September 1, 1972 the Director of BNDD announced his refusal to 
accept the petition for filing, stating that he was not authorized to 
institute proceedings for the action requested because of the provisions  
of the Single Convention on Narcotic Drugs, 1961.  NORML appealed this  
action to the United States Court of Appeals for the District of Columbia  
Circuit.  The court held that the Director had erred in rejecting the  
petition without "a reflective consideration and analysis," observing  
that the Director's refusal "was not the kind of agency action that  
promoted the kind of interchange and refinement of views that is the  
lifeblood of a sound administrative process."  NORML v. Ingersoll, 162  
U.S. App. D.C. 67, 497 F.2d 654, 659 (1974).  The court remanded the  
matter in January 1974 for further proceedings not inconsistent with its  
opinion, "to be denominated a consideration on the merits."  Id. 

     A three-day hearing was held at DEA [footnote 2] by Administrative  
Law Judge Lewis Parker in January 1975.  The judge found in NORML's favor  
on several issues but the Acting Administrator of DEA entered a final  
order denying NORML's petition "in all respects."  NORML again petitioned  
the court for review.  Finding fault 
_________________ 
2    DEA became the successor agency to BNDD in a reorganization carried 
     out pursuant to Reorganization Plan No. 2 of 1973, eff. July 1, 
     1973.  38 Fed Reg. 15932 (1973). 

                                  - 2 - 

with DEA's final order the court again remanded for further proceedings  
not inconsistent with its opinion.  NORML v. DEA, 182 U.S. App. D.C. 114,  
559 F.2d 735 (1977).  The Court directed the then-Acting Administrator of  
DEA to refer NORML's petition to the Secretary of the Department of  
Health, Education and Welfare (HEW) for findings and, thereafter, to  
comply with the rulemaking procedures outlined in the Act at 21 U.S.C.   
811 (a) and (b). 

     On remand the Administrator of DEA referred NORML's petition to HEW 
for scientific and medical evaluation.  On June 4, 1979 the Secretary of 
HEW advised the Administrator of the results of the HEW evaluation and 
recommended that marijuana remain in Schedule I.  Without holding any 
further hearing the Administrator of DEA proceeded to issue a final order 
ten days later denying NORML's petition and declining to initiate 
proceedings to transfer marijuana from Schedule I.  44 Fed. Reg. 36123 
(1979).  NORML went back to the Court of Appeals. 

     When the case was called for oral argument there was discussion of  
the then-present status of the matter.  DEA had moved for a partial  
remand.  The court found that "reconsideration of all the issues in this  
case would be appropriate" and again remanded it to DEA, observing: "We  
regrettably find it necessary to remind respondents [DEA and HEW] of an  
agency's obligation on remand not to 'do anything which is contrary to  
either the letter or spirit of the mandate construed in the light of the  
opinion of [the] court deciding the case.'"  (Citations omitted.)  NORML  
v. DEA, et al., No. 79.1660, United States Court of Appeals for the  
District of Columbia Circuit, unpublished order filed October 16, 1980.   
DEA was directed to refer all the substances at issue to the Department  
of Health and Human Services (HHS), successor agency to HEW, for scien- 

                                  - 3 - 

tific and medical findings and recommendations on scheduling.  DEA did so 
and HHS has responded.  In a letter dated April 1, 1986 the then-Acting 
Deputy Administrator of DEA requested this administrative law judge to 
commence hearing procedures as to the proposed rescheduling of marijuana 
and its components. 

     After the Judge conferred with counsel for NORML and DEA, a notice  
was published in the Federal Register on June 24, 1986 announcing that  
hearings would be held on NORML's petition for the rescheduling of  
marijuana and its components commencing on August 21, 1986 and giving any  
interested person who desired to participate the opportunity to do so.   
51 Fed. Reg. 22946 (1986). 

     Of the three original petitioning organizations in 1972 only NORML  
is a party to the present proceeding.  In addition the following entities 
responded to the Federal Register notice and have become parties, 
participating to varying degrees:  the Alliance for Cannabis Therapeutics 
(ACT), Cannabis Corporation of America (CCA) and Carl Eric Olsen, all 
seeking transfer of marijuana to Schedule II; the Agency, National 
Federation of Parents for Drug free Youth (NFP) and the International 
Association of Chiefs of Police (IACP), all contending that marijuana 
should remain in Schedule I. 

     Preliminary prehearing sessions were held on August 21 and December  
5, 1986 and on February 20, 1987. [footnote 3]  During the preliminary  
stages, on January 20, 1987, NORML filed an amended petition for  
rescheduling.  This new petition abandoned NORML's previous requests for  
the complete descheduling of marijuana or rescheduling to Schedule V.  It  
asks only that marijuana be placed in Schedule II. 

     At a prehearing conference on February 20, 1987 this amended  
petition was 
_______________ 
3    Transcripts of these three preliminary prehearing sessions are 
     included in the record. 

                                  - 4 - 

discuss. [footnote 4]  All Parties present stipulated, for the purpose of 
this proceeding, that marijuana has a high potential for abuse and that 
abuse of the marijuana plant may lead to severe psychological or physical 
dependence.  They then agreed that the principal issue in this proceeding 
would be stated thus: 

          Whether the marijuana plant, considered as a whole, [footnote 
          5] may 
________________ 
4    The transcript of this prehearing conference and of the subsequent 
     hearing session comprise 15 volumes numbered as follows: 

          Vol. I     -  Prehearing Conference, October 16, 1987 

          Vol. II    -  Cross Examination, November 19, 1987 

          Vol. III   -  Cross Examination, December 8, 1987 

          Vol. IV    -  Cross Examination, December 9, 1987 

          Vol. V     -  Cross Examination, January 5, 1988 

          Vol. VI    -  Cross Examination, January 6, 1988 

          Vol. VII   -  Cross Examination, January 7, 1988 

          Vol. VIII  -  Cross Examination, January 26, 1988 

          Vol. IX    -  Cross Examination, January 27, 1988 

          Vol. X     -  Cross Examination, January 28, 1988 

          Vol. XI    -  Cross Examination, January 29, 1988 

          Vol. XII   -  Cross Examination, February 2, 1988 

          Vol. XIII  -  Cross Examination, February 4, 1988 

          Vol. XIV   -  Cross Examination, February 5, 1988 

          Vol. XV    -  Oral Argument, June 10, 1988 

Pages of the transcript are cited herein by volume and page, e.g. "Tr. V- 
96"; "G-" identifies an Agency exhibit. 

5    Throughout this opinion the term marijuana" refers to "the marijuana 
     plant, consider as a whole". 

                                  - 5 - 

          lawfully be transferred from Schedule I to Schedule II of the 
          schedules established by the Controlled Substances Act. 

     Two subsidiary issues were agreed on, as follows: 

          1.  Whether the marijuana plant has a currently accepted 
              medical use in treatment in the United States, or a 
              currently accepted medical use with severe restrictions. 

          2.  Whether there is a lack of accepted safety for use of 
              the marijuana plant under medical supervision. 

As stated above, the parties favoring transfer from Schedule I to 
Schedule II are NORML, ACT, CCA and Carl Eric Olsen.  Those favoring 
retaining marijuana in Schedule I are the Agency, NFP and IACP. 

     During the Spring and Summer of 1987 the parties identified their 
witnesses and put the direct examination testimony of each witness in 
writing in affidavit form.  Copies of these affidavits were exchanged. 
Similarly, the parties assembled their proposed exhibits and exchanged 
copies.  Opportunity was provided for each party to submit objections to 
the direct examination testimony and exhibits proffered by the others.   
The objections submitted were considered by the administrative law judge  
and ruled on.  The testimony and exhibits not excluded were admitted into  
the record.  Thereafter hearing sessions were held at which witnesses  
were subjected to cross-examination.  These sessions were held in New  
Orleans, Louisiana on November 18 and 19, 1987; in San Francisco,  
California on December 8 and 9, 1987; and in Washington, D.C. on January  
5 through 8 and 26 through 29, and on February 2, 4 and 5, 1988.  The  
parties have submitted proposed findings and conclusions and briefs.   
Oral arguments were heard by the judge on June 10, 1988 in Washington. 

                                  - 6 - 

                                   II. 

                            RECOMMENDED RULING 


     It is recommended that the proposed findings and conclusions  
submitted by the parties to the administrative law judge be rejected by  
the Administrator except to the extent they are included in those  
hereinafter set forth; for the reason that they are irrelevant or unduly  
repetitious or not supported by a preponderance of the evidence.  21  
C.F.R.  1316.65(a)(1). 


                                   III. 

                                  ISSUES 


     As noted above, the agreed issues are as follows: 

          Principle issue: 

          Whether the marijuana plant, considered as a whole, may 
          lawfully be transferred from Schedule I to Schedule II of 
          the schedules established by the Controlled Substances Act. 

          Subsidiary issues: 

          1.  Whether the marijuana plant has a currently accepted 
              medical use in treatment in the United States, or a 
              currently accepted medical use with severe restrictions. 

          2.  Whether there is a lack of accepted safety for use of 
              the marijuana plant under medical supervision. 

                                  - 7 - 

                                   IV. 

                  STATUTORY REQUIREMENTS FOR SCHEDULING 

     The Act provides (21 U.S.C.  812(b)) that a drug or other substance 
may not be placed in any schedule unless certain specified findings are 
made with respect to it.  The findings required for Schedule I and  
Schedule II are as follows: 

          Schedule I. - 

            (A)  The drug or other substance has a high potential 
          for abuse. 

            (B)  The drug or other substance has no currently accepted 
          medical use in treatment in the United States. 

            (C)  There is a lack of accepted safety for use of the 
          drug or other substance under medical supervision. 

          Schedule II. - 

            (A)  The drug or other substance has a high potential for 
          abuse. 

            (B)  The drug or other substance has a currently accepted 
          medical use in treatment in the United States or a currently 
          accepted medical use with severe restrictions. 

            (C)  Abuse of the drug or other substances [sic] may lead to 
          severe psychological or physical dependence. 

     As noted above the parties have stipulated, for the purpose of this 
proceeding, that marijuana has a high potential for abuse and that abuse  
of it may lead to severe psychological or physical dependence.  Thus the 
dispute between the two sides in this proceeding is narrowed to whether  
or not marijuana has a currently accepted medical use in treatment in the 
United States, and whether or not there is a lack of accepted safety for 
use of marijuana under medical supervision. 

     The issues as framed here contemplate marijuana's being placed only  
in 

                                  - 8 - 

Schedule I or Schedule II.  The criteria for placement in any of the  
other three schedules established by the Act are irrelevant to this  
proceeding. 

                                  - 9 - 

                                    V. 

                    ACCEPTED MEDICAL USE IN TREATMENT 

                              - CHEMOTHERAPY 

     With respect to whether or not marijuana has a "currently accepted 
medical use in treatment in the United States" for chemotherapy patients, 
the record shows the following facts to be uncontroverted. 


Findings Of Fact 

          1.  One of the most serious problems experienced by cancer 
patients undergoing chemotherapy for their cancer is severe nausea and 
vomiting caused by their reaction to the toxic (poisonous) chemicals 
administered to them in the course of this treatment.  This nausea and 
vomiting at times becomes life threatening.  The therapy itself creates a 
tremendous strain on the body.  Some patients cannot tolerate the severe 
nausea and vomiting and discontinue treatment.  Beginning in the 1970's 
there was considerable doctor-to-doctor communication in the United  
States concerning patients known by their doctors to be surreptitiously  
using marijuana with notable success to overcome or lessen their nausea  
and vomiting. 

          2.  Young patients generally achieve better control over nausea 
and vomiting from smoking marijuana than do older patients, particularly 
when the older patient has not been provided with detailed information on 
how to smoke marijuana. 

          3.  Marijuana cigarettes in many cases are superior to  
synthetic THC capsules in reducing chemotherapy-induced nausea and  
vomiting.  Marijuana 

                                  - 10 - 

cigarettes have an important, clear advantage over synthetic THC capsules 
in that the natural marijuana is inhaled and generally takes effect more 
quickly than the synthetic capsule which is ingested and must be  
processed through the digestive system before it takes effect. 

          4.  Attempting to orally administer the synthetic THC capsule  
to a vomiting patient presents obvious problems - it is vomited right  
back up before it can have any effect. 

          5.  Many physicians, some engaged in medical practice and some 
teaching in medical schools, have accepted smoking marijuana as effective 
in controlling or reducing the severe nausea and vomiting (emesis) 
experienced by some cancer patients undergoing chemotherapy for cancer. 

          6.  Such physicians include board-certified internists, 
oncologists and psychiatrists.  (Oncology is the treatment of cancer 
through the use of highly toxic chemicals, or chemotherapy.) 

          7.  Doctors who have come to accept the usefulness of marijuana 
in controlling or reducing emesis resulting from chemotherapy have dose  
so as the result of reading reports of studies and anecdotal reports in  
their professional literature, and as the result of observing patients  
and listening to reports directly from patients. 

          8.  Some cancer patients who have acknowledged to doctors that 
they smoke marijuana for emesis control have indicated in their  
discussions that, although they may have first smoked marijuana  
recreationally, they accidentally found that doing so helped reduce the  
emesis resulting from their chemotherapy.  They consistently indicated  
that they felt better and got symptomatic relief from the intense nausea  
and vomiting caused by the chemotherapy.  These patients  

                                  - 11 - 

were no longer simply getting high, but were engaged in medically  
treating their illness, albeit with an illegal substance.  Other  
chemotherapy patients began smoking marijuana to control their emesis  
only after hearing reports that the practice had proven helpful to  
others.  Such patients had not smoked marijuana recreationally. 

          9.  This successful use of marijuana has given many cancer 
chemotherapy patients a much more positive outlook on their overall 
treatment, once they were relieved of the debilitating, exhausting and 
extremely unpleasant nausea and vomiting previously resulting from their 
chemotherapy treatment. 

         10.  In about December 1977 the previously underground patient 
practice of using marijuana to control emesis burst into the public media 
in New Mexico when a young cancer patient, Lynn Pearson, began publicly  
to discuss his use of marijuana.  Mr. Pearson besought the New Mexico 
legislature to pass legislation making marijuana available legally to 
seriously ill patients whom it might help.  As a result, professionals in 
the public health sector in New Mexico more closely examined how  
marijuana might be made legally available to assist in meeting what now  
openly appeared to be a widely recognized patient need. 

         11.  In many cases doctors have found that, in addition to 
suppressing nausea and vomiting, smoking marijuana is a highly successful 
appetite stimulant.  The importance of appetite stimulation in cancer 
therapy cannot be overstated.  Patients receiving chemotherapy often lose 
tremendous amounts of weight.  They endanger their lives because they  
lose interest in food and in eating.  The resulting sharp reduction in  
weight may well affect their prognosis.  Marijuana smoking induces some  
patients to eat.  The benefits are obvious, doctors have found.  There is  
no significant loss of weight.  Some patients will gain weight. 

                                  - 12 - 

This allows them to retain strength and makes them better able to fight  
the cancer.  Psychologically, patients who can continue to eat even while 
receiving chemotherapy maintain a balanced outlook and are better able to 
cope with their disease and its treatment, doctors have found. 

         12.  Synthetic anti-emetic agents have been in existence and 
utilized for a number of years.  Since about 1980 some new synthetic  
agents have been developed which appear to be more effective in  
controlling and reducing chemotherapy-induced nausea and vomiting than  
were some of those available in the 1970's.  But marijuana still is found  
more effective for this purpose in some people than any of the synthetic  
agents, even the newer ones. 

         13.  By the late 1970's in the Washington, D.C. area there was a 
growing recognition among health care professionals and the public that 
marijuana had therapeutic value in reducing the adverse effects of some 
chemotherapy treatments.  With this increasing public awareness came 
increasing pressure from patients on doctors for information about 
marijuana and its therapeutic uses.  Many patients moved into forms of 
unsupervised self-treatment.  While such self-treatment often proved very 
effective, it has certain hazards, ranging from arrest for purchase or  
use of an illegal drug to possibly serious medical complications from 
contaminated sources or adulterated materials.  Yet, some patients are 
willing to run these risks to obtain relief from the debilitating nausea 
and vomiting caused by their chemotherapy treatments. 

         14.  Every oncologist known to one Washington, D.C. practicing 
internist and board-certified oncologist has had patients who used 
marijuana with great success to prevent or diminish chemotherapy-induced 
nausea and vomiting.  Chemotherapy patients reporting directly to that 
Washington doctor that they 

                                  - 13 - 

have smoked marijuana medicinally vomit less and eat better than patients 
who do not smoke it.  By gaining control over their severe nausea and 
vomiting these patients undergo a change of mood and have a better mental 
outlook than patients who, using the standard anti-emetic drugs, are  
unable to gain such control. 

         15.  The vomiting induced by chemotherapeutic drugs may last up  
to four days following the chemotherapy treatment.  The vomiting can be 
intense, protracted and, in some instances, is unendurable.  The nausea 
which follows such vomiting is also deep and prolonged.  Nausea may  
prevent a patient from taking regular food or even much water for periods  
of weeks at a time. 

         16.  Nausea and vomiting of this severity degrades the quality  
of life for these patients, weakening them physically, and destroying the  
will to fight the cancer.  A desire to end the chemotherapy treatment in  
order to escape the emesis can supersede the will to live.  Thus the  
emesis, itself, can truly be considered a life-threatening consequence of  
many cancer treatments.  Doctors have known such cases to occur.  Doctors  
have known other cases where marijuana smoking has enabled the patient to 
endure, and thus continue, chemotherapy treatments with the result that  
the cancer has gone into remission and the patient has returned to a  
full, active satisfying life. 

         17.  In San Francisco chemotherapy patients were surreptitiously 
using marijuana to control emesis by the early 1970's.  By 1976 virtually 
every young cancer patient receiving chemotherapy at the University of 
California in San Francisco was using marijuana to control emesis with 
great success.  The use of marijuana for this purpose had become  
generally accepted by the patients and increasingly by their physicians  
as a valid and effective form of treatment.  This was particularly true  
for younger cancer patients, somewhat less common for 

                                  - 14 - 

older ones.  By 1979 about 25% to 30% of the patients seen by one San 
Francisco oncologist were using marijuana to control emesis, about 45 to 
50 patients per year.  Such percentages and numbers vary from city to  
city.  A doctor in Kansas City who sees about 150 to 200 new cancer  
patients per year found that over the 15 years 1972 to 1987 about 5% of  
the patients he saw, or a total of about 75, used marijuana medicinally. 

         18.  By 1987 marijuana no longer generated the intense interest  
in the world of oncology that it had previously, but it remains a viable  
tool, commonly employed, in the medical treatment of chemotherapy  
patients.  There has evolved an unwritten but accepted standard of  
treatment within the community of oncologists in the San Francisco,  
California area which readily accepts the use of marijuana. 

         19.  As of the Spring of 1987 in the San Francisco area,  
patients receiving chemotherapy commonly smoked marijuana in hospitals  
during their treatments.  This in-hospital use, which takes place in  
rooms behind closed doors, does not bother staff, is expected by  
physicians and welcomed by nurses who, instead of having to run back and  
forth with containers of vomit, can treat patients whose emesis is better  
controlled than it would be without marijuana.  Medical institutions in  
the Bay area where use of marijuana obtained on the streets is quite  
common, although discrete, include the University of California at San  
Francisco Hospital, the Mount Zion Hospital and the Franklin Hospital.   
In effect, marijuana is readily accepted throughout the oncologic  
community in the bay area for its benefits in connection with  
chemotherapy.  The same situation exists in other large metropolitan  
areas of the United States. 

         20.  About 50% of the patients seen by one San Francisco 
oncologist 

                                  - 15 - 

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