Hospitals & Asylums
Drug Evaluation Agency Reform of the Controlled Substances Amendments HA-31-10-09
By Tony Sanders
sanderstony@live.com
Be the quintupling of
the prison population sufficient duplication for the Administrator to initiate
rulemaking procedure under 21CFR§1308.43
diverted to the Food and Drug Administration (FDA)
I.Controlled Substances Act
II.
Diplomatic Conference
III. Schedules of
Psychotropic Substances
IV. Prohibition
V. Administrative
and Enforcement Cooperation
VI. Import and
Export
VII. Change of
Address
VIII. Probable
Cause of PTSD
IX. Control
of Toxic Substances and Drug Regulation in General
§1317.01 Scope of Part 1317
§1317.02 Epidemiologic Statistical Studies
§1317.03 DEA Arm of the Food and Drug Administration
§1317.04
Human Research Protection of the Poison Control Centers
§1317.05 New Registration and Annual Renewal
§1317.06 Inspection
§1317.07 Initial Inventory
§1317.08 Patent Cooperation
§1317.10 Type Setting
Type I Poison
Type II Deadly Pathogens
Type III Disabling Pathogens
Type IV Chemotherapy and Hard Drugs
Type V Prescription
Drugs
Type VI Over-the-Counter
Drugs
Type VII Alcohol, Tobacco, Marijuana,
Coca and Opium
Type VIII Tea, Coffee and Stimulating
Beverages
Type IX Endangered Species, Toxic
Plants and Animals
Type X Medicinal
Herbs, Dietary Supplements, Vitamins and Minerals
I.Controlled Substance Act
1.The
Comprehensive Drug Abuse Prevention and Control Act, now known as the
Controlled Substances Act (CSA), was signed by President Richard Nixon October
27, 1970, it is codified in two subchapters at Title 21 of the United States Code Chapter 13 §801-971. Shortly thereafter the International
Convention on Psychotropic Substances signed in Vienna on 11 July 1971 that at
the urging of the United States put Marijuana in Schedule I with other narcotic
and psychotropic drugs with a high risk of abuse and no medical use. The Drug Enforcement Administration (DEA) was
founded by Reorganization No. 2 signed by President Richard Nixon on 28 March
1973, codified at 21CFR§1300-1399.
2. Being the only drug consumers able to
tolerate the abuse of power narcotic drugs have been subjected to the
jurisdiction of international regulation and prohibition of the torturer,
justice, during the 20th century.
Unfortunately after consuming a number of mind expanding hallucinogenic
psychotropic substances during the 1960s in the 1970s the oppressive drug
regulatory regime, particularly that of the United States, rhetorically
expanded their control to all controlled substances, but in fact only breached
the confidentiality of medical practice and the pharmaceutical industry, at the
expense of an addicted jurisdiction that tolerates abuse. Infringing on the free market the United
States immediately began to show an international trade deficit and suffered an
oil embargo from hashish smoking countries, while civil war broke out in
Columbia and Afghanistan. Seeking refuge
from justice the US medical establishment underwent several decades of
privatization while the rest of the industrialized world progressed towards a
national health service. The perversion
of the Customs Court Act of 1980 infected southern Africa, the IV drug and gay
communities with HIV and the prison population quintupled primarily as the
result of mandatory minimum sentencing of drug offenders. Since 2001, after the Taliban had
successfully prohibited opium poppy cultivation in 2000 and the subsequent 9-11
attacks, the United States and NATO have been involved in just military
operations in Afghanistan, where opium production is higher than ever.
3. To
begin to redress three decades of drug slavery, disease and widening income
inequality, now a global economic depression, it is proposed to enact a Drug
Evaluation Agency reform of the Controlled Substances Act to correct this fatal
flaw that has undermined socio-economic progress over the past three
decades. After years hallucinating about
slavery and then pharmacy the truth has been tortured out of me – drugs and
disease are poison (doughnut anyone?) and no comprehensive controlled substance
regulatory system can omit the pathogens used to cause diagnosable disease in
laboratory animals and hypothetically cause the vast majority of disease and
death in the 21st century.
Thus the philosophical principles of pharmacologic jurisprudence are
that pharmacy is a health profession, toxicology is an understudy of
pharmacology and that drug regulation should foster the free trade in
therapeutic drugs and prohibit poison for benefit of public health. To foster the development of a rational
institutional ideology after such a long, strange and delusional trip, the
following reforms are tried, to change the name of the Drug Enforcement
Administration (DEA) to Drug Evaluation Agency (DEA), to transfer the DEA to
the Food and Drug Administration (FDA) and to lead the Customs of the United
Nations to set the Type for a whole new comprehensive method to control and
prohibit bio-medical substances. In Oregon v. Ashcroft No. 02-35587 of August 11, 2004, the 9th
Circuit Court of Appeals ruled that the Attorney General may not define the
scope of legitimate medical practice and requires an agency represented by
Secretary of Health and Human Services "to determine the appropriate
methods of professional practice". Gonzalez v. Oregon No. 04-623 (2006) upheld the
ruling in that the Attorney General did not have standing to prohibit doctors
from prescribing drugs for physician assisted suicide.
II. Diplomatic Conference
4.In reward for this dissertation of Congress
and the transfer of all her mandatory benefit programs to the supervision of
the Social Security Administration, the Secretary of Health and Human Services,
shall be readmitted to the academic freedom of the Department of Health,
Education and Welfare from whence she was expelled for unspeakable things in
1979, a Secretary of Public Health entitled to all the privileges and
immunities of the Secretary of the United Nations and Socio-Economic
Administration, provided she amend the Public Health Service statute to accept
this change in political status from whence she shall graduate upon the
restitution of Chapter 6A to Chapter 1 of the Title 42 of the United States
Code repealed of all corpses from WWI.
For their part the DEA shall be transferred to the Public Health
Service, respect the authority of the Commissioner of the FDA and control the
pathogens used in bio-medical research. Chapter
13 of Title 21 of the United States Code is amended so that the phrase “Drug
Abuse Prevention and Control” is changed to “Substance Abuse Prevention and
Customs” and Subchapter I on Control and Enforcement is changed to “Control and
Prohibition”. Secretary of Health and Human Services is amended to “Secretary
of Public Health” at 21USC(13)§801a (3)(C). 21USC(13)§802 is
amended at (4) is amended so that the term “Drug Evaluation Agency” means the
Drug Evaluation Agency in the Food and Drug Administration. At (6) after Schedule I-V “
or Type I-VII” is inserted and the second sentence pertaining to the
exclusion of alcoholic beverages and tobacco is repealed. At (32) is added ‘A
“poison” is a controlled substance that causes death in humans or animals
listed as a Type I. A “pathogen” is a
controlled substance, whether it be a toxic substance, bacteria, virus or gene,
that causes a diagnosable disease or torturous condition in humans or animals
and is catalogued with the disease it causes under Type II or III of part B of
this subchapter ’. At 32 At (9, B, iii & D) and at (34, 35
& 36) and at (39, A, iii & iv, II and vi) and at (conclusion of 41,
A) the Attorney General is stricken and
replaced with Secretary of the Public Health Department. At (4,1 B) Secretary of Health and Human Services
is stricken and replaced with Administrator of the United States Department of
Agriculture. At (44)
“or medicinal” before substances.
5.21USC(13)§811
is amended at (a) four times from Attorney General to “Secretary of Public
Health” the first and “Secretary” thereafter.
At (b) the first sentence is amended so, “The Secretary shall, before
initiating proceedings under subsection (a) of this section to control a drug
or other substance or to remove a drug or other substance entirely from the
schedules or Types, and after gathering the necessary data, request a
scientific and medical evaluation, as to whether such drug or other substance
should be so controlled or removed as a controlled substance.” Sentences three,
four and five are repealed and the final sentence is amended so Attorney
General reads, “Secretary”. At (c & d, 1) Attorney General is amended to
“Secretary”. At (d, 2, A & B)
Secretary of Health and Human Services is twice changed to, “Secretary of
Public Health” in both subsections. At
(d, 3) Secretary of Health and Human Services is changed to Secretary of Public
Health. At both (d, 3, A & B)
Secretary of Health and Human Services is changed to “Attorney General”,
Secretary to “Attorney General” and Attorney General to “Secretary of Public
Health” and “or she” is appended to he.
At (d, 3, C) Secretary of Health and Human Services is changed to “Attorney
General”, Secretary to “Attorney General” and at (i)
Attorney General is changed to “Secretary of Public Health” and “or she”
appended to he. At (d, 4, A) Attorney
General is changed to “Secretary of Public Health”, Secretary of Health and
Human Services to “Attorney General” thrice.
At (d, 4, B) “the Attorney
General, after consultation with the Secretary of Health and Human Services” is
stricken and replaced with “Secretary of Public Health” where after Attorney
General is twice changed to “Secretary” where after “after consultation with
the Secretary” is repealed and “or she” appended to he. At (d, 5) Secretary of Health and Human
Services is changed to “Secretary of Public Health”. At (e) Attorney General is
once changed to “Secretary of Public Health” and once to “Secretary”. At (f) “or toxic” is inserted before
stimulant. At (g, 1 & 3) Attorney
General is changed to “Secretary of Public Health” and at (g, 3, C) “Upon the
recommendation of the Secretary of Health and Human Services” is repealed. At (h) Attorney General is changed to
“Secretary” “or she” is added after he; “by order and without regard to the requirements of
subsection (b) of this section relating to the Secretary of Health and Human
Services”, is repealed. Attorney General
is changed to “Secretary” in (h, 1A, 1B, 2, 3, and twice in 4). –General is repealed from Secretary of the
United Nations at (d, 2, A & 3, C, ii & 4, A & B). Economic and Social Council is changed to
Socio-Economic Administration at (d, 3, iii).
III. Schedules of
Psychotropic Substances
6. It was attempted to reschedule the psychotropic drug
schedules to incorporate everything but it was previously noted that Schedule
is not really as funny with torturous tinctures as it is with narcotic
addiction and after discovering the List Chemicals decided it would be simpler
and of less impact upon the existing laws to write a whole new list classifying
bio-medical substances without poisoning the entire class. The Title of Part B is amended so it reads,
“Authority to Control, Standards, Schedules and Types” The caption of Schedules
of Controlled Substances at 21USC(13)§812
is amended so it reads “Schedules of Psychotropic Substances” in (a) controlled
is changed to “psychotropic”. Under the
scheduling authority of the Administrator in consultation with the Secretary at
21CFR§1308.43(d) at Schedule I (c, 10) and at
21CFR§1308.11(d, 22 ) Marihuana (DEA # 7360) is
removed and subsequent numbering is changed correspondingly and Marihuana is
inserted at Schedule III at §812(f) and in the reservation at 21CFR§1308.13(g,
2). At 21USC(13)§813 the
fist reference to controlled is changed to “psychotropic”. At 21USC(13)§814 Attorney
General is changed to “Secretary of Public Health” once at (a) and a second
time to “Secretary” and to “Secretary” in (b, c. d, 1, 2, & 3). At 21USC(13)§821
Attorney General is changed to “Secretary of Public Health”. Attorney General is changed to “Secretary of
Public Health at 21USC(13)§822 and to “Secretary” at (b, d & f) and at
(c, 1 & 2) controlled is changed to “psychotropic”. Attorney General is
changed to “Secretary” at 21USC(13)§823(a)
and at (b, d, e, f, g, 1, A, B, 2, D, ii, iii, E, i,
g, 1, C & g, 2, C, ii). (after consultation with the Attorney
General) is repealed, at (g, 2, ii, I), “both the
Secretary and the Attorney General are” is repealed and replaced with “the
Secretary is”. At (g, 2, H, i & ii) Drug Enforcement Administration is changed to
“Drug Evaluation Agency” and Substance Abuse Mental Health Services
Administration to Social Work Administration. At (J) (i & ii)
are repealed and (I & II) are changed to (i &
ii). At (h) Attorney General is changed thrice to Secretary.
5.Attorney General is changed to “Secretary of Public Health” at 21USC(13)§824(a)
and thereafter to “Secretary” at (a, b, c, d, f, g). At (f & g) controlled substances is
changed to “psychotropic”. There is
appended (h) Destruction of Type II & III Pathogens in Controversy. When the possession of Type II or III
chemical is determined to be suspicious by the regional Poison Control Center,
Institutional Ethics Committee, local, state or federal law enforcement those
pathogenic substances shall be promptly destroyed or properly disposed of and
this destruction or disposal shall be documented and witnessed. (1) Courts and law enforcement officers shall
never possess Type I, II or III controlled substances and if the registered
chemical analysts are not themselves able to document the destruction of the
substance, or it is seized from an unregistered possessor, licensed hazardous
material handlers shall be summoned to document the seizure and destruction of
the substance(s). (2) If the registered
chemical analysts wish to defend their possession and use of the Type II or III
substance(s) in question they shall be subjected to prosecution therefore by
the Secretary and the substances themselves shall be impounded by a hazardous
material handler under the authority of the Secretary at (f & g). (3) Type I poisons that are experimental in
nature are subject to the same treatment as (h, 1 & 2) above, and those
properly packaged and sealed poisons with legitimate use shall be accounted for
under the procedure in (f & g) of this section. (4) Complaints and suspicions regarding type
I, II, and III substances shall be given due process by the Secretary regarding
revocation, suspension of their license(s) and bio-security.
6. Attorney General is changed to “Secretary of Public
Health” at 21USC(13)§825
(a) and to “Secretary at (b & d) and it is inserted (d) Type I, II, or III
controlled substances. Attorney General is changed to “Secretary of Public
Health” at 21USC(13)§826
(a) and to “Secretary” at (b-f). There
shall be appended (h) Quotas for Type I, II and III Substances: The Secretary
shall determine the total quantity and establish production quotas for estimated
legitimate registered research, veterinary and lethal injection needs to be
manufactured each year. Production quotas shall be exactly sufficient to meet
legitimate demand of the prior year. For
good reason the Secretary may increase or reduce the production for a specific
substances or eliminate the legitimate production of a substance
completely. Attorney General is changed
to “Secretary of Public Health” at 21USC(13)§827(b)
and thereafter to “Secretary” at (b, c, 3, d, e, f, g & h) at (f) after
consultation with the Attorney General, is repealed. Attorney General is changed to “Secretary of
Public Health” at 21USC(13)§828(a)
and to “Secretary” at (c, 1, 2, d, 1 & 2) and at (a) it is inserted “Type
I, II, III or IV” before controlled substance and after is inserted “or”. At
the end of (b, 1), “it is forbidden to export Type II or III controlled
substances. Attorney General is changed
to “Secretary of Public Health” at 21USC(13)§829(a)
and to “Secretary” at (b & d). Attorney General is changed to “Secretary”
at 21USC(13)§830
(a, 2, 3, b, 1, B, 2, 3, B, D, v, E, c, 3, e, 1, A, iii, v, vii, B, i, ii, iii, iv, C, F, 2, A, 3)
IV. Prohibition
7. The hypocrisy regarding the up to five years sentence
for poisoning and mandatory sentences for popular illicit drugs is resolved
pursuant to Blakely v. Washington No. 02-1632 (2004). Attorney General
is changed to “Secretary” at 21USC(13)§841(g,
2 & 3). The sentences at (b) are changed
to, “up to 10 years or up to 20 years where corruption of a minor, bodily
injury, involuntary manslaughter occurred through the negligence of the dealer,
or up to life where there were many preventable deaths”, at least is changed to
“up to” twice and the last two sentences are repealed At (b,1 B) sentencing is
changed to up to five years and up to 20 years where corruption of a minor,
serious bodily injury or involuntary manslaughter occurs as the result of the
negligence of the dealer or up to life where there were many preventable
deaths, at least is changed to “up to” twice, and the last two sentences are
repealed. At (b, 1, C) sentencing is
changed to up to 20 years and where death resulted, up to life. At (b, 6) “on Federal lands” is repealed, so
that the sentence for hazardous poisoning is increased to a fine under Title 18
to cover the cost of cleanup, damages and the courts and up to 5 years if
causing only minor accidental bodily injury to a human or death to a few
animals, or up to 10 if involuntary manslaughter occurred or if a participant
in organized torture caused serious bodily injury and up to 20 for the
mastermind of an organized torture operation that didn’t kill but seriously
injured many people and up to life imprisonment if death was the result of an
intentional act of criminal mischief.
After 21USC(13)§841(a,
14 & 4, A) Attorney General is changed to
“Secretary”. At 21USC(13)§848 (a) the penalty for continuing criminal
enterprise shall be up to 20 years, at (b) insert “up to” to at (d) “under this
section, imposition or execution of such sentence shall not be suspended,
probation shall not be granted, and…not” are repealed (e) is repealed (s) is
repealed. At 21USC(13)§859 (a, 2) “a term of imprisonment under this subsection shall be not less
than one year. The mandatory minimum” is repealed” and at (b, 2) except and the
two sentences following are repealed. At 21USC(13)§860 “(b)(6)” is added after (a)(1) and at (a, 2)
“ . Except to the extent a greater minimum sentence is otherwise provided by
section 841 (b) of this title, a person shall be sentenced under this
subsection to a term of imprisonment of not less than one year. The mandatory
minimum” is repealed and at (b, 2) ‘Except to the extent a greater minimum
sentence is otherwise provided by section 841 (b) of this title, a person shall be sentenced under this
subsection to a term of imprisonment of not less than three years.” is
repealed, subpart (d) is repealed and (e) is relettered
(d). At 21USC(13)§861(b) the
second sentence and the second sentence at (c) shall be repealed and (e) is
repealed and (f) relettered (e). Secretary of Health and Human Services is
changed to Secretary at 21USC(13)§862 (a, 2 &
b, 2). At 21USC(13)§862a (a) after
eligible shall be inserted “while in prison”.
8.
A new section, “Torture 21USC(13)§866” shall be
inserted whereby,
(a)Torture
or conspiracy to intentionally torture people using Type II or III controlled
substances or a medically unnecessary combination of prescription drugs, whose
labels warn of serious adverse reaction or to without informed consent dose a
person with a schedule I hallucinogen to induce mental illness, is a felony for
which a perpetrator faces fines and up to life in prison, if death or mass
murder results from their abuse of a Type I, II or III controlled
substance.
(1)Registrants
convicted of torturing people generally shall be disbarred for up to ten
years. Employees, particularly those
caring for vulnerable people, are usually dismissed. Law enforcement officers are routinely
dismissed from the evidence and employment.
A judge or lawyer negligently acquitting a torturer shall face
malpractice proceedings for negligence and those found conspiring to torture
and issuing orders to torture people shall be disbarred and punished as if they
had committed the offense themselves.
(2)
Although civil and criminal penalties for torture are required of statute under
Arts. 2 & 4 of the Convention against Torture, Cruel, Inhuman and Degrading
Punishment or Treatment of 1986 as the result of the frequency with which the
crime of torture occurs, it is far more important, than torturing the
perpetrator with legal sanctions in revenge, for the victim, or the family of
the deceased, to be compensated and provided for as complete a recovery as
possible under Art. 14. No criminal
investigation is justified without having paid the victim/witness/researcher
compensation, purchased rights.
(3)
Properly performed, in writing, the civil tort should be sufficient to correct
the offender, the ailment of the victim and any systemic abuse. Proceedings are confidential. The civil conviction must be sent to the
professional license board, DEA, employer and any research grants the
registrant is participating in, for the registrant’s record, keeping the
victim’s identifying information confidential, and outlining the particulars of
the offense.
V.
Administrative and Enforcement Cooperation
9.The Administrative and Enforcement Provisions transfer
significant authority to Secretary of Public but retain the cooperation of the
Attorney General for the regulation of arresting law enforcement officers with
firearms employed by the Secretary and court proceedings involving the District
Attorney. The Attorney General
essentially has power of attorney for the Secretary in whose name proceedings
are undertaken and who is informed of case proceedings and statistics. Attorney General is changed to “Secretary of
Public Health” at 21USC(13)§871 and to “Secretary” at (a, b, and c);
Department of Justice is changed to “Drug Evaluation Agency” at (a) and “or
she” is inserted after he at (b & c).
Attorney General is changed to “Secretary” at 21USC(13)§871a, at (a, 1) Drug Enforcement
Administration is changed to “Drug Evaluation Agency” and the phrase “involving
methamphetamine” is repealed. At (a, 2,
A) “of methamphetamine or
scheduled listed chemicals (as defined pursuant to the amendment made by
section 711 (a)(1)” is repealed and “controlled
substances” inserted and at (a, 2, A, 1) methamphetamine is changed to
“controlled substances”. Attorney
General is changed to “Secretary of Public Health” at 21USC(13)§872 and to “Secretary at (a, b, c, e & f), 21USC(13)§872a.(a & b). At 21USC(13)§873 after
agencies is inserted “Secretary of Public Health”. Attorney General is changed to “Secretary” at
21USC(13)§874, §875(a), §876(a & c), §877, Drug Enforcement
Administration is changed to “Drug Evaluation Agency” and after Attorney
General is inserted “to be employed by the Secretary of Public Health” at
21USC(13)878(a) and after designate at (a, 5) is inserted “within the
discretion of Secretary”. Attorney
General is changed to “Secretary” at 21USC(13)§880(a, 2, b, 1, 2) At 21USC(13)§881(f, 1 & 2)
before schedule I and II is inserted “Type I, II or III or” and at (g, 1) after schedule I or II is
inserted “or type I, II, or III” and Attorney General is changed to “Secretary”
at (b, c, d, e, 1, D, 2, A, B, 3, 4, A, B, f, 2, g, 2, 3 and l). The Drug Enforcement Administration is
changed to Drug Evaluation Agency at 21USC(13)§883 and §886(a & b) where. Attorney General is changed to
“Secretary” at (a & c). Drug Enforcement Administration is changed to
“Drug Evaluation Agency” at 21USC(13)§886a (1, a, b
& c) and Attorney General to “Secretary” at (1, D). Attorney General is changed to “Secretary” at
21USC(13)§887. Drug
Enforcement Administration is changed to Drug Evaluation Agency at 21USC(13)§890. Attorney General is changed to “Secretary”
and Department of Justice to “Drug Evaluation Agency” at 21USC(13)§904.
VI. Import and
Export
10.Attorney General is changed to “Secretary of Public Health”
at 21USC(13)§952(a,
1) and to “Secretary” at( 2, A, B, C, b, 2, c, d, 1, 2, B, C). A new paragraph “(f) Importation of Type II
and III Pathogens are Prohibited”, is added that states, “Type I poisons and
Type II and III pathogens may not be imported into the United States. The Secretary of Public Health may apply to
the Secretary of State for an exception, that will be
made available to the public. (1) In the
annual application for Type I poisons he or she must explain the legitimate
commercial applications of the poison, market analysis, quota
and safety measures thereto. (2) In the
special application for Type II or III pathogens he or she must name the
pathogen, explain the disease caused by the pathogen, the public health threat
posed by the pathogen, where the disease is endemic, why US scientists want to
study the pathogen, why US scientists don’t go to where the disease is endemic
and could quarantine and prohibit the pathogen scientifically, what
laboratories have approved applications to study the pathogen, what safety and
containment methods they have in place, exactly how much of the pathogen they
expect to need for their chemical analysis and what detection, anti-toxin,
safety or regulatory technology of legitimate, prophylactic or medicinal merit
they hope to develop.”
11.
Attorney General is changed to “Secretary of Public Health” at 21USC(13)§953 (a, 2) and “Secretary” at (1, 4, b, c,
1, 3, 4, e, 1, 2, 3, f, 2, 4, 6, 7). A
new paragraph “(g) Exports of Type II and III Pathogens Prohibited” is added
that states, “The export of Type I poisons without legitimate commercial
applications and Type II and III pathogens from the United States is
prohibited. The Secretary of Public
Health may apply to the President of the United States for an exception, that will be made available to the public. (1) In the case of Type I poisons the
Secretary shall annually report on those poisons legitimately manufactured in
the United States for export, the purchasing nations, the purchasing
corporations, whether the purchasers have adequate safeguards in place, set
quotas. (A) Individuals, who have not
been licensed in both the sending and receiving country for possession and
legitimate use of a poison are not be permitted to cross the border in
possession of poison or to use the Postal Service for the shipping of
poisons. (2) In the case of Type II and
III Pathogens the Secretary shall make a special application when he or she
approves of a plan to export pathogens to foreign scientists, other than the
World Health Organization, for analysis.
In the application the Secretary shall name the pathogen, explain the
disease caused by the pathogen, why foreign scientists want to study the pathogen,
why the foreign scientists don’t come to the United States to study the
pathogen where it is quarantined and prohibited against export and malevolent
distribution, what nations and laboratories have approved applications to
receive the pathogen, what safety and containment methods they have in place,
exactly how much of the pathogen they want for the chemical analysis and what
detection, anti-toxin, safety or regulatory technology of legitimate,
prophylactic or medicinal merit they hope to develop. (A) In regards to the export of pathogens to
the World Health Organization, or other approved receivers, the Secretary shall
annually, or when suspicions pertaining to the export of pathogens exist but
are not sufficiently substantiated to justify individual prohibitive action on
the part of the Secretary, report to the Secretary of State.”
12.
Controlled is changed “psychotropic” and Attorney General is changed to
“Secretary of Public Health” at 21USC(13)§954(1&2). “Type I, II or III or” is inserted before
schedule at 21USC(13)§955.
Attorney General is changed to “Secretary” in 21USC(13)§956 (a & b) and controlled is changed
to “psychotropic” at (a, 1 & 2).
Attorney General is changed to “Secretary” at 21USC(13)§975 (a & b, 2), §958
(a, c, 1, 2, A, B, d, 1-6, e, f, g & i). “Type I, II, or III or” is inserted at §959 (a). At 21USC(13)§960
(b, 1 & 2) not less than is changed to “up to” thrice and at least to “up
to” twice and the last two sentences are repealed in both; at (3) at least
changed to “up to” twice and the last two sentences are repealed, at (4, A
& B) not less than is changed to “up to” in both; at (d, 5) Attorney
General is changed to “Secretary”. At §960a(a) not less than twice the minimum is
changed to “up to twice the” and at least to “up to”. Attorney General is changed to “Secretary”
at 21USC(13)§961. “Secretary and” is twice inserted
before Attorney General at §965. Attorney General is changed to “Secretary” at
21USC(13)§971(a, b, 1, 2, c, 1, 2, d, 1, B, C, D, 2,
A, i, B, f, 1, 2, 3, g, h, 2, 3).
VII. Change of Address
13. The Drug Enforcement Administration and references to the Department of Justice shall be repealed in the indexing of Title 21 of the Code of Federal Regulations to read Drug Evaluation Agency.
In both 21CFR§1300.01 and §1300.02 (b)(2) the term Drug Enforcement Administration is changed to Drug Evaluation Agency (DEA) and at (b)(3) the term Administrator means Administrator of
the Drug Evaluation Agency and the second sentence pertaining to the delegation of authority is repealed. §1301.03 requests for information on rules and §1301.13 (2) requests for forms §1301.14
applications §1301.18(c) research protocol increase requests §1301.51 modification of registration §1301.52(c) termination of registration §1309.32 application should be sent to Registration Unit,
strike - Drug Enforcement Administration, Department of Justice, Post Office – insert - Drug Evaluation Agency - Box 28083, Central Station, Washington, DC 20005. Department of Justice repealed
from the mailing addresses at §1301.52(b), §1301.71(d ), §1303.12(b&d), §1303.22. Drug Enforcement Administration repealed from mailing address in §1304.31(a) and §1304.32(a) . Administrator,
Drug Enforcement Administration, Department of Justice changed to Administrator, Drug Evaluation Agency §1301.17, §1307.03, §1307.22, §1308.25. §1308.24 (d), §1308.32, §1308.34, §1308.43
repeal Drug Enforcement Administration, Department of Justice and insert Drug Evaluation Agency. Drug Enforcement Administration changed to Drug Evaluation Agency at 28 CFR 0.100, §1306.03(d),
§1309.12(b), §1309.33(a), §1309.61, §130971(c), §1310.05 (e,2), §1310.06(d & g), §1310.21(b), §1311.08(c), §1312.13, §1312.18(b), §1312.19(b), §1312.22(a & d, 8), §1312.27(a & b, 5, iv),
§1312.28(d), §1312.30, §1312.31(b), §1312.32(a), §1313.12(b, d & e), §1313.14(b), §1313.21 (b, d & e), §1313.22(e), §1313.23(b), §1313.24 conclusion, §1313.31(b), §1313.32(b), §1313.34(b),
§1314.110(a, 1 & 2), §1316.02(b), §1316.21(a & b), §1316.22(b), §1316.23(a & b), §1316.24(a, b), §1316.31, §1316.45, §1316.46(a), §1316.47(a), §1316.48, §1316.72, §1316.77(a).
VIII. Probable Cause of PTSD
14. In Title 21 of the Code of Federal Regulations §1305.13(f) Procedure for filling DEA Forms 222 for Schedule I controlled substances states, “(f) DEA Forms 222 submitted by registered
procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than
the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting
the order.” It goes on in §1305.22 Procedure for Filling Electronic Order so that at (f) A supplier must ship the controlled substances to the registered location associated with the digital certificate
used to sign the order, except as specified in paragraph (h) of this section. (h) Registered procurement officers of the Defense Supply Center of the Defense Logistics Agency may order controlled
substances for delivery to armed services establishments within the United States. These orders may be shipped to locations other than the registered location, and in partial shipments at different
times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.” Schedule I substances include a number of hallucinogens, not popular
on the street, that could be responsible for the spike in suicide rates among deployed troops, as well as the mental illness aspects of Post Traumatic Stress Disorder. Also of concern to Gulf War
Illness sufferers are substances causing sciatica and neuromuscular pain and dysfunction as well deadly Lou Gehrig’s disease and also lock picks. §1305.13(f) and the exception clause ending
§1305.22(f) that states, “Except as specified in paragraph (h) of this section” and (h) need to be repealed. All contracts there-under need to be terminated under 41USC(2)§101(f) to prevent
improper payments and to detect and prosecute fraud and under 21CFR§1308.43.
15.There shall be inserted (8) Afghanistan and (9) Myanmar at
21CFR§1312.13(f) pertaining to nations
from whence the approved importation of narcotic raw material (opium, poppy
straw, and
concentrate of poppy straw) may have its source. At §1312.13(g) the import requirement that
at least 80% of the narcotic raw material in the United States shall have as
its original source
Indian
and Turkey and, except in times of shortage, not more than 20% of raw material
from Spain, France, Poland, Hungary and Australia shall be amended so that, “at
least 80% of the
narcotic raw material imported into the United States shall
have as its original source in Afghanistan.
Except under conditions of insufficient supplies of narcotic raw
materials, not more
than 20% of narcotic raw materials imported into the United
States annually shall have as its source, Turkey, India, Spain, France, Poland,
Hungary, Australia and Myanmar.” 96% of
the
world’s illicit opium supply is produced in Afghanistan,
three times the world’s licit demand.
Whereas the United States and the international community have invested
so heavily in
Afghanistan
they must arrange with the Afghan government to purchase a quota of opium
legitimately from the Afghan Opium Agency.
To consume the rest of the Afghan opium
production
without much trouble with the law scholars in the field of Asian opium trade
recommend turning Afghanistan into something of a red light district for tourists
the population,
8%
of whom are involved in the opium trade, would
support, to arrest the manufacturers of heroin and smugglers, like they do in
the Netherlands, more than in the rest of Europe.
IX. Control of Toxic Substances and Drugs Regulation in General
To extend the registration and prohibition of controlled substances by the DEA to all pathogens causing diagnosable disease used in laboratories, so that the criminal malevolence of the
DEA would be directed against society’s real organized criminals from whence the high levels of vehemence against substance abuse have been diverted to the slavery of relatively harmless
narcotic addicts, a new Part of DEA statute in the CFR and Type setting of substances controlled by drug regulation are drafted for both the CFR and CSA to set forth a rational regime for
the registration of the possession, transfer and use of named pathogens to facilitate the control, inspection, prohibition and destruction of poisons and disease pathogens. The new Part 1317
is as follows:
§1317.01 Scope of Part 1317
(a)Procedure for the registration, inspection and prosecution of all laboratories possessing, using, transferring, distributing and manufacturing Type II and III pathogens and for their
destruction, pursuant the definitions in §1317.12 & 13 and 21USC(13)(I)(B)§815 (as amended by this Act) and the Prohibitions with Respect to Biological Weapons under
18USC(10)§175 and their Destruction under §176 of Title 18 .
(b) To put drug and disease control in perspective Typesetting extends farther than the responsibility of the DEA to cover all substances with medicinal or toxic qualities for the benefit
of pharmacology and the understudy of toxicology, but the new authority of the DEA extends only to Type II and III pathogens, without further statutory authorization.
(c) Cooperative arrangements are established with the Food and Drug Administration (FDA) under §1317.03, the Center for Disease Prevention and Control (CDC) and Agency for
Toxic Substances and Disease Registry (ATSDR) under §1317.02(c), and US Patent and Trademark Office under §1317.08, to name and classify Type II and III laboratory pathogens
in need of control and prohibition.
(d) Cooperative arrangements are established with the American Association of Poison Control Centers and Office of Human Research Protection to process complaints from the public
regarding exposure to laboratory pathogens in the community under §1317.04.
§1317.02 Epidemiologic Statistical Studies
(a)The existing system of control of laboratory pathogens is reliant entirely upon epidemiologic statistics pertaining to the incidence of disease under geographic or institutional control.
The theory is that disease is caused by exposure to a pathogen. When there is a statistically rise or disparity in the rates of a diagnosable disease the epidemiologist seeks to eliminate
the source of the pathogen. In contemporary society, where there is adequate control of environmental toxins, the source of deadly and disabling disease are usually leaks from animal
laboratories. The names of the pathogens of most concern are however protected by a conspiracy of silence in the peer reviewed literature that is hereby classified as conspiracy in
violation of 21USC(13)(ID)§846 and 841(b, 6), as amended.
(b) The confidentiality of statistical research must be enforced. The commonly used term “epidemiologic surveillance” is easily abused to finance the malevolent distribution of pathogens.
Whereby the DEA and registrants shall assure the confidentiality of patients, human research subjects and the personally identifying information of all humans vulnerable to victimization
by biological experimentation pursuant to the discretion of the Secretary under 21USC(13)IE§872(c) to pay witnesses, condone the use of the term “epidemiologic statistical study” and
suspect the term “epidemiologic surveillance” of abuse of power.
(c) When registering any new pathogen under §1317.05 the DEA will commission an epidemiologic statistical study of the incidence of the disease, disorder or condition caused by
the pathogen from the ATSDR. The report from ATSDR shall show,
(1) Contemporary understanding of the toxicology of the pathogen.
(2) National associations specializing in the treatment of the disease, disorder or condition caused by the pathogen.
(3) Total number of reported incidences of the disease, disorder or condition in the United States over time.
(4) Regional disparities in the incidence of the disease, disorder or condition, particularly in the jurisdiction of the registrant.
(d) When inspecting a registrant under §1317.06 the DEA shall commission an epidemiologic statistical study on the local and institutional incidence of the disease.
(e) The first report shall be a thorough statistical analysis of the incidences of mental illness that could be caused by involuntary exposure or overexposure to Schedule I hallucinogens
for which the Administrator sets production quotas. The more malevolent hallucinogens are due consideration for Typesetting and control as Type III pathogens under §1317.13.
(f) In producing their epidemiologic reports the Administration shall not perform or authorize any human or animal toxicological experimentation but shall instead solicit for toxicological
and statistical information and the voluntary testimony of people regarding their written accounts of exposure to toxic substances and any documented forensic evidence or discriminatory
lack thereof.
(g) After dissemination pursuant to §1317.10 research on the DEA website, shall link the name of diseases to the name of the pathogens that cause it and the name of the pathogens to
registered manufacturers, distributors, possessors and users.
§1317.03 DEA Arm of the Food and Drug Administration
(a)The DEA shall be responsible to the Commissioner of the Food and Drug Administration (FDA), the Food, Drug and Cosmetic Act and Title 21 of the Code of Federal Regulations.
The Commissioner shall recommend the Administrator and senior officials of the DEA for the nomination of the President. The Commissioner of the FDA or Secretary may dismiss an
Administrator or any DEA agent for probable cause.
(b) The DEA shall continue to be co-operate with the Attorney General in regards to their certification to carry firearms, make arrests and prosecute felonies under 21USC(13)IE§878.
Although DEA Agents are employees of the Secretary they shall not fail to prosecute organized crime, fraud and abuse of power concerning controlled substances or the laws of the United
States or nations, within either Department. The most desirable trait in DEA agents shall be their prosecution of violations under Title 21 of the Code of Federal Regulations and United
States Code in the best interest of the public health of the United States and United Nations.
(c) Although the DEA is charged with registering the possession, transfer and use of all pathogens within the Public Health Service, their approved programs, all laboratories licensed in
the United States, or licensed to do business with the United States, the DEA shall never possess any pathogens.
(d) All pathogens or other bio-hazardous materials subjected forfeiture to the United States under 21USC(13)IE§881(a) by order of the DEA, or any other federal, state or local law
enforcement officer or Court, shall be seized by a hazardous material handler licensed by the Department of Public Health. The DEA shall witness and document the secure storage
of the controlled substances during proceedings, if any, and destruction of such controlled substances under 18USC(10)§176 and 21USC(13)IE§881(f).
(e) The DEA Controlled Substance Code Number system may be adapted by statute to any type of controlled substance. Under existing law cooperation between the DEA and the
FDA is exclusively along the lines of registering the manufacturers and distributors of all narcotic and hallucinogenic drugs under the Schedules I-V adapted at 21USC(13)IB§812 and
Part 1308 of Title 21 of the Code of Federal Regulations from the International Convention on Psychotropic Substances of 1971. Under this law the DEA Controlled Substance Code
number system shall be adapted to regulate the manufacture, distribution, possession and destruction of Type I and II pathogens defined at 21USC(13)IB§815 and in this Part.
(1)The FDA shall cooperate with the DEA by requiring all bio-medical research laboratories possessing pathogens within the United States to annually register their entire inventories
of pathogens with the DEA under 21USC(13)IC§822 thereafter all new manufacture, acquisition, transfer, use and destruction of pathogens must be registered with the DEA.
§1317.04 Human Research Protection of the Poison Control Centers
(a)To
better protect the population against being involuntarily subjected to
biomedical research pathogens diverted from their intended for use in animal
toxicology studies, or adapted
for
use there from, or other laboratory pathogen, the American Association and
regional Poison Control Centers shall be informed by the DEA of all
manufacture, distribution,
possession and use of investigational pathogens in
laboratories in their respective jurisdictions.
(1)The
Poison Control Centers shall have observational access to the registration
database and shall receive a 33% share of all license fees under §1317.05(d)
(2)
The Poison Control Centers shall personally inspect the documentation and
security of all laboratories manufacturing, distributing, possessing and using
pathogens registered with
the DEA pursuant to 21USC(13)IE§880.
(3)
The Poison Control Center shall send one copy of their inspection report to the
Institutional Ethics Committee of the laboratory, if any, and one copy of their
inspection report to the
office of the DEA that registered the manufacture,
possession or use of the controlled substance(s).
(4)If
consent to inspect the laboratory is denied, the Poison Control Center shall
inform the Institutional Ethics Committee, if any, and the DEA of probable
cause for an inspection
warrant under 21ISC(13)IE§880(d).
(b)
Institutional Ethics Committees authorized under Title 45 of the Code of
Federal Regulations Part 46 shall not be subjected to any regulation by the DEA
whereas their independent
judgment pertaining to the ethics of human research projects
undertaken by the institution or institutions that employs them, must be
protected. Under this section however
Institutional
Ethics
Committees shall take responsibility for the mockery of the IRB in their
authorizing statute and shall inventory all pathogens in their institutions in
cooperation with the regional
Poison
Control Centers in accordance with (a)(3) above. This section shall help Institutional Ethics
Committees to prevent grave breaches of human research protection involving
leaks
of hazardous pathogens from laboratories in their institution,
where there is no informed consent.
(1)In
reward for materially complying with their Institutional Ethics Committee and
Poison Control Centers in regards to their inventories of pathogens
institutional laboratories will be
annually entitled to a highly reduced “institutional”
license fee. For the purpose of granting
an institutional discount the DEA shall verify that the Institutional Ethics
Committee is
authorized by the Office of Human Research Protection
(OHRP).
(c)
Once inspection has confirmed the control of DEA registered laboratories, and
the American Association is statistically prepared, the regional Poison Control
Centers shall take
calls from the public in regards to their suspected exposure
to laboratory pathogens and investigate those reports.
(1)Registrants
shall respect the order of the Poison Control Center or Institutional Ethics
Committees, to destroy their stockpiles of any pathogen and document their
compliance to
the DEA.
(2) If the laboratory wishes to contest the order to destroy a pathogen the pathogen or other bio-hazardous materials shall be considered subjected to the forfeiture to the United States
under 21USC(13)IE§881(a) by order of the DEA, and shall be seized by a hazardous material handler licensed by the Department of Public Health. The DEA shall witness and
document the secure storage of the controlled substances during proceedings, if any, and destruction of such controlled substances under 18USC(10)§176 and 21USC(13)IE§881(f).
The DEA shall never possess any pathogens.
§1317.05 New Registration and Annual Renewal
(a)Every laboratory who manufactures, distributes, possesses or uses any Type II or III controlled substance or who proposes to engage in the manufacture, distribute, possess or use
of any controlled substance shall obtain a registration from the DEA. If an institution or corporation has more than one laboratory each laboratory must register, but they shall be filed
together under the name of the institution or corporation, and provided they have an Institutional Ethics Committee approved by the Office of Human Research Protection (OHRP)
shall be entitled to a discount institutional rate.
(b) To protect DEA staff against exposure all registration and orders shall be done electronically, over a secure Internet connection. Digital signatures shall be required. After a form
is filled out the computer shall generate an easily printable receipt of all the information in the form. Payment will also be taken online. An application will not be processed without
payment. The registrant is required to print out at least one copy for their records. Not to burden the proof with tampered evidence DEA records should be particularly secure. The
DEA is liable to ensure that all their law enforcement activities are lawful and that the premises and people and computers of the laboratory and central DEA computer program are
free of malevolent searches and tampering under 21USC(13)§885(d).
(c) The initial application for DEA registration account must include:
(1)Investigator:
(i)Name, address of laboratory, and DEA registration number; if any.
(ii) Email address, telephone number
(iii) Institutional affiliation.
(iv) Qualifications, including a curriculum vitae and an appropriate bibliography (list of publications).
(2)
Research project:
(i) Title of project.
(ii)
Statement of the purpose.
(iii)
Name of the controlled substance or substances involved, whether they
manufacture it on site, and the amount of each needed.
(iv) Disease, disorder or condition caused by the pathogen.
(v)
Description of the research to be conducted, including the number and species
of research subjects, the dosage to be administered, the route and method of
administration, and
the duration of the project.
(vi) Location where the research will be conducted.
(vii)
Statement of the security provisions for storing the controlled substances (in
accordance with §1301.75) and for dispensing the controlled substances in order
to prevent diversion.
(3)
Authority:
(i)Institutional
approval.
(ii)
Applicable federal, state and local laws and licenses.
(ii)
Approval of a Human Research Committee for human studies and certification in
research not intended for humans.
(iii)
Indication of an approved active Notice of Claimed Investigational Exemption
for a New Drug (number).
(iv) Indication of an approved funded grant (number), if
any.
(v)
If the investigator desires to manufacture, export or import any Type II or III
controlled substance for distribution a statement of the quantity to be
manufactured or imported and the sources of
the chemicals to be used or the substance to be imported the
investigator may pay for the registration but must be approved by both the
Secretary of Public Health and Secretary of State
before beginning to engage in the activity.
(d)
Prohibitive Cost
(1)
Each registration for authorization to acquire, manufacture
or purchase to possess and use a justified quantity of one Type III pathogen,
for one year, costs $5,000
(2)
Each registration for authorization to acquire,
manufacture or purchase to possess and use a justified quantity of one Type II
pathogen, for one year, costs $10,000
(3)
Each registration for authorization to distribute a
justified quantity of one Type III pathogen, for one year, costs $25,000
(4)
Each registration for authorization to distribute a
justified quantity of one Type II pathogen, for one year, costs $50,000
(5)
Each registration for authorization to manufacture and
distribute a justified quantity of one Type III pathogen, for one year, costs
$50,000
(6)
Each registration for authorization to manufacture and
distribute a justified quantity of one Type II pathogen, for one year, costs
$100,000
(7)
Each registration for an institution with an OHRP
approved Human Research Board, other than for manufacture and distribution,
shall be half the price.
(i)
33% of filing fees go to the regional Poison Control Center
who shall also inspect the facility.
(ii)
33% of filing fees shall be put in a
victim/witness/independent prohibition authors and hazardous material
destruction fund.
(iii)
33% of filing fees shall go to finance the diversion
control operations of DEA.
(e)
Applications submitted for filing are dated upon receipt. Applications failing
to comply with the requirements will not generally be accepted for filing. In
the case of minor defects as
to completeness, the Administrator may accept the
application for filing with a request to the applicant for additional
information. A defective application will be returned to the applicant
within 10 days following its receipt with a statement of the
reason for not accepting the application for filing. If found to be complete, the application will
be filed with ATSDR for
toxicological and epidemiologic analysis. Provided these are not novel substances, when
the DEA possesses official government toxicological and epidemiologic
information regarding
all the pathogens in question an inspector shall be
dispatched. If they are novel substances
the laboratory will also be required to pay for a patent pursuant to §1317.08
and the DEA shall
issue the substance a DEA Controlled Substance Number when
the substance is sufficiently understood.
Once background information is found to be complete and filed the DEA
inspector
shall call upon the laboratory to conduct an
inspection. Registration will not be
granted unless the DEA inspector feels the documentation and security of the
laboratory are sufficient to
contain the pathogen and the proposed research is morally
justified. The DEA inspector will not
accept any bribes or gifts.
§1317.06 Inspection
(a)The
inspector shall be a salaried employee of the DEA. The inspector shall have a post-graduate
degree in toxicology, pharmacy, chemistry, public health, or medicine and
laboratory
experience sufficient to verify the veracity of normal
scientific inventory claims. The
inspector shall be versed in medical ethics, human rights, federal, state and
local law pertaining
bio-medical research laboratories and bio-hazardous material
in his or her jurisdiction. The
inspector shall be trained and certified by the Attorney General to make
arrests and to bear
firearms. During the
course of a normal inspection the inspector shall not bear firearms or
handcuffs. Authority to inspect
controlled premises of laboratories comes from the Secretary
of Public Health (formerly the Secretary of Health and Human
Services) under 21USC(13)IE§880
(1)It
is forbidden to give a DEA inspector any bribes or gifts or to intimidate them
or their family or commit acts of violence against them.
(2)
The inspector shall be in perfect health, entitled to up to 20 sick days a
year, eligible for transfer to another position or disability or retirement
benefits.
(3)
Should the inspector fall ill the laboratories inspected over the past two or
three days will be re-inspected.
(4)The
inspector shall be clean and polite.
(b)
The inspector must be permitted, upon furnishing appropriate credentials and a
written notice of inspection to enter the controlled premises of the laboratory
for the purposes of:
(1)Inspecting, copying, and verifying
the correctness of records, reports, or other documents required to be kept.
(2) Inspecting, within reasonable
limits and in a reasonable manner prescribed by guided tour of the principal
investigator or knowledgeable staff, the controlled premises and all
pertinent equipment, finished and unfinished pathogens,
finished or unfinished drugs, listed chemicals, and other substances or
materials, containers, and labeling found therein and
the wellbeing and treatment of any animal
laboratory animals.
(3) Questioning knowledgeable staff
regarding the operations of the laboratory, the records, equipment, treatment
and inventory.
(4)In most circumstances the inspector
will call to schedule an appointment.
Usually the inspector wishes to interview the principal investigator or
staff or for their guided tour, in
which case he or she shall call before he
comes. Inspections are however at the leisure of the inspector, on the receipt
of a confidential complaint, or on a semi-annual basis.
(c)
Within a reasonable time after the inspection has been complete, not to exceed
one week, the inspector shall prepare an inspection report. If the inspector finds the stockpile of
pathogens is too large or all or part of the experiment is
unethical or otherwise unjustified or makes any other finding with which the
laboratory must materially comply, the laboratory
shall have to comply with the directives to limit their use
of pathogens, for the continuing approval of their registration. The inspector shall return after a reasonable
time to verify
compliance with the order.
If the inspector decides to deny or revoke an authorization for the
possession of pathogens the laboratory must request hearing within 20 days
under
§1316.47. If the registrant decides to withdraw their
application and is verified to have destroyed their pathogens, the initial
filing fee or remainder of the year’s registration shall
be returned. If the
registrant decides to appeal they shall be responsible for the cost of the
entire of the year if they must be ordered to destroy their stockpiles. If the registrant
wishes to contest a negative decision of the DEA in Court
the pathogens shall be seized by a licensed a hazardous materials handler
employed at the expense of the DEA, for the
duration of Court proceedings. If the Court decides against the Registrant
they shall be liable for $25,000 court costs.
(d)
If the inspector determines that the laboratory is involved in grave violations
of the Controlled Substances Act, the Registrants shall be tried for felony
upon conviction of which
will warrant their suspension under 21USC(13)IC§824 and
prosecution under Prohibitions with Respect to Biological Weapons under
18USC(10)§175 and their Destruction
under §176 of Title 18.
§1317.07 Initial Inventory
(a)The
initial inventory filings to the DEA will be voluminous. Within three months from the passage of this
Act all licensed bio-medical research laboratories possessing pathogens
capable of causing deadly or disabling disease shall either
destroy their pathogens or be required to file for and pay the registration
fees for their entire inventories.
Failure to either
destroy their pathogens or pay the filing fee for pathogens
within their possession or control, after three months will result in a reasonable
fine not to exceed $250,000 for simple
possession under Prohibitions with Respect to Biological
Weapons under 18USC(10)§175 to pay for their Destruction under §176 of Title
18.
(b)
To process the applications the first thing that must be developed in
cooperation with ATSDR and the FDA is a computer program to accept applications
and payment under
§1317.05
and to monitor all subsequent transfers of pathogens between Registrants.
(c)
The initial workload will be divided geographically and into months. Application fees will provide money to hire
new toxicologists and will provide technical and Within
one
year all Registrants should be inspected and those
Registrants who are approved authorized.
Stockpiles of deadly and disabling pathogens in the United States should
be dramatically
depleted. The DEA
Diversion Control website should have a fairly comprehensive list of pathogens
with DEA Controlled Substance Numbers indexed to the disease they cause and
Registrants
manufacturing, distributing and possessing those pathogens searchable by
pathogen, geographic area, name of Registrant and .
(c)
The DEA will be required to report on their operations and prosecutions
lowering national and regional levels of laboratory pathogens and corresponding
impact on epidemiology,
as available, under this Part one year after the
implementation of this program and every year thereafter, when it should be
possible to gauge epidemiologic progress under the existing
two year delay on mortality statistics.
§1317.08 Patent Cooperation
(a)The
DEA shall cooperate with the US Patent and Trademark Office (USPTO) to inform
the scientific community and public of the names, and chemical formulas or
physical composition
of pathogens, to facilitate their control and the
development of detection, anti-dote, prohibition and elimination
technology.
(1)The
application must include the name of the pathogen; the chemical formula or
material composition of the pathogen; the disease or pathogenesis it causes;
the threat it poses to public
health; method of manufacture, acquisition or purchase (mail
order catalogues and formulary books of pathogens should be attached), method
of control and containment, method of
destruction, neutralization or disposal; plan for the
elimination, control or limitation on the legitimate medical research uses of
the pathogen; and any confidentiality or security concerns
the scientists wishes the Patent Office to honor.
(b)The
DEA shall receive pathogen patent applications under §1308.43 as they pertain
to Typesetting decisions under §1317.10 and mostly to the granting of DEA
Controlled Substance
Numbers to pathogens being put under control.
(1)
The USPTO shall devise a special patent classification number for pathogens
(c)
Designation as a weapon by the government under 35USCIII(27)§267
is insufficient whereas biological weapons are prohibited pursuant to
18USC(10)I§175. In regards to pathogens
it is not the substance that is useful but the patent, in
eliminating the substance. The DEA Controlled Substances Number and
registration system promises to give pathogens
the process of control and prohibition they are due. The patent system offers to promote the
development of detection, containment and anti-toxin technology for a
reasonable fee under
35USC(I)(4)§41.
(c)
When the DEA receives patent applications from Registrants or non registrants
with novel pathogens the first thing the DEA shall do is request the Registrant
to either destroy the
pathogen or pay a registration fee for its possession under
§1317.05. Regardless of whether or not
applicant pays the registration fee the DEA shall consult with the
toxicologists of
the ATSDR and Secretary of Public Health (HHS) for
corroborating toxicology and epidemiologic reports. Within three months, but not longer than
three years, the DEA will
determine whether of not to grant the pathogen a DEA
Controlled Substances Number. The
applicant will be informed of the decision and consulted in regards to future
control efforts,
if this is agreeable.
§1317.10 Type Setting
Also
published at 21USC(13)IB§815
(a)When
determining whether or not to grant a DEA Controlled Substances Number under
§1308.43 the Administrator of the DEA, in consultation with the Secretary,
shall primarily
decide whether the risk of abuse posed by a laboratory
pathogen qualifies as a Type II deadly pathogen or III disabling pathogen. The Administrator shall also make decisions
under
§1308.43
whether commonly prescribed drugs, such as chemotherapy, qualify as Type IV
hard “drugs” and whether certain hallucinogens in Schedule I qualify as Type
III for their
particularly high risk of mental illness and should be
prohibited from circulation by Registrants under the Convention on Psychotropic
Convention.
(b)
When the Administrator receives an application for a novel controlled substance
whether by patent application or Registrant the Administrator shall send the
information with a
Request
for Toxicology and Epidemiology Corroboration to the FDA who may consult with
the Chemical Weapons Convention Implementation Assistance Program, ATSDR or
National Select Agent Registry of the Secretary of Public Health
(HHS) and Secretary of State.
(1)The
FDA shall respond to the DEA with either a Response Corroborating the Toxicity
and Theoretical Epidemiology of a Pathogen and Directives on Typesetting and
Control,
within one month, or a Request for Extension of Time.
(c)
The FDA shall set the Type for a pathogen in accordance with the decision of
the FDA and report the decision for publication in the Federal Register.
(1)All
federal bio-medical research grantees shall be notified of the Type setting for
a particular pathogen and within three months all manufacturers, distributors,
possessors and
users shall be expected to either destroy the pathogens
within their possession and control or file and pay for Registration.
Type I Poison
§1317.11 Type I Poisons
(a) All poisons and compounds deadly to human and animals shall be listed in Type I.
(b) Type I shall consist of those poisons, or deadly
compounds, by whatever official name, common or usual name and brand name
designated. The list shall be compiled
by credible
science in cooperation with the Chemical Weapons Convention
Implementation Program as follows:
Type II Deadly
Pathogens
§1317.12 Type II Deadly Pathogens
(a)Each controlled substance is assigned the DEA Controlled
Substances Code Number set forth opposite it.
All toxins, bacteria, viruses and pathogens known to toxicology to cause
a
diagnosable, deadly, disease, such as AIDS, atherosclerosis,
Alzheimer’s, cancer, diabetes, etc., in humans or animals shall be listed in
Type II.
(1)Permits for Type II pathogens shall be issued only to authorized chemical analysts for developing detection,
anti-dote or safety technology and all applicable local, state and federal law.
(b) Type II shall consist of those toxins, bacteria,
viruses and pathogens, known to toxicology to cause deadly disease in humans or
animals, by whatever official name, common or usual
name or brand name designated and the disease or condition they cause. The list shall be compiled by credible
science in cooperation with the Agency for Toxic Substances and Disease
Registry with particular attention to the pathogens used in
academic animal toxicology studies, as follows:
(1)HIV Human Immunodeficiency Virus causes AIDS Acquired
Immunodeficiency Syndrome.
(2)H(1-5)N(1-5) cause Influenza A
Type III Disabling Pathogens
§1317.13 Type III Disabling Pathogens
(a)Each controlled substance is assigned the DEA Controlled
Substances Code Number set forth opposite it.
All toxins, bacteria, viruses and pathogens known to toxicology to cause
a
diagnosable, painful and/or debilitating, disease or
disability, other than deadly, such back pain, knee pain, irritable bowel
syndrome, migraines, paranoid schizophrenia, depression,
arthritis, etc., shall be listed in Type III.
(1)Permits for Type III pathogens shall be issued only to authorized chemical analysts for developing detection,
anti-dote or safety technology in accordance with all applicable local, state
and
federal law.
(b) Type III shall consist of those toxins, bacteria,
viruses and pathogens, known to toxicology to cause painful and/or debilitating
disease or disability in humans or animals, by whatever
official name, common or usual name or brand name designated and
the disease or condition they cause. The
list shall be compiled by credible science in cooperation with the Agency for
Toxic Substances and Disease Registry, Secretary of HHS and
Administrator of the UDSA, with particular attention to the pathogens used in
academic animal and human toxicology
studies, as follows:
Type IV Chemotherapy and Hard
Drugs
§1317.14 Type IV Chemotherapy and Hard Drugs
(a)Each controlled substance is assigned the DEA Controlled
Substances Code Number and an FDA National Drug Code (NDC) set forth opposite
it. All controlled substances
considered to be therapeutic “drugs” but known to
pharmacology for their particularly high potential for abuse as the result of
dangerous or debilitating side effects or addiction or
otherwise subjected to heightened regulation shall be listed in
Schedule IV.
(1)Quotas for Schedule IV drugs shall be set in accordance
with the Controlled Substances Act and projected legitimate demand.
(2) A prescription for a controlled substance must be
issued for a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice under
§1306.04 or is specially registered to administer narcotic
maintenance of detoxification treatment under §1306.07 or to administer
chemo-therapy that should be subjected to extra
regulation.
(b) Type IV shall consist of therapeutic “drugs” with a
high potential for abuse as the result of harmful side-effects, mental illness,
or addiction such as chemotherapy, heroin,
cocaine, crack cocaine, methamphetamine, LSD, gamma-hydroxybutyric acid etc. by whatever official name, common
or usual name or brand name designated, that are for good
reason or government inability to remove, in circulation and
consumed as drugs. The list shall be
compiled by credible science in cooperation with the Food and Drugs
Administration,
as
follows:
Type V Prescription Drugs
§1308.08 Type V Prescription Drugs
(a)Each controlled substance is assigned a DEA Controlled
Substances Code Number and a
FDA National Drug Code (NDC).
All controlled substances considered to be prescription
drugs shall not have any special hazards, such as
extraordinarily debilitating or dangerous side effects or a high risk of
dependency, or otherwise not subjected to extra regulation or
prohibition shall be listed in Type V.
(1)A prescription for a controlled substance may be issued only by an individual practitioner authorized to dispense controlled substances in the jurisdiction in which they practice
under §1306.03.
(2) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional
practice under §1306.04.
(3) A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed
in a registered pharmacy, a registered central fill pharmacy, or registered institutional practitioner under §1306.06.
(b) Type V shall consist of all prescription drugs listed in the FDA National Drug Code (NCD) without a particularly high risk of abuse. There are too many to list herein. Due
process is for the patient, physician and pharmacist to evaluate them with particular concern for potential adverse drug reactions warned about in the warning label or in combination
with other drugs being taken or particular to that person.
(1)When drugs are found to be particularly dangerous the policy is to recall them, or if the therapeutic benefits cannot be found in other safer drugs or consumer demand is too strong,
to move them to Schedule IV for heightened regulation and when drugs are found to be particularly useful and harmless to move them to Schedule VI so they can be sold over the
counter.
(c) In 2003 there were 17 therapeutic classes of prescription drugs. These classes in order of sales are (1) Antidepressants
(SSRIs, SNRIs) (2) Anti-hyperlipidemics (Statins) (3)
Anti-ulcerants
(Proton-pump inhibitors) (4) Anti-hypertensives
(ARBs, ACE inhibitors) (5) Antibiotics (Broad- and medium-spectrum) (6)
Diabetes Therapies (Oral, injectible)
(8)Anti-arthritics (COX-2
inhibitors) (8) Antipsychotics (9) Antihistamines (Oral) (10) Neurological
Drugs (For seizures or pain) (11) Other Vascular Drugs (Calcium- or beta-
blockers)
(12) Anti-asthmatics (13) Aalgesics (Non-narcotic)
(14) Bone Density Regulators (15) Oral Contraceptives (16) Anti-allergy Drugs
(Nasal steroids) (17) Analeptics
(ADHD treatments)
Type VI Over-the-Counter Drugs
§1308.09 Type VI Over-the-Counter Drugs
(a)Type
VI shall consist of the over-the-counter drugs and other substances, by whatever
official name, common or usual name, chemical name, or brand name designated to
be safe
for use without a prescription.
(1)Regulations
on the format and content requirements for nonprescription drug product
labeling are contained in 21 CFR 201.66.
(b)
Type VI shall consist of all drugs and controlled substances approve for
over-the-counter including those listed in §1308.15 that has contain trace
amounts of drugs controlled
under the International Convention on Psychotropic
Substances. There are too many for any but the FDA to list.
Type VII Alcohol, Tobacco,
Marijuana and Opium
§1308.10
Type VII Alcohol, Tobacco, Marijuana, Coca and Opium
(a)Type VII is for popular recreational drugs sold to
adults legally although they are highly addictive in the case of tobacco and
impairing and sometimes addictive in the case of
alcohol, or are cultivated plants with mildly hallucinogenic or
analgesic properties from whence a large number of pharmaceutical drugs are
manufactured. They are all mildly
addictive and are sold illegally, although several states have
passed medical marijuana laws.
Marijuana, coca and opium have DEA Controlled Substances Code Numbers.
(1)Alcohol has been brewed for thousands of years and in
the United States it is legally sold only to people over the age of 21 in most
counties. Tobacco was smoked by native
Americans and today around 25% of the world population
smokes, in the United States it is legally only to people over the age of 18.
(2)Although there are no known fatalities from marijuana
and it is attributed with a number of medicinal qualities, for which reason
many states have legalized medical marijuana a
nd have considered. In
defiance of common sense marijuana is considered a Schedule I Substance for the
purpose of import and export under the International Convention on
Psychotropic Substances at §1308.11
(3) Coca leaf and Opium are plant products listed as Schedule
II Substance for the purpose of import and export under the International
Convention on Psychotropic Substances at
§1308.12. Coca and
opium grow primarily in the Andes and the so-called Golden Triangle and Golden
Crescent in Asia, respectively. An
extensive pharmacopeia of narcotic
analgesic and anesthetic drugs of varying strength are manufactured
from coca leaves and opium poppy straw or opium gum, including several illicit
hard drugs – heroin, cocaine
and
crack. Coca leaf is a mild stimulant and
opium a mild analgesic. The natural
forms might be more therapeutic and cost effective than their derivatives, but
are not traditional to
American culture, and are prohibited.
Type VIII Tea,
Coffee and Stimulating Beverages (reserved)
Type IX Endangered
Species, Toxic Plants and Animals (reserved)
Type X Medicinal Herbs, Dietary
Supplements, Vitamins & Minerals (reserved)