I 114th CONGRESS 2d Session H. R. 6243 IN THE HOUSE OF REPRESENTATIVES September 28, 2016 Mr. Donovan (for himself and Mr. Rooney of Florida ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committees on the Judiciary , and Oversight and Government Reform , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To improve the ability of the Federal Government to address synthetic opioids, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Comprehensive Fentanyl Control Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Findings; sense of Congress. Sec. 3. Controlled substance analogues. Sec. 4. Treatment of controlled substance analogues. Sec. 5. Enhanced penalties. Sec. 6. Endangering human life while illegally manufacturing controlled substance. Sec. 7. Temporary scheduling of synthetic opioid analgesics. Sec. 8. Tableting machines, encapsulating machines, and controlled substance counterfeiting materials. 2. Findings; sense of Congress (a) Findings The Congress finds as follows: (1) Fentanyl is a dangerous, synthetic opioid that’s 50 to 100 times more potent than heroin and morphine and lethal in doses as small as approximately 2 milligrams. Current sentencing enhancements do not reflect the danger fentanyl poses at lower quantities compared to other illicit substances. (2) Because a lethal dose of fentanyl can be accidentally inhaled or absorbed through the skin, it’s not just deadly to its users, but it also threatens the lives of law enforcement and customs officials, public health workers, first responders and postal workers who risk unknowingly coming into contact with fentanyl in its different forms. (3) From 2013 to 2014, the number of drug seizures by law enforcement that tested positive for fentanyl increased by 426 percent and synthetic opioid-related deaths increased by 79 percent, with over 700 overdose deaths related to fentanyl. However, due to variations in States’ medical examiner and coroner testing and reporting techniques, and deaths attributed to heroin, this figure is believed to be significantly higher. (4) Illicitly manufactured fentanyl, pill press machines, and other supplies needed to manufacture counterfeit pills containing fentanyl are primarily sourced from China and widely available for purchase on the Internet. Traffickers can typically purchase a kilogram of fentanyl powder for as little as $2,000 from a Chinese supplier, transform it into hundreds of thousands of pills, and sell the counterfeit pills for millions of dollars in profit. (5) In 2015, the Drug Enforcement Administration (DEA) and Centers for Disease Control and Prevention (CDC) issued nationwide alerts identifying fentanyl as a threat to public health and safety and stating that the rise of counterfeit pills that contain fentanyl in the illicit drug market will likely result in more opioid-dependent individuals, overdoses, and deaths. (6) The DEA has identified two key challenges for using the Controlled Substances Analogue Enforcement Act of 1986 ( 21 U.S.C. 801 note) to prosecute individuals for violations relating to fentanyl: (A) The law requires that the substance have a substantially similar chemical structure to a controlled substance in order to be considered an analogue, yet the threshold for substantially similar has been cited by numerous courts as difficult to apply. (B) Each case requires additional investigation to determine whether the substance in question was intended for human consumption and can therefore be considered an analogue. (7) Illicit fentanyl manufacturers are continuously manipulating the chemical structures of the analogues in order to stay ahead of researchers and law enforcement, thus making prosecuting these crimes overly onerous. Furthermore, the speed at which these alterations can be made outpace the current authorities of the Department of Justice to schedule new compounds and analogues under the Controlled Substances Act ( 21 U.S.C. 801 et seq. ). (b) Sense of Congress It is the sense of the Congress that— (1) the trafficking in fentanyl and other synthetic opioids represents a public health emergency in the United States and requires a comprehensive legislative response; (2) the United States Government should use all available measures to reduce the availability of illicit fentanyl, its chemical precursors, and the equipment by which fentanyl may be milled into counterfeit prescription pills; (3) the United States Government should make grants available for State and local medical examiners and coroners to screen for fentanyl in suspected opioid overdose cases in regions reporting increases in fentanyl seizures, fentanyl-related overdose fatalities, or unusually high spikes in heroin or unspecified drug overdose fatalities; (4) State and local law enforcement should, if safe and possible, prioritize and expedite testing of drug samples taken from drug overdose scenes and share the data on fentanyl drug seizures with local health departments, coroners, and medical examiners; (5) grants made available to address the opioid epidemic should be used to improve States’ surveillance of fentanyl-related deaths and to expand access to naloxone for first responders, law enforcement, and health care personnel given that multiple doses of naloxone must be administered per overdose event; and (6) the United States Government, including the Secretary of State, the Attorney General, the Secretary of Homeland Security, and the Director of the Office of National Drug Control Policy, should use the broad diplomatic and law enforcement resources of the United States, in partnership with the Governments of Mexico and China, to stop the trafficking of illicit fentanyl into the United States. 3. Controlled substance analogues (a) In general Clauses (i), (ii), and (iii) of section 102(32)(A) of the Controlled Substances Act ( 21 U.S.C. 802(32)(A) ) are amended by striking substantially each place it appears. (b) Rule of construction Section 102(32)(A) of the Controlled Substances Act ( 21 U.S.C. 82(32)(A) ) shall not be construed to require that a substance satisfy more than one of the clauses listed in such section 102(32)(A) to meet the definition of a controlled substance analogue. 4. Treatment of controlled substance analogues Section 203 of the Controlled Substances Act ( 21 U.S.C. 813 ) is amended by striking shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a controlled substance in schedule I and inserting shall, to the extent to which it should be reasonably known to the manufacturer, distributor, or dispenser that the controlled substance analogue is intended for human consumption, be treated, with respect to such manufacturer, distributor, or dispenser, respectively, for the purpose of any Federal law as a controlled substance in schedule I . 5. Enhanced penalties (a) Controlled Substances Act amendments The Controlled Substances Act is amended— (1) in section 401(b)(1) ( 21 U.S.C. 841(b)(1) )— (A) in subparagraph (A)(vi)— (i) by striking 400 grams and inserting 20 grams ; and (ii) by striking 100 grams and inserting 5 grams ; and (B) in subparagraph (B)(vi)— (i) by striking 40 grams and inserting 2 grams ; and (ii) by striking 10 grams and inserting 0.5 grams ; and (2) by adding at the end of section 401(b) ( 21 U.S.C. 841(b) ) the following: (8) In the case of a violation of subsection (a), if the mixture or substance contains a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide and also contains a detectable amount of another controlled substance, then a court shall— (A) not impose a term of probation; (B) in addition to the term of punishment for the violation of this section, impose a term of imprisonment not to exceed 5 years; and (C) no term of imprisonment imposed on a person under subparagraph (B) shall run concurrently with any term of imprisonment imposed on the person under any other provision of law. (9) In the case of a violation of subsection (a), if the mixture or substance containing a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide was represented to be or sold as another controlled substance, then a court shall— (A) not impose a term of probation; (B) in addition to the term of punishment for the violation of this section, impose a term of imprisonment not to exceed 5 years; and (C) no term of imprisonment imposed on a person under subparagraph (B) shall run concurrently with any term of imprisonment imposed on the person under any other provision of law. . (b) Controlled substances import and export act amendments Section 1010(b) of the Controlled Substances Import and Export Act ( 21 U.S.C. 960(b) ) is amended by adding at the end the following: (8) In the case of a violation of subsection (a), if the mixture or substance containing a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide also contains a detectable amount of another controlled substance, then a court shall— (A) not impose a term of probation; (B) in addition to the term of punishment for the violation of this section, impose a term of imprisonment not to exceed 5 years; and (C) no term of imprisonment imposed on a person under subparagraph (B) shall run concurrently with any term of imprisonment imposed on the person under any other provision of law. (9) In the case of a violation of subsection (a), if the mixture or substance containing a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide or any analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide was represented to be or sold as another controlled substance, then a court shall— (A) not impose a term of probation; (B) in addition to the term of punishment for the violation of this section, impose a term of imprisonment not to exceed 5 years; and (C) no term of imprisonment imposed on a person under subparagraph (B) shall run concurrently with any term of imprisonment imposed on the person under any other provision of law. . 6. Endangering human life while illegally manufacturing controlled substance Section 417 of the Controlled Substances Act ( 21 U.S.C. 858 ) is amended to read as follows: 417. Endangering human life while illegally manufacturing controlled substance (a) In general Whoever, while manufacturing a controlled substance in violation of this title, or attempting to do so, or transporting or causing to be transported materials, including chemicals, to do so, creates a substantial risk of harm to human life shall be fined in accordance with title 18, United States Code, or imprisoned not more than 10 years, or both. (b) Rebuttable presumption For purposes of this section, there shall be rebuttable presumption that any violation of subsection (a) involving a detectable amount of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide, any analogue of N-phenyl-[1-(2-phenylethyl)-4-piperidinyl] propanamide, or the immediate precursor of such a substance, creates a substantial risk of harm to human life. . 7. Temporary scheduling of synthetic opioid analgesics Section 201 of the Controlled Substances Act ( 21 U.S.C. 811 ) is amended by adding at the end the following: (k) Temporary scheduling of synthetic opioid analgesics (1) Issuance of order The Attorney General may, by order and without regard to the findings required by subsection (a) of this section or section 202(b) and without regard to the procedures prescribed by subsections (a) and (b) of this section, place a substance in schedule I if— (A) the substance is not listed in any other schedule in section 202; (B) no exemption, approval, or licensing is in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act; and (C) the Attorney General has reason to believe that such substance— (i) is a synthetic opioid analgesic; (ii) is the object or intended object of clandestine importation, manufacture, or distribution; and (iii) poses an imminent hazard to public health and safety. (2) Effective date of order An order issued under paragraph (1) may not take effect until 5 days after its publication in Federal Register. (3) Expiration of order An order issued under paragraph (1) shall expire not later than 6 months after the date on which it becomes effective, except that the Attorney General may extend the order for up to 6 months. (4) Conclusion of rulemaking An order issued under paragraph (1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under subsection (a) with respect to such substance. (5) Order not subject to judicial review An order issued under paragraph (1) is not subject to judicial review. . 8. Tableting machines, encapsulating machines, and controlled substance counterfeiting materials (a) Mailability (1) In general Chapter 30 of title 39, United States Code, is amended by inserting after section 3002a, the following new section: 3002b. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials (a) Any tableting machine, encapsulating machine, or controlled substance counterfeiting material is nonmailable matter, shall not be carried or delivered by mail, and shall be disposed of as the Postal Service directs, unless such device or material is mailed— (1) to a regulated person (as defined in section 102(38) of the Controlled Substances Act); or (2) to a person registered to manufacture a controlled substance by the Attorney General pursuant to section 302 of the Controlled Substances Act. (b) For the purpose of this section— (1) the controlled substance counterfeiting material means any punch, die, plate, stone, or other thing described section 403(a)(5) of the Controlled Substances Act; (2) the term encapsulating machine means any manual, semiautomatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semisolid, or liquid material; and (3) the term tableting machine means any manual, semiautomatic, or fully automatic equipment which may be used for the compaction or molding of powdered or granular solids, or semisolid material, to produce coherent solid tablets. . (2) Clerical amendment The table of sections for chapter 30 of title 39, United States Code, is amended by inserting after the item relating to section 3002a the following new item: 3002b. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials. . (b) Penalty (1) In general Chapter 83 of title 18, United States Code, is amended by inserting after section 1716E the following new section: 1716F. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials Whoever knowingly deposits for mailing or delivery, or knowingly causes to be delivered by mail according to the direction thereon, or at any place to which it is directed to be delivered by the person to whom it is addressed, any matter declared to be nonmailable by section 3002c of title 39, shall be fined under this title or imprisoned not more than 1 year, or both. . (2) Clerical amendment The table of sections for chapter 83 of title 18, United States Code, is amended by inserting after the item relating to section 1716E the following new item: 1716F. Nonmailability of tableting machines, encapsulating machines, and controlled substance counterfeiting materials. .