U.S. GOVERNMENT PUBLISHING OFFICE

31–451PDF WASHINGTON : 2018

TACKLING FENTANYL: THE CHINA CONNECTION

HEARING

BEFORE THE

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, 

GLOBAL HUMAN RIGHTS, AND 

INTERNATIONAL ORGANIZATIONS

OF THE

COMMITTEE ON FOREIGN AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED FIFTEENTH CONGRESS

SECOND SESSION

SEPTEMBER 6, 2018

Serial No. 115–169

Printed for the use of the Committee on Foreign Affairs

(

Available: http://www.foreignaffairs.house.gov/, http://docs.house.gov,

or www.govinfo.gov 

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COMMITTEE ON FOREIGN AFFAIRS 

EDWARD R. ROYCE, California, Chairman 

CHRISTOPHER H. SMITH, New Jersey 

ILEANA ROS-LEHTINEN, Florida 

DANA ROHRABACHER, California 

STEVE CHABOT, Ohio 

JOE WILSON, South Carolina 

MICHAEL T. MCCAUL, Texas 

TED POE, Texas 

DARRELL E. ISSA, California 

TOM MARINO, Pennsylvania 

MO BROOKS, Alabama 

PAUL COOK, California 

SCOTT PERRY, Pennsylvania 

RON DESANTIS, Florida 

MARK MEADOWS, North Carolina 

TED S. YOHO, Florida 

ADAM KINZINGER, Illinois 

LEE M. ZELDIN, New York 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

ANN WAGNER, Missouri 

BRIAN J. MAST, Florida 

FRANCIS ROONEY, Florida 

BRIAN K. FITZPATRICK, Pennsylvania 

THOMAS A. GARRETT, JR., Virginia 

JOHN R. CURTIS, Utah 

ELIOT L. ENGEL, New York 

BRAD SHERMAN, California 

GREGORY W. MEEKS, New York 

ALBIO SIRES, New Jersey 

GERALD E. CONNOLLY, Virginia 

THEODORE E. DEUTCH, Florida 

KAREN BASS, California 

WILLIAM R. KEATING, Massachusetts 

DAVID N. CICILLINE, Rhode Island 

AMI BERA, California 

LOIS FRANKEL, Florida 

TULSI GABBARD, Hawaii 

JOAQUIN CASTRO, Texas 

ROBIN L. KELLY, Illinois 

BRENDAN F. BOYLE, Pennsylvania 

DINA TITUS, Nevada 

NORMA J. TORRES, California 

BRADLEY SCOTT SCHNEIDER, Illinois 

THOMAS R. SUOZZI, New York 

ADRIANO ESPAILLAT, New York 

TED LIEU, California

AMY PORTER, Chief of Staff THOMAS SHEEHY, Staff Director

JASON STEINBAUM, Democratic Staff Director 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND

INTERNATIONAL ORGANIZATIONS

CHRISTOPHER H. SMITH, New Jersey, Chairman 

MARK MEADOWS, North Carolina 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

THOMAS A. GARRETT, JR., Virginia 

KAREN BASS, California 

AMI BERA, California 

JOAQUIN CASTRO, Texas 

THOMAS R. SUOZZI, New York 

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C O N T E N T S 

Page

WITNESSES 

The Honorable Kirsten D. Madison, Assistant Secretary, Bureau of International Narcotics and Law Enforcement Affairs, U.S. Department of State 7

Mr. Paul E. Knierim, Deputy Chief of Operations, Office of Global Enforcement, Drug Enforcement Administration, U.S. Department of Justice .......... 16

Mr. Joseph D. Coronato, prosecutor, Prosecutor’s Office, Ocean County, New 

Jersey .................................................................................................................... 39

Bryce Pardo, Ph.D., associate policy researcher, RAND Corporation ................. 51

Daniel Ciccarone, M.D., professor of family and community medicine, University of California, San Francisco ......................................................................... 67

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

The Honorable Kirsten D. Madison: Prepared statement .................................... 10

Mr. Paul E. Knierim: Prepared statement ............................................................ 18

Mr. Joseph D. Coronato: Prepared statement ....................................................... 43

Bryce Pardo, Ph.D.: Prepared statement ............................................................... 53

Daniel Ciccarone, M.D.: Prepared statement ........................................................ 70

APPENDIX 

Hearing notice .......................................................................................................... 94

Hearing minutes ...................................................................................................... 95

The Honorable Christopher H. Smith, a Representative in Congress from 

the State of New Jersey, and chairman, Subcommittee on Africa, Global 

Health, Global Human Rights, and International Organizations: 

Statement by Don Holman .................................................................................. 96

Statement by Christopher J. Gramiccioni, prosecutor, Monmouth County, 

New Jersey ........................................................................................................ 100

Information on the Blue HART Program ........................................................... 104

Questions submitted for the record to the Honorable Kirsten D. Madison 

and to Mr. Paul E. Knierim ............................................................................. 106

Questions submitted for the record by the Honorable F. James Sensenbrenner, Jr., a Representative in Congress from the State of Wisconsin ........ 109

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TACKLING FENTANYL: THE CHINA 

CONNECTION 

THURSDAY, SEPTEMBER 6, 2018

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,

GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS,

COMMITTEE ON FOREIGN AFFAIRS,

Washington, DC. 

The subcommittee met, pursuant to notice, at 2 o’clock p.m., in 

room 2200 Rayburn House Office Building, Hon. Christopher H. 

Smith (chairman of the subcommittee) presiding. 

Mr. SMITH. The committee will come to order. And I want to, 

first of all, thank all of our witnesses including our very distinguished witnesses from the administration, one, for your tremendous work that you are doing in this opioid crisis, and secondly, for 

taking the time out here to provide expert testimony. We do have 

a second panel of experts who will follow, so this, I think, will be 

a very enlightening and hopefully motivating hearing on what do 

we do next, and of course to go very deeply into the nature of the 

problem and how it has been exacerbated almost from month to 

month it is getting worse as we all know. 

Chinese made fentanyl, a synthetic opioid, is killing Americans, 

more than 29,000 in 2017 alone. We must hold the Chinese Government accountable. Kirsten Madison, Assistant Secretary of 

State for International Narcotics and Law Enforcement Affairs will 

testify today that China is a ‘‘primary source of illicit synthetic 

drugs coming to the United States.’’

Paul Knierim, Deputy Chief of Operations at the Office of Global 

Enforcement for Drug Enforcement Administration, or DEA, stated 

in his testimony that China is one of the world’s top producers of 

precursor chemicals used to manufacture fentanyl as well as chemicals used to process heroin and cocaine. 

In our second panel we will hear from again some amazing experts. One is Ocean County, New Jersey prosecutor, Joseph 

Coronato, who has called the China-made fentanyl influx into the 

United States a synthetic storm that is ‘‘devastating.’’ He will 

thankfully note that local law enforcement is doing something 

about it, like his program, the first in the State of New Jersey, to 

allow drug abusers who voluntarily turn themselves in at a police 

station, and thus far it has been over 800 since 2017, without being 

prosecuted. The idea of an engraved invitation that states, ‘‘Come 

we will help you.’’ He is obviously very tough on crime but he also 

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has a great humanitarian heart and is saying we want to help and 

treatment is a way of intervening for a positive outcome. 

And the program based on statistics has almost certainly reduced 

deaths. Still, Prosecutor Coronato will note that based on his medical examiner’s toxicology analysis, in 2014, 10 percent of overdose 

deaths in the county had fentanyl in their systems. Shockingly, in 

2018, fentanyl related deaths have jumped to over 80 percent or 

even more. He will tell the committee that synthetics will become 

the predominant type of illegal drugs abused within the next 5 

years and that in many instances is being sold right over the internet. 

I will ask both of our distinguished witnesses from State and 

DEA what the United States is doing to hold China accountable for 

fentanyl in the United States, what kind of cooperation are we receiving, are we using existing tools to hold bad actors in China accountable? We have tools such as the Global Magnitsky Act which 

targets corrupt officials and human rights abusers. Is that under 

consideration when it comes to this crisis that is slaughtering so 

many Americans? 

Recently, the House passed bipartisan, comprehensive legislation 

to address the opioid crisis including the Synthetics and Overdose 

Prevention Act now pending in the Senate. The bill requires the 

U.S. Postal Service, as private carriers like UPS and FedEx are 

currently required to do, to obtain advanced electronic data, or 

AED provides detailed info on the shipper and the addressee and 

other data, empowering law enforcement, Customs and Border Protection and others, to target fentanyl and other illegal drug shipments. 

Bryce Pardo of the RAND Corporation will testify today, and this 

is of high significance of course, that the potency of fentanyl has 

sharply increased the number of opioid overdoses and that the drug 

overdose crisis, in his words, now surpasses major public health 

epidemics of prior generations including the HIV AIDS epidemic. 

As we all know, every single congressional district in America 

has felt the scourge of the epidemic. Two fathers, Don Holman and 

Eric Bolling, who are both in the audience today, both lost their 

sons to opioid overdoses last year. Don lost his son Garrett to an 

overdose to synthetic fentanyl, and as he will show in a written 

statement submitted to this committee for the record, the package 

came straight from China. His son ordered it online not knowing 

of the poisonous effects fentanyl has. His daughter Kristen testified 

before the House Judiciary Committee earlier this year and described how her loving brother fell into this trap. Eric’s son had a 

similar ordeal in September 2017, losing his beloved son Eric 

Chase. 

Last week, I spoke at a Mercer County International Overdose 

Awareness Day sponsored by Mercer County Prosecutor Onofri and 

Robinsville Mayor David Fried. Personal testimonies offered by 

survivors and recovering abusers were deeply moving. Trenton Police Chief Pedro Medina spoke of the loss of his son Petey. And I 

have known Pedro for decades, loves his son, he is a good guy. Not 

just him but his son, and yet he was overcome by this terrible, terrible opioid problem. In his comments he talked about how he has 

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relied on God to get him through this crisis and said God can help 

all of you who are surviving, the family members and the friends. 

Advocate Mark Manning, who lost his son Christopher, made it 

very clear that his horrors of the addiction in losing his son Christopher, and the pain that just doesn’t go away is ever-present. 

And then we heard from Adrienne Petta who recounted the horrors of her addiction. She is one of the lucky ones who was able 

to get through it and she, herself, is now a recovery specialist. One 

of the moving parts of her testimony was she said, I have two children, and this was after she was off, she thought she was clean. 

And then she said, if you would have put a pack in front of me, 

a bag, my two kids would take second and the bag would come 

first. That is how strong, as you know so well from your good work, 

this terrible chemical is. 

For the record, Monmouth County Prosecutor Christopher 

Gramiccioni’s opioid diversion program steers certain low-income, 

nonviolent offenders to treatment rather than traditional criminal 

prosecution. And again Angelo Onofri from Mercer County is doing 

the same thing and announced that every municipality in Mercer 

County had agreed to sign up. And I think that is a very important 

step and a model for every municipality in this country to look at 

this as a disease. Go after those who do our hawking it and selling 

it, put them behind bars, but for the victims, treat it for what it 

is, a disease. 

I would like to yield to my good friend and colleague, Karen 

Bass, for any comments you might have. 

Ms. BASS. Thank you. Thank you, good afternoon, and thank our 

witnesses today and Chairman Smith for calling today’s hearing 

and bringing attention to fentanyl and the horrific effects this drug 

has had on Americans of every stripe. Some foreign affairs issues 

seem remote and inconsequential to everyday Americans, but this 

issue has eviscerated individuals, families, and entire communities 

here at home. 

Opioid addiction negatively impacts our healthcare system, our 

criminal justice system, our education system, and our child welfare system which is where the children go when the parents are 

unable to take care of them. And the primary reason that children 

are removed and put in foster care is substance abuse. Sourced 

mainly from China and Mexico, fentanyl have contributed to a dramatic uptick in opioid related overdoses and deaths in recent years. 

I have also learned that fentanyl is being sprinkled into marijuana in States where marijuana is illegal. So it is not just in 

opioids. According to estimates, foreign-sourced fentanyl and its related compounds killed nearly 20,000 Americans in 2016, more 

than any other illicit drugs, even more than breast cancer. Between 

2013 and 2016 these deaths increased over 600 percent. 

Beyond death, we also know that fentanyl has insidious effects 

for pregnant mothers and children. The Washington Post reported 

on a recent study that found that learning disabilities and other 

special education needs are common in children born with opioid 

related symptoms from their mother’s drug use while pregnant. I 

will say though that I do not believe that a child that is exposed 

to opioid at birth is necessarily condemned for side effects for their 

entire life. We actually thought that about the cocaine epidemic 

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and thought that children that were exposed to crack would be impacted their entire life. 

So we have seen modest progress in international cooperation between the U.S. and China. Chinese authorities through pressure 

from the U.S. imposed domestic scheduling controls on 116 new 

psychoactive substances and 10 fentanyl analogues in recent years. 

I don’t know if this is something that has continued, but we will 

certainly see through this hearing. 

So, obviously much more needs to be done to move the needle on 

the opioid crisis and I look forward to hearing from today’s panelists. I do want to make note though that one thing that has happened in our country over the years is when one drug presents 

itself all of our focus and efforts go on that one drug. And although 

opioid is a horrible scourge and thousands of people are dying from 

it, people are also continuing to die from crack, from meth and that 

might not be sourced from China, but when you look at Mexico, 

when you look at other countries where the crack and the meth is 

coming from, that is still impacting our communities terribly. 

And as the chairman said, we need to look to how we prevent 

the drugs from coming into the country, but when they do come in 

the country we need to address it and one way we need to address 

it is through treatment. Twenty years ago when the crack cocaine 

epidemic was here we thought we could incarcerate the problem. 

And I am hoping that given this new epidemic we have learned 

better and when people are addicted it is a health problem, as you 

said, and the way you address a health problem is through substance abuse treatment. 

So once again I thank you, Mr. Chairman, and yield back my 

time. 

Mr. SMITH. Thank you very much, Ms. Bass. I would like to now 

yield to Dan Donovan who is a former prosecutor from Staten Island. He was very involved with combating drug abuse as a prosecutor and is a distinguished member of this committee. 

Mr. DONOVAN. Thank you, Mr. Chairman. I think you and Ranking Member Bass described the problem very adequately. 

As the chairman said, I was the elected DA for 12 years in Staten Island before I came to Congress. Before that for 8 years I was 

Deputy Chief of Narcotics at the Manhattan DA’s Office. I am very 

well aware of in 1996 when the physicians who used to treat four 

vital signs—your heart rate, your respiratory rate, your blood pressure, and your temperature—were then tasked with dealing with 

the fifth vital sign, pain. Except that was subjective. They 

couldn’t—they had to trust the patient to tell them. I remember in 

the hospitals the smiley faces going down to the frown and a physician or a physician’s assistant would ask the patient show me 

where your pain is on this chart, because it couldn’t be measured. 

And that started the overprescribing of opioids for pain relief for 

people who legitimately had pain. When we did some things like 

InterConnect and formed a nationwide system database where people couldn’t circumvent the restrictions on prescriptions, I on Staten Island had three crossings to New Jersey. We curtailed the 

availability of prescription drugs, but my residents just went over 

one of three bridges to New Jersey to get their prescriptions either 

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written or filled. But when I got to Congress we got New York included in that InterConnect. 

So I understand the problem. I do also understand it took us 

awhile to get our hands around this fentanyl problem. I remember 

the medical examiners during an autopsy of an overdose never tested for fentanyl. They would see heroin in the system and they 

would deem it to be a heroin overdose. It took us awhile to then 

start to test for fentanyl and we found that so many of those 

overdoses were the results of this substance. 

So I look forward to hearing from our experts on how we are 

going to deal with the importation of this deadly drug from China 

onto the streets of our nation. And, Mr. Chairman, with that I yield 

back. 

Mr. SMITH. Mr. Donovan, thank you very much. I would like to 

now yield to Dr. Bera from California. 

Mr. BERA. Thank you, Mr. Chairman. Thank you to the ranking 

member and to my colleague, Mr. Donovan. I remember that because I was practicing at that time and there was a push to more 

adequately assess pain and treat it. And now in this position, you 

know, having sat with parents who have lost their children, you 

know, who may have very legitimately injured themselves, you 

know, we were giving them a prescription of Vicodin and then, you 

know, became addicted and went down a dangerous path. 

I am glad that this body and this country is taking this epidemic 

seriously. But as the ranking member mentioned, this is just a long 

chain of other illicit drugs that are out there, whether it was the 

crack epidemic of the ’80s and we have been dealing with 

methamphetamines in California for awhile. But again I am glad 

that we are taking this seriously and using the language of the fact 

that this is a disease and thinking about it from the perspective 

of, you know, prevention, but then also treatment as opposed to, 

you know, just looking at it from the law enforcement perspective 

which is absolutely necessary as well. 

You know, when I think about what is happening in California 

and even in our four-county Sacramento region, you know, we had 

over 250 deaths, many of them due to fentanyl and that is low compared to some of my colleagues. And I think, you know, we very 

much have to get ahead of this. I am glad that we are discussing 

this. 

I am glad that we have through State Department and other 

means, exerted some pressure on China to stop producing some of 

the precursors to fentanyl. I am very much looking forward to the 

witnesses to, you know, get a sense of how effective that has been. 

But I also know that we have to do a lot more. I mean we have 

a lot of folks that currently are addicted and we have to use all of 

our measures to treat those individuals and help them rehab their 

lives and help them put their families back together. And in some 

cases, you know, help entire communities put their communities 

back together. 

So again thank you for having this hearing and I will yield back. 

Mr. SMITH. Thank you very much, Dr. Bera. I would like to yield 

now to Mr. Castro. 

Mr. CASTRO. Well, thank you for your testimony today. 

6

And, you know, for the last several years fentanyl and the opioid 

epidemic has ravaged many communities in many States in this 

country and I am glad that we are having this hearing. That we 

are talking about it for what it is, a health crisis. That addiction 

is a health crisis and hopefully together we can determine how best 

to help treat it. I am convinced that by and large the folks who suffer from this addiction want to get on with their lives, don’t want 

to be addicted, want to get back to their families and back to their 

work. And so thank you for everything you all are doing in that regard. 

Mr. SMITH. Thank you, Mr. Castro. 

Mr. Suozzi, the gentleman from New York. 

Mr. SUOZZI. Thank you, Mr. Chairman. Thank you, Ranking 

Member. Thank you to all the members here and for everyone testifying here today. 

I don’t think anyone has to be persuaded that this is a major crisis in our country right now, not only opioid addiction but the introduction of fentanyl, a synthetic drug that people really don’t 

know that they are getting sometimes. I have personal experience 

with this where I have been called to the hospital, friends of mine, 

their son dead on the table because he took a pill that he didn’t 

know had fentanyl in it and he overdosed immediately. 

This is a very real problem for real families throughout America 

every single day. And I appreciate the chairman and ranking member for holding this hearing, for us to try and identify whether 

there is a link between Chinese production of fentanyl and whether 

or not it is being introduced to our country in large quantities in 

illicit ways and if there is anything we can do to try and combat 

the introduction of this manufactured substance into our country. 

There are so many other drug problems in our country that have 

been going on and have been pointed out so eloquently by my colleagues for many years. It is important that we look at this as a 

health crisis, but we also have to look at where this drug is coming 

from and why it is being shipped here to the United States of 

America and what we can, if anything, do about it. 

Mr. SMITH. Thank you. I would like to now introduce our distinguished panel beginning first with the Assistant Secretary for 

International Narcotics and Law Enforcement Affairs, Kirsten 

Madison, where she is responsible for the State Department programs combating illicit drugs and organized crime. Prior to her current post, Ms. Madison served in senior leadership positions in the 

executive branch including Deputy Secretary in the Bureau of 

Western Hemisphere Affairs; Director for Western Hemisphere Affairs on the National Security Council; the Foreign Policy Advisor 

to the Commandant of the Coast Guard. 

She has also served as a senior professional staff member and 

deputy staff member of the U.S. Senate Committee on Foreign Relations, as well as legislative director and international affairs advisor for Chairman Porter Goss. Outside the government, Ms. 

Madison has held positions of senior advisor to the Secretary General of the Organization of American States and recently worked at 

the American Enterprise Institute as deputy director for foreign 

and defense policy studies. She holds a master of science from the 

London School of Economics and a B.A. from Goucher College. 

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Next, we will hear from the Deputy Chief of Operations, Office 

of Global Enforcement at the DEA, Paul Knierim. In this role he 

is responsible for overseeing operations to dismantle national and 

international drug trafficking organizations and supporting DEA 

investigative operations internationally. Mr. Knierim previously 

served in other positions in the DEA, starting his career in 1991 

as a Special Agent in the Denver Field Division. 

He has served in various posts internationally ranging from Ecuador, Costa Rica, and Mexico. Domestically, Mr. Knierim has 

worked in the DEA, Miami Field Division, served as Staff Coordinator in the DEA Headquarters Office of Congressional and Public 

Affairs, and as Special Agent in Charge of the Dallas Field Operation. He holds a degree from the University of Utah. 

And again I thank both of them for your leadership and, without 

objection, your full statements will be made a part of the record, 

but please proceed as you would like. 

STATEMENT OF THE HONORABLE KIRSTEN D. MADISON, ASSISTANT SECRETARY, BUREAU OF INTERNATIONAL NARCOTICS AND LAW ENFORCEMENT AFFAIRS, U.S. DEPARTMENT OF STATE 

Ms. MADISON. Chairman Smith, Ranking Member Bass, distinguished members of the subcommittee, thank you for your efforts 

to highlight the tragic impact of synthetic opioids across this country. Across this administration, agencies are working to combat the 

illicit opioid threat and to blunt its impact on Americans. 

My INL team understands that the work the State Department 

does to forge partnerships and consensus, to secure international 

cooperation, and to use foreign assistance to build the capacity of 

our partners to help disrupt the flow of opioids and other illicit narcotics is really just about one thing. It is about contributing to a 

larger effort to save American lives. 

Traffickers have capitalized on the boom and global access to information and technology to facilitate their lethal trade. Illegal 

drug producers exploit the anonymity and convenience of the dark 

Web, encrypted peer-to-peer messaging applications, and other information platforms to market and sell aggressively to global clients including directly to American drug consumers. It is a new 

frontier in illicit trafficking and therefore a new frontier in our efforts to push back. 

And I would just pick up on what some of the members of the 

panel have said, this I think is not displacing other parts of the 

drug market. We can’t stop paying attention to 

methamphetamines, cocaine, or anything else. Those are all still 

real threats. This is additive not displacement. 

With China, the Department is building upon the commitments 

made in President Trump’s November 2017 meeting with President 

Xi to deepen bilateral counternarcotics cooperation. This effort has 

yielded concrete results including arrests, seizures, and take-downs 

of clandestine labs by Chinese law enforcement. Law enforcement 

information sharing has increased, including information used to 

combat the export of drugs that are controlled here but not in 

China. 

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Additionally, China has taken significant action to domestically 

control 175 substances with the 32 that were added to that list just 

last week including fentanyl analogues and key precursors to 

fentanyl production. We continue to press China to use every available tool to aggressively counter illegal production and the trafficking of synthetic opioids. Some synthetic opioids from China are 

flowing through Mexico where traffickers sometimes mix them, 

often mix them with cocaine and heroin before shipping them 

across our southwest border. Countering this flow is part of our 

partnership with the Mexican Government to disrupt drug production, dismantle drug distribution networks, prosecute drug traffickers, and deny transnational criminal organizations access to illicit revenue. 

State also works multilaterally to address the proliferation of illicit synthetic drugs and uses foreign assistance working through 

international organizations to support real-time coordination and 

information sharing between law enforcement and forensic officials 

around the world. This increases the identification, detection, and 

tracking of synthetic drugs and precursor chemicals worldwide. 

Working through multilateral organizations, we also deliver specialized training to strengthen the ability of key countries to intercept suspicious drugs and chemicals sold online and shipped 

through the mail and express consignments. The international 

tools that we use must actually be capable of addressing the 21st 

century challenge that we are facing. And I think this includes supporting an acceleration of the rate at which drugs are controlled at 

the international, regional, and national level. As is the case with 

China, international controls lay the groundwork for enhanced law 

enforcement cooperation with the U.S. 

In March 2018, we mobilized countries at the U.N. Commission 

on Narcotic Drugs to control the deadly opioid carfentanil, for example, plus additional fentanyl analogues. The CND was also the 

venue in 2017 to assert controls on two primary fentanyl precursor 

chemicals, NPP and ANPP. And, at the U.S. instigation, the International Narcotics Control Board recently issued a call to all nations to voluntarily restrict 93 new substances that have no known 

medical use. 

To have impact these controls have to be implemented. So in INL 

we are helping countries actually institute the treaty-mandated 

controls that they are supposed to at a national level. My team and 

I have been looking as well at additional ways that we can adapt 

INL’s work to address the dynamic threat that is presented by illicit synthetics and to help our partners both in the U.S. Government and law enforcement and in the international community to 

tackle, really, all of the links in the illicit synthetic supply chain. 

For example, we are developing new partnerships to expand global capacities to detect and interdict synthetic drugs shipped 

through the mail and express consignment shipping, including by 

expanding the global collection and sharing of advanced electronic 

data. INL also aims to broaden its cooperation with U.S. law enforcement partners to expand training and the use of technology to 

detect and interdict suspicious mail. 

INL is also considering what additional practical steps it can 

take with international partners to prevent the diversion of legitiVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
9

mate chemicals for illegal uses and to support partner governments’ ability to seize and dispose of diverted chemicals and build 

law enforcement capacities to detect and safely dismantle clandestine labs. As part of this effort, we believe firmly that we will need 

to seek increased cooperation with industry to make licit modes of 

commerce more inhospitable to criminals without encumbering licit 

activity. 

In addition to its other work, INL will be tapping into U.S. law 

enforcement expertise to provide foreign law enforcement counterparts with the skills to investigate, prosecute, and dismantle online 

drug vendors and to help our partners follow the digital money 

trail when vendors use crypto currencies to facilitate transactions. 

I think, finally, we must respond to the global nature of this 

threat and prepare for the proliferation of synthetic drug production distribution and abuse well beyond China and the countries 

currently impacted. This problem requires a strategic and coordinated international response. In practical terms, this means that 

we are not alone and that our diplomacy needs to focus on ensuring 

that other countries share our commitment and dedication to tackling this issue. 

Mr. Chairman, Ranking Member Bass, and members of the subcommittee, I can assure you that the Department is fully committed to the effort to address the threat posed by synthetic drugs 

and to address the impact that they are having on our citizens, on 

our communities, and on our families. Thank you for your time and 

I look forward to your questions. 

[The prepared statement of Ms. Madison follows:]

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31451a-1.eps

Prepared Statement of: 

Kirsten D. Madison 

Assistant Secretary of State for 

Intemational Narcotics and Law Enforcement Affairs 

Hearing before the: 

House Foreign Affairs Subcommittee for Africa, Global Health, Global 

Human Rights and International Organizations 

Tackling Fentanyl: The China Connection 

September 6, 2018 
11


31451a-2.eps

Chairman Smith, Ranking Member Bass, distin1,,>uished members of the Subcommittee: 

Thank you for the opportunity to testify today and for the efforts of this committee to highlight 

the tragedy that is unfolding every day in families and communities across this country. 

We have all heard and read the stories of promising young lives cut short, of families 

bankrupted emotionally and financially-often in failed attempts to save loved ones from 

addiction. Since I was nominated, I have found that people want to share tragic stories about the 

devastating impact of addiction and overdose on their families and their friends, even as they ask 

me -- as they should- what we are doing to help. The battle against opioids is being fought on 

many fronts. Doctors, nurses and other health care professionals are providing treatment and 

running prevention programs to help keep more Americans from joining the long line of 

Americans lost in this epidemic. Men and women in law enforcement are fighting drug dealers 

on our streets and leading interdiction efforts to prevent opioids from entering our country. This 

Administration has committed considerable resources and energy toward fighting this epidemic 

and toward the essential work that must be done on all fronts. My dedicated Bureau of 

International Narcotics and Law Enforcement Affairs (INL) team is a part of this larger 

effort. We understand that the work we do to forge partnerships and consensus, to secure 

international cooperation, and to use foreign assistance to build the capacity of our partners to 

help disrupt the flow of opioids and other illicit narcotics to our country is about one 

thing: contributing to a larger effort in our country to save America lives, American families, 

and American communities. 

This opioid epidemic is the most severe drug crisis our country has ever faced, claiming 

tens of thousands of American lives annually. This crisis arose largely from over reliance on 

prescription opioids and increasing availability of heroin that led to rapid increases in opioid 

misuse. The emergence of dangerous new synthetic drugs, often mixed into supplies of heroin or 

other illicit drugs and trafficked through global illicit supply chains, has now morphed this crisis 

into an ever more deadly phenomenon with complex transnational linkages. The Centers for 

Disease Control and Prevention (CDC) estimates that more than 72,000 Americans died from 

drug overdoses in 2017. Over forty percent of these deaths involved synthetic opioids like 

fentanyl. Between 20 I 2 and 20 I 6, the number of overdose deaths involving synthetic opioids 

increased by nearly 640 percent, and provisional data from 20 I 7 suggest that this trend is 

continuing upwards. A confluence of dangerous new trends in the transnational production, 

sales, and trafficking of illicit drugs has contributed to this tragic climb in American deaths. 

Criminals are developing new substances at a rate faster than national and international 

frameworks can respond. Production costs are low, and drug tratlickers, using low-level 

criminal chemists, can tailor the expected psychoactive effects of new psychoactive drug 

substances, or NPS, to meet consumer demand. The United Nations Office on Drugs and Crime 

(UNO DC) reports that there are currently more than 800 new known synthetic drugs, with 

approximately one new substance created each week. At the same time, interrupting illicit drug 

production has become more challenging; unlike drugs derived trom plant-based crops, synthetic 

drugs have lower overhead requirements -they are immune to weather conditions, and do not 

require large tracts ofland or workers to cultivate them. Synthetic drugs can be produced 

wherever the necessary chemicals can be obtained. 
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31451a-3.eps

2 

Traffickers have exploited the boom in global access to information and technology to 

facilitate their lethal trade. Illegal drug producers exploit the perceived anonymity and 

convenience of the Internet, including the "Dark Web," encrypted peer-to-peer messaging 

applications, and other emerging infonnation and communications technologies to market and 

sell aggressively to global clients, including directly to American drug users. Due to the extreme 

potency of synthetic opioids in particular, small quantities can readily be trafficked through 

international mail and express consignment shipments, in addition to traditional trafficking 

methods, yielding substantial illicit profits. Criminal misuse of these tools mal<es today's illicit 

drug trade high! y profitable and difficult to monitor, investigate, and disrupt. 

In October 2017, President Trump directed the Department of Health and Human 

Services to declare this epidemic a national public health emergency and has made combating 

this deadly drug crisis a cornerstone of his Administration. The vast majority of emerging 

synthetic drugs available in the United States will continue to be produced overseas, and the 

methods and locations of production and trafficking will continue to diversify. We cannot stem 

the flow of this crisis while ignoring its international components. Disrupting the illicit supply 

chains that are fueling thousands of American deaths is the Department of State's top drug 

control priority, and we are working tirelessly to facilitate the work of our partners to arrest the 

criminals and dismantle the criminal organizations facilitating this illicit trade. The Department 

of State's Bureau of International Narcotics and Law Enforcement Affairs (INL) is leading our 

response to these international challenges through our foreign assistance programs and 

diplomatic engagement 

With China, a primary source of illicit synthetic drugs coming to the United States, the 

Department of State is building upon the commitments made during President Trump's 

November 2017 meeting with President Xi to explore opportunities to deepen existing bilateral 

counternarcotics cooperation. This bilateral cooperation has yielded concrete results, including 

arrests, seizures, and takedowns of clandestine labs by Chinese law enforcement. Law 

enforcement information sharing has increased, including information used to combat the export 

of drugs that are controlled in the United States but not in China. Additionally, since 2015, 

China has taken significant action, primarily at the United States' request, to domestically 

control 143 substances, including 23 fentanyl analogues and the two key precursors to fentanyl 

production. And most recently on August 29, China's National Narcotics Control Commission 

announced controls on 32 additional NPS, which will bring the total to 175. We continue to 

encourage China to use every available tool to aggressively counter the threat from illegal 

production and trafficking of synthetic opioids. Further, the Department of State is engaging 

with China to promote effective drug demand reduction through prevention, treatment, and 

recovery support. 1n May, several members of China's government participated in a study visit 

to Washington, D.C. to observe best practices in the treatment and prevention of drug use, and 

further bilateral expert exchanges are being discussed. 

Some of the synthetic opioids from China are flowing through Mexico, where traffickers 

sometimes mix them with cocaine and heroin before shipping them across our southwest border. 

Countering this flow is part of our partnership with the Mexican government to disrupt drug 

production, dismantle drug distribution networks, prosecute drug traffickers, and deny 

transnational criminal organizations' access to illicit revenue. 
13


31451a-4.eps

In addition to bilateral engagement with China and Mexico, the Department of State is 

using multilateral channels to address the proliferation of illicit synthetic drugs, including 

synthetic opioids. The Department uses foreign assistance to support real-time coordination and 

information sharing between law enforcement and forensic officials around the world. This 

international cooperation increases the identification, detection, and tracking of synthetic drugs 

and precursor chemicals in illicit markets worldwide. These programs illuminate emerging 

synthetic drug and precursor chemical trafficking trends and alert law enforcement and forensic 

practitioners to the presence of these substances in illicit markets. In turn, law enforcement 

officials worldwide use this infonnation to solve drug trafficking cases. To reduce the presence 

of these drugs in illicit U.S. markets, we are also working through multilateral organizations to 

deliver specialized training that will strengthen the capacities of key countries, such as those in 

the western hemisphere, to intercept suspicious drugs and chemicals being sold online and 

shipped through the mail and express consignments. 

An essential component of our efforts to address these threats is to adapt the international 

architecture to more etTectively address these new 21 ''century challenges. For example, we 

must accelerate the rate at which these drugs are controlled at the international, regional, and 

national levels. Increased controls can drastically reduce the availability of these drugs for 

criminal purposes and will save American lives. As is the case in our cooperation with China, 

these international controls also can lay the groundwork for enhanced law enforcement 

cooperation with key nations. In March 2018, we continued mobilizing a response to the new 

synthetic drug threat through the international community at the UN Commission on Narcotics 

Drugs. With U.S leadership, the world came together to control the deadly opioid carfentanil, 

plus five other fentanyl analogues. This was preceded by action, at the 2017 CND at our behest, 

to control the two primary fentanyl precursor chemicals NPP and ANPP. Recently, at U.S. 

instigation, the International Narcotics Control Board (INCB) issued a call to all nations to 

voluntarily restrict 93 new substances with no known medical use, including fentanyl analogs. 

However, international controls are only the first step. It is also imperative to ensure that 

countries are able to institute these treaty-mandated controls at the national level. Key countries 

involved in the illicit trafficking of drugs, such as those in Central America, require significant 

capacity-building support to be able to establish the national regulatory frameworks to control 

drugs and precursor chemicals. For this reason, INL is training foreign law enforcement, 

regulatory, and forensic officials to establish the required domestic controls and to increase the 

identification and detection of these substances and chemicals in order to disrupt the illicit 

markets. 

We are cognizant of the grave threat posed by synthetic drugs and the evolving nature of 

the illicit opioid trade, which is compounded by the rise of the internet and globalization. So, 

shortly after I arrived in INL, my team and I decided to take a hard look at what was missing in 

our strategy and to give some critical thought to how to realign our strategy to be more nimble, 

more adaptive, and more exhaustive in our approach to rise to the challenge of the dynamic 

threats we are combating. This process is still underway, but I can already tell you that we 

intend to use our diplomatic and foreign assistance tools- and our critical partnerships in law 

enforcement- to attack each link of the illicit synthetic drug manufacturing and supply chains, 

including production, sales, and transport. We will focus our detection and interdiction efforts 

across transit routes and at key borders and, working with overseas and U.S. government 
14


31451a-5.eps

4 

partners, we will take on online sales and the use of cryptocurrencies. The private sector largely 

controls the tools of commerce upon which the traffickers operate, and therefore it is a vital part 

of the solution. So, we plan to seek increased cooperation with industry to explore how we can 

work together to mal<e licit modes of commerce inhospitable to criminals without encumbering 

entrepreneurs and businesses with unnecessary regulation. 

To counter the production of dangerous synthetic substances, TNL is considering what 

additional steps it can take with international partners to prevent the diversion of legitimate 

chemicals for illegal uses, support partner governments' abilities to seize and dispose of diverted 

chemicals, and build law enforcement capacities to detect and safely dismantle clandestine labs. 

INL is looking at additional efforts, together with our allies, to strengthen international 

institutions to identify emerging threats so governments can mobilize their public health and law 

enforcement agencies to counter more rapidly these challenges as they arise. 

lNL will continue to support efforts to improve the ability oflaw enforcement to confront 

the threat posed by the online trafficking of illicit synthetic drugs and chemicals. In its training 

programs, INL will need to tap into U.S law enforcement expertise to provide foreign law 

enforcement counterparts with the skills to investigate, prosecute, and dismantle online drug 

vendors, including on the "Dark Web." This includes training and technical assistance on 

following the digital money trail when drug vendors use cryptocurrencies to facilitate 

transactions. The online marketplace allows direct interactions between illegal drug producers 

and users, subverting the hierarchical cartel organization and making it harder for law 

enforcement to investigate and detect them. We must continue to collaborate across the U.S. 

government to curb illicit online sales of synthetic drugs and precursor chemicals. To do this, 

INL plans to deepen relationships with our interagency colleagues to identify new opportunities 

for partnership and complementary interventions aimed at reducing online trafficking of drugs 

and chemicals. 

We are exploring new partnerships to expand global capacities to detect and interdict 

synthetic drugs shipped through the mail and express consignment shipping, including by 

expanding the global collection and sharing of advanced electronic data (AED). This AED helps 

ret,>ulatory and law enforcement authorities prioritize screening to target suspicious shipments. 

INL also aims to broaden its cooperation with U.S. law enforcement partners to expand training 

and the use of technology to detect and interdict suspicious mail and shipping at international 

ports and other facilities, keeping them from U.S. shores. 

In addition to working to reduce the availability of synthetic drugs entering the United 

States, INL will build upon its efforts with international partners to share research and promote 

best practices for prevention and treatment interventions. This includes supporting public health 

messaging on the risks of synthetics, assisting foreign governments in implementing evidencebased prevention, treatment, and recovery support services, and fostering the adoption evidencebased practices to reduce the likelihood of accidental exposure to dangerous synthetic drugs. 

INL is working with international partners to improve data collection on synthetics, including 

consumption trends, toxicological screening of synthetic drug profiles, and the prevalence of 

toxic adulterants in illicit drug supplies. 

This is an enormous undertaking, and INL cannot do it alone. For an effective response, 

we will rely on close coordination with interagency partners, civil society, private industry, 
15


31451a-6.eps

5 

international organizations, and partner governments. Any person in a nation with internet 

access and international shipping services can import this deadly opioid crisis, so we know this is 

not a uniquely American concern and we know that many countries are already experiencing 

significant impacts. This crisis is a global one touching many other countries, including those in 

Latin America, Europe, and Africa. According to UNO DC' s 2018 World Drug Report, opioid 

misuse remains high in Africa, the Middle East, and Oceania, and it has been expanding in 

Western Europe and North America. An estimated 168,000 deaths globally were directly 

attributed to drug use disorders in 2015, with more than 75 percent of cases involving opioids. 

This international problem requires a smart, strategic, and coordinated international response. In 

practical terms, this means that we are not alone and our diplomacy needs to focus on calling 

other impacted countries to ensure that they share our commitment and dedication to tackling 

this issue. 

Mr. Chairman, Ranking Member Bass, and members of the Subcommittee, the 

Department of State is fully committed to fighting the new threat posed by the proliferation and 

new trat1ick:ing modalities of synthetic drugs. It is not an easy task, and the new initiatives and 

programs we think will be needed will take relentless effort, but we are driven by the goal of 

securing the health and safety of American citizens. I know this is an issue about which you and 

your constituents care deeply, and it is one that I care deeply about, because it affects so many 

American lives. I look forward to working with Congress as we seek to disrupt the t1ow of 

synthetic drugs, particularly deadly opioids, and thereby save American lives. 
16

Mr. SMITH. Secretary Madison, thank you for your testimony and 

for leadership. 

I would like to now recognize Mr. Knierim. 

STATEMENT OF MR. PAUL E. KNIERIM, DEPUTY CHIEF OF OPERATIONS, OFFICE OF GLOBAL ENFORCEMENT, DRUG ENFORCEMENT ADMINISTRATION, U.S. DEPARTMENT OF JUSTICE 

Mr. KNIERIM. Good afternoon, Chairman Smith, Ranking Member Bass, and members of the subcommittee. It is an honor to be 

here today and speak with you about DEA’s cooperation with 

China, Mexico, and our worldwide enforcement efforts to combat 

the opioid crisis. Heroin, fentanyl, and related analogues are the 

number one drug threat to our nation. Sadly, the use of these illicit 

drugs is destroying individuals, families, and American communities on a daily basis and in record numbers. 

Over the last several years, we have witnessed a dangerous new 

trend, the convergence of synthetic drug threat and the epidemic 

opioid abuse. Recent preliminary CDC reporting for 2017 indicates 

that an estimated 49,000 Americans lost their lives to an opioid 

overdose. Similar to 2016, the increase in overdose deaths is being 

fueled by synthetics, primarily fentanyl and its analogues coming 

from China and Mexico. 

Fentanyl and related analogues are often shipped directly to the 

U.S. via postal or express mail from China. These synthetic drugs 

are cheap to make, hard to detect, and dangerously potent. A kilogram of fentanyl from China can be purchased for less than $5,000 

and potential profits from the sale of that kilogram yields roughly 

$1.5 million. 

Further complicating the crisis are transnational criminal organizations. Let me be clear, the most significant criminal threat to 

the U.S. today are the Mexican drug cartels. The cartels continue 

to be the primary source of illicit drugs that are decimating our 

communities. Now Chinese and Mexican nationals are increasingly 

operating in concert resulting in an alignment responsible for the 

proliferation of heroin, fentanyl, and related synthetics coming 

across the southwest border. 

This leads me to what DEA is doing to counter the threat. We 

recognize this will take persistent efforts across a broad spectrum 

to include interagency and global partnerships. For decades, we 

have maintained a worldwide presence to address the source of 

drugs and in this case we have a robust presence and critical partnerships in both China and Mexico. 

Over the past decade, our relationship with China has steadily 

progressed. Many of the synthetic drugs encountered in the U.S. 

were not controlled in China. Through continued engagement by 

DEA and DOJ highlighting this serious issue, China passed legislation in 2015 that improved their ability to more effectively control 

newly identified destructive substances. China has now controlled 

175 new psychoactive substances and precursor chemicals which 

have a direct and immediate impact and effect on the availability 

of these drugs in the United States. We are also encouraged by recent discussions with China drug control officials about the prosVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
17

pect of scheduling fentanyl as a class. This would eliminate the 

need to control fentanyl and related substances one by one. 

While we are appreciative of China’s scheduling actions and enhanced cooperation on investigations, there is opportunity for more 

to be done. In 2019, DEA will be opening a new office in 

Guangzhou, China, where much of the shipping of fentanyl and 

other illicit drugs originate, to facilitate greater collaboration with 

our law enforcement counterparts and INL. We are also looking at 

opening an office in Shanghai as well. 

In Mexico, DEA continues to synchronize and expand capabilities 

to combat the growing epidemic. We have developed the bilateral 

heroin strategy for intelligence sharing, coordinated investigations, 

training, increased sharing of forensic information, and the control 

of precursor chemicals. We participate in the North American Drug 

Dialogue along with Federal Government officials from Mexico, 

Canada, and the United States to include INL which focuses on 

building a strategy to attack the production, trafficking, consumption, and misuse of illicit narcotics in North America. 

Domestically, DEA has moved aggressively to place temporary 

schedule controls on new and emerging synthetic drugs. Unfortunately, the temporary emergency scheduling process of a substance 

is reactive, requiring us to first observe deadly consequences and 

synthetic drug abuse before initiating control. Given the proliferation of synthetic substances including fentanyl across the nation, it 

is necessary to explore novel solutions to more expeditiously schedule these new substances. On February 6th, 2018, DEA proactively 

placed temporary emergency controls on the entire class of fentanyl 

related substances to curb fentanyl related overdose deaths. This 

is an unprecedented step to combat an unprecedented threat. 

In closing, we are grateful for the tremendous support that Congress has provided to DEA to combat this national crisis. In addition to increased resources, the House passed H.R. 2851, Stop the 

Importation and Trafficking of Synthetic Analogues Act, which 

DEA believes is critical to combat the synthetic analogue threat 

and save lives. 

We look forward to continuing our work with Congress to identify the resources and authorities necessary to address this devastating crisis and have a positive impact on our communities. 

Thank you for the opportunity to testify before your committee on 

this important issue today and I look forward to your questions. 

[The prepared statement of Mr. Knierim follows:]

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ileparlmeut nf Justite 

STATEMENT OF 

PAUL E. KNIERIM 

DEPUTY CHIEF OF OPERATIONS 

OFFICE OF GLOBAL ENFORCEMENT 

DRUG ENFORCEMENT ADMINISTRATION 

U.S. DEPARTMENT OF JUSTICE 

BEFORE THE 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN 

RIGHTS AND INTERNATIONAL ORGANIZATIONS 

COMMITTEE ON FOREIGN AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

FOR A HEARING ENTITLED 

"TACKLING FENTANYL: THE CHINA CONNECTION" 

PRESENTED 

SEPTEMBER 6, 2018 
19


31451b-2.eps

Statement of Paul E. Knierim 

Deputy Chief of Operations, Office of Global Enforcement 

Drug Enforcement Administration 

Before the Subcommittee on Africa, Global Health, Global Human Rights and 

International Organizations 

Committee on Foreign Affairs 

U.S. House of Representatives 

September 6, 2018 

Chairman Smith, Ranking Member Bass, and Members of the Subcommittee: on behalf 

of the Department of Justice (the Department), and in particular the approximately 9,000 

employees of the Drug Enforcement Administration (DEA), thank you for the opportunity to 

discuss current cooperation between United States law enforcement agencies and China in the 

areas of drug enforcement. 

Drug overdoses, suffered by family, friends, neighbors, and colleagues, are now the 

leading cause of injury-related deaths in the United States, eclipsing those from motor vehicle 

crashes or firearms. 1 An in-depth analysis of2016 U.S. drug overdose data shows that 

America's overdose epidemic is spreading geographically, and is increasing across demographic 

groups. The sharp increase in drug overdose deaths between 2015 to 2016 was fueled by a surge 

in fentanyl and fentanyl analogue (synthetic opioids) involved overdoses 2 " Unfortunately, 

provisional drug overdose data from the Centers of Disease Control and Prevention (CDC) 

shows that fentanyl use drove drug overdose deaths to a record high in 2017. Annual deaths 

from all drug overdoses in 2017 rose to 72,287, with 49,060 of those deaths involving opioids. 

Overdose deaths in 2017 are expected to exceed 2016 figures with synthetic opioids being the 

prime driver of the increase4 

Under U.S. federal law, fentanyl is a Schedule II controlled substance, which is lawfully 

produced in the United States and widely used in medicine. It is an extremely potent analgesic 

used for anesthesia and pain control in people with serious pain problems, and, in such cases, it is 

generally indicated only for use in people who have a high opioid tolerance. 111icit fentanyl, 

fentanyl analogues, and their immediate precursors are often produced in China. From China, 

these substances are shipped primarily through express consignment carriers or international 

mail directly to the United States, or, alternatively, shipped directly to transnational criminal 

organizations (TCO) in Mexico, Canada, and the Caribbean. Once in the Western Hemisphere, 

fentanyl or its analogues are prepared for mixing into the heroin supply, other non-opioid drugs, 

or pressed into a tablet form, and then moved into the illicit U.S. market where demand for 

prescription opioids and heroin remains at epidemic proportions. In some instances, drug 

trafficking organizations have industrial pill presses shipped directly into the United States from 

China, which allows them to press fentanyl pills domestically. Mexican TCOs have seized upon 

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31451b-3.eps

this business opportunity because of the profit potential of synthetic opioids, and have invested 

in growing their share of this market. Because of its low dosage range and potency, one 

kilogram offentanyl purchased in China for $3,000- $5,000 can generate upwards of $1.5 

million in revenue on the illicit market with the potential of being lethal for 500,000 people 5 

According to the DEA National Forensic Laboratory Information System (NFLIS), from 

January 2013 through December 2016, over 58,000 fentanyl exhibits were identified by federal, 

state, and local forensic laboratories. 6 During 2016, there were 36,061 fentanyl reports 

compared to 1,042 reports in 2013, 7 an exponential increase over the past four years. The 

consequences of fentanyl misuse are ot1:en fatal and occur amongst a diverse user base. 

According to a December 2017 CDC Data Briet: from 2015 to 2016, the death rate from 

synthetic opioids other than methadone, a category that includes fentanyl, doubled from 9,580 

(age adjusted rate 3.1) to 19,413. The age-adjusted rate of drug overdose deaths involving 

synthetic opioids other than methadone (drugs such as fentanyl, fentanyl analogues, and 

tramadol) doubled between 2015 and 2016, from 3.1 to 6.2 per 100,0008 

CURRENT CHALLENGES WITH FENTANYL AND RELATED ANALOGUES 

Traffickers Adapting to the Law 

Even though fentanyl and fentanyl analogues, as well as other New Psychoactive 

Substances (NPS), have been controlled in Schedule I or Schedule II of the Controlled 

Substances Act (CSA), entrepreneurs procure new synthetic compounds with relative ease. 9 

Over the past several years, DEA has identified numerous illicit fentanyl class substances and 

hundreds of synthetic drugs from at least eight different drug classes, the vast majority of which 

are manufactured in China. 

Using published data from the patent and scientific literature as their guide, clandestine 

chemists have continued to develop and synthesize new synthetic opioids, cannabinoids, and 

cathinones for the illicit market. Clandestine chemists can easily continue developing and 

synthesizing new synthetic opioids that do not appear on any schedule of controlled substances. 

Sadly, these substances are often first discovered when DEA receives reports from local 

hospitals and coroners in connection with a spate of overdoses. Temporary scheduling alone is 

not enough to address this epidemic. When DEA takes action to temporarily schedule a 

substance, traffickers begin selling new versions of their products made from new, noncontrolled substances in as little as several weeks. Unfortunately, the existing process to 

'U.S. Department of Jmhce, Drug EntOrcement Administration. 2017 J\ational1J111g lhreat lVosessment Summary. October. 

2017. 

6 U.S. Department of JustlCc. DhA ]\FUS, actual data queried on October 13,2017. 7 U.S. Department of Jmhce. DhA .t'-J,US, actual data queried on October 13,2017. 

R Rose A. Rudd, :-Juab .!\J..:;shin;, Jon E. Zibbdl, & R. :tviat1h.,;w Gladdvi1H.xkgaard, H., :\Iargan;1 Vv'am~,.,T, and Arialdi :\I ]'vhnifio. Drug Ov~,.,nlo~.,; 

D~lhs in 1hc llmled Sl11ks. 1999-2016hu;rease~ in Drug and Opioid Ov~nlo~c Deaths- Unikd Slak~. 2000-2014 :\Iorbidity and :tviorlali1y 

Weekly Repot1.t\CllS Data Urie[ 2016;64:137!S-13!':2No 294. Dec 2017. b1!R~~'/2Yl""vs.Q.;-._;Qy_n_d.l2'.S:!rr:!::t'•;t"1.t!llrlff~~0~.42.·tl~lf 9 On Pebmary 6, 201 R, DL\ publi~hed a tit1al order in the federal R.::gist~ scheduling all tentanyl-related substances (i.e., t~ntat1yl analogues) in 

Sch<:Xiulc I 0111111 em~rgcmcy basis. Th~ final ordd" \\1lS made eiTective o11lh~ date ofpublic.alilm. 

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31451b-4.eps

temporarily schedule a substance is reactionary and not agile enough to keep up with bad actors 

engineering illicit substances for the express purpose of skirting our laws. 

importation vs. Domestic Production and Use oft he internet 

lllicit fentanyl, fentanyl analogues, and other NPS are relatively inexpensive, available 

via the Internet and are often manufactured in China where they may be shipped (via the 

international postal system or express consignment couriers) to the United States; alternatively, 

they may be shipped directly to transnational criminal organizations in Mexico, Canada, and the 

Caribbean. Once in the Western Hemisphere, fentanyl and fentanyl analogues in particular are 

combined with heroin, cocaine, and other substances and often pressed into counterfeit pills 

made to look like controlled prescription drugs containing oxycodone or hydrocodone. They are 

then sold online from anonymous darknet markets and even overtly operated web sites. It is 

extremely difficult for the Department of Homeland Security (DHS), U.S. Customs and Border 

Protection (CBP), U.S. Immigration and Customs Enforcement (ICE), and Homeland Security 

Investigations (HSI), and the U.S. Postal Inspection Service (USPIS) to address the threat at 

ports of entry, due to the combination of: the questionable legal status of these substances, which 

are not specifically named in the CSA itself or by DEA through scheduling actions; the 

enormous volume of international parcel traffic by mail and express consignment couriers; and 

the technological and logistical challenges of detection and inspection. These challenges have 

paved the way for non-cartel-affiliated individuals to undertake fentanyl trafficking. DEA is 

working with CBP, HSI, and USPIS, to increase coordination on seized parcels. 

Us·e of Freight Forwarders 

Traffickers often use freight forwarders, companies that arrange importing and exporging 

of goods, to ship fentanyl, fentanyl analogues, and other NPS from China to TCOs in the United 

States, Mexico, and Canada. Several DEA investigations have revealed that the original supplier 

will provide the package to a freight forwarding company or individual, who transfers it to 

another freight forwarder, who then takes custody and presents the package to customs for 

export. The combination of a chain of freight forwarders and multiple transfers of custody 

makes it challenging for law enforcement to track these packages. Often, the package will 

intentionally have missing, incomplete, and/or inaccurate information. 

DEPARTMENT OF JUSTICE INTERACTIONS WITH CHINESE COUNTERPARTS 

China: Government Action and Cooperation 

China is one of the world's top producers of the precursor chemicals used to manufacture 

methamphetamine and fentanyl, as well as the chemicals used to process heroin and 

cocaine. There are approximately 160,000 chemical companies in China. 10 Although the 

10 U.S. Department of State. 2014 International ~arcotics Control Strategy Report (I\ICSR). ,:>vi arch 2014. 

http://1,v\\'\'V.~tate.gm·ij-'inlirls·nrcrpti201-l.i'vol1 /221172.htm: Rog~· nat<:. Phake: The Deadl~y YVorld of falsified and Suhstandard '1\Tedicin.::s, 

American Enterprise In~titutc for Public Policy Rc~carch. 2012, 186.67 

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31451b-5.eps

majority of chemical production is intended for legitimate use, illicit drug manufacturers directly 

source or divert their chemicals from China for their drug production. The three major 

destinations for Chinese-sourced, illicit precursor chemicals are: Southwest Asia for opium and 

heroin production; Southeast Asia for opium, heroin, and methamphetamine production; and 

Latin America for cocaine, methamphetamine, and heroin production. Significant amounts of 

precursor chemicals are shipped from China to Central America for the production of 

methamphetamine, heroin, and fentanyl. Additionally, precursor chemicals transit through any 

number of Latin American countries on to Peru and Colombia for cocaine processing. 

Combating illicit fentanyl is a top priority of this Administration. Recognizing that a 

significant amount of illicit fentanyl, fentanyl analogues, and their immediate precursors are 

manufactured in China, Attorney General Sessions and Deputy Attorney General Rosenstein 

both requested that China take action to stop the flow of these materials in meetings with thenState Councilor Guo Shengkun of the Chinese Ministry of Public Security. Deputy Attorney 

General Rosenstein met with Guo in Beijing, China on September 25, 2017, followed by a 

meeting with the Attorney General at the Law Enforcement and Cybersecurity Dialogue in 

Washington, D.C. on October 3-4, 2017. 

The Attorney General and the Deputy Attorney General's efforts are built on longstanding working-level engagements with the Chinese on a number of levels. For example, 

DEA has maintained a liaison presence in the People's Republic of China, with an office in 

Beijing for the last three decades. DEA is currently working to staff offices in both Guangzhou 

and Shanghai. DEA's office in Beijing has direct engagement with drug control officials from 

China's Ministry of Public Security, Narcotics Control Bureau (NCB). DEA's well-established 

relationship with Chinese drug control authorities is a primary significant bilateral mechanism 

for addressing the threat from the shipment of illicit fentanyls, their precursors, and other 

synthetic drugs to the United States and elsewhere. 

DEA and the NCB share drug-related intelligence and trends through the Bilateral Drug 

Intelligence Working Group (BDIWG), led by DEA's Intelligence Division. This annual 

engagement was established through a memorandum of agreement between DEA and the NCB 

in 2002. 

At a higher policy level, the United States Government has also engaged China through 

two bilateral fora on law enforcement and counternarcotics matters: first, the Law Enforcement 

and Cybersecurity Dialogue (LECD), which is co-chaired by the Attorney General and the 

Secretary of Homeland Security and the Chinese Ministry of Public Security; and second, the 

U.S.-China Joint Liaison Group (JLG) on Law Enforcement (now re-cast as the LECD Senior 

Officials Meeting or "LECD-SOM"), a sub-ministerial group co-chaired by the Department, the 

Department of State's Bureau oflnternational Narcotics and Law Enforcement Affairs (INL), 

and DHS. At the working level, DEA and the NCB participate in the Counter-Narcotics 

Working Group (CNWG) which has operated within the LECD-SOM framework, and that is 

chaired, respectively, by the Department and the Ministry of Public Security on the Chinese side. 

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31451b-6.eps

These efforts have resulted in positive actions being taken by the Chinese Government 

over the last year. China, which has not yet suffered a domestic fentanyl misuse problem, has 

been increasingly cooperative with the United States in this area. Their actions are steps in the 

right direction, but more can be done. 

Since 2014, the Department, DEA, and Chinese officials have met regularly to discuss 

bilateral efforts to counter the threat to the United States from fentanyl class substances. For the 

past four years, representatives from China's National Narcotics Laboratory have met with DEA 

experts to exchange information on emerging substances, trafficking trends, and drug sampling 

standards. This dialogue fosters an ongoing information exchange about new substances of 

misuse in the United States to be considered for control in China. In May 2017, and again in 

June 2018, China NCB and DEA hosted bilateral meetings of experts in Beijing to exchange 

information and perspectives at the technical level on the science and law pertaining to emerging 

NPS, including fentanyl class substances. These meetings answered China's request for more 

information about the misuse and pharmacology of the substances we were urging them to 

consider for scheduling. China's reform measures, effective in October 2015, allow their drug 

control authorities to consider public health harm in other countries, including the United States. 

A key moment in enhanced cooperation on synthetic drugs came in October 2015, when, 

following similar discussions, China implemented domestic control on 116 New Psychoactive 

Substances (NPS), including a number of fentanyl analogues, and streamlined its procedures to 

control additional substances. 

On December 28, 2017, China's Ministry of Public Security announced scheduling 

controls on two key fentanyl precursor chemicals, NPP and 4-ANPP. This action, taken with 

U.S. encouragment, also complied with the decision taken by the UN Commission on Narcotic 

Drugs (CND) in March 2017, to impose international controls on the precursors. The scheduling 

controls took effect on February I, 2018. Chinese control of these substances, combined with 

the effects ofprior control efforts, on the availability of these substances in the United States is 

significant and reaffirms the need for the continued collaboration between DEA and the NCB. 

On March I, 2017, China's National Narcotics Control Commission announced 

scheduling controls on four fentanyl-class substances: carfentanil; furanyl fentanyl; valery! 

fentanyl; and, aery! fentanyl. This announcement was the culmination of the ongoing efforts of 

the United States and the Government of China, and reaffirms an expanding bilateral 

collaborative commitment to countering illicit fentanyl. On July I, 2017, China controlled 

U-47700, also in compliance with the March 2017 CND decision. While not a fentanyl class 

substance, U-4 7700 is a powerful synthetic opioid that has been trafficked and misused in the 

United States. On August 29, 2018, the Government of China announced the control of an 

additional 32 NPS, bringing the total number ofNPS and precursor chemicals controlled to 175 

since 2015. 

DEA will continue to engage the Chinese on the control of emerging fentanyl analogues 

and other NPS. We are further encouraged that the Chinese are willing to engage in discussions 

and technical exchanges with DEA regarding scheduling fentanyl as a class. Tn spite of the 

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31451b-7.eps

complexity of this process, and the fact that Chinese authorities claim that domestic misuse of 

fentanyl and related substances is not a problem in China, they have continued to show an 

understanding of the problem and a willingness to listen and discuss class scheduling. 

As the opioid epidemic continues, the Department and DEA are committed to working 

with Chinese officials through well-established bilateral efforts, including the high-level 

mechanisms noted above liaison presence; the CNWG; the BDIWG; the scientific working 

group, as well as enhancing collaboration with DEA's interagency partners stationed abroad and 

in the United States. 

The Department and DEA continue to expand the robust relationship between Mexico 

and the United States, particularly with regards to countering the threat from heroin and synthetic 

opioids. 

Mexico is the primary producer and supplier of heroin to the United States, and as poppy 

cultivation in Mexico has increased over the last three years, the Department and DEA have 

engaged with the Government of Mexico to address this issue. DEA has developed a 

U.S.-Mexico bilateral heroin strategy to increase intelligence sharing, coordination of 

investigations, training, sharing of forensic information, and the control of precursor chemicals. 

DEA 's Mexico City Country Office has engaged the interagency within the U.S Embassy 

through creation of a Heroin Fentanyl Working Group (HFWG). The HFWG, first convened in 

April 2015, meets on a monthly basis and synchronizes interagency efforts and capabilities. Tn 

early 2016 this forum became part of the Office of National Drug Control Policy's (ONDCP) 

Heroin Availbility Reduction Plan (HARP) implementation as a video teleconference, co-chaired 

by Mission Mexico and ONDCP and regularly attended by the National Security Council, DEA, 

the Department of Defense (DOD) U.S Northern Command, and the Department of State 

Bureaus of Western Hemisphere Affairs and lNL. This one-hour monthly forum has become the 

most effective tool for synchronizing policy formulation and implementation between Mission 

Mexico and ONDCP. The HFWG has allowed the Federal government to speak with one voice 

and maintain critical security relationships with our Mexican partners. The HFWG has enabled 

close coordination on efforts to develop accurate Mexican heroin yield estimates, improve the 

Government of Mexico's poppy eradication efforts, support investigations of fentanyl seizures, 

track ongoing clandestine lab training, and reinforce interdiction efforts. 

DEA also participates in the North American Drug Dialogue (NADD), a trilateral 

Assistant Secretary-level forum between the United States, Mexico, and Canada. Chaired by 

ONDCP and TNL, the NADD provides a framework for expanding cooperation on the heroin and 

fentanyl problem-set across the entire continent. For example, as a result of the NADD, and with 

funding from TNL, the Royal Canadian Mounted Police (RCMP) has provided fentanyl detection 

training to Mexican Federal Police (PF) and canine units affiliated with Mexico's Tax 

Administration Service (SAT), which performs a customs function. 

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SIGNIFICANT ENFORCEMENT AND DOMESTIC EFFORTS 

Heroin Fenlanvf Task hn·ce 

The DEA Special Operations Division's (SOD) Heroin/Fentanyl Task Force (HFTF) 

working group consists of several agencies using a joint "whole of government" approach to 

counter the fentanyl/opioid epidemic in the United States. The HFTF consists of personnel from 

DEA, ICE, HIS, and CBP, supplemented by the Federal Bureau of Investigation (FBI) and 

USPIS. The HFTF utilizes every resource available, including support from the Department's 

Organized Crime Drug Enforcement Task Forces (OCDETF), OCDETF Fusion Center (OFC) 

and the Criminal Division, DOD, the Intelligence Community (IC), and other government 

entities, and provides field offices (of all agencies) with valuable support in their respective 

investigations. 

The HFTF mission aims to: 

Identify, target, and dismantle command and control networks of national and 

international fentanyl and NPS trafficking organizations. 

Provide case coordination and de-confliction on all domestic and foreign investigations to 

ensure that multi-jurisdictional, multi-national, and multi-agency investigations and 

prosecutions have the greatest impact on targeted organizations. 

Provide direct and dynamic operational and investigative support for domestic and foreign 

field offices for all agencies. 

Identify new foreign and domestic trafficking, manufacturing, importation, production, 

and financial trends utilized by criminal enterprises. 

Analyze raw intelligence and documented evidence from multiple sources to develop 

actionable leads on viable target(s) involved in possible illicit pill production and/or 

distribution networks. 

Educate overall awareness, handling, trafficking trends, investigative techniques, and 

safety to domestic and foreign field offices for all law enforcement, DOD, IC, and 

governmental agencies. 

Facilitate, coordinate, and educate judicial districts during prosecutions of fentanyl and 

other NPS related cases. 

Close interagency cooperation via the HFTF has led to several key enforcement actions, 

including the announcement on October 17, 2017, of the first-ever indictments, in two separate 

OCDETF cases, of two Chinese nationals responsible for the manufacturing and distribution of 

illicit fentanyl in the United States. The indictments represented the first of manufacturers and 

distributors of fentanyl and other opioid substances designated as Consolidated Priority 

Organization Targets (CPOTs). CPOT designations are of those who have "command and 

control'' elements of the most prolific international drug trafficking and money laundering 

organizations operating in the world. 

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In addition, SOD's HFTF played an integral role in the July 2017 seizure and shutting 

down of the largest criminal marketplace on the Internet, AlphaBay. As outlined by the Attorney 

General and DEA's then Acting Principal Deputy Administrator, AlphaBay operated for over 

two years on the dark web, and was used to sell deadly illegal drugs, stolen and fraudulent 

identification documents and access devices, counterfeit goods, mal ware and other computer 

hacking tools, firearms, and toxic chemicals throughout the world. The international operation to 

seize AlphaBay's infrastructure was led by the United States and involved cooperation and 

efforts by law enforcement authorities in Thailand, the Netherlands, Lithuania, Canada, the 

United Kingdom, and France, as well as the European law enforcement agency Europol. 

Multiple interagency OCDETF investigations into AlphaBay revealed that numerous vendors, 

including many in China, sold illicit fentanyl and heroin on the site, and that there have been a 

substantial number of overdose deaths across the country attributed to such purchases. 

Scheduling bv Administrative Rulemaking: Temporarv Control 

DEA continues to utilize its regulatory authority to place many synthetic substances into 

the CSA, pursuant to the aforementioned temporary scheduling authority. Once a substance is 

temporarily placed in Schedule I, DEA moves towards permanent control by requesting a 

scientific and medical evaluation, and a scheduling recommendation, from the Department of 

Health and Human Services (HHS). DEA also gathers and analyzes additional scientific data 

and other information collected from all sources, including poison control centers, hospitals, 

medical examiners, treatment professionals, and law enforcement agencies, in order to consider 

the additional factors warranting its permanent control. Since March 2011, DEA has utilized this 

authority on 19 occasions to place 56 synthetic drugs temporarily (emergency control) into 

Schedule I, including 17 fentanyl analogues. In comparison, over the first 25 years (1985-201 0) 

after Congress created this authority, DEA utilized it a total of 13 times to control 25 substances. 

The process is workable but often lags behind the dynamic pace of illicit drug producers and 

distributors. In a significant step, on February 6, 2018, DEA temporarily placed Schedule I 

controls on all "fentanyl related substances," which includes any substance structurally related to 

fentanyl based on specific chemical changes not otherwise controlled in any other schedule. 

Heroin-Fentanvl Enforcement Teams 

Utilizing the appropriations under the Consolidated Appropriations Act of 2017 (P.L. 

115-31 ), DEA has created six new heroin-fentanyl enforcement teams to combat trafficking in 

heroin, fentanyl, and fentanyl analogues. The establishment of the teams began in January 2018, 

and they will be located in some of the regions hardest hit by the opioid epidemic: New Bedford, 

Massachusetts; Charleston, West Virginia; Cincinnati, Ohio; Cleveland, Ohio; Raleigh, North 

Carolina; and Long Island, New York. Thanks to the robust Consolidated Appropriations Act of 

2018 (P.L. 115-141) appropriation, DEA will be creating three additional heroin-fentanyl teams. 

In determining the locations for these teams, DEA will consider multiple factors, including rates 

of opioid mortality, level of heroin and fentanyl seizures, and where additional resources would 

make the greatest impact in addressing the ongoing threat. While the teams will be based in 

specific cities, their investigations will not be geographically limited. DEA has always, and will 

continue, to pursue investigations wherever the evidence leads. 

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Fentanyl Signature Profiling Program 

The overarching goal of the Fentanyl Signature Profiling Program (FSPP) is to provide 

new insights in support of ongoing DEA investigations. The FSPP does this by providing both 

real-time data from the in-depth analyses of seized samples and unique science-based forensic 

investigative leads on seizures where linkages were unknown or only suspected. For instance, 

examples from qualified seizures throughout DEA (e.g., exhibits containing a sufficient amount 

of fentanyl necessary for in-depth testing) are automatically submitted to DEA laboratories for 

FSPP testing; each profiled sample is then compared to all other such fentanyl submissions. If 

linkages between samples are identified, this information is communicated to the appropriate 

DEA Field Division to advance the investigation. Since the program's implementation, over 500 

illicit fentanyl samples have been examined, resulting in the establishment of several sets of 

seizure linkages tying separate cases and seizures together. 

ADDITIONAL AUTHORITIES TO COMBAT SYNTHETIC DRUG THREAT 

Illicit manufacturers and distributors have and will continue, if unabated, to stay one-step 

ahead of any state or federal drug-specific banning or control action by introducing and 

repackaging new synthetic products that are not listed as such in any of the controlled substance 

schedules. Given the proliferation of synthetic analogues, including fentanyl, across the nation, 

it is necessary to explore novel solutions to more expeditiously schedule these new substances. 

H.R. 2851, the "Stop the Importation and Trafficking of Synthetic Analogues Act of2017 

or SIT SA, as passed by the House of Representatives, would provide critical tools to DEA to 

address the rapid proliferation, trafficking, and misuse of synthetic drugs. The proposed 

Schedule A would allow the Attorney General to more efficiently control synthetic analogue 

substances as they emerge, providing law enforcement with a much needed tool to enable us to 

keep up with this fast-moving threat. The bill also includes a provision that criminalizes exports 

of substances to a country where they are banned or controlled, regardless of their control status 

in the United States. This provision would enact a law in the United States parallel to the one we 

are asking China to consider. DEA believes that the enactment of STTSA and other schedulingrelated legislation would show the United States' commitment to combating this scourge. 

CONCLUSION 

DEA will continue to engage the Government of China and others in our efforts to stem 

the flow of fentanyl and fentanyl precursors, which are fueling the national opioid epidemic. 

DEA is further committed to working with the interagency and foreign partners in targeting, 

indicting, and arresting leadership of criminal networks, both foreign and domestic. 

We look forward to continuing to work with Congress to find solutions necessary to 

address the threats posed by fentanyl, its analogues, and other NPS. 

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Mr. SMITH. Thank you very, very much for your testimony. Let 

me just begin, if I could, with some questions and I will, since we 

have a large attendance today I will throw out a few questions 

right off the bat and then come back later if we don’t get everything covered. 

Chinese officials have repeatedly dodged the blame for contributing to the fentanyl crisis, as you know. Liu Yuejin, Deputy Chief 

of China’s National Narcotics Control Commission, stated in June 

that and I quote Liu, the U.S. should adopt a comprehensive and 

balanced strategy to address fentanyl demand, remarking that 

when fewer and fewer Americans use fentanyl there will be no 

market for it. 

As recently as last month, Yu Haibin, an official with China’s 

National Narcotics Control Commission, stated, ‘‘The United States 

has no proof that most fentanyl in the country comes from China.’’ 

And both of you have obviously testified otherwise. Despite the 

banning of multiple variations of fentanyl by the Chinese Government, the export of fentanyl from China to the U.S., as we know, 

persists. 

I wonder if you could tell us law enforcement, all laws all that 

well, you can have the greatest law in the world, if it is not enforced what good is it. Those kinds of high level statements send 

a shiver down my spine about how you may on an operational level 

be working with some very dedicated Chinese colleagues, but if at 

the very top or at other places in the chain of command there is 

a dismissal that most of the fentanyl is not coming from China, it 

certainly raises questions. 

I know that the President, mid-August, called for stronger action 

and I know he directed his Attorney General to do so. You might 

speak to what has been done in terms of mobilizing any additional 

resources or policies. 

What other countries are known sources of fentanyl? Is India one 

of those countries, for example, you might want to speak to that. 

Because when we say majority coming, or most, where is the rest 

of it coming from? What holes in existing legislation need to be 

fixed? As I have said, and you said it just a moment ago, the idea 

of getting the Postal Service to finally adopt a system that at least 

gives another tool to border security and others to make sure that 

we know where it is coming from and where it is going, because 

they can ship it in small packages, unlike big hauls that they are 

taking through other routes. 

And let me also ask if I could, the April announcement by DOJ 

of Chinese nationals’ indictments, do we expect others to follow? 

What has been the progress on that indictment? I was encouraged 

when I saw it, I think most of us were, that DOJ is taking this 

very seriously, but obviously it is very hard when people are in 

China to apprehend them. 

Is there any kind of ability for the Chinese Government to allow 

us to prosecute or at least to have them prosecute? How many arrests of Chinese narco traffickers has DEA made in cooperation 

with the Chinese authorities? It is cooperation with a capital C, or 

with a small C? Are they really working with us? 

I think your statement moments ago about the opening in Shanghai and elsewhere of new efforts is an encouraging sign. But I have 

29

been in Congress 38 years. I have worked on Chinese human rights 

since the day I got here and human rights all over the globe. The 

Chinese have been masters at purporting to be in compliance with 

international treaties including the U.N. treaty, the International 

Covenant on Civil and Political Rights, they milked that big time 

for years when high level officials would come and say we have 

signed it, but they wouldn’t ratify it. And they would get this big 

upsurge that they are cooperating and yet at the level of human 

rights abuse, torture, and all the other abuses have gotten worse 

under Xi Jinping. 

So I am wondering, what is your true assessment? Is that cooperation real, robust? I know that they could take offense at something any of us say here, but we have to be candid. Our American 

brothers and sisters are dying in every one of our districts. We 

have so many people who are dying from fentanyl and it is sneaking into so many other drugs as well, especially heroin. And so the 

idea would be to say there is a line here of real seriousness. And 

of course we combat all the other bad drugs as well, crack, everyone is on board with that. But this one kills so fast and so surreptitiously and it is so powerful that this calls for extraordinary efforts. 

I did ask in my opening comment whether or not you think the 

Magnitsky Act would have applicability here. I think it does. I was 

the House sponsor of that legislation and believe that when you 

hold public officials especially accountable for egregious behavior, 

human rights violations, killing Americans, when you send 

fentanyl to the U.S. Americans will die, or anywhere else where 

you send it. So to me that is a gross violation of human rights 

which would fit the definition of the Magnitsky Act. 

So if you could begin with that. 

Ms. MADISON. Thank you for your questions, Mr. Chairman. I 

will start at the beginning which is this question of Chinese rhetoric and the pushback that you have seen with regard to treatment 

and demand reduction. It reminds me very much of back in the 

day, the kind of conversations we would have with Mexico and we 

have sort of evolved beyond that point. 

And I think from my perspective, I think what is important with 

the Chinese is what they are actually doing. Personally, I know I 

have raised this issue with the Embassy of China, this issue of 

their rhetoric on demand reduction being the only answer, but I 

think what they are doing is what is important. They are working 

with us on controlling more substances. They are working with us 

in multilateral fora to advance controls. They are working through 

multilateral fora on real-time law enforcement cooperation. They 

are working with us on advanced electronic data for the mail. 

And I think as disconcerting as the rhetoric might be, I think the 

results that we get out of them in terms of how they cooperate in 

practical terms is more meaningful. I think there is plenty of places 

where the rhetoric between our two governments is, you know, 

there are rub points. But I think as long as we are getting the cooperation we need out of them that is the most important thing. 

I would imagine that Paul might have some things to say about 

that cooperation just as a——

30

Mr. SMITH. If I could on that point and maybe weave it further 

into your answer, I was the sponsor of the global online security 

act, held a series of hearings that began in ’06 about the police 

state and how their surveillance is second to none in the world. 

The police state knows what people are doing, when they are doing 

it and in order, in my humble opinion, for such huge amounts. I 

know they can be done in small environs, but it doesn’t take much 

for a police state like China if it is serious to crackdown. They certainly crackdown on dissent. They crackdown on labor unions. They 

crackdown if you want a labor union in China, good luck, you are 

going to jail. They know what people are saying when they go on 

Facebook or any of the other social media. You know, their abilities 

they are incredible. 

So my question again further to your answer, cooperation with 

a capital C, are they employing those kinds of assets where they 

say we are serious about this, the way they are about even to some 

degree serious about surveilling their own people 24/7? 

Ms. MADISON. I think that—and again Paul may have more to 

add on the law enforcement side. I think that we are actually seeing real cooperation with them on taking down labs, on helping us 

to get to end game on law enforcement and so I think that that is 

not to be taken lightly. I think even, you know, a year ago we were 

not where we are today with the Chinese. Is there much more to 

be done, without a doubt, but I do think that we are making 

progress. 

Do you have anything? 

Mr. KNIERIM. Thank you. I would just like to echo a few things 

that my friend and colleague Assistant Secretary Madison has 

mentioned. I can tell you that our cooperation and our coordination 

and collaboration with China, in my estimation, has expanded tremendously over the last several years. I firmly believe that they 

understand the nature of the threat. That they are working with 

us, I think, is evident by the fact that they have controlled 175 

chemicals and new psychoactive substances, precursor chemicals 

and the like, fentanyl related substances as well. 

I do believe that the relationships that have been established 

over three decades of presence in China are significant. I believe 

that those relationships are leading to a very robust dialogue and 

engagement. There is exchange of information both ways and it is 

very helpful to identify those substances and the individuals responsible which is our main focus to identify the persons and the 

organizations responsible for trafficking these substances to the 

United States. 

I would also like to add that I think over the last few years it 

has also been evident that, you know, the impact of them controlling these substances through our high level engagements and our 

direct personal relationship and engagement with them does have 

an immediate impact on the substances that are analyzed in our 

laboratories. So we do see when they control and regulate those 

substances through the engagement with us and really working 

with us on a significant way does have an immediate impact at 

home. 

And we are talking about the illicit fentanyl situation and the 

ability of these manufacturers to change the molecular structure in 

31

order to circumvent the controls, so that is really a very challenging situation. And I think it is also important to highlight the 

subject matter exchanges and technical exchanges in order to identify for them the substances that we are finding so that they can 

work with us on a very significant way to take action and control 

those substances as well. 

Mr. SMITH. Is fentanyl a problem in China itself? 

Mr. KNIERIM. Fentanyl is not currently a problem in China. 

Mr. SMITH. So it is an export? 

Mr. KNIERIM. So it is, they are, these organizations and individuals are exporting it to the U.S., Mexico, and Canada and then it 

is brought in to the United States directly from China or through 

Mexico, but it is not a substance abuse issue in China. 

Mr. SMITH. Now with crystal meth when they realized, they 

being the Chinese Government, that that was a serious problem for 

them, there has been a very significant crackdown on the mainland 

of China. A hundred and fifty tons, according to the Sydney morning news, was apprehended. And they are very serious because it 

is so horrifically affecting the Chinese people. Thousands of police 

are now engaged in the meth crisis that they are experiencing. Do 

we see any sign that there is any kind of mobilization like that visa-vis fentanyl? And if I could, is there any sign of complicity of high 

government officials or even operatives at midlevels with regards 

to fentanyl? 

And I say that because, again, I have chaired 65-plus hearings 

on Chinese human rights abuses, and the complicity of the Chinese 

Government and human rights abuse is legendary. It is so awful. 

Even the U.N. has found that—Manfred Nowak when he did his 

piece on torture found it was everywhere in their laogai and prison 

system. If you are arrested you will be tortured. And if you are a 

political prisoner or a religious prisoner you are going to be tortured, horribly. 

And so with all kinds of high government buy-ins to that again 

underscoring the need perhaps at least to have as a tool, utilization 

of the Magnitsky sanctions against individuals. Then I will go to 

Mr. Castro. 

Do you want to speak to that? 

Mr. KNIERIM. Regarding the Magnitsky Act, sir, honestly I am 

not familiar with that so I will have to take that back and work 

with you on getting a response for you at that later. 

Ms. MADISON. So if——

Mr. SMITH. We need to be looking to see if high government officials are looking the other way or complicit, getting money. I mean 

this is, the money that can be gleaned from this is astronomical. 

Ms. MADISON. And Global Magnitsky, it is a tool I am familiar 

with because we considered it on the Foreign Relations Committee 

when I was on the staff. 

Mr. SMITH. Sure. 

Ms. MADISON. I do not personally have any information to suggest the complicity of specific individuals but I understand the 

point, which is that Global Magnitsky is another tool that allows 

you to go after corruption and we are happy to sort of take that 

back and look at the question. But I understand the point which 

is it is another tool. 

32

Mr. SMITH. Please go back and maybe get back to the subcommittee as soon as you can. 

Mr. Castro? 

Mr. CASTRO. Sure. 

Let me ask you a practical question. Can you describe the tools 

and practices that you employ to detect fentanyl? For example, 

what tools do you use in regard to mail routed through the postal 

system? 

Mr. KNIERIM. Go ahead. 

Ms. MADISON. So INL’s piece of this, we are not law enforcement 

on the front lines. CBP really owns the front line on this as stuff 

enters the country because they have the authorities to intercept 

and actually look at things as they enter. From an INL perspective, 

from a State Department perspective what we try to do, what we 

are working on is trying to get countries to provide more advanced 

electronic data that would allow our law enforcement folks to actually go after this. And we also work with countries like Mexico to 

provide fentanyl sniffing dogs and port inspection mechanisms and 

to work with them on controlling their port. 

So our piece of it is the piece where we are trying to line up the 

tools that would actually help our law enforcement. And the advanced electronic data, CBP and the U.S. Postal Inspection Service 

have said that they need more data and it would be extraordinarily 

helpful to them as they try and control inbound packages. 

So from a State Department perspective, we are working in the 

Universal Postal Union to try and continue to advance a requirement that all countries provide advanced electronic data. The second piece of that is, the challenge of that is there is a soft requirement for countries actually to do 100 percent advanced electronic 

data by 2020. Many countries are not capable of it. 

So INL, one of the new partnerships that we are trying to build 

is a partnership with UPU. They have a training program that 

they have 13 countries in a pilot project trying to build their capability to provide advanced electronic data. So one of the things that 

the State Department is doing is we are negotiating with UPU to 

actually expand that program and to tap into their training. And 

really we would have to identify the priority countries that are the 

transport points for mail packages, but if we can help build the capacity of some of these countries to provide advanced electronic 

data that supports our law enforcement folks who are at the border. 

I don’t know if you have more to add, Paul. 

Mr. KNIERIM. Well, I can’t respond directly to what technical and 

tools are being used by CBP and the Postal Service. What I can tell 

you, however, is that we have a very robust interaction and collaboration with both CBP and the Postal Service to identify the organizations and have an impact on the availability. 

One of the things that is very difficult and challenging and I will 

use this as a little demonstration, is if this were—this is about one 

gram. If this were a packet of fentanyl there is approximately 500 

lethal doses in here. So we are looking for very small amounts at 

certain times. These aren’t the tons that are coming in specific 

shipments through maritime efforts and things like that. 

33

So it does represent challenges, but I do want you to understand 

and be aware that there is a very robust interaction amongst law 

enforcement to address this issue and work with our CBP and U.S. 

Postal Service partners. And also with our foreign partners, I think 

the Assistant Secretary made a very valuable point in recognizing 

that we are providing opportunities for training and capacity building so that our counterparts can also be prepared to handle and 

understand the significance of these threats from a safety and security perspective from their investigators as well. 

Mr. CASTRO. Thank you. Just one more question from me which 

is of all the fentanyl in the United States how much of it comes 

from China versus Mexico versus somewhere else? Do you all have 

a sense for that? 

Mr. KNIERIM. Sir, I don’t know if we have a specific sense. One 

of the things that we do use as an identifier or origin is the purity. 

What we understand and find is that if it is coming directly from 

China it is over 90 percent pure. And if it is coming from Mexico 

it is generally less than 10 percent. We see it coming——

Mr. SMITH. Will the gentleman yield on that point? 

Mr. CASTRO. Sure. 

Mr. SMITH. Through Mexico, but what would be the origin? 

Mr. KNIERIM. We see the origin coming from China as well. So 

when it gets to Mexico it is mixed in with heroin or other 

adulterants and also made and pressed into pills that would mimic 

or look like pharmaceuticals. So that is when we see it come, when 

it comes across the southwest border it is generally a little less 

than 10 percent. 

Mr. CASTRO. And is any of it native to the United States? 

Mr. KNIERIM. From the licit side or from the illicit sides? From 

the illicit side again coming in from China, and this does create a 

challenge as well because it is creating individuals who are capable 

of being non-cartel affiliated traffickers. There was an example of 

one in Utah where one individual was responsible for shipping over 

400,000 packages throughout the United States. He was getting it 

on the Web and purchasing it and then putting it in and manufacturing it into fake pills in the basement of his mother’s residence. 

So it does create a challenge identifying those types of non-cartel 

affiliated individuals as well. 

Mr. CASTRO. All right, thank you. I am going to have to leave 

you, Chairman. I have my other subcommittee at the same time. 

Mr. SMITH. I am going to be there too. 

I would like to now yield to Mr. Donovan. 

Mr. DONOVAN. Thank you, Chairman. Most of my questions are 

already asked. I was going to ask the question about does China 

have a fentanyl problem as well and if they don’t they really don’t 

care what it is doing to our citizens. If it is so inexpensive why 

aren’t we making it here? If it is made in labs, it is synthetic, why 

aren’t our drug dealers making it, does anybody know? 

Mr. KNIERIM. The precursor chemicals are controlled. So I think 

identifying and obtaining the precursor chemicals is——

Mr. DONOVAN. Is it difficult? 

Mr. KNIERIM [continuing]. More challenging than obtaining the 

substance. 

34

Mr. DONOVAN. It is just easier to buy. And I think you hit on it 

before that there is detection methods, you know, our dogs hit on 

cocaine packages or coffee beans or Ty-D-Bol cubes, whatever they 

are called. So are there methods that we are detecting fentanyl as 

it comes through the country that you are aware of? 

Ms. MADISON. So from INL’s work in Mexico it is the dog program that we have found to be the most effective. I don’t know if 

there are other technical methods but that is certainly—and that 

is actually something that came out of the North American Drug 

Dialogue with the Canadians because the Canadians were the first 

to say hey, the dogs are actually the most effective way to detect 

this. 

And the RCMP is, actually they started the training in Mexico, 

for example, which again it is a shared border so that is in our interest. And we in INL have supported the program in Mexico with 

dogs and additional training. So that is the primary one we work 

on in INL. 

Mr. KNIERIM. And, sir, one thing I can highlight is the fact that 

there is technical equipment that does detect it, but we are still at 

least from my understanding within DEA looking at the technology 

to see what is the most effective. My understanding is that CBP 

does have some of this that they are using. I don’t know specifically 

what it is, but I can take that back and find that out for you and 

get back to you. 

Mr. DONOVAN. What are the sizes that we are seizing when they 

come across? I mean, you know, we used to do cocaine seizures of 

hundreds of kilos. We are not seeing that with fentanyl, right? 

Mr. KNIERIM. We have seen some very significant seizures in 

Mexico in particular, upwards of 50 to 60 kilograms and then you 

are getting into the thousands of pills. So it is coming across in significant numbers and those are some seizures that have happened, 

some polydrug seizures recently by our Mexican counterpart. 

Mr. DONOVAN. Do we see any other substances, narcotics being 

shipped, heroin from the Far East, cocaine from the south being 

shipped by mail, or is it fentanyl the predominant substance that 

we are seeing shipped by mail? 

Mr. KNIERIM. In my experience, cocaine and meth is getting here 

in every way conceivable to include through the southwest border, 

being shipped through the mail, couriers, maritime; so they use all 

the available resources to get it across. 

Mr. DONOVAN. Thank you, Mr. Chairman, I yield back. 

Mr. SMITH. Thank you very much, Mr. Donovan. 

Mr. Suozzi? 

Mr. SUOZZI. So, first, I have a preliminary question. Fentanyl is 

used for legal purposes as well, it is used for anesthesia and things 

like that; is that correct? 

Ms. MADISON. It is correct. The synthetics are actually used for 

licit purposes as well. 

Mr. SUOZZI. And when you talked about the precursor chemicals 

before and the lack of availability of the precursor chemicals here 

in America because it is regulated, but the unregulated nature of 

the precursor chemicals in China, for example, what are the precursor chemicals? 

35

Mr. KNIERIM. That is a great question and I do want to just reiterate that precursor chemicals have been regulated by China and 

there are two specifically. One is NPP and one is 4ANPP, both 

have been controlled by China. 

Mr. SUOZZI. Okay. I am not going to try and get you to tell me 

what NPP stands for, right? 

Mr. KNIERIM. I couldn’t do it, sir. 

Mr. SUOZZI. Okay. All right, so just I want to try and get some 

clarity. So there are four parts that contribute to this problem. One 

is the lack of, we think, Chinese enforcement to go after these 

drugs being manufactured in China and then being shipped here. 

Two is detection of these drugs as they are entering our border, 

and I want you to talk about that just to clarify for me that you 

think mainly the way it is coming in is through the mail. 

Three is the prosecution of the substances, the possession for 

these substances based upon the fact that they are these different 

analogues and they change the makeup and they are not all necessarily scheduled drugs that can be prosecuted for. And four of 

course is, you know, the demand for the drugs itself. 

So are those the four big areas and can you just talk a little bit 

about each one like what is the biggest parts of the problem? Is it 

the lack of Chinese enforcement? Is it the failure or inability to detect the stuff coming across the border? Is it the inability to prosecute because of the different analogues or is it just simply because 

people are using this stuff too much? Or is there something I am 

leaving out? 

Ms. MADISON. Paul will add after I do, but from my perspective 

I think all of these things are part of the challenge. I think you 

have a very agile part of the drug market, right. You have synthetics that are able to be produced and altered very rapidly. It is 

the reason we are asking China to control as a class, because basically if they tweak a formula and on a particular drug it is suddenly no longer controlled. I think it is very agile. 

I think another big——

Mr. SUOZZI. So just China right now. You know, they are doing 

better now, they have gone after some precursor drugs. From 1 to 

10, 10 doing the great job of enforcement and 1 they are not doing 

a great job of enforcement, how would you rank them from 1 to 10? 

Mr. KNIERIM. What I would like to say is that they are working 

with us on a collaborative basis on our investigative efforts and so 

I think that over the last few years and what I have seen is that 

investigative cooperation and that exchange and those partnerships 

have significantly increased. So they have exchange information 

with us and us with them, they have taken action on the investigative information that is being passed. So I believe that those relationships are going to continue to strengthen. In particular, why we 

are opening an office in Guangzhou and looking at opening an office in Shanghai, because those partnerships and those relationships develop further investigative efforts and joint investigations. 

I think on the detection piece, it is coming through the mail, 

right, so that does present challenges for us. I think we are looking 

at the cartels. And to your point about that with the prosecution 

and those types of things, I think again want to recognize and 

thank Congress for SITSA, because we do feel that that is a very 

36

important legislative issue. As evidenced by our emergency scheduling, we also think any additional legislation that would permanently schedule these as a class would be very helpful as well. 

Mr. SUOZZI. Anything you want to add, Ms. Madison? 

Ms. MADISON. Just to say that I do think in addition to the——

Mr. SUOZZI. I am letting you off on the 1 to 10 thing because you 

obviously don’t want to answer that. 

Ms. MADISON. It is very merciful of you. 

I would say, you know, that the issue of the scheduling as a class 

is so important because of the agility of the synthetic, illicit synthetic producers. I think the mail presents a really profound challenge because it is very diffuse. You know, this is not our old school 

interdiction approach. It is not what we have done with cocaine. It 

is not what we have done with——

Mr. SUOZZI. It is not some people taking a boat across the Caribbean and coming in some places, no border control and sneaking 

in that way. 

Ms. MADISON. Right. And then there is the dark Web piece of it. 

It is very—this is not the word I want to use, but it is sort of democratized access, right. People can go online. They can go onto the 

dark Web. They can make these purchases. They can pay for them 

with crypto currencies and they can get them dumped in the mail 

and shipped to them. And then we are in a position where CBP is 

trying to stop it all at the border. So this is a very different kind 

of business model and it is a sort of new horizon in the challenge. 

So, and I think that—and you can’t ignore any piece of what you 

talk about. The demand piece of it is very important. It is not the 

work that the State Department does or DEA does, but it is a piece 

of this puzzle. But I think this is a very, very agile piece of the illicit drug market and it is requiring us to think differently and develop new techniques because it is not the old school way of trafficking or selling drugs. 

Mr. SUOZZI. And how, is there a way that it could be detected 

in the mail if we changed the procedures or processes? I mean how 

we could we, I mean if it is coming in these small packages and 

that could be wrapped in something else and wrapped in something 

else, I mean how would we—it is not an x-ray thing. It is not a 

smell. How would you detect it in the mail? 

Mr. KNIERIM. I think through the mail facilities is what CBP and 

U.S. Postal is trying to do through the express mail consignment. 

Shipping the volume is significant of the mail that is coming in 

from China. So I think from our perspective it is also continuing 

to focus our interagency efforts on identifying those individuals and 

organizations responsible and heading it off in that perspective and 

prosecuting them. 

I think to piggyback on something that the Assistant Secretary 

said with regard to the internet and I previously mentioned it, this 

has created non-cartel affiliated trafficking opportunities for some 

individuals. So the robust efforts and our interagency efforts to address the internet and not just the dark Web but the open Web as 

well, and then to follow up with our, you know, money laundering 

investigations to identify the flow and to identify those assets for 

seizure is also something that we take very seriously. 

37

You know, this is a top priority and so I think our interagency 

efforts and our international efforts collectively are going to continue to strengthen and improve as we identify these other areas 

of mutual interest. 

Mr. SUOZZI. The last thing, so you are talking about, you know, 

we need to do a better job surveilling the dark Web, surveilling the 

open Web, and watching for where people get access to this stuff 

in the first place. And then there is a concern about surveilling the 

mails about where the origination point is for these drugs and then 

trying to track where they end up in the United States and look 

for patterns and processes of where the drugs are going related to 

where the overdoses are taking place or the use is taking place 

which will raise concerns of the libertarians and civil liberties folks 

that, you know, we are watching too much of what everybody is 

doing. 

But you are saying that is the only way you can really track 

what is going on or am I putting words in your mouth? 

Mr. KNIERIM. I think it is a combination of investigative efforts 

to include and incorporate the information and the investigations 

that we have that utilize the mail, utilize the internet, the cartel 

involvement, the non-cartel affiliated traffickers. So it is really a 

combined and faceted, multifaceted approach to address this significant problem. 

Mr. SUOZZI. Thank you. Thank you, Mr. Chairman. 

Mr. SMITH. I have some other additional questions, but we do 

have a vote series, five votes that are up, regrettably, in terms of 

time. I apologize for the inconvenience to our next panel, because 

we will have to take a short recess. 

But I would, for the record you didn’t say it when I asked it earlier, but maybe for the record you could provide it, how many arrests have Chinese narco traffickers had with the DEA? What kind 

of, I mean what are the numbers? Are they working with us? What 

is the outcome of the announced April indictments? Where is that 

if you could bring us to successful prosecution sometimes breeds 

more successful prosecution showing that it is doable and of course 

we learn lessons on cooperation when we actually do it and cooperate. 

So I do have those questions. If you could provide that for the 

record I would appreciate that. And again getting back to enforcement, you have made the point that they have legal controls on the 

precursors. Again just my experience, I could be dead wrong, but 

by and large when the government gives an assurance of something that it has no willingness to execute, and nowhere is that 

more notorious than their utter failure to respect the human rights 

of their own people in a myriad of categories, they will have a piece 

of paper that says look, it is right here it is outlawed, and yet the 

proof has to be in how are you executing it. 

So if you could get back to us with maybe some additional insight 

on how they are executing. Like I mentioned with the methamphetamine, they are serious about that one because Chinese citizens 

are dying from it and of course that is made in a lab too. So please 

get back to us on that one as well unless you wanted to comment 

right now. 

Mr. KNIERIM. We will be happy to get back to you, sir. 

38

Mr. SMITH. I appreciate that. Thank you. 

I will do the introductions to our next panel and again I deeply 

apologize to the next panel. 

And thank you again for your testimonies. 

And then we will come back right after the vote to reconvene. 

Maybe we will go in brief recess and then I will invite everybody 

to the witness table in a few moments. Thank you. 

[Recess.] 

Mr. SMITH. The subcommittee will resume its sitting and I do 

want to apologize for that hour delay or a little over because of 

votes. We did have five votes. So, but please accept that apology 

and I thank you for your patience most of all. 

Let me begin, first of all, with our first witness on Panel 2, Joseph Coronato who has served as the prosecutor in Ocean County, 

New Jersey since 2013. Prior to his current position, Mr. Coronato 

established a private practice in Toms River, New Jersey, specializing in municipal prosecution, civil litigation, criminal matters, 

and personal injury, among other things. 

He also served as assistant prosecutor at the Atlantic County 

Prosecutor’s Office and was appointed deputy attorney general by 

the attorney general of New Jersey back in 1976, where he investigated and tried organized crime, narcotics, and white-collar crime 

as well, and worked in the Organized Crime Special Prosecutor 

Section of the Attorney General’s Office. 

Secondly, we will hear from Bryce Pardo who is an associate 

health policy researcher at the RAND Corporation where his work 

focuses on drug policy, specifically in the areas of cannabis regulation, opioid control, and new psychoactive substance markets. Prior 

to his current position, Mr. Pardo worked for 5 years as a legislative and policy analyst at the Inter-American Drug Abuse Control 

Commission within the OAS, the Organization of American States, 

and has independently consulted with multilateral institutions 

such as PAHO, the Pan American Health Organization and U.N. 

Office on Drugs and Crime. 

In 2015, Mr. Pardo served as an analyst with BOTEC Analysis 

Corporation assisting the Government of Jamaica in drafting medical cannabis regulations. Mr. Pardo holds a doctorate of philosophy 

in public policy from the University of Maryland, an M.A. in Latin 

American studies, and a B.A. in political science from George 

Washington University. 

And then finally we will hear from Dr. Dan Ciccarone who is a 

professor in the Department of Family and Community Medicine at 

the University of California San Francisco. He specializes in family 

medicine and addiction medicine, has been principal or co-investigator on numerous NIH-sponsored public health research projects. 

He currently leads the Heroin in Transition Study which aims to 

examine the rise in heroin use, the expanding diversity of heroin 

source forms, and illicitly made synthetic opioids such as fentanyl 

and their relationship to the increase in illicitly opioid involved 

mortality as well as morbidity. He is the associate editor of the 

International Journal of Drug Policy and recently edited a special 

issue of the Journal on opioids, heroin, and fentanyl in the United 

States. 

39

Three outstanding experts to inform the panel and, by extension, 

to inform the Congress, so I thank you for being here. And, Mr. 

Coronato, if you could begin. 

STATEMENT OF MR. JOSEPH D. CORONATO, PROSECUTOR, 

PROSECUTOR’S OFFICE, OCEAN COUNTY, NEW JERSEY 

Mr. CORONATO. My name is Joe Coronato and I am the prosecutor in Ocean County. Ocean County is the second largest 

landmass county in New Jersey. Our population is slightly over 

600,000 which is the fifth largest, But during the summer months 

our population exceeds 1.2 million. That is due to our beaches 

along the Atlantic coast. 

I was sworn in as prosecutor back in March 2013. As the prosecutor, I am the chief law enforcement officer for the county. As 

such, the police chiefs of 32 police departments and approximately 

1,600 sworn officers report to my authority. My office itself consists 

of 200 employees: 50 assistant prosecutors, 95 detectives, and 

agents and support staff, just to show that we are an average county within not only the State of New Jersey but probably throughout 

the country. 

Within 2 weeks of being sworn in as prosecutor there were eight 

overdose deaths in Ocean County. All the victims were under the 

age of 28. I had one young girl 18 years of age died in a motel 

room. This young woman was doing 50 packs of heroin a day, 25 

in the morning and 25 at night. As a father of two children, I knew 

it was my responsibility to use every effort possible to address this 

epidemic. 

Ocean County has become ground zero for the overdose deaths 

in New Jersey in the last several years. Back in 2012, before I was 

prosecutor, it was 53 overdose deaths due to opiates. In 2013 it 

went up to 112. In 2014 it went down to 106 and that is because 

of Narcan. In 2015 it went back up to 120. In 2016 it was the year 

where we had 217 people in my county died. I will note that in 

2017 there was 174 people died. It was a 20 percent reduction and 

I will explain that later on. 

The Ocean County Prosecutor’s Office and its local and State and 

Federal partners have attacked the opiate epidemic and it appears 

that we are having some success in this regard. But that being 

said, the impact of what I call the synthetic storm, the addition of 

fentanyl to the mix has been devastating and continues to be a 

major concern. 

Based on our medical examiner toxicology analysis, in 2014, 10 

percent of my dead bodies had fentanyl in them. In 2015, 30 percent of my dead bodies had fentanyl in it. In 2016, 60 percent of 

my dead bodies had fentanyl in it. In 2017, 65 percent of my dead 

bodies had fentanyl in it. And now 2018, 80 percent of my dead 

bodies have fentanyl and I do say by the end of the year probably 

will rise to about 85 percent. 

A brief summary from Ocean County Forensic Laboratory for 

2017 and 2018 is also startling. The number of fentanyl-laced submissions rose from 37 percent, meaning of what we tested in 2017 

to about 52 percent of our submissions now have fentanyl in it in 

2018. Fentanyl-laced submissions now appear to be frequently combined with at least 14 other drugs such as cocaine, methamphetVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
40

amine, and alprazolam. Our county labs are consistent with the 

New Jersey State Police Forensic Science Lab. So far the State lab 

is showing a 53 percent increase in fentanyl-laced submissions 

statewide in 2018. 

Ocean County has been tracking the opioid death rate on a 

monthly basis since 2014. To further emphasize the impact of synthetic opioids, in February 2017 there were seven overdose deaths. 

In February 2018 there was a dramatic increase to 20 deaths. The 

increase can be attributed to a free heroin day that was promoted 

by the drug dealers in Camden, New Jersey. On that day there was 

no charge for heroin wax folds. Ocean County suffered eight deaths 

within a 3-day period. It should be noted that Camden and surrounding counties, Gloucester and Cumberland, had similarly high 

death rates for that same period. Essentially, a bad batch of synthetic-laced opioid was the cause. 

To note, on June 25th, 2018, this year, the Customs and Border 

Protection seized 110 pounds of fentanyl in Philadelphia. The U.S. 

Customs and Protection agents in Philadelphia last week discovered 100 pounds inside barrels of iron oxide being shipped from 

China. The seizure occurred on June 25th and netted fentanyl with 

a street value of $1.7 million. An agency spokesman said the cargo 

was flown into Chicago then shipped by truck through Philadelphia, but the officials that are not going to specify exactly where 

the seizure occurred or identify the cargo’s intended final destination. 

That seizure further illustrates a significant impact that synthetic opioids have on the drug trade not only in New Jersey and 

Philadelphia area, but throughout the entire country. The drug 

traffickers are businessmen who are seizing the opportunity to 

maximize their profits simply through their distribution of same. 

Why grow a plant when you can synthetically produce and manufacture at a significantly lesser cost. 

In recognition of that threat that heroin and opioids presents in 

my region, the DEA and HIDTA recently established a Monmouth 

County Post of Duty Task Force which will focus additional law enforcement resources to our problem. To that end, I really want to 

thank Chairman Smith, Senator Booker, and also Congressman 

Tom MacArthur who helped me get Ocean County to be part of 

that HIDTA task force. 

As a result of that already strong working relationship between 

my office and federal, state, and local authorities, a drug investigation was recently conducted which involved six counties in New 

Jersey, New York, and the Dominican Republic. One of the target 

dealers, investigators from Jersey City—and basically what happened is that we were able to trace the drug dealer through Ocean 

County through Monmouth, up to Middlesex, up to Hudson County 

into Jersey City. That dealer then went over to the Bronx and then 

flew from the Bronx down to Miami, eventually going to the Dominican Republic. 

We then were able to track that individual back into Miami, who 

then flew to California, and eventually was stopped crossing the 

United States. And when we did that stop was transporting 40 

pounds of cocaine and 40 pounds of meth that was designated for 

the East Coast. And I use that to show how a county prosecutor 

41

can show how it becomes an international source of drug dealing 

that actually leaves our shore, goes to another country, and comes 

clear across the State. 

In my opinion, synthetics will become the predominant type of illegal drugs abused within the next 5 years. In fact, we now can see 

in Ocean County that synthetic drug transactions are being transacted at an alarming rate, in many instances right over the internet from sites located abroad. The subsequent delivery of the internet synthetic drugs is literally to the doorstep of our abusers and 

dealers by the U.S. Postal Service, Federal Express, and other delivery services as the case may be. 

At least in Ocean County we have created a partnership between 

law enforcement and the healthcare community and additional 

services which has had a substantial impact on reducing our overdose rate by 20 percent of the synthetic storm. The death rate in 

Ocean County for 2018 matches our death rate of 2017 which 

means that we are holding our own. 

While I am very proud of our anti-heroin/opiate programs we 

have implemented in Ocean County, I am most proud of our Blue 

HART Program. Blue HART allows an addict to voluntarily turn 

themselves into one of our eight police departments in our county 

and without fear of prosecution be referred to a long-term rehab 

center. 

Since we rolled the program out and starting in January 2017, 

over 800 individuals have availed themselves of this program. Because of these synthetic opiates, our efforts to reduce overdose 

deaths here in Ocean County and elsewhere will be increasingly 

more difficult. I look forward to Congress to take the lead in this 

synthetic epidemic and to assist law enforcement and healthcare 

communities with adopting comprehensive legislation to address 

this epidemic. 

I believe there are a couple recommendations this committee can 

consider in helping to stop the international illegal sale of fentanyl. 

First, I believe our Federal law enforcement needs to develop new 

partnership with law enforcement in China and other countries 

where we have traditionally not had a significant presence. It is extremely important to control the production and distribution of synthetic opioids worldwide, and I think we need to do that through 

the partnership of law enforcement agencies. 

Secondly, I would also recommend to the committee to consider 

new investigative techniques needed to implement in this illegal 

drug trade. We have seen especially with fentanyl internet purchases with home delivery of this dangerous drug. Traditional drug 

enforcement needs to adapt to this change in distribution patterns 

and Federal resources need to be devoted to this issue. The internet ordering of illegal drugs including fentanyl and delivery of that 

drug to your doorstep is the next storm. 

I would like to thank you for the opportunity to address this committee and express my thoughts and concerns. I would like to add 

one other thing, if I may. When I talk about the Blue HART Program, okay, that all kind of evolved out of Narcan. When it came 

in 2014, I could see that our death rate was climbing alarmingly. 

We turned to Narcan. We were the first county in the State of New 

Jersey to give out Narcan to the law enforcement officials. We gave 

42

it to all the police departments and we used forfeiture funds to 

fund the Narcan within each of the departments. 

But I soon learned even though our death rate started to go 

down as a result of giving out the Narcan that that was only a temporary fix. So the next program that we worked on in 2015 and 

2016 was what we called the OORP program, which is the Opioid 

Overdose Response Program. And that meant that once an individual that was sprayed with Narcan and brought to the hospital, 

there would be a recovery coach that would approach him in that 

hospital, so we would have somebody available 7 days a week, 24 

hours a day in the hospital that would be able to, as I would call 

them, catch that individual, tell them they were at death’s doorstep, and get them into help. So we did that in 2015 and 2016. 

But then it became upon me to say, wait a minute. The only way 

we are helping these people is that they almost have to die and almost have to be at death’s doorstep to help them, and that is when 

the Blue HART Program came into being where you can walk into 

a police station without fear of being charged and that we would 

get help. I never thought in my wildest dreams that 800 people 

would be walking into my police stations to do that. But what that 

does show is why did they come into a police station and not 

present themselves to a hospital? 

There is a gap there and obviously that is something that we 

needed to work with, with the hospitals to understand because this 

is a medical issue. It is a disease that needs to be worked upon. 

I really would believe that the next phase is a step-down unit within the hospital. I truly believe that we can’t tie up the emergency 

room and have a throughput issue in the emergency room, but that 

we need to develop within the hospital a step-down unit where almost where we can hold them for 24 that may be up to 72 hours, 

that there be a clinical evaluation done and that we would then be 

able to process them through the system. 

I think it also would give the State Health Department a better 

feel as to what the volume is going to be because we would have 

these step-down units located throughout the State. They would be 

able to better track and better assess the problems as they go forward. I think it is also a one-step, a one-flow issue because it would 

not only be limited to opiates, but it would also be for alcohol problems, mental health problems. I think that it would be broad-based 

as a result. 

And then we would then, once we have these entries into this 

river as I call it to one, we should improve our river system and 

improve our recovery system as it goes through. So I think there 

is a lot of work. I think there is a bright future. I think you can 

see by the standard that we created that despite the fact that we 

have this storm and despite that we have fentanyl coming in that 

there is a possibility that we can work around this problem and actually reduce the death rate. Thank you. 

[The prepared statement of Mr. Coronato follows:]

43


31451e-1.eps

TESTIMONY 

Presented by 

Joseph D. Coronato 

Ocean County Prosecutor 

Before the 

Subcommittee on Africa, Global Health, 

Global Human Rights, and International Organizations 

2 P.M. 

Addressing 

U.S. House of 

6,2018 

Fentanyl exports 

Room 2200 

House Office 
44


31451e-2.eps

Good afternoon, Chairman Smith, ranking member Bass and 

members of the committee. My name is Joseph D. Coronato, I am the 

Prosecutor in Ocean County, New Jersey. Ocean County is the second 

largest county (land wise) in New Jersey. Our population is slightly over 

600,000 people, 5

1

h largest in New Jersey, but during the summer 

months our population exceeds 1,200,000, due to our beaches along 

the Atlantic Ocean. 

I was sworn in as Prosecutor of Ocean County on March 22, 2013. 

As Prosecutor, I am the Chief Law Enforcement officer for the county. 

As such, the police chiefs of 32 departments and their approximately 

1,600 sworn officers report to my authority. My office itself consists of 

approximately 200 employees: 50 Assistant Prosecutors; 95 Detectives 

and Agents and Support Staff. 

Within two weeks of being sworn in as Prosecutor, there were 

eight opiate overdose deaths in Ocean County. All the victims were 

under the age of 28. One young girl, 18 years of age, died in a motel 

room. This young woman was doing 50 packs of heroin a day, 25 in the 

morning and 25 at night. 

As a father of 2 children, I knew it was my responsibility to use 

every effort possible to address this epidemic. 

Ocean County has become ground zero for overdose deaths in 

New Jersey in the last several years: 

1 
45


31451e-3.eps

2012 53 Deaths 

2013 112 Deaths 

2014 106 Deaths 

2015 120 Deaths 

2016 217 Deaths 

2017 174 (20% Reduction) 

The Ocean County Prosecutor's Office and its local, State and 

Federal partners have attacked the opiate epidemic and it appears that 

we are having some success in this regard. With that being said, the 

impact of the "synthetic storm", the addition of fentanyl to the mix, has 

been devastating and continues to be a major concern. 

Based upon our medical examiner toxicology analysis: 

2014 - 10% of the overdose deaths had the synthetic 

component of Fentanyl in their systems 

2015 - 30% of the overdose deaths had the synthetic 

component of Fentanyl in their systems 

2016- 60% of the overdose deaths had the synthetic 

component of Fentanyl in their systems 

2017- 65% of the overdose deaths had the synthetic 

component of Fentanyl in their systems 

2 
46


31451e-4.eps

2018 80% of the 

component of 

deaths had the 

in their systems 

brief summary from the Ocean Forensic for 

2017 and 2018 is The number of laced submissions 

rose from 35% in 2017 to 52% so far in 2018. In 

laced submissions now appear to be combined with at least 

1.4 other such as 

Our lab results are consistent with the New State Police 

Forensic Science 

53% increase in 

:>hr-.r::>tnr-., results. So far the State lab is 

laced submissions statewide for 2018. 

a 

Ocean has been the death rate on a 

since 2014. To further of 

2017 there were 7 overdose deaths. In 

there was a dramatic increase to 20 deaths. The increase can be 

attributed to a free heroin that was dealers 

in New On that for the heroin 

wax folds. Ocean suffered 8 deaths within a 3 It 

should be noted that Camden and the 

Gloucester and Cumberland had death rates for the same 

laced was the 

cause. 

On June the U. S. Customs & Border Protection seized 

110 in As in The 

3 
47


31451e-5.eps

U. S. Customs and Border Protection Agents in Philadelphia 

last week discovered 110 pounds of Fentanyl inside barrels 

of iron oxide shipped from China, authorities said. 

The seizure June 251

h netted Fentanyl with a street value of 

about 1.7 million, according to the agency. Stephen Sapp, 

an agency spokesman, said the cargo was flown into Chicago 

and then shipped by "truck in bound" through Philadelphia, 

but the officials did not specify where the seizure occurred 

or identify the cargo's intended final destination. 

This seizure further illustrates the significant impact that synthetic 

opioids have on the drug trade not only in the New Jersey/Philadelphia 

area, but throughout the entire country. The drug traffickers are 

businessmen who are seizing the opportunity to maximize their profits 

and simplify their distribution of same. Why grow a plant when you can 

synthetically produce/manufacture it at a significantly lesser cost. 

In recognition of the threat that heroin and opioids presents 

to my region, the DEA/HIDTA recently established the 

Monmouth/Ocean County Post of Duty Task Force which will focus 

additional law enforcement resources to our problem. To that end, I 

want to again thank Senator Cory Booker, Representative Tom 

MacArthur, Representative Christopher Smith, NY/NJ HIDTA Executive 

Director Chauncey Parker and Monmouth County Prosecutor Chris 

Gramiccioni for their efforts. 

As a result of an already strong working relationship between my 

Office and Federal, State and local authorities, a drug investigation was 

recently conducted which involved 6 counties in New Jersey, New York 

4 
48


31451e-6.eps

and the Dominican One of dealers led 

""'''~icr::.t,n.-c from to the Bronx to Miami to the Dominican 

He then came back to Miami went to California and was 

This is 

aspect of the trade. 

the Mid West. The individual was 

of cocaine and 40 

East 

of the national and international 

type 

abused within the next 5 years. In fact we can now see in 

Ocean that transactions are transacted at 

rate, in many instances over the internet from sites 

located abroad. The of the internet 

Postal 

may be. 

Federal 

l\t least in Ocean 

of our the U. 5. 

or other services as the case 

we have created a between 

law the health care and additional services 

which has had a substantial on our overdose death 

rate the storrnn. The death rate in Ocean 

for 2018 matches our 2017 level to with no increase even 

as continue to be more 

While I am very 

programs we have 

our Blue HART 

of a number of 

in Ocean 

Blue HART allows addicts to 

5 

of 

turn 
49


31451e-7.eps

themselves into one of eight different police departments in our 

County/ and/ without fear of prosecution/ be referred into a long term 

rehabilitation program. Since we rolled the program out 1-17-17, over 

600 individuals have availed themselves of the program. 

Because of these synthetic opiates our effort to reduce overdose 

deaths here in Ocean County and elsewhere will be increasingly more 

difficult. I look towards the Congress to take the lead in this synthetic 

epidemic and to assist the law enforcement and health care 

communities with adopting comprehensive legislation to address the 

epidemic. 

I believe there are a couple recommendations this committee 

could consider in helping to stop the international illegal sale of 

fentanyl. First, I believe our federal law enforcement needs to develop 

new partnerships with law enforcement in China and other countries 

where we have traditionally not had a significant presence. It is 

extremely important to control the production and distribution of 

synthetic opioids worldwide. 

Secondly, I would ask the committee to consider that new 

investigative techniques need to be implemented for this illegal drug 

trade. We have seen/ especially with fentanyl, internet purchases with 

home delivery of this dangerous drug. Traditional drug enforcement 

needs to adapt to this change in distribution patterns and federal 

resources need to be devoted to this issue. The internet ordering of 

illegal drugs, including fentanyl, and the delivery of that drug to your 

doorstep is the next storm. 

6 
50


31451e-8.eps

I would like to thank you for the opportunity to address this 

Committee and express my thoughts and concerns before you. 

7 
51

Mr. SMITH. Thank you very much, Mr. Coronato, a tough prosecutor with a great big heart for those who are suffering from drug 

abuse, so really appreciate it. 

Dr. Pardo. 

STATEMENT OF BRYCE PARDO, PH.D., ASSOCIATE POLICY 

RESEARCHER, RAND CORPORATION 

Mr. PARDO. Chairman Smith, Ranking Member Bass, and other 

distinguished members of the subcommittee, thank you very much 

for the opportunity to testify before you today. 

For almost 30 years, the RAND Drug Policy Research Center has 

worked to help decision makers in the United States and throughout the world understand and address issues involving alcohol and 

other drugs. I was asked to speak to you today about ongoing developments related to the opioid crisis in the United States and 

China’s role in supplying synthetic opioids. 

First, I briefly describe the emergence of these drugs. I then 

focus on elements related to the production and supply of substances coming from China. Finally, I conclude with some policy 

options aimed at the new challenges posed by synthetic opioids. 

The opioid crisis was originally fueled by oversupply of prescription 

painkillers, yet by 2017, synthetic opioids such as fentanyl were involved in approximately 60 percent of the almost 50,000 opioid 

overdose deaths that year. Similarly, in 2016, about 40 percent of 

fatal cocaine overdoses included synthetic opioids. 

The upward trend in synthetic opioid overdoses is mirrored by 

supply-side indicators. Customs and Border Protection seized 675 

kilograms of fentanyl in fiscal year 2017, up from just one kilogram 

in fiscal year 2013. Calculations in my written statement show that 

approximately 80 percent of the purity adjusted fentanyl seized by 

CBP in fiscal year 2017 occurred in the international postal and express consignment systems, almost all originating from China. This 

supports law enforcement’s assessments that that country is a substantial source of synthetic opioids. 

China is an important source of many legitimate chemicals and 

pharmaceutical ingredients. Today it is the world’s largest exporter 

of active pharmaceutical ingredients and a leading exporter of 

chemicals for industrial and commercial use. However, economic 

growth in these sectors has outpaced the central government’s ability to monitor producers. 

As detailed in my written statement, there are several factors 

that allow for unscrupulous manufacturers to operate with impunity. First, regulatory design and enforcement is scattered across 

a handful of agencies creating gaps and oversight. Second, misaligned incentives between those who write the rules and those 

who enforce them allow for regulatory capture and corruption. And 

third, the central government’s enforcement capacity is limited 

given the number of producers and distributors. Such conditions 

create a favorable environment for firms to operate in the legal 

margins allowing them to produce and export synthetic drugs to 

global markets. 

This problem is not unique to pharmaceuticals or illicit drugs. 

Chinese manufacturers have been implicated in cutting corners at 

the expense of consumer safety. This includes manufacturing pet 

52

food that contained melamine, toothpaste tainted with antifreeze, 

children’s toys painted with lead, and contaminated blood thinners. 

Considering the future, there are several things that Congress or 

Federal authorities could do. However, given the scope of this problem and the new challenges it presents, Congress must look beyond 

traditional and existing drug policy tools. First, given the lack of 

information on supply and demand Congress could ensure improved and streamlined data collection and analysis methods by 

Federal agencies. This includes directing law enforcement and public health authorities to improve measurement and analysis of seizures and other outcomes such as overdoses. Most of our drug policy collection and data analysis systems are inadequate to appropriately assess developments related to the arrival of these new 

and emerging drugs. 

Second, Congress could encourage Federal authorities to utilize 

supply-side interventions strategically by working with Chinese 

counterparts to strengthen the country’s regulatory and interdiction capabilities. Congress could consider appropriating additional 

resources to aid U.S. authorities that work with international partners as well as direct the FDA, the DEA, and the Department of 

State to improve interagency coordination and cooperation with the 

Chinese Government, encouraging it to close regulatory gaps, move 

more quickly with scheduling decisions, and increase enforcement 

capacity. 

Third, Congress could encourage Department of State to engage 

diplomatically with China for the purposes of discussing an extradition agreement to prosecute and deter suppliers. Lack of such an 

agreement impedes U.S. law enforcement’s ability to prosecute Chinese nationals that traffic synthetic opioids. And lastly and most 

importantly, Congress could increase demand reduction efforts at 

home. This includes encouraging the expansion of pharmacological 

treatments covered by private and public insurance, subsidizing the 

cost of medication therapies for those who cannot afford them, and 

reviewing and reducing regulatory barriers on their provision. 

The arrival of illicitly manufactured synthetic opioids creates uncertainty in retail drug markets raising the risk of overdose. These 

substances are changing the drug policy landscape and stretching 

our ability to respond effectively. Decision makers will need to consider the new challenges presented by fentanyl and related substances to stem the rising trend in overdoses. 

Thank you and I look forward to your questions. 

[The prepared statement of Mr. Pardo follows:]

53


31451c-1.eps

Testimony 

Evolution of the U.S. Overdose Crisis 

Understanding China's Role in the Production and Supply 

of Synthetic Opioids 

Bryce Pardo 

CT-497 

Testimony presented before the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and 

International Organizations on Tackling Fentanyl: The China Connection on September 6, 2018. 
54


31451c-2.eps

For more information on this publication, visit Vivvw.rand.org/pubs/testimonies/CT497.html 

Testimonies 

RAND testimonies record testimony presented or submitted by RAND associates to federal, 

state, or local legislative committees; government-appointed commissions and panels; and 

private review and oversight bodies. 

Published by the RAND Corporation, Santa Monica, Calif 

©Copyright 2018 RAND Corporation 

RAND® is a registered trademark. 

Limited Print and Electronic Distribution Rights 

This document and trademark(s) contained herein are protected by law. This representation of 

RAND intellectual property is provided for noncommercial use only. Unauthorized posting of 

this publication online is prohibited. Pennission is given to duplicate this document for personal 

use only, as long as it is unaltered and complete. Permission is required from RAND to 

reproduce, or reuse in another form, any of its research documents for commercial use. For 

information on reprint and linking permissions, please visit 

www.rand.org/pubs/pennissions.html. 

www.rand.org 
55


31451c-3.eps

i__'volution of the US Overdose Crisis: Understanding China's Role in the Production and 

Supply ()[Synthetic Opioids 

Testimony of Bryce Pardo1 

The RAND Corporation2 

Before the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human 

Rights, and International Organizations on Tackling Fentanyl: The China Connection 

September 6, 2018 

Chairman Smith, Ranking Member Bass, and other distinguished members of the 

Subcommittee on Africa, Global Health, Global Human Rights, and International 

Organizations, thank you very much for the opportunity to testify before you today, 1 am 

a drug policy researcher at the RAND Corporation. For almost thirty years, the RAND Drug 

Policy Research Center has worked to help decisionmakers in the United States and throughout 

the world address issues involving alcohol and other drugs. In doing so, the center brings an 

objective and data-driven perspective to this often emotional and fractious policy arena. 1 was 

asked to speak to you today about ongoing developments related to the current opioid crisis in 

the United States and China's role in supplying potent synthetic opioids. 

The introduction of illicitly manufactured synthetic opioids to U, S. drug markets presents 

new challenges for contemporary drug policy: The potency of many synthetic opioids increases 

risk to users and poses challenges for first responders, the development of novel opioids that fall 

outside existing drug controls complicates regulatory etl'orts, and their ability to be produced and 

shipped with ease disrupts traditional supply chains. 

Today, l will briefly describe our country's ongoing opioid overdose crisis. Understanding 

recent developments and the shifting supply of opioids is critical to policy design. l will then 

describe the emergence of synthetic opioids, which have complicated many of our drug policy 

efforts. Given the topic of this hearing, l focus most of my testimony on China's role as a source 

of synthetic psychoactives and chemical precursors, describing what we know about the 

manufacture and export of potent opioids, such as fentanyl, to the United States. Although most 

of these substances appear to come from China, many dimensions of this problem remain 

1 The opinions and conclusions expressed in this testimony are the author" s alone and should not be interpreted as 

representing those of the RAND Corpomtion or any of the sponsors of its research. 

' The RAND Corporation is a research organiLalionllmt develops solutions to public policy challenges to help nmkc 

communities throughout the '\vor1d safer and more secure, healthier and more prosperous. RAND is nonprofit 

nonpartisan, and committed to the public interest 
56


31451c-4.eps

unclear. That said, China's export-led economic strategy and lack of regulatory oversight have 

created favorable conditions for the production and exportation of synthetic opioids and related 

chemicals. I conclude with some policy options going forward, aimed at the new challenges 

posed by these substances. 

Arrival of Synthetic Opioids to Illicit Markets 

A decade and a half into the opioid crisis, the number of overdose deaths continues to 

accelerate, increasing by 6.6 percent from just 2016 to 2017-' The crisis was initially fueled by 

oversupply of prescription painkillers, such as oxycodone and hydrocodone. Yet, in 2017, 

synthetic opioids, such as fentanyl, were involved in approximately 60 percent of all opioid 

overdose deaths. Although diversion of prescription fentanyl (e.g., transdermal patches and 

transmucosallozenges) has been documented,' today's problem largely comes from illicitly 

manufactured synthetic opioid powders. Unlike traditionally available street-sourced opioids, 

such as heroin or diverted prescription pills, synthetic opioids found in today's drug markets are 

often much more potent. Some of these chemicals are active in the tens of micrograms,' making 

precise dosing very difficult without sophisticated equipment. As the supply of fentanyl 

permeates U.S. markets, so does the risk of fatal overdose. 

Provisional numbers from the Centers for Disease Control and Prevention (CDC) suggest 

that there were as many as 49,000 opioid-involved overdose deaths in 2017. Separating these by 

drug class shows that there were approximately 29,000 recorded overdoses involving synthetic 

opioids6 This is almost a tenfold increase since 2013. Today's drug overdose crisis now 

surpasses major public health epidemics of prior generations, including the IITV/AIDS epidemic. 

Moreover, overdose figures and law enforcement reports suggest that synthetic opioids, 

initially sold as powdered heroin or prescription pills, are entering non-opioid drug markets7 

Although about one-third of heroin-involved deaths in 2016 also involved synthetic opioids, 

approximately 40 percent of fatal cocaine overdoses included synthetic opioids. Fie,>ure 1 shows 

some trends regarding the presence of synthetic opioids among fatal overdoses with various 

other drugs. Early numbers for 2017 indicate that overdoses involving heroin and prescription 

opioids have remained steady since 2016, while overdoses from synthetic opioids increased by 

almost 50 percent, suggesting a continued diffusion across markets. 

1 F. B. Ahmad, L. M. Rossen. M. R. Spencer. M. Wamer, and P. Sutton, Provisional Drug Orerdose Death Counts. 

Hyattsville. Md.: National Center for Health Statistics. 2018. 

1 J. Kuhhmll R. McCaulley, T. J. Valoucll and G. S. Bchonick. "Fentanyl Usc. Misuse. and Abuse: A Sumnmry of 

2J Postmortem Cases. Journal (?fA.IwZvtical Toxicology, VoL 27, No.7, 2003, pp. 499-50-t.. 

'i According to the European Monitoring Centre for Dmgs and Dmg Addiction, the lethal dose of fentanyl for those 

\vithout opioid tolerance is approximately two milligrams (2,000 micrograms), roughly the amount of t\\·O grains of 

salt. Sec http://www .emcdda.curopa.eu/publications/drng-proliles/fentany l#phannacology. Transdennal patches 

containing fentanyl release 12.5 to 100 micrograms per hour. depending on the prescription. 

" Alnnad eta!.. 2018. 

U.S. Dmg Enforcement Administration, Special Testing and Research Laboratol)·, F.mergmg Threat Report 

Annual 2017. Springfield. Va .. 2018. 

2 
57


31451c-5.eps

Figure 1. Number of Fatal Drug Overdoses in the United States 

Cocaine Heroin 

15,000 

10,000 

5,000 

0 

Opioids Synthetic Opioids' 

15,000 

10.000 

5,000 

0 

2008 2042 2016 2008 2012 2016 

SOURCE Data are deidentified public-use Multiple Cause of Death certificate files produced by the National Center 

for Health Statistics for 2008-2016 

The upward trend in overdoses is mirrored by supply-side indicators. U.S. Customs and 

Border Protection (CBP) seized approximately one kilogram of fentanyl in FY 2013; by FY 

2017, CBP seized 675 kilograms-" Likewise, reports by the U.S. Drug Enforcement 

Administration's (DEA 's) National Forensic Laboratory Information System (NFLIS) show a 

sharp increase in the number of seizures containing fentanyl submitted to state and local drug 

laboratories. Although this may be partially explained by changes in law enforcement procedures 

when handling unknown substances, reports of the number of incidents of fentanyl seizures 

submitted to NFLIS also jumped, from 978 in 2013 to more than 34,000 in 20169 In addition to 

the rise in reports of seized fentanyl in domestic drug markets, DEA has noted increases in the 

number of novel synthetic opioids. According to DEA's Fmerging Threat Report for 2017, ten 

synthetic opioids were seized and identified for the first time. 10 In other words, these chemicals 

::; U.S. Customs and Border Protectioll CBP Border Secunly Report: f<iscal Year 2017, Washington. D.C., 

December 5, 2017. 

9 U.S. DmgEnforcement Administration, Diversion Control Division, lv'l'J.JS Brief l'elltanyl, 2001 2015, 

Springfield, Va .. 2017~ U.S. Drug Enforcement AdministratioiL Diversion Control Division. SFLIS Brief Fentanyl 

and Fenlan.vi-Relaled Substances Reporled in _,_\iFLJS, 2015-2016. Springfield, Va .. 2017. 

l(• U.S. Dmg Enforcement Administration, Special Testing and Research Laboratory, 2018. 

-' 
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31451c-6.eps

were previously unknown in US. drug markets. Even though producers continue to innovate and 

create new substances, fentanyl remains the dominant synthetic opioid reported in laboratory 

seizure reports. 

Although fentanyl and several of its analogues are controlled substances with recognized 

medical and veterinary applications in the United States, annual aggregate production quotas and 

prescriptions have remained relatively stable over time. 11 Today, the most likely source of these 

drugs is illicit manufacture. There was a brief period in the mid-2000s when illicitly 

manufactured fentanyl appeared in street markets in the Midwest, claiming about 1,000 lives. 12 

The federal and local responses were swift, expanding access to naloxone and seizing product 

from markets. In May 2006, Mexican law enforcement and DEA identified and closed the illicit 

manufacturing operation in Toluca, Mexico. 13 lllicitly-manufactured synthetic opioids were not 

again a concern until late 2013. 

Much has changed since the closure of the lab in Toluca. Members oflaw enforcement in the 

United States and Canada suggest that most synthetic opioids and precursors originate from 

manufacturers and vendors in China. 14 One route of supply comes via the international postal 

system and private express consignment carriers, such as FedEx and DHL. 15 According to DEA, 

Mexican drug traffickers are the other major source. 16 Given that drug trafficking organizations 

in Mexico have a history of importing methamphetamine precursors from China, 17 it is likely 

that they are doing the same with fentanyl precursors. 

CBP reports seizing synthetic opioids, such as fentanyl, at land points of entry and 

checkpoints on the southwest border. Table 1 shows that for FY 2017, seizures offentanyl near 

or at the border outweighed those at mail and express consignment carrier facilities. However, 

after adjusting for reported potency, almost 80 percent of purity-adjusted fentanyl seized by CBP 

in FY 2017 occurred at mail and express consignment carrier facilities. Law enforcement and 

II Production quotas for fentanyl trended upward starting in 2013, butt hey returned to their baseline levels by 2017. 

U.S. Drug Enforcement Administration, "Aggregate Production Quota History for Selected Substances:· November 

15. 2017: R. Gladden, Fentanyl Lmr i!_'nforcement Submissions and increases in S~vnthetic Opioid-Jnvolved 

Overdose Dea1hs 27 States, 1013 201../., Atlanta. Ga.: Centers for Disease Control and Prcvcntioll Morbidity and 

Mortality Weeklv Report. August 16, 2016. 

12 Centers for Disease Control and Prevention, Vonpharmaceutical Fentanyl-Related Deaths-.Afultiple States, April 

2005-March 2007. Atlanta, Ga., Morbidity and Mortality Weekly Report. July 25, 2008. 

11 U.S. Dmg Enforcement AdministratioiL National Dmg Intelligence Center. Fentanyl: Situation Report, 

Springfield. Va., SR-00000 I. June 5, 2006. 

11 C. Baims. "Clmges to Be Laid Involving Fentanyl Shipments from Chim: RCMP," Globe and Mail. September 

18, 20 17; U.S. Dmg Enforcement Administration, L'ounte1:fi?it Prescription Pt!ls Contaming Fentanyl.~·: A (Jlohal 

Threat. Springfield, Va .. 2016. 

15 U.S. Se1mte. Committee on Homeland Security and Govenunental Affairs, Penlk1nenl Subcormnittee on 

Investigations, Comhaiiing the Opioid Crisis: Fxploiting Vulnerahilities in Jnternalionalldail, Washington. D.C., 

staff report. 2018. 

1

" U.S. Dmg Enforcement Administrdtion, 2016. 

~ S. O'Connor_ .\feth Precursor ('hemtcal.\'.fi'om ('hma: Jmplicatwn:o•fhr the [/nlted ,\'rates. \Vashington. D.C.: U.S.-

China Economic and Security Revie\v Cmmnission, 2016. 

4 
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31451c-7.eps

congressional investigations have suggested that these packages originated from China18 If we 

think that CBP seizures represent the true nature oftratlicking patterns (i.e., that these are 

minimally biased samples), then these preliminary calculations support law enforcement's 

conclusion that the mail and express carrier consignment systems are a substantial supply 

channel of synthetic opioids coming from China. 

Table 1. Breakdown of CBP Seizures Reported to Contain Fentanyl in FY 2017 

Average 

Weight of 

Amount Number of Seizures Reported Purity-Adjusted 

Point of Interdiction Seized (kg) Seizures (kg) Purity(%) Amount (kg) 

Express consignment carrier facilities 110 118 0.932 90.0 99.0 

International mail network 42 227 0.185 90.0 37.8 

Land points of entry (southwest border) 388 65 5.970 7.5 29.1 

Remainder* (presumably Border Patrol 135 7.5 10.1 

checkpomts) 

Total 675 176.0 

SOURCE: Owen, 2018. 

NOTE: Purity at border is reportedly 5-10 percent; here, we use the midpoint. 

• Remainder was calculated by taking the difference of reported fentanyl seizures from the FY 2017 total of 675 kg. 

Nevertheless, smuggling trends may be evolving. In late June 2018, CBP at Philadelphia's 

port seized 50 kilograms of 4-flouroisobutyryl fentanyl hidden in barrels of iron oxide in a 

container ship from China19 CBP noted high purity, which would make this single seizure one of 

the largest to originate from China. 

By most accounts, China remains an important source of synthetic opioids and fentanyl 

precursors entering North America, whether sent by mail or cargo or smuggled over the border 

by drug trafficking organizations. 

China as a Source of New Drugs and Chemical Precursors 

The manufacture of many of these new drugs and precursors, including synthetic opioids, is 

linked to China's large and underregulated chemical and pharmaceutical sectors. China is a 

leading exporter of active pharmaceutical ingredients and chemicals that can be used in the 

production of controlled substances. These include methamphetamine precursors and cocaine 

li( U.S. Senate, 2018: T. 0\veiL Executive Assistant Commissioner for Office of Field Opemtions, U.S. Customs 

nnd Border Protection, testimony before the U.S. Senate Committee on Homeland Security and Governmental 

Affairs, January 25. 2018. 

19 U.S. Customs and Border Protection, ·'Philadelphia CBP Seizes Nearlv $1.7 Million in Fentanyl Shipped from 

China." Jtme 28. 2018. 

5 
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31451c-8.eps

reagents, such as ephedrine, pseudoephedrine, and potassium permanganate 20 To avoid detection 

at points of import, Chinese producers or distributors often employ technically legal 

workarounds and, when necessary, outright deception. It has been reported that Chinese 

traffickers and chemical exporters will mislabel shipments, modify chemicals, or ship preprecursors that fall outside international controls 21 

As tbis relates to synthetic opioids, lack of international scheduling has allowed Chinese 

manufacturers to export fentanyl precursors. Although they have been scheduled in the United 

States for a decade, N-Phenethyl-4-piperidinone (NPP) and anilino-N-phenethylpiperidine 

(ANPP) were not listed or subject to international controls until October 2017. 22 In late 2016, the 

US. Department of State identified nearly 260 producers of these precursors, more than half of 

which were in China.23 These chemicals were finally scheduled in China this past February24 

Prior to then, there was little scrutiny on their manufacture, and producers faced little, if any, 

reporting, production, or exporting restrictions. 

Much like circumvention of precursor regulations, Chinese manufacturers have synthesized 

new substances that fall outside national and international laws, including drugs that mimic the 

effects of cannabis, stimulants, benzodiazepines, and opioids. In the case of synthetic opioids, 

such as fentanyl, individuals can order these substances online and have them shipped directly to 

destinations in the United States2 ' Chinese chemical and phannaceutical finns openly advertise 

such drugs on English-language websites accessible by a simple internet search. Vendors will 

sometimes purposefully conceal shipments through freight forwarding systems, mislabel 

packages, or route them through a third country to conceal efforts to trace packages to their 

original source26 

To stem the growing production of uncontrolled psychoactives, the Chinese government has 

added new chemicals to national drug schedules. In late 2015, China added 116 new substances, 

including 38 synthetic cannabinoids, 26 synthetic cathinones (e.g., "bath salts"), 23 

phenethylamines (e.g., MDMA analogues), as well as half a dozen synthetic opioids, to its drug 

controllaws27 Since then, China has scheduled additional fentanyl analogues as they are brought 

to the attention of authorities by U.S. and Canadian law enforcement 28 In January 2017, China's 

O'Cmmor. 2016; U S. Department of State. international Narcotics Control Strategy Report. Washington, D.C.. 

2017. 

21 O'Connor, 2016. 

::International Narcotics Control Board. "!NCB: Scheduling of Fentanyl Precursors Comes into Force," October 18. 

2017. 

23 J. Whale!L "U.S. Seeks Curb on Chemicals Used to Make FentanyL a Powerful Opioid," Wall Street Journal. 

October 1~. 2016. 

2

-1- U.S. Dmg Enforcement Administration. "China Announces Scheduling Controls on T\vo Fentanyl Precursor 

Chemicals," January 5, 201 R. 

"U.S. Senate. 2018. 

"'U.S. Senate. 201 R. 

::::'United Nations Office on Drugs and Crime. '·Chinn Announces Controls over 116 New Psychonctive Substances," 

October 2015. 

28 U.S. Dmg Enforcement Administmtion. 2018: Royal Canadian Mounted Police ... RCT\IfP and Chinese Ministry of 

Public Secmity Commit to Combat the Flow of Fentanyl into Canada.'. November 16, 2016. 

6 
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Ministry of Public Security listed four additional synthetic opioids acrylfentanyl, cartentanil, 

furanylfentanyl, and valerylfentanyl.29 This was followed six months later with the control of 

four new substances, including two non-fentanyl synthetic opioids, U-47700 and MT-45 30 

Industry Growth and Regulatory Deficiencies 

Although the Chinese central government has taken steps to control new chemicals and 

precursors, the problem persists. There are two likely factors for this. First, as previously 

mentioned, many manufacturers adapt to controls by designing new drugs. But, more important, 

regulatory capacity in China appears to be inadequate to effectively police its expansive 

pharmaceutical and chemical industries. I now turn to this second factor. 

Government-led market reforms in the past thirty years have helped China become a global 

manufacturing center driven by exports. The expansion of e-commerce and inexpensive shipping 

have made global trade cheaper and more convenient. Together, these phenomena helped make 

many of China's industries important links in international supply chains. The same is true for its 

expansive pharmaceutical and chemical industries. Initially, China prioritized the development of 

these sectors under strong central planning, but, over the years, it has slowly introduced 

privatization31 

As state-run producers privatized, the pharmaceutical and chemical industries experienced 

rapid economic development. During the 1980s, the pharmaceutical industry grew, on average, 

by 17 percent per year32 During the 1990s, the pharmaceutical industry was one of the fastestgrowing sectors in China. By 1995, the number of pharmaceutical manufacturers had hit a peak 

of 5,300 firms 

Today, China's pharmaceutical industry counts some 5,000 manufacturers that produce more 

than 2,000 products, with an annual production capacity of more than 2 million tons, making the 

country the single largest exporter of active pharmaceutical ingredients (APis) in the world. 33 

According to the World Health Organization (WHO), most Chinese APis are imported by the 

United States to produce legitimate pharmaceutical products. China's pharmaceutical industry is 

now the second-largest in the world, with recent annual sales revenues of more than $100 

billion34 

In addition to China's pharmaceutical industry, the Department of State estimates that, in 

China, there are approximately 400,000 chemical manufacturers or distributors, some of which 

29 Chinese Minisll)' of Public Security. "Notice on Inclusion of Four Fentanyl Substances. Such as Fentanyl. in the 

Supplement to the Catalog of Non-Medical Narcotic Dmgs and Psychotropic Substances Control," March 1, 2017. 

10 U.S. Dmg Enforcement Administration. "China Am10unces Scheduling Controls of New Psychoactive 

Substances/Fentanyl-Class Substances," June 19, 2017. 

31 World Health OrganiLation, China Pohcies w Pro mole Local Production (~{Pharmaceutical Products and Pro/eel 

Puhlic Health, Geneva, 2017. 

32 H. Li. and H. Slm. ··The Historical Evolution of China· s Dmg Regulatory System." Value in Health, Vol. 17. No. 

3, 2014. pp. A30-A3L 

11 World Heallh OrganiLation, 2017. 

14 World Health Organization. 2017. 

7 
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are operating without legal approval 35 These firms produce tons of chemicals each week 

intended for industrial and commercial use36 China is the world's leading chemical exporter by 

value. 37 One private-sector analysis estimates that China's chemical industry has grown by an 

annual average of9 percent in recent years and made up 3 percent of the national economy in 

2016, generating more than $100 billion in profits that year38 

Market-oriented refonns have generated rapid growth but also necessitated the creation of an 

independent regulatory system to police the industry and ensure product quality. Rapid 

commercial growth has outpaced the capacity and design of China's regulatory regime 3 '' 

Regulatory gaps and bureaucratic fragmentation continue to hamper China's ability to oversee its 

phannaceutical and chemical industries. 

In 1998, the State Drug Administration (forerunner to today's China Food and Drug 

Administration [CFDA]) was created to regulate manufacturers ofphannaceutical and medical 

products. Henceforth, the regulatory authority was formally prohibited from joint ventures or 

profit-seeking activities in the pharmaceutical industry40 In the past decade, efforts have been 

made to adopt better enforcement and production guidelines, including good manufacturing 

practices (GMPs). The GMP standards cover most basic aspects of manufacturing, including 

environmental protections, sanitary working conditions, product testing and tracking, and record 

keeping. 

However, the division of regulatory design and enforcement responsibilities among national 

governmental entities is a commonly noted problem. Given the confusing and competing overlap 

among agencies, etTorts to regulate the chemical industry have been overlooked at times. By one 

account, API producers that were registered as non-phannaceutical chemical manufacturers 

escaped the CFDA's regulatory oversight until 2014. 41 

Lack of coordination and competing regulatory oversight allow for such gaps to exist. This 

creates opportunities for some firms to hide unregulated activities in plain sight. According to 

one report written by staff of the U.S.-China Economic and Security Review Commission, there 

were eight governmental entities involved in promulgating and enforcing production and export 

requirements for pharmaceuticals or chemicals. These include the CFDA, the State Council 

Leading Group on Product Quality and Food Safety, the National Narcotics Control 

Commission, the Anti-Smuggling Bureau within the General Administration of Customs, the 

~ U.S. Dcparlmcnt of Statc.lnlernalional _,_\iarcolics Control Slralegv Report. Washington. D.C.: Bureau of 

International Nmcotics and Lmv Enforcement Affnirs. 2014; U.S. Department of State. !nternatwnal Varcotics 

C'ontrol Strategy Report. \Vashington, D.C .. Bureau of Intemational Narcotics and Law Enforcement Affairs. 2015. 

'"O'Connor, 2016. 

1

' International Trade Centre. ·'Trade Map,' yearlv tmde data. 2018. 

38 Atradius, ··Market Monitor: Focus on Chemicals Performance and Outlook," 2017. 

39 Li and Stm. 201~: World Health Organization, 2017. 4

" Li and Stm. 201~. 

41 S. O'Connor_ Fentanyl: Chuw':o• Dead~v Jl;xport to the Umted ,)'tate,\', \Vashington, D.C: U.S.-China Economic and 

Security Revie\v Commission. 2017. 

8 
63


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Ministry of Chemical Industry, the Ministry of Agriculture, the Ministry of Commerce, and the 

General Administration of Quality Supervision, Inspection, and Quarantine42 

In addition to the patchwork of responsible agencies, competing incentives between levels of 

government may impede enforcement. Provincial authorities protect, promote, and sometimes 

manage local economies and industries 43 Although the central government, through the CFDA, 

designs rules to govern GMP standards, it relies on provincial governments to enforce them. 

According to the WHO, the CFDA inspects manufacturers of products deemed sensitive by the 

central government (such as radioactive pharmaceuticals and biologics), whereas provincial 

governments are mainly tasked with inspecting and certifying companies for GMP approval. 44 

This creates a principal-agent situation between the central and provincial governments. This 

division in regulatory design and enforcement generates opportunities for regulatory capture, 

non-enforcement, or outright corruption when the economic incentives of provincial 

governments misalign with those of good governance. In some cases, there is little or no 

independent regulatory oversight affirms. 

Beyond gaps in regulatory design and misaligned incentives, the government's regulatory 

capacity is limited. The division in enforcement strategy, in which the CFDA inspects only a 

subset of manufacturers, leaving the rest up to provincial authorities, may reflect this limitation. 

The CFDA and other regulators are unable to effectively inspect and police the large number of 

phannaceutical manufacturers. The WHO notes that, although the CFDA is attempting to hire 

more inspectors, its efforts are complicated by lack of time and resources; private industry 

salaries are highly competitive, complicating efforts to retain qualified stafi4 ' 

Data from the CFDA, produced in Table 2, show that regulators are increasing the number of 

inspections, yet gaps remain. Figures from annual reports show an increase in inspected finns 

and applicants from 698 in 2015 to 751 in 2017, although there was a dip in inspections in 

2016.46 The number of CFDA inspectors has remained around 2,000 over the same period; 

however, regulators have shifted focus to GMP certification inspections away from other forms 

of inspections, such as pre-approval and overseas inspections. These regulatory efforts, which 

have traditionally been assigned to provincial governments, more than doubled from just over 

200 in 2015 and 2016 to 428 in 2017. 47 The number of unannounced inspections remained steady 

over this period, while those that included international inspectors (such as the U.S. Food and 

Drug Administration [FDA]) modestly increased in recent years. 

Of the 428 GMP inspections carried out in 2017, 37 firms or applicants did not pass, and 

one-quarter were issued warning letters for violations. According to the most recent CFDA 

O'Collllor, 2017. 

4

-' T. Gong, ··com1ption and Local Governance: The Double Identity of Chinese Local Govenunents in Market 

Refonn." 1he l'acific Revim. Vol. 19. No. I. 2006. pp. 85-102. 

44 World Health Organization. 2017. 

15 World Health OrganiLation, 2017. 

46 China Food and Dmg Administration, Center for Food and Dmg Inspection,".Jnnual Report ofDrug Inspection 

2015, 2016: China Food and Dmg Administration. Center for Food and Dmg Inspection, ,1nnual Report ofTJrug 

Inspection 2016. 2017: China Food and Dmg Administration, Center for Food and Dmg InspectioiLAnnual Report 

of Drug lmpection 2017. 2018. 

4

' China Food and Dmg Administration, Center for Food and Dmg Inspection, 2016, 2017. 2018. 

9 
64


31451c-12.eps

annual report, 15 tirms that manufacture narcotic or psychotropic drugs, precursors, or 

phannaceuticals were inspected that year; three did not pass inspection for failure to properly 

handle mailing and transportation certificates or failure to control samples 48 These numbers 

suggest that regulators are inspecting a small share of companies and that a sizable portion of 

manufacturers of controlled substances assessed in 2017 failed inspection for improper handling 

and transport. 

Table 2. China Food and Drug Inspections 

Number of Inspected 

Firms/Applicants Number of Inspectors 

Inspection Type 2015 2016 2017 2015 2016 2017 

GM P certification 221 204 428 784 47 1,234 

Unannounced 59 39 57 170 155 183 

Observation by international inspectors 74 81 84 76 85 92 

Other 334 107 182 1,052 990 556 

Total 698 431 751 2,082 1,277 2,065 

SOURCES. Ch1na Food and Drug Adm1n1strat1on, Center for Food and Drug Inspection, 

2016,2017, 2018. 

The situation is similar for China's chemical regulators, who cannot adequately enforce 

regulations on all manufacturers and distributors. 49 Regulatory gaps have led to a large increase 

in the number of unlicensed or "semi-legitimate" chemical manufacturers or distributors50 There 

are reports that use of shell facilities and weak oversight lets some chemical and pharmaceutical 

manufacturers avoid scrutiny, allowing companies to produce and sell beyond their legal limits." 

In 2007, industry insiders estimated that uncertified chemical manufacturers produced half of the 

APls sold in China, with most exported to foreign markets. 52 It is unclear what proportion of 

uncertified manufacturers are supplying international API markets today or what amount of 

synthetic opioids is produced and exported via shell entities. 

Gaps in regulatory design, the division of responsibility between provincial and central 

governments, and a lack of oversight and government and corporate accountability increase 

opportunities for corruption. The Regional Representative of the United Nations Office on Drugs 

and Crime, Jeremy Douglas, has asserted that corruption contributes to the ongoing illicit 

manufacturing and export of synthetic drugs and precursors. In 2015, after a major seizure of two 

and half tons of methamphetamine in Hong Kong-one of the biggest seizures in Asia at the 

time--Douglas stated, "To operate a lab like this, you need a lot of chemicals, which are 

legitimate, regulated chemicals from the pharmaceutical industry. There is some kind of 

"'China Food and Dmg Administration, Center for Food and Dmg Inspection, 2018. 

49 O'Connor, 2017. 

50 O"Collllor, 2016. 

'

1 O"Cmmor. 2016. 

'' W. Bogdanich, "Chinese Chemicals Flow Unchecked onto World Drug Market ... New York Tuues. October 31. 

2007. 

10 
65


31451c-13.eps

corruption in the chemical/pharmaceutical industry taking place allowing this to happen "53 The 

Department of State also points to insufficient regulatory oversight and corruption of local 

government otlicials as explanations behind illicit drug and chemical production54 

Chinese authorities recognize these problems, and the government has made some efforts to 

expel corrupt otiicials. The high-profile conviction and execution of the former director of the 

forerunner to the CFDA in 2007 is one such example. 55 The central government has been tough 

on local o±licials and businesses, arresting nearly 2,000 people in a nationwide crackdown on 

counterfeit drug manufacturers in 2012 56 ln 2015, President Xi Jinping demanded that 

authorities increase penalties and stiffen drug regulation. 57 This past March, the central 

government proposed another reorganization of the CFDA, combining it with other regulatory 

entities." Details are not final, but industry observers suggest that this reorganization is intended 

to extend the agency's regulatory reach and reduce gaps in oversight59 

Potential Policy Options 

There are several options that Congress and federal authorities could consider. However, 

given the scope of this problem and the new challenges it presents, Congress must look beyond 

traditional drug policy tools. 

First, given the lack of information about supply and demand, one option that Congress could 

take is to ensure improved and streamlined data collection and analysis methods. This includes 

directing law enforcement and public health authorities to improve measurement and analysis of 

seizures and outcome measures-such as overdoses, which are likely to be undercounted 

because of the novelty of analot,>ues 60 Most of our drug policy data collection and analysis 

systems are inadequate to appropriately assess developments related to the arrival of these new 

and emerging drugs. Congress could direct federal authorities to reintroduce expanded data 

collection systems, such as the Arrestee Drug Abuse Monitoring Program (ADAM) and the Drug 

Abuse Warning Network (DAWN) or other early warning systems. Given how fast new 

substances emerge in consumer markets, we need to improve measurement and reduce data lags. 

Second, Congress could encourage federal authorities to use supply-side interventions 

strategically by working with Chinese counterparts to strengthen the country's ret,>ulatory and 

interdiction capabilities. Congress should consider appropriating additional resources to aid US. 

authorities that work with international partners and direct the FDA, DEA, and Department of 

"B. Hanis. "Corrupt Mainland Dmg Finns 'fuelling Crystal Meth Scourge,' Says UN OfficiaL" South China 

.-\forning Posl, Fcbrunry 22, 2015. 

U.S. Department of Stnte, 2017. 

55 A Olcscrl "China Ex-Food and Drug Chief Executed." Associated Press, July 10. 2007. 

"' M. Lee and B. Hirschlcr, "Special Report: China's 'Wild East' Dmg Store:· Reuters. August 28. 2012. 

'' World Health OrganiLation, 2017. 

Xinhun News Agency. "Explanation of the Stntc Council's Institutional Refonn Plart" March 14, 2018. 

59 A. Liu, "China Creates New· Dmg Regulator in Biggest Government Overhnul in Yems," PiercePharma, Mnrch 

13. 2018. 

6

° C. l Ruhm, "Corrected US Opioid-Tnvolved Dmg Poisoning Deaths and Mortnlity Rates, 1999-2015 ... AddJct10n. 

VoL 113. No.7, 2018. 

11 
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31451c-14.eps

State to improve interagency coordination and cooperation with Chinese counterparts. In some 

cases, source-country supply controls aimed at eradicating plant-based drugs have been limited 

in reducing total supply or have been seen as a source of political instability. 61 However, these 

factors may be less of a concern for synthetic opioids produced illegally by manufacturers. 

Congress could also encourage US. ret,>ulators to engage with Chinese counterparts to improve 

joint monitoring and evaluation etTorts of regulation violations, as well as aid the CFDA in 

hiring, training, and retaining qualified personnel. Through these etTorts and high-level 

diplomatic channels, China should be encouraged to modernize its regulatory regime to 

etTectively address the corruption and oversight problems in its growing pharmaceutical and 

chemical industries. This includes etTorts to improve China's scheduling system and, more 

importantly, its enforcement capacity. 

Third, Congress could encourage the Department of State to engage diplomatically with 

China for the purposes of discussing an extradition agreement to prosecute and deter suppliers. 

The United States does not have an extradition agreement with China, but it does with several 

other major drug-producing and drug-trafficking countries that supply illicit drugs to the United 

States. The lack of an extradition agreement impedes U.S. law enforcement's ability to prosecute 

Chinese nationals who tratllc synthetic opioids. Although the US. Department of Justice has 

indicted a handful of Chinese nationals since late last year,62 it is unclear whether these 

individuals or others will be prosecuted63 

Lastly and most importantly, Congress could strengthen federal efforts aimed at reducing 

demand for illicit opioids. Demand reduction could help lessen economic incentives for drug 

dealers while saving the lives of those suffering from opioid-use disorder. Demand reduction 

includes improving access to existing and proven therapies, such as methadone and 

buprenorphine. Some steps that Congress could take are encouraging the expansion of 

phannacological treatments covered by private and public insurance, subsidizing the cost of 

medication treatments to those who cannot afford them, and reviewing and reducing regulatory 

barriers on their provision. Congress could also direct federal health authorities, such as the 

FDA, to assess additional innovative and evidence-inforrned medication treatments. Similarly, 

increasing the availability of naloxone is one possible short-term, life-saving intervention. The 

advent of illicitly manufactured synthetic opioids coming from China creates uncertainty in the 

supply of drugs in markets. However, there is less uncertainty surrounding the impact of 

medication therapies when it comes to saving lives64 

01 P. Reuter. F. Trautmann, R. L. Pacula, B. Kilmer, A. Gageldonlc and D. van der Gomve. Assessing C'hanges in 

Global Drug Problems, 1998 2007. Santa Monica. Calif.: RAND Corporation, lR-70~-EC, 2009. 

6

: U.S. Department of Justice, .. Justice Department Announces First Eyer Indictments Against Designated Chinese 

Manufacturers of Deadly Fentanyl and Other Opiate Substances:· October 17. 20 17~ U.S. Department ofJustice, 

.. T,vo Chinese Nationals Clk1rged vvith Operating Global Opioid and Drug Manufacturing Conspiracy Resulting in 

Deaths,'' August 22. 20 IS. 

63 S. L \Vee and J. Hernandez, '·Despite Trump's Plens, China's Online Opioid Bazaar Ts Booming:' ./Vew rork 

Times, NovemberS. 2017. 

6

-1- R. Mattick, C. Breen, l Kimber_ and M. Davoli ... Buprenorphine Maintenance Versus Placebo or Methadone 

Maintenance for Opioid Dependence_·· Cochrane Database ofS)•stematic Reviews, February G, 201-J.. 

12 
67

Mr. SMITH. Thank you very much, Dr. Pardo. 

Dr. Ciccarone. 

STATEMENT OF DANIEL CICCARONE, M.D., PROFESSOR OF 

FAMILY AND COMMUNITY MEDICINE, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 

Dr. CICCARONE. Chairman Smith, Ranking Member Bass, and 

other distinguished members of this subcommittee, thank you for 

the opportunity to testify before you today. 

I have been a clinician for the past 30 years. I am also an academic researcher who has been focused on the public health consequences of heroin for the past 20 years. I have been asked to 

speak today on the public health dimensions of the fentanyl crisis 

in America. This is a drug crisis of historic proportions. For the 

first time in two generations, the U.S. death rate has gone up 2 

years in a row. Driving this is drug poisoning deaths. 

Since the beginning of the opioid epidemic, 1⁄2 million Americans 

have died from drug poisoning. Annual deaths due to drug 

overdoses now exceed deaths due to gun violence, motor vehicle accidents, and even HIV at the height of the 1990s epidemic. The 

leading cause of drug poisoning is due to opioids. We are witnessing a triple wave epidemic of overdoses from three classes of 

opioids: Prescription pills followed by heroin and now fentanyl. 

Each wave is crested on top of the one before, such that fentanyl 

deaths now exceed heroin deaths and heroin deaths exceed those 

from opioid pills. 

For a drug epidemic to get to this size it requires both forces of 

supply and demand to create the enormous wave of consumption 

and consequences we are witnessing. Supply forces include an iatrogenic source with the tripling of opioid pill prescribing. In the 

second wave a new, unrecognized source of technologically advanced heroin from Mexico. And in the third wave, a new illicit 

opioid class, fentanyl, from a new source, China. 

We also see demand in play. There are large-scale social and economic root causes driving pain pill demand and population dependency on opioid pills leading to spillover effects, driving heroin and 

subsequently fentanyl demand. Fentanyl is a synthetic opioid and 

is a well-regarded pharmaceutical. It is a highly potent drug, about 

80 to 100 times as potent as morphine by weight. 

The fentanyl we are discussing today is not a diverted pharmaceutical. It is illicitly manufactured and clandestinely distributed 

fentanyl. It is part of a chemical family that includes a number of 

analogues some of which are less potent than fentanyl, and some 

like carfentanil have much greater potency. 

What is most telling in terms of supply is how regionally problematic the fentanyl epidemic is. Drug seizure data and overdose 

data are highest in the Midwest, down to Appalachia, over to the 

Mid-Atlantic, and up to New England. This strong regional distribution suggests that a large supply player or players are involved. 

The demand side of the equation is complicated. Fentanyl is integrated into the illicit drug supply and sold as heroin in powder 

form or as counterfeit pills. Its intentional use is far outweighed by 

non-intentional use. That is, street users of illicit opioids are lookVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00071 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
68

ing for heroin or pills and the fentanyl comes along as an unexpected adulterant. 

I have noted in my street-based research the lack of lingo or 

slang for fentanyl. Desired drugs have strong slang for them. This 

supports the notion that this fentanyl wave is supply not demand 

driven. However, there is still a demand element. Recall that demand for opioid pills feeds demand both directly and indirectly for 

heroin. Demand for heroin is indirectly feeding demand for synthetics as substitute. 

Now onto addressing the fentanyl crisis. Fentanyl represents a 

strong supply shock in the U.S. illicit drug market. Thus, it is 

tempting to focus our efforts on controlling supply. The evidence 

shows that supply side interventions can work if part of a comprehensive program that includes demand reduction. Unipolar supply side interventions may actually cause paradoxical or unwanted 

results and we may have already seen some of this in play in the 

current crisis. 

Considering source control we need to work, as has been mentioned a number of times today, diplomatically with the Chinese 

Government to curtail production and export of synthetic opioids. 

Considering interdiction, this is where it gets challenging given the 

size of the fentanyl flows. Fentanyl’s potency allows it to be packaged in very small quantities. According to the congressional testimony given by Richard Baum, former Acting Director of ONDCP, 

an estimated 668 kilograms of illicit fentanyl was seized in 2016. 

This volume would fit into approximately three industrial drum 

barrels. A tiny volume that if divided up over the huge Pacific Rim 

is analogous to finding the proverbial needle in the haystack. 

In constraining fentanyl supply we must be cognizant of potential balloon effects. There are dozens of known fentanyl analogues. 

It has been calculated that the number of potential analogues in 

this chemical family could exceed 600. We need to be careful not 

to foster the ingenuity and creativity of the illicit drug manufacturers to push in even more dangerous directions. 

So I have heard today that one of the recommendations for that 

is to regulate the entire class and I would support that. One supply 

side intervention with potential wide impact is drug surveillance. 

There is an opportunity here with the rapidly evolving synthetic 

opioids to improve our surveillance techniques so that we can better detect the chemicals, their flows, and their mixtures. 

Government officials have called for greater public safety and 

public health collaboration to address this crisis and the collection 

and sharing of this data is one key to that collaboration. Surveillance will help us in the low prevalence states. I am reminded that 

one of our subcommittee members is from California. In the low 

prevalence States we need to stay ahead of the curve. Drug surveillance will help us with that. 

In addition, we also need to invest heavily in demand reduction 

which would include prevention, medical treatment, and harm reduction. Opioid use disorder has a number of effective treatment 

options including opiate agonist therapy. Low-barrier programs 

such as the Blue HART program in New Jersey are outstanding 

and need to be promoted. They also fit along with that public safety/public health collaboration. 

69

We also must consider the benefits of harm reduction programs. 

The Surgeon General has called for greater distribution of 

naloxone, the antidote for opioid overdose. Harm reduction programs can aid in the prevention not just of overdose, but also in 

Hepatitis C and HIV transmission. We need a crisis-level response. 

The HIV epidemic of the 1990s provides an example of government 

intervention to curtail a crisis. The Ryan White Care Act led to a 

dramatic increase in funding for HIV prevention and treatment 

and for basic science. That fostered medical progress leading to a 

dramatic decrease in HIV incidence and mortality. The same can 

happen in this crisis. 

Thank you for listening and I look forward to answering any 

questions you have. 

[The prepared statement of Dr. Ciccarone follows:]

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The Triple Wave Epidemic: Opioids, Heroin and Fentanyl: Supply Issues and Public 

Health Consequences 

Testimony of Daniel Ciccarone, M.D., M.P.H. 

Professor, Department of Family and Community Medicine, 

University of California San Francisco 

Before the Committee on Foreign Ail'airs, 

Subcommittee on Atrica, Global Health, Global Human Rights, and International Organizations, 

United Sates House of Representatives 

Hearing: Tackling Fentanyl: The China Connection 

September 6, 2018 

Chairman Smith, ranking member Bass and other distinguished members of the 

subcommittee on Africa, Global Health, Global Human Rights and International Organizations, 

thank you very much for the opportunity to testify before you today. My name is Dan 

Ciccarone. I am a professor offamily and community medicine at the University of California, 

San Francisco. I have been a clinician for over 30 years and an academic researcher in the area 

of substance use with a focus on heroin use and the medical and public health consequences of 

heroin use for the past 20 years. I have been asked to spealc on the public health dimensions of 

the fentanyl and synthetic opioid crisis in America today. 

My research and that of my team is multidisciplinary and multi-level. We use the tools of 

epidemiology, statistics, economics, clinical and basic sciences as well as ethnography and 

anthropological discipline. I am appreciative of my funder, which is the National Institutes of 

Health, National Institute on Drug Abuse, as well as my team, which includes Dr. Jay Unick, 

University of Maryland, Dr. Sarah G. Mars, UCSF, Dr. Dan Rosenblum, Dalhousie University, 

and Dr. Georgiy Bobashev from RTI, North Carolina. 

In this testimony I will discuss the rapidly-evolving intertwined epidemic of overdose due to 

opioid pills, heroin, and fentanyl with a focus specifically on fentanyl and other synthetic 

opioids. I will discuss firstly the dimension of the public health crisis. Secondly, supply-side 

and demand-side issues that are feeding the triple wave epidemic. I will then focus specifically 

on fentanyl supply and demand. Finally, I discuss possible responses. 

A Drug Crisis of Historic Proportions 

For the first time in over two generations, the US death rate has gone up two years in a row 

from 2014 to 2015 and then again to 20I6. 1 Correspondingly, life expectancy for an infant born 

1 NCHS Data Brief No. 293 December 2017. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Centers for Disease 

Control and Prevention. National Center for Health Statistics. Mortality in the United States, 2016 
71


31451d-2.eps

in 2015 and 2016 has also declined year over year. By examining the 10 leading causes of death, 

we see that heart disease and cancer, historically the top two causes of death, have maintained 

their positions but have gone, expectedly, down in rate. Most of the top 10 causes of death are 

expectedly declining year over year. However, the third leading cause of death in 2016, 

unintentional injuries, has been climbing the ranks following a dramatic increase in rate from 

2014to2016. 

Historically, the leading cause of unintentional injury death has been motor vehicle 

accidents but, as our cars have gotten safer, there's been another cause of unintentional injury 

that has constantly and steadily grown to surpass deaths due to motor vehicle accidents and that 

is deaths due to drug poisoning. Drug poisoning deaths exceeded motor vehicle deaths as of 

2011 and continue to climb. According to the latest data from the US Centers for Disease 

Control and Prevention, deaths due to drug poisoning exceeded 72,000 in 20172 Since the 

beginning of the opioid epidemic, a half a million Americans have died from drug poisoning. 

Annual deaths due to drug overdoses now exceed deaths due to car accidents, gun violence, and 

even HIV at the height of the 1990's HIV epidemic. 

The Triple Wave Epidemic: Opioids, Heroin and Fentanyl 

The current leading cause of drug poisoning is due to the family of chemicals called opioids. 

We are witnessing a triple wave epidemic of overdoses from three classes of opioids: 

prescription pills (semi-synthetic opioids), heroin and illicitly manufactured fentanyl (synthetic 

opioids). Figure 1 shows three waves of opioid use and consequences, each wave cresting on top 

of the one before it to produce even deadlier consequences. 

Figure 1: Opioid Overdose Deaths by Type of Opioid 

20:DOO 

c 1\bturaland Semi<;~nthelic 

Opioids(e.g.o):ycodone. 

hgd'Ollru:IDn,.} 

a Synther.icOpioids.Gther!h;m Y Heroin 

Methadone(e.g.fentanyl. 

tr.madnl) 

Source: Kaiser Family Foundation State Health Facts I Centers for Disease Control and Prevention.· 

2 NCHS, National Vital Statistics System. Estimates for 201 7 ore based on provisional data. Estimates for 2015 and 2016 are 

based on final data (available from: at 

(CDC), National Center for Health 

1999-2016 on CDC WONDER Online Database, released 2017. Data are from the 

1999-2016, as from data provided by the 57 vital through 

at ~·: '-2il .. '£'!.S.1.:~::c?.~~~-~i.KJJ~ .. Lln~-J _; '- c)Jill..:.!:..C:..!l on 31 , 201 8. 
72


31451d-3.eps

The tirst wave, overdoses related to prescription pain medicines, started around the year 

2000 and has steadily grown, according to the latest official data, through 2016. The second 

wave, building upon the tirst, are overdose deaths due to heroin, which started increasing around 

2010 and continued to rise through 2016 passing the number of deaths due to opioid pills. The 

third wave, which is even deadlier, is that due to fentanyl, fentanyl analQb'lles, and other 

synthetic opioids of illicit supply (i.e., not methadone). This wave began in 2014 and has 

climbed dramatically. Provisional2017 drug overdose counts data from the National Center for 

Health Statistics, shows synthetic, e.g., fentanyl, opioid deaths continuing to rise, reaching a peak 

of almost 30,000, while semisynthetic and heroin overdose deaths level otl albeit at very high 

levels, approximately 15,000 per wave. 4 

Drug policy academics describe substance use upcycles as having two principle drivers, 

supply and demand; this comes out of economic theory and holds true for most consumable 

goods. For a drug epidemic to get to this size, it requires not just one, but both forces of supply 

and demand to create the enonnous wave of consumption and consequences we are witnessing. 

First a bit of history and then I will brietly examine each of the aforementioned waves, one at a 

time, describing supply issues, demand issues, demographics of the population at risk, as well as 

some differences that exist between these three waves. 

The opioid class of medications was developed to treat pain, to facilitate surgery and in 

general to reduce suffering at the extreme. These medications are both a miracle in their proper 

use, but also problematic in their misuse. Examining just this class of medications, we can 

consider the tirst epidemic of misuse and medical consequences due to morphine and heroin 

following their discoveries in the late 19'h century. 5 They were novel drugs sourced through 

physicians and phannacies and thus the subsequent misuse problem was iatrogenic, meaning 

medically caused. There was also a technological advance, the hypodermic syringe, which both 

advanced appropriate use, but also promoted problems related to misuse. 

Heroin, diacetylmorphine, had a short life as a licit medication. We've seen a number of 

illicit heroin waves, beginning around the 1920's. The first of which may have been due to 

restriction on licit supplies driving drug use underground. We had heroin in the 1930-40's Jazz 

Era that had a social and cultural root to it. Moving on to the 1970's and the Vietnam Era, the 

heroin epidemic also had a sociocultural root to it as well as supply-driven factors including a 

new sources of heroin imported from Southeast and Southwest Asia. Then, in the 1990's, a new 

form of heroin produced by Colombian criminal trafficking organizations was brought into the 

United States. That new source of heroin caused a small epidemic of medical consequences6 In 

sum, the first century of opioids availability, including both licit, e.g. morphine and illicit e.g. 

heroin, opioids had a number of misuse and medical consequences waves caused by supply 

(iatrogenic, new illicit sources and forms) and demand forces (cultural and social, new 

technologies for use). Moving onto the current triple wave crisis, we see both forces at work 

again. Supply forces: iatrogenic source of opioid pills, a new source of technologically advanced 

heroin and a novel illicit opioid- fentanyl- also from a new source. Demand forces: social, 

' NCHS, National Vital Statistics System. Ibid. 5 This history section is gleaned from multiple sources including: Courtwight, D.T., Dark Paradise: A History of 

Opiate Addiction in America. Cambridge: Harvard University Press, 2001. McCoy, A. W .. The Politics of 

Heroin, 2nd Ed., Chicago: Lawrence Hill Books, 2003. Musto, D. F., The American Disease: Origins of Narcotic 

Control, 3rd ed., New York: Oxford University Press. 1999. 6 Ciccarone D. Unick GJ. Kraus A. Impact of South American heroin on the US heroin market 1993-2004. The 

International journal on drug policy. 2009;20(5):392-401. Epub 2009/02/10. doi: 10.1016/j.drugpo.2008.12.001. 

PubMed PMID: 19201184; PubMed Central PMCID: PMC2719678. 
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31451d-4.eps

cultural and economic root causes of opioid use; population dependency on opioid pills leading 

to spill-over effects driving heroin and subsequently, fentanyl demand. 

The supply side drivers of the tirst wave of prescription opioid misuse and overdose have 

been extensively discussed in academic and policy circles. Wave one is often considered to have 

been driven by increased supply, i.e, a tripling of opioid prescriptions starting in the 90's and 

crescendoing around 2011. 7 This tripling of opioid prescriptions has been correlated to rising 

consequences, particularly overdose.' The introduction of extended release long-acting (ERLA) 

opioid formulations support both supply-side and demand-side pressure. ERLAs are a source of 

opioid in a novel form with a technological advance that allowed higher doses in a single 

capsule. Ease of misuse, e.g. crushing leading to insut11ation (nasal 'snorting') or injection, led a 

wave ofmisuse 9 

The conventional wisdom on the ±irst wave places much the blame on the drugs involved 

and the sources of those drugs. A demand-side are,>ument has been recently introduced 

examining the structural and social factors that might be driving the epidemic. The most 

compelling structural determinants include economic hardship and social and psychological 

malaise that may have led an at-risk population to seek opioids in the ±irst place. 10 

Beginning in the late 2000's, especially by 2012, we began getting concerned about the 

rising number of heroin users and heroin-related overdose. Our team demonstrated a statistical 

relationship between the ±irst two waves of the epidemic, opioid pills and heroin, describing 

them as "intertwined epidemics." 11 We also described how young and new heroin users at the 

time had transitioned to heroin tram high dependency on opioid pills. 12 A new consciousness 

around the opioid pill epidemic led to a decline in physicians prescribing of opioids. Opioid pills 

became more ditlicult to get illicitly and as a consequence, a small proportion of patients found 

their way over to a new drug, heroin, which was more available, and at a lower price point, on 

the street. Thus, an unintended consequence of restrictions on opioid pill prescribing led to 

heroin use. There was a demand for powerful opioids that heroin fulfilled. 

Data on users entering drug treatment showed that in successive cohorts from the 1960's 

through the 2000's, increasingly folks coming in with heroin use disorder reported starting their 

opioid dependency with opioid pills. 13 However, this has begun to change now as an increasing 

proportion of heroin dependent patients entering treatment report having started with heroin. 14 

Another dramatic change occurred in late 2010, when OxyContin•m, a brand name ERLA 

7 Kolodny, A .• Courtwright. D. T .. Hwang, C. S .. Kreiner, P .. Eadie. J. L .. Clark. T. W .. & Alexander. G. C. (2015). 

The prescription opioid and heroin crisis: A public health approach to an epidemic of addiction. Annual 

Review of Public Health. 36. 559-57 4. 8 CDC. Vital signs: overdoses of prescription opioid pain reliever>-United States, 1999-2008. MMWR Morb 

Mortal Wkly Rep 2011 ;60:1487-92. 9 Mars, S., Bourgois, P., Karandinos, G., Montero, F. and Ciccarone, D., Every 'Never' I Ever Said Came True: 

Pathways from pills to heroin injecting. International Journal of Drug Policy, 2014. 25(2): p. 257-266. 

10 Dasgupta, N .. Beletsky, L .. Ciccarone, D .. Am J Public Health. 2018 Feb;I08(2):182-186. doi: 

I 0.2105/ AJPH.2017.304187. Epub 2017 Dec 21.PMID:29267060 11 Unick, G.J., et al., Intertwined epidemics: national demographic trends in hospitalizations for heroin- and 

opioid related overdoses. 1993-2009. PloS One, 2013. 8(2): p. e54496. 

12 Mars et al. Ibid. 

13 Cicero TJ, Ellis MS. JAMA Psychiatry. 2015 May;72 (5) :424-30. doi: I 0.1 001/jamapsychiatry.2014.3043. 

PMID:25760692 

14 Cicero TJ. Ellis MS. Kasper ZA. Addict Behav. 2017 Nov;74:63-66. doi: 10.1 016/j.addbeh.2017.05.030. Epub 

2017 May 23. PMID:28582659 
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formulation of Oxycodone, was reformulated to be less abuse-able, ie less insut11atable or 

injectable. Because oftbis refonnulation, that route of abuse was severely curtailed. This may 

be one of the triggers that increased interest in and use of illicit heroin. This reformulation of a 

popular drug, along with restrictions in prescribing and a new consciousness around more 

judicious prescribing of opioids, may in combination have had unintended consequences driving 

a small proportion of the at-risk population to heroin. 

The tirst and second waves do have some contrasts in terms of demographics and regional 

distribution. 15 The age distribution of patients hospitalized for prescription opioid overdose, has 

its largest peaks in the 50 to 64 year old group and this has been stable for several years. In 

hospitalizations for heroin overdose, one sees a very ditl'erent picture. The age group at highest 

risk are 20 to 34 year-aids with a rate of hospitalizations that is growing year by year. Another 

strong difference between prescription opioid overdose and heroin overdose is seen in their 

geographic distribution. Opioid pill overdose is relatively even across the four major US regions 

of the Northeast, Midwest, South and West, whereas heroin overdose is much higher, with rates 

of increase also higher, in the Northeast and Midwest. So, we see elements of demand-side 

drivers in wave two, with rising numbers of heroin users who are transitioning from prescription 

opioid dependency, as well as younger persons, naturally greater risk takers, initiating heroin 

use. ln addition, there's also this notion that heroin is becoming more dangerous. lts supply is 

changing in quantity, source and quality and is being adulterated by synthetic opioids. 

According to reports from the U.S. Drug Enforcement Administration (DEA), the U.S. 

heroin supply is changing dramatically, particularly during the wave two era tram 2010 to 2015 

in which we see an almost tripling of U.S. heroin seizures at the Southwest border. 16 Seizures 

are a proxy for supply, so as seizures go up, considering that the rate of seizure is not 

dramatically increasing, we assume that the supply has also expanded. 

Another dramatic transformation in heroin supply, changes in sourcing, has occurred in the 

last 10 years. Historically imported heroin came from four source regions/countries in the world, 

including Southeast Asia, Southwest Asia, Mexico, and South America. In the 2000's we began 

an era in which most of our heroin came solely from to sources: Colombian and Mexican 

criminal trafficking organizations (CTOs). 17 Accelerating this trend towards fewer sources, since 

the mid 2000's to present, Mexican CTO's have increasingly dominated the U.S. heroin market; 

with 50% market share in 2005 and growing to 90% with the latest data. 18 

Mexican-sourced heroin is also becoming more refined. DEA documents reveal, that for a 

period of time in the late 2000's and early 2010's, that a substantial proportion of heroin samples 

were from an unknown source and of unknown quality. 19 This is now better understood as heroin 

sourced from Mexican CTOs, but is of a ditl'erent, more refined, chemical composition than 

previous Mexican-sourced heroin. DEA reports highlight the evidence that the Mexico-based 

15 Unick GJ, Ciccarone D. US regional and demographic differences in prescription opioid and heroinrelated overdose hospitalizations. lnt J Drug Policy. 2017 Aug;46:112-119. doi: I 0.1016/j.drugpo.2017.06.003. 

Epub 2017 Jul5. PMID:28688539 16 National Seizure System. Reported in the 2016 National Heroin Threat Assessment Summary; DOJ, DEA. 

2016 

17 Update: Heroin Signature Program. Reported in the 2015 National Drug Threat Assessment Summary; DOJ, 

DEA. 2015 18 Drug Enforcement Administration, 2017 National Drug Threat Assessment. DEA-DCTDIR-040-17, October 

2017. 

19 Source: Domestic Monitoring Program. Reported in the 2015 National Drug Threat Assessment Summary; 

DOJ. DEA, 2015 
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Sinaloa Cartel in particular has control of the US heroin retail market, with particular 

domination in the Midwest, Mid-Atlantic and New England regions 20 

In summary, there are significant supply-side forces behind rising heroin overdose- wave 

two- that we see in the Midwest, Mid-Atlantic, and New England areas. Mexican-sourced 

opium and heroin production has grown dramatically trading otl'with Colombian production. A 

more retined product coming from Mexico, so-called "Mexican White" heroin, which is a 

Colombian mimic, is going to areas where, traditionally, Colombia-sourced heroin has gone; this 

perhaps under the control of the Sinaloa CTO. 

That brings us to the third wave, fentanyl and synthetic opioids in the heroin market 21 

Fentanyl is a synthetic opioid, i.e. a chemical manufactured in a pharmaceutical facility. This is 

different than, for example, morphine, which is a natural product derived from the opium poppy 

plant It also distinguishes it from several other highly used pain medications like oxycodone 

and hydrocodone, which are semi-synthetic opioids derived tram chemical constituents of the 

poppy plant, but then altered to make them more useful as phannaceuticals. Heroin, which is 

diacetylmorphine, is also a semi-synthetic. 

Fentanyl is a well-regarded pharmaceutical, used in surgery and to control severe pain.lt's 

short-acting, so physicians and surgeons can dose it with a lot of control. On the other end of the 

spectrum, it can be used as a long-acting patch, in which the embedded fentanyl slowly enters the 

body; this is considered a boon to both chronic pain and hospice patients. 

The fentanyl we are discussing today is not a diverged pharmaceutical product, it is an 

illicitly manufactured, clandestinely distributed fentanyl 22 This fentanyl is integrated into the 

illicit drug supply and sold as "heroin" in powder form, or as counterfeit opioid or 

benzodiazepine pills. It is rarer, particularly on the street, that it is being sold as-is. Its 

intentional use is far outweighed by non-intentional use, that is, street users of illicit opioids are 

looking for heroin, or opioid pills, and the fentanyl comes along as an unexpected contaminant. 

Fentanyl is a highly potent drug, about 80-100 times as strong as morphine by weight, which 

makes it 30-40 times stronger than heroin by weight. 

Heroin, particularly in the region with the greatest increases in wave two overdose, i.e. the 

Midwest, Mid-Atlantic and New England regions, exists as afentanyl-suhstituted and or 

fentanyl-adulterated heroin. 23 There is also increasing concerns of fentanyl contamination of the 

street market in methamphetamine and cocaine. 

Fentanyl is the main chemical in a growing family of chemicals. 24 The central chemicalfentanyl- is also the main one of concern. However, there is also a growing family of analogues, 

which are like chemical cousins, to the fentanyl molecule. They would include such things as 

2o Domestic Monitoring Program. Reported in the 2015 National Drug Threat Assessment Summary; DOJ, 

DEA. 2015 

21 Ciccarone D. Fentanyl in the US heroin supply: A rapidly changing risk environment. lnt J Drug Policy. 2017 

Aug;46:1 07-111. doi: 10.1 016/j.drugpo.2017.06.010. Epub 2017 Jul 20. PMID:28735776 

22 Gladden RM, Martinez P, Seth P. Fentanyl Law Enforcement Submissions and Increases in Synthetic 

Opioid-lnvolved Overdose Deaths- 27 States, 2013-2014. MMWR Morb Mortal Wkly Rep. 2016 Aug 

26;65(33):837-43. doi: 10.15585/mmwr.mm6533a2. 

23 Ciccarone D, Ondocsin J, Mars SG. Heroin uncertainties: Exploring users' perceptions of fentanyladulterated and -substituted 'heroin'.lnt J Drug Policy. 2017 Aug;46:146-155. doi: 

10.1 016/j.drugpo.2017.06.004. Epub 2017 Jul 18. PMID:28735775 

24 Suzuki J, EI-Haddad S. A review: Fentanyl and non-pharmaceutical fentanyls. Drug Alcohol Depend. 2017 

Feb I ;171 :107-116. doi: I 0.1 016/j.drugalcdep.2016.1l.033. Epub 2016 Dec 16. Review. PMID:28068563 
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acetyl fentanyl and furanyl fentanyl, etc. The fentanyl analot,>ues come in a range of morphineequivalent potencies with some, e.g., acetyl-fentanyl being less potent than fentanyl by weight, 

while others have greater potency. 

In addition to fentanyl and its analogues there are additional novel synthetics opioids that we 

are concerned about including U4 7700 and U48800, as well as others. The biggest concern is 

around a branch of the fentanyl family that includes some incredibly powerful medications 

including carfentanil, alfentanil, and sufentanil , which are exceedingly potent It is unclear 

whether these super-high potency fentanyls will tal<e otiin the marketplace, or if they are just 

'accidents' in the rapidly evolving illicit opioid supply. 

According to the DEA, the main source of illicitly manufactured fentanyl is China25 

Fentanyl sourced from China takes a number of routes on its way into the US. It is shipped 

directly into the United States in powdered fonn and sold as heroin, or pressed into counterfeit 

opioid pills and sold. It is also shipped into Canada, where it is sold domestically as heroin or 

pressed into pills and exported to the U.S. However, perhaps the largest part segment of this 

illicit market, is fentanyl that is shipped to Mexico, where it is then processed by the Mexican 

CTOs and either cut into heroin or transshipped with heroin for mixing in the regional markets of 

the US. 

According to testimony given by Richard Bamn, former Acting Director Office of National 

Drug Control to the Congressional Committee on Energy and Commerce, March 29, 2017, an 

estimated 668 kilograms of illicitly manufactured fentanyl, bound for the U.S. market was seized 

in 201626 There is both CTO distribution of fentanyl in the United States, as well as individual 

and entrepreneurial distribution. The former is typically large scale with low purity product; the 

latter is small scale, often shipped through the postal system, albeit with high purity product. 

Fentanyl seizures stemming from screening of inbound international mail by Customs and 

Border Protection included 15 kilograms of inbound international mail and 21 kilograms from 

express mail carriers. 1n addition, Department of Homeland Security reported seizing 58 illicit 

pill pressing machines in 2016. 

What is most telling, in terms of supply, about the third wave fentanyl epidemic is how 

regionally discrete it is in the United States. Comparing drug seizure data, from the DEA, with 

overdose death data, from the CDC, one finds remarkable geographical correlation between 

fentanyl seizures and fentanyl-related overdoses. 27 We see this overlap in the Midwest, e.g., 

Ohio, Pennsylvania, and down into Appalachia, e.g., Kentucky and West Virginia. We see it in 

the Mid-Atlantic region, e.g., New Jersey, and then up into England, e.g., New Hampshire and 

Massachusetts. Where the fentanyl is distributed is where the fentanyl-related deaths are. This 

strong regional distribution suggests, with support from DEA reports, that a large supply player 

or players are involved. lfthe epidemic of fentanyl overdose was more evenly spread around the 

country it would support the notion that the supply was entrepreneurially driven, e.g., people 

interested in fentanyl were finding it on the dark web and shipping it to their individual locations; 

that perhaps it is a culturally driven, or demand-driven event. The fact that it is so regional is 

evidence that illicitly manufactured fentanyl is predominately cartel CTO-driven; that this is a 

supply-side event. The DEA has in some of their documents agreed that the Sinaloa Cartel 

25 Drug Enforcement Administration, 2016 National Drug Threat Assessment, DEA-DCTDIR-00 1-17, November 

2016. 

26 Baum, R J. 2017. Letter to Congress: Response to questions concerning fentanyl. Washington DC: Office 

of National Drug Control Policy. 27 Gladden RM, et al. Ibid 
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seems to be heavily implicated2 ' We need to keep in mind that there are fentanyl and other 

synthetic opioid deaths elsewhere in the country, e.g., rising fentanyl-related overdose deaths in 

California are a growing concern, albeit of! ower magnitude than in the most impacted regions. 

I mentioned in the earliest part of my testimony that my team and I use ethnographic 

techniques in our research, which means we have the privilege of talking to people who are most 

impacted by this epidemic. We document their stories of how they are coping with changes in 

the drug supply, the decisions they are making, what they like and what they don't like about the 

drugs, and what kind of help they most want. They confinn that the changes in heroin due to its 

substitution by, or adulteration with fentanyl have been disturbing to them. That fentanyl was not 

a demand-driven phenomenon. There is currently a range of desirability for fentanyl, but this is 

only after several years of its constant presence in the heroin supply29 

One piece of evidence supporting the lack of demand for fentanyl is the lack of cultural 

idioms for fentanyL Most desired illicit drugs have a slang for them. There is no slang 

developed yet for fentanyl despite four years of steady supply. 

In addition to the dangerous potency of fentanyl, our ethnographic observations support the 

notion of a possibly greater danger: rapid changes in purity, as well as different mixtures of 

heroin and fentanyl and its analogues. 10 These vicissitudes, we may discover, may have 

profound effects on the overdose rate in a given location. 

In summary of this description of the supply-side and demand-side drivers of the triple-wave 

epidemic, we have to consider whether this is one intertwined epidemic, or three separately 

evolving epidemics. The geographic, demographic, and supply disparities seen in the data 

confound any simple story. All three waves have impressive supply-side drivers including 

excessive medication prescribing, new forms of Mexican-sourced heroin and a new illicit source 

of opioid, Chinese-sourced synthetics adulterating heroin and counterfeit pills. Demand for 

opioid pills drove demand, both directly and indirectly, for heroin: demand for heroin indirectly 

feeds demand for synthetics-as-substitute. What is driving increases in opioid mortality now are 

deaths due to heroin and heroin adulterated by fentanyl. The second and third waves are 

regional, with the Midwest, Northeast, Mid-Atlantic and Appalachia regions affected the most. 

There are other medical consequences, in addition to overdose, that are growing in concern. 

The change from pill misuse to heroin involved, for many, a change in route of administration. 

Pills tend to be swallowed although, as mentioned above, with ERLA oxycodone misuse some 

people were crushing them and insufflating or injecting the powder. Heroin, while it can be 

smoked or insufflated tends, in the U.S., to be injected. As the at-risk population shifts from oral 

misuse to injection we have to be cognizant of the infectious disease risk, including that due to 

blood-borne viruses such as hepatitis C and HIV. The U.S. has now had two documented 

injection-drug-related HIV epidemics, Scott County, Indiana, 31 and more recently in 

Massachusetts. 32 In addition to blood-borne viruses, we have to be concerned about injectionrelated bacterial infections such as endocarditis and skin and soft tissue infections. 

28 DEA, 2017. Ibid. 29 Ciccarone D., et al., 2017. Ibid 

3o Ciccarone D., 2017. Ibid 31 P.J. Peters, P. Pontones, K.W. Hoover, M.R. Patel, R.R. Galang. J. Shields, eta/. for the Indiana HIV 

Outbreak Investigation Team (2016). HIV infection linked to injection use of oxymorphone in Indiana. 2014-

2015. The New England Journal of Medicine, 375 (20 16), pp, 229-239 

32 CDC, Epi-Aid Number: 2018-D27. Undetermined Risk Factors and Mode of Transmission for HIV Infection 

Among Persons Who Inject Drugs -Massachusetts. 2018. July 17, 2018 
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Addressing the Fentanyl Crisis 

We can see this triple-wave epidemic as an intertwined, three drug epidemic, but to comprehend 

it fully we need to appreciate the drivers of each wave. We have noted how supply shocks can 

lead to drug epidemics both historically and in the current opioid crisis. Fentanyl in particular 

comes as a strong supply shock leading to disastrous consequences. Thus it is tempting to focus 

our efforts on controlling supply. We can examine supply control as one answer, but it must be 

one part of a more complex answer. The evidence shows that supply-side interventions can work 

if part of a comprehensive program that also includes demand reduction33 Unipolar supply-side 

interventions may actually cause paradoxical, unwanted results. 34 We may have already seen 

these phenomena within the current crisis. Downward pressure on opioid prescribing may be 

driving a portion of the at-risk population from opioid pill misuse to heroin, thus exposing them 

to the even more dangerous chemical family offentanyls. Another driver of unintended 

consequences may have been the reformulation of ERLA opioids to abuse-deterrent 

formulations, examples ofwhich include OxyContin'" and Opana1", another ERLA, misuse of 

which has been implicated in the Scott County Indiana HlV outbreak. 35 This is not to say that 

we should not pursue these goals of creating abuse-deterrent formulations or curtailing excessive 

prescribing practices. As we do these things we must also consider the consequences of our 

actions and respond accordingly. 

Supply-Side Interventions 

Considering the inadequate and paradoxical effects of current opioid supply interventions, 

we must broaden our supply-side policies to cover the range of illicit opioid flows andcrucially- combine these efforts with expansion of effective drug treatment and hann 

reduction. 36 Regarding fentanyl, supply-side interventions includes source control and 

interdiction in the drug supply chain. Considering source control, we need to work 

diplomatically and politically with representatives from the Chinese government and find 

incentives to have them curtail the production and export of fentanyl and other synthetic opioids. 

Interdiction will be challenging given the size of the fentanyl flows. In 2016 an estimated 668 

kilograms offentanyl was seized in the US 37 This is but a fraction of the estimated 11 metric 

tons of cocaine seized, just at the U.S. Southwest Border, in 2016." Fentanyl is a drug which 

has high potency in small volumes. Considering a seizure to importation ratio of 1 :4, a total of 

2.6 metric tons of fentanyl are distributed- per year- for the whole U.S. This would fit into 

approximately I 0 industrial drum barrels. And that's a small volume that if divided up over the 

33 Caulkins, J.P., Reuter. P., Iguchi, Y.P., Chiesa. J. How Goes the "War on Drugs"? An Assessment of U.S. 

Drug Problems and Policy. RAND Drug Policy Research Center, 2005. 

34 Ciccarone. et al. 2009. Ibid. 

'' Broz D, Zibbell J, Foote C. Roseberry JC. Patel MR. Conrad C. Chapman E. Peters PJ. NeedleR. McAlister 

C, Duvvve JM. Multiple injections per injection episode: High-risk injection practice among people who 

injected pills during the 2015 HIV outbreak in Indiana. lnt J Drug Policy. 2018 Feb:52:97-l 01. 

doi:IO.I 016/j.drugpo.2017.12.003. 35 Pacula RL and Powell D. A supply-side perspective on the opioid crisis. Journal of Policy Analysis and 

Management. 2018 DOl: 10.1002/pam 

'' Baum, 2017. Ibid. 

38 Drug Enforcement Administration, Colombian Cocaine Production Expansion Contributes to Rise in 

Supply in the United States, DEA Intelligence Brief. DEA-DCI-DIB-014-17, August 2017. 
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huge trade that occurs across the Pacific Rim constitutes a proverbial needle in a haystack of 

detection. 

In drug policy theory there a famous notion of the balloon hypothesis, i.e., by squeezing 

drug supply too harshly in one direction it simply balloons out with a ditferent source, or a 

ditferent drug, routed to a ditferent area. The concern is if we constrain fentanyl, i.e., the mother 

chemical, too robustly and too rapidly, it will foster the supply in fentanyl analogues. The 

number of known fentanyl analot,>ues exceeds 60; the number of potential fentanyl analot,>ues 

could exceed 600. We need to be careful not to foster the ingenuity and creativity of the illicit 

drug manufacturers to push in even more dangerous directions. 

Surveillance of the Drug Supply 

One supply-side intervention with potential wide impact is drug surveillance. Investments in 

drug monitoring, identification and data collection could assist in interdicting supplyJ9 There is 

an opportunity here, with the rapidly evolving synthetic opioids, to improve our surveillance 

techniques so that we can better detect the chemicals, their flows and their mixtures. Of crucial 

import: how rapidly are those substances, flows, and mixtures changing? Surveillance is a 

crucial and underplayed card in our hand of options in addressing this crisis. Government 

officials have called for greater public safety and public health collaboration to address this 

crisis. One way for these two domains to work together is by increasing drug surveillance- and 

sharing of the data. Improved surveillance would benetit not just folks on the interdiction and 

public safety side, but also the public health side including first responders, emergency and 

hospital clinicians as well as those who work in community based programs serving the atfected 

population. 40 

Demand Reduction 

In summary, complex problems require complex solutions. We need combined approaches 

to reduce the unintended consequences of unipolar actions. In addition to putting our creativity 

and ingenuity into supply side detection, surveillance, interdiction and diplomatic supply control 

strategies, we also need to heavily invest in demand reduction, which would include prevention, 

medical substance use treatment and harm reduction. Opioid use disorder has a number of 

medical treatment options that have been shown to be effective as well as cost-effective41 

Opiate agonist therapy with methadone and buprenorphine has been shown to be efficacious 

when coupled with high quality and low barrier treatment programs. We also must also consider 

the benefits of harm reduction programs. The Surgeon General has called for greater distribution 

of naloxone, the opioid antagonist used to treat an opioid, heroin or fentanyl overdose. 42 Getting 

wider distribution of naloxone into the community is an essential strategy in the current 

epidemic. Other harm reduction strategies include sterile syringe provision and supervised 

consumption spaces to aid in prevention of overdose and HIV and HCV transmission. These 

39 Pacula and Powell. 2018. Ibid 

40 Ciccarone. IJDP, 2017. Ibid 

" N.D. Volkow. T.R. Frieden, P.S. Hyde. and S.S. Cha. "Medication-Assisted Therapies-Tackling the OpioidOverdose Epidemic," New Eng/and Journal of Medicine, Vol. 370. No. 22. 2014. 42 Surgeon General's Advisory on Naloxone and Opioid Overdose. U.S. Department of Health and Human 

Services. 2018. 
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services can provide a hub or magnet for persons at risk and provide them with the resources and 

referrals to services. 

This is a crisis that requires crisis level response. We know that government intervention 

and funding can help. The lllV crisis of the 1990's provides a shining example of government 

intervention assisting to curtail a crisis. The Ryan White Care Act led to a dramatic increase in 

funding for lllV prevention and treatment. That coupled with scientific and medical progress on 

treatment and prevention led to a dramatic decrease in mv incidence, prevalence, morbidity, and 

mortality. The costs of the current triple opioid crisis are enonnous, some estimates approach 80 

billion per year, and the costs to address it are ultimately likely to be very high. Estimates range 

from $60 billion for treatment over the next 5 years 43 to $100 billion for a multi-pronged 

approach to prevention, treatment and community resilience efforts. 44 

Thank you for inviting me and listening to my testimony. I welcome the opportunity to 

answer your questions. 

43 Simmons A. M. White House commission recommends president declare a national emergency over the deadly 

opioid epidemic. Los Angeles Times, Jul31, 2017 . .h!!£.;//ww\N.!at.imes.com/[Jation/!a-Q..§.:QQlQids-commissio!J.: 

Katz, K. How a police chief, a governor and a sociologist would spend $100 billion to solve the opioid crisis. The 

Upshot, New York Times, Feb 14, 2018. b!lP.2.ji:~~Y!..:.:.'l\1.LtiL~~£Q_:::O..iiDJ~<if:!lYJ:>lf2:.110!JL:U1.1:L!.JP..W_9JlQQJQL9..:s;r1.~i~. 

?.2.\illJQJ:l;Lhtrnl 
81

Mr. SMITH. Thank you, Dr. Ciccarone, for your testimony and 

your leadership, all of you. I have a lot of questions but I will try 

to narrow it just because of the lateness of the hour because you 

have been so patient. 

Is there any way, generally speaking, that someone who is intent 

on using heroin, for example, can detect the presence of fentanyl? 

Are many of these deaths inadvertent in the sense that they had 

no idea fentanyl was laced with the heroin that they are consuming? 

Mr. CORONATO. I mean from my standpoint I will say this, I don’t 

think that the user has any idea what they are consuming. They 

think it is heroin. They think it is good heroin. And certainly the 

answer would be I think they have no idea that they are taking 

fentanyl. 

Mr. SMITH. Yes, Dr. Pardo? 

Mr. PARDO. No, I definitely agree. The fact that 40 percent of cocaine overdose deaths in 2016 included mention of synthetic opioids 

is a shocking statistic. Users are just not aware. 

Dr. CICCARONE. Most people are consuming it unknowingly. 

There is some ability to detect it. I have observed, I have listened 

to a lot of users as they consume. There is some sense they can detect, it is just clearly not good enough because people are still 

dying. 

Mr. CORONATO. And I have one other comment if I can. 

Mr. SMITH. Sure. 

Mr. CORONATO. It used to be and I used to believe that you 

would go to get your marijuana dealer, you would go to your cocaine dealer, and you would go to your heroin dealer. I think now 

the dealers are all encompassing. I think that you go to your dealer 

and they will provide you with marijuana, they will provide you 

with cocaine, they will provide you with meth. 

In that respect I think that you now can see that the fentanyl 

is in the heroin, it is in the meth, it is in the cocaine, and, you 

know, now starting to come into the marijuana. So I think the answer is nobody would know that they are consuming that and it is 

what they are looking to do is to kind of capture that individual 

so that, you know, it was a unique feeling that they got so this way 

they would come back. It is almost a marketing tool. 

Mr. SMITH. We know that some people die from their first use 

of fentanyl. What is the common denominator there in terms of the 

number of times somebody might take it, say, with heroin and 

maybe on the fifth time that is when it takes their life? Or is it 

often the first? 

Mr. CORONATO. I will try to answer that. I will tell you this. 

From my opinion, I think very few people take fentanyl the second 

or third time. I think that they aren’t used to it. I think their body 

all of a sudden it is so strong it causes a reaction. The only difference that may happen is that if they take it and they are younger, and I know it sounds crazy but there happens to be somebody 

else present at the time there is a possibility that they can call 9-

1-1, they can call the police, or they may have some Narcan and 

they may apply it. 

But normally what happens is if they take it and they are by 

themselves, okay, it is not—if it is one, they are going to die. 

82

Mr. SMITH. Let me just ask you—oh, did you, Dr. Pardo? 

Mr. PARDO. I mean I would go again to the fact that if an individual, if these are entering non-opioid markets that is a serious 

concern. As individuals who are not tolerant of opioids coming into 

contact with fentanyl that presents a huge risk of overdose for 

those non-opioid markets, the methamphetamine and cocaine in 

particular. 

As far as opioid users——

Dr. CICCARONE. I will agree with Dr. Pardo that if the fentanyl 

is contaminating a non-opiate such as methamphetamine or cocaine, the danger looms large for those folks because they do not 

have any tolerance. Among folks that are opioid tolerant, and that 

it would be a daily heroin user, there are a couple to several million daily heroin users in this country right now who are using 

fentanyl safely every day. It is a bit like Russian roulette because 

they don’t know when the analogue is going to change or the purity 

is going to bump up or there is another powerful adulterant in 

there. 

In our research what we found is that the drug supply, because 

of the mixtures of analogues and because of the unevenness of 

what is going on in the heroin market right now, is changing on 

a daily or weekly basis and those vicissitudes are quite likely causing the danger that we are seeing. 

Mr. SMITH. As I think all of you know, on August 18th, the President at a Cabinet meeting admonished Jeff Sessions to really increase significantly the efforts regarding to fentanyl and to the 

opioid crisis. You heard two of our witnesses earlier today for the 

administration speak of things that they are doing and I wonder 

if you could give any insights as to if you think we are doing 

enough. 

There is a bill, H.R. 6 that passed, a comprehensive bill pending 

in the Senate. It does include another bill that had passed independently that has stalled in the Senate with regards to the ability 

for the Postal Service to gather more information when packages 

are sent from there to here. But I am just wondering if you feel 

that we are doing enough. 

Some of the answers that they will get back to leaves open, I 

think, some question as to whether or not this is an all-out effort. 

Added to that, I am the prime author of the Trafficking Victims 

Protection Act of 2000. It is our primary landmark law, government-wide, domestic and international to combat human trafficking. For years, administrations would not put China on what 

we call tier 3, egregious violator for labor and sex trafficking. This 

administration thankfully last year and again just a month ago or 

so did that, 2 months ago, made it very clear that they are horrible. 

The Chinese reaction was predictable. It was filled with lie and 

deception because they are not doing anywhere near enough to 

mitigate this modern-day slavery. On international religious freedom they do the same thing. They had been designated a Country 

of Particular Concern and I wrote a law on that as well, the Frank 

Wolf International Religious Freedom Act. He did the original in 

1998 and China gets on that list because of their attacks on all 

faiths from Falun Gong to Christians to the Tibetan Buddhists, 

Muslims, Uyghers to the Dalai Lama and Buddhists. 

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It is an all-out assault on religion and to hear the Chinese Government’s response is as if religious freedom flourishes within the 

PRC. So you see time and again in human rights abuses there is 

no candor and which is why in my earlier questions to the administration we need to see concrete results, how many convictions, 

where are we really collaborating, you know, the DEA and their 

counterpart in the PRC? And added to that—and, Doctor, you 

might want to speak to this. 

There are reports that they are cracking down on meth labs because it is taking a terrible toll on Chinese citizens and I am glad 

they are because all human life is absolutely valuable. But because 

fentanyl does not affect Chinese, per se, it is affecting Americans 

primarily, there seems to be a laissez-faire, if not an enabling response, on the part of the Chinese. 

So the question is, is it time for some asymmetrical—do we need 

to be levying? You try to work with them, be disappointed as I am, 

you know, maybe they will do some things. Putting these precursor 

chemicals on a no-list or a controlled list, what does that really 

mean if there is no enforcement, or minimal enforcement that is 

PR oriented? 

So if you could speak to that because I think, you know, if we 

don’t get serious about this and, Mr. Coronato, you talked about 

the next 5 years. This is where the drugs are going, synthetic. We 

are in an epidemic and you had said three waves. 

And, Dr. Pardo, you talked about it being worse than the HIV’s 

pandemic and Congress did step up on that both domestically and 

with the President’s Emergency Plan for AIDS Relief. 

And I am the author—it hasn’t passed yet—of a 5-year renewal 

of that tremendous program started by President Bush. You know, 

if don’t really attack it and say real resources and, if necessary, 

real penalties levied on the Chinese. They rely on exports in all 

things. That is their economy. They are killing Americans. Your 

thoughts on that? 

Dr. CICCARONE. Well, first, Chairman Smith, thank you for your 

leadership on human trafficking. It has been outstanding work and 

a big success. So, in short, to your first question is the Federal Government doing enough, I am sorry to say the answer is no. The 

death rate continues to increase year over year without end. We do 

not foresee how this turns around or how this ends. 

We do need a crisis level response. I do believe that supply control—I am not an expert here. Supply control does have a role. I 

don’t know how they are going to do it with such small volumes. 

But I agree with you that as much pressure diplomatic and otherwise on the Chinese Government is necessary. They do have responsibility here. They are the main source. 

And then I will say the crisis level response has to include demand reduction. There are estimates from $60 billion to $100 billion are needed just on the demand side. We need to make our communities more resilient. As was mentioned earlier, I think it was 

by Representative Bass, we seem to have a decade over decade, 

continuous one drug morphing into another kind of problem. The 

way you address that is by addressing the root causes. The root 

causes are social, psychological and spiritual, and probably even 

economic. We need to kind of finally get serious. 

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Fentanyl might be the end game in terms of interdiction. We 

may not be able to stop the supply adequately. It is a 600-analogue 

family and processes to make these drugs are not that complicated. 

If we stop it in China how do we know it won’t go to India or to 

somewhere else in Latin America? And so, multi-pronged, multilateral approaches and unfortunately the price tag will be big. The 

cost is estimated at $78 billion per year in loss of productivity for 

the current opioid crisis. Seventy-eight billion dollars. So to address 

it with $100 billion over 5, 10 years is not unreasonable. 

Mr. PARDO. I would echo a lot of what Dr. Ciccarone said. To add 

specifically to the point about what the Federal Government is 

doing with regard to China, there were a lot of high level engagements with DEA and State with Chinese counterparts. Those 

haven’t really happened as of recent so fostering high level cooperation would be encouraging. 

Getting China to move more quickly with scheduling would also 

be encouraging. Adopting some sort of reciprocal scheduling system 

has been on the table, but that as far as I know has kind of stalled. 

So getting back to basics here and just trying to engage with them, 

trying to help them really improve their own capacity to enforce 

their own manufacturers and really clean house, I think, is key. 

China has recently started to move in the area of restructuring 

its food and drug administration. It has taken efforts to increase 

inspector capacity to focus on this problem specifically in addition 

to all active pharmaceutical ingredient manufacturers. So working 

with our Chinese counterparts would be one way of trying to improve our ability to seize, detect, and regulate these substances 

coming out of China. I think I will stop with that. 

Mr. CORONATO. Well, I would say I don’t think that there is a 

magic bullet that is going to solve our problem. I would say Chairman Smith that we need to do it all. Look, this epidemic is killing 

our children. It is ripping apart our families and our family life. I 

think that you need to go back to the source and the source right 

now happens to be China. 

And it doesn’t necessarily have to come directly from China. It 

could be going through from China to either Mexico to China to 

India to China to Russia and then working its way back to the 

United States. We need to attack that and we need from the law 

enforcement standpoint to hold those people accountable for their 

actions because they are killing our children. 

More importantly, I think that if we are going to look on the 

short term to save lives I think law enforcement has to communicate better and work with the healthcare community because this 

is a disease. And we need to treat it as a healthcare epidemic that 

is taking place and we need to treat it at the cause to help these 

people understand that we don’t need, we need to defer them from 

the legal system not put them through the legal system. 

And we need to be able to take these individuals—again that is 

why we use recovery coaches in New Jersey. We need to be able 

to communicate to get them the help that they need and then we 

need to have a better follow-up or a better tracking once they are 

in that system so we can make sure that they are going to complete 

the system and do it and not fall off the wagon after 30 days or 

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45 days, because quite honestly that is when they become more 

vulnerable. 

To answer the question, they are going to go back and use again. 

They are going to use something that is really more powerful and 

actually what we are doing is killing them. So the bottom line for 

me is that we need to do it all. 

Mr. SMITH. Let me ask you, Mr. Coronato, you were the first 

with your Blue HART program in the State of New Jersey to swing 

open the doors of our police departments and say you are welcome, 

we want to help you because this is a disease. I was just with Angelo Onofri. They have done that in Mercer County now, the prosecutor there, and they finally got the last municipality to join in 

that fight by being on the side of disease mitigation and intervention. 

Any of you if you could, what are the other States and municipalities doing with regards to this? Is this a model that needs legislation and perhaps incentive grants coming out of the Federal Government? Is this perhaps a role for some new legislation to say let’s 

take what you have done and perhaps what others have done, best 

practices, and get the police—I have found every police chief I talk 

to and every cop, because there were a lot of cops at last week’s 

gathering in Robinsville, New Jersey with Mayor Fried, are gungho on this, you know, they want to help. They realize like you said 

it is a disease. 

So I am just wondering, how do we roll this out to the country? 

Does it take legislation? Because we have to get ahead of this. 

Every municipality should have this. 

Mr. CORONATO. I think an initiative, a financial initiative would 

make a difference, would make a difference with regard to it. I 

think in New Jersey, again the county prosecutor is the chief law 

enforcement so when I sat with my police chiefs they were all on 

board. Again we were the first county to use Narcan. And once the 

other police departments and the other county prosecutors saw how 

successful we were in using Narcan it spread throughout the entire 

State. 

I think the same thing is happening with Blue HART. I think 

the problem with Blue HART though quite honestly is that you 

need a clinical evaluation that is going to take place. There is not 

enough beds. There is not enough availability. And that is why you 

kind of need to shift it into partnering up with the health care to 

be able to make a better assessment. 

The bottom line is that we need to work cooperatively and also 

what we need to do is work more efficiently. Sometimes it is not 

that we need more money, it just needs—the money needs to be 

put in the right place. I think that really would make a difference. 

Mr. SMITH. Well, Dr. Ciccarone had said about a crisis level response. Would this be part of that crisis level response? 

Dr. CICCARONE. Oh yes. I have had the privilege of working in 

my research in a number of hotspot areas including Charleston, 

West Virginia, Baltimore, towns in Massachusetts and Chicago, as 

well as my hometown of San Francisco. There are a number of creative initiatives which would be under this umbrella of public safety/public health partnerships and I really applaud them. I mean I 

think this idea of diversion works, i.e., of recognizing that people 

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have a chronic disease that we can enable treatment capture and 

also work on, you know, treatment longevity. However, I don’t 

know of any place that if you asked them, do you have enough resources to do what you want to do where the answer is yes. They 

will either say I have a labor shortage, I don’t have enough docs, 

or they will say I have a financial resource problem where we liked 

this program, but we had to cap it at a certain number of people, 

and there are people knocking on the door but we had to cap it because we ran out of money. 

We also need consistent flows of money, and maybe I will let Dr. 

Pardo jump in here because we were talking last night about this 

about how a lot of places are worried that, you know, the money 

is here this year, will it be here next year? Do I start a program, 

how big do I start a program because I don’t know if I am going 

to have money in the next fiscal year? So, just like businesses in 

America, they want to know that there is some steady trajectory 

in the U.S. policy regarding fill in the blank. 

Mr. PARDO. I mean, yes, to get to that we do know that drug addiction is a chronic relapsing disorder so we do need to have more 

sustained Federal funding or funding in general to treat and address this. But to get to both of these points, really what we need 

to, given this crisis what we need to be thinking about are kind of 

a broad branch approach to extracting individuals from these markets. So whether that is using the public safety system to get them 

into some sort of treatment facility or just reviewing regulations 

and limits on access and provision to medication therapies. 

Talking with Dr. Ciccarone last night, the problem that some 

States still have moratoriums on opiate treatment provision, the 

fact that it is difficult for some people to access methadone and 

buprenorphine that puts a serious, it really hinders our ability to 

combat this problem at the domestic level. 

Mr. SMITH. Now has the administration, DOJ, HHS, any others 

reached out for these kinds of insights that you are providing 

today? I mean they have good people I know around them, but you 

had said, Dr. Ciccarone, that we are not doing enough in response 

to that request for an answer and I appreciate your candor. Not 

doing enough means more dead people. Any thoughts that you have 

for what model legislation might look like we would appreciate it, 

even if it wasn’t legislation, executive order, something that could 

be done overnight to further mobilize us. 

Mr. CORONATO. I would want to add one thing. We have been 

talking about substance abuse the whole day today. But this is cooccurring. There is a mental health component of it. And I think 

that if you don’t do both, if you don’t attack both and go both at 

the mental health and also at the substance abuse and attack it 

at the same time—that is why the clinical evaluation is so important. And there is a benefit and there is a cost benefit because I 

will tell you this, the other benefit that we had in 2017, we were 

the only county in the State of New Jersey that had a reduced 

death rate and it was at 20 percent. It was significant. Not only 

did my death rate go down, but my spray rate went down. We 

sprayed 35 percent less people in Ocean County with Narcan in 

2017, so it was a correlation. 

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Then I went back and took a look. My crime rate went down. My 

larceny rate went down. My shoplifting rate went down. The bottom line is, is that there are benefits if we do the job right. We are 

kind of defective in how we handle this and there is not a good, 

what I would call follow-through and not—it has to be outcomebased. I am really looking at outcomes. What I don’t want to do is 

just recycle these individuals. I want to attack the problem and 

have good outcomes and that what we need to hold people accountable for. That is law enforcement. 

Mr. SMITH. I did ask the previous panel a couple of times, they 

deferred, what other countries perhaps is this coming from, and I 

asked specifically whether or not India has become because they 

are a major producer of drugs that end up in our pharmacies. And 

I am just wondering if China were to get a handle on this does the 

labs just move and relocate? 

Mr. PARDO. Yes. That is definitely a fear. That is a concern. They 

do have a robust pharmaceutical industry. There has been instances where they are producing controlled substances for export 

illicitly. So there are instances where I mean it definitely is a concern from a drug policy perspective. So thinking about this more 

holistically we do need to address, and getting back to Dr. 

Ciccarone’s point, we need to really think about demand reduction 

as well as getting countries to focus on supply side initiatives. 

Mr. SMITH. Is there anything else you would like to add? 

Dr. CICCARONE. So just two comments, one is there is another 

major source of illicit fentanyl and that is Estonia with Russian 

connections. I don’t think that will affect the U.S. market, it is 

more likely to affect the European market. The synthetic, you 

know, as Mr. Coronato said, the synthetic cat is out of the bag, 

right. The future of illicit drugs is going to be increasingly labbased and less plant-based. We need to prepare for that future and 

understand what the chemicals are, what mixtures are coming in, 

what purities, what flows—back to the surveillance suggestion that 

is in my written testimony. 

And then a comprehensive approach that allows not just a crisis 

response now, but a long response. We have been 15 years into this 

epidemic. It will quite likely last another 15 years. Drug epidemics 

do naturally cycle downward, but this is a long one. This is big one. 

This could go on for another almost generation if we don’t act. If 

we do act, then we can see the curve that we saw with HIV in the 

1990s with the Ryan White Care Act and technological and scientific medical progress: The death rate came plummeting down 

within a few years. 

The same opportunity exists here. We have three medications 

that work. They need to be expanded. We need to work with 

SAMHSA and other regulatory agencies to allow greater access. 

Right now, docs are limited. They can prescribe. They have a certain number of patients that they can have put on buprenorphine. 

Why? I don’t know of any other medication that limits a doctor’s 

prescribing ability. 

So I agree with you, Chairman Smith, that Congress can take 

leadership here, both in terms of dollars, but also in terms of working with the regulatory system, HHS and the subdivisions of HHS, 

to allow them the creative freedom, if you will, to explore new opVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00091 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
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tions given this crisis, even if they are temporary provisions. We 

don’t want to, you know, liberalize the rules on buprenorphine forever, but what about a 5-year change, you know, so that we can 

get through this crisis? Buprenorphine is a high-benefit, low-risk 

drug. It has some risks. Not zero. No drug, no pharmaceutical we 

make has zero risks. A high-benefit, low-risk drug that is very useful in this current crisis. 

Mr. SMITH. Would a White House—oh, I am sorry, Dr. Pardo. 

Mr. PARDO. No, I would just to extend onto that we were talking 

last night and the fact that a doctor doesn’t need a waiver to prescribe fentanyl transdermal patches to treat chronic pain but needs 

a waiver to prescribe buprenorphine to treat an individual’s addiction problem is a notable problem here. 

So thinking about this problem in terms of stock and flow, we 

have a massive stock of individuals who are potentially addicted to 

prescription painkillers. Trying to intervene before they enter the 

illicit market is probably the best way to save lives. So getting 

them to some sort of medication therapy before they enter the illicit markets, so expanding access to prescription buprenorphine or 

methadone is one thing that Congress should be looking into more 

aggressively. 

Mr. CORONATO. I would agree with my esteemed colleagues, but 

the one thing I would say, and I believe in MAT treatment, is that 

we need best practices, true best practices that can be applied by 

the doctors. And I think that if we were going to go in that direction and I would advocate that we go in that direction, I really 

would want to see best practices both for methadone, suboxone, 

and also for Vivitrol as we go through and to make sure that the 

mental health component is being adequately addressed and not 

just a substance abuse. 

Mr. SMITH. USAID does great work with infectious diseases, but 

health diplomacy is largely handled by HHS. What is your assessment as to how well or poorly how our efforts with WHO, PAHO—

and I know you have worked with them in the past—other organizations like the African Union although this may not be an issue 

there, but it certainly is with PAHO and the OAS and of course the 

U.N. and WHO; are we doing enough there? 

Mr. PARDO. So the State Department was very successful in 

working with international partners to get both major fentanyl precursors controlled in 2016. They worked with through the traditional channels, the Commission on Narcotic Drugs in Vienna. 

They worked with major pharmaceutical manufacturers in these 

countries to understand, you know, who is producing what. 

So there was a very robust effort to get these precursors controlled. And we may be seeing, whether or not we see those benefits, it is going to take some time to kind of see whether or not 

those supply-side interventions are working. But it is true that the 

Canadians have controlled these substances. The Mexicans have 

controlled these precursor substances. The Chinese as well have 

started to control these precursor substances. So working with our 

international partners is one way to put some of the, you know, put 

some control measures on these firms that are producing these 

things in kind of these gray areas in underregulated industry so to 

speak. 

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Mr. CORONATO. And I will make one other comment if I could. 

In the State of New Jersey under Governor Christie and the legislature what they did is they limited the amount of prescription 

drugs that you can get right initially. I think you can get 5 days’ 

worth of drugs initially. To me, I think if you set up a national 

standard with regard to that because it is clear that the pills is 

what really fueled this both in the ’90s and the early 2000, I think 

that the government can come back and again regulate the distribution through the prescription plans that are being done, basically saying that you get 5 days’ worth of prescriptions and then 

you have to go back to the doctor and you can monitor it. 

Because the significance between the fifth day and the sixth day 

is tremendous, it is like a 60 or 70 percent addiction rate when you 

go from the fifth day to the sixth day. So, and you know that would 

also be another regulation I think that the Federal Government 

should look at. 

Mr. SMITH. Let me just—is there any fear given that China has 

been expert at weaponizing so many things, even locally in my 

hometown of Hamilton Township when we got hit with the anthrax 

crisis that killed a couple of people here in Washington, and we 

had people sickened in Hamilton Township Post Office. Weaponized 

anything can be a very serious danger. 

This is an outlier question, but is there any concern that somehow this could be weaponized since it is so highly concentrated and 

so lethal? 

Dr. CICCARONE. The super high potency ones, yes. Carfentanil 

has made it into the news a lot about, you know, 1,000 next to morphine. There are even more potent by volume opioids than 

carfentanil. There are ones that make carfentanil look moderate. 

And so yes, and they could be aerosolized. Yes they could contaminate water supplies. So yes, we definitely have fears in that direction. 

Mr. CORONATO. Yes, I will add this. We don’t do, when we do our 

raids right now we don’t do onsite any kind of testing because just 

the fact of either inhaling it possibly as it goes airborne, also if you 

touch or touch something that touched fentanyl it gets onto your 

skin and it actually will be absorbed right through your skin. And 

we have had police officers I know in Atlantic City and other parts 

of the State that overdosed on the fact of when they did a raid with 

regard going into. 

So the answer is absolutely, depending on the analogue and depending on what you have in there. So, and that was a good reason 

why to be honest with you we weren’t using dogs to sniff it because 

the dogs would die. So the bottom line is—that the K-9. So it is, 

it is a project. That it is something that we need to look at. It is 

something that has all kinds of ramifications and it is evolving as 

we speak. 

Mr. PARDO. So two points I think that might—it is true that first 

responders are put at higher risk when engaging with this. As far 

as I am aware it is a concern when touching and then touching a 

mucous membrane, so getting in your eye or nose. Transdermally, 

powdered fentanyl from what I understand that risk is overstated. 

Nonetheless, for postal system workers, for police officers it can, it 

does increase the risk of overdose. 

90

The second point is that there is, there was one event in Russia 

where Chechen terrorists were—yes, are you familiar with this? So 

the Russian Government did use two different forms of fentanyl 

to—they aerosolized it and pumped it into this theater to knock everybody out. In doing so they ended up killing over 120 people. So 

it could be, in theory, weaponized. Beyond that I have not seen any 

indication that it has been though. 

Dr. CICCARONE. And just to add, DOJ has just come out with a 

letter supporting best practices in protecting law enforcement and 

other first responders with regards to fentanyl. A quick read of it, 

it looks very responsible and evidence-based. 

Mr. CORONATO. We are pushing it out now because——

Mr. SMITH. Now the Department of Education, do you feel they 

are doing enough to warn our students about this dire risk? 

Mr. CORONATO. I will just jump on the bandwagon on that. That 

is kind of similar to the tobacco industry, how long it took to get 

in schools. It took like what, 25, 30 years before we really addressed the tobacco industry in the schools. And I think it needs 

to be embedded in the curriculum. I think that it is something that 

needs—and it shouldn’t be just in the fifth grade and just in the 

eighth grade and just in the twelfth grade. For me it needs to be 

repetitive every single year. It needs to understand. It needs to 

start in the first grade, because what we are looking at today with 

today’s social media, everything is being driven down further and 

further into the grades at least that for me on the boots on the 

ground type thing. 

So to me, if you ask my opinion we should be starting in the first 

grade and every single grade ever talking about drugs and how you 

don’t want to put bad chemicals into your body. You need to put 

good nutriments into your body, not bad things into your body. And 

that is how I would start it off. 

Dr. CICCARONE. So our former ONDCP director, Michael Botticelli, who is a recovering user himself, spoke very eloquently and 

has written eloquently about reducing stigma. If I was in charge 

of education of Americans, especially at the young level, I would 

tell them that addiction is just another problem that comes up with 

being human. And that we treat it medically, we treat it responsibly, we treat it sensitively and humanistically just like we treat 

diabetes or heart disease or cancer, which are the biggest killers 

of Americans. 

Stigma gets in the way of everything that we do. It gets in the 

way of the patient entering the clinic. It gets in the way of them 

staying in treatment. It gets in the way of average Americans all 

the way up to the highest levels of government in doing our best 

in terms of this problem. It is a barrier. So reducing stigma, normalization of chemical dependency is what we need to do and then 

with open arms we get people into care, all levels of care. 

The beauty of this notion is that people will come into care before 

they are the long-term, heavy, chronic user. They will come and 

they will say, ‘‘Whoa, what was I doing? I don’t know, I was just 

messing around with that stuff for 3 months and I want off now.’’ 

And they come and they can get help getting off sooner and more 

effectively. Like any disease, if I want to prevent cancer I want to 

screen for it before it is stage 3. Just like heart disease, get someVerDate 0ct 09 2002 12:27 Dec 03, 2018 Jkt 000000 PO 00000 Frm 00094 Fmt 6633 Sfmt 6633 Z:\WORK\_AGH\090618\31451 SHIRL
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one on a statin when the lipid levels are going up, but they haven’t 

had a heart attack yet, that is prevention. Reducing stigma get us 

to lower stages of disease and makes prevention work better. 

Mr. PARDO. I would agree with both statements. I can’t speak 

specifically to what Department of Education is doing with regard 

to fentanyl, but I would state that drug prevention education programs do have their, they do have a place in the broader drug policy tool system. However, this crisis is an acute crisis. These individuals that are using fentanyl or coming into contact with 

fentanyl on the streets, they are already drug users in the system. 

They are already a high risk, so it might not do much to think 

about educating someone, you know, who may pick up a substance 

10 years from now. 

We need to figure out how to inform them about the risks in the 

illicit system. So trying to create some sort of transparency in those 

markets, letting them know that, for example, police seizures this 

week are showing high potency fentanyl in the markets, letting 

users know that the toxicity of those substances are in those markets might be one way of kind of reducing their harm or reducing 

their exposure to these substances in these markets today. 

Mr. CORONATO. I am going to say something funny and I don’t 

mean to criticize because these guys are great. But I tried that and 

it actually backfired. We used to come out and say, wait a minute, 

don’t buy this type of bag of heroin that is stamped bud light or 

whatever it was stamped, and we drove the individuals to go and 

buy it. It was the most incredible sight that I have ever seen. 

So we don’t say that anymore because if we did we would actually market it for the drug dealers because then all of a sudden 

they are all going out looking out for this great stuff that is 

stamped bud light. It is the most—it is the exact opposite of what 

you would think it would be. 

And I will just end up with this. I actually think that we all bear 

a certain amount of responsibility for where we are today. And 

what I mean by that is that when we raise our children we always 

seem to say this is a magic pill that is going to help you, that is 

going to solve your problem that is going to get you out of this cold, 

it is going to get you out of this infection. 

And then before you know it, if a kid has a headache and they 

are 3 years old and but wait a minute they weigh 40 pounds and 

you now can take two tablets instead of three tablets depending on 

your weight, we teach our children to self-medicate and as a result 

everybody thinks they know their body. So they say, you know, this 

is what it is supposed to do, but I know my body, I can tolerate 

that. And by the time they are in their teens and their 20s, they 

say, you know, I know what I can tolerate, what I can’t tolerate. 

I know what my body can handle. 

And we all have a hand in this epidemic. That is what I am trying to say. So I think that the bottom line is that we need to educate our children. I think that we need to be woven into the school 

system because what it is, it is attack on our children. It is attack 

on our family, it is on an attack of way of living and unless we get 

a handle on this we are going to suffer the consequences. 

Mr. SMITH. I want to thank you. If you have anything further 

you would like to add, your expertise is tremendous and I thank 

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you for that on behalf of the committee. We will follow up as a committee and me as chairman. You have given us so much to digest 

and convey to different parts of the government including the 

White House and I thank you for that. 

And without any further comments, the hearing is adjourned. 

And I thank you. 

[Whereupon, at 5:18 p.m., the subcommittee was adjourned.] 

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31451n.eps

SUBCOMMITTEE HEARING NOTTCE 

COMMITTEE ON FOREIGN AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

W ASHJNGTON, DC 20515-6128 

Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations 

Christopher H. Smith (R-NJ), Chairman 

August 30, 2018 

TO: MEMBERS OF THE COMMITTEE ON FOREIGN AFFAIRS 

You are respectfully requested to attend an OPEN hearing of the Committee on Foreign Affairs to be held by 

the Subcommittee on Africa, Global Health, Global Human Rights, and international Organizations in Room 2200 

of the House Office Building (and available live on the Conunittee website at 

DATE: 

TIME: 

SUBJECT: 

WITNESSES: 

Thursday, September 6, 2018 

2:00p.m. 

Tackling Fentanyl: Holding China Accountable 

Panel! 

The Honorable Kirsten D. Madison 

Assistant Secretary 

Bureau of International Narcotics and Law Enforcement AfTairs 

U.S. Department of State 

Mr. Paul E. Knierim 

Deputy Chief of Operations 

Office of Global Entorccment 

Drug Enforcement Administration 

U.S. Department of Justice 

Panel II 

Bryce Pmdo, Ph.D. 

Associate Policy Researcher 

RAND Corporation 

Daniel Ciccarone, M.D. 

Professor ofFamily and Community Medicine 

University of California, San Francisco 

Mr. Joseph D. Coronato 

Prosecutor 

Prosecutor's OHicc 

Ocean County, New J erscy 

By Direction of the Chairman 
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ON AFF'AIRS 

MINUTES OF SUBCOMMlTml:' ON 

Day Tharsda,v__ Dato_ Septel::nb:::e::.:_r_:62,==-R•wm, ___ _::2:::2:_::1Jc:O ___ _ 

lime__ 2:01p]11 __ Time -~5~:_,_1"'8Peclc:;11c__ 

(3:iHipr.1 to 4:15pm) ( __ to )( ___ to __ )( __ to __ )L_lo __ )L_to __ ) 

D 

;::TI;::T;:-LE-:::, -:::O-:::F-:;:;;HE-:::~A-;-:;R-:;:;;1:-:cNG:::-,,-------------------------­

Tackfing Feutanyl: Tile Cilina Conuection 

SLllt:UJI!lMffi'l<:E MEl\UlERS PRESENT: 

Ranking i1•Iember Bas._">\ Rep. Rep. Rem, Rep. Rep. Sum;zi 

Rep. Chabot 

Jersey 

Tl:viE SCIIElHJLED TO RECONVENE ___ _ 

or 

'l'l:viE ADJOrRNED 
96

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND

INTER*NATIONAL ORGANIZATIONS


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Like so many parents, we would make excuses for Garrett's behavior to friends, family, and 

coworkers but never reveal the extent on which his illness had progressed. This is where the 

stigma plays a tough role in the person afflicted as well as the family that supports them. 

Mental Illness, Substance Abuse, and Addiction are not things that people want to talk about or 

other people want to hear. I never gave up hope and I was proud of my son. I did not want to 

imply that he was any more than a little wild and would settle down soon and be on track. 

My wife and I were desperate, so I took a project in D.C. and brought Garrett with me to get 

him out of his current environment and hopefully give him a new start. Unfortunately, meeting 

legal obligations took precedence over any treatment for Mental Health or Substance Abuse. 

He was under a lot of pressure but the whole time still struggling with the need to escape 

reality. He needed medication for Anxiety but due to his legal issues and his tendency to abuse, 

he was never diagnosed or treated properly. Finally, someone told him about a Synthetic 

Opioid that would not show up on a drug test and that is all he heard. 

Sometime in November 2016, he ordered a synthetic Opioid U-47700 online and it was 

delivered to the apartment by the mail carrier. So today, the mail carrier can inadvertently be 

the new drug dealer: (Garrett's story is sited in the WSJ Article, "When the Mailman Unwittingly 

Becomes the Drug Dealer" by Jon Kamp). 

This was the beginning of the end. 

Garrett overdosed the first time in early December 2016 and I had to perform CPR until the 

paramedics arrived to administer Naloxone and transport him to the Hospital. Once he 

awakened in ICU it was obvious that this was not the wakeup call we had hoped, so he was 

forced into a mental health evaluation by us. The system is weak and he was only required to 

stay 5 days. From there he reluctantly went into a 30 day in-house treatment program but a 

week after he got out he overdosed the second time and once again I called 911 and gave him 

CPR until Paramedics arrived and revived him. I forced him into a second evaluation but the 

judge decided he did not belong in a mental health facility and released him on Feb 6, 2017. His 

final overdose was three days later on Feb 9, 2017. His cause of death was determined 

accidental as a result of mixed drug use. He had taken the synthetic Opioid U-47700 and Xanax. 

I am not sharing my story because I have the answer, I am sharing because I am sure I am not 

alone and I would like to do my part to make it easier to have the conversation. You may read a 

headline about the opioid epidemic and get information about Heroin, or fentanyl laced Heroin 

or maybe over prescribing of Pain medication. All of which are relevant and still carry the 

negative stigma and in many cases the opinion that a person addicted made a choice and 

deserves what they get. My son's Opioid exposure was less than 2 months. He did not have 

time to hit bottom. At 20 years old, I do not believe my son deserved to die for his initial bad 

choices. 
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Today's hearing is to focus on the role China plays in combating (or not) the illegal Fentanyl 

being produced and distributed from China to the United States. There are many Political and 

legal concerns when dealing with this topic and China but, I believe together we can accomplish 

more than working against each other. I am in regular communication with individuals I have 

met at Customs and Border Protection (CBP) and Homeland Security Investigations (HIS). Over 

the last 18 months I have seen improvements in both Federal Agencies in their efforts to detect 

illegal Fentanyl shipments and to trace those back to the source in China. I am also told that 

China is cooperating with the U.S. in identifying and shutting down the Labs that produce these 

drugs and the websites used to sell them. I know firsthand how compassionate and motivated 

both Federal agencies are in fighting the Opioid crisis. 

With that said, is it enough? Imagine someone standing on a roof with a bucket of 1000 

marbles. They dump the bucket and scatter the marbles into the grass. Now a team of 

individuals with an arsenal of tools scour through the grass to locate the marbles. While they 

are looking another individual shows up on the roof and dumps a different bucket of 1000 

marbles into the grass. Now the team on the ground is still hunting for the first 1000 marbles 

but if they find a marble from the second bucket they can't pick it up because they are waiting 

for approval on those, so they must only focus on the marbles from the first bucket. 

In the meantime, individuals keep showing up on the roof dumping more marbles into the 

grass. This is an analogy of the illegal fentanyl being dumped from China into the U.S. As hard as 

we are working to locate and intercept the marbles, the only way to get this under control is to 

have someone on the roof to prevent anymore buckets of marbles from being dumped into the 

grass. Is China committed and focused 100% on preventing the manufacture and distribution 

of illegal Fentanyl to the United States? If not, why? I would have to ask if they are being 

complacent and if so this may be interpreted as acceptance by those in China involved in the 

business of killing Americans via the manufacture and distribution of illegal Fentanyl and 

Fentanyl analogs. 

One of the Challenges of prosecuting for illegal Fentanyl and Fentanyl analogs is that as soon as 

one substance is classified as illegal, a similar substance is created that just misses that criteria 

and is considered legal. A non-scientific explanation of Fentanyl Analogs: Imagine the family 

secret bar-b-que sauce recipe. Everyone that has one basically has a list of ingredients and qty's 

of each that make up the secret blend. Now imagine that the recipe calls for 1 teaspoon of cyan 

pepper, but you decide to add a 1 Y, teaspoons to your recipe. In the world of illegal Fentanyl 

Analogs, the recipe with 1 teaspoon is classified as illegal but by adding an additional Y, 

teaspoon to your recipe you changed the documented criteria that makes it illegal therefore 

authorities are limited in the ability to prosecute. Once the Senate acts, they have several bills 

the House Judiciary Committee has recently passed to fight the Opioid Crisis including some 

that will help streamline the process to declare these slight variations of an illegal substance 

illegal. 
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Garrett was able to go online and using Bitcoins, make a purchase for a Fentanyl Analog known 

as U-47700 (Street name "Pinky") that was inexpensive and shipped directly to the apartment a 

few miles from Capital Hill. I challenge all of you to go online and simply search for U-4770. 

Your search will first return sponsored sites that will offer you the chance to purchase the drugs 

for around 50.00. If you continue to search you will see several links to articles that outline the 

dangers of this drug. Below is an image sent to me later by an ex-girlfriend of Garrett that 

shows the envelope he received in the mail and the white powder substance it contained 

inside. 

Looking close at the return address on the envelope you can see plainly it originated from 

China. As Americans we must take responsibly for self-inflicting this Opioid Crisis on ourselves 

because of over prescribing and under acknowledging the addictive nature of Opioids. But if 

your house is on fire, would you expect your neighbor to help by pouring water on it or be 

enraged to find out they are dumping fuel? We need China to be our good neighbor and help us 

save lives. 

Chairman Smith, Ranking Member Bass, and the Members of the Africa, Global Health, Global 

Human Rights, and International Organizations Sub Committee, when Americans go online to 

order illegal Fentanyl and Fentanyl Analogs from China, they are not required to disclose if they 

are Male or Female, Gay or Straight, Black or White or Hispanic, Asian, Indian or any other race, 

Christian, Jewish, Muslim, Hindu or any religion, and I am positive they do not have to disclose 

if they are Democrat or Republican. Today I encourage all of you to come together using your 

talents and strengths to focus holistically on this Bi Partisan issue that is a threat to our National 

Security. 

Thank you for the opportunity to share my son's story. 

Donald A. Holman 

(Garrett's Dad) 

804-335-8262 

donholmansml@yahoo.com 
100

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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In 2016, we implemented a county-wide Opioids Diversion Program that allowed 

defendants arrested for smaller possessory opioids charges to be diverted from traditional 

criminal prosecution, on the condition that he/she seek and continue drug rehabilitation 

treatment. Treatment sites and are typically arranged through our great relationships with 

recovery specialist companies (e.g., Lifeline Recovery Support Services/John Brogan). Upon 

successfully completing conditional terms, charges against the defendant may be downgraded 

or dismissed by the State. The key to all these programs is to leverage the risk of criminal 

culpability, and steer those struggling from an addiction to an appropriate level of care with the 

end goal of breaking that all-too-common cycle of addiction. Our Office, in addition to six 

municipal police departments have seen great success with this program, and more towns 

continue to agree to participate. 

In this same year, we were the first of two counties to participate in the grant-funded, 

pilot Opioids Overdose Recovery Program {OORP). Like the diversion program, the OORP 

similarly employs recovery specialists and patient navigators to help hospitalized individuals 

saved from an overdose obtain the necessary treatments and services towards rehabilitation. 

These programs and initiatives are but a few examples of our efforts to reduce demand for 

dangerous opioids, but this is only half the equation. 

MCPO's Efforts to Reduce the Supply of Opioids Plaguing our Region 

Equally important is a robust enforcement effort to eradicate illegal narcotics and 

narcotics distribution networks that thrive from this epidemic. To that end, the MCPO began 

concerted opioids interdiction efforts in 2013, focusing 85% of our Narcotics Strike Force 

investigations on opioids trafficking organizations where fatal overdose deaths were trending. 

In 2016, we were the first county to secure a co-located High Intensity Drug Trafficking 

Organization {HIDTA) Task Force, designed to disrupt and dismantle regional drug trafficking 

organizations without jurisdictional challenges or limitations. 

As a result of the combination of the aforementioned efforts, we have seen a 10% 

reduction of overdose deaths from 2016 to 2017 across the 53 municipalities in Monmouth 

County. Compared to this time last year in May 2017, we have seen a 15% reduction in 

overdose deaths, and a 30% reduction compared to May 2016. Moreover, Narcan deployments 

have increased by 15% from 2016 to 2017, with the number of successful saves increasing by 

14%. This is welcome progress, but we certainly are not declaring victory by any means until 

we see such declines over a longer term. 

The Rise a (Even More Deadly Fentanyl 

As a complement to these efforts, we continue to gather valuable intelligence on the 

scope of the overall opioids epidemic through our MCPO Intelligence Bureau, and strong 

federal, state and municipal law enforcement partnerships. Sadly, we continue to see more 

fatal overdoses with toxicology results indicating ingestion of fentanyl. What's more, our 

2 
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enforcement efforts show increasing seizures of drugs containing fentanyl. Dozens of 

intelligence sources recognize that more than 90% of the Fentanyl entering our region (and the 

U.S.) is produced in China. Fentanyl is sent by Chinese manufacturers and other conspirators 

via mail from dark web purchases, or through traditional drug trafficking routes via the porous 

southern border. Fentanyl ultimately makes its way to a demand center. DEA and other law 

enforcement intelligence estimates that the illegal fentanyl market will completely usurp the 

illegal heroin market in the coming years. The reason is that fentanyl production and 

manufacture costs a fraction of what it takes to manufacture and process heroin, and is 

conservatively 50 times more powerful than heroin or morphine. Consumption of a quarter of 

a milligram can instantly kill you. A more powerful substance like this yields a quicker 

addiction, which leads to greater demand at a much cheaper production cost. With an 

increased profit margin realized by drug trafficking organizations, the outlook for a region 

already struggling from this epidemic is dangerous to say the least. 

The Ask: Address the Fentanyl Problem at its Manufacturing Source- China 

Prior to my appointment as the Prosecutor in Monmouth, I worked as a federal 

prosecutor at the United States Attorney's Office in both the Districts of New Jersey and 

Maryland for 10 years. Some of those years were spent investigating and prosecuting drug 

trafficking organizations that sent narcotics to the U.S. for American consumption, many of 

which operated outside of the U.S. and its territories. Examples included drug kingpins and 

conspirators operating in countries such as Colombia, the United Kingdom, Panama, Mexico, 

Japan, Belize, and dozens of other countries. American federal prosecutors are able to 

investigate and prosecute foreign nationals involved in illegal drug trafficking like this due to 

the existence of Mutual Legal Assistance Treaties (MLATs) that exist between our governments. 

MLATs are treaties that allow for the exchange of evidence and information in an effort to 

enforce criminal laws. The MLATs set forth mechanisms for doing things such as, arresting and 

extraditing foreign nationals who commit crimes under United States law; obtaining evidence 

and information for criminal investigations and prosecutions; and investigating criminal activity 

that may be occurring abroad. 

Currently, there are no such MLA Ts that exist between the U.S. and China that allow for 

American federal/ow enforcement agencies to extradite Chinese nationals who manufacture 

and distribute fentanyl that ultimately arrives on U.S. shores. As stated earlier, more than 90% 

of illegal fentanyl coming to America is manufactured in China. What this means is that Chinese 

nationals and their conspirators, profiting off American citizens' addiction, operate with near 

immunity without fear of extradition to the U.S. to face federal criminal charges. My experience 

with prosecuting South American drug traffickers and money launderers dictates that, without 

such agreements in place in the nation that serves as the source of fentanyl supply, it will be 

extremely difficult to limit the flow of fatal fentanyl coming to the U.S. Any federal prosecutor 

would recognize that an MLAT with China to extradite narcotics manufacturers and traffickers 

would be a vital tool to help cut the fentanyl supply coming to America. 

3 
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I presume that we retain a great deal of leverage with the tariffs recently imposed on 

Chinese exports, and generally considering how reliant China is on U.S. exports (an estimated 

20% of their export sales are to the U.S.). My hope is that seeking the necessary MLAT with 

China to address the fentanyl source of supply will continue to be a strategic goal and priority in 

our negotiations with China. Successful extradition and prosecution of foreign nationals in 

American federal courts, coupled with appropriate criminal sentences, would create a great 

deterrence to others involved in manufacturing and distributing fentany1. 1 Most importantly, it 

will go far in saving American lives by making creating penalties for illegal fentanyl traffickers 

operating with impunity in China. 

Thank you for your consideration and review of this request, and please feel free to 

contact me with any questions or concerns. 

Christopher J. Gramiccioni 

Monmouth County Prosecutor 

(908) 216-0582 (cell) 

1 In my experience, the point of deterrence cannot be overstated. Imagine the Chinese national profiting from 

sales of fatal fentanyl being arrested and extradited to the U.S. to face criminal charges in an American federal 

court. He or she is taken into custody, separated from family and forced to leave their home country to a foreign 

country thousands of miles from home. They remained detained pending trial and, if convicted, can serve decades 

or more in a foreign prison, isolated from their own family and culture. For example, Colombian drug traffickers 

feared nothing, except for extradition to the U.S. As American and Colombian diplomatic relationships improved, a 

great deal of the illegal narcotics trade dried up in Colombia, due in large part to concerns over arrest and 

extradition to face charges in United States courts. 

4 
104

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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PARTICIPATING POLiCE DEPARTMENTS 

/Vi'/ person whcl-Joiuntarily enl0rS-Onc ot t'le polle-e depait'!l€nts 

{H1 1he day 3;1d dnd requests help with addiction 

hero;n, 

OCEAN GATE POLICE DEPARTMENT 

801 Ocean Gate Avenue 

Ocecm Gate, New Jersey 087 40 

732-2G9-6931 

(MONDAY 9 00 A.M. to 5:00PM.) 

LITTLE EGG HARBOR POLICE DEPARTMENT 

665 Radio Road 

Lillie Egg Harbor. New Jersey 08087 

609-296-3666 

(TUESDAY 90DAM. to 5:00P.M.) 

POLICE DEPARTMENT 

08050 

POINT PLEASANT BOROUGH POLICE DEPARTMENT 

2233 Bndge Av-enue 

Point Pleasant, Nev·l Jersey 08742 

732-892-0060 

(TUESDAY to 5:00 P.t\;1.) 

MANCHESTER TOWNSHIP POLICE DEPARTMENT 

1 Co!on1al Drive 

fl.1ar.chesler, New Jersey 

732-657-2009 

(WEDNESDAY 9:00A.M. to 3:00PM) 

wifl 

HEAlJI:LQAREITRt:;_ATMENTf'.80VIDERS 

SUNRISE DETOX 

16 Whttesvrlle Road 

Suite A 

Toms River, New Jersey 08753 

732-797 2502 

INTEGRITY HOUSE 

310 Main Street 

Suite 8-2nd Floor 

Toms Fliver, New Jersey 08753 

848-238-7000 x406 

PREFERRED BEHAVIORAL HEALTH 

700 Airport road 

Lakewood, New Jersey 08701 

732-367-4700 

OCEAN MENTAL HEALTH SERVICES 

687 Atlantic City Boulevard #1 

Bayville, New Jersey 08721 

732-269-4849 

LIFE LINE RECOVERY SUPPORT SERVICE 

108 Indian Head Road 

Toms F\iver, New Jersey 08753 

888-520-0040 
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Question: 

Question for the Record Submitted to 

Assistant Secretary Kirsten D. Madison by 

Representative Chris Smith 

House Foreign Affairs Committee 

September 6, 2018 

Has the U.S. Government considered using the Global Magnitsky Act to target narco-traffickers 

and corrupt officials in China who facilitate the fentanyl trade1 If not, why not1 

Answer: 

The Global Magnitsky sanctions program is intended to disrupt and deter serious human 

rights abuse and corruption abroad. Serious human rights abuse and corruption come in 

innumerable forms and while we cannot discuss potential or prospective actions related to 

sanctions, we remain deeply concerned about the fentanyl trade. We would also note that other 

sanctions authorities might address these topics. We recognize the importance of addressing this 

issue and its profound impact on so many Americans and will continue to consider which of our 

tools wi11 be impactful in addressing it. 

Question: 

In 2002 there was an infamous hostage crisis at a Moscow theater (known as the "2002 Nord-Ost 

siege"). During the standoff: Russian special forces Spetsnaz opted to use a weaponized gas to 

snutl'out the hostage takers. The identity of the gas was never disclosed, although it is 

considered by many experts to have been the fentanyl derivative carfentanil. In total, the special 

forces ended up ki11ing not only 40 hostage takers but also between 100 and 200 of the hostages. 

a. How easily can fentanyl be weaponized? 

Thank you for the question. The Department would need and be wi11ing to address this issue in a 

classified setting. 

Question: 

In 2002 there was an infamous hostage crisis at a Moscow theater (known as the "2002 Nord-Ost 

siege"). During the standoff: Russian special forces Spetsnaz opted to use a weaponized gas to 

snuff out the hostage takers. The identity of the gas was never disclosed, although it is 

considered by many experts to have been the fentanyl derivative carfentanil. In total, the special 

forces ended up ki11ing not only 40 hostage tal<ers but also between 100 and 200 of the hostages. 

b. What is you assessment of the threat posed by weaponized fentanyl in the hands of 

State and non-State actors? 
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Answer: 

Thank you for the question. The Department would be willing to address this issue in a 

classified setting. 

Question: 

ln 2002 there was an infamous hostage crisis at a Moscow theater (known as the "2002 Nord-Ost 

siege"). During the standoff, Russian special forces Spetsnaz opted to use a weaponized gas to 

snuff out the hostage takers. The identity of the gas was never disclosed, although it is 

considered by many experts to have been the fentanyl derivative carfentanil. ln total, the special 

forces ended up killing not only 40 hostage takers but also between 100 and 200 of the hostages. 

c. Do you know of any other country, or non-state actor that has weaponized fentanyl? 

Please be specific. 

Thank you for the question. The Department would be willing to address this issue in a 

classified setting. 

Question: 

Tn 2002 there was an infamous hostage crisis at a Moscow theater (known as the "2002 Nord-Ost 

siege"). During the standoff, Russian special forces Spetsnaz opted to use a weaponized gas to 

snuff out the hostage takers. The identity of the gas was never disclosed, although it is 

considered by many experts to have been the fentanyl derivative carfentanil. 1n total, the special 

forces ended up killing not only 40 hostage takers but also between 100 and 200 of the hostages. 

d. 1fyes, what is the U.S. response to this threat" 

Thank you for the question. The Department would be willing to address this issue in a 

classified setting. 
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Question: 

Question for the Record Submitted to 

Deputy Chief of Operations Paul E. Knierim by 

Representative Chris Smith 

House Foreign Affairs Committee 

September 6, 2018 

Please provide a list of Chinese fentanyl traffickers that have been arrested through joint 

cooperation between the Drug Enforcement Agency and their Chinese counterparts. 

Question: 

a. Have any of them been extradited to the U.S.? 

b. Assuming not, since China generally never extradites nationals, what is the 

punishment for these tratlickers in China? 

How does China really execute its law enforcement against drug tratlicking? 

a. With drugs like Methamphetamine (known in China as "Ice"), China has been known to 

mobilize its forces and crackdown as it affects Chinese people. 

Question: 

i. Have launched the same type of crackdown with regards to the illicit 

fentanyl labs that export fentanyl globally? 

u. 1f not, why do you think that is? 

Have we created and disseminated best practices for responding to weaponized fentanyl among 

law enforcement, first responders, state and local officials, and medical personnel? (If necessary, 

answers may be provided in a classified annex or conveyed via classified briefing.) 

[Note: No responses were received to the above questions prior to printing.] 
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QUESTION FOR THE RECORD 

Representative F. James Sensenbrenner, Jr. formally submits the following question to the House 

Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International 

Organization's official record concerning its September 6, 2018 hearing titled: Tackling 

Fe many!: The China Conneclion 

To Mr. Paul Knierim: 

"As the United States' law enforcement agencies combat the spread of fentanyl, 

there is a growing concern over the spread of opioid analogues that allow fentanyl 

traffickers to circumvent our laws and continue to protlt over these dangerous 

drugs. In February of this year, I introduced the Stopping Overdoses of Fentanyl 

Analogues (SOFA) Act. The legislation would immediately add nineteen identified 

fentanyl analogues to the Schedule T drug list, and provide the DEA with the tools 

to quickly add additional analogues as they are discovered." 

• Has the DEA seen fentanyl analogues coming from China? 

• How much (in quantity or value) of fentanyl analogues are imported to the United 

States each year? 

How many individuals have been able to avoid criminal prosecution because the 

trafficker was peddling an analogue rather than Schedule I fentanyl? 

o Has the DEA ever caught someone trafficking analogues on multiple occasions, 

but unable to aggressively pursue because the analogues weren't Schedule 1? 

• Given DEA's temporary emergency scheduling of the fentanyl class, can I assume 

that DEA supports my SOFA legislation that permanently places fentanyl analogues 

in Schedule I? 

o Would passage of SOFA be helpful to the DEA? 

[Note: No responses were received to the above questions prior to printing.]