FROM: U.S. JUSTICE DEPARTMENT
Monday, December 22, 2014
Alstom Pleads Guilty and Agrees to Pay $772 Million Criminal Penalty to Resolve Foreign Bribery Charges
Alstom S.A. (Alstom), a French power and transportation company, pleaded guilty today and agreed to pay a $772,290,000 fine to resolve charges related to a widespread scheme involving tens of millions of dollars in bribes in countries around the world, including Indonesia, Saudi Arabia, Egypt and the Bahamas.
Deputy Attorney General James M. Cole, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, First Assistant U.S. Attorney Michael J. Gustafson of the District of Connecticut and FBI Executive Assistant Director Robert Anderson Jr. made the announcement.
“Alstom’s corruption scheme was sustained over more than a decade and across several continents,” said Deputy Attorney General Cole. “It was astounding in its breadth, its brazenness and its worldwide consequences. And it is both my expectation – and my intention – that the comprehensive resolution we are announcing today will send an unmistakable message to other companies around the world: that this Department of Justice will be relentless in rooting out and punishing corruption to the fullest extent of the law, no matter how sweeping its scale or how daunting its prosecution.”
“This case is emblematic of how the Department of Justice will investigate and prosecute FCPA cases – and other corporate crimes,” said Assistant Attorney General Caldwell. “We encourage companies to maintain robust compliance programs, to voluntarily disclose and eradicate misconduct when it is detected, and to cooperate in the government’s investigation. But we will not wait for companies to act responsibly. With cooperation or without it, the department will identify criminal activity at corporations and investigate the conduct ourselves, using all of our resources, employing every law enforcement tool, and considering all possible actions, including charges against both corporations and individuals.”
“Today’s historic resolution is an important reminder that our moral and legal mandate to stamp out corruption does not stop at any border, whether city, state or national,” said First Assistant U.S. Attorney Gustafson. “A significant part of this illicit work was unfortunately carried out from Alstom Power’s offices in Windsor, Connecticut. I am hopeful that this resolution, and in particular the deferred prosecution agreement with Alstom Power, will provide the company an opportunity to reshape its culture and restore its place as a respected corporate citizen.”
“This investigation spanned years and crossed continents, as agents from the FBI Washington and New Haven field offices conducted interviews and collected evidence in every corner of the globe,” said FBI Executive Assistant Director Anderson. “The record dollar amount of the fine is a clear deterrent to companies who would engage in foreign bribery, but an even better deterrent is that we are sending executives who commit these crimes to prison.”
Alstom pleaded guilty to a two-count criminal information filed today in the U.S. District Court for the District of Connecticut, charging the company with violating the Foreign Corrupt Practices Act (FCPA) by falsifying its books and records and failing to implement adequate internal controls. Alstom admitted its criminal conduct and agreed to pay a criminal penalty of $772,290,000. U.S. District Judge Janet B. Arterton of the District of Connecticut scheduled a sentencing hearing for June 23, 2015 at 3pm.
In addition, Alstom Network Schweiz AG, formerly Alstom Prom (Alstom Prom), Alstom’s Swiss subsidiary, pleaded guilty to a criminal information charging the company with conspiracy to violate the anti-bribery provisions of the FCPA. Alstom Power Inc. (Alstom Power) and Alstom Grid Inc. (Alstom Grid), two U.S. subsidiaries, both entered into deferred prosecution agreements, admitting that they conspired to violate the anti-bribery provisions of the FCPA. Alstom Power is headquartered in Windsor, Connecticut, and Alstom Grid, formerly Alstom T&D, was headquartered in New Jersey.
According to the companies’ admissions, Alstom, Alstom Prom, Alstom Power and Alstom Grid, through various executives and employees, paid bribes to government officials and falsified books and records in connection with power, grid and transportation projects for state-owned entities around the world, including in Indonesia, Egypt, Saudi Arabia, the Bahamas and Taiwan. In Indonesia, for example, Alstom, Alstom Prom, and Alstom Power paid bribes to government officials – including a high-ranking member of the Indonesian Parliament and high-ranking members of Perusahaan Listrik Negara, the state-owned electricity company in Indonesia – in exchange for assistance in securing several contracts to provide power-related services valued at approximately $375 million. In total, Alstom paid more than $75 million to secure $4 billion in projects around the world, with a profit to the company of approximately $300 million.
Alstom and its subsidiaries also attempted to conceal the bribery scheme by retaining consultants purportedly to provide consulting services on behalf of the companies, but who actually served as conduits for corrupt payments to the government officials. Internal Alstom documents refer to some of the consultants in code, including “Mr. Geneva,” “Mr. Paris,” “London,” “Quiet Man” and “Old Friend.”
The plea agreement cites many factors considered by the department in reaching the appropriate resolution, including: Alstom’s failure to voluntarily disclose the misconduct even though it was aware of related misconduct at a U.S. subsidiary that previously resolved corruption charges with the department in connection with a power project in Italy; Alstom’s refusal to fully cooperate with the department’s investigation for several years; the breadth of the companies’ misconduct, which spanned many years, occurred in countries around the globe and in several business lines, and involved sophisticated schemes to bribe high-level government officials; Alstom’s lack of an effective compliance and ethics program at the time of the conduct; and Alstom’s prior criminal misconduct, including conduct that led to resolutions with various other governments and the World Bank.
After the department publicly charged several Alstom executives, however, Alstom began providing thorough cooperation, including assisting the department’s prosecution of other companies and individuals.
To date, the department has announced charges against five individuals, including four corporate executives of Alstom and its subsidiaries, for alleged corrupt conduct involving Alstom. Frederic Pierucci, Alstom’s former vice president of global boiler sales, pleaded guilty on July 29, 2013, to conspiring to violate the FCPA and a charge of violating the FCPA for his role in the Indonesia bribery scheme. David Rothschild, Alstom Power’s former vice president of regional sales, pleaded guilty on Nov. 2, 2012, to conspiracy to violate the FCPA. William Pomponi, Alstom Power’s former vice president of regional sales, pleaded guilty on July 17, 2014, to conspiracy to violate the FCPA. Lawrence Hoskins, Alstom’s former senior vice president for the Asia region, was charged in a second superseding indictment on July 30, 2013, and is pending trial in the District of Connecticut in June 2015. The charges against Hoskins are merely allegations, and he is presumed innocent unless and until proven guilty. The high-ranking member of Indonesian Parliament was also convicted in Indonesia of accepting bribes from Alstom, and is currently serving a three-year term of imprisonment.
In connection with a corrupt scheme in Egypt, Asem Elgawhary, the general manager of an entity working on behalf of the Egyptian Electricity Holding Company, a state-owned electricity company, pleaded guilty on Dec. 4, 2014, in federal court in the District of Maryland to mail fraud, conspiring to launder money, and tax fraud for accepting kickbacks from Alstom and other companies. In his plea agreement, Elgawhary agreed to serve 42 months in prison and forfeit approximately $5.2 million in proceeds.
This case is being investigated by the FBI’s Washington Field Office, with assistance from the FBI’s Meriden, Connecticut Resident Agency, and the FBI’s Newark and Baltimore Divisions. The department appreciates the significant cooperation provided by its law enforcement colleagues in Indonesia at the Komisi Pemberantasan Korupsi (Corruption Eradication Commission), the Office of the Attorney General in Switzerland, the Serious Fraud Office in the United Kingdom, as well as authorities in Germany, Italy, Singapore, Saudi Arabia, Cyprus and Taiwan.
The case is being prosecuted by Assistant Chief Daniel S. Kahn of the Criminal Division’s Fraud Section and Assistant U.S. Attorney David E. Novick of the District of Connecticut, together with Assistant U.S. Attorney Zach Intrater of the District of New Jersey on the investigation of Alstom Grid and Assistant U.S. Attorney David I. Salem of the District of Maryland on the investigation of Asem Elgawhary. The Criminal Division’s Office of International Affairs also provided substantial assistance.
Monday, December 22, 2014
WHITE HOUSE STATEMENT ON ELECTION IN TUNISIA
FROM: THE WHITE HOUSE PRESIDENTIAL
December 22, 2014
Statement by the Press Secretary on the Presidential Election in Tunisia
President Obama congratulates President-elect Beji Caid Essebsi on his victory and the people of Tunisia on the successful conclusion of the first presidential election under the new constitution, a vital step toward the completion of Tunisia’s momentous transition to democracy. The United States looks forward to working closely with President-elect Caid Essebsi and the new government as they work to uphold the ideals of the Tunisian revolution and to meet all Tunisians’ aspirations for security, economic opportunity, and dignity. The United States intends to continue to strengthen and expand our strategic partnership with the Tunisian people.
The strong commitment by Tunisia's leaders and the Tunisian people to inclusive political dialogue, consensus-building, and democratic values has been crucial to the success of the political transition and will be equally important during the next phase of Tunisia's history. This historic moment is an opportunity for the international community to reaffirm and deepen its commitment to Tunisia. The United States stands at the forefront of this effort.
December 22, 2014
Statement by the Press Secretary on the Presidential Election in Tunisia
President Obama congratulates President-elect Beji Caid Essebsi on his victory and the people of Tunisia on the successful conclusion of the first presidential election under the new constitution, a vital step toward the completion of Tunisia’s momentous transition to democracy. The United States looks forward to working closely with President-elect Caid Essebsi and the new government as they work to uphold the ideals of the Tunisian revolution and to meet all Tunisians’ aspirations for security, economic opportunity, and dignity. The United States intends to continue to strengthen and expand our strategic partnership with the Tunisian people.
The strong commitment by Tunisia's leaders and the Tunisian people to inclusive political dialogue, consensus-building, and democratic values has been crucial to the success of the political transition and will be equally important during the next phase of Tunisia's history. This historic moment is an opportunity for the international community to reaffirm and deepen its commitment to Tunisia. The United States stands at the forefront of this effort.
U.S. SENDS WARM WISHES TO JAPAN'S EMPEROR ON HIS BIRTHDAY
FROM: U.S. STATE DEPARTMENT
The Emperor of Japan's Birthday
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of President Obama and the people of the United States, I would like to send warm wishes to His Imperial Majesty on his 81st birthday this December 23 and congratulate Japan on this national day of celebration.
As I have mentioned in my many meetings with Foreign Minister Kishida, and as President Obama reiterated when he spoke with Prime Minister Abe last week, the United States-Japan Alliance has long been the cornerstone of peace and security in the Asia-Pacific region.
Based on our shared values and interests, Japan and the United States have forged an effective global partnership. We are grateful for Japan’s efforts to strengthen democratic institutions, advance women’s empowerment, promote sustainable economic development, respond generously to global challenges, and reinforce the rule of law throughout the world. The United States looks forward to continued cooperation with Japan in the years ahead.
We wish all Japanese people around the world peace and prosperity over the coming year.
The Emperor of Japan's Birthday
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of President Obama and the people of the United States, I would like to send warm wishes to His Imperial Majesty on his 81st birthday this December 23 and congratulate Japan on this national day of celebration.
As I have mentioned in my many meetings with Foreign Minister Kishida, and as President Obama reiterated when he spoke with Prime Minister Abe last week, the United States-Japan Alliance has long been the cornerstone of peace and security in the Asia-Pacific region.
Based on our shared values and interests, Japan and the United States have forged an effective global partnership. We are grateful for Japan’s efforts to strengthen democratic institutions, advance women’s empowerment, promote sustainable economic development, respond generously to global challenges, and reinforce the rule of law throughout the world. The United States looks forward to continued cooperation with Japan in the years ahead.
We wish all Japanese people around the world peace and prosperity over the coming year.
U.S. CONGRATULATES PEOPLE OF TUNISIA ON THEIR PRESIDENTIAL ELECTION
FROM: U.S. STATE DEPARTMENT
Tunisia's Presidential Election
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of the government and people of the United States, I would like to congratulate President-elect Beji Caid Essebsi on his victory and the Tunisian people on the successful completion of their process to elect a new government under the constitution adopted last January. Tunisia has provided a shining example to the region and the world of what can be achieved through dedication to democracy, consensus, and an inclusive political process. I would also like to offer my congratulations to the Independent Election Commission, which successfully managed a very complex and challenging process this year to democratically elect a parliament and president.
Tunisia’s achievements this year lay the groundwork for a more stable, prosperous, and democratic future for the country. I look forward to working with President-elect Caid Essebsi and Tunisia’s new parliament and government to strengthen and expand our countries’ enduring friendship and strategic partnership. The United States will continue to support Tunisia as it joins the ranks of the world’s democracies, and we call on other members of the international community to do the same.
Tunisia's Presidential Election
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of the government and people of the United States, I would like to congratulate President-elect Beji Caid Essebsi on his victory and the Tunisian people on the successful completion of their process to elect a new government under the constitution adopted last January. Tunisia has provided a shining example to the region and the world of what can be achieved through dedication to democracy, consensus, and an inclusive political process. I would also like to offer my congratulations to the Independent Election Commission, which successfully managed a very complex and challenging process this year to democratically elect a parliament and president.
Tunisia’s achievements this year lay the groundwork for a more stable, prosperous, and democratic future for the country. I look forward to working with President-elect Caid Essebsi and Tunisia’s new parliament and government to strengthen and expand our countries’ enduring friendship and strategic partnership. The United States will continue to support Tunisia as it joins the ranks of the world’s democracies, and we call on other members of the international community to do the same.
SEC CHARGES FIRM, IT'S PRESIDENT & 2 SALES ASSOCIATES IN FRAUDULENT IPO OFFERINGS SCHEME TARGETING SENIORS
FROM: U.S. JUSTICE DEPARTMENT
The Securities and Exchange Commission charged a Staten Island, N.Y.-based firm, its former president, and two sales representatives involved in a fraudulent boiler room scheme targeting seniors to invest in speculative start-up companies.
The SEC alleges that Dwayne Malloy, Chris Damon, and Theirry Ruffin treated vulnerable older investors as their personal ATM machines. They cold-called names from a list they maintained at Premier Links Inc. and used high-pressure sales tactics to convince seniors to invest in companies purportedly on the brink of conducting initial public offerings (IPOs). They never disclosed to the investors that only a small fraction of the money would be transmitted to the promoted companies, and Premier Links diverted investor funds to other entities controlled by the sales representatives or other associates.
According to the SEC’s complaint filed in U.S. District Court for the Eastern District of New York, Premier Links has never been registered with the SEC as a broker-dealer as required under the federal securities laws to conduct this type of business with investors. Premier Links, Malloy, Damon, and Ruffin fraudulently obtained at least $9 million from more than 300 investors across the country by building a relationship of purported trust and confidence with them. In one particularly egregious example, Damon and Malloy spent months earning the trust of an elderly veteran in order to defraud him of $300,000. In many instances, investors were provided with misleading account statements showing the shares they purportedly purchased as being held for safekeeping in their Premier Links accounts while awaiting the promised IPOs. Yet transfer agent records for the relevant companies indicate that shares were never purchased for these investors. Investor money was simply stolen instead.
“Premier Links was a boiler room operated by unscrupulous schemers who made their living by cold-calling seniors and inducing them to buy worthless stock as they stole their money outright,” said Andrew M. Calamari, Director of the SEC’s New York Regional Office.
In a parallel action, the U.S. Attorney’s Office for the Eastern District of New York today filed criminal charges.
The SEC’s complaint charges Premier Links, Malloy (who was company president from 2007 to 2012), Damon, and Ruffin with violating the antifraud provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934 as well as the broker-dealer registration provisions of the Exchange Act. They also are charged with selling securities without a registration statement filed with the SEC. The complaint seeks disgorgement of ill-gotten gains and financial penalties among other remedies. The complaint also names several relief defendants for the purposes of recovering money from the scheme in their possession.
The SEC’s investigation was conducted by Joshua Newville, Peter Pizzani, Thomas P. Smith Jr., and Michael Osnato of the SEC’s New York Regional Office. The case was supervised by Amelia A. Cottrell, and the litigation will be led by Todd Brody. The SEC appreciates the assistance of the U.S. Attorney’s Office for the Eastern District of New York and the Federal Bureau of Investigation.
The Securities and Exchange Commission charged a Staten Island, N.Y.-based firm, its former president, and two sales representatives involved in a fraudulent boiler room scheme targeting seniors to invest in speculative start-up companies.
The SEC alleges that Dwayne Malloy, Chris Damon, and Theirry Ruffin treated vulnerable older investors as their personal ATM machines. They cold-called names from a list they maintained at Premier Links Inc. and used high-pressure sales tactics to convince seniors to invest in companies purportedly on the brink of conducting initial public offerings (IPOs). They never disclosed to the investors that only a small fraction of the money would be transmitted to the promoted companies, and Premier Links diverted investor funds to other entities controlled by the sales representatives or other associates.
According to the SEC’s complaint filed in U.S. District Court for the Eastern District of New York, Premier Links has never been registered with the SEC as a broker-dealer as required under the federal securities laws to conduct this type of business with investors. Premier Links, Malloy, Damon, and Ruffin fraudulently obtained at least $9 million from more than 300 investors across the country by building a relationship of purported trust and confidence with them. In one particularly egregious example, Damon and Malloy spent months earning the trust of an elderly veteran in order to defraud him of $300,000. In many instances, investors were provided with misleading account statements showing the shares they purportedly purchased as being held for safekeeping in their Premier Links accounts while awaiting the promised IPOs. Yet transfer agent records for the relevant companies indicate that shares were never purchased for these investors. Investor money was simply stolen instead.
“Premier Links was a boiler room operated by unscrupulous schemers who made their living by cold-calling seniors and inducing them to buy worthless stock as they stole their money outright,” said Andrew M. Calamari, Director of the SEC’s New York Regional Office.
In a parallel action, the U.S. Attorney’s Office for the Eastern District of New York today filed criminal charges.
The SEC’s complaint charges Premier Links, Malloy (who was company president from 2007 to 2012), Damon, and Ruffin with violating the antifraud provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934 as well as the broker-dealer registration provisions of the Exchange Act. They also are charged with selling securities without a registration statement filed with the SEC. The complaint seeks disgorgement of ill-gotten gains and financial penalties among other remedies. The complaint also names several relief defendants for the purposes of recovering money from the scheme in their possession.
The SEC’s investigation was conducted by Joshua Newville, Peter Pizzani, Thomas P. Smith Jr., and Michael Osnato of the SEC’s New York Regional Office. The case was supervised by Amelia A. Cottrell, and the litigation will be led by Todd Brody. The SEC appreciates the assistance of the U.S. Attorney’s Office for the Eastern District of New York and the Federal Bureau of Investigation.
LYNPARZA GETS FDA APPROVAL TO TREAT OVARIAN CANCER
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves Lynparza to treat advanced ovarian cancer
First LDT companion diagnostic test also approved to identify appropriate patients
For Immediate Release
December 19, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Ovarian cancer forms in the ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The National Cancer Institute estimates that 21,980 American women will be diagnosed with and 14,270 will die from ovarian cancer in 2014.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.
The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices. Until now, the manufacturer, a clinical laboratory, had been marketing this test, although not specifically for use as a companion diagnostic, without FDA approval as a laboratory developed test (LDT), which is a test that is designed, manufactured and used in a single laboratory. The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with Lynparza.
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”
The FDA’s approval of the BRACAnalysis CDx is based on data from the clinical study used to support approval of Lynparza. Blood samples from clinical trial participants were tested to validate the test’s use for detecting BRCAmutations in this population.
Lynparza’s efficacy was examined in a study where 137 participants with gBRCAm-associated ovarian cancer received the drug. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 34 percent of participants experienced ORR for an average of 7.9 months.
Common side effects of Lynparza included nausea, fatigue, vomiting, diarrhea, distorted taste (dysgeusia), indigestion (dyspepsia), headache, decreased appetite, common cold-like symptoms (nasopharyngitis), cough, joint paint (arthralgia), musculoskeletal pain, muscle pain (myalgia), back pain, rash (dermatitis) and abdominal pain. Serious side effects included the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells; acute myeloid leukemia, a bone marrow cancer; and lung inflammation.
The most common laboratory abnormalities were increased creatinine, increased average volume of red blood cells (mean corpuscular volume elevation), decreased red blood cell count (hemoglobin), decreased white blood cell count (lymphocytes and neutrophils) and decreased platelet levels.
In June, Lynparza was reviewed by the FDA’s Oncologic Drugs Advisory Committee for potential use as maintenance therapy (treatment given to keep cancer from returning). The committee advised the agency in a vote of 11 to 2 that the data did not support Lynparza’s accelerated approval for this use. After the meeting, the company submitted additional information supporting Lynparza’s use for a different use: in patients with gBRCAm-associated ovarian cancer who have received three or more chemotherapy treatments.
The FDA is approving Lynparza under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Lynparza’s application was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
BRACAnalysis CDx’s application was reviewed under the FDA’s priority review program for devices, which provides for priority review of devices that meet certain criteria, including that the devices are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and, if approved, would offer significant, clinically meaningful advantages compared to marketed products.
Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA approves Lynparza to treat advanced ovarian cancer
First LDT companion diagnostic test also approved to identify appropriate patients
For Immediate Release
December 19, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Ovarian cancer forms in the ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The National Cancer Institute estimates that 21,980 American women will be diagnosed with and 14,270 will die from ovarian cancer in 2014.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.
The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices. Until now, the manufacturer, a clinical laboratory, had been marketing this test, although not specifically for use as a companion diagnostic, without FDA approval as a laboratory developed test (LDT), which is a test that is designed, manufactured and used in a single laboratory. The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with Lynparza.
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”
The FDA’s approval of the BRACAnalysis CDx is based on data from the clinical study used to support approval of Lynparza. Blood samples from clinical trial participants were tested to validate the test’s use for detecting BRCAmutations in this population.
Lynparza’s efficacy was examined in a study where 137 participants with gBRCAm-associated ovarian cancer received the drug. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 34 percent of participants experienced ORR for an average of 7.9 months.
Common side effects of Lynparza included nausea, fatigue, vomiting, diarrhea, distorted taste (dysgeusia), indigestion (dyspepsia), headache, decreased appetite, common cold-like symptoms (nasopharyngitis), cough, joint paint (arthralgia), musculoskeletal pain, muscle pain (myalgia), back pain, rash (dermatitis) and abdominal pain. Serious side effects included the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells; acute myeloid leukemia, a bone marrow cancer; and lung inflammation.
The most common laboratory abnormalities were increased creatinine, increased average volume of red blood cells (mean corpuscular volume elevation), decreased red blood cell count (hemoglobin), decreased white blood cell count (lymphocytes and neutrophils) and decreased platelet levels.
In June, Lynparza was reviewed by the FDA’s Oncologic Drugs Advisory Committee for potential use as maintenance therapy (treatment given to keep cancer from returning). The committee advised the agency in a vote of 11 to 2 that the data did not support Lynparza’s accelerated approval for this use. After the meeting, the company submitted additional information supporting Lynparza’s use for a different use: in patients with gBRCAm-associated ovarian cancer who have received three or more chemotherapy treatments.
The FDA is approving Lynparza under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Lynparza’s application was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
BRACAnalysis CDx’s application was reviewed under the FDA’s priority review program for devices, which provides for priority review of devices that meet certain criteria, including that the devices are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and, if approved, would offer significant, clinically meaningful advantages compared to marketed products.
Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
T-MOBILE SETTLES CRAMMING CASE WITH FTC AND WILL PAY MINIMUM $90 MILLION
FROM: U.S. FEDERAL TRADE COMMISSION
T-Mobile to Pay At Least $90 Million, Including Full Consumer Refunds To Settle FTC Mobile Cramming Case
Settlement Requires Company To Pay Fines to States and FCC
T-Mobile has agreed to fully refund its customers for unwanted third-party charges it placed on their phone bills, a practice known as mobile cramming, paying at least $90 million to settle a Federal Trade Commission lawsuit filed earlier this year.
In addition to the full refunds T-Mobile is providing, which will resolve the FTC’s lawsuit if approved by the court, T-Mobile is paying $18 million in fines and penalties to the attorneys general of all 50 states and the District of Columbia and $4.5 million to the Federal Communications Commission.
“Mobile cramming is an issue that has affected millions of American consumers, and I’m pleased that this settlement will put money back in the hands of affected T-Mobile customers,” said FTC Chairwoman Edith Ramirez. “Consumers should be able to trust that their mobile phone bills reflect the charges they authorized and nothing more.”
Under the terms of the settlement, T-Mobile will be required to offer full refunds to all affected consumers. The amount of money the company pays must reach at least $90 million in redress or other payments. Should the company fail to do so, the balance must be remitted to the FTC for additional consumer redress, consumer education, or other uses. The settlement requires T-Mobile to contact all of its crammed customers – current and former – to inform them of the refund program and claims process, and to do so in a clear and conspicuous way.
The FTC filed suit against T-Mobile in July, alleging that the company placed millions of dollars in unwanted third-party charges on its customers’ mobile phone bills, receiving 35 to 40 percent of every charge they placed. The charges were for services like horoscopes, love tips and celebrity gossip, for which T-Mobile typically billed consumers $9.99 per month.
The FTC’s complaint alleges that in some cases, T-Mobile was charging consumers for services that had refund rates of up to 40 percent in a single month. The FTC has alleged that because such a large number of people were seeking refunds, it was an obvious sign to T-Mobile that the charges were never authorized by its customers.
According to the FTC’s July complaint, T-Mobile’s phone bills made it nearly impossible for consumers to find and understand third-party subscription charges. The FTC’s complaint against T-Mobile noted that in many instances information about the third-party charges crammed on to customers’ bills was buried deep in phone bills that totaled more than 50 pages in length.
In addition to requiring T-Mobile to provide consumers with full refunds, the settlement requires the company to get consumers’ express informed consent before placing third-party charges on their bills. The company also must ensure that consumers are notified of any third-party charges on their bills and provide them with information about the option to block third-party charges.
The FTC has brought numerous cases related to mobile cramming in recent months, taking action against mobile carriers and the third parties who place unauthorized charges.
The Commission vote approving the proposed stipulated order was 5-0. It is subject to court approval. The FTC filed the proposed stipulated order in the U.S. District Court for the Western District of Washington.
NOTE: Stipulated orders have the force of law when approved and signed by the District Court judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
T-Mobile to Pay At Least $90 Million, Including Full Consumer Refunds To Settle FTC Mobile Cramming Case
Settlement Requires Company To Pay Fines to States and FCC
T-Mobile has agreed to fully refund its customers for unwanted third-party charges it placed on their phone bills, a practice known as mobile cramming, paying at least $90 million to settle a Federal Trade Commission lawsuit filed earlier this year.
In addition to the full refunds T-Mobile is providing, which will resolve the FTC’s lawsuit if approved by the court, T-Mobile is paying $18 million in fines and penalties to the attorneys general of all 50 states and the District of Columbia and $4.5 million to the Federal Communications Commission.
“Mobile cramming is an issue that has affected millions of American consumers, and I’m pleased that this settlement will put money back in the hands of affected T-Mobile customers,” said FTC Chairwoman Edith Ramirez. “Consumers should be able to trust that their mobile phone bills reflect the charges they authorized and nothing more.”
Under the terms of the settlement, T-Mobile will be required to offer full refunds to all affected consumers. The amount of money the company pays must reach at least $90 million in redress or other payments. Should the company fail to do so, the balance must be remitted to the FTC for additional consumer redress, consumer education, or other uses. The settlement requires T-Mobile to contact all of its crammed customers – current and former – to inform them of the refund program and claims process, and to do so in a clear and conspicuous way.
The FTC filed suit against T-Mobile in July, alleging that the company placed millions of dollars in unwanted third-party charges on its customers’ mobile phone bills, receiving 35 to 40 percent of every charge they placed. The charges were for services like horoscopes, love tips and celebrity gossip, for which T-Mobile typically billed consumers $9.99 per month.
The FTC’s complaint alleges that in some cases, T-Mobile was charging consumers for services that had refund rates of up to 40 percent in a single month. The FTC has alleged that because such a large number of people were seeking refunds, it was an obvious sign to T-Mobile that the charges were never authorized by its customers.
According to the FTC’s July complaint, T-Mobile’s phone bills made it nearly impossible for consumers to find and understand third-party subscription charges. The FTC’s complaint against T-Mobile noted that in many instances information about the third-party charges crammed on to customers’ bills was buried deep in phone bills that totaled more than 50 pages in length.
In addition to requiring T-Mobile to provide consumers with full refunds, the settlement requires the company to get consumers’ express informed consent before placing third-party charges on their bills. The company also must ensure that consumers are notified of any third-party charges on their bills and provide them with information about the option to block third-party charges.
The FTC has brought numerous cases related to mobile cramming in recent months, taking action against mobile carriers and the third parties who place unauthorized charges.
The Commission vote approving the proposed stipulated order was 5-0. It is subject to court approval. The FTC filed the proposed stipulated order in the U.S. District Court for the Western District of Washington.
NOTE: Stipulated orders have the force of law when approved and signed by the District Court judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
SAMANTHA POWER'S REMARKS ON TERRORIST GROUPS AND TRANSNATIONAL CRIMINAL ORGANIZATIONS
FROM: U.S. STATE DEPARTMENT
Samantha Power
U.S. Permanent Representative to the United Nations
New York, NY
December 19, 2014
AS DELIVERED
Thank you, Foreign Minister Faki. And thank you again for being here with us in person. The United States greatly appreciates Chad’s leadership and its work to focus the Council on the nexus between terrorism and transnational organized crime. Thank you, also, Foreign Minister Wali and Minister Asselborn for your presence here today underscoring the critical importance of these issues. I particularly appreciated Luxembourg’s attention to the impact these issues have on the welfare of children – an issue that Luxembourg insistently raises with regard to all the challenges we face and a critical part of Luxembourg’s legacy on this Council. The United States is very eager to support Nigeria, and Chad, and the other multinational partners in the effort against Boko Haram – a monstrous movement.
While the motivations of terrorists and transnational criminal organizations may differ, their use of brutal violence, and the insecurity, fear, and suffering that they cause, are often remarkably similar. Terrorists and transnational criminal organizations are increasingly learning from one another’s sophisticated tactics to raise funds, to move people and arms, and to spread the fear that is a critical source of their power.
We see this cross-pollination between terrorist groups and transnational organized crime all around us. Al-Qaeda in the Islamic Maghreb, Boko Haram, the al-Nusra Front, and numerous other terrorist organizations raise tens of millions of dollars annually through kidnapping for ransom. In Somalia, al-Shabaab has filled its coffers through illegal and environmentally devastating charcoal exports; of the $250 million worth of charcoal estimated to have been exported from Somalia in 2013 and 2014, 30 percent is estimated to have gone to al-Shabaab. AQIM and other terrorist groups regularly obtain arms through Maghreb and Sahel trafficking networks, relying on the same trade routes as transnational smugglers. And extremist groups raise cash through a variety of other criminal activities that cross borders – from selling drugs to stealing natural resources.
ISIL is another example of the increasingly similar modus operandi between these groups. While continuing to carry out deadly attacks propelled by its sadistic ideology, ISIL is also increasingly operating like a profit-driven criminal organization. Using fear, threats, and attacks, ISIL extorts money from local businesses and traders, and robs from banks and households alike. Working through long-established regional smuggling networks, ISIL transports oil across borders, netting roughly $1 million a day through black-market oil sales. And there are credible reports that ISIL is profiting from the sale of Syrian and Iraqi so-called "blood antiquities,” sold by criminal middlemen to unscrupulous or unknowing buyers worldwide. These new sources of financing allow extremist groups to diversify their revenue streams and reduce risk of disruption of the funds that they need to carry out their horrific attacks.
As terrorists’ criminal activities become more entrepreneurial and business-minded, the Security Council needs to better understand their tactics. And we must develop and deploy a set of sophisticated tools to disrupt these expanding networks, and cut off the funds that they are generating. To this end, the Council should prioritize three tasks.
First, the Council should build greater international cooperation needed to fight the interrelated problems of terrorism and organized crime. We have taken steps to address this urgent need in previous resolutions, including Resolution 2170 on ISIL, and Resolution 2178 on Foreign Terrorist Fighters. And we have established a robust international legal framework under the UN Convention Against Transnational Organized Crime, the UN Convention Against Corruption, and the three UN drug control conventions that, taken together and implemented effectively, provide common parameters and tools for recognizing and responding to different forms of transnational crime.
Building on this work, the Council should encourage member states to do more to collectively address transnational threats. For example, greater international cooperation should facilitate the exchange of information and analysis about terrorist and crime networks. For its part, the United States has effectively used the UN Convention Against Transnational Organized Crime as the basis for international legal and law enforcement cooperation against transnational organized crime with more than 55 countries. And our use of the UN Convention Against Transnational Organized Crime and bilateral treaties has led to the return of nearly 30 fugitives to face prosecution in the United States. Greater cooperation is needed both among and within governments, so we can bring together experts from the law enforcement, military, diplomatic and intelligence communities. This is why today the Council called on Member States to work together to secure their borders, counter illicit financing and money laundering, and implement international best practices and existing conventions.
Second, the Security Council should acknowledge that weak governance both encourages and is exacerbated by terrorist use of crime. Terrorist groups and criminals gravitate towards places with rampant corruption and impunity. For this reason, strengthening criminal justice systems in vulnerable countries is one of the most effective ways to fight transnational organized crime. Since our collective security is only as strong as our weakest link, we have a shared interest in building stronger, more transparent governance and justice institutions beyond our own borders. Military measures alone will not be enough.
Third, the Security Council should call on states to provide assistance to those states most affected by these terrible threats. Tackling these challenges requires deploying all the tools we have, from innovative law enforcement and criminal justice tools, to financial measures and sanctions. Yet all states do not currently have the same ability to take these steps. Member states should therefore identify areas where targeted assistance is most needed, and focus support in those places. We particularly welcome the role of the UN's counterterrorism bodies – particularly the al-Qaeda Sanctions Committee’s Monitoring Team, the Counterterrorism Executive Directorate and the UN Office on Drugs and Crime – in identifying threat and capacity gaps.
We have come through a horrific week, as others have mentioned, of terrorist attacks. On Tuesday, the Pakistani Taliban killed 145 people – 132 of them kids, age 5 to 17. It was an appalling attack on a school. A young student named Zeeshan told a reporter: “I saw militants walking past rows of students, shooting them in the head.” On Wednesday, more than 230 bodies of people believed to have been executed by ISIL were found in a mass grave in Syria’s Deir al-Zor province. And yesterday, we learned that more than 100 women and children were kidnapped, and 35 people killed, during a weekend raid in the northeastern Nigerian village of Gumsuri, believed to have been carried out by Boko Haram.
We know that we must do more to prevent these attacks – not only in Pakistan, Syria, and Nigeria, but in all of our countries. We must dismantle the groups that threaten our collective security. But we cannot achieve that goal without tackling the organized criminal networks that extremists increasingly rely upon to fuel their terror. That is the work before us and we must succeed.
Thank you.
Samantha Power
U.S. Permanent Representative to the United Nations
New York, NY
December 19, 2014
AS DELIVERED
Thank you, Foreign Minister Faki. And thank you again for being here with us in person. The United States greatly appreciates Chad’s leadership and its work to focus the Council on the nexus between terrorism and transnational organized crime. Thank you, also, Foreign Minister Wali and Minister Asselborn for your presence here today underscoring the critical importance of these issues. I particularly appreciated Luxembourg’s attention to the impact these issues have on the welfare of children – an issue that Luxembourg insistently raises with regard to all the challenges we face and a critical part of Luxembourg’s legacy on this Council. The United States is very eager to support Nigeria, and Chad, and the other multinational partners in the effort against Boko Haram – a monstrous movement.
While the motivations of terrorists and transnational criminal organizations may differ, their use of brutal violence, and the insecurity, fear, and suffering that they cause, are often remarkably similar. Terrorists and transnational criminal organizations are increasingly learning from one another’s sophisticated tactics to raise funds, to move people and arms, and to spread the fear that is a critical source of their power.
We see this cross-pollination between terrorist groups and transnational organized crime all around us. Al-Qaeda in the Islamic Maghreb, Boko Haram, the al-Nusra Front, and numerous other terrorist organizations raise tens of millions of dollars annually through kidnapping for ransom. In Somalia, al-Shabaab has filled its coffers through illegal and environmentally devastating charcoal exports; of the $250 million worth of charcoal estimated to have been exported from Somalia in 2013 and 2014, 30 percent is estimated to have gone to al-Shabaab. AQIM and other terrorist groups regularly obtain arms through Maghreb and Sahel trafficking networks, relying on the same trade routes as transnational smugglers. And extremist groups raise cash through a variety of other criminal activities that cross borders – from selling drugs to stealing natural resources.
ISIL is another example of the increasingly similar modus operandi between these groups. While continuing to carry out deadly attacks propelled by its sadistic ideology, ISIL is also increasingly operating like a profit-driven criminal organization. Using fear, threats, and attacks, ISIL extorts money from local businesses and traders, and robs from banks and households alike. Working through long-established regional smuggling networks, ISIL transports oil across borders, netting roughly $1 million a day through black-market oil sales. And there are credible reports that ISIL is profiting from the sale of Syrian and Iraqi so-called "blood antiquities,” sold by criminal middlemen to unscrupulous or unknowing buyers worldwide. These new sources of financing allow extremist groups to diversify their revenue streams and reduce risk of disruption of the funds that they need to carry out their horrific attacks.
As terrorists’ criminal activities become more entrepreneurial and business-minded, the Security Council needs to better understand their tactics. And we must develop and deploy a set of sophisticated tools to disrupt these expanding networks, and cut off the funds that they are generating. To this end, the Council should prioritize three tasks.
First, the Council should build greater international cooperation needed to fight the interrelated problems of terrorism and organized crime. We have taken steps to address this urgent need in previous resolutions, including Resolution 2170 on ISIL, and Resolution 2178 on Foreign Terrorist Fighters. And we have established a robust international legal framework under the UN Convention Against Transnational Organized Crime, the UN Convention Against Corruption, and the three UN drug control conventions that, taken together and implemented effectively, provide common parameters and tools for recognizing and responding to different forms of transnational crime.
Building on this work, the Council should encourage member states to do more to collectively address transnational threats. For example, greater international cooperation should facilitate the exchange of information and analysis about terrorist and crime networks. For its part, the United States has effectively used the UN Convention Against Transnational Organized Crime as the basis for international legal and law enforcement cooperation against transnational organized crime with more than 55 countries. And our use of the UN Convention Against Transnational Organized Crime and bilateral treaties has led to the return of nearly 30 fugitives to face prosecution in the United States. Greater cooperation is needed both among and within governments, so we can bring together experts from the law enforcement, military, diplomatic and intelligence communities. This is why today the Council called on Member States to work together to secure their borders, counter illicit financing and money laundering, and implement international best practices and existing conventions.
Second, the Security Council should acknowledge that weak governance both encourages and is exacerbated by terrorist use of crime. Terrorist groups and criminals gravitate towards places with rampant corruption and impunity. For this reason, strengthening criminal justice systems in vulnerable countries is one of the most effective ways to fight transnational organized crime. Since our collective security is only as strong as our weakest link, we have a shared interest in building stronger, more transparent governance and justice institutions beyond our own borders. Military measures alone will not be enough.
Third, the Security Council should call on states to provide assistance to those states most affected by these terrible threats. Tackling these challenges requires deploying all the tools we have, from innovative law enforcement and criminal justice tools, to financial measures and sanctions. Yet all states do not currently have the same ability to take these steps. Member states should therefore identify areas where targeted assistance is most needed, and focus support in those places. We particularly welcome the role of the UN's counterterrorism bodies – particularly the al-Qaeda Sanctions Committee’s Monitoring Team, the Counterterrorism Executive Directorate and the UN Office on Drugs and Crime – in identifying threat and capacity gaps.
We have come through a horrific week, as others have mentioned, of terrorist attacks. On Tuesday, the Pakistani Taliban killed 145 people – 132 of them kids, age 5 to 17. It was an appalling attack on a school. A young student named Zeeshan told a reporter: “I saw militants walking past rows of students, shooting them in the head.” On Wednesday, more than 230 bodies of people believed to have been executed by ISIL were found in a mass grave in Syria’s Deir al-Zor province. And yesterday, we learned that more than 100 women and children were kidnapped, and 35 people killed, during a weekend raid in the northeastern Nigerian village of Gumsuri, believed to have been carried out by Boko Haram.
We know that we must do more to prevent these attacks – not only in Pakistan, Syria, and Nigeria, but in all of our countries. We must dismantle the groups that threaten our collective security. But we cannot achieve that goal without tackling the organized criminal networks that extremists increasingly rely upon to fuel their terror. That is the work before us and we must succeed.
Thank you.
DOJ ANNOUNCES CHARGES FILED RELATED TO INTERNATIONAL CYBER COUNTERFEITING SCHEME BASED IN UGANDA
FROM: U.S. JUSTICE DEPARTMENT
Thursday, December 18, 2014
Criminal Charges Filed Against U.S. Citizen in Connection with a Multi-Million Dollar International Cyber Counterfeiting Scheme Based in Uganda
U.S. Attorney David J. Hickton for the Western District of Pennsylvania and U.S. Secret Service Special Agent in Charge Eric P. Zahren of the Pittsburgh Field Office today announced the filing of a criminal complaint in Pittsburgh charging a U.S. citizen with leading an international counterfeit currency operation headquartered in the Republic of Uganda.
Ryan Andrew Gustafson, aka Jack Farrel, aka Willy Clock, 27, a U.S. citizen currently residing in Kampala, Uganda, was charged with conspiracy and counterfeiting acts committed outside of the U.S. When he lived in the United States, he mainly resided in Texas and Colorado.
“This complicated, international cyber counterfeiting conspiracy was broken as a result of expert investigation by the Secret Service and a total commitment of all cooperating law enforcement to reject the premise that criminals committing cybercrimes in the U.S. – but who reside outside our borders – cannot be reached,” stated U.S. Attorney Hickton. “We will hold cyber criminals accountable and bring them to justice no matter where they reside.”
“This investigation involves the manufacture of counterfeit U.S. currency, which has been the Secret Service’s core mission since 1865,” said Special Agent in Charge Zahren. “Add to that the modern elements of an international counterfeiting conspiracy utilizing new-age, cyber technology, and it represents the full evolution and unique investigative capabilities of today’s Secret Service.”
As detailed in the affidavit in support of the criminal complaint, in December 2013, the Secret Service began investigating the passing of counterfeit Federal Reserve Notes (FRNs), believed to be manufactured in Uganda, at Pittsburgh-area retail stores and businesses. Agents determined that an individual identified as J.G. had passed these notes and was renting a postal box at The UPS Store on Pittsburgh’s South Side. On Feb 19, 2014, law enforcement learned that J.G. received three packages addressed from Beyond Computers, located in Kampala, Uganda. Agents executing a search warrant on the packages found $7,000 in counterfeit $100, $50 and $20 FRNs located in two hidden compartments within the packaging envelopes. A fingerprint on a document inside one of the packages was identified as belonging to Ryan Andrew Gustafson.
The Secret Service subsequently worked with Ugandan authorities to identify the source of the counterfeit FRNs. Their efforts led to A.B., who admitted to sending the packages, explaining that an American named “Jack Farrel,” and another person, provided him the counterfeit notes to ship. Based on information provided by A.B., the Secret Service used facial recognition to identify Jack Farrel as Ryan Andrew Gustafson.
According to the affidavit, J.G. met “Willy Clock” on an online criminal forum called Tor Carding Forum. Through private messaging, J.G. and Clock discussed counterfeit currency and J.G. agreed to purchase counterfeit FRNs.
In January 2014, Clock told J.G. that he had established his own online forum called Community-X, a website dedicated to the selling of counterfeit reserve notes. The forum requires a username and password to access the site, and individuals must be invited and approved by Clock to become members. Secret Service used an undercover operative to communicate with Clock through the website, to purchase additional counterfeit $100 FRNs, and to become a re-shipper of counterfeit notes.
In November 2014, the Secret Service executed a search warrant at the residence of another re-shipper, who had been an active member of Community-X. This person cooperated and provided information that a forum member had traveled to Uganda and brought back more than $300,000 in counterfeit notes.
The Secret Service, working with Ugandan authorities, engaged yet another confidential informant, in Uganda, who had knowledge of Jack Farrel and his counterfeiting operations. On Dec. 11 2014, this confidential informant called Farrel to arrange to purchase counterfeit FRNs. The informant met Farrel’s associate and made the buy. Two trusted sources followed the associate back to Farrel’s home and reported the location to the Secret Service who turned it over to the Uganda Special Investigations Unit. Their search of Farrel’s residence netted two million Ugandan shillings from the buy; $180,420 in counterfeit FRNs; counterfeit Euros, Indian Rupees, Ugandan Shillings, Congo Francs, and Ghana Cedis; computers and printers; inks and ink jet cartridges; paper cutters; glue sticks; “Give a Child Hope Today” pamphlets with counterfeit FRNs in between glued together pages; and a pair of “Anon Hands.” Anon Hands are life-like rubber molds that fit like gloves over the user’s hands and are meant to conceal the wearer’s fingerprints. As noted above Farrel has been identified as Gustafson. Evidence collected at the scene also allowed investigators to identify Gustafson as Willy Clock.
Gustafson was charged by Ugandan authorities on Dec. 16 with conspiracy, possession of counterfeit, selling/dealing in counterfeit, and unlawful possession of ammunition. He was brought before the court that day to be informed about the charges; he also is being represented by counsel in Uganda.
U.S. Secret Service estimates $1.8 million in counterfeit FRNs have been seized and passed in Uganda. The total amount of Ugandan-made counterfeit FRNs seized or passed domestically was approximately $270,000. This amount was limited due to early detection by the Secret Service.
U.S. law provides for a maximum total sentence of 25 years in prison, a fine of $500,000, or both. Under the Federal Sentencing Guidelines, the actual sentence imposed would be based upon the seriousness of the offense and the prior criminal history, if any, of the defendant.
U.S. Attorney Hickton commended numerous agencies and organizations for conducting the investigation leading to charges in this case, including the Directorate of Public Prosecution, the Criminal Investigations and Intelligence Department, the Special Investigations and Intelligence Unit, and Stanbic Bank in Uganda; various domestic and foreign Secret Service Field Offices, including the Rome, Italy, Field Office and the Criminal Investigative Division in Washington, D.C.; the U.S. State Department; the U.S. Postal Inspection Service; the Federal Bureau of Investigation; Homeland Security Investigations; U.S. Customs and Border Protection and the National Cyber-Forensics & Training Alliance.
Assistant U.S. Attorney Shardul S. Desai is prosecuting this case on behalf of the government.
A criminal complaint contains charges and is not evidence of guilt. A defendant is presumed to be innocent until and unless proven guilty.
Thursday, December 18, 2014
Criminal Charges Filed Against U.S. Citizen in Connection with a Multi-Million Dollar International Cyber Counterfeiting Scheme Based in Uganda
U.S. Attorney David J. Hickton for the Western District of Pennsylvania and U.S. Secret Service Special Agent in Charge Eric P. Zahren of the Pittsburgh Field Office today announced the filing of a criminal complaint in Pittsburgh charging a U.S. citizen with leading an international counterfeit currency operation headquartered in the Republic of Uganda.
Ryan Andrew Gustafson, aka Jack Farrel, aka Willy Clock, 27, a U.S. citizen currently residing in Kampala, Uganda, was charged with conspiracy and counterfeiting acts committed outside of the U.S. When he lived in the United States, he mainly resided in Texas and Colorado.
“This complicated, international cyber counterfeiting conspiracy was broken as a result of expert investigation by the Secret Service and a total commitment of all cooperating law enforcement to reject the premise that criminals committing cybercrimes in the U.S. – but who reside outside our borders – cannot be reached,” stated U.S. Attorney Hickton. “We will hold cyber criminals accountable and bring them to justice no matter where they reside.”
“This investigation involves the manufacture of counterfeit U.S. currency, which has been the Secret Service’s core mission since 1865,” said Special Agent in Charge Zahren. “Add to that the modern elements of an international counterfeiting conspiracy utilizing new-age, cyber technology, and it represents the full evolution and unique investigative capabilities of today’s Secret Service.”
As detailed in the affidavit in support of the criminal complaint, in December 2013, the Secret Service began investigating the passing of counterfeit Federal Reserve Notes (FRNs), believed to be manufactured in Uganda, at Pittsburgh-area retail stores and businesses. Agents determined that an individual identified as J.G. had passed these notes and was renting a postal box at The UPS Store on Pittsburgh’s South Side. On Feb 19, 2014, law enforcement learned that J.G. received three packages addressed from Beyond Computers, located in Kampala, Uganda. Agents executing a search warrant on the packages found $7,000 in counterfeit $100, $50 and $20 FRNs located in two hidden compartments within the packaging envelopes. A fingerprint on a document inside one of the packages was identified as belonging to Ryan Andrew Gustafson.
The Secret Service subsequently worked with Ugandan authorities to identify the source of the counterfeit FRNs. Their efforts led to A.B., who admitted to sending the packages, explaining that an American named “Jack Farrel,” and another person, provided him the counterfeit notes to ship. Based on information provided by A.B., the Secret Service used facial recognition to identify Jack Farrel as Ryan Andrew Gustafson.
According to the affidavit, J.G. met “Willy Clock” on an online criminal forum called Tor Carding Forum. Through private messaging, J.G. and Clock discussed counterfeit currency and J.G. agreed to purchase counterfeit FRNs.
In January 2014, Clock told J.G. that he had established his own online forum called Community-X, a website dedicated to the selling of counterfeit reserve notes. The forum requires a username and password to access the site, and individuals must be invited and approved by Clock to become members. Secret Service used an undercover operative to communicate with Clock through the website, to purchase additional counterfeit $100 FRNs, and to become a re-shipper of counterfeit notes.
In November 2014, the Secret Service executed a search warrant at the residence of another re-shipper, who had been an active member of Community-X. This person cooperated and provided information that a forum member had traveled to Uganda and brought back more than $300,000 in counterfeit notes.
The Secret Service, working with Ugandan authorities, engaged yet another confidential informant, in Uganda, who had knowledge of Jack Farrel and his counterfeiting operations. On Dec. 11 2014, this confidential informant called Farrel to arrange to purchase counterfeit FRNs. The informant met Farrel’s associate and made the buy. Two trusted sources followed the associate back to Farrel’s home and reported the location to the Secret Service who turned it over to the Uganda Special Investigations Unit. Their search of Farrel’s residence netted two million Ugandan shillings from the buy; $180,420 in counterfeit FRNs; counterfeit Euros, Indian Rupees, Ugandan Shillings, Congo Francs, and Ghana Cedis; computers and printers; inks and ink jet cartridges; paper cutters; glue sticks; “Give a Child Hope Today” pamphlets with counterfeit FRNs in between glued together pages; and a pair of “Anon Hands.” Anon Hands are life-like rubber molds that fit like gloves over the user’s hands and are meant to conceal the wearer’s fingerprints. As noted above Farrel has been identified as Gustafson. Evidence collected at the scene also allowed investigators to identify Gustafson as Willy Clock.
Gustafson was charged by Ugandan authorities on Dec. 16 with conspiracy, possession of counterfeit, selling/dealing in counterfeit, and unlawful possession of ammunition. He was brought before the court that day to be informed about the charges; he also is being represented by counsel in Uganda.
U.S. Secret Service estimates $1.8 million in counterfeit FRNs have been seized and passed in Uganda. The total amount of Ugandan-made counterfeit FRNs seized or passed domestically was approximately $270,000. This amount was limited due to early detection by the Secret Service.
U.S. law provides for a maximum total sentence of 25 years in prison, a fine of $500,000, or both. Under the Federal Sentencing Guidelines, the actual sentence imposed would be based upon the seriousness of the offense and the prior criminal history, if any, of the defendant.
U.S. Attorney Hickton commended numerous agencies and organizations for conducting the investigation leading to charges in this case, including the Directorate of Public Prosecution, the Criminal Investigations and Intelligence Department, the Special Investigations and Intelligence Unit, and Stanbic Bank in Uganda; various domestic and foreign Secret Service Field Offices, including the Rome, Italy, Field Office and the Criminal Investigative Division in Washington, D.C.; the U.S. State Department; the U.S. Postal Inspection Service; the Federal Bureau of Investigation; Homeland Security Investigations; U.S. Customs and Border Protection and the National Cyber-Forensics & Training Alliance.
Assistant U.S. Attorney Shardul S. Desai is prosecuting this case on behalf of the government.
A criminal complaint contains charges and is not evidence of guilt. A defendant is presumed to be innocent until and unless proven guilty.
Sunday, December 21, 2014
AG HOLDER'S STATEMENT ON ASSASSINATION OF NEW YORK CITY POLICE OFFICERS
FROM: U.S. JUSTICE DEPARTMENT
Saturday, December 20, 2014
Attorney General Holder Statement on Assassination of Two New York City Police Officers in Line of Duty
Attorney General Eric Holder released the following statement Saturday regarding the fatal shootings of two New York City police officers:
“I condemn this afternoon's senseless shooting of two New York City police officers in the strongest possible terms. This was an unspeakable act of barbarism, and I was deeply saddened to hear of the loss of these two brave officers in the line of duty.
“On behalf of all those who serve in the United States Department of Justice, I want to express my heartfelt condolences to the officers' loved ones and colleagues. I will make available all of the resources of the Department to aid the NYPD in investigating this tragedy.
"This cowardly attack underscores the dangers that are routinely faced by those who protect and serve their fellow citizens. As a nation we must not forget this as we discuss the events of the recent past. These courageous men and women routinely incur tremendous personal risks, and place their lives on the line each and every day, in order to preserve public safety. We are forever in their debt.
"Our nation must always honor the valor -- and the sacrifices -- of all law enforcement officers with a steadfast commitment to keeping them safe. This means forging closer bonds between officers and the communities they serve, so that public safety is not a cause that is served by a courageous few, but a promise that's fulfilled by police officials and citizens working side by side."
Saturday, December 20, 2014
Attorney General Holder Statement on Assassination of Two New York City Police Officers in Line of Duty
Attorney General Eric Holder released the following statement Saturday regarding the fatal shootings of two New York City police officers:
“I condemn this afternoon's senseless shooting of two New York City police officers in the strongest possible terms. This was an unspeakable act of barbarism, and I was deeply saddened to hear of the loss of these two brave officers in the line of duty.
“On behalf of all those who serve in the United States Department of Justice, I want to express my heartfelt condolences to the officers' loved ones and colleagues. I will make available all of the resources of the Department to aid the NYPD in investigating this tragedy.
"This cowardly attack underscores the dangers that are routinely faced by those who protect and serve their fellow citizens. As a nation we must not forget this as we discuss the events of the recent past. These courageous men and women routinely incur tremendous personal risks, and place their lives on the line each and every day, in order to preserve public safety. We are forever in their debt.
"Our nation must always honor the valor -- and the sacrifices -- of all law enforcement officers with a steadfast commitment to keeping them safe. This means forging closer bonds between officers and the communities they serve, so that public safety is not a cause that is served by a courageous few, but a promise that's fulfilled by police officials and citizens working side by side."
SECRETARY KERRY'S OP-ED ON CUBA POLICY
FROM: U.S. STATE DEPARTMENT
President Obama's New Cuba Policy Looks Forward, Not Back
Op-Ed
John Kerry
Secretary of State
Secretary of Commerce Penny Pritzker, Treasury Secretary Jacob J. Lew
Miami Herald
December 20, 2014
President Obama’s decision to begin normalizing relations with Cuba will advance United States’ interests and those of the Cuban people. The 11 million people of this island nation have waited far too long — over half a century — to fulfill their democratic aspirations and build closer ties with the rest of the world in the 21st century. Our new U.S. policy on Cuba reflects the reality that past policies — although well-intentioned — no longer suit today’s situation. The president’s announcement reflects a historic turning of the page on enmities born of a different era and toward a brighter and more promising future.
Early in his administration, the president took steps to ease restrictions on Cuban-American visits and remittances that opened new pathways for family reunification — and later expanded this to include religious, academic and cultural exchanges for all Americans. Last week’s decision builds boldly on those initial measures and will increase communications, commerce and travel between our two countries. The State Department will lead discussions to restore regular diplomatic relations with Cuba for the first time since 1961 and re-establish an embassy in Havana. In our bilateral discussions, the United States will seek to advance cooperation on issues of mutual interest, including counter-narcotics, migration, combating trafficking-in-persons, the Ebola crisis and shared environmental challenges.
The president has made clear that a critical focus of these actions will include continued strong support for improved human-rights conditions and democratic reforms in Cuba. The promotion of democracy supports universal human rights by empowering civil society and supporting the freedom of individuals to exercise their freedoms of speech and assembly. For these reasons, we welcome Cuba’s decision to release more than 50 political prisoners, expand Internet access for Cuba’s citizens and allow better human-rights monitoring by the International Red Cross and United Nations. Our firm support for progress in these areas will be unwavering, and we will continue to implement programs to promote positive change in Cuba.
As Albert Einstein said long ago, it’s just not rational to continue doing the same thing in the expectation of obtaining a different result. Since U.S.-Cuban relations were frozen, the world has been transformed; the Cold War ended a quarter century ago. Over time the U.S. effort to isolate Cuba began to have the reverse effect of isolating the United States especially in the Western Hemisphere. Meanwhile, Cuban leaders used our stance as a source of propaganda, to justify policies that have no place in the 21st century. It has been an open secret that the relationship has been in a rut that benefits no one on either side. The time has come to cease looking backward and to begin to move forward in the interests of both freedom-loving Cubans and the United States.
What, specifically, has the president decided to do?
First, he has authorized U.S. officials to expand travel, increase remittances and grow bilateral trade. To facilitate this and ensure proper oversight, the Treasury Department will also make banking easier and allow the use of U.S. debit and credit cards in Cuba. In addition, it will strengthen the monitoring and transparency of financial flows between the United States and Cuba by allowing American financial institutions to open correspondent accounts at Cuban banks. One effect of all of the changes will be to increase the ability of Americans to provide business training and other support for Cuba’s nascent private sector, which already includes 500,000 employees. In this regard, the Commerce Department will ease current export limits on a variety of products that would help Cuban small businesses grow such as construction firms, agricultural companies, automobile repair and others.
Second, the president’s decision will support new efforts to tear down the digital wall that isolates Cubans. The country has an Internet penetration rate of 5 percent, among the lowest in the world. Prices are high, and services are limited. Under the new policy, we will permit the sale of technology that will begin to unleash the transformative effects of the Internet on the island.
Third, the president has ordered reforms in the application of U.S. sanctions to Cubans in third countries.
Fourth, the president has asked the State Department to review Cuba’s designation as a state sponsor of terrorism to ensure that any such designation is guided entirely by the facts and law.
All this is in addition to the start of talks aimed at the restoration of normal diplomatic relations. Next month, Assistant Secretary of State Roberta Jacobson will lead the U.S. delegation to the next round of U.S.-Cuba Migration talks, and the Commerce Department will lead a business delegation to the country in the coming months. In the spring, President Obama will travel to Panama for the 2015 Summit of the Americas, where we are encouraging full participation by representatives of Cuban civil society. Meanwhile, the United States has welcomed home USAID subcontractor Alan Gross, who was wrongfully jailed in Cuba for more than five years, and also an American intelligence agent who had been imprisoned for two decades.
President Obama’s announcement last week is forward-looking and emphasizes the value of people-to-people relations, increased commerce, more communications and respectful dialogue. It will enhance our ability to have a positive impact on events inside Cuba and to help improve the lives of the Cuban people. It will put American businesses on a more equal footing. And it will enhance the standing of our own country in the hemisphere and around the world.
President Obama's New Cuba Policy Looks Forward, Not Back
Op-Ed
John Kerry
Secretary of State
Secretary of Commerce Penny Pritzker, Treasury Secretary Jacob J. Lew
Miami Herald
December 20, 2014
President Obama’s decision to begin normalizing relations with Cuba will advance United States’ interests and those of the Cuban people. The 11 million people of this island nation have waited far too long — over half a century — to fulfill their democratic aspirations and build closer ties with the rest of the world in the 21st century. Our new U.S. policy on Cuba reflects the reality that past policies — although well-intentioned — no longer suit today’s situation. The president’s announcement reflects a historic turning of the page on enmities born of a different era and toward a brighter and more promising future.
Early in his administration, the president took steps to ease restrictions on Cuban-American visits and remittances that opened new pathways for family reunification — and later expanded this to include religious, academic and cultural exchanges for all Americans. Last week’s decision builds boldly on those initial measures and will increase communications, commerce and travel between our two countries. The State Department will lead discussions to restore regular diplomatic relations with Cuba for the first time since 1961 and re-establish an embassy in Havana. In our bilateral discussions, the United States will seek to advance cooperation on issues of mutual interest, including counter-narcotics, migration, combating trafficking-in-persons, the Ebola crisis and shared environmental challenges.
The president has made clear that a critical focus of these actions will include continued strong support for improved human-rights conditions and democratic reforms in Cuba. The promotion of democracy supports universal human rights by empowering civil society and supporting the freedom of individuals to exercise their freedoms of speech and assembly. For these reasons, we welcome Cuba’s decision to release more than 50 political prisoners, expand Internet access for Cuba’s citizens and allow better human-rights monitoring by the International Red Cross and United Nations. Our firm support for progress in these areas will be unwavering, and we will continue to implement programs to promote positive change in Cuba.
As Albert Einstein said long ago, it’s just not rational to continue doing the same thing in the expectation of obtaining a different result. Since U.S.-Cuban relations were frozen, the world has been transformed; the Cold War ended a quarter century ago. Over time the U.S. effort to isolate Cuba began to have the reverse effect of isolating the United States especially in the Western Hemisphere. Meanwhile, Cuban leaders used our stance as a source of propaganda, to justify policies that have no place in the 21st century. It has been an open secret that the relationship has been in a rut that benefits no one on either side. The time has come to cease looking backward and to begin to move forward in the interests of both freedom-loving Cubans and the United States.
What, specifically, has the president decided to do?
First, he has authorized U.S. officials to expand travel, increase remittances and grow bilateral trade. To facilitate this and ensure proper oversight, the Treasury Department will also make banking easier and allow the use of U.S. debit and credit cards in Cuba. In addition, it will strengthen the monitoring and transparency of financial flows between the United States and Cuba by allowing American financial institutions to open correspondent accounts at Cuban banks. One effect of all of the changes will be to increase the ability of Americans to provide business training and other support for Cuba’s nascent private sector, which already includes 500,000 employees. In this regard, the Commerce Department will ease current export limits on a variety of products that would help Cuban small businesses grow such as construction firms, agricultural companies, automobile repair and others.
Second, the president’s decision will support new efforts to tear down the digital wall that isolates Cubans. The country has an Internet penetration rate of 5 percent, among the lowest in the world. Prices are high, and services are limited. Under the new policy, we will permit the sale of technology that will begin to unleash the transformative effects of the Internet on the island.
Third, the president has ordered reforms in the application of U.S. sanctions to Cubans in third countries.
Fourth, the president has asked the State Department to review Cuba’s designation as a state sponsor of terrorism to ensure that any such designation is guided entirely by the facts and law.
All this is in addition to the start of talks aimed at the restoration of normal diplomatic relations. Next month, Assistant Secretary of State Roberta Jacobson will lead the U.S. delegation to the next round of U.S.-Cuba Migration talks, and the Commerce Department will lead a business delegation to the country in the coming months. In the spring, President Obama will travel to Panama for the 2015 Summit of the Americas, where we are encouraging full participation by representatives of Cuban civil society. Meanwhile, the United States has welcomed home USAID subcontractor Alan Gross, who was wrongfully jailed in Cuba for more than five years, and also an American intelligence agent who had been imprisoned for two decades.
President Obama’s announcement last week is forward-looking and emphasizes the value of people-to-people relations, increased commerce, more communications and respectful dialogue. It will enhance our ability to have a positive impact on events inside Cuba and to help improve the lives of the Cuban people. It will put American businesses on a more equal footing. And it will enhance the standing of our own country in the hemisphere and around the world.
U.S. STATEMENT ON COUTERTERRORISM EFFORTS IN KENYA
FROM: U.S. STATE DEPARTMENT
Kenya's Counterterrorism Efforts
Press Statement
Jen Psaki
Department Spokesperson
Washington, DC
December 19, 2014
The U.S. Government is firmly committed to supporting Kenya's efforts to defeat al-Shabaab and to ensure security of all of its citizens. We are disappointed, however, by the very limited time allowed for debate and consultation on the 2014 Security Laws (Amendment) Bill prior to its passage and enactment into law. We are also concerned about several provisions in the legislation, including those that appear to limit freedom of assembly and media, and access to asylum for refugees. As a key partner in the global effort to counter terrorism, we expect the Kenyan Government to ensure that its counterterrorism efforts live up to Kenya’s international commitments and its own constitution. Protecting Kenya’s constitution and upholding human rights, democracy, and international obligations are among the most effective ways to bolster security.
The U.S. Government is also seeking further information about the December 16 announcement by the Kenyan NGO Board to deregister hundreds of NGOs for failing to file their audited reports and another 15 for suspected links to terrorism. The 15 NGOs have not been identified. A strong civil society is vital to democracy, security, and prosperity. We urge the Government of Kenya to ensure the regulation of NGOs is transparent, fair, and grounded in clear criteria that do not limit free expression, association, or assembly.
Kenya's Counterterrorism Efforts
Press Statement
Jen Psaki
Department Spokesperson
Washington, DC
December 19, 2014
The U.S. Government is firmly committed to supporting Kenya's efforts to defeat al-Shabaab and to ensure security of all of its citizens. We are disappointed, however, by the very limited time allowed for debate and consultation on the 2014 Security Laws (Amendment) Bill prior to its passage and enactment into law. We are also concerned about several provisions in the legislation, including those that appear to limit freedom of assembly and media, and access to asylum for refugees. As a key partner in the global effort to counter terrorism, we expect the Kenyan Government to ensure that its counterterrorism efforts live up to Kenya’s international commitments and its own constitution. Protecting Kenya’s constitution and upholding human rights, democracy, and international obligations are among the most effective ways to bolster security.
The U.S. Government is also seeking further information about the December 16 announcement by the Kenyan NGO Board to deregister hundreds of NGOs for failing to file their audited reports and another 15 for suspected links to terrorism. The 15 NGOs have not been identified. A strong civil society is vital to democracy, security, and prosperity. We urge the Government of Kenya to ensure the regulation of NGOs is transparent, fair, and grounded in clear criteria that do not limit free expression, association, or assembly.
THE LAST 2 COLOMBIAN NATIONALS INVOLVED IN MURDER OF DEA AGENT TERRY WATSON PLEAD GUILTY
FROM: U.S. JUSTICE DEPARTMENT
Friday, December 19, 2014
Two Remaining Colombian Nationals Involved in the Kidnapping and Murder of DEA Agent Terry Watson Plead Guilty
All Seven Defendants Charged Have Now Been Convicted
Two Colombian nationals pleaded guilty today to second degree murder and conspiracy to kidnap an internationally protected person for their roles in the kidnapping and murder of Drug Enforcement Administration (DEA) Special Agent James “Terry” Watson in Bogotá, Colombia, on June 20, 2013.
Attorney General Eric H. Holder, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, U.S. Attorney Dana J. Boente of the Eastern District of Virginia, Special Agent in Charge George L. Piro of the FBI’s Miami Field Office, DEA Administrator Michele M. Leonhart and Bill A. Miller, Director, U.S. State Department’s Diplomatic Security Service made the announcement.
“The Department of Justice has now obtained pleas for all seven individuals charged with the kidnapping and murder of Special Agent Watson, as well as the attempt to cover up the crime,” said Attorney General Eric Holder. “Although this marks an important milestone in our effort to achieve justice for a fallen hero, our work is far from over. The Justice Department will never rest in its commitment to honor the service, and the profound sacrifice, of Special Agent Watson and so many other courageous men and women in federal law enforcement. And we will never waver in our pursuit of criminals who target or seek to harm Americans anywhere in the world.”
“Special Agent Terry Watson’s kidnapping and murder resulted in a loss that will always be felt by the men and women of DEA,” said DEA Administrator Michele M. Leonhart. “Today’s admission of guilt brings us closer to ensuring that justice is served in this tragedy. DEA will never forget Terry’s outstanding career and the work he did with our global partners in the shared fight against international drug traffickers.”
In the statements of facts filed with their plea agreements, Omar Fabián Valdes Gualtero, 28, and Édgar Javier Bello Murillo, 28, both of Bogotá, admitted that they conspired with four other individuals— Edwin Gerardo Figueroa Sepúlveda, Julio Estiven Gracia Ramírez, Héctor Leonardo López, and Andrés Álvaro Oviedo García—to conduct “paseo milionarios” or “millionaire’s rides” in which victims were lured into taxi cabs, kidnapped, and then robbed. Valdez Gualtero admitted that he was responsible for helping to organize the robbery crew and obtaining disposable cell phones for use during the robberies. Both defendants admitted that on the evening of June 20, 2013, their robbery crew targeted Special Agent Watson outside of a restaurant in Bogotá. Gracia Ramírez picked up Special Agent Watson in his taxi, while López drove a second taxi carrying Valdes Gualtero, Bello Murillo and Figueroa Sepúlveda. After Gracia Ramírez pretended to have mechanical trouble and stopped the taxi, Bello Murillo and Figueroa Sepúlveda entered the back seat with Special Agent Watson. A struggle ensued and Figueroa Sepúlveda shocked Special Agent Watson with a stun gun while Bello Murillo stabbed him at least four times. Special Agent Watson was able to escape from the taxi, but he later collapsed and died from his injuries.
In total, seven defendants were arrested and extradited from Colombia to the United States to face charges in connection with Special Agent Watson’s murder and the subsequent attempt to cover up the crime. Six defendants were charged with murder and conspiracy to kidnap. A seventh defendant, Wilson Daniel Peralta-Bocachica, was charged with obstruction of justice for his role in cleaning the victim’s blood from the backseat of the taxi. All of the defendants have pleaded guilty for their roles in this incident. Gracia Ramírez, López, and Oviedo García were sentenced on Dec. 14, 2014, to 20 years, 25 years, and 27 years, in prison respectively. Figueroa Sepúlveda and Peralta-Bocachica are scheduled to be sentenced on Feb. 18, 2015. Valdes Gualtero and Bello Murillo are scheduled to be sentenced on April 10, 2015.
This case was investigated by the FBI, DEA and the Diplomatic Security Service, in close cooperation with Colombian authorities and with assistance from INTERPOL and the Justice Department’s Office of International Affairs. The case is being prosecuted by Special Counsel Stacey Luck of the Criminal Division’s Human Rights and Special Prosecutions Section and Assistant U.S. Attorney Michael P. Ben’Ary of the U.S. Attorney’s Office of the Eastern District of Virginia.
The Department of Justice gratefully acknowledges the Colombian Attorney General’s Office, Colombian National Police, Colombian Directorate of Criminal Investigation and Interpol (DIJIN), DIJIN Special Investigative Unit, Bogotá Metropolitan Police, Bogotá Police Intelligence Body (CIPOL) Unit and Colombian Technical Investigation Team for their extraordinary efforts, support and professionalism in responding to this incident.
Friday, December 19, 2014
Two Remaining Colombian Nationals Involved in the Kidnapping and Murder of DEA Agent Terry Watson Plead Guilty
All Seven Defendants Charged Have Now Been Convicted
Two Colombian nationals pleaded guilty today to second degree murder and conspiracy to kidnap an internationally protected person for their roles in the kidnapping and murder of Drug Enforcement Administration (DEA) Special Agent James “Terry” Watson in Bogotá, Colombia, on June 20, 2013.
Attorney General Eric H. Holder, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, U.S. Attorney Dana J. Boente of the Eastern District of Virginia, Special Agent in Charge George L. Piro of the FBI’s Miami Field Office, DEA Administrator Michele M. Leonhart and Bill A. Miller, Director, U.S. State Department’s Diplomatic Security Service made the announcement.
“The Department of Justice has now obtained pleas for all seven individuals charged with the kidnapping and murder of Special Agent Watson, as well as the attempt to cover up the crime,” said Attorney General Eric Holder. “Although this marks an important milestone in our effort to achieve justice for a fallen hero, our work is far from over. The Justice Department will never rest in its commitment to honor the service, and the profound sacrifice, of Special Agent Watson and so many other courageous men and women in federal law enforcement. And we will never waver in our pursuit of criminals who target or seek to harm Americans anywhere in the world.”
“Special Agent Terry Watson’s kidnapping and murder resulted in a loss that will always be felt by the men and women of DEA,” said DEA Administrator Michele M. Leonhart. “Today’s admission of guilt brings us closer to ensuring that justice is served in this tragedy. DEA will never forget Terry’s outstanding career and the work he did with our global partners in the shared fight against international drug traffickers.”
In the statements of facts filed with their plea agreements, Omar Fabián Valdes Gualtero, 28, and Édgar Javier Bello Murillo, 28, both of Bogotá, admitted that they conspired with four other individuals— Edwin Gerardo Figueroa Sepúlveda, Julio Estiven Gracia Ramírez, Héctor Leonardo López, and Andrés Álvaro Oviedo García—to conduct “paseo milionarios” or “millionaire’s rides” in which victims were lured into taxi cabs, kidnapped, and then robbed. Valdez Gualtero admitted that he was responsible for helping to organize the robbery crew and obtaining disposable cell phones for use during the robberies. Both defendants admitted that on the evening of June 20, 2013, their robbery crew targeted Special Agent Watson outside of a restaurant in Bogotá. Gracia Ramírez picked up Special Agent Watson in his taxi, while López drove a second taxi carrying Valdes Gualtero, Bello Murillo and Figueroa Sepúlveda. After Gracia Ramírez pretended to have mechanical trouble and stopped the taxi, Bello Murillo and Figueroa Sepúlveda entered the back seat with Special Agent Watson. A struggle ensued and Figueroa Sepúlveda shocked Special Agent Watson with a stun gun while Bello Murillo stabbed him at least four times. Special Agent Watson was able to escape from the taxi, but he later collapsed and died from his injuries.
In total, seven defendants were arrested and extradited from Colombia to the United States to face charges in connection with Special Agent Watson’s murder and the subsequent attempt to cover up the crime. Six defendants were charged with murder and conspiracy to kidnap. A seventh defendant, Wilson Daniel Peralta-Bocachica, was charged with obstruction of justice for his role in cleaning the victim’s blood from the backseat of the taxi. All of the defendants have pleaded guilty for their roles in this incident. Gracia Ramírez, López, and Oviedo García were sentenced on Dec. 14, 2014, to 20 years, 25 years, and 27 years, in prison respectively. Figueroa Sepúlveda and Peralta-Bocachica are scheduled to be sentenced on Feb. 18, 2015. Valdes Gualtero and Bello Murillo are scheduled to be sentenced on April 10, 2015.
This case was investigated by the FBI, DEA and the Diplomatic Security Service, in close cooperation with Colombian authorities and with assistance from INTERPOL and the Justice Department’s Office of International Affairs. The case is being prosecuted by Special Counsel Stacey Luck of the Criminal Division’s Human Rights and Special Prosecutions Section and Assistant U.S. Attorney Michael P. Ben’Ary of the U.S. Attorney’s Office of the Eastern District of Virginia.
The Department of Justice gratefully acknowledges the Colombian Attorney General’s Office, Colombian National Police, Colombian Directorate of Criminal Investigation and Interpol (DIJIN), DIJIN Special Investigative Unit, Bogotá Metropolitan Police, Bogotá Police Intelligence Body (CIPOL) Unit and Colombian Technical Investigation Team for their extraordinary efforts, support and professionalism in responding to this incident.
DOT SANCTIONS MOTHER-IN-LAW OF DRUG LORD TO RECOUP HIDDEN ASSETS
FROM: U.S. TREASURY DEPARTMENT
Treasury Sanctions Mother-in-Law of Sinaloa Cartel Drug Lord “El Azul”
Action Exposes Sinaloa Cartel Leader’s Attempts to Hide Assets
WASHINGTON – Today, the U.S. Department of the Treasury designated Alejandra Araujo Uriarte, a Mexican national, as a Specially Designated Narcotics Trafficker pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act). Araujo Uriarte was designated for her role in holding and concealing assets in her name on behalf of her son-in-law Juan Jose Esparragoza Moreno (a.k.a. “El Azul”), a leader of Mexico's Sinaloa Cartel. As a result of today’s action, allassets of those designated that are based in the United States or in the control of U.S. persons are frozen, and U.S. persons are generally prohibited from engaging in transactions with them.
“Araujo Uriarte has knowingly concealed the assets of an influential drug lord,” said Adam J. Szubin, Director of the Office of Foreign Assets Control. “As the third action that we have taken against the family accomplices of Esparragoza Moreno, today’s designation builds on our unrelenting efforts to disrupt the Sinaloa Cartel and other narcotics organizations around the world.”
The Treasury Department previously designated family members of Esparragoza Moreno on July 24, 2012 and September 30, 2013. The first action designated seven family members who act on behalf of Esparragoza Moreno, including his wife, Ofelia Monzon Araujo. Shortly thereafter, Monzon Araujo began to transfer land in Culiacan, Sinaloa to her mother, Alejandra Araujo Uriarte, in an attempt to hide these assets and evade sanctions. This includes land occupied by designated gasoline retailers that are controlled by Esparragoza Moreno. The Treasury Department previously exposed attempts by these gasoline retailers to evade sanctions by changing their names.
The United States identified Esparragoza Moreno and the Sinaloa Cartel as significant foreign narcotics traffickers pursuant to the Kingpin Act in 2003 and 2009, respectively. Esparragoza Moreno was indicted on drug trafficking charges in the U.S. District Court for the Western District of Texas in 2003. He is wanted in both the United States and Mexico; the U.S. State Department Narcotics Rewards Program is offering a reward of up to $5 million for information leading to his arrest and/or conviction, while Mexican authorities are offering 30 million pesos for information leading to his capture. Esparragoza Moreno has been active in drug trafficking since the 1970s.
Today’s designation was taken in close coordination with U.S. law enforcement agencies, including the Drug Enforcement Administration, and is part of a larger effort by the Treasury Department to collaborate with Mexican authorities in the sanctioning of Mexican drug trafficking organizations.
Since June 2000, more than 1,700 entities and individuals have been named pursuant to the Kingpin Act for their role in international narcotics trafficking. Penalties for violations of the Kingpin Act range from civil penalties of up to $1.075 million per violation to more severe criminal penalties. Criminal penalties for corporate officers may include up to 30 years in prison and fines of up to $5 million. Criminal fines for corporations may reach $10 million. Other individuals could face up to 10 years in prison and fines pursuant to Title 18 of the United States Code for criminal violations of the Kingpin Act.
Treasury Sanctions Mother-in-Law of Sinaloa Cartel Drug Lord “El Azul”
Action Exposes Sinaloa Cartel Leader’s Attempts to Hide Assets
WASHINGTON – Today, the U.S. Department of the Treasury designated Alejandra Araujo Uriarte, a Mexican national, as a Specially Designated Narcotics Trafficker pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act). Araujo Uriarte was designated for her role in holding and concealing assets in her name on behalf of her son-in-law Juan Jose Esparragoza Moreno (a.k.a. “El Azul”), a leader of Mexico's Sinaloa Cartel. As a result of today’s action, allassets of those designated that are based in the United States or in the control of U.S. persons are frozen, and U.S. persons are generally prohibited from engaging in transactions with them.
“Araujo Uriarte has knowingly concealed the assets of an influential drug lord,” said Adam J. Szubin, Director of the Office of Foreign Assets Control. “As the third action that we have taken against the family accomplices of Esparragoza Moreno, today’s designation builds on our unrelenting efforts to disrupt the Sinaloa Cartel and other narcotics organizations around the world.”
The Treasury Department previously designated family members of Esparragoza Moreno on July 24, 2012 and September 30, 2013. The first action designated seven family members who act on behalf of Esparragoza Moreno, including his wife, Ofelia Monzon Araujo. Shortly thereafter, Monzon Araujo began to transfer land in Culiacan, Sinaloa to her mother, Alejandra Araujo Uriarte, in an attempt to hide these assets and evade sanctions. This includes land occupied by designated gasoline retailers that are controlled by Esparragoza Moreno. The Treasury Department previously exposed attempts by these gasoline retailers to evade sanctions by changing their names.
The United States identified Esparragoza Moreno and the Sinaloa Cartel as significant foreign narcotics traffickers pursuant to the Kingpin Act in 2003 and 2009, respectively. Esparragoza Moreno was indicted on drug trafficking charges in the U.S. District Court for the Western District of Texas in 2003. He is wanted in both the United States and Mexico; the U.S. State Department Narcotics Rewards Program is offering a reward of up to $5 million for information leading to his arrest and/or conviction, while Mexican authorities are offering 30 million pesos for information leading to his capture. Esparragoza Moreno has been active in drug trafficking since the 1970s.
Today’s designation was taken in close coordination with U.S. law enforcement agencies, including the Drug Enforcement Administration, and is part of a larger effort by the Treasury Department to collaborate with Mexican authorities in the sanctioning of Mexican drug trafficking organizations.
Since June 2000, more than 1,700 entities and individuals have been named pursuant to the Kingpin Act for their role in international narcotics trafficking. Penalties for violations of the Kingpin Act range from civil penalties of up to $1.075 million per violation to more severe criminal penalties. Criminal penalties for corporate officers may include up to 30 years in prison and fines of up to $5 million. Criminal fines for corporations may reach $10 million. Other individuals could face up to 10 years in prison and fines pursuant to Title 18 of the United States Code for criminal violations of the Kingpin Act.
AMBASSADOR PRESSMAN'S REMARKS ON IRAN'S NUCLEAR PROGRAM
FROM: U.S. STATE DEPARTMENT
Ambassador David Pressman
Alternate Representative to the UN for Special Political Affairs
New York, NY
December 18, 2014
AS DELIVERED
Thank you, Mr. President. Thank you, Ambassador Quinlan, for your briefing and your leadership of this Committee over the last two years. Because of your diligence and commitment, this Committee's work has been energized. You and your team have done a great job helping the Committee carry out its mandate, improve the transparency of its work and tighten relationships with other international bodies. Please accept the United States’ deep appreciation of your efforts.
Mr. President, the Security Council established this Committee eight years ago this month, back in 2006 because the international community had serious doubts about the peaceful intentions of Iran's nuclear program. Since then, the Committee's work has been an integral element to our broader diplomatic strategy. This Committee has helped many countries implement the increasingly robust UN sanctions. This Committee, with the support of its Panel of Experts, has investigated serious sanctions violations and developed an impressive understanding of Iran's proliferation networks. This Committee has also helped crack down on Iran's arms smuggling, stemming the flow of weapons to a volatile region.
Yet today, several years later, the international community still does not have confidence in Iran's nuclear program. To resolve these issues, Iran is now in a serious dialogue with the P-5+1 countries. To give these negotiations the best chance of success, last month we decided to extend them for an additional seven months. While we continue to believe that the best way to achieve our goals is through diplomacy, we are not going to sit at the negotiating table forever. As we have said many times, we don't want just any agreement – we want the right agreement. Plainly and simply, these negotiations must find ways to ensure that Iran does not, and cannot, acquire a nuclear weapon.
As these talks continue, we should consider how the Security Council's Iran Sanctions Committee can best support them. Our advice to the Committee is simple: keep doing what you're doing. During this period, the Committee must absolutely continue its vital work monitoring and improving enforcement of these critical sanctions. Similarly, the Panel of Experts should continue its work investigating violations and reaching out to Member States. Unless or until the Security Council modifies these sanctions, the pace and intensity of this work should remain robust.
Recent reporting from the Panel of Experts reminds us why this is so important. We know that Iran is still trying to procure sensitive nuclear technology. We know Iran is still smuggling arms in violation of resolution 1747. And we know that Iran's leaders forthrightly reject this Council's resolutions, speaking publicly about their destabilizing arms shipments to Syria, Hezbollah in Lebanon and Iraq.
Responding effectively to these violations is at the core of the Committee's mandate. Any breach of the sanctions is a serious matter, as it is dangerous, violates international law, and undermines the Security Council's credibility. In the coming weeks and months, we will continue to work with Committee members to ensure that the Security Council's resolutions are not violated with impunity. The Committee's outreach work in advising Member States and answering questions about these sanctions is critically important. The Committee and the Panel must continue to remind Member States of the need to sustain full and robust implementation of these sanctions.
Our determination to prevent Iran from obtaining a nuclear weapon remains clear and we are committed to resolving this issue peacefully, through diplomacy. Sanctions are critical to that effort and we intend to ensure that this important body is able to carry out its mandate effectively.
Thank you, Mr. President.
Ambassador David Pressman
Alternate Representative to the UN for Special Political Affairs
New York, NY
December 18, 2014
AS DELIVERED
Thank you, Mr. President. Thank you, Ambassador Quinlan, for your briefing and your leadership of this Committee over the last two years. Because of your diligence and commitment, this Committee's work has been energized. You and your team have done a great job helping the Committee carry out its mandate, improve the transparency of its work and tighten relationships with other international bodies. Please accept the United States’ deep appreciation of your efforts.
Mr. President, the Security Council established this Committee eight years ago this month, back in 2006 because the international community had serious doubts about the peaceful intentions of Iran's nuclear program. Since then, the Committee's work has been an integral element to our broader diplomatic strategy. This Committee has helped many countries implement the increasingly robust UN sanctions. This Committee, with the support of its Panel of Experts, has investigated serious sanctions violations and developed an impressive understanding of Iran's proliferation networks. This Committee has also helped crack down on Iran's arms smuggling, stemming the flow of weapons to a volatile region.
Yet today, several years later, the international community still does not have confidence in Iran's nuclear program. To resolve these issues, Iran is now in a serious dialogue with the P-5+1 countries. To give these negotiations the best chance of success, last month we decided to extend them for an additional seven months. While we continue to believe that the best way to achieve our goals is through diplomacy, we are not going to sit at the negotiating table forever. As we have said many times, we don't want just any agreement – we want the right agreement. Plainly and simply, these negotiations must find ways to ensure that Iran does not, and cannot, acquire a nuclear weapon.
As these talks continue, we should consider how the Security Council's Iran Sanctions Committee can best support them. Our advice to the Committee is simple: keep doing what you're doing. During this period, the Committee must absolutely continue its vital work monitoring and improving enforcement of these critical sanctions. Similarly, the Panel of Experts should continue its work investigating violations and reaching out to Member States. Unless or until the Security Council modifies these sanctions, the pace and intensity of this work should remain robust.
Recent reporting from the Panel of Experts reminds us why this is so important. We know that Iran is still trying to procure sensitive nuclear technology. We know Iran is still smuggling arms in violation of resolution 1747. And we know that Iran's leaders forthrightly reject this Council's resolutions, speaking publicly about their destabilizing arms shipments to Syria, Hezbollah in Lebanon and Iraq.
Responding effectively to these violations is at the core of the Committee's mandate. Any breach of the sanctions is a serious matter, as it is dangerous, violates international law, and undermines the Security Council's credibility. In the coming weeks and months, we will continue to work with Committee members to ensure that the Security Council's resolutions are not violated with impunity. The Committee's outreach work in advising Member States and answering questions about these sanctions is critically important. The Committee and the Panel must continue to remind Member States of the need to sustain full and robust implementation of these sanctions.
Our determination to prevent Iran from obtaining a nuclear weapon remains clear and we are committed to resolving this issue peacefully, through diplomacy. Sanctions are critical to that effort and we intend to ensure that this important body is able to carry out its mandate effectively.
Thank you, Mr. President.
FDA WARNS PARENTS ABOUT LASER TOYS
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Laser Toys: Not Always Child's Play
Many a kid (and parent) who has seen Luke Skywalker battle Darth Vader with a lightsaber thinks lasers are cool.
What they may not know is this: When operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not just to the person using a laser, but to anyone within range of the laser beam.
The Food and Drug Administration (FDA) is particularly concerned about this potential danger to children and those around them, and has issued a draft guidance document on the safety of toy laser products.
According to Dan Hewett, health promotion officer at FDA's Center for Devices and Radiological Health, "A beam shone directly into a person's eye can injure it in an instant, especially if the laser is a powerful one."
However, laser injuries usually don't hurt, and vision can deteriorate slowly over time. Eye injuries caused by laser light may go unnoticed, for days and even weeks, and could be permanent, he says.
Some examples of laser toys are:
lasers mounted on toy guns that can be used for "aiming;"
spinning tops that project laser beams while they spin;
hand-held lasers used during play as "lightsabers;" and
lasers intended for entertainment that create optical effects in an open room.
FDA Regulates Lasers
A laser creates a powerful, targeted beam of electromagnetic radiation that is used in many products, from music players and printers to eye-surgery tools. FDA regulates radiation-emitting electronic products, including lasers, and sets radiation-safety standards that manufacturers must meet. Hewett explains that this includes all laser products that are marketed as toys.
Toys with lasers are of particular interest to the FDA because it's often children who are injured by these products, says Hewett. He notes that because advertisers promote them as playthings, parents and kids alike may believe they're safe to use.
"For toys to be considered minimal risk, we recommend that the levels of radiation and light not exceed the limits of Class 1, which is the lowest level in regulated products," Hewett says. Lasers used for industrial and other purposes often require higher radiation levels, he explains. But in toys, those levels are unnecessary and potentially dangerous.
In recent years, Hewett says, lasers have increased markedly in power and have gone way down in price. And while adults may buy a laser pointer for use in work, kids often buy them for amusement.
"Low-cost, compact laser pointers used to be quite low in power," Hewett says; but, in the last 10 years, many laser pointers have increased in power 10-fold and more. The fact that lasers can be dangerous may not be evident, particularly to the children who use them as toys, or to the adults who supervise them.
Tips to Keep in Mind
Never aim or shine a laser directly at anyone, including animals. The light energy from a laser aimed into the eye can be hazardous, perhaps even more than staring directly into the sun.
Do not aim a laser at any reflective surface.
Remember that the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car or otherwise negatively affect someone who is engaged in other activity (such as playing sports).
Look for a statement that it complies with 21 CFR (the Code of Federal Regulations) Subchapter J on the label.
"If you buy a laser toy or pointer and you don't see this information in the labeling, it's best not to make any assumptions about its safety," Hewett says.
Laser Toys: Not Always Child's Play
Many a kid (and parent) who has seen Luke Skywalker battle Darth Vader with a lightsaber thinks lasers are cool.
What they may not know is this: When operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not just to the person using a laser, but to anyone within range of the laser beam.
The Food and Drug Administration (FDA) is particularly concerned about this potential danger to children and those around them, and has issued a draft guidance document on the safety of toy laser products.
According to Dan Hewett, health promotion officer at FDA's Center for Devices and Radiological Health, "A beam shone directly into a person's eye can injure it in an instant, especially if the laser is a powerful one."
However, laser injuries usually don't hurt, and vision can deteriorate slowly over time. Eye injuries caused by laser light may go unnoticed, for days and even weeks, and could be permanent, he says.
Some examples of laser toys are:
lasers mounted on toy guns that can be used for "aiming;"
spinning tops that project laser beams while they spin;
hand-held lasers used during play as "lightsabers;" and
lasers intended for entertainment that create optical effects in an open room.
FDA Regulates Lasers
A laser creates a powerful, targeted beam of electromagnetic radiation that is used in many products, from music players and printers to eye-surgery tools. FDA regulates radiation-emitting electronic products, including lasers, and sets radiation-safety standards that manufacturers must meet. Hewett explains that this includes all laser products that are marketed as toys.
Toys with lasers are of particular interest to the FDA because it's often children who are injured by these products, says Hewett. He notes that because advertisers promote them as playthings, parents and kids alike may believe they're safe to use.
"For toys to be considered minimal risk, we recommend that the levels of radiation and light not exceed the limits of Class 1, which is the lowest level in regulated products," Hewett says. Lasers used for industrial and other purposes often require higher radiation levels, he explains. But in toys, those levels are unnecessary and potentially dangerous.
In recent years, Hewett says, lasers have increased markedly in power and have gone way down in price. And while adults may buy a laser pointer for use in work, kids often buy them for amusement.
"Low-cost, compact laser pointers used to be quite low in power," Hewett says; but, in the last 10 years, many laser pointers have increased in power 10-fold and more. The fact that lasers can be dangerous may not be evident, particularly to the children who use them as toys, or to the adults who supervise them.
Tips to Keep in Mind
Never aim or shine a laser directly at anyone, including animals. The light energy from a laser aimed into the eye can be hazardous, perhaps even more than staring directly into the sun.
Do not aim a laser at any reflective surface.
Remember that the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car or otherwise negatively affect someone who is engaged in other activity (such as playing sports).
Look for a statement that it complies with 21 CFR (the Code of Federal Regulations) Subchapter J on the label.
"If you buy a laser toy or pointer and you don't see this information in the labeling, it's best not to make any assumptions about its safety," Hewett says.
Saturday, December 20, 2014
JAPAN, AUSTRALIA PROVIDING MAINTENANCE SITES FOR F-35
An F-35C Lightning II joint strike fighter carrier variant prepares to launch from the aircraft carrier USS Nimitz in the Pacific Ocean, Nov. 6, 2014. U.S. Navy photo, courtesy of Lockheed Martin by Andy Wolfe .
Japan, Australia to Provide F-35 Maintenance Sites in Pacific Region
By Claudette Roulo
DoD News, Defense Media Activity
WASHINGTON, Dec. 17, 2014 – Japan and Australia will be sharing maintenance and upgrade duties for the F-35 Lightning II joint strike fighter based or operating in the Pacific region, the program executive officer for the aircraft announced today.
F-35 heavy air frame maintenance, repair, overhaul and upgrade capabilities will be provided by Japan in the northern Pacific and Australia in the southern Pacific, Air Force Lt. Gen. Christopher C. Bogdan told reporters. Both countries are expected to have their facilities operational no later than 2018.
Initial heavy engine maintenance capability will be provided by Australia by early 2018, he said, and Japan will provide additional capability 3 to 5 years later.
Once Japan’s heavy engine capability is achieved, Bogdan said, the program office will look at the footprint and distribution of F-35's in the Pacific to “see if these decisions are still appropriate and if we have to make any kind of adjustments in terms of the assignment capabilities and moving forward.”
Similar Process in Europe
A similar process will take place in Europe, and all of the assignments will be reviewed every three to five years, he added.
Over the next two years, assignments for other components, systems and repair capabilities will be determined for both Europe and the Pacific, Bogdan noted.
Japan’s final assembly and check-out facility will be quite different from the facilities in Italy and Fort Worth, Texas, the general said.
“Both the plant at Fort Worth and the plant in Italy are expansive in terms of distance on the ground,” he said, but Japan is building vertically. Manufacturing will take place on a number of different floors, Bogdan said, and the aircraft will move through the facility on elevators as it is assembled.
Efficiencies learned through experience at the Fort Worth facility are being incorporated into the Japanese facility as it is constructed, he said.
Just like in Europe, he said, Japan is responsible for the funding and construction of their facility, which will be operated by a Japanese company. Lockheed-Martin will oversee technical aspects of production in Italy and Japan, Bogdan noted, and the U.S. government will oversee security.
Factors Drove Decisions
Geography and operational necessity played a considerable role in the Defense Department’s final decision to place air frame facilities in two locations, the general said.
Seven thousand miles separate the two primary areas where F-35s will be concentrated in the Pacific, Bogdan said. Moving entire aircraft over that distance would require significant amounts of fuel and other support, he said, making it uneconomical. And, he said, “Quite often, some of those airplanes that have to be inducted into a depot are going in there because they need upgrades or there's something wrong.”
Operationally, it didn’t make sense to introduce a long transportation delay into the MRO&U process, the general said.
“If you're having airplanes in the northern Pacific that need a rapid upgrade to respond to a new threat, having to move them 7,000 miles to do that mod in Australia, or vice versa, has an operational impact, because the war fighter won't get the airplane as quickly as he needed to,” he explained.
Geography wasn’t as serious an initial consideration for engines, Bogdan said.
Easier, Quicker, Cheaper
“You can break the engines down into modules, and when you break them down into modules, transportation is much easier, quicker and cheaper,” he said.
As more aircraft arrive in the Pacific theater, Australia’s heavy engine maintenance, repair, overhaul and upgrades capability will eventually be supplemented by Japan, the general said.
“Bringing a Japanese capability online after that represents the fact that as more airplanes come to the Pacific over time, we want to make sure we have enough throughput to get all the engines done in the region in a timely way.”
“This is another example of the continuing expansion of global sustainment opportunities for the international F-35 community,” Bogdan said in a release that accompanied today’s announcement.
“The F-35 international users will remain a vital part of the support structure of the program,” he said. “Their continuing participation is critical to driving down cost and getting the best value for the F-35 team and improving the strength of the global sustainment base for many years to come."
PRESIDENT ANNOUNCES DELEGATION TO ATTEND INAUGUATION OF DILMA ROUSSEFF AS PRESIDENT OF BRAZIL
FROM: THE WHITE HOUSE
President Obama Announces Presidential Delegation to the Federative Republic of Brazil to Attend the Inauguration of Her Excellency Dilma Rousseff
President Barack Obama today announced the designation of a Presidential Delegation to Brasilia to attend the Inauguration of Her Excellency Dilma Rousseff as President of the Federative Republic of Brazil on January 1, 2015.
The Honorable Joseph R. Biden, Jr., Vice President of the United States, will lead the delegation.
Members of the Presidential Delegation:
The Honorable Liliana Ayalde, United States Ambassador to the Federative Republic of Brazil, Department of State
The Honorable Roberta S. Jacobson, Assistant Secretary of State for Western Hemisphere Affairs
The Honorable Ricardo Zuniga, Special Assistant to the President and Senior Director for Western Hemisphere Affairs, National Security Council
President Obama Announces Presidential Delegation to the Federative Republic of Brazil to Attend the Inauguration of Her Excellency Dilma Rousseff
President Barack Obama today announced the designation of a Presidential Delegation to Brasilia to attend the Inauguration of Her Excellency Dilma Rousseff as President of the Federative Republic of Brazil on January 1, 2015.
The Honorable Joseph R. Biden, Jr., Vice President of the United States, will lead the delegation.
Members of the Presidential Delegation:
The Honorable Liliana Ayalde, United States Ambassador to the Federative Republic of Brazil, Department of State
The Honorable Roberta S. Jacobson, Assistant Secretary of State for Western Hemisphere Affairs
The Honorable Ricardo Zuniga, Special Assistant to the President and Senior Director for Western Hemisphere Affairs, National Security Council
FDA APPROVES VIEKIRA PAK FOR TREATMENT OF HEPATITIS C
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves Viekira Pak to treat hepatitis C
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.
The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.
Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
FDA approves Viekira Pak to treat hepatitis C
The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.
Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).
“The new generation of therapeutics for hepatitis C virus is changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens.”
Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.
Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.
The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily.
The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.
Viekira Pak is the eleventh new drug product with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Viekira Pak was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.
Viekira Pak is marketed by AbbVie Inc., based in North Chicago, Illinois. Olysio is marketed by Raritan, New Jersey-based Janssen Pharmaceuticals. Sovaldi and Harvoni are marketed by Gilead Sciences, based in Foster City, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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FORMER FEDERAL AGENT PLEADS GUILTY TO STEALING AMMUNITION
FROM: U.S. JUSTICE DEPARTMENT
Thursday, December 18, 2014
Former Federal Law Enforcement Agent Pleads Guilty to Theft of Agency's Ammunition
A former special agent with the Department of Health and Human Services-Office of Inspector General (HHS-OIG) pleaded guilty today to theft of government property for stealing thousands of rounds of law enforcement ammunition, announced Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division and Special Agent in Charge Elton Malone of HHS-OIG’s Special Investigations Branch.
Josef A. Riekers, 44, of Rockwall, Texas, pleaded guilty before Chief U.S. District Judge Jorge A. Solis of the Northern District of Texas, who set a sentencing hearing for April 8, 2015.
According to admissions in his plea agreement, Riekers, who had served as a federal law enforcement agent for over 15 years, stole ammunition from the armory at HHS-OIG’s Dallas regional office. Riekers then traded the stolen ammunition on Internet forums for other, non-government-issued ammunition that he used for his own personal benefit.
This case was investigated by HHS-OIG’s Special Investigations Branch, with assistance from the Dallas Police Department’s Criminal Intelligence Unit. The case is being prosecuted by Trial Attorneys Kevin Driscoll and Justin Weitz of the Public Integrity Section.
Thursday, December 18, 2014
Former Federal Law Enforcement Agent Pleads Guilty to Theft of Agency's Ammunition
A former special agent with the Department of Health and Human Services-Office of Inspector General (HHS-OIG) pleaded guilty today to theft of government property for stealing thousands of rounds of law enforcement ammunition, announced Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division and Special Agent in Charge Elton Malone of HHS-OIG’s Special Investigations Branch.
Josef A. Riekers, 44, of Rockwall, Texas, pleaded guilty before Chief U.S. District Judge Jorge A. Solis of the Northern District of Texas, who set a sentencing hearing for April 8, 2015.
According to admissions in his plea agreement, Riekers, who had served as a federal law enforcement agent for over 15 years, stole ammunition from the armory at HHS-OIG’s Dallas regional office. Riekers then traded the stolen ammunition on Internet forums for other, non-government-issued ammunition that he used for his own personal benefit.
This case was investigated by HHS-OIG’s Special Investigations Branch, with assistance from the Dallas Police Department’s Criminal Intelligence Unit. The case is being prosecuted by Trial Attorneys Kevin Driscoll and Justin Weitz of the Public Integrity Section.
STATE DEPARTMENT OFFICIAL'S RECENT REMARKS ON NUCLEAR DISARMAMENT
FROM: U.S. STATE DEPARTMENT
U.S. Perspectives on the Opportunities and Challenges of Nuclear Disarmament
Remarks
Robert Wood
Special Representative to the Conference on Disarmament
Geneva Center for Security Policy
Geneva, Switzerland
December 17, 2014
Professor Mohamedou, thank you for that gracious introduction, and for hosting this event. It is an honor to join the ranks of distinguished visitors who have spoken at GCSP venues. Ladies and gentlemen, I also appreciate your interest in American perspectives on the opportunities and challenges of nuclear disarmament.
Disarmament, arms control, and nonproliferation are the focus of my professional life here in Geneva, and nuclear disarmament is under particularly close scrutiny as we approach the 2015 Nuclear Non-Proliferation Treaty Review Conference, which we refer to in the shorthand of this business as the “NPT RevCon.” The last NPT RevCon, in 2010, generated a consensus Action Plan for all States Parties. We put great stock in that historic achievement, we are working on it, and want to see it through. Acknowledging that the pace of nuclear disarmament is under criticism in some quarters, I would underline that the United States remains firmly committed to achieving the peace and security of a world without nuclear weapons – but I would also emphasize that there are no easy solutions to the challenge of advancing nuclear disarmament while also maintaining vital strategic stability and enhancing security for all.
So: Where are we now? And most important, where we are going?
As vital as those questions are, it can be easy to lose sight of the significant progress that has been made in this area. Indeed, in the forums in which I routinely work it is regrettably common for some participants to state flatly that “nothing has happened” or “nothing is happening” on nuclear disarmament. This is not the case.
How can such misperceptions persist? It is well known that global stocks of nuclear weapons are at their lowest level in over half a century, far below the levels existing when the NPT entered into force in 1970. This largely reflects very significant treaty-based arms reductions by the United States of America and the Russian Federation. The latest such bilateral arms control treaty, the New START Treaty, entered into force on February 5, 2011, and when it is fully implemented in 2018, New START will limit deployed strategic nuclear warheads to their lowest levels since the 1950s.
Behind these headlines is an ongoing, intense web of daily, practical implementation activities that support strategic stability and transparency, which are conducive to future progress in disarmament. For example, the United States and Russian Federation together continue to implement successfully the New START Treaty. The two sides have exchanged more than 7,700 New START Treaty notifications through the Nuclear Risk Reduction Centers. These notifications include biannual New START Treaty data exchanges, which provide a detailed picture of U.S. and Russian strategic forces. In addition, the Treaty’s on-site inspections continue to enable each side to verify the validity of those data. These exchanges and inspections, together with detailed discussions in the Bilateral Consultative Commission, help build confidence, stability, and predictability. Historically, implementation of strategic arms control treaties with the former Soviet Union and Russia has proceeded without interruption even during the most challenging periods in the bilateral relationship.
The United States also has reduced the role of nuclear weapons in its national security strategy as outlined in the U.S. Nuclear Posture Review (NPR). Specifically, as outlined in the 2010 NPR, the United States will not develop new nuclear warheads, and life extension programs for existing weapons will not support new military capabilities or provide for new military capabilities. Additionally, as reflected in the NPR, the United States has strengthened the negative security assurances that it provides to non-nuclear weapon states who are party to the NPT, and made clear that the United States would only consider the use of nuclear weapons in extreme circumstances to defend the vital interests of the United States or its allies and partners.
Proceeding further to the heart of the matter, we reported earlier this year that over the past two decades alone the United States has dismantled 9,952 nuclear warheads. That works out to dismantling an average of more than one warhead per day, every day, for 20 years. And the work continues. By the way, the dismantlement of just one nuclear warhead is not an easy process – it is extremely demanding work.
I hope that does not surprise you. But unfortunately, since taking up my duties as ambassador here four months ago, I have repeatedly heard the claim that, while non-nuclear weapons states have by and large honored their nonproliferation obligations, nuclear weapons states have abdicated their nuclear disarmament obligations.
I will let other Nuclear Weapons States speak for themselves. I think that the U.S. can be very proud of our own record. Please consider these facts:
• Over all, the United States has slashed its nuclear arsenal from its Cold War high by 85%. 85%. That is not a percentage pulled out of a hat. It is not fiction or fantasy. It is real!
• Before 1991, the U.S. eliminated an entire category of missiles, scrapping all of its intermediate-range and shorter-range ground-launched nuclear- and conventional-capable missiles and their associated launchers and equipment in accordance with the Intermediate Nuclear Forces (INF) Treaty.
• And just since 1991, the United States has reduced its non-strategic nuclear arsenal by approximately 90%.
When we pledge to continue to pursue nuclear disarmament and to keep faith with our NPT Article VI disarmament obligations, those are not empty words. Our responsible approach to disarmament has borne fruit in the form of major reductions in nuclear weapons, fissile material stocks, and infrastructure. Our nuclear complex has been completely transformed from one built for the mass production of fissile material and warheads and the design and testing of new weapons to one dedicated to the maintenance of a steadily shrinking stockpile.
Underpinning all of our efforts, stretching back decades, has been our clear understanding and recognition of the severe consequences of the use of these weapons. That is the message the United States took to the Conference on the Humanitarian Impact of Nuclear Weapons in Vienna last week. We participated to reinforce the message that the practical step-by-step path we have followed so successfully remains the only realistic route to our shared goal of a nuclear weapons-free world. We cannot and will not support efforts to move to a nuclear weapons convention or the false hope of a fixed timeline for the elimination of all nuclear weapons. We cannot support and will oppose any effort to move to an international legal ban on nuclear weapons.
Looking ahead, it remains the policy of the United States to achieve the peace and security of a world without nuclear weapons. And we are facing new challenges as we consider how to responsibly eliminate the last 15% of those weapons. As we move to smaller and smaller numbers, leading to zero globally, we must in turn become rigorously more and more confident and trusting that all are fulfilling their commitments.
In considering future reductions, the United States believes that the focus must be on responsible measures that can be trusted and verified. We will learn from our past experience and continue to move ahead with each step building on the last. While there is no pre-determined sequence of steps, and indeed we should pursue progress on multiple paths, there is no way to skip to the end and forgo the hard work of preparing for the technical and political disarmament challenges that lie ahead. Patience and persistence are needed from all NPT parties both among and beyond the P5.
Earlier this month in Prague, Under Secretary Gottemoeller announced a new International Partnership for Nuclear Disarmament Verification. We propose to work with nuclear-weapon states and non-nuclear-weapon states to better understand the challenges of verifying nuclear disarmament and to develop solutions to address those challenges.
This new partnership will draw on the talents of experts around the world, both inside and outside government. It will build on the pathbreaking efforts of the U.K.-Norway initiative, begun in 2007, to investigate ways to address nuclear disarmament verification challenges. The Nuclear Threat Initiative will be a prime partner in organizing this exciting new effort.
The United States is committed to a responsible approach to nuclear disarmament in accordance with our obligations under the Treaty on the Non-Proliferation of Nuclear Weapons. The United States has made it clear that we are ready to engage Russia to discuss the full range of issues related to strategic stability, and that we should take real and important actions that can contribute to creating a more predictable and secure world. We hope that these negotiations will take place when the conditions become more favorable for constructive interaction.
Broadening the aperture, I would underline that NPT Parties have committed as a next step in the multilateral nuclear disarmament sphere to negotiations on a treaty banning the production of fissile material for use in nuclear weapons or other nuclear explosive devices, the Fissile Material Cut-off Treaty (FMCT). This goal was embraced by all NPT Parties. Indeed, the 2010 NPT Action 15 notes that “All States agree that the Conference on Disarmament should . . . begin negotiation of a treaty banning the production of fissile material for use in nuclear weapons. . . .”
Achieving such a ban would support our collective Article VI obligations. The United States regrets that the CD remains in deadlock, unable to agree on a Program of Work that takes us forward and puts us on a path toward FMCT negotiations. It is clear that we still have our work cut out for us. And it is difficult to have a meaningful discussion, to set the stage for productive negotiations in the CD, without a better grasp of the facts, without recognition of what has been accomplished as well as the challenges that remain.
For the United States, the CD remains an essential multilateral institution for the negotiation of arms control and disarmament agreements. As a consensus-based body, it is the ideal venue to deal with the most sensitive national security issues multilaterally. While the United States and many other Member States are frustrated by the inability of the CD to get back to the business of negotiating, we need to find creative ways to energize it and put it back to work.
In conclusion, I would emphasize that it is a welcome fact that there remains strong support among governments and publics for nuclear disarmament. For the United States, the task at hand is to help to channel that support into constructive, effective measures that will strengthen international security while further reducing the number of nuclear weapons. Indeed, the United States has led the international community in responsibly reducing nuclear arsenals in a safe and practical step-by-step manner, and we remain firmly committed to our obligations under the NPT. We welcome contributions by all to this important task, but will firmly resist any efforts to oversimplify the path forward and ignore the real security challenges we face along that path. As President Obama has said, the path to zero will require patience and persistence. It requires a broad strategy aimed at strengthening the nonproliferation regime, preventing nuclear terrorism, and pursuing concrete steps that build a foundation for future progress and lead in the direction of nuclear disarmament. Thank you for your attention.
U.S. Perspectives on the Opportunities and Challenges of Nuclear Disarmament
Remarks
Robert Wood
Special Representative to the Conference on Disarmament
Geneva Center for Security Policy
Geneva, Switzerland
December 17, 2014
Professor Mohamedou, thank you for that gracious introduction, and for hosting this event. It is an honor to join the ranks of distinguished visitors who have spoken at GCSP venues. Ladies and gentlemen, I also appreciate your interest in American perspectives on the opportunities and challenges of nuclear disarmament.
Disarmament, arms control, and nonproliferation are the focus of my professional life here in Geneva, and nuclear disarmament is under particularly close scrutiny as we approach the 2015 Nuclear Non-Proliferation Treaty Review Conference, which we refer to in the shorthand of this business as the “NPT RevCon.” The last NPT RevCon, in 2010, generated a consensus Action Plan for all States Parties. We put great stock in that historic achievement, we are working on it, and want to see it through. Acknowledging that the pace of nuclear disarmament is under criticism in some quarters, I would underline that the United States remains firmly committed to achieving the peace and security of a world without nuclear weapons – but I would also emphasize that there are no easy solutions to the challenge of advancing nuclear disarmament while also maintaining vital strategic stability and enhancing security for all.
So: Where are we now? And most important, where we are going?
As vital as those questions are, it can be easy to lose sight of the significant progress that has been made in this area. Indeed, in the forums in which I routinely work it is regrettably common for some participants to state flatly that “nothing has happened” or “nothing is happening” on nuclear disarmament. This is not the case.
How can such misperceptions persist? It is well known that global stocks of nuclear weapons are at their lowest level in over half a century, far below the levels existing when the NPT entered into force in 1970. This largely reflects very significant treaty-based arms reductions by the United States of America and the Russian Federation. The latest such bilateral arms control treaty, the New START Treaty, entered into force on February 5, 2011, and when it is fully implemented in 2018, New START will limit deployed strategic nuclear warheads to their lowest levels since the 1950s.
Behind these headlines is an ongoing, intense web of daily, practical implementation activities that support strategic stability and transparency, which are conducive to future progress in disarmament. For example, the United States and Russian Federation together continue to implement successfully the New START Treaty. The two sides have exchanged more than 7,700 New START Treaty notifications through the Nuclear Risk Reduction Centers. These notifications include biannual New START Treaty data exchanges, which provide a detailed picture of U.S. and Russian strategic forces. In addition, the Treaty’s on-site inspections continue to enable each side to verify the validity of those data. These exchanges and inspections, together with detailed discussions in the Bilateral Consultative Commission, help build confidence, stability, and predictability. Historically, implementation of strategic arms control treaties with the former Soviet Union and Russia has proceeded without interruption even during the most challenging periods in the bilateral relationship.
The United States also has reduced the role of nuclear weapons in its national security strategy as outlined in the U.S. Nuclear Posture Review (NPR). Specifically, as outlined in the 2010 NPR, the United States will not develop new nuclear warheads, and life extension programs for existing weapons will not support new military capabilities or provide for new military capabilities. Additionally, as reflected in the NPR, the United States has strengthened the negative security assurances that it provides to non-nuclear weapon states who are party to the NPT, and made clear that the United States would only consider the use of nuclear weapons in extreme circumstances to defend the vital interests of the United States or its allies and partners.
Proceeding further to the heart of the matter, we reported earlier this year that over the past two decades alone the United States has dismantled 9,952 nuclear warheads. That works out to dismantling an average of more than one warhead per day, every day, for 20 years. And the work continues. By the way, the dismantlement of just one nuclear warhead is not an easy process – it is extremely demanding work.
I hope that does not surprise you. But unfortunately, since taking up my duties as ambassador here four months ago, I have repeatedly heard the claim that, while non-nuclear weapons states have by and large honored their nonproliferation obligations, nuclear weapons states have abdicated their nuclear disarmament obligations.
I will let other Nuclear Weapons States speak for themselves. I think that the U.S. can be very proud of our own record. Please consider these facts:
• Over all, the United States has slashed its nuclear arsenal from its Cold War high by 85%. 85%. That is not a percentage pulled out of a hat. It is not fiction or fantasy. It is real!
• Before 1991, the U.S. eliminated an entire category of missiles, scrapping all of its intermediate-range and shorter-range ground-launched nuclear- and conventional-capable missiles and their associated launchers and equipment in accordance with the Intermediate Nuclear Forces (INF) Treaty.
• And just since 1991, the United States has reduced its non-strategic nuclear arsenal by approximately 90%.
When we pledge to continue to pursue nuclear disarmament and to keep faith with our NPT Article VI disarmament obligations, those are not empty words. Our responsible approach to disarmament has borne fruit in the form of major reductions in nuclear weapons, fissile material stocks, and infrastructure. Our nuclear complex has been completely transformed from one built for the mass production of fissile material and warheads and the design and testing of new weapons to one dedicated to the maintenance of a steadily shrinking stockpile.
Underpinning all of our efforts, stretching back decades, has been our clear understanding and recognition of the severe consequences of the use of these weapons. That is the message the United States took to the Conference on the Humanitarian Impact of Nuclear Weapons in Vienna last week. We participated to reinforce the message that the practical step-by-step path we have followed so successfully remains the only realistic route to our shared goal of a nuclear weapons-free world. We cannot and will not support efforts to move to a nuclear weapons convention or the false hope of a fixed timeline for the elimination of all nuclear weapons. We cannot support and will oppose any effort to move to an international legal ban on nuclear weapons.
Looking ahead, it remains the policy of the United States to achieve the peace and security of a world without nuclear weapons. And we are facing new challenges as we consider how to responsibly eliminate the last 15% of those weapons. As we move to smaller and smaller numbers, leading to zero globally, we must in turn become rigorously more and more confident and trusting that all are fulfilling their commitments.
In considering future reductions, the United States believes that the focus must be on responsible measures that can be trusted and verified. We will learn from our past experience and continue to move ahead with each step building on the last. While there is no pre-determined sequence of steps, and indeed we should pursue progress on multiple paths, there is no way to skip to the end and forgo the hard work of preparing for the technical and political disarmament challenges that lie ahead. Patience and persistence are needed from all NPT parties both among and beyond the P5.
Earlier this month in Prague, Under Secretary Gottemoeller announced a new International Partnership for Nuclear Disarmament Verification. We propose to work with nuclear-weapon states and non-nuclear-weapon states to better understand the challenges of verifying nuclear disarmament and to develop solutions to address those challenges.
This new partnership will draw on the talents of experts around the world, both inside and outside government. It will build on the pathbreaking efforts of the U.K.-Norway initiative, begun in 2007, to investigate ways to address nuclear disarmament verification challenges. The Nuclear Threat Initiative will be a prime partner in organizing this exciting new effort.
The United States is committed to a responsible approach to nuclear disarmament in accordance with our obligations under the Treaty on the Non-Proliferation of Nuclear Weapons. The United States has made it clear that we are ready to engage Russia to discuss the full range of issues related to strategic stability, and that we should take real and important actions that can contribute to creating a more predictable and secure world. We hope that these negotiations will take place when the conditions become more favorable for constructive interaction.
Broadening the aperture, I would underline that NPT Parties have committed as a next step in the multilateral nuclear disarmament sphere to negotiations on a treaty banning the production of fissile material for use in nuclear weapons or other nuclear explosive devices, the Fissile Material Cut-off Treaty (FMCT). This goal was embraced by all NPT Parties. Indeed, the 2010 NPT Action 15 notes that “All States agree that the Conference on Disarmament should . . . begin negotiation of a treaty banning the production of fissile material for use in nuclear weapons. . . .”
Achieving such a ban would support our collective Article VI obligations. The United States regrets that the CD remains in deadlock, unable to agree on a Program of Work that takes us forward and puts us on a path toward FMCT negotiations. It is clear that we still have our work cut out for us. And it is difficult to have a meaningful discussion, to set the stage for productive negotiations in the CD, without a better grasp of the facts, without recognition of what has been accomplished as well as the challenges that remain.
For the United States, the CD remains an essential multilateral institution for the negotiation of arms control and disarmament agreements. As a consensus-based body, it is the ideal venue to deal with the most sensitive national security issues multilaterally. While the United States and many other Member States are frustrated by the inability of the CD to get back to the business of negotiating, we need to find creative ways to energize it and put it back to work.
In conclusion, I would emphasize that it is a welcome fact that there remains strong support among governments and publics for nuclear disarmament. For the United States, the task at hand is to help to channel that support into constructive, effective measures that will strengthen international security while further reducing the number of nuclear weapons. Indeed, the United States has led the international community in responsibly reducing nuclear arsenals in a safe and practical step-by-step manner, and we remain firmly committed to our obligations under the NPT. We welcome contributions by all to this important task, but will firmly resist any efforts to oversimplify the path forward and ignore the real security challenges we face along that path. As President Obama has said, the path to zero will require patience and persistence. It requires a broad strategy aimed at strengthening the nonproliferation regime, preventing nuclear terrorism, and pursuing concrete steps that build a foundation for future progress and lead in the direction of nuclear disarmament. Thank you for your attention.
Friday, December 19, 2014
JUSTICE DEPARTMENT GIVES UPDATE ON SONY INVESTIGATION AND THE "GUARDIANS OF PEACE"
FROM: U.S. JUSTICE DEPARTMENT
Friday, December 19, 2014
Update in Sony Investigation
Today, the FBI would like to provide an update on the status of our investigation into the cyber attack targeting Sony Pictures Entertainment (SPE). In late November, SPE confirmed that it was the victim of a cyber attack that destroyed systems and stole large quantities of personal and commercial data. A group calling itself the “Guardians of Peace” claimed responsibility for the attack and subsequently issued threats against SPE, its employees, and theaters that distribute its movies.
The FBI has determined that the intrusion into SPE’s network consisted of the deployment of destructive malware and the theft of proprietary information as well as employees’ personally identifiable information and confidential communications. The attacks also rendered thousands of SPE’s computers inoperable, forced SPE to take its entire computer network offline, and significantly disrupted the company’s business operations.
After discovering the intrusion into its network, SPE requested the FBI’s assistance. Since then, the FBI has been working closely with the company throughout the investigation. Sony has been a great partner in the investigation, and continues to work closely with the FBI. Sony reported this incident within hours, which is what the FBI hopes all companies will do when facing a cyber attack. Sony’s quick reporting facilitated the investigators’ ability to do their jobs, and ultimately to identify the source of these attacks.
As a result of our investigation, and in close collaboration with other U.S. Government departments and agencies, the FBI now has enough information to conclude that the North Korean government is responsible for these actions. While the need to protect sensitive sources and methods precludes us from sharing all of this information, our conclusion is based, in part, on the following:
Technical analysis of the data deletion malware used in this attack revealed links to other malware that the FBI knows North Korean actors previously developed. For example, there were similarities in specific lines of code, encryption algorithms, data deletion methods, and compromised networks.
The FBI also observed significant overlap between the infrastructure used in this attack and other malicious cyber activity the U.S. Government has previously linked directly to North Korea. For example, the FBI discovered that several Internet protocol (IP) addresses associated with known North Korean infrastructure communicated with IP addresses that were hardcoded into the data deletion malware used in this attack.
Separately, the tools used in the SPE attack have similarities to a cyber attack in March of last year against South Korean banks and media outlets, which was carried out by North Korea.
We are deeply concerned about the destructive nature of this attack on a private sector entity and the ordinary citizens who worked there. Further, North Korea’s attack on SPE reaffirms that cyber threats pose one of the gravest national security dangers to the United States. Though the FBI has seen a wide variety and increasing number of cyber intrusions, the destructive nature of this attack, coupled with its coercive nature, sets it apart. North Korea’s actions were intended to inflict significant harm on a U.S. business and suppress the right of American citizens to express themselves. Such acts of intimidation fall outside the bounds of acceptable state behavior. The FBI takes seriously any attempt – whether through cyber-enabled means, threats of violence, or otherwise – to undermine the economic and social prosperity of our citizens.
The FBI stands ready to assist any U.S. company that is the victim of a destructive cyber attack or breach of confidential business information. Further, the FBI will continue to work closely with multiple departments and agencies as well as with domestic, foreign, and private sector partners who have played a critical role in our ability to trace this and other cyber threats to their source. Working together, the FBI will identify, pursue, and impose costs and consequences on individuals, groups, or nation states who use cyber means to threaten the United States or U.S. interests.
Friday, December 19, 2014
Update in Sony Investigation
Today, the FBI would like to provide an update on the status of our investigation into the cyber attack targeting Sony Pictures Entertainment (SPE). In late November, SPE confirmed that it was the victim of a cyber attack that destroyed systems and stole large quantities of personal and commercial data. A group calling itself the “Guardians of Peace” claimed responsibility for the attack and subsequently issued threats against SPE, its employees, and theaters that distribute its movies.
The FBI has determined that the intrusion into SPE’s network consisted of the deployment of destructive malware and the theft of proprietary information as well as employees’ personally identifiable information and confidential communications. The attacks also rendered thousands of SPE’s computers inoperable, forced SPE to take its entire computer network offline, and significantly disrupted the company’s business operations.
After discovering the intrusion into its network, SPE requested the FBI’s assistance. Since then, the FBI has been working closely with the company throughout the investigation. Sony has been a great partner in the investigation, and continues to work closely with the FBI. Sony reported this incident within hours, which is what the FBI hopes all companies will do when facing a cyber attack. Sony’s quick reporting facilitated the investigators’ ability to do their jobs, and ultimately to identify the source of these attacks.
As a result of our investigation, and in close collaboration with other U.S. Government departments and agencies, the FBI now has enough information to conclude that the North Korean government is responsible for these actions. While the need to protect sensitive sources and methods precludes us from sharing all of this information, our conclusion is based, in part, on the following:
Technical analysis of the data deletion malware used in this attack revealed links to other malware that the FBI knows North Korean actors previously developed. For example, there were similarities in specific lines of code, encryption algorithms, data deletion methods, and compromised networks.
The FBI also observed significant overlap between the infrastructure used in this attack and other malicious cyber activity the U.S. Government has previously linked directly to North Korea. For example, the FBI discovered that several Internet protocol (IP) addresses associated with known North Korean infrastructure communicated with IP addresses that were hardcoded into the data deletion malware used in this attack.
Separately, the tools used in the SPE attack have similarities to a cyber attack in March of last year against South Korean banks and media outlets, which was carried out by North Korea.
We are deeply concerned about the destructive nature of this attack on a private sector entity and the ordinary citizens who worked there. Further, North Korea’s attack on SPE reaffirms that cyber threats pose one of the gravest national security dangers to the United States. Though the FBI has seen a wide variety and increasing number of cyber intrusions, the destructive nature of this attack, coupled with its coercive nature, sets it apart. North Korea’s actions were intended to inflict significant harm on a U.S. business and suppress the right of American citizens to express themselves. Such acts of intimidation fall outside the bounds of acceptable state behavior. The FBI takes seriously any attempt – whether through cyber-enabled means, threats of violence, or otherwise – to undermine the economic and social prosperity of our citizens.
The FBI stands ready to assist any U.S. company that is the victim of a destructive cyber attack or breach of confidential business information. Further, the FBI will continue to work closely with multiple departments and agencies as well as with domestic, foreign, and private sector partners who have played a critical role in our ability to trace this and other cyber threats to their source. Working together, the FBI will identify, pursue, and impose costs and consequences on individuals, groups, or nation states who use cyber means to threaten the United States or U.S. interests.
SECRETARY KERRY CONDEMNS CYBER-ATTACKS BY NORTH KOREA
FROM: U.S. STATE DEPARTMENT
Condemning Cyber-Attack by North Korea
Press Statement
John Kerry
Secretary of State
Washington, DC
December 19, 2014
The United States condemns North Korea for the cyber-attack targeting Sony Pictures Entertainment and the unacceptable threats against movie theatres and moviegoers. These actions are a brazen attempt by an isolated regime to suppress free speech and stifle the creative expression of artists beyond the borders of its own country.
Freedom of expression is at the center of America’s values and a founding principle of our Bill of Rights. We’re a country where artists openly mock and criticize the powerful, including our own government. We don’t always like what they say about us or about others, and sometimes we’re even deeply offended. But those offenses have always taken a backseat to freedom of expression. That’s why the United States is and always will be a staunch advocate for and protector of the right of artists to express themselves freely and creatively. Whatever one’s system of government or views about free expression, there is absolutely no justification whatsoever for an attack like this.
We are deeply concerned about the destructive nature of this state sponsored cyber-attack targeting a commercial entity and its employees in the United States. These lawless acts of intimidation demonstrate North Korea’s flagrant disregard for international norms. Threats in cyberspace pose one of the greatest national security challenges to the United States, and North Korea’s actions – intended to inflict significant economic damage and suppress free speech – are well beyond the bounds of acceptable state behavior in cyberspace. This provocative and unprecedented attack and subsequent threats only strengthen our resolve to continue to work with partners around the world to strengthen cybersecurity, promote norms of acceptable state behavior, uphold freedom of expression, and ensure that the Internet remains open, interoperable, secure and reliable. We encourage our allies and partners to stand with us as we defend the values of all of our people in the face of state-sponsored intimidation.
Condemning Cyber-Attack by North Korea
Press Statement
John Kerry
Secretary of State
Washington, DC
December 19, 2014
The United States condemns North Korea for the cyber-attack targeting Sony Pictures Entertainment and the unacceptable threats against movie theatres and moviegoers. These actions are a brazen attempt by an isolated regime to suppress free speech and stifle the creative expression of artists beyond the borders of its own country.
Freedom of expression is at the center of America’s values and a founding principle of our Bill of Rights. We’re a country where artists openly mock and criticize the powerful, including our own government. We don’t always like what they say about us or about others, and sometimes we’re even deeply offended. But those offenses have always taken a backseat to freedom of expression. That’s why the United States is and always will be a staunch advocate for and protector of the right of artists to express themselves freely and creatively. Whatever one’s system of government or views about free expression, there is absolutely no justification whatsoever for an attack like this.
We are deeply concerned about the destructive nature of this state sponsored cyber-attack targeting a commercial entity and its employees in the United States. These lawless acts of intimidation demonstrate North Korea’s flagrant disregard for international norms. Threats in cyberspace pose one of the greatest national security challenges to the United States, and North Korea’s actions – intended to inflict significant economic damage and suppress free speech – are well beyond the bounds of acceptable state behavior in cyberspace. This provocative and unprecedented attack and subsequent threats only strengthen our resolve to continue to work with partners around the world to strengthen cybersecurity, promote norms of acceptable state behavior, uphold freedom of expression, and ensure that the Internet remains open, interoperable, secure and reliable. We encourage our allies and partners to stand with us as we defend the values of all of our people in the face of state-sponsored intimidation.
U.S. CONGRATULATES PEOPLE OF MAURITIUS ON ELECTIONS
FROM: U.S. STATE DEPARTMENT
United States Congratulates Mauritius on Successful Elections
Press Statement
John Kerry
Secretary of State
Washington, DC
December 18, 2014
On behalf of the American people, I congratulate the people of Mauritius on the peaceful transition of power that resulted from the successful elections held on December 10. Mauritius’ series of free, fair, democratic, and peaceful elections stand as a model for the rest of the world. Prime Minister Jugnauth returns to lead Mauritius with a wealth of experience, and the U.S. government looks forward to working with him and his cabinet of ministers and continuing our valued partnership with Mauritius.
United States Congratulates Mauritius on Successful Elections
Press Statement
John Kerry
Secretary of State
Washington, DC
December 18, 2014
On behalf of the American people, I congratulate the people of Mauritius on the peaceful transition of power that resulted from the successful elections held on December 10. Mauritius’ series of free, fair, democratic, and peaceful elections stand as a model for the rest of the world. Prime Minister Jugnauth returns to lead Mauritius with a wealth of experience, and the U.S. government looks forward to working with him and his cabinet of ministers and continuing our valued partnership with Mauritius.
NASA AMES RESEARCH CENTER CELEBRATES 75TH ANNIVERSARY
FROM: NASA
December 20, 2014 marks NASA Ames Research Center's 75th Anniversary. The center was established in 1939 as the second laboratory of the National Advisory Committee for Aeronautics, and was named for the chair of the NACA, Joseph S. Ames. It was located at Moffett Field in Sunnyvale, California, now at the heart of Silicon Valley. The Laboratory was renamed the NASA Ames Research Center with the formation of NASA in 1958. This June 2, 1943 photograph shows the construction of the Ames full-scale 40- by 80-foot wind tunnel, with a side view of the entrance cone and a blimp in the background. Image Credit: NASA.
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