SECRETARY KERRY'S REMARKS ON UKRAINE

FROM:  U.S. STATE DEPARTMENT 

Remarks on Ukraine

Remarks

John Kerry

Secretary of State

State Department Press Briefing Room

Washington, DC

April 24, 2014

It has now been a week since the United States, the European Union, Russia, and Ukraine met in Geneva.  We did so after a phone call between President Putin and President Obama, in which both leaders expressed a desire to avoid further escalation in Ukraine.  We met in Geneva with a clear mission: to improve security conditions and find political solutions to the conflict threatening the sovereignty and unity of Ukraine.  And right there in Geneva, EU High Representative Ashton and I made clear that both Russia and Ukraine had to demonstrate more than good faith.  They needed to take concrete actions in order to meet their commitments.

The simple reality is you can’t resolve a crisis when only one side is willing to do what is necessary to avoid a confrontation.  Every day since we left Geneva – every day, even up to today, when Russia sent armored battalions right up the Luhansk Oblast border – the world has witnessed a tale of two countries, two countries with vastly different understandings of what it means to uphold an international agreement.

One week later, it is clear that only one side, one country, is keeping its word.  And for anyone who wants to create gray areas out of black, or find in the fine print crude ways to justify crude actions, let’s get real – the Geneva agreement is not open to interpretation.  It is not vague.  It is not subjective.  It is not optional.  What we agreed to in Geneva is as simple as it is specific.

We agreed that all sides would refrain from violence, intimidation, and taking provocative actions.  We agreed that illegal groups would lay down their arms and that, in exchange for amnesty, they would hand over the public buildings and spaces that they occupied.  We agreed that to implement these objectives – and this is important, to implement this – monitors from the Organization for Security and Cooperation in Europe would have unfettered access to parts of Ukraine where they were needed most.  And we agreed that all parties would work to create that access and to provide help to the OSCE in order to do this.  We agreed that the OSCE would report from the ground whether the rights, security, and dignity of Ukrainian citizens was being protected.

From day one, the Government of Ukraine started making good on its commitments – from day one.  From day one, Prime Minister Yatsenyuk has kept his word.  He immediately agreed to help vacate buildings.  He suspended Ukraine’s counterterrorism initiative over Easter, choosing de-escalation, despite Ukraine’s legitimate, fundamental right to defend its own territory and its own people.  From day one, the Ukrainian Government sent senior officials to work with the OSCE, in keeping with the agreement, to send them to work in regions where Russia had voiced its most urgent concerns about the security of Russian speakers and ethnic Russians.  And on day one, Prime Minister Yatsenyuk went on live television and committed his government publicly to all of the people of Ukraine that – and these are his words – committed them to undertake comprehensive constitutional reform that will strengthen the powers of the regions.  He directly addressed the concerns expressed by the Russians, and he did so on day one.

He also made a personal appeal to Russian-speaking Ukrainians, pledging to support – and again, these are his words – a special status to the Russian language and the protection of the language.  And in keeping with his Geneva commitments, Prime Minister Yatsenyuk has publicly announced amnesty legislation – once more, in his words – for all those who surrender arms, come out of the premises and will begin with the Ukrainian people to build a sovereign and independent Ukraine.  That is a promise made by the interim government to the people of Ukraine.

And by complying with actions requested by Russia, like removing the barricades in the Maidan and cleaning up the square and ensuring that all ongoing demonstrations in Kyiv are actually government-approved and peaceful, Ukraine is thereby taking tangible, concrete steps to move beyond the division of the last months.  That is how a government defines keeping your word.  That is leadership that upholds both the spirit and the letter of a Geneva agreement.

The world has rightly judged that Prime Minister Yatsenyuk and the Government of Ukraine are working in good faith.  And the world, sadly, has rightly judged that Russia has put its faith in distraction, deception, and destabilization.  For seven days, Russia has refused to take a single concrete step in the right direction.  Not a single Russian official, not one, has publicly gone on television in Ukraine and called on the separatists to support the Geneva agreement, to support the stand-down, to give up their weapons, and get out of the Ukrainian buildings.  They have not called on them to engage in that activity.

In fact, the propaganda bullhorn that is the state-sponsored Russia Today program, has been deployed to promote – actually, Russia Today network – has deployed to promote President Putin’s fantasy about what is playing out on the ground.  They almost spend full time devoted to this effort to propagandize and to distort what is happening or not happening in Ukraine.  Instead, in plain sight, Russia continues to fund, coordinate, and fuel a heavily armed separatist movement in Donetsk.

Meanwhile, Russian leaders are making increasingly outrageous claims to justify their action – that the CIA invented the internet in order to control the world or that the forces occupying buildings, armed to the teeth, wearing brand new matching uniforms and moving in disciplined military formation, are merely local activists seeking to exercise their legitimate rights.  That is absurd, and there is no other word to describe it.

But in the 21st century, where every citizen can broadcast messages, images, and video from the palm of their hand, no amount of propaganda is capable of hiding such actions.  No amount of propaganda will hide the truth, and the truth is there in the social media and across the pages of newspapers and in the video of televisions for all of the world to see.  No amount of propaganda can withstand that kind of scrutiny today.

The world knows that peaceful protesters don’t come armed with grenade launchers and automatic weapons, the latest issue from the Russian arsenal, hiding the insignias on their brand new matching military uniforms, and speaking in dialects that every local knows comes from thousands of miles away.  The world knows that the Russian intelligence operatives arrested in Ukraine didn’t just take a wrong turn on the highway.  In fact, we have seen soldiers wearing uniforms identical to the ones Russian soldiers wore in Crimea last month.

As international observers on the ground have borne witness, prior to Russia’s escalation, there was no violence.  There was no broad-scale assault on the rights of people in the east.  Ukraine was largely stable and peaceful, including in the south and the east.  Even as we were preparing to meet in Geneva, we know that the Russian intelligence services were involved in organizing local pro-Russian militias.  And during the week leading up to the Geneva meetings, separatists seized at least 29 buildings.  This is one more example of how Russia is stoking the very instability that they say they want to quell.

And in the weeks since this agreement, we have seen even more violence visited upon Ukrainians.  Right after we left Geneva, separatists seized TV and radio stations that broadcast in the Ukrainian language.  The mayor of Slovyansk was kidnapped the very day after the parties committed to end the violence and intimidations.  Two days ago, one journalist was kidnapped and another went missing, bringing the total number of kidnapped journalists into the double digits.  That same day, two dead bodies were found near Slovyansk.  One of them was a city councilmember who had been knocked unconscious and thrown in a river with a weighted backpack strapped to him.

The Government of Ukraine has reported the arrest of Russian intelligence agents, including one yesterday who it says was responsible for establishing secure communications allowing Russia to coordinate destabilizing activities in Ukraine.  And then, just this morning, separatist forces tried to overrun another arms depot.

Having failed to postpone Ukraine’s elections, having failed to halt a legitimate political process, Russia has instead chosen an illegitimate course of armed violence to try and achieve with the barrel of a gun and the force of a mob what couldn’t be achieved any other way.  They’ve tried to create enough chaos in the east to delay or delegitimize the elections, or to force Ukraine to accept a federalism that gives Russia control over its domestic and foreign policies, or even force Ukraine to overreact and create an excuse for military intervention.  This is a full-throated effort to actively sabotage the democratic process through gross external intimidation that has brought inside Ukraine, and it is worse even.

We have seen this movie before.  We saw it most recently in Crimea, where similar subterfuge and sabotage by Russia was followed by a full invasion – an invasion, by the way, for which President Putin recently decorated Russian special forces at the Kremlin.

Now Russia claims that all of this is exaggerated, or even orchestrated, that Ukrainians can’t possibly be calling for a government free of corruption and coercion.  Russia is actually mystified to see Ukraine’s neighbors and likeminded free people all over the world united with Ukrainians who want to build a better life and choose their leaders for themselves, by themselves.

Nobody should doubt Russia’s hand in this.  As NATO’s Supreme Allied Commander in Europe wrote this week, “What is happening in eastern Ukraine is a military operation that is well planned and organized and we assess that it is being carried out at the direction of Russia.”  Our intelligence community tells me that Russia’s intelligence and military intelligence services and special operators are playing an active role in destabilizing eastern Ukraine with personnel, weapons, money, operational planning, and coordination.  The Ukrainians have intercepted and publicized command-and-control conversations from known Russian agents with their separatist clients in Ukraine.  Some of the individual special operations personnel, who were active on Russia’s behalf in Chechnya, Georgia, and Crimea have been photographed in Slovyansk, Donetsk, and Luhansk.  Some are even bragging about it by themselves on their Russian social media sites.  And we’ve seen weapons and gear on the separatists that matches those worn and used by Russian special forces.

So following today’s threatening movement of Russian troops right up to Ukraine’s border, let me be clear:  If Russia continues in this direction, it will not just be a grave mistake, it will be an expensive mistake.  Already the international response to the choices made by Russia’s leaders is taking its toll on Russia’s economy.  Prime Minister Medvedev has alluded to the cost Russia is already paying.  Even President Putin has acknowledged it.

As investors’ confidence dwindles, some $70 billion in capital has fled the Russian financial system in the first quarter of 2014, more than all of last year.  Growth estimates for 2014 have been revised downward by two to three percentage points.  And this follows a year in which GDP growth was already the lowest since 2009.  Meanwhile, the Russian Central Bank has had to spend more than $20 billion to defend the ruble, eroding Russia’s buffers against external shocks.  Make no mistake that what I’ve just described is really just a snapshot and is also, regrettably, a preview of how the free world will respond if Russia continues to escalate what they had promised to de-escalate.

Seven days, two opposite responses, and one truth that cannot be ignored:  The world will remain united for Ukraine.  So I will say it again.  The window to change course is closing.  President Putin and Russia face a choice.  If Russia chooses the path of de-escalation, the international community – all of us – will welcome it.  If Russia does not, the world will make sure that the cost for Russia will only grow.  And as President Obama reiterated earlier today, we are ready to act.

DEFENSE SECRETARY HAGEL WANTS TO STRENGTHEN TIES WITH CANADA AND MEXICO

FROM:  THE DEFENSE DEPARTMENT 

Defense Secretary Chuck Hagel, left, greets Canadian Defense Minister Robert Nicholson before meeting in Mexico City, April 23, 2014. Hagel will attend a defense ministerial conference with Mexico, Canada and the United States before traveling to Guatemala. 

Hagel Looks to Strengthen Ties With Canada, Mexico.
By Cheryl Pellerin
American Forces Press Service

MEXICO CITY, April 24, 2014 – Defense Secretary Chuck Hagel met here last night with Canadian Defense Minister Rob Nicholson, ahead of today’s North American Defense Ministerial conference, which brings together the defense leaders from the United States, Canada and Mexico.

The conference is the second since 2012, when Canada hosted the first North American defense ministers meeting, and on the flight here, Hagel told reporters traveling with him that it’s important to keep the momentum going.
“Every time we meet,” he said, “we add muscle and sinew --substance -- to what we’re doing and what we could be doing.”

Hagel said the defense ministerial arose from President Barack Obama’s attendance in February in Toluca, Mexico, with Mexican President Pena Nieto and Canadian Prime Minister Stephen Harper at the North American Leaders Summit. There, the leaders discussed their vision for a prosperous and secure future for North American citizens and a shared commitment to work together to realize that vision. The leaders announced initiatives by the three countries to enhance competitiveness in the global economy, expand opportunities for North American citizens, and promote peace, security and development through multilateral action.
The secretary said his visit here would focus on the importance of the region and specific relationships within the region -- in particular, the trilateral relationship among the United States, Mexico and Canada.

“I don't think over the years we've done enough to reach out to our Latin American partners, partly because we suffer from a pretty good relationship,” Hagel said. “The places that get most of the attention around the world are the trouble spots.”
A senior defense official traveling with the secretary said the focus on the North American trilateral relationship “is the defense component of what we're trying to do in the [Western] Hemisphere -- drawing the United States, Mexico and Canada closer together as three partners.”

“We've always had very strong bilateral relationships with both countries, and it's not meant to supplant those … relationships, but we're trying to leverage the capabilities of all three countries,” the official added.

And because the three nations share threat perceptions and interests in so many places in the region and increasingly around the world, the defense official said, the focus on the trilateral partnership is an effort to build on those shared interests.
The official said the defense ministers would meet in several different kinds of meetings, large and small. Though the trilateral conference involves three countries, four ministers will attend the meetings, because in Mexico, two government ministries are directly responsible for national defense: the Mexican National Defense Secretariat, shortened as SEDENA in its Spanish acronym, and the Navy Secretariat, SEMAR.

Hagel’s counterparts in Mexico are Secretary of National Defense Gen. Salvador Zepeda Cienfuegos and Naval Secretary Adm. Vidal Francisco Soberon Sanz, and the secretary will meet with them for the first time today.

These military officers hold Cabinet rank and have regular and direct access to the Mexican president, who also is supreme commander of the armed forces.
Hagel has met with his Canadian counterpart several times, the defense official said, most recently in February during a NATO defense ministers meeting in Brussels.

When the two leaders met here today, Pentagon Press Secretary Navy Rear Adm. John Kirby said, they discussed a range of issues of mutual concern, including the situation in Ukraine, recent developments in the Asia-Pacific region, and common security challenges in the Western Hemisphere.

During the 30-minute meeting, Kirby added, both Hagel and Nicholson “expressed eagerness to discuss in more detail ways in which all three nations can work more closely together to deal with the threats posed by criminal networks, cyberattacks and natural disasters.”

Hagel also thanked Nicholson for his leadership and for Canada's strong contributions to the NATO alliance, the press secretary said, including the International Security Assistance Force mission in Afghanistan.

The senior defense official characterized Hagel’s visit here as a great opportunity to establish relationships with partners in the Western Hemisphere and to continue to work with Mexico on the bilateral relationship with the United States.
“The Mexicans are our regional partners, regional leaders, and increasingly, in the world they're becoming more of a global player,” the defense official said.
“The relatively new president of Mexico made quite a splash on the world scene, and he's got big challenges at home with the economy,” he added, “but he's an impressive leader, and President Obama had a good meeting with him a couple of months ago.”

As indicated by the potential sale of 18 Black Hawk helicopters by the United States to Mexico, as announced this week by the State Department, the Mexicans are interested in acquiring a range of U.S. capabilities, the official said.
The potential Black Hawk sale is a high-visibility request by Mexico, he added, “but we are talking to them about a range of capabilities that they are interested in, … like our assistance in their own security.”

“There are partnership things we can do and things we can do together,” he added, “but they also want to acquire their own capabilities, and we're interested in helping.”

When Hagel leaves Mexico, he’ll travel to Guatemala to meet with defense and government leaders.

CHIEF OFFICER AND HIS FIRM CHARGED WITH ILLEGALLY SHIPPING MACHINERY TO IRAN

FROM:  U.S JUSTICE DEPARTMENT 

Wednesday, April 23, 2014

Pennsylvania Firm and Chief Officer Charged with Shipping Machinery to Iran in Violation of U.S. Export License Requirements

A criminal information has been filed against a Pennsylvania firm and its chief officer, charging them with conspiracy to evade export reporting requirements and with attempting to smuggle to Iran a lathe machine in violation of U.S. export regulations.   The announcement was made today by the U.S. Attorney Peter J. Smith for the Middle District of Pennsylvania.

Charged in the Criminal Information were Hetran Inc., an engineering and manufacturing plant in Orwigsburg, Pa., and its chief executive officer, Helmut Oertmann.   At the same time, an indictment was unsealed that had previously been voted by a federal grand jury in Harrisburg in December 2012 against three Iranians and two Iranian firms connected with the criminal scheme: Mujahid Ali, Khosrow Kasraei, Reza Ghoreishi, FIMCO FZE, and Crescent International Trade and Services FZE.

Also charged was Suniel Malhotra, an Indian national, an overseas sales representative for Hetran Inc.

According to U.S. Attorney Peter Smith, Hetran allegedly manufactured a horizontal lathe, also described as a bar peeling machine (peeler), valued at more than $800,000 and weighing in excess of 50,000 pounds.   A horizontal lathe, or peeling machine, is used in the production of high grade steel or bright steel,” a product used, among other things, in the manufacture of automobile and aircraft parts.

On or about June 2009, Hetran was allegedly contacted by representatives of FIMCO, an Iranian company with offices in Iran and the United Arab Emirates, and Crescent International, an affiliated company based in Dubai in the United Arab Emirates.  FIMCO allegedly wanted to purchase the peeler.  During negotiations, it became apparent that the peeler was intended for shipment to Iran.  American companies are forbidden to ship “dual use” items (such as the peeler) to Iran without first obtaining a license from the U.S. Department of Commerce.  Aware that it was unlikely that such a license would be granted, Hetran, Helmut Oertmann and other co-conspirators agreed to falsely state on the shipping documents that the end-user of the peeler was Crescent International in Dubai.

On June 17, 2012, Hetran allegedly caused the peeling machine to be shipped to Dubai in the United Arab Emirates, fraudulently listing Crescent International in Dubai as the end-user, knowing that the shipment was ultimately being sent to Iran in violation of federal law.

Hetran is charged with conspiring to violate the export laws of the United States, and is subject to a sentence of up to $1,000,000.  Helmut Oertmann, charged with attempting to smuggle goods from the United States to Iran, faces a potential penalty of up to 10 years imprisonment, a fine of up to $250,000 and up to 5 years supervised release.  The Iranian and Indian defendants are charged with conspiring to violate and with attempting to violate the export laws of the United States, each carrying potential penalties of up to 10 years imprisonment, a fine of up to $250,000 and up to 5 years supervised release for the individual defendants and a $1,000,000 fine for each corporate defendant.

The case was investigated by the Office of Export Enforcement of the U.S. Department of Commerce.  The prosecution is being coordinated by Assistant U.S. Attorney Christy Fawcett and Senior Litigation Counsel Gordon Zubrod and is being overseen by the National Security Division of the U.S. Department of Justice.

Indictments and criminal informations are only allegations. All persons charged are presumed to be innocent unless and until found guilty in court.

A sentence following a finding of guilty is imposed by the Judge after consideration of the applicable federal sentencing statutes and the Federal Sentencing Guidelines.

In this case, the maximum penalty under the federal statute is 10 years imprisonment, a term of supervised release following imprisonment and a fine. Under the Federal Sentencing Guidelines, the Judge is also required to consider and weigh a number of factors, including the nature, circumstances and seriousness of the offense; the history and characteristics of the defendant; and the need to punish the defendant, protect the public and provide for the defendant’s educational, vocational and medical needs.  For these reasons, the statutory maximum penalty for the offense is not an accurate indicator of the potential sentence for a specific defendant.

FDA POINTS OUT SEVERAL TYPES OF TOBACCO PRODUCTS

FROM:  FEDERAL FOOD AND DRUG ADMINISTRATION 
Recognize Tobacco in its Many Forms

Tobacco use is the single largest preventable cause of disease and death in the United States, but can you recognize all the different forms of a tobacco product? The marketplace includes an array of new products, with many looking very different from the traditional tobacco products you may know about.
To attract users, tobacco companies regularly modify their products and introduce novel tobacco products to the market. “Parents should stay updated on the various products available and, discuss the dangers of tobacco use with their children,” says Ii-Lun Chen, M.D., a pediatrician and medical branch chief in the Office of Science at FDA’s Center for Tobacco Products.

The basic components of most cigarettes are tobacco, a filter, and paper wrapping. Although smokers use cigarettes to get nicotine, they are exposed to toxic and cancer-causing chemicals that are created when the cigarette is burned.

Cigars, Little Cigars, Cigarillos

Generally, cigars are cured tobacco wrapped in leaf tobacco or a substance containing tobacco. Cigars vary in size — with smaller sizes sometimes referred to as little cigars or cigarillos. Large cigars can deliver as much as 10 times the nicotine, 2 times more tar, and more than 5 times the carbon monoxide than a filtered cigarette. Although cigarettes with characterizing flavors are illegal, there are products available on the market that look like cigarettes but are labeled as “little cigars,” and some include candy and fruit flavors that appeal to adolescents and youth adults. Cigars also may appeal to youth because they may be less expensive than cigarettes. In addition, young adults may think that cigars are less addictive and present fewer health risks than cigarettes.

Dissolvable Products

In the past, smokeless tobacco products have required spitting or discarding the product remains. There are new tobacco products that are not smoked and are often called “dissolvables.” These products can be more easily concealed as no product disposal is needed. They are sold as lozenges, strips, or sticks, and may look like candy. The advertised appealing flavor and discreet forms of these products may encourage young people to take them up, but the nicotine content can lead to addiction and may also present an accidental poisoning risk for children.


Electronic Cigarettes (Also Referred to as: Vape Pen, e-Hookah, Hookah Pen)

Electronic cigarettes often resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn “e-liquid,” a liquid that usually contains nicotine from tobacco and flavorings, into an aerosol that is inhaled by the user. The amount of nicotine in the aerosol may vary by brand. Little information about the safety of electronic cigarettes exists.

Traditional Smokeless Tobacco Products

There are two main types of smokeless tobacco that have been traditionally marketed in the United States: chewing tobacco and moist snuff. Chewing tobacco is cured tobacco in the form of loose leaf, plug, or twist. Snuff is finely cut or powdered, cured tobacco that can be dry, moist, or packaged in sachets. Snus is a finely ground moist snuff that can be loose or packaged. Most smokeless tobacco use involves placing the product between the cheek or lip and the gum.

The availability of flavored, lower-nicotine, smokeless tobacco products lacking harsh attributes promoted by manufacturers may allow for experimentation by new users, but may also lead to nicotine addiction and continued use of smokeless or other tobacco products. Over time, smokeless tobacco users may switch from lower-nicotine smokeless tobacco products to products that deliver more nicotine.

Waterpipes (Also Referred to as: Hookah, Shisha, Narghile, Argileh)

Waterpipes (also known as hookah, shisha, narghile, or argileh) are used to smoke specially made tobacco that comes in a variety of flavors like mint, cherry and licorice. Waterpipe smoking delivers the addictive drug nicotine and the smoke from a waterpipe is at least as toxic as, or more toxic than cigarette smoke. In fact, research shows that waterpipe smokers may absorb even more of the harmful components found in cigarette smoke because smoking sessions are longer. A typical one-hour hookah session involves inhaling 100–200 times the volume of smoke from a single cigarette. Waterpipe tobacco flavoring, exotic paraphernalia, and social use at hookah bars have increased its popularity with people who don’t already smoke cigarettes and younger people in the United States.

What FDA Currently Regulates

Currently, FDA regulates the manufacture, marketing and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has recently issued a proposed rule to bring additional products that meet the Tobacco Control Act’s definition of a tobacco product under FDA’s regulatory authority, including electronic cigarettes, some or all cigars, pipe tobacco, dissolvables, and waterpipe tobacco. The proposed rule will be available for public comment for 75 days and FDA encourages the public to submit comments, data, research, or other information related to the proposed rule.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

April 24, 2014

PRESIDENT OBAMA MARKES REMARKS TO MIRAIKAN SCIENCE AND YOUTH EXPO IN TOKYO, JAPAN

FROM:  THE WHITE HOUSE PRESIDENT 

Remarks by President Obama to Miraikan Science and Youth Expo

Miraikan Museum

Tokyo, Japan

3:27 P.M. JST

PRESIDENT OBAMA:  Konnichiwa.  Please sit down.  Thank you so much.  Well, I want to thank Dr. Mohri and everyone at The Miraikan for welcoming me here today.  And it is wonderful to see all of these outstanding students.  Dr. Mohri is a veteran of two space shuttle missions, embodies the spirit that brings us here together —- the incredible cooperation in science and technology between Japan and the United States.

I want to thank all the students that I had a chance to meet with as we went around the various exhibits.  We heard a message from the international space station.  We saw some truly amazing robots -- although I have to say the robots were a little scary. They were too lifelike.  They were amazing.  And these students showed me some of their experiments, including some soccer-playing robots that we just saw.  And all of the exhibits I think showed the incredible breakthroughs in technology and science that are happening every single day.

And historically, Japan and the United States have been at the cutting-edge of innovation.  From some of the first modern calculators decades ago to the devices that we hold in our hands today -- the smartphones that I’m sure every young person here uses -- Japan and the United States have often led the way in the innovations that change our lives and improve our lives.

And that’s why I’m so pleased that the United States and Japan are renewing the 10-year agreement that makes so much of our science and technology cooperation possible.  Both of our societies celebrate innovation, celebrate science, celebrate technology.  We’re close partners in the industries of tomorrow. And it reminds us why it’s so important for us to continue to invest in science, technology, math, engineering.  These are the schools -- these are the skills that students like all of you are going to need for the global economy, and that includes our talented young women.

Historically, sometimes young women have been less represented in the sciences, and one of the things that I’ve really been pushing for is to make sure that young women, just like young men, are getting trained in these fields, because we need all the talent and brainpower to solve some of the challenges that we’re going to face in the future.

Earlier today, Prime Minister Abe and I announced a new initiative to increase student exchanges, including bringing more Japanese students to the United States.  So I hope you’ll come.  Welcome.  And it’s part of our effort to double students exchanges in the coming years.  As we saw today, young people like you have at your fingertips more technology and more power than even the greatest innovators in previous generations. So there’s no limit to what you can achieve, and the United States of America wants to be your partner.

So I’m very proud to have been here today.  I was so excited by what I saw.  The young people here were incredibly impressive.  And as one of our outstanding astronauts described, as we just are a few days after Earth Day, it’s important when we look at this globe and we think about how technology has allowed us to understand the planet that we share, and to understand not only the great possibilities but also the challenges and dangers from things like climate change -- that your generation is going to help us to find answers to some of the questions that we have to answer.  Whether it’s:  How do we feed more people in an environment in which it’s getting warmer? How do we make sure that we’re coming up with new energy sources that are less polluting and can save our environment?  How do we find new medicines that can cure diseases that take so many lives around the globe?  To the robots that we saw that can save people’s lives after a disaster because they can go into places like Fukushima that it may be very dangerous for live human beings to enter into.  These are all applications, but it starts with the imaginations and the vision of young people like you.

So I’m very proud of all of you and glad to see that you’re doing such great work.  You have counterparts in the United States who share your excitement about technology and science.  I hope you get a chance to meet them.  I hope you get a chance to visit the United States.  As far as I know, we don’t have one of those cool globes, but we have some other pretty neat things in the United States as well.  And I hope we can share those with you if and when you come.

Thank you very much.  And I just want you to know in closing that I really believe that each of you can make a difference.  Gambatte kudasai.  You can do this thing if you apply yourselves.  Thank you.  (Applause.)

END

FORMER ARMY SGT. WILL ACCEPT MEDAL OF HONOR IN HONOR OF SIX WHO GAVE THEIR LIVES

FROM:  THE DEFENSE DEPARTMENT 

White to Accept Medal of Honor in Memory of Comrades

By J.D. Leipold

Army News Service

WASHINGTON, April 24, 2014 – Former Army Sgt. Kyle J. White said that when he accepts the Medal of Honor from President Barack Obama at the White House on May 13, he will do so in honor of the five soldiers and one Marine "who gave their lives in the defense of freedom and the American way of life."
White spoke at a press conference yesterday at the National Guard Center in Charlotte, N.C., near where he now lives. White was just 20 when he was deployed to Afghanistan. On Nov. 9, 2007, his 14-man unit and squad of Afghan soldiers were brutally ambushed on three sides by Taliban fighters on a path descending from the village of Aranas into a valley.

"On May 13th when I'm awarded the Medal of Honor, I will tell their stories and preserve their memories… they will not be forgotten," the now-27-year-old Seattle native told the press and bloggers. "Their sacrifice and the sacrifices of so many others are what motivate me to wake up each and every day to be the best I can. Everything I do in my life is done to make them proud."
White was asked how strong the memory of the battle is now, after almost seven years, during which time he attained a bachelor's degree and became an investment analyst for a major bank.

"I would say for the first couple of years, memories were more vivid than today. As time goes on certain things you think about less and less, but at any given moment I can close my eyes and hear the sounds and smell the gunpowder in the air; but six and a half years later, I don't think about it as much as I used to," he said.

He did share that there were two things he can always visualize as if it were yesterday -- when he looked up from applying a tourniquet to wounded Marine Sgt. Phillip Bocks to see then-Spc. Kain Schilling take an enemy round to his left leg. White rushed to his buddy and for the second time that day applied a second tourniquet to Schilling, the only one he had left, his own belt.
White will receive the Medal of Honor for his disregard of his own life while trying to save the lives of a Marine and two fellow soldiers after his team of 14 U.S. soldiers and squad of Afghan National Army soldiers were set up and ambushed by a much larger and more heavily armed Taliban force, who engaged in a three-prong attack from elevated ground.

He will become the seventh living recipient of the nation's highest military decoration for conspicuous gallantry and valor during actions in Iraq or Afghanistan.

PRESIDENT OBAMA'S STATEMENT ON ARMENIAN REMEMBRANCE DAY

FROM:  THE WHITE HOUSE 

Statement by the President on Armenian Remembrance Day

Today we commemorate the Meds Yeghern and honor those who perished in one of the worst atrocities of the 20th century.  We recall the horror of what happened ninety-nine years ago, when 1.5 million Armenians were massacred or marched to their deaths in the final days of the Ottoman Empire, and we grieve for the lives lost and the suffering endured by those men, women, and children.   We are joined in solemn commemoration by millions in the United States and across the world.   In so doing, we remind ourselves of our shared commitment to ensure that such dark chapters of human history are never again repeated.
 
I have consistently stated my own view of what occurred in 1915, and my view has not changed.  A full, frank, and just acknowledgement of the facts is in all of our interests.  Peoples and nations grow stronger, and build a foundation for a more just and tolerant future, by acknowledging and reckoning with painful elements of the past.  We continue to learn this lesson in the United States, as we strive to reconcile some of the darkest moments in our own history.   We recognize and commend the growing number of courageous Armenians and Turks who have already taken this path, and encourage more to do so, with the backing of their governments, and mine.  And we recall with pride the humanitarian efforts undertaken by the American Committee for Syrian and Armenian Relief, funded by donations from Americans, which saved the lives of countless Armenians and others from vulnerable communities displaced in 1915.
 
As we honor through remembrance those Armenian lives that were unjustly taken in 1915, we are inspired by the extraordinary courage and great resiliency of the Armenian people in the face of such tremendous adversity and suffering.  I applaud the countless contributions that Armenian-Americans have made to American society, culture, and communities.  We share a common commitment to supporting the Armenian people as they work to build a democratic, peaceful, and prosperous nation. 
 
Today, our thoughts and prayers are with Armenians everywhere, as we recall the horror of the Meds Yeghern, honor the memory of those lost, and reaffirm our enduring commitment to the people of Armenia and to the principle that such atrocities must always be remembered if we are to prevent them from occurring ever again.

CO. AND AFFILIATES TO PAY $150 MILLION FOR ALLEGEDLY BILLING MEDICARE FOR INELIGIBLE PATIENTS AND SERVICES

FROM:  U.S. JUSTICE DEPARTMENT 
Wednesday, April 23, 2014

Amedisys Home Health Companies Agree to Pay $150 Million to Resolve False Claims Act Allegations

Amedisys Inc. and its affiliates (Amedisys) have agreed to pay $150 million to the federal government to resolve allegations that they violated the False Claims Act by submitting false home healthcare billings to the Medicare program, the Department of Justice announced today.  Amedisys, a Louisiana-based for-profit company, is one of the nation’s largest providers of home health services and operates in 37 states, the District of Columbia and Puerto Rico.  
“It is critical that scarce Medicare home health dollars flow only to those who provide qualified services,” said Stuart F. Delery, Assistant Attorney General for the Civil Division.  “This settlement demonstrates the department’s commitment to ensuring that home health providers, like other providers, comply with the rules and don’t misuse taxpayer dollars.”

The settlement announced today resolves allegations that, between 2008 and 2010, certain Amedisys offices improperly billed Medicare for ineligible patients and services.  Amedisys allegedly billed Medicare for nursing and therapy services that were medically unnecessary or provided to patients who were not homebound, and otherwise misrepresented patients’ conditions to increase its Medicare payments.  These billing violations were the alleged result of management pressure on nurses and therapists to provide care based on the financial benefits to Amedisys, rather than the needs of patients.  

Additionally, this settlement resolves certain allegations that Amedisys maintained improper financial relationships with referring physicians.  The Anti-Kickback Statute and the Stark Statute restrict the financial relationships that home healthcare providers may have with doctors who refer patients to them.  The United States alleged that Amedisys’ financial relationship with a private oncology practice in Georgia – whereby Amedisys employees provided patient care coordination services to the oncology practice at below-market prices – violated statutory requirements.

“Combating Medicare fraud and overbilling is a priority for my office, other components of the Department of Justice, and United States Attorneys’ Offices across the country,” said Zane David Memeger, United States Attorney for the Eastern District of Pennsylvania.  “We have recovered billions of dollars in federal health care funds from schemes such as the one alleged in this case.  Those are health care dollars that should be spent on legitimate medical needs.”
“Home health services are a large and growing part of our federal health care system,” said Sally Quillian Yates, United States Attorney for the Northern District of Georgia.  “Health care dollars must be reserved to pay for services needed by patients, not to enrich providers who are bilking the system.”
  “Amedisys made false Medicare claims, depriving the American taxpayer of millions of dollars and unlawfully enriching Amedisys,” said Joyce White Vance, U.S. Attorney for the Northern District of Alabama.  “The vigorous enforcement work by assistant U.S. attorneys in my office, along with their colleagues in North Georgia, Eastern Pennsylvania, Eastern Kentucky and the Civil Division of the Justice Department, has secured the return of $150 million to the taxpayers and stands as a warning to future wrongdoers that we will aggressively pursue them.”
“This settlement represents a significant recovery of public funds and an important victory for the taxpayers,” said Kerry B. Harvey, United States Attorney for the Eastern District of Kentucky.  “Fighting health care fraud and recovering tax payer dollars that fund our vital health care programs is one of the highest priorities for our district.”

Amedisys also agreed to be bound by the terms of a Corporate Integrity Agreement with the Department of Health and Human Services – Office of Inspector General that requires the companies to implement compliance measures designed to avoid or promptly detect conduct similar to that which gave rise to the settlement.  
“Improper financial relationships and false billing, as alleged in this case, can shortchange taxpayers and patients,” said Daniel R. Levinson, Inspector General for the U.S. Department of Health and Human Services.  “Our compliance agreement with Amedisys contains strong monitoring and reporting provisions to help ensure that people in Federal health programs will be protected.”  
This settlement resolves seven lawsuits pending against Amedisys in federal court – six in the Eastern District of Pennsylvania and one in the Northern District of Georgia – that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.  As part of today’s settlement, the whistleblowers – primarily former Amedisys employees – will collectively split over $26 million.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $19.2 billion through False Claims Act cases, with more than $13.6 billion of that amount recovered in cases involving fraud against federal health care programs.

The United States’ investigation was conducted by the Justice Department’s Commercial Litigation Branch of the Civil Division; the United States Attorneys’ Offices for the Eastern District of Pennsylvania, Northern District of Alabama, Northern District of Georgia, Eastern District of Kentucky, District of South Carolina, and Western District of New York; the Department of Health and Human Services’ Office of Inspector General; the Federal Bureau of Investigation; the Office of Personnel Management’s Office of Inspector General; the Defense Criminal Investigative Service of the Department of Defense; and the Railroad Retirement Board’s Office of Inspector General.

The lawsuits are captioned United States ex rel. CAF Partners et al. v. Amedisys, Inc. et al. 10-cv-2323 (E.D. Pa.); United States ex rel. Brown v. Amedisys, Inc. et al., 13-cv-2803 (E.D. Pa.); United States ex rel. Umberhandt  v. Amedisys, Inc., 13-cv-2789 (E.D. Pa.); United States ex rel. Doe et al. v. Amedisys, Inc., 13-cv-3187 (E.D. Pa.); United States ex rel. Ognen et al. v. Amedisys, Inc. et al. 13-cv-4232 (E.D. Pa.); United States ex rel. Lewis v. Amedisys, Inc., 13-cv-3359 (E.D. Pa.); and United States ex rel. Natalie Raven et al. v. Amedisys, Inc. et al., 11-cv-0994 (N.D. Ga.).  The claims settled by the agreement are allegations only, and there has been no determination of liability.

ECOLOGISTS LOOK AT RELATIONSHIP BETWEEN YELLOWSTONE'S WILLOWS AND STREAMS

Photo:  Yellowstone Stream.  From: Wikimedia.

FROM:  NATIONAL SCIENCE FOUNDATION 
Earth Week: Whither Yellowstone's willows and the streams they shade?

Yellowstone's water table dropping below riverbank willow trees
Willows and streams. In Yellowstone, where there's one, the other isn't far behind.

On Earth Week, scientists are asking: How far do such connections reach?

New research on water-dependent willows shows that streams and willows may be conducting the music on Yellowstone's ecological dance floor.

Ecologists Tom Hobbs, Kristin Marshall and David Cooper published the results in a recent issue of the Journal of Ecology. Hobbs and Cooper are with Colorado State University (CSU) in Fort Collins, Marshall is at NOAA.

After wolves were extirpated from Yellowstone almost 100 years ago, elk multiplied, says Hobbs. The herbivores roamed across the landscape, nibbling willows to nubbins.

But the story doesn't end there.

With fewer willows to gnaw on, beavers began to decline. Crucially for willows, without the dams beavers build, which slow the flow of water, streams ran faster. Brooks soon became deeply carved into their banks from the force of rapidly-moving water.

Before long, the water table fell below the reach of streamside willows' roots.

Wolves and elk, beavers and willows: carefully choreographed parts

"All the possible interactions among plants and animals in nature are impossible to separately identify and measure," says Henry Gholz, program director in the National Science Foundation's (NSF) Division of Environmental Biology, which funds the Yellowstone willow research through its Long Term Research in Environmental Biology (LTREB) Program.

"Yet scientists know these links are critical to the maintenance of functional ecosystems."

Over a 30-year-period, Hobbs and colleagues studied riparian willow (Salix spp.) establishment and stem growth. In Yellowstone's northern range, the scientists reconstructed willows' history from tree rings. The three-decade time-frame covered the reintroduction of wolves in 1995.

"What happens to willows is shaped more by how high the water table is," says Hobbs, "than by any other factor."

The finding shows how complicated ecosystem links can be, says Gholz. "The effects of elk browsing on streamside willows in Yellowstone over the past 30 years are related more to variations in year-to-year climate, age of the willow trees, and changes in streams due to declining numbers of beavers."

The scientists used climate variables such as annual precipitation, stream flow and growing season length; the abundance of herbivores (elk); and landscape elevation and an index of "topographic wetness" (how soggy the ground is) to predict willow growth before and after the reintroduction of wolves.

"Explaining variability in [willow] establishment required models with stream flow, annual precipitation and elk abundance," write the ecologists in their paper.

"The results show that changes in the growth of willows after the reintroduction of wolves," says Marshall, "can't be understood without considering all the variables."

Life as a willow: water required

Picture a willow as it leans over a river or stream. Willows, sallows and osiers form the genus Salix, made up of some 400 species of deciduous trees and shrubs. All are found on moist soils in cold and temperate regions of the Northern Hemisphere.

Most are known as willows, but some narrow-leaved shrub species are called osiers, and broader-leaved species are referred to as sallows, from an Old English word derived from the Latin term salix.

Willows are the dominant riparian, or riverside, woody vegetation in Yellowstone and across the Rocky Mountains, according to Hobbs.

In Yellowstone, willows are found along rivers and streams, as well as near springs, seeps and anywhere water is available.

"As long as willows' roots can reach groundwater," says Hobbs, "the trees can survive--and withstand very high levels of browsing by elk. It all comes down to water."

On Earth Week and every week, the dance of life needs all the partners

Restoring an ecologically complete ecosystem in Yellowstone requires the return of willows--and with them, beavers, says Hobbs.

Once willows have returned, beavers will gnaw down a certain number of the trees to build dams. The dams will slow stream flow, allowing yet more willows to grow.

Willows, streams and beavers; wolves and elk. Willows and streams may have the first dance. But without them all, Yellowstone's ecological music will eventually fade away.

-- Cheryl Dybas
Investigators
Fred Watson
David Cooper
Jennifer Hoeting
Matthew Kauffman
N. Thompson Hobbs
Related Institutions/Organizations
Colorado State University

JAPANESE AUTO PARTS MANUFACTURER PLEADS GUILTY IN PRICE FIXING/BID RIGGING CASE

FROM:  U.S. JUSTICE DEPARTMENT 

Wednesday, April 23, 2014

Japanese Automotive Parts Manufacturer Agrees to Plead Guilty to Price Fixing and Bid Rigging on Automobile Parts Installed in U.S. Cars

Company Agrees to Pay $19.9 Million Criminal Fine

Showa Corp., an automotive parts manufacturer based in Saitama, Japan, has agreed to plead guilty and to pay a $19.9 million criminal fine for its role in a conspiracy to fix prices and rig bids for pinion-assist type electric powered steering assemblies installed in cars sold in the United States and elsewhere, the Department of Justice announced today.

According to a one-count felony charge filed today in the U.S. District Court for the Southern District of Ohio in Cincinnati, Showa engaged in a conspiracy to suppress and eliminate competition in the automotive parts industry by agreeing to rig bids for, and to fix, stabilize and maintain the prices of, certain pinion-assist type electric powered steering assemblies sold to Honda Motor Co. Ltd. and certain of its subsidiaries in the United States and elsewhere.  In addition to the criminal fine, Showa has agreed to cooperate with the department’s ongoing investigation.  The plea agreement will be subject to court approval.

“Today’s guilty plea marks the 27th time a company has been held accountable for fixing prices on parts used to manufacture cars in the United States,” said Bill Baer, Assistant Attorney General in charge of the Department of Justice’s Antitrust Division.  “The Antitrust Division and its law enforcement partners remain committed to prosecuting illegal cartels that harm U.S. consumers and businesses.”

According to the charge, Showa and its co-conspirators carried out the conspiracy through meetings, conversations and communications in which they discussed and agreed upon bids and price quotations on pinion-assist type electric powered steering assemblies to be submitted to Honda.  Showa then submitted quotations in accordance with those agreements and sold pinion-assist type electric powered steering assemblies at collusive and noncompetitive prices.  Showa and its co-conspirators monitored adherence to the agreed-upon bid-rigging and price-fixing scheme.  The conspirators kept their conduct secret by using code names and meeting at remote locations, among other things.  Showa’s involvement in the conspiracy lasted from at least as early as 2007 until as late as September 2012.

Showa manufactures and sells pinion-assist type electric powered steering assemblies.  These devices provide power to the steering gear pinion shaft from electric motors to assist the driver to more easily steer the automobile.  Pinion-assist type electric powered steering assemblies include an electronic control unit and link the steering wheel to the tires but do not include the column, intermediate shaft, steering wheel or tires.

Including Showa, 27 companies and 24 executives have pleaded guilty or agreed to plead guilty in the division’s ongoing investigation into price fixing and bid rigging in the auto parts industry and have agreed to pay a total of $2.3 billion in criminal fines.

Showa Corp. is charged with price fixing and bid rigging in violation of the Sherman Act, which carries maximum penalties of a $100 million criminal fine for corporations.  The maximum fine may be increased to twice the gain derived from the crime or twice the loss suffered by the victims of the crime, if either of those amounts is greater than the statutory maximum fine.

Today’s charge is the result of an ongoing federal antitrust investigation into price fixing, bid rigging and other anticompetitive conduct in the automotive parts industry, which is being conducted by the Antitrust Division’s criminal enforcement sections and the FBI.  Today’s charge was brought by the Antitrust Division’s Chicago Office and the FBI’s Cincinnati Field Office with assistance from the U.S. Attorney’s Office for the Southern District of Ohio.

FDA TOUTS ADULT STEM CELL RESEARCH

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Adult Stem Cell Research Shows Promise

So What Are Stem Cells?

Why Is FDA Studying These Cells?

What's Being Done?

Scientists sporting white coats and safety gloves are working in a bright Food and Drug Administration (FDA) lab on an incredible project.

They are part of FDA’s MSC Consortium, a large team of FDA scientists studying adult mesenchymal stem cells (MSCs)—cells that could eventually be used to repair, replace, restore or regenerate cells in the body, including those needed for heart and bone repair.

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

The research could ultimately be key to the advancement of personalized medicine, the practice in which medical treatment is tailored to the needs of an individual patient. “It’s not science fiction,” says Steven R. Bauer, Ph.D., chief of the Cellular and Tissue Therapy Branch in FDA’s Office of Cellular Tissue and Gene Therapies. “For me, regenerative medicine is the most exciting part of what we regulate in our office.”

So What Are Stem Cells?
There are two basic kinds of stem cells that are currently useful in the field of regenerative medicine: multipotent and pluripotent stem cells. Multipotent stem cells are generally taken from adults and can divide and develop into many different cell types. Pluripotent stem cells can develop into any type of cell in the body. Both types could divide to replenish cells damaged by injury, illness or normal wear. When stem cells divide, the new cells can either remain stem cells or develop into a new type of cell with a more specific function.
Two types of pluripotent stem cells exist: human embryonic stem cells and induced pluripotent stem cells, which are created by reprogramming adult cells that had already changed into a mature type of cell.

FDA’s MSC Consortium is not studying stem cells taken from embryos. “We’re looking at a particular kind of multipotent adult stem cell—the MSC—which is being used in a lot of regenerative medicine clinical trials,” adds Bauer.

The group is currently studying eight unique cell lines, each acquired from commercial sources and sourced to one of eight distinct, adult donors. (Males and females age 22 to 47 donated stem cells from bone marrow.)

The cells under study are multipotent: “They can differentiate (mature into) at least three cell types: bone, fat and cartilage, primarily,” Bauer explains. “They can also differentiate into nerve cells, liver cells and a kind of cell called ‘stroma’ that is in the bone marrow and supports blood forming cells. Then, for investigational clinical uses, they’ve been used for repairing hearts, repairing bone and repairing cartilage.”

Why Is FDA Studying These Cells?
In addition to differentiating into a variety of replacement cell types, MSCs can limit a patient’s immune response. So they can potentially be taken from one human donor and placed into a different recipient with less possibility of rejection.

But growing stem cells and making sure they are safe and effective is challenging, which is one reason why stem-cell based clinical trials have not yet resulted in a marketed product.

“The major challenge is that cells are much more complex than traditional products that FDA regulates. And they have the ability to respond to their environment,” Bauer explains. “Taking them out of the body and manufacturing them—that is, growing large numbers of them—or isolating them can change their biology. And it can change the way they behave if they are put back into the patient.”

For instance, if cells are manufactured in large quantities outside their natural environment, they may become ineffective or develop harmful characteristics. For example, they can produce tumors, severe immune reactions or growth of unwanted tissue. So FDA is trying to develop methods that would predict with more certainty how manufactured or isolated adult stem cells will behave in patients.

What's Being Done?
In the labs, cells are suspended in a nutrient liquid solution and grown in sterile containers called tissue culture flasks. Cells then multiply and go through three, five or seven generations of growth.
FDA scientists are using a variety of cutting-edge methods to characterize cells and then determine if any of these characteristics can predict the behavior of the cells in biological assays or in animal models. The next step will be to determine if any characteristics they measure will predict the safety or effectiveness of stem-cell based products in patients.

Specifically, scientists will continue studying whether factors such as different methods of growing the cells, donor age or gender affects the cells’ quality and performance. This research will ultimately provide new tools to the community of academic and private industry scientists who are interested in evaluating and developing stem cells into new clinical treatments.

“The consortium has shown that widely accepted ways to identify and characterize MSCs do not reveal some important biological differences between batches of these cells,” Bauer says. So the consortium seeks to demonstrate ways to better characterize MSCs that will be used in clinical trials. That’s important because, if investigators can improve the tools used to characterize MSCs used for clinical trials, the data generated from their studies could also improve because their MSC products will be more predictable, he adds.

And the improved predictability of their products will, in turn, allow FDA scientists to more easily evaluate the safety and effectiveness of new stem cell technologies—a key part of the regulatory science that is the foundation of FDA decisions.

Agency scientists already have published six papers in scientific journals such as Tissue Engineering and Cytotherapy. “We’re hoping this project will inspire people to do more research in this area,” Bauer says.

Stem cells, like other medical products intended to treat, cure or prevent disease, require FDA approval before they can be marketed. “It is important for FDA to maintain a sound regulatory science research program to promote the development of safe and effective products in emerging areas that hold great promise,” Bauer says.

“My colleagues and I hope our scientific findings will be helpful in the field of regenerative medicine, including the ability to repair or even replace organs and tissues more safely and effectively than traditional means,” he adds. “Although there are many scientific hurdles to overcome before the use of stem cells reaches its full potential, I think this medicine will eventually have the capacity to do that.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

DEFENSE SECRETARY HAGEL OBSERVES DEVELOPING TECH DEMONSTRATION

Right:  Arati Prabhakar, director of the Defense Advanced Research Projects Agency, briefs Defense Secretary Chuck Hagel on the Atlas robot and other robotics at the Pentagon, April 22, 2014. The program showcased DARPA technologies and how they contribute to U.S. national security. DOD photo by Marine Corps Sgt. Aaron Hostutler.  

FROM:  U.S. DEFENSE DEPARTMENT 
DARPA Officials Show Hagel Technologies Under Development
American Forces Press Service

WASHINGTON, April 23, 2014 – Defense Advanced Research Projects Agency program personnel demonstrated five technologies under development to Defense Secretary Chuck Hagel in the secretary's conference room yesterday.
DARPA Director Arati Prabhakar provided the secretary with a demonstration of the agency's latest prosthetics technology.

The wounded warrior demonstrating the device was Fred Downs Jr., an old friend of Hagel's who lost an arm in a landmine explosion while fighting in Vietnam. Hagel hugged him and shook his mechanical hand, with Downs joking, "I don't want to hurt you."

"He and I worked together many years ago," said Hagel, who earned two Purple Hearts during his service as an enlisted soldier in Vietnam. "How you doing, Fred? How's your family?"

Downs demonstrated how he controls movements of the arm, which appeared to be partly covered in translucent white plastic, with two accelerometers strapped to his feet. Through a combination of foot movements, he's able to control the elbow, wrist and fingers in a variety of movements, including the “thumbs-up” sign he gave Hagel.

It took only a few hours to learn to control the arm, Downs said.
"It's the first time in 45 years, since Vietnam, I'm able to use my left hand, which was a very emotional time," he said.

Dr. Justin Sanchez, a medical doctor and program manager at DARPA who works with prosthetics and brain-related technology, told Hagel that DARPA's arm is designed to mimic the shape, size and weight of a human arm. It's modular too, so it can replace a lost hand, lower arm or a complete arm.

Hagel said such technology would have a major impact on the lives of injured troops.

"This is transformational," he said. "We've never seen anything like this before."
Next, Sanchez showed Hagel a video of a patient whose brain had been implanted with a sensor at the University of Pittsburgh, allowing her to control an arm with her thoughts.

Matt Johannes, an engineer from the Johns Hopkins University Applied Physics Laboratory, showed Hagel a shiny black hand and arm that responds to brain impulses. The next step is to put sensors in the fingers that can send sensations back to the brain.

"If you don't have line of sight on something you're trying to grab onto, you can use that sensory information to assist with that task," Johannes said.
The tactile feedback system should be operational within a few months, he said.
"People said it would be 50 years before we saw this technology in humans," Sanchez said. "We did it in a few years."

Next, officials gave Hagel an overview of the DARPA Robotic Challenge, a competition to develop a robot for rescue and disaster response that was inspired by the March 2011 Fukushima nuclear incident in Japan.

Virginia Tech University's entrant in the contest, the hulking 6-foot-2-inch Atlas robot developed by Boston Dynamics, stood in the background as Hagel was shown a video of robots walking over uneven ground and carrying things.

Brad Tousley, head of DARPA's Tactical Technology Office, explained to Hagel that Hollywood creates unrealistic expectations of robotic capability. In fact, he said, building human-like robots capable of autonomously doing things such as climbing ladders, opening doors and carrying things requires major feats of engineering and computer science.

Journalists were escorted out before the remaining three technologies could be demonstrated because of classified concerns. A defense official speaking on background told reporters that Hagel was brought up to date on the progress of three other DARPA programs:

-- Plan X, a foundational cyberwarfare program to develop platforms for the Defense Department to plan for, conduct and assess cyberwarfare in a manner similar to kinetic warfare;

-- Persistent close air support, a system to, among other things, link up joint tactical air controllers with close air support aircraft using commercially available tablets; and

-- A long-range anti-ship missile, planned to reduce dependence on intelligence, surveillance and reconnaissance platforms, network links and GPS navigation in electronic warfare environments. Autonomous guidance algorithms should allow the LRASM to use less-precise target cueing data to pinpoint specific targets in the contested domain, the official said. The program also focuses on innovative terminal survivability approaches and precision lethality in the face of advanced countermeasures.

(From a pool report.)

U.S. DEFENSE DEPARTMENT CONTRACTS FOR APRIL 23, 2014

FROM:  U.S. DEFENSE DEPARTMENT 

CONTRACTS

NAVY

Midwest Air Traffic Control Service Inc., Overland Park, Kan. (N65236-14-D-4984) and Readiness Management Support LC, Panama City, Fla. (N65236-14-D-4985), are each being awarded an indefinite-delivery/indefinite-quantity, cost-plus-fixed-fee, with provisions for firm-fixed-price task orders, performance based contract. The contracts are for the procurement of air traffic management and electronic equipment maintenance services to support air traffic control operations, airfield management, air to ground communications operations and maintenance, surveillance and precision radar systems operations and maintenance, voice communications systems operations and maintenance, and aviation command and control operations and maintenance. The cumulative, estimated ceiling value of the base year is $109,874,600. These contracts include options, which if exercised, would bring the cumulative ceiling value of these contracts to an estimated $330,295,200. This contract action merely establishes a potential ceiling value and does not obligate the Navy to fund to the ceiling. Work will be performed in Southwest Asia. Work is expected to be completed by April 2015. If all options are exercised, work could continue until April 2019. SPAWAR Systems Center Atlantic Navy working capital funds in the amount of $25,000 will be obligated at the time of award as the minimum guarantee and will be split among the two awardees; these funds will not expire at the end of the current fiscal year. This contract action establishes a potential ceiling value, in which funds are obligated on individual task orders for efforts that fall within the core competency areas. The multiple award contracts were competitively procured by full and open competition via the Space and Naval Warfare Systems Center e-Commerce Central website and the Federal Business Opportunities website, with three offers received. Space and Naval Warfare Systems Center Atlantic, Charleston, S.C., is the contracting activity.

Alliant Techsystems Operations LLC, Defense Electronic Systems, Northridge, Calif., is being awarded an $83,399,073 modification to a previously awarded firm-fixed-price contract (N00019-13-C-0162) for the full rate production Lot III of the advanced anti-radiation guided missile, to include conversion of 110 AGM-88B high-speed anti-radiation missiles to AGM-88E all-up-rounds and captive air training missiles, to include related supplies and services. Work will be performed in Northridge, Calif. (90 percent); Fusaro, Italy (8 percent); and Ridgecrest, Calif. (2 percent), and is expected to be completed in December 2016. Fiscal 2014 weapons procurement, Navy contract funds in the amount of $83,399,073 will be obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command, Patuxent River, Md., is the contracting activity.

CDW Government, Vernon Hills, Ill., is being awarded $22,982,965 for delivery order 0024, under a previously awarded requirements contract (M67854-12-D-4153) for a quantity of 19,073 general purpose laptops to support the next generation enterprise network computer refresh. Work will be performed in Whitsett, N.C., and is expected to be completed by March 30, 2015. Fiscal 2012 procurement Marine Corps funds in the amount of $11,621,020 and fiscal 2013 procurement Marine Corps funds in the amount of $11,361,945 will be obligated at the time of award. Contract funds in the amount of $11,621, 020 will expire at the end of the current fiscal year. The Marine Corps Systems Command, Quantico, Va., is the contracting activity.

Battelle Memorial Institute, Columbus, Ohio, is being awarded $15,000,000 modification under a previously awarded cost-plus-fixed-fee contract (N62583-11-D-0515) to exercise the third option period for environmental services and technologies support at Naval Facilities Engineering and Expeditionary Warfare Center, Port Hueneme, Calif. The work to be performed provides for environmental services and technology support to satisfy overall operational objectives of the U.S. Navy and Marine Corps installations and to other federal organizations world-wide. Support services include technology implementation, technical consultation, research and development, testing and evaluation, administrative support, range cleanup, sustainability and management, site operation and maintenance, climate change initiatives, green and sustainable remediation practices development, leadership in environmental and energy design support, and training. After award of this option, the total cumulative contract value will be $60,000,000. No task orders are being issued at this time. Work will be performed at various installations world-wide, and work for this option period is expected to be completed April 2015. No funds will be obligated at time of award; funds will be obligated on individual task orders as they are issued using fiscal 2014 operations and maintenance, Navy; fiscal 2014 Navy working capital funds; and fiscal 2014 base realignment and closure funds. The Naval Facilities Engineering and Expeditionary Warfare Center, Port Hueneme, Calif., is the contracting activity.

Raytheon Co., El Segundo, Calif., is being awarded a $12,635,487 modification to a previously awarded cost-plus-incentive-fee contract (N00019-13-C-0128) to provide additional funding for developmental efforts in support of the Technology Development Phase of the Next Generation Jammer Program, which will replace the aging ALQ-99 Tactical Jamming System for integration on the EA-18G tactical aircraft. Work will be performed in El Segundo, Calif. (63 percent); Dallas, Texas (21 percent); and Fort Wayne, Ind. (16 percent), and is expected to be completed in February 2016. Fiscal 2014 research, development, test and evaluation, Navy funds in the amount of $9,969,811 are being obligated at time of award, none of which will expire at the end of the current fiscal year. The Naval Air Systems Command, Patuxent River, Md., is the contracting activity.

ARMY

Northrop Grumman Systems Corp., Linthicum Heights, Md. was awarded a $40,691,060 firm-fixed-price multi-year contract to provide up to 94 systems of Small Tactical Radar - Lightweight (STARLite) Synthetic Aperture Radar/Ground Moving Target Indicator (SAR/GMTI) systems [a STARLite consists of one Aviation (A-Kit) and one B-Kit] for the U.S. Army. Fiscal 2013 other procurement, Army funds in the amount of $34,941,007 and fiscal 2014 other procurement, Army funds in the amount of $5,750,053 were obligated at the time of the award. Estimated completion date is April 22, 2017. One bid was solicited and one received. Work will be performed in Linthicum Heights Md. Army Contracting Command, Aberdeen, Md. is the contracting activity (W15P7T-14-C-C005).

Architura Corp.,* Indianapolis, Ind. (W91SMC-14-D-0001); Bailey Edward Design, Inc.,* Chicago, Ill. (W91SMC-14-D-0002); Integrated Design JV,* Taylor Springs, Ill (W91SMC-14-D-0003) were awarded a $10,000,000 firm-fixed-price, multi-year task order contract for the acquisition of architecture- engineering services (design and rehab) for the Illinois Air and Army National Guard. Funding and work location will be determined with each order. Estimated completion date is April 24, 2019. Bids were solicited via the Internet with thirty-three received. National Guard Bureau, Springfield, Ill. is the contracting activity.
Jacobs Engineering Group, Inc., St. Louis, Mo. was awarded a $9,000,000 firm-fixed-price indefinite-delivery/indefinite-quantity contract for architect/engineer services, and design for Army Reserve projects nationwide and military projects within the Great Lakes and Ohio River Division Boundaries. Funding and work location will be determined with each order. Estimated completion date is April 22, 2019. Bids were solicited via the Internet with thirty-two received. Army Corps of Engineers, Louisville, Ky. is the contracting activity (W912QR-14-D-0009).

Overhaul Support Services, LLC, East Granby, Conn. was awarded a $7,469,306 firm-fixed-price contract for the Drag Brace Landing for the Blackhawk weapons system. The minimum quantity is 300 each and the maximum quantity is 1,224 each. Funding and work location will be determined with each order. Estimated completion date is April 23, 2019. Two bids were solicited with one received. Army Contracting Command, Redstone Arsenal, Ala. is the contracting activity (W58RGZ-14-D-0077).

AIR FORCE

URS Federal Technical Services Inc., Germantown, Md., has been awarded a $15,815,983 modification (P00056) for the exercise of option year four of a fixed-price-plus-award-fee contract (FA4890-10-C-0007) to continue to provide program support for Air Combat Command's Unmanned Aircraft System Operations Center Support currently, but not limited to, the MQ-1 Predator and MQ-9 Reaper, that provide warfighter long endurance, real time reconnaissance and surveillance, and precision attack against fixed and time critical targets. The contract modification is for the exercise of option year four services for the period of performance from July 1, 2014 through June 30, 2015. Work will be performed at Creech Air Force Base, Nev., Ellsworth AFB, S.D., Holloman AFB, N.M., and Whiteman AFB, Mo., and is expected to be completed by June 30, 2015. The modification is being incrementally funded, and the first three months of funding will be obligated via this modification in the amount of $3,617,882 with fiscal 2014 operations and maintenance funds. The contract includes eight percent foreign military sales for the United Kingdom. ACC AMIC/PKCC, Newport News, Va., is the contracting activity.

Thales Defense & Security Inc., Clarksburg, Md., has been awarded an $11,704,727 firm-fixed-price contract to deliver to the Saudi Arabia National Guard (SAG) equipment to implement an air traffic control system. It includes one cost-plus-fixed-fee line item for repair and return services. This system will provide precision approach services, airspace control services and navigational capabilities to support visual flight rules, special visual flight rules and instrument flight rules operational and mission requirements within the terminal area for fixed and rotary wing aircraft. This ATC system is for two SAG airbases, Khasam Al An and Dirab Air Bases, and work is expected to be completed by 2024. This award is the result of a competitive acquisition, one solicitation was issued and six offers were received. This is 100 percent foreign military sales for the Kingdom of Saudi Arabia. Air Force Life Cycle Management Center/HBAK, Hanscom Air Force Base, Mass., is the contracting activity (FA8730-14-C-0004).

DOD WILL CERTIFY TO CONGRESS, EGYPT IS MEETING OBLIGATIONS UNDER '79 EGYPT-ISRAEL PEACE TREATY

FROM:  U.S. DEFENSE DEPARTMENT 
Hagel Notifies Egypt of Upcoming U.S. Certification
American Forces Press Service

WASHINGTON, April 23, 2014 – Defense Secretary Chuck Hagel informed his Egyptian counterpart yesterday that Secretary of State John F. Kerry soon will certify to Congress that Egypt is sustaining the strategic relationship with the United States and is meeting its obligations under the 1979 Egypt-Israel Peace Treaty.

In a statement summarizing Hagel’S phone call to Egyptian Defense Minister Col. Gen. Sedki Sobhy, Pentagon Press Secretary Navy Rear Adm. John Kirby said these certifications are required to obligate fiscal year 2014 funds for assistance to the Egyptian government.

“Secretary Hagel told General Sobhy that we are not yet able to certify that Egypt is taking steps to support a democratic transition,” Kirby said, “and he urged the Egyptian government to demonstrate progress on a more inclusive transition that respects the human rights and fundamental freedoms of all Egyptians.”
Hagel also informed Sobhy of President Barack Obama's decision to deliver 10 Apache helicopters in support of Egypt’s counterterrorism operations in the Sinai, Kirby said.

“The secretary noted that we believe these new helicopters will help the Egyptian government counter extremists who threaten U.S., Egyptian, and Israeli security,” he added. “This is one element of the president’s broader efforts to work with partners across the region to build their capacity to counter terrorist threats, and is in the United States’ national security interest.”

Why Earth Matters to NASA: A Conversation with Harrison Ford

NSF ON ROCKY MOUNTAIN BARK BEETLES AND WATER QUALITY

Photo:  Rocky Mountains. Credit:  Wikimedia, Williams Jim, U.S. Fish and Wildlife Service. 

FROM:  NATIONAL SCIENCE FOUNDATION 

Earth Week: Bark beetles change Rocky Mountain stream flows, affect water quality

What happens when millions of dead trees, killed by beetles, no longer need water?

On Earth Week--and in fact, every week now--trees in mountains across the western United States are dying, thanks to an infestation of bark beetles that reproduce in the trees' inner bark.

Some species of the beetles, such as the mountain pine beetle, attack and kill live trees. Others live in dead, weakened or dying hosts.

In Colorado alone, the mountain pine beetle has caused the deaths of more than 3.4 million acres of pine trees.

What effect do all these dead trees have on stream flow and water quality? Plenty, according to new research findings reported this week.

Dead trees don't drink water

"The unprecedented tree deaths caused by these beetles provided a new approach to estimating the interaction of trees with the water cycle in mountain headwaters like those of the Colorado and Platte Rivers," says hydrologist Reed Maxwell of the Colorado School of Mines.

Maxwell and colleagues have published results of their study of beetle effects on stream flows in this week's issue of the journal Nature Climate Change.

As the trees die, they stop taking up water from the soil, known as transpiration. Transpiration is the process of water movement through a plant and its evaporation from leaves, stems and flowers.

The "unused" water then becomes part of the local groundwater and leads to increased water flows in nearby streams.

The research is funded by the National Science Foundation's (NSF) Water, Sustainability and Climate (WSC) Program. WSC is part of NSF's Science, Engineering and Education for Sustainability initiative.

"Large-scale tree death due to pine beetles has many negative effects," says Tom Torgersen of NSF's Directorate for Geosciences and lead WSC program director.

"This loss of trees increases groundwater flow and water availability, seemingly a positive," Torgersen says.

"The total effect, however, of the extensive tree death and increased water flow has to be evaluated for how much of an increase, when does such an increase occur, and what's the water quality of the resulting flow?"

The answers aren't always good ones.

Green means go, red means stop, even for trees

Under normal circumstances, green trees use shallow groundwater in late summer for transpiration.

Red- and gray-phase trees--those affected by beetle infestations--stop transpiring, leading to higher water tables and greater water availability for groundwater flow to streams.

The new results show that the fraction of late-summer groundwater flows from affected watersheds is about 30 percent higher after beetles have infested an area, compared with watersheds with less severe beetle attacks.

"Water budget analysis confirms that transpiration loss resulting from beetle kill can account for the increase in groundwater contributions to streams," write Maxwell and scientists Lindsay Bearup and John McCray of the Colorado School of Mines, and David Clow of the U.S. Geological Survey, in their paper.

Dead trees create changes in water quality

"Using 'fingerprints' of different water sources, defined by the sources' water chemistry, we found that a higher fraction of late-summer streamflow in affected watersheds comes from groundwater rather than surface flows," says Bearup.

"Increases in stream flow and groundwater levels are very hard to detect because of fluctuations from changes in climate and in topography. Our approach using water chemistry allows us to 'dissect' the water in streams and better understand its source."

With millions of dead trees, adds Maxwell, "we asked: What's the potential effect if the trees stop using water? Our findings not only identify this change, but quantify how much water trees use."

An important implication of the research, Bearup says, is that the change can alter water quality.

The new results, she says, help explain earlier work by Colorado School of Mines scientists. "That research found an unexpected spike in carcinogenic disinfection by-products in late summer in water treatment plants."

Where were those water treatment plants located? In bark beetle-infested watersheds.

-- Cheryl Dybas, NSF
Investigators
Reed Maxwell
Eric Dickenson
Jonathan Sharp
Alexis Navarre-Sitchler
Related Institutions/Organizations
Colorado School of Mines

DOJ RELEASES ENVIRONMENT AND NATURAL RESOURCES DIVISION 2013 ACCOMPLISHMENTS

FROM:  U.S. JUSTICE DEPARTMENT 

Tuesday, April 22, 2014

Environment and Natural Resources Division Releases FY 2013 Accomplishments Report

The Justice Department’s Environment and Natural Resources Division (ENRD) today released its Fiscal Year (FY) 2013 Accomplishments Report {http://www.justice.gov/enrd/ENRD_Assets/ENRD_Accomplishments_Report_2013.pdf}, detailing its work alongside other federal agencies, U.S. Attorneys’ Offices, and state, local and tribal governments to enforce environmental and wildlife laws, protect our nation’s natural resources and ensure that all Americans enjoy clean air, water and land.

In the last fiscal year, the Justice Department continued carrying out its commitment to environmental justice to ensure the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental and natural resources laws and policies.   The division’s work advancing the goals of environmental justice is illustrated in a separate chapter of the report.

“The Environment Division’s work to protect our air, land and water from pollution is as critical to our nation’s health, security, and sustainability as it has ever been,” said Deputy Attorney General James M. Cole.  “As we face significant challenges from climate change, in developing alternative and sustainable sources of energy and addressing pollution to protect public health and the environment, we are grateful to the division and its attorneys for the work they do each day on behalf of the American people and future generations of Americans.”

“As this report shows, every day, the division works with client agencies, U.S. Attorneys’ offices, and state, local and tribal governments to enforce federal environmental, natural resources, and wildlife laws,” said Robert G. Dreher, Acting Assistant Attorney General for the Environment and Natural Resources Division.  “It also defends federal agency actions and rules when they are challenged in the courts, keeping the nation’s air, water, and land free of pollution, promoting military preparedness and national security, and supporting responsible stewardship of America’s forests, wildlife and other natural resources.   The division also handles a broad array of important matters affecting Indian tribes and their members.   Across all this work, we strive to ensure that all Americans enjoy clean air, water and land, implementing the department’s deep commitment to environmental justice.”

In FY 2013, the division secured over $1.78 billion in civil and stipulated penalties, cost recoveries, natural resource damages and other civil monetary relief, including almost $637 million recovered for the Superfund.   The division obtained almost $6.5 billion in corrective measures, through court orders and settlements, to protect the nation’s air, water and other natural resources.   It concluded 53 criminal cases against 87 defendants, obtaining nearly 65 years in confinement and over $79 million in criminal fines, restitution, community service funds and special assessments.   Finally, the handling of defensive and condemnation cases closed in fiscal year 2013 saved the United States an estimated $6.8 billion.

Among other highlights included in the FY 2013 Accomplishments report:

Accountability for the Deepwater Horizon Oil Spill

The division’s top civil enforcement priority remains the ongoing civil litigation and trial stemming from the April 20, 2010 explosion and fire that destroyed the Deepwater Horizon offshore drilling rig in the Gulf of Mexico and triggered a massive oil spill.  In December 2010, the United States brought a civil suit against BP, Anadarko, MOEX, and Transocean for civil penalties under the Clean Water Act and a declaration of liability under the Oil Pollution Act, as part of multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana.

Thus far, the department has secured over $1 billion in civil penalties through Deepwater Horizon settlements (with MOEX and Transocean), as well as far-reaching injunctive relief that should make Transocean’s deepwater drilling safer in the Gulf of Mexico.

The department tried the first phase of the U.S. case against the remaining defendants (addressing the cause of the disaster and liability) for nine weeks from February through April 2013, as part of a mass trial in which thousands of private plaintiffs also tried parts of their cases relating to liability and fault.   The second phase of the U.S. case (principally addressing how much oil was discharged into the Gulf) took place over three weeks in September and October 2013.   Both phases have been submitted to the district court for decision.   The district court in New Orleans has scheduled the third phase of trial in this matter, addressing assessment of civil penalties, to begin in January 2015.

Addressing Climate Change

Over the past year, the division made important contributions to combating the effects of climate change.  In January 2011, the Environmental Protection Agency’s (EPA’s) regulations governing motor vehicle emissions of greenhouse gases took effect, triggering not only mobile source regulation, but also regulation of the largest stationary sources in accordance with EPA’s greenhouse gas tailoring rule.   As of September 2012, the D.C. Circuit in Coalition for Responsible Regulation v. EPA upheld the agency’s greenhouse gas-related regulatory actions in their entirety.   Challengers filed nine separate petitions for writs of certiorari with the U.S. Supreme Court.   In July 2013, the Department’s Office of the Solicitor General, working closely with Division and client agency attorneys, filed an opposition to the petitions for certiorari.   On Oct. 15, 2013, the Supreme Court granted certiorari on six of the petitions, which were consolidated and limited to a single issue: “Whether EPA permissibly determined that its regulation of greenhouse gas emissions from new motor vehicles triggered permitting requirements under the Clean Air Act for stationary sources that emit greenhouse gases.”   The court denied the remaining three petitions, and rejected consideration of numerous additional issues raised by the petitions that were partially granted.   In February 2014, the Supreme Court heard oral argument in the case.

In March 2013, the D.C. Circuit affirmed the district court’s decision in In re Polar Bear Endangered Species Act Listing, thereby upholding the U.S. Fish and Wildlife Service’s 2008 listing of the polar bear under the Endangered Species Act as a threatened species throughout its range.   The listing decision was based primarily on the polar bears’ dependence on arctic sea ice for their survival, existing and projected reductions in the extent and quality of sea ice habitat due to global climate change, and the inadequacy of existing regulatory measures to preserve the species.

In a settlement reached with the United States in September 2013, Safeway, the nation’s second largest grocery store chain, agreed to pay a $600,000 civil penalty and to implement a corporate-wide plan to significantly reduce its emissions of ozone-depleting substances from refrigeration equipment at over 650 of its stores nationwide, at an estimated cost of $4.1 million.   The settlement resolves allegations that Safeway violated the Clean Air Act by failing to promptly repair leaks of HCFC-22, a hydrochlorofluorocarbon that has a global warming potential that is 1,800 times more potent than carbon dioxide.   This first-of-its-kind settlement should also serve as a model for comprehensive solutions across a company.

Combating Wildlife Trafficking

The department has long been a leader in the fight against wildlife trafficking.   Over the last year, the department engaged fully in the administration’s effort to combat wildlife trafficking through its role as one of the three agency co-chairs of the Presidential Task Force on Wildlife Trafficking, established by President Obama’s July 2013 Executive Order—Combating Wildlife Trafficking.   In the past decade, wildlife trafficking has escalated into an international crisis, making it both a critical conservation concern and a threat to global security.   Beyond decimating the world’s iconic species, this illegal trade threatens international security.   Transnational criminal organizations, including some terrorist networks, armed insurgent groups and narcotics trafficking organizations, are increasingly drawn to wildlife trafficking due to the exorbitant proceeds from this illicit trade.

The task force emphasizes the need for a “whole of government” approach to combating this problem and identifies three key priority areas: (1) strengthening domestic and global enforcement; (2) reducing demand for illegally traded wildlife at home and abroad; and (3) strengthening partnerships with foreign governments, international organizations, nongovernmental organizations, local communities, private industry, and others to combat illegal wildlife poaching and trade.

The division works with U.S. Attorneys’ offices around the country and federal agency partners (such as the U.S. Fish and Wildlife Service and the National Oceanic and Atmospheric Administration) to combat wildlife trafficking under the Endangered Species Act and the Lacey Act, as well as statutes prohibiting smuggling, criminal conspiracy and related crimes.   In fiscal year 2013, a prominent example of the division’s robust prosecution of illegal wildlife trafficking was “Operation Crash,” an ongoing multi-agency effort to detect, deter and prosecute those engaged in the illegal killing of rhinoceros and the illegal trafficking of endangered rhinoceros horns.   This initiative has resulted in multiple convictions, significant jail time, penalties and asset forfeiture.

CYRAMZA APPROVED BY FDA FOR TREATMENT OF STOMACH CANCER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

For Immediate Release: April 21, 2014

Consumer Inquiries: 888-INFO-FDA

FDA approves Cyramza for stomach cancer

The U.S. Food and Drug Administration today approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach.

Stomach cancer forms in the tissues lining the stomach and mostly affects older adults. According to the National Cancer Institute, an estimated 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die from the disease, this year.

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

Cyramza’s safety and effectiveness were evaluated in a clinical trial of 355 participants with unresectable or metastatic stomach or gastroesophageal junction cancer. Two-thirds of trial participants received Cyramza while the remaining participants received a placebo. The trial was designed to measure the length of time participants lived before death (overall survival).

Results showed participants treated with Cyramza experienced a median overall survival of 5.2 months compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo. Results from a second clinical trial that evaluated the efficacy of Cyramza plus paclitaxel (another cancer drug) versus paclitaxel alone also showed an improvement in overall survival.

Common side effects experienced by Cyramza-treated participants during clinical testing include diarrhea and high blood pressure.

The FDA reviewed Cyramza under its priority review program, which provides an expedited review for drugs that have the potential, at the time the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition. Cyramza was also granted orphan product designation because it is intended to treat a rare disease or condition.

Cyramza is marketed by Indianapolis-based Eli Lilly.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

FDA: Drug Innovation

NCI: Stomach Cancer

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.

U.S. NAVY CONTINUES ASSISTANCE DURING SEARCH AND RESCUE OPERATIONS FOR SEWOL

FROM:  U.S. DEFENSE DEPARTMENT 

U.S. helicopter crews prepare to take off from the flight deck of the USS Bonhomme Richard, April 21, 2014, to assist South Korea's search operations for the Sewol, the ferry that sank April 16 off the coast of Jindo island. U.S. Navy photo by petty Officer 2nd Class Adam D. Wainwright.

An MV-22 Osprey tiltrotor aircraft conducts search and rescue efforts, April, 21, 2014, for the Sewol, the ferry that sank April 16 off the coast of Jindo island. The crew is assigned to Marine Medium Tiltrotor Squadron 265, 31st Marine Expeditionary Unit, aboard the amphibious assault ship USS Bonhomme Richard. U.S. Marine Corps photo by Lance Cpl. Alexander Pool.