FROM: U.S. STATE DEPARTMENT
Remarks With Qatari Foreign Minister Khalid al-Atiyah Before Their Meeting
Remarks
John Kerry
Secretary of State
U.S. Chief of Mission Residence
Paris, France
October 21, 2013
SECRETARY KERRY: Thank you very much. I want to thank Foreign Minister Laurent Fabius for his gracious hospitality here in Paris, and I will be meeting with him tomorrow morning. I look forward to that meeting. And I want to express my deep appreciation to Secretary General Elaraby of the Arab League and to the members of the Arab League Follow-On Committee in the Mideast peace process for their commitment to peace and for their willingness to come to Paris today for yet another meeting and briefing which we have promised them with respect to the Mideast peace process, and we’ve promised to do it on a regular basis or as needed.
I especially want to recognize my friend, the Foreign Minister of Qatar, Khalid al-Atiyah. I am very appreciative to him. He’s been a good partner in this effort of keeping the committee moving and of keeping it engaged. And this is the fourth time now in six months that the United States and the Arab League have gathered as part of our regular consultations in order to make sure that the final status negotiations between the Israelis and the Palestinians are very much accountable to those who have a great stake in it. And as everybody knows, the Arab Peace Initiative, which I have many times mentioned, was a very significant step forward, is still a very important ingredient of the possibilities of peace.
Excuse me. The breadth and the depth of the participation that we had here today and in all of our meetings is really a clear demonstration of the continued support that President Abbas and the Palestinian Authority continue to receive from the Arab community as a whole, and I think it is significant. The Arab League understands precisely what is at stake here. I might comment that in the middle of our meeting today, His Highness Prince Saud al-Faisal of Saudi Arabia very eloquently stated, “You know, if you’re thinking about what the vision for peace of the Arab world, all you really have to do is look at the Arab Peace Initiative, which offers immediate peace to Israel when settling the Palestinian issue, a peace that will bring normal commerce, embassies, normal relations, connections between people and between countries, not with one or two nations, but with 57 nations all at one time – 35 Muslim nations, 22 Arab nations. That’s a vision, and it’s a vision worth fighting for.
From the very first visit with the Arab Peace Initiative Follow-up Committee in Washington earlier this year, to the key meeting that we had in Amman in July, the Arab League Follow-on Committee has shown a remarkable commitment to this effort, and we’re very grateful to them for that.
Their support for a final status agreement is essential to the agreement of a negotiated, two-state solution for Palestinians and Israelis, and it is critical to creating the momentum and the seriousness of purpose that is essential in order to be able to be successful in these talks.
It’s no secret to anybody that this is and remains a difficult process, there is no shortage of passionate skeptics. But I want to underscore that the goal is clear and it is achievable, and those who are closest to it – the neighbors as well as the parties themselves – understand what is at stake: a just and a lasting peace that’s based on a two-state solution which is the only solution. Two states for a simple reason, because two proud peoples deserve the opportunity to realize their legitimate aspirations, their security, and their freedom, and their future.
The Israeli and the Palestinian people both have leaders who absolutely understand what is at stake, and they have taken risks in order to bring both parties to the table. They showed courage to begin the process and they have shown courage to continue it even in the face of criticism. The two parties have been engaged now in 13 meetings, serious meetings. They had three meetings in the last four days. The pace has intensified. All the core issues are on the table, and they have been meeting with increased intensity.
But for everybody to live up to the challenges of making peace, we have to support them, including living up to our obligations on the economic front. I want to stress that no economic track, no economic package or financial assistance will ever be a substitute for the political track. But with our partnership and with our support and our economic investment, we can all help in order to provide a difference to the lives of people living in the neighborhood. That is why I am especially pleased to announce tonight – and I’m very grateful to the Amir of Qatar, to the Qatari people, and to the Foreign Minister who has really helped bring this about – they have agreed to provide $150 million in urgently needed debt relief to the Palestinian Authority. And I am very grateful to Khalid al-Atiyah for helping to make that happen. I’m confident that other Arab governments are currently evaluating and making their decisions, and there will be others who will join in this initiative as we go forward.
So the support of donors has been critical to helping us get where we are today, and it is important ultimately for the parties themselves to make the key decisions and reasonable compromises necessary for a final status agreement. That includes taking all of the steps that are necessary to create a positive atmosphere for the negotiations, which incidentally was one of the key things agreed upon by both parties as they entered into these negotiations.
So my friends, I might comment that in his – in that vein, I was very pleased to see that Prime Minister Netanyahu made an Eid al-Adha statement, a message earlier this week, and he made it clear that Israel is committed to maintaining the status quo in the holy places, and he made it clear that the hand of Israel is extended to the Palestinian people in the hope of peace.
So my friends, there is an opportunity for peace over the horizon. But to seize that opportunity, we need the continued support of the Arab League, we need the engagement of the Arab League, and we need the rest of the international community also to continue to be supportive. I believe that with our work together, we can provide for the peaceful, prosperous, hopeful outcome that people in the region, and particularly Israelis and Palestinians, have hoped for for a long, long time.
Mr. Foreign Minister, thank you.
FOREIGN MINISTER AL-ATIYAH: Thank you very much, and I’ll do it in Arabic if you’d like to put your headset, please.
(Via interpreter) In the beginning, as my friend John Kerry did, I would like to extend my thanks also to our common friend Laurent for allowing for this meeting to take place in France. Yes, indeed, we did meet today for a fourth time about the peace process. We discussed and confirmed some (inaudible) issues, which is the solution – a two-state solution based on the 1967 borders with Jerusalem as its capital. We also addressed some very important issues.
I would like to be very brief because my friend John here covered most of the issues. But there are some issues that we addressed in this meeting. For example, we talked about the issue of Gaza and the futility of isolating Gaza because that wouldn’t help the peace process, and the closure of crossing points. There are millions of people living in Gaza, and they are in need of supply – food supplies and medicine. Therefore, there must be a way to open crossing points by all parties so that we could enable the people of Gaza to live, because they are an inseparable part of the Palestinian people.
As for the negotiations, we confirmed the need – affirmed the need for American participation, actual participation, in the negotiations. And I would like to thank my friend John for the serious effort that is expended, but we would like him to be fully engaged in this process. We are concerned concerning the environment surrounding the negotiations, and we did address this concern. For example, the most recent measures, we are seeing settlement expansion, not just destruction of homes but destruction of entire communities similar to what’s happening in the Jordan Valley. Also, raising the Israeli flag, we consider this to be a transgression that we cannot possibly accept, not in the Arab world or the Islamic world. Therefore, we urge that the conducive environment for the negotiations be created. Also, some statements made by Israeli officials harm the peace process.
We addressed – we talked about most – several issues – economics and economic openness, and we asserted that the initiative of the sovereignty of the holy places in 2002 was very clear, and it also included all the possibilities that could take place in the event of a comprehensive peace. I would like also to – I wanted to shed light on these issues because my friend John has gone into the specifics of the meeting, and thank you very much.
MODERATOR: The first question will be from Arshad Mohammed of Reuters.
QUESTION: Thank you. Secretary Kerry, when you took office as Secretary of State, you repeatedly said that it was necessary to change President Assad’s calculation. When you and Foreign Minister Lavrov announced your hopes to hold Geneva 2 in May, the circumstances seemed somewhat better for the possibility of a peace conference. The government seemed – the Syrian Government seemed to be losing ground at the time. Now, many months later, the Syrian Government seems to be in a stronger position. President Assad says – is talking about the possibility of running for re-election. And the opposition, as you well know, is fighting on two fronts, something that your – even your own aides say makes it harder to extract concessions from the Syrian Government. What makes you think that the Assad government has any reason, given the way events have moved in the last six months, to actually make concessions and give up power? And what makes you think that the opposition, which seems to grow more fractured and has seen defections even in the last few weeks, is in any position or shape to assume a transitional governing role?
SECRETARY KERRY: Well, Arshad, obviously a central question to all of this, and I’ll give you as complete and direct an answer as I can. You are correct to say that when Sergey Lavrov and I announced this in Moscow, I think back in May, that the situation on the ground was different than the way it is today. But the situation on the ground is irrelevant to the question of the implementation of Geneva 1. And maybe President Assad needs to go back and read Geneva 1 again, or for the first time, but Geneva 1 says you will have a transition government by mutual consent. So it doesn’t matter whether you’re up or whether you’re down on the battlefield; the objective of Geneva 2 remains the same, which is the implementation of Geneva 1, which means a transition government arrived at by mutual consent of the parties.
Now, I don’t know anybody who believes that the opposition will ever consent to Bashar al-Assad being part of that government. And if he thinks he’s going to solve problems by running for re-election, I can say to him, I think with certainty, this war will not end as long as that’s the case or he is there.
Now, the Geneva 2 process is a negotiated resolution of a war that is taking place because Bashar al-Assad decided to meet the demands of young people in his country for a participatory role in the future of Syria – he decided to meet them with bullets and bombs and artillery shells. And he has shelled universities and killed innocent students sitting at their desks. He shelled schools with napalm and burned innocent children who were there trying to learn. He has bombed and gassed people in his country so that more than 115,000 or so are dead. How can that man claim to rule under any legitimacy in the future?
So I believe that it’s very clear what the purpose of this negotiated settlement is. And those who support the implementation of Geneva 1 should come to Geneva and be part of the process of building a new future for the people of Syria. But I do not believe that it is dependent on whether you’re up or down.
Now secondly, there are plenty of qualified people within the opposition in Syria – not necessarily fighters, but people who are opposed to Assad who run a business or a hospital or who have a great distinguished career and have been part of building the fabric of a secular society of Syria. And there are people who are qualified to be able to help manage the future affairs of Syria. There is nothing ordained, nothing is written that suggests that it belongs to one family and one man, particularly after what has happened over the course of these past two and a half years.
Now, there’s a human catastrophe awaiting the world if you can’t have a negotiated solution, because there are more and more refugees, more and more displaced people, more and more destruction, and the potential of the absolute implosion of the state of Syria is what lies in front of everybody if there cannot be a negotiated solution. I would hope that ultimately, Assad himself, certainly his supporters like the Russians, the Iranians, would understand that if you want peace in the region, it’s not going to come by prolonging the war with the presence of Bashar al-Assad.
Now, finally, why has the situation on the ground changed? Not because of the Syrian military, but because of Iran and Hezbollah, and Hezbollah and Iran represent the two only outside organized forces in Syria fighting on behalf of a party, the only two. And they are the ones who have made that difference. So I think it’s time for the United Nations and for others to consider the appropriateness of their activity and the need to try to press towards the negotiated solution that is critical to the people of Syria and to its future.
MODERATOR: The next question will be from Randa Takieddine from Al-Hayat.
QUESTION: Mr. Secretary, I have a question for you and a question for Minister Khalid al-Atiyah. In Arabic, if possible, to Mr. al-Atiyah, and English for you.
Mr. Secretary, the concerns of people came about the American policy change on Syria – they came out of the fact that you are insisting so much on the chemical disarmament of Syria, and that people thought that you want really to do with this regime – with Assad’s regime. So do you need, in fact, this coordination with this regime for the chemical disarmament? And when is Geneva 2, actually? Because we don’t – we still don’t have a date. Some people say 23rd, some others say no. And then, is Iran going to be part of this conference?
(Via interpreter.) Is Qatar – has Qatar changed its policy regarding Syria? Is there a rapprochement or letters with President – being exchanged with President Bashar al-Assad?
SECRETARY KERRY: Well, just very quickly, on the date, I can’t tell you precisely when the date is. That’s up to the United Nations and up to the Special Envoy Lakhdar Brahimi to announce. But I have heard people talking about sometime in later part of November. Foreign Minister Lavrov and I both urged that it be as soon as possible, and we both certainly would be in agreement, along with a lot of other ministers who believe that it ought to happen sooner, not later. So I hope it would be somewhere in that period of time. But it’s up to them to announce it.
With respect to the question of the weapons, is Assad necessary, the answer is no. Assad doesn’t go out into the field and control a particular depot where you have chemical weapons. Assad isn’t driving the trucks that back up to the depot and pick up the weapons and take them somewhere. There are lots of people in Syria within the military structure who have knowledge of where the weapons are and how they can be moved who actually have responsibilities for safeguarding them. So Assad himself is not critical to the containment and the identification and ultimate removal of those weapons, number one.
Number two, those weapons could be gathered and located and brought to a location over the course of these next few months, barring something surprising. I’m not sure this will be settled in that period of time, but he is not absolutely essential to the effort to remove the chemical weapons. They can be removed once identified and secured by the normal process of chemical weapons destruction.
With respect to the first part of your question, which was the policy change, no, there has been no policy change. President Obama made a decision with respect to military force, and I am absolutely 100 percent convinced that had he not made that decision, those weapons would not be being removed now under an agreement that we reached at the United Nations. It happened because of that decision. And you have to ask yourself: Is it better that all of the weapons are being secured and removed, rather than that you had a military strike that tried to deter him from using them again but left them in his possession? That’s the choice. I think it’s clear there’s a benefit.
Now, some were disappointed the strike didn’t take place because they thought it was a sign of other things. But the fact is that the same airplanes that were killing people before the chemical weapons and the same artillery that was killing people before the chemical weapons and the same bombs and Scud missiles are still doing it. And we remain as concerned about that today, if not more so, than we were before the chemical weapons agreement.
And that is why we are focused on assisting the moderate opposition. We are helping them. It’s a known fact. And we will continue, as are others of our friends continuing, to help them, because we believe you need to get to the negotiation because there is no ultimate military solution. But we’re not going to sit by while Assad slaughters his people with impunity and not help those who are struggling against him to have their ability to do so with some of the support from the international community.
QUESTION: On Iran?
SECRETARY KERRY: Oh, Iran. Fourth question, okay.
On Iran, the answer is if Iran accepts – Iran has not accepted the implementation of Geneva 1, so it’s very hard to see how Iran can be constructive in the absence of their willingness to come for the purpose of the negotiation. So if they accept Geneva 1 and want to be constructive in helping to set up a transition government, that’s a different issue. But until that happens, it would be very difficult to see how it could be constructive.
FOREIGN MINISTER AL-ATIYAH: (Via interpreter) The question is: Did the Syrian regime stop its massacres against its people? Did the Syrian people attain its freedom that it deserves? And did it get the justice and freedom? If the answer is no, then the position of Qatar is the same. We are standing by the Syrians until they attain their freedom, and even though we’re pushing for a political solution that would help the Syrian people, but the Qatari decision has not changed. Thank you.
SECRETARY KERRY: Thank you. Is that it?
MS. PSAKI: One more. The final question is from Patricia Allemoniere – I don’t know if I said it the right way – TF-1.
QUESTION: (Via interpreter) Mr. Secretary, I have one question, first question. The French this evening are deeply shocked by the revelations that were made by the newspaper Le Monde regarding the extent of the wiretaps conducted by an allied and friendly country to France. What answer can you give? Can the United States stop and does it want an end to these listenings?
And another question for Qatar. Qatar is oftentimes accused in the West of being at the origin of the rise of radical Islamic groups because Qatar helped them to obtain weapons. What do you have to say with respect to that comment or analysis?
SECRETARY KERRY: Well, thank you very much for the question. Look, France is one of our oldest allies in the world, and I have a very close working relationship with Laurent Fabius since the day I started this job on many issues, ranging from Syria to protecting the security of our citizens. And protecting the security of our citizens in today’s world is a very complicated, very challenging task, and it is an everyday, 24/7, 365 task, unfortunately, because there are lots of people out there seeking to do harm to other people. We see much more suicide bombs taking place in various parts of the world right now.
So Ambassador Rivkin met today with Alexandre Ziegler, the cabinet director to Foreign Minister Fabius, at the request of the Government of France. And our ongoing – we will have ongoing bilateral consultations, including with our French partners, that address this question of any reports by the United States Government gathering information from some of the agencies, and those consultations are going to continue.
Now, I’m not going to comment on the specifics. As a matter of policy, we don’t discuss intelligence matters. And lots of countries are engaged in the activity of trying to protect their citizens and the world. As the President – as President Obama said very clearly in a recent speech that he gave at the United Nations General Assembly just a few weeks ago, he said we in the United States are currently reviewing the way that we gather intelligence. And I think that’s appropriate. And our goal is always to try to find the right balance between protecting the security and the privacy of our citizens. And this work is going to continue, as well as our very consultations with our friends here in France.
FOREIGN MINISTER AL-ATIYAH: (Via interpreter) In the beginning, I would like to say that anyone who doesn’t know what’s happening in Syria would say that Qatar is supporting radical groups. But the truth is when someone is Christian or Jewish or even Muslim and is subjected to a catastrophe similar to what the Syrian people have experienced, then it will be very closer to God. So this is the situation in Syria.
We are working in Syria through the Friends of Syria group, and there’s also a group that all people have agreed to support the Syrian people, whether in terms of helping it defend itself or in terms of humanitarian aid. We are working through this group and the allies to support very known parties. Therefore, talking about us supporting radical groups or extremist groups, this cannot be true in any way when we’re working with allies closely.
SECRETARY KERRY: Thank you very much.
Tuesday, October 22, 2013
$10.5 MILLION GRANT
FROM: U.S. EDUCATION DEPARTMENT
National Center on Deaf-Blindness Awarded $10.5 Million Grant to Help Improve Services for Children who are Deaf-Blind
OCTOBER 21, 2013
Contact: Press Office, (202) 401-1576, press@ed.gov
The U.S. Department of Education announced today a $10.5 million grant over five years to the National Center on Deaf-Blindness, a consortium of the Teaching Research Institute at Western Oregon University, the Helen Keller National Center, and Perkins School for the Blind for the continued operation of the National Technical Assistance Center for Children who are Deaf-Blind. The grant money was disbursed before the recent government shutdown and was not affected by the temporary lapse in funding.
The center will improve services and results for children who are deaf- blind by implementing systems change efforts that have proven successful. The center will also develop and implement innovative technology applications to support improved systems integration between the national center and the state and multi-state projects, and will engage in knowledge synthesis and product development activities to guide and evaluate universal, targeted, and intensive technical assistance efforts.
"This grant will help the National Center on Deaf-Blindness continue its very important work to ensure that deaf-blind students get the support and resources they need to succeed in their education," said U.S. Secretary of Education Arne Duncan. "All students deserve to be equipped with the appropriate tools and services they need to help them improve academically."
To provide these services nationally, the university plans several activities, including developing an efficient, integrated national system for delivery of deaf-blind technical assistance and facilitating its use by the Deaf-Blind Technical Assistance Network; promoting the use of evidence-based interventions and instruction for infants, children, and youth who are deaf-blind; delivering technical assistance at universal, targeted, and intensive levels in focused areas of high need; and improving opportunities for high-quality family engagement and partnerships, including enhanced collaborations with parent centers.
The grant is being awarded by the Education Department’s Office of Special Education Programs.
National Center on Deaf-Blindness Awarded $10.5 Million Grant to Help Improve Services for Children who are Deaf-Blind
OCTOBER 21, 2013
Contact: Press Office, (202) 401-1576, press@ed.gov
The U.S. Department of Education announced today a $10.5 million grant over five years to the National Center on Deaf-Blindness, a consortium of the Teaching Research Institute at Western Oregon University, the Helen Keller National Center, and Perkins School for the Blind for the continued operation of the National Technical Assistance Center for Children who are Deaf-Blind. The grant money was disbursed before the recent government shutdown and was not affected by the temporary lapse in funding.
The center will improve services and results for children who are deaf- blind by implementing systems change efforts that have proven successful. The center will also develop and implement innovative technology applications to support improved systems integration between the national center and the state and multi-state projects, and will engage in knowledge synthesis and product development activities to guide and evaluate universal, targeted, and intensive technical assistance efforts.
"This grant will help the National Center on Deaf-Blindness continue its very important work to ensure that deaf-blind students get the support and resources they need to succeed in their education," said U.S. Secretary of Education Arne Duncan. "All students deserve to be equipped with the appropriate tools and services they need to help them improve academically."
To provide these services nationally, the university plans several activities, including developing an efficient, integrated national system for delivery of deaf-blind technical assistance and facilitating its use by the Deaf-Blind Technical Assistance Network; promoting the use of evidence-based interventions and instruction for infants, children, and youth who are deaf-blind; delivering technical assistance at universal, targeted, and intensive levels in focused areas of high need; and improving opportunities for high-quality family engagement and partnerships, including enhanced collaborations with parent centers.
The grant is being awarded by the Education Department’s Office of Special Education Programs.
FDA'S APPROACH TO HARVESTING SAFE CLAMS
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Novel Program Restarts Clam Harvest
One of the largest clam beds in the world closed in 1990 because people could get sick and even die from eating clams contaminated with a deadly marine toxin.
This year, however, a large portion of the area called Georges Bank, 62 miles off the coast of New England, reopened after the Food and Drug Administration (FDA) developed a new approach toward this risk to public health.
One major element involves having an FDA scientist train fishermen to perform sophisticated scientific tests on the clams while at sea, sometimes under extreme conditions.
"This program has almost doubled the number of quahog clams available on the market, and increases the availability of surf clams by about 40%," says David Wallace, a consultant for the seafood industry. "If it hadn't been for the FDA, these multi-billion dollar resources would be going to waste. It's good for fishermen, for consumers and for the economy." (The meat of quahog clams is tougher than surf clams and is often used in chowder, while surf clams often show up in raw bars.)
This is the story of how fishermen, industry representatives, state officials and multiple branches of the federal government worked together to create a novel plan that is allowing clams to be harvested from a major portion of Georges Bank—a vast submerged sandbank that extends from Massachusetts to Nova Scotia.
A Once Risky Catch
The story begins in the late 1980s, when harvest areas were temporarily closed due to the reports of toxins in surf clams from Georges Bank. After a brief reopening in early 1990, harvest areas were closed again when fishermen clamming on Georges Bank ate contaminated mussels caught while fishing for clams and became extremely ill.
The diagnosis: paralytic shellfish poisoning, caused by a toxin produced by Alexandrium algae. The toxic algae has been cited for centuries and is sometimes referred to as "red tide," even though not all red tides are toxic, and not all toxic blooms are red.
The toxin concentrates in the flesh of mollusks, including clams and mussels, and doesn't seem to hurt them. But in high enough concentrations, this potent toxin can temporarily paralyze humans. If this happens, the paralyzed person could die of asphyxiation if he or she is not put on life support until the toxins are flushed from the body. Cooking the mollusks does not neutralize the toxins.
FDA officials, who are responsible for the safety of seafood caught in federal waters, could not put scientists on board every clam fishing vessel far out at sea to test the clams for the toxin. It didn't make economic sense for fishermen to spend the time and money harvesting clams if they might arrive at the harbor, discover they had a boat filled with toxic clams, and then be responsible for safely disposing of them.
The 1990 closure of Georges Bank was a huge blow to the clam industry. The situation became even more dire in 2005, when a massive algal bloom near the New England shores temporarily closed another 15,000 square miles of ocean to clamming.
The clam industry, finding itself in peril, decided to invest the time and money required to find a solution, and began working with state and federal officials. After years of research on a harvesting procedure that could deliver safe clams at the dock, followed by an intense, years-long research and a pilot program, a huge portion of Georges Bank reopened in 2013 to clam fishermen who agreed to work under a new FDA procedure. This includes having fishermen take the FDA-provided training needed to conduct very precise scientific tests of clam samples while out to sea.
"There was a lot of skepticism. How would the fishermen react to listening to days of lectures from a young government scientist? Could they accurately conduct tests that sometimes even challenge lab scientists?" says FDA marine biotoxin expert Stacey DeGrasse, who has provided the FDA training.
"The project, however, is incredibly successful. The fishermen take great pride in performing the on-board lab tests and provide exact, pristine data," says DeGrasse.
The Tale of a Solution
The apex of the crisis in the clamming industry occurred just as FDA was conducting a research project with Woods Hole Oceanographic Institution. This extensive research project provided a greater understanding of the source of the toxins, movement of the toxins within the marine food web, the role of Alexandrium cyst (seed) beds as sources for future toxic algal blooms, and more.
Continued research efforts in this area focus on identifying effective early warning systems that could be used by state and federal regulators to determine when to open and close fishing areas. The policy side of the project is led by Paul Distefano, a consumer safety office in FDA's Center for Food Safety and Applied Nutrition.
One aspect of the project was aimed at training fishermen to use a field kit to test their product for the presence of dangerous marine toxins.
As one major aspect of the first test procedure, fishermen were first trained how to collect the correct number of representative samples of their catch and to shuck the clams without piercing the flesh. The samples were then mixed together in a kind of upscale blender to get an even, well-mixed consistency. Using household chemicals in the kit, the fishermen then learned to separate out any toxins that might be present. Finally, using something akin to a drugstore pregnancy test, the fishermen would test whether the potency of any toxin was at a dangerous level.
Tests of the field kit began at sea in 2007, but the kits provided too many results that were false positives. A better field kit was needed, and one used by lab scientists was identified. "I had doubts about how this was going to go," says DeGrasse. "The new kit was definitely more complicated, but I figured it was worth a try."
She worked with Abraxis, a test kit manufacturer, to make some adjustments. For one thing, the kit needed to be recalibrated to better target the toxins of concern. It also required modifications to make it usable at sea.
In 2009, after FDA had collected sufficient data, the new Abraxis kits were approved by the Interstate Shellfish Sanitation Conference (ISSC), a consortium of government officials, industry representatives and academics devoted to seafood safety. For a pilot program, the National Oceanic and Atmospheric Administration (NOAA) agreed to allow one fishing vessel to dredge for clams in the closed waters of Georges Bank for a year, a maximum of one time per week.
DeGrasse trained the fishermen for one day on land, then took the test kit out to sea and did further training on two-to-three-day clamming cruises. Once they were trained, the fishermen performed the onboard testing and sent portions of their samples to FDA for further scientific analyses. Later, when the vessel docked, state officials in Massachusetts performed a bioassay—an even more robust test that measures the overall potency of any toxins present.
That year, on just 37 fishing trips, that single vessel hauled in $2.7 million worth of surf clams that passed testing for toxins.
"The exciting part came when we put all the data together, and in 2011 the ISSC adopted the on-board screening protocol," says DeGrasse.
This year, NOAA reopened a large portion of Georges Bank to any fishermen who follow the established protocol, which includes on-board testing at sea by fishermen and back-up tests on land by government scientists.
"This has allowed the catch of literally billions of dollars worth of clams that otherwise would have died of old age," said Wallace. "It's a perfect example of how states, federal agencies and industry can work together to find solutions."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Sept 17, 2013
Novel Program Restarts Clam Harvest
One of the largest clam beds in the world closed in 1990 because people could get sick and even die from eating clams contaminated with a deadly marine toxin.
This year, however, a large portion of the area called Georges Bank, 62 miles off the coast of New England, reopened after the Food and Drug Administration (FDA) developed a new approach toward this risk to public health.
One major element involves having an FDA scientist train fishermen to perform sophisticated scientific tests on the clams while at sea, sometimes under extreme conditions.
"This program has almost doubled the number of quahog clams available on the market, and increases the availability of surf clams by about 40%," says David Wallace, a consultant for the seafood industry. "If it hadn't been for the FDA, these multi-billion dollar resources would be going to waste. It's good for fishermen, for consumers and for the economy." (The meat of quahog clams is tougher than surf clams and is often used in chowder, while surf clams often show up in raw bars.)
This is the story of how fishermen, industry representatives, state officials and multiple branches of the federal government worked together to create a novel plan that is allowing clams to be harvested from a major portion of Georges Bank—a vast submerged sandbank that extends from Massachusetts to Nova Scotia.
A Once Risky Catch
The story begins in the late 1980s, when harvest areas were temporarily closed due to the reports of toxins in surf clams from Georges Bank. After a brief reopening in early 1990, harvest areas were closed again when fishermen clamming on Georges Bank ate contaminated mussels caught while fishing for clams and became extremely ill.
The diagnosis: paralytic shellfish poisoning, caused by a toxin produced by Alexandrium algae. The toxic algae has been cited for centuries and is sometimes referred to as "red tide," even though not all red tides are toxic, and not all toxic blooms are red.
The toxin concentrates in the flesh of mollusks, including clams and mussels, and doesn't seem to hurt them. But in high enough concentrations, this potent toxin can temporarily paralyze humans. If this happens, the paralyzed person could die of asphyxiation if he or she is not put on life support until the toxins are flushed from the body. Cooking the mollusks does not neutralize the toxins.
FDA officials, who are responsible for the safety of seafood caught in federal waters, could not put scientists on board every clam fishing vessel far out at sea to test the clams for the toxin. It didn't make economic sense for fishermen to spend the time and money harvesting clams if they might arrive at the harbor, discover they had a boat filled with toxic clams, and then be responsible for safely disposing of them.
The 1990 closure of Georges Bank was a huge blow to the clam industry. The situation became even more dire in 2005, when a massive algal bloom near the New England shores temporarily closed another 15,000 square miles of ocean to clamming.
The clam industry, finding itself in peril, decided to invest the time and money required to find a solution, and began working with state and federal officials. After years of research on a harvesting procedure that could deliver safe clams at the dock, followed by an intense, years-long research and a pilot program, a huge portion of Georges Bank reopened in 2013 to clam fishermen who agreed to work under a new FDA procedure. This includes having fishermen take the FDA-provided training needed to conduct very precise scientific tests of clam samples while out to sea.
"There was a lot of skepticism. How would the fishermen react to listening to days of lectures from a young government scientist? Could they accurately conduct tests that sometimes even challenge lab scientists?" says FDA marine biotoxin expert Stacey DeGrasse, who has provided the FDA training.
"The project, however, is incredibly successful. The fishermen take great pride in performing the on-board lab tests and provide exact, pristine data," says DeGrasse.
The Tale of a Solution
The apex of the crisis in the clamming industry occurred just as FDA was conducting a research project with Woods Hole Oceanographic Institution. This extensive research project provided a greater understanding of the source of the toxins, movement of the toxins within the marine food web, the role of Alexandrium cyst (seed) beds as sources for future toxic algal blooms, and more.
Continued research efforts in this area focus on identifying effective early warning systems that could be used by state and federal regulators to determine when to open and close fishing areas. The policy side of the project is led by Paul Distefano, a consumer safety office in FDA's Center for Food Safety and Applied Nutrition.
One aspect of the project was aimed at training fishermen to use a field kit to test their product for the presence of dangerous marine toxins.
As one major aspect of the first test procedure, fishermen were first trained how to collect the correct number of representative samples of their catch and to shuck the clams without piercing the flesh. The samples were then mixed together in a kind of upscale blender to get an even, well-mixed consistency. Using household chemicals in the kit, the fishermen then learned to separate out any toxins that might be present. Finally, using something akin to a drugstore pregnancy test, the fishermen would test whether the potency of any toxin was at a dangerous level.
Tests of the field kit began at sea in 2007, but the kits provided too many results that were false positives. A better field kit was needed, and one used by lab scientists was identified. "I had doubts about how this was going to go," says DeGrasse. "The new kit was definitely more complicated, but I figured it was worth a try."
She worked with Abraxis, a test kit manufacturer, to make some adjustments. For one thing, the kit needed to be recalibrated to better target the toxins of concern. It also required modifications to make it usable at sea.
In 2009, after FDA had collected sufficient data, the new Abraxis kits were approved by the Interstate Shellfish Sanitation Conference (ISSC), a consortium of government officials, industry representatives and academics devoted to seafood safety. For a pilot program, the National Oceanic and Atmospheric Administration (NOAA) agreed to allow one fishing vessel to dredge for clams in the closed waters of Georges Bank for a year, a maximum of one time per week.
DeGrasse trained the fishermen for one day on land, then took the test kit out to sea and did further training on two-to-three-day clamming cruises. Once they were trained, the fishermen performed the onboard testing and sent portions of their samples to FDA for further scientific analyses. Later, when the vessel docked, state officials in Massachusetts performed a bioassay—an even more robust test that measures the overall potency of any toxins present.
That year, on just 37 fishing trips, that single vessel hauled in $2.7 million worth of surf clams that passed testing for toxins.
"The exciting part came when we put all the data together, and in 2011 the ISSC adopted the on-board screening protocol," says DeGrasse.
This year, NOAA reopened a large portion of Georges Bank to any fishermen who follow the established protocol, which includes on-board testing at sea by fishermen and back-up tests on land by government scientists.
"This has allowed the catch of literally billions of dollars worth of clams that otherwise would have died of old age," said Wallace. "It's a perfect example of how states, federal agencies and industry can work together to find solutions."
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Sept 17, 2013
COMPANY SETTLES FTC CHARGES OF DECEIVING CONSUMERS WITH "MADE IN A USA" LABELS
FROM: U.S. FEDERAL TRADE COMMISSION
Marketer of Outdoor Accessories Agrees to Drop Made-in-the-USA Claims
A marketer of iPhone accessories, bottle holders, lens cleaners, dog collars, leashes, and other outdoor accessories has agreed to settle Federal Trade Commission charges that it falsely claimed certain of its products were “Made in the U.S.A,” or “Truly Made in the USA” even though the products contained substantial foreign content.
The proposed settlement prohibits the company from deceiving consumers about the degree to which its products are made in the United States.
Based in Logan Utah, E.K. Ekcessories, Inc. sells merchandise directly to consumers on its website, ekusa.com, and through online sellers such as Amazon and REI.
The company claimed on its website that “For 28 years E.K. Ekcessories has been producing superior quality made accessories in our 60,000 sq. ft. facility in Logan, Utah;” and “Our source of pride and satisfaction abounds from a true ‘Made in USA’ product.” In fact, the company imports many of its products and components, according to the complaint. The FTC also alleged that the company distributed deceptive promotional materials for its products to third-party retailers such as Amazon and REI.
The FTC alleged that E.K. Ekcessories, Inc. violated the Federal Trade Commission Act by making false and unsupported statements that its products were all or virtually all made in the United States.
Under the proposed order, the company is prohibited from claiming that any product is made in the United States unless that product is all or virtually all made in the United States. The company also is prohibited from making any misleading claims about a product’s country of origin and from providing deceptive promotional material to third-party retailers, or otherwise providing the “means or instrumentalities” for others to make deceptive U.S.-origin claims. The company also is required to contact all distributors who bought or received products between January 1, 2010 and May 1, 2013, and provide them with a notice and a copy of the order.
According to the Commission’s 1997 U.S. Origin Claims Enforcement Policy Statement, for a product to be advertised or labeled as “Made in the U.S.A,” the product must be “all or virtually all” made in the United States – that is, all significant parts and processing must be of U.S. origin, and the product should contain no (or negligible) foreign content.
The Commission vote to accept the consent agreement package containing the proposed consent order for public comment was 4-0. The FTC will publish a description of the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through November 21, 2013, after which the Commission will decide whether to make the proposed consent order final. Interested parties can submit written comments electronically or in paper form by following the instructions in the “Invitation To Comment” part of the “Supplementary Information” section. Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments can also be submitted electronically.
NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.
Marketer of Outdoor Accessories Agrees to Drop Made-in-the-USA Claims
A marketer of iPhone accessories, bottle holders, lens cleaners, dog collars, leashes, and other outdoor accessories has agreed to settle Federal Trade Commission charges that it falsely claimed certain of its products were “Made in the U.S.A,” or “Truly Made in the USA” even though the products contained substantial foreign content.
The proposed settlement prohibits the company from deceiving consumers about the degree to which its products are made in the United States.
Based in Logan Utah, E.K. Ekcessories, Inc. sells merchandise directly to consumers on its website, ekusa.com, and through online sellers such as Amazon and REI.
The company claimed on its website that “For 28 years E.K. Ekcessories has been producing superior quality made accessories in our 60,000 sq. ft. facility in Logan, Utah;” and “Our source of pride and satisfaction abounds from a true ‘Made in USA’ product.” In fact, the company imports many of its products and components, according to the complaint. The FTC also alleged that the company distributed deceptive promotional materials for its products to third-party retailers such as Amazon and REI.
The FTC alleged that E.K. Ekcessories, Inc. violated the Federal Trade Commission Act by making false and unsupported statements that its products were all or virtually all made in the United States.
Under the proposed order, the company is prohibited from claiming that any product is made in the United States unless that product is all or virtually all made in the United States. The company also is prohibited from making any misleading claims about a product’s country of origin and from providing deceptive promotional material to third-party retailers, or otherwise providing the “means or instrumentalities” for others to make deceptive U.S.-origin claims. The company also is required to contact all distributors who bought or received products between January 1, 2010 and May 1, 2013, and provide them with a notice and a copy of the order.
According to the Commission’s 1997 U.S. Origin Claims Enforcement Policy Statement, for a product to be advertised or labeled as “Made in the U.S.A,” the product must be “all or virtually all” made in the United States – that is, all significant parts and processing must be of U.S. origin, and the product should contain no (or negligible) foreign content.
The Commission vote to accept the consent agreement package containing the proposed consent order for public comment was 4-0. The FTC will publish a description of the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through November 21, 2013, after which the Commission will decide whether to make the proposed consent order final. Interested parties can submit written comments electronically or in paper form by following the instructions in the “Invitation To Comment” part of the “Supplementary Information” section. Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments can also be submitted electronically.
NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.
Monday, October 21, 2013
PRESIDENT OBAMA ADDRESSES HEALTHCARE ROLLOUT PROBLEMS
FROM: U.S. WHITE HOUSE
Remarks by the President on the Affordable Care Act
Rose Garden
11:33 A.M. EDT
THE PRESIDENT: Everybody, have a seat.
MS. BAKER: Hello. My name is Janice Baker. I have the privilege to say that I'm the first person in the state of Delaware to enroll for health insurance through the new marketplace. (Applause.) Like many consumers out there, it took me a number of frustrating attempts before I could apply for and select my plan. I kept trying because I needed access to the new health care options.
I had applied to three private insurance companies only to be rejected due to preexisting health conditions. I am too young for Medicare, but I'm too old not to have some health issues. I was able to find a policy I am thrilled with, saving $150 a month, and much lower deductibles than my previous policy that I held through my small business.
I'm here today to encourage other people like me who needs access to quality, affordable insurance, and to tell them to have patience with such a new system. Without this ability to get this insurance, I know that a single hospital stay could have bankrupted me and my business.
Thank you all. And I am now honored to introduce the President of the United States. (Applause.)
THE PRESIDENT: Great job.
MS. BAKER: Thank you. Thank you.
THE PRESIDENT: Thank you. (Applause.) Thank you, everybody. Well, thank you, Janice. And thanks to everybody here for coming on this beautiful day. Welcome to the White House.
About three weeks ago, as the federal government shut down, the Affordable Care Act’s health insurance marketplaces opened for business across the country. Well, we’ve now gotten the government back open for the American people, and today I want to talk about how we’re going to get the marketplaces running at full steam, as well. And I’m joined today by folks who have either benefited from the Affordable Care Act already, or who are helping their fellow citizens learn about what this law means for them and how they can get covered.
Of course, you’ve probably heard that HealthCare.gov –- the new website where people can apply for health insurance, and browse and buy affordable plans in most states –- hasn't worked as smoothly as it was supposed to work. And the number of people who have visited the site has been overwhelming, which has aggravated some of these underlying problems.
Despite all that, thousands of people are signing up and saving money as we speak. Many Americans with a preexisting condition, like Janice, are discovering that they can finally get health insurance like everybody else.
So today, I want to speak to every American who’s looking to get affordable health insurance. I want you to know what’s available to you and why it may be a good deal for you. And for those who’ve had some problems with the website, I want to tell you what we’re doing to make it work better and how you can sign up to get covered in other ways.
But before I do that, let me remind everybody that the Affordable Care Act is not just a website. It's much more. For the vast majority of Americans -- for 85 percent of Americans who already have health insurance through your employer or Medicare or Medicaid -– you don’t need to sign up for coverage through a website at all. You've already got coverage. What the Affordable Care Act does for you is to provide you with new benefits and protections that have been in place for some time. You may not know it, but you're already benefiting from these provisions in the law.
For example, because of the Affordable Care Act, young people like Jasmine Jennings, and Jessica Ugalde, and Ezra Salop, all of whom are here today, they’ve been able to stay on their parents’ plans until they’re 26. Millions of other young people are currently benefiting from that part of the law. (Applause.) Another part of the Affordable Care Act is providing seniors with deeper discounts on their prescription medicine. Billions of dollars have been saved by seniors already. That’s part of the law. It’s already in place. It’s happening right now.
Already, because of the Affordable Care Act, preventive care like mammograms and birth control are free through your employers. That’s part of this law. (Applause.) So there are a wide range of consumer protections and benefits that you already have if you’ve got health insurance. You may not have noticed them, but you’ve got them, and they’re not going anywhere. And they’re not dependent on a website.
Here’s another thing that the Affordable Care Act does. In states where governors and legislatures have wisely allowed it, the Affordable Care Act provides the opportunity for many Americans to get covered under Medicaid for the first time. So in Oregon, for example, that’s helped cut the number of uninsured people by 10 percent just in the last three weeks. Think about that. That’s 56,000 more Americans who now have health care. (Applause.) That doesn’t depend on a website.
Now, if you’re one of the 15 percent of Americans who don’t have health insurance -- either because you can’t afford it or because your employer doesn’t offer it, or because you’re a small businessperson and you have to go out on the individual market and buy it on your own and it’s just too expensive -- October 1st was an important date. That’s when we opened the new marketplaces where people without health insurance, or who can’t afford health insurance, or who aren’t part of a group plan, can finally start getting affordable coverage.
And the idea is simple. By enrolling in what we’re calling these marketplaces, you become part of a big group plan -- as if you were working for a big employer -- a statewide group plan that spreads risk between sick people and healthy people, between young and old, and then bargains on your behalf for the best deal on health care. What we’ve done is essentially create a competition where there wasn’t competition before. We created these big group plans, and now insurers are really interested in getting your business. And so insurers have created new health care plans with more choices to be made available through these marketplaces.
And as a result of this choice and this competition, prices have come down. When you add the new tax credits that many people are eligible for through the law, then the prices come down even further. So one study shows that through new options created by the Affordable Care Act, nearly 6 in 10 uninsured Americans will find that they can get covered for less than $100 a month. Think about that. (Applause.)
Through the marketplaces, you can get health insurance for what may be the equivalent of your cell phone bill or your cable bill, and that’s a good deal.
So the fact is the product of the Affordable Care Act for people without health insurance is quality health insurance that’s affordable. And that product is working. It’s really good. And it turns out there’s a massive demand for it. So far, the national website, HealthCare.gov, has been visited nearly 20 million times. Twenty million times. (Applause.) And there’s great demand at the state level as well, because there are a bunch of states that are running their own marketplaces.
We know that nearly one-third of the people applying in Connecticut and Maryland, for example, are under 35 years old. They understand that they can get a good deal at low costs, have the security of health care, and this is not just for old folks like me -- that everybody needs good quality health insurance. And all told, more than half a million consumers across the country have successfully submitted applications through federal and state marketplaces. And many of those applications aren’t just for individuals, it’s for their entire families. So even more people are already looking to potentially take advantage of the high quality, affordable insurance that is provided through the Affordable Care Act.
So let me just recap here. The product is good. The health insurance that’s being provided is good. It’s high quality and it’s affordable. People can save money, significant money, by getting insurance that’s being provided through these marketplaces. And we know that the demand is there. People are rushing to see what’s available. And those who have already had a chance to enroll are thrilled with the result. Every day, people who were stuck with sky-high premiums because of preexisting conditions are getting affordable insurance for the first time, or finding, like Janice did, that they’re saving a lot of money. Every day, women are finally buying coverage that doesn’t charge them higher premiums than men for the same care. (Applause.) Every day, people are discovering that new health insurance plans have to cover maternity care, mental health care, free preventive care.
So you just heard Janice’s story -- she owns her own small business. She recently became the first woman to enroll in coverage through Delaware’s exchange. And it’s true, it took her a few tries, but it was worth it after being turned down for insurance three times due to minor preexisting conditions. So now she’ll be covered, she’ll save 150 bucks a month, and she won’t have to worry that one illness or accident will cost her her business that she’s worked so hard to build.
And Janice is not alone. I recently received a letter from a woman named Jessica Sanford in Washington State. And here’s what she wrote: “I am a single mom, no child support, self-employed, and I haven’t had insurance for 15 years because it’s too expensive. My son has ADHD and requires regular doctor visits and his meds alone cost $250 per month. I have had an ongoing tendinitis problem due to my line of work that I haven’t had treated. Now, finally, we get to have coverage because of the ACA for $169 per month. I was crying the other day when I signed up. So much stress lifted.”
Now, that is not untypical for a lot of folks like Jessica who have been struggling without health insurance. That’s what the Affordable Care Act is all about. The point is, the essence of the law -- the health insurance that’s available to people -- is working just fine. In some cases, actually, it’s exceeding expectations -- the prices are lower than we expected, the choice is greater than we expected.
But the problem has been that the website that’s supposed to make it easy to apply for and purchase the insurance is not working the way it should for everybody. And there’s no sugarcoating it. The website has been too slow, people have been getting stuck during the application process. And I think it’s fair to say that nobody is more frustrated by that than I am -- precisely because the product is good, I want the cash registers to work. I want the checkout lines to be smooth. So I want people to be able to get this great product. And there’s no excuse for the problems, and these problems are getting fixed.
But while we’re working out the kinks in the system, I want everybody to understand the nature of the problem. First of all, even with all the problems at HealthCare.gov, the website is still working for a lot of people -- just not as quick or efficient or consistent as we want. And although many of these folks have found that they had to wait longer than they wanted, once they complete the process they’re very happy with the deal that’s available to them, just like Janice’s.
Second, I want everybody to remember that we’re only three weeks into a six-month open enrollment period, when you can buy these new plans. (Applause.) Keep in mind the insurance doesn’t start until January 1st; that’s the earliest that the insurance can kick in. No one who decides to purchase a plan has to pay their first premium until December 15th. And unlike the day after Thanksgiving sales for the latest Playstation or flat-screen TVs, the insurance plans don’t run out. They’re not going to sell out. They’ll be available through the marketplace -- (applause) -- throughout the open enrollment period. The prices that insurers have set will not change. So everybody who wants insurance through the marketplace will get insurance, period. (Applause.) Everybody who wants insurance through the marketplace will get insurance.
Third, we are doing everything we can possibly do to get the websites working better, faster, sooner. We’ve got people working overtime, 24/7, to boost capacity and address the problems. Experts from some of America’s top private-sector tech companies who, by the way, have seen things like this happen before, they want it to work. They're reaching out. They're offering to send help. We’ve had some of the best IT talent in the entire country join the team. And we’re well into a “tech surge” to fix the problem. And we are confident that we will get all the problems fixed.
Number four -- while the website will ultimately be the easiest way to buy insurance through the marketplace, it isn’t the only way. And I want to emphasize this. Even as we redouble our efforts to get the site working as well as it’s supposed to, we’re also redoubling our efforts to make sure you can still buy the same quality, affordable insurance plans available on the marketplace the old-fashioned way -- offline, either over the phone or in person.
And, by the way, there are a lot of people who want to take advantage of this who are more comfortable working on the phone anyway or in person. So let me go through the specifics as to how you can do that if you’re having problems with the website or you just prefer dealing with a person.
Yesterday, we updated the website’s home page to offer more information about the other avenues to enroll in affordable health care until the online option works for everybody. So you’ll find information about how to talk to a specialist who can help you apply over the phone or to receive a downloadable application you can fill out yourself and mail in.
We’ve also added more staff to the call centers where you can apply for insurance over the phone. Those are already -- they've been working. But a lot of people have decided first to go to the website. But keep in mind, these call centers are already up and running. And you can get your questions answered by real people, 24 hours a day, in 150 different languages. The phone number for these call centers is 1-800-318-2596. I want to repeat that -- 1-800-318-2596. Wait times have averaged less than one minute so far on the call centers, although I admit that the wait times probably might go up a little bit now that I've read the number out loud on national television. (Laughter.)
But the point is the call centers are available. You can talk to somebody directly and they can walk you through the application process. And I guarantee you, if one thing is worth the wait, it’s the safety and security of health care that you can afford, or the amount of money that you can save by buying health insurance through the marketplaces. (Applause.)
Once you get on the phone with a trained representative, it usually takes about 25 minutes for an individual to apply for coverage, about 45 minutes for a family. Once you apply for coverage, you will be contacted by email or postal mail about your coverage status.
But you don't have to just go through the phone. You can also apply in person with the help of local navigators -– these are people specially trained to help you sign up for health care, and they exist all across the country, or you can go to community health centers and hospitals. Just visit LocalHelp.HealthCare.gov to find out where in your area you can get help and apply for insurance in person.
And finally, if you’ve already tried to apply through the website and you’ve been stuck somewhere along the way, do not worry. In the coming weeks, we will contact you directly, personally, with a concrete recommendation for how you can complete your application, shop for coverage, pick a plan that meets your needs, and get covered once and for all.
So here’s the bottom line. The product, the health insurance is good. The prices are good. It is a good deal. People don’t just want it; they’re showing up to buy it. Nobody is madder than me about the fact that the website isn’t working as well as it should, which means it’s going to get fixed. (Laughter and applause.)
And in the meantime, you can bypass the website and apply by phone or in person. So don’t let problems with the website deter you from signing up, or signing your family up, or showing your friends how to sign up, because it is worth it. It will save you money. If you don't have health insurance, if you’ve got a preexisting condition, it will save you money and it will give you the security that your family needs.
In fact, even with the website issues, we’ve actually made the overall process of buying insurance through the marketplace a lot smoother and easier than the old way of buying insurance on your own. Part of the challenge here is that a lot of people may not remember what it’s like to buy insurance the traditional way.
The way we’ve set it up, there are no more absurdly long application forms. There’s no medical history questionnaire that goes on for pages and pages. There’s no more getting denied because you’ve had a preexisting condition. Instead of contacting a bunch of different insurers one at a time, which is what Janice and a lot of people who are shopping on the individual market for health insurance had to do, there’s one single place you can go shop and compare plans that have to compete for your business. There’s one single phone number you can call for help. And once the kinks in the website have been ironed out, it will be an even smoother and even easier. But in the meantime, we will help you sign up -- because consumers want to buy this product and insurance companies want to sell it to you.
Now, let me close by addressing some of the politics that have swirled around the Affordable Care Act. I recognize that the Republican Party has made blocking the Affordable Care Act its signature policy idea. Sometimes it seems to be the one thing that unifies the party these days. (Laughter.) In fact, they were willing to shut down the government and potentially harm the global economy to try to get it repealed. And I’m sure that given the problems with the website so far, they’re going to be looking to go after it even harder. And let's admit it -- with the website not working as well as it needs to work, that makes a lot of supporters nervous because they know how it's been subject to so much attack, the Affordable Care Act generally.
But I just want to remind everybody, we did not wage this long and contentious battle just around a website. That’s not what this was about. (Applause.) We waged this battle to make sure that millions of Americans in the wealthiest nation on Earth finally have the same chance to get the same security of affordable quality health care as anybody else. That’s what this is about. (Applause.) And the Affordable Care Act has done that.
People can now get good insurance. People with preexisting conditions can now afford insurance. And if the launch of this website proves anything, it’s that people across the country don’t just need that security, they want that security. They want it. (Applause.) And in the meantime -- I’ve said many times -- I’m willing to work with anyone on any idea to make this law perform even better. But it’s time for folks to stop rooting for its failure, because hardworking, middle-class families are rooting for its success. (Applause.) And if the product is good, they're willing to be patient.
I got a letter last week from a self-employed man named John Mier in Leetsdale, Pennsylvania. He used the new marketplace to get himself and his wife covered and save a lot of money. And here’s what he said, because it pretty much sums up my message today: “Yes, the website really stank for the first week.” (Laughter.) “But instead of paying $1,600 per month for a group insurance plan, we have a plan that will only cost us $692 a month –- a savings of $900 per month.” (Applause.) John said that while he saw -- when he saw what they’d be paying, he turned to his wife and told her, “We might just pull through. We can afford this.” And John eventually predicted that “the website will work like a champ.”
So John, he was frustrated by the website, but he's feeling a little less frustrated once he found out that he was saving 900 bucks a month on his health insurance. (Applause.) And John is right, the website is going to get fixed and the law works. That's why we fought so hard to pass this law -- to save folks like John money; to give people who don't have health insurance the chance to get it for the first time; to lift from the American people the crushing burden of unaffordable health care; to free families from the pervasive fear that one illness -- (on-stage participant becomes ill) -- there you go, you are ok. I'm right here. I got you. (Laughter.) No, no -- you're okay. This happens when I talk too long. (Laughter.) You'll be okay. Here, why don't you go. (Applause.)
Good catch, by the way, whoever was here. (Laughter.)
But that's always our goal, to free families from the pervasive fear that one illness or one injury might cost you everything that you dedicated a lifetime to build. Our goal has always been to declare that in this country the security of health care is not a privilege for a fortunate few. It's a right for all to enjoy. (Applause.) That's what the Affordable Care Act is all about. That's its promise. And I intend to deliver on that promise.
Thank you very much, everybody. God bless you. (Applause.)
END
Remarks by the President on the Affordable Care Act
Rose Garden
11:33 A.M. EDT
THE PRESIDENT: Everybody, have a seat.
MS. BAKER: Hello. My name is Janice Baker. I have the privilege to say that I'm the first person in the state of Delaware to enroll for health insurance through the new marketplace. (Applause.) Like many consumers out there, it took me a number of frustrating attempts before I could apply for and select my plan. I kept trying because I needed access to the new health care options.
I had applied to three private insurance companies only to be rejected due to preexisting health conditions. I am too young for Medicare, but I'm too old not to have some health issues. I was able to find a policy I am thrilled with, saving $150 a month, and much lower deductibles than my previous policy that I held through my small business.
I'm here today to encourage other people like me who needs access to quality, affordable insurance, and to tell them to have patience with such a new system. Without this ability to get this insurance, I know that a single hospital stay could have bankrupted me and my business.
Thank you all. And I am now honored to introduce the President of the United States. (Applause.)
THE PRESIDENT: Great job.
MS. BAKER: Thank you. Thank you.
THE PRESIDENT: Thank you. (Applause.) Thank you, everybody. Well, thank you, Janice. And thanks to everybody here for coming on this beautiful day. Welcome to the White House.
About three weeks ago, as the federal government shut down, the Affordable Care Act’s health insurance marketplaces opened for business across the country. Well, we’ve now gotten the government back open for the American people, and today I want to talk about how we’re going to get the marketplaces running at full steam, as well. And I’m joined today by folks who have either benefited from the Affordable Care Act already, or who are helping their fellow citizens learn about what this law means for them and how they can get covered.
Of course, you’ve probably heard that HealthCare.gov –- the new website where people can apply for health insurance, and browse and buy affordable plans in most states –- hasn't worked as smoothly as it was supposed to work. And the number of people who have visited the site has been overwhelming, which has aggravated some of these underlying problems.
Despite all that, thousands of people are signing up and saving money as we speak. Many Americans with a preexisting condition, like Janice, are discovering that they can finally get health insurance like everybody else.
So today, I want to speak to every American who’s looking to get affordable health insurance. I want you to know what’s available to you and why it may be a good deal for you. And for those who’ve had some problems with the website, I want to tell you what we’re doing to make it work better and how you can sign up to get covered in other ways.
But before I do that, let me remind everybody that the Affordable Care Act is not just a website. It's much more. For the vast majority of Americans -- for 85 percent of Americans who already have health insurance through your employer or Medicare or Medicaid -– you don’t need to sign up for coverage through a website at all. You've already got coverage. What the Affordable Care Act does for you is to provide you with new benefits and protections that have been in place for some time. You may not know it, but you're already benefiting from these provisions in the law.
For example, because of the Affordable Care Act, young people like Jasmine Jennings, and Jessica Ugalde, and Ezra Salop, all of whom are here today, they’ve been able to stay on their parents’ plans until they’re 26. Millions of other young people are currently benefiting from that part of the law. (Applause.) Another part of the Affordable Care Act is providing seniors with deeper discounts on their prescription medicine. Billions of dollars have been saved by seniors already. That’s part of the law. It’s already in place. It’s happening right now.
Already, because of the Affordable Care Act, preventive care like mammograms and birth control are free through your employers. That’s part of this law. (Applause.) So there are a wide range of consumer protections and benefits that you already have if you’ve got health insurance. You may not have noticed them, but you’ve got them, and they’re not going anywhere. And they’re not dependent on a website.
Here’s another thing that the Affordable Care Act does. In states where governors and legislatures have wisely allowed it, the Affordable Care Act provides the opportunity for many Americans to get covered under Medicaid for the first time. So in Oregon, for example, that’s helped cut the number of uninsured people by 10 percent just in the last three weeks. Think about that. That’s 56,000 more Americans who now have health care. (Applause.) That doesn’t depend on a website.
Now, if you’re one of the 15 percent of Americans who don’t have health insurance -- either because you can’t afford it or because your employer doesn’t offer it, or because you’re a small businessperson and you have to go out on the individual market and buy it on your own and it’s just too expensive -- October 1st was an important date. That’s when we opened the new marketplaces where people without health insurance, or who can’t afford health insurance, or who aren’t part of a group plan, can finally start getting affordable coverage.
And the idea is simple. By enrolling in what we’re calling these marketplaces, you become part of a big group plan -- as if you were working for a big employer -- a statewide group plan that spreads risk between sick people and healthy people, between young and old, and then bargains on your behalf for the best deal on health care. What we’ve done is essentially create a competition where there wasn’t competition before. We created these big group plans, and now insurers are really interested in getting your business. And so insurers have created new health care plans with more choices to be made available through these marketplaces.
And as a result of this choice and this competition, prices have come down. When you add the new tax credits that many people are eligible for through the law, then the prices come down even further. So one study shows that through new options created by the Affordable Care Act, nearly 6 in 10 uninsured Americans will find that they can get covered for less than $100 a month. Think about that. (Applause.)
Through the marketplaces, you can get health insurance for what may be the equivalent of your cell phone bill or your cable bill, and that’s a good deal.
So the fact is the product of the Affordable Care Act for people without health insurance is quality health insurance that’s affordable. And that product is working. It’s really good. And it turns out there’s a massive demand for it. So far, the national website, HealthCare.gov, has been visited nearly 20 million times. Twenty million times. (Applause.) And there’s great demand at the state level as well, because there are a bunch of states that are running their own marketplaces.
We know that nearly one-third of the people applying in Connecticut and Maryland, for example, are under 35 years old. They understand that they can get a good deal at low costs, have the security of health care, and this is not just for old folks like me -- that everybody needs good quality health insurance. And all told, more than half a million consumers across the country have successfully submitted applications through federal and state marketplaces. And many of those applications aren’t just for individuals, it’s for their entire families. So even more people are already looking to potentially take advantage of the high quality, affordable insurance that is provided through the Affordable Care Act.
So let me just recap here. The product is good. The health insurance that’s being provided is good. It’s high quality and it’s affordable. People can save money, significant money, by getting insurance that’s being provided through these marketplaces. And we know that the demand is there. People are rushing to see what’s available. And those who have already had a chance to enroll are thrilled with the result. Every day, people who were stuck with sky-high premiums because of preexisting conditions are getting affordable insurance for the first time, or finding, like Janice did, that they’re saving a lot of money. Every day, women are finally buying coverage that doesn’t charge them higher premiums than men for the same care. (Applause.) Every day, people are discovering that new health insurance plans have to cover maternity care, mental health care, free preventive care.
So you just heard Janice’s story -- she owns her own small business. She recently became the first woman to enroll in coverage through Delaware’s exchange. And it’s true, it took her a few tries, but it was worth it after being turned down for insurance three times due to minor preexisting conditions. So now she’ll be covered, she’ll save 150 bucks a month, and she won’t have to worry that one illness or accident will cost her her business that she’s worked so hard to build.
And Janice is not alone. I recently received a letter from a woman named Jessica Sanford in Washington State. And here’s what she wrote: “I am a single mom, no child support, self-employed, and I haven’t had insurance for 15 years because it’s too expensive. My son has ADHD and requires regular doctor visits and his meds alone cost $250 per month. I have had an ongoing tendinitis problem due to my line of work that I haven’t had treated. Now, finally, we get to have coverage because of the ACA for $169 per month. I was crying the other day when I signed up. So much stress lifted.”
Now, that is not untypical for a lot of folks like Jessica who have been struggling without health insurance. That’s what the Affordable Care Act is all about. The point is, the essence of the law -- the health insurance that’s available to people -- is working just fine. In some cases, actually, it’s exceeding expectations -- the prices are lower than we expected, the choice is greater than we expected.
But the problem has been that the website that’s supposed to make it easy to apply for and purchase the insurance is not working the way it should for everybody. And there’s no sugarcoating it. The website has been too slow, people have been getting stuck during the application process. And I think it’s fair to say that nobody is more frustrated by that than I am -- precisely because the product is good, I want the cash registers to work. I want the checkout lines to be smooth. So I want people to be able to get this great product. And there’s no excuse for the problems, and these problems are getting fixed.
But while we’re working out the kinks in the system, I want everybody to understand the nature of the problem. First of all, even with all the problems at HealthCare.gov, the website is still working for a lot of people -- just not as quick or efficient or consistent as we want. And although many of these folks have found that they had to wait longer than they wanted, once they complete the process they’re very happy with the deal that’s available to them, just like Janice’s.
Second, I want everybody to remember that we’re only three weeks into a six-month open enrollment period, when you can buy these new plans. (Applause.) Keep in mind the insurance doesn’t start until January 1st; that’s the earliest that the insurance can kick in. No one who decides to purchase a plan has to pay their first premium until December 15th. And unlike the day after Thanksgiving sales for the latest Playstation or flat-screen TVs, the insurance plans don’t run out. They’re not going to sell out. They’ll be available through the marketplace -- (applause) -- throughout the open enrollment period. The prices that insurers have set will not change. So everybody who wants insurance through the marketplace will get insurance, period. (Applause.) Everybody who wants insurance through the marketplace will get insurance.
Third, we are doing everything we can possibly do to get the websites working better, faster, sooner. We’ve got people working overtime, 24/7, to boost capacity and address the problems. Experts from some of America’s top private-sector tech companies who, by the way, have seen things like this happen before, they want it to work. They're reaching out. They're offering to send help. We’ve had some of the best IT talent in the entire country join the team. And we’re well into a “tech surge” to fix the problem. And we are confident that we will get all the problems fixed.
Number four -- while the website will ultimately be the easiest way to buy insurance through the marketplace, it isn’t the only way. And I want to emphasize this. Even as we redouble our efforts to get the site working as well as it’s supposed to, we’re also redoubling our efforts to make sure you can still buy the same quality, affordable insurance plans available on the marketplace the old-fashioned way -- offline, either over the phone or in person.
And, by the way, there are a lot of people who want to take advantage of this who are more comfortable working on the phone anyway or in person. So let me go through the specifics as to how you can do that if you’re having problems with the website or you just prefer dealing with a person.
Yesterday, we updated the website’s home page to offer more information about the other avenues to enroll in affordable health care until the online option works for everybody. So you’ll find information about how to talk to a specialist who can help you apply over the phone or to receive a downloadable application you can fill out yourself and mail in.
We’ve also added more staff to the call centers where you can apply for insurance over the phone. Those are already -- they've been working. But a lot of people have decided first to go to the website. But keep in mind, these call centers are already up and running. And you can get your questions answered by real people, 24 hours a day, in 150 different languages. The phone number for these call centers is 1-800-318-2596. I want to repeat that -- 1-800-318-2596. Wait times have averaged less than one minute so far on the call centers, although I admit that the wait times probably might go up a little bit now that I've read the number out loud on national television. (Laughter.)
But the point is the call centers are available. You can talk to somebody directly and they can walk you through the application process. And I guarantee you, if one thing is worth the wait, it’s the safety and security of health care that you can afford, or the amount of money that you can save by buying health insurance through the marketplaces. (Applause.)
Once you get on the phone with a trained representative, it usually takes about 25 minutes for an individual to apply for coverage, about 45 minutes for a family. Once you apply for coverage, you will be contacted by email or postal mail about your coverage status.
But you don't have to just go through the phone. You can also apply in person with the help of local navigators -– these are people specially trained to help you sign up for health care, and they exist all across the country, or you can go to community health centers and hospitals. Just visit LocalHelp.HealthCare.gov to find out where in your area you can get help and apply for insurance in person.
And finally, if you’ve already tried to apply through the website and you’ve been stuck somewhere along the way, do not worry. In the coming weeks, we will contact you directly, personally, with a concrete recommendation for how you can complete your application, shop for coverage, pick a plan that meets your needs, and get covered once and for all.
So here’s the bottom line. The product, the health insurance is good. The prices are good. It is a good deal. People don’t just want it; they’re showing up to buy it. Nobody is madder than me about the fact that the website isn’t working as well as it should, which means it’s going to get fixed. (Laughter and applause.)
And in the meantime, you can bypass the website and apply by phone or in person. So don’t let problems with the website deter you from signing up, or signing your family up, or showing your friends how to sign up, because it is worth it. It will save you money. If you don't have health insurance, if you’ve got a preexisting condition, it will save you money and it will give you the security that your family needs.
In fact, even with the website issues, we’ve actually made the overall process of buying insurance through the marketplace a lot smoother and easier than the old way of buying insurance on your own. Part of the challenge here is that a lot of people may not remember what it’s like to buy insurance the traditional way.
The way we’ve set it up, there are no more absurdly long application forms. There’s no medical history questionnaire that goes on for pages and pages. There’s no more getting denied because you’ve had a preexisting condition. Instead of contacting a bunch of different insurers one at a time, which is what Janice and a lot of people who are shopping on the individual market for health insurance had to do, there’s one single place you can go shop and compare plans that have to compete for your business. There’s one single phone number you can call for help. And once the kinks in the website have been ironed out, it will be an even smoother and even easier. But in the meantime, we will help you sign up -- because consumers want to buy this product and insurance companies want to sell it to you.
Now, let me close by addressing some of the politics that have swirled around the Affordable Care Act. I recognize that the Republican Party has made blocking the Affordable Care Act its signature policy idea. Sometimes it seems to be the one thing that unifies the party these days. (Laughter.) In fact, they were willing to shut down the government and potentially harm the global economy to try to get it repealed. And I’m sure that given the problems with the website so far, they’re going to be looking to go after it even harder. And let's admit it -- with the website not working as well as it needs to work, that makes a lot of supporters nervous because they know how it's been subject to so much attack, the Affordable Care Act generally.
But I just want to remind everybody, we did not wage this long and contentious battle just around a website. That’s not what this was about. (Applause.) We waged this battle to make sure that millions of Americans in the wealthiest nation on Earth finally have the same chance to get the same security of affordable quality health care as anybody else. That’s what this is about. (Applause.) And the Affordable Care Act has done that.
People can now get good insurance. People with preexisting conditions can now afford insurance. And if the launch of this website proves anything, it’s that people across the country don’t just need that security, they want that security. They want it. (Applause.) And in the meantime -- I’ve said many times -- I’m willing to work with anyone on any idea to make this law perform even better. But it’s time for folks to stop rooting for its failure, because hardworking, middle-class families are rooting for its success. (Applause.) And if the product is good, they're willing to be patient.
I got a letter last week from a self-employed man named John Mier in Leetsdale, Pennsylvania. He used the new marketplace to get himself and his wife covered and save a lot of money. And here’s what he said, because it pretty much sums up my message today: “Yes, the website really stank for the first week.” (Laughter.) “But instead of paying $1,600 per month for a group insurance plan, we have a plan that will only cost us $692 a month –- a savings of $900 per month.” (Applause.) John said that while he saw -- when he saw what they’d be paying, he turned to his wife and told her, “We might just pull through. We can afford this.” And John eventually predicted that “the website will work like a champ.”
So John, he was frustrated by the website, but he's feeling a little less frustrated once he found out that he was saving 900 bucks a month on his health insurance. (Applause.) And John is right, the website is going to get fixed and the law works. That's why we fought so hard to pass this law -- to save folks like John money; to give people who don't have health insurance the chance to get it for the first time; to lift from the American people the crushing burden of unaffordable health care; to free families from the pervasive fear that one illness -- (on-stage participant becomes ill) -- there you go, you are ok. I'm right here. I got you. (Laughter.) No, no -- you're okay. This happens when I talk too long. (Laughter.) You'll be okay. Here, why don't you go. (Applause.)
Good catch, by the way, whoever was here. (Laughter.)
But that's always our goal, to free families from the pervasive fear that one illness or one injury might cost you everything that you dedicated a lifetime to build. Our goal has always been to declare that in this country the security of health care is not a privilege for a fortunate few. It's a right for all to enjoy. (Applause.) That's what the Affordable Care Act is all about. That's its promise. And I intend to deliver on that promise.
Thank you very much, everybody. God bless you. (Applause.)
END
SECRETARY OF STATE KERRY'S REMARKS WITH PRIME MINISTER OF PAKISTAN SHARIF
FROM: U.S. STATE DEPARTMENT
Remarks With Prime Minister of the Islamic Republic of Pakistan Nawaz Sharif
Remarks
John Kerry
Secretary of State
Washington, DC
October 20, 2013
Let me just say that I’m really pleased to welcome Prime Minister Sharif here. He was just telling me that he hasn’t been here since 1999 when he was last in office. He has received me several times very generously in Pakistan. We’re very anxious to have a series of high-level, important discussions over the course of the next few days – the Vice President, the President, tonight’s dinner. We have a lot to talk about and the relationship with Pakistan could not be more important. On its own, a democracy that is working hard to get its economy moving and deal with insurgency and also important to the regional stability. So, we’re very happy to have you here, Mr. Prime Minister. I look forward to the conversations
Remarks With Prime Minister of the Islamic Republic of Pakistan Nawaz Sharif
Remarks
John Kerry
Secretary of State
Washington, DC
October 20, 2013
Let me just say that I’m really pleased to welcome Prime Minister Sharif here. He was just telling me that he hasn’t been here since 1999 when he was last in office. He has received me several times very generously in Pakistan. We’re very anxious to have a series of high-level, important discussions over the course of the next few days – the Vice President, the President, tonight’s dinner. We have a lot to talk about and the relationship with Pakistan could not be more important. On its own, a democracy that is working hard to get its economy moving and deal with insurgency and also important to the regional stability. So, we’re very happy to have you here, Mr. Prime Minister. I look forward to the conversations
PORTRAIT OF SATURN LOOKING DOWN ON RINGS
This portrait looking down on Saturn and its rings was created from images obtained by NASA's Cassini spacecraft on Oct. 10, 2013. It was made by amateur image processor and Cassini fan Gordan Ugarkovic. This image has not been geometrically corrected for shifts in the spacecraft perspective and still has some camera artifacts.The mosaic was created from 12 image footprints with red, blue and green filters from Cassini's imaging science subsystem. Ugarkovic used full color sets for 11 of the footprints and red and blue images for one footprint. The Cassini-Huygens mission is a cooperative project of NASA, the European Space Agency and the Italian Space Agency. The Jet Propulsion Laboratory, a division of the California Institute of Technology in Pasadena, manages the mission for NASA's Science Mission Directorate, Washington, D.C. The Cassini orbiter and its two onboard cameras were designed, developed and assembled at JPL. The imaging operations center is based at the Space Science Institute in Boulder, Colo.
TAX RETURN PREPARERS FACE ADDITIONAL CHARGES IN OFFSHORE ACCOUNT SCHEME
FROM: U.S. JUSTICE DEPARTMENT
Friday, October 18, 2013
Additional Charges Brought Against Tax Return Preparers Previously Charged with Helping Clients Hide Millions in Offshore Israeli Banks
David Kalai and Nadav Kalai face additional charges after a federal grand jury in the Central District of California returned a second superseding indictment yesterday. The superseding indictment charged each with two counts of willfully failing to file a Report of Foreign Bank and Financial Accounts (FBAR). In June 2012, the grand jury charged David Kalai, Nadav Kalai, and David Almog with conspiring to defraud the United States, the Department of Justice and Internal Revenue Service (IRS) announced today.
As alleged in the June 2012 superseding indictment, David Kalai and Nadav Kalai were principals of United Revenue Service Inc. (URS), a tax preparation business with 12 offices located throughout the United States. David Kalai worked primarily at URS’ former headquarters in Newport Beach, Calif., and later at URS’ location in Costa Mesa, Calif. Nadav Kalai, who is David Kalai’s son, worked out of URS’ headquarters in Bethesda, Md., as well as URS locations in Newport Beach and Costa Mesa. David Almog was the branch manager of the New York office of URS and supervised tax return preparers for URS East Coast locations.
U.S. citizens, resident aliens and legal permanent residents have an obligation to report to the IRS on Schedule B of the U.S. Individual Income Tax Return, Form 1040, whether they had a financial interest in, or signature authority over, a financial account in a foreign country in a particular year by checking “Yes” or “No” in the appropriate box and identifying the country where the account was maintained. They further have an obligation to report all income earned from the foreign financial account on the tax returns. Separately, U.S. citizens, resident aliens and permanent legal residents with a foreign financial interest in, or signatory authority over, a foreign financial account worth more than $10,000 in a particular year, must also file a FBAR with the Treasury disclosing such an account by June 30 of the following year.
The superseding indictment further alleged that the co-conspirators prepared false individual income tax returns which did not disclose the clients’ foreign financial accounts nor report the income earned from those accounts. In order to conceal the clients’ ownership and control of assets and conceal the clients’ income from the IRS, the co-conspirators incorporated offshore companies in Belize and elsewhere and helped clients open secret bank accounts at the Luxembourg locations of two Israeli banks referred to as Bank A and Bank B in court documents. Bank A is a large financial institution headquartered in Tel-Aviv, Israel, with branches worldwide. Bank B is a mid-size financial institution headquartered in Tel-Aviv, with a worldwide presence on four continents.
The indictment also alleged, the co-conspirators incorporated offshore companies in Belize and elsewhere to act as named account holders on the secret accounts at the Israeli banks. The co-conspirators then facilitated the transfer of client funds to the secret accounts and prepared and filed tax returns that falsely reported the money sent offshore as a false investment loss or a false business expense. The co-conspirators also failed to disclose the existence of, and the clients’ financial interest in, and authority over, the clients’ secret accounts and caused the clients to fail to file FBARs with the Department of the Treasury.
In addition to the earlier charges, yesterday’s superseding indictment alleges that David Kalai and Nadav Kalai each failed to file a FBAR for calendar years 2008 and 2009 concerning a foreign account held at Bank A in Luxembourg. The second superseding indictment alleges that both David Kalai and Nadav Kalai had a financial interest, signature or other authority over a foreign financial account that had an aggregate value of more than $10,000 during 2008 and 2009.
If convicted, each defendant faces a maximum of five years in prison for each count and a maximum fine of $250,000 for each count. The charges contained in the indictment are only allegations. The defendants are presumed innocent and it is the government’s burden to prove guilt beyond a reasonable doubt.
Kathryn Keneally, Assistant Attorney General of the Justice Department’s Tax Division, thanked Tax Division Trial Attorneys Christopher S. Strauss and Ellen M. Quattrucci, who prosecuted the case, and Assistant U.S. Attorney Sandra A. Brown of the U.S. Attorney’s Office for the Central District of California, who assisted with the prosecution. The case was investigated by special agents of IRS – Criminal Investigation.
Friday, October 18, 2013
Additional Charges Brought Against Tax Return Preparers Previously Charged with Helping Clients Hide Millions in Offshore Israeli Banks
David Kalai and Nadav Kalai face additional charges after a federal grand jury in the Central District of California returned a second superseding indictment yesterday. The superseding indictment charged each with two counts of willfully failing to file a Report of Foreign Bank and Financial Accounts (FBAR). In June 2012, the grand jury charged David Kalai, Nadav Kalai, and David Almog with conspiring to defraud the United States, the Department of Justice and Internal Revenue Service (IRS) announced today.
As alleged in the June 2012 superseding indictment, David Kalai and Nadav Kalai were principals of United Revenue Service Inc. (URS), a tax preparation business with 12 offices located throughout the United States. David Kalai worked primarily at URS’ former headquarters in Newport Beach, Calif., and later at URS’ location in Costa Mesa, Calif. Nadav Kalai, who is David Kalai’s son, worked out of URS’ headquarters in Bethesda, Md., as well as URS locations in Newport Beach and Costa Mesa. David Almog was the branch manager of the New York office of URS and supervised tax return preparers for URS East Coast locations.
U.S. citizens, resident aliens and legal permanent residents have an obligation to report to the IRS on Schedule B of the U.S. Individual Income Tax Return, Form 1040, whether they had a financial interest in, or signature authority over, a financial account in a foreign country in a particular year by checking “Yes” or “No” in the appropriate box and identifying the country where the account was maintained. They further have an obligation to report all income earned from the foreign financial account on the tax returns. Separately, U.S. citizens, resident aliens and permanent legal residents with a foreign financial interest in, or signatory authority over, a foreign financial account worth more than $10,000 in a particular year, must also file a FBAR with the Treasury disclosing such an account by June 30 of the following year.
The superseding indictment further alleged that the co-conspirators prepared false individual income tax returns which did not disclose the clients’ foreign financial accounts nor report the income earned from those accounts. In order to conceal the clients’ ownership and control of assets and conceal the clients’ income from the IRS, the co-conspirators incorporated offshore companies in Belize and elsewhere and helped clients open secret bank accounts at the Luxembourg locations of two Israeli banks referred to as Bank A and Bank B in court documents. Bank A is a large financial institution headquartered in Tel-Aviv, Israel, with branches worldwide. Bank B is a mid-size financial institution headquartered in Tel-Aviv, with a worldwide presence on four continents.
The indictment also alleged, the co-conspirators incorporated offshore companies in Belize and elsewhere to act as named account holders on the secret accounts at the Israeli banks. The co-conspirators then facilitated the transfer of client funds to the secret accounts and prepared and filed tax returns that falsely reported the money sent offshore as a false investment loss or a false business expense. The co-conspirators also failed to disclose the existence of, and the clients’ financial interest in, and authority over, the clients’ secret accounts and caused the clients to fail to file FBARs with the Department of the Treasury.
In addition to the earlier charges, yesterday’s superseding indictment alleges that David Kalai and Nadav Kalai each failed to file a FBAR for calendar years 2008 and 2009 concerning a foreign account held at Bank A in Luxembourg. The second superseding indictment alleges that both David Kalai and Nadav Kalai had a financial interest, signature or other authority over a foreign financial account that had an aggregate value of more than $10,000 during 2008 and 2009.
If convicted, each defendant faces a maximum of five years in prison for each count and a maximum fine of $250,000 for each count. The charges contained in the indictment are only allegations. The defendants are presumed innocent and it is the government’s burden to prove guilt beyond a reasonable doubt.
Kathryn Keneally, Assistant Attorney General of the Justice Department’s Tax Division, thanked Tax Division Trial Attorneys Christopher S. Strauss and Ellen M. Quattrucci, who prosecuted the case, and Assistant U.S. Attorney Sandra A. Brown of the U.S. Attorney’s Office for the Central District of California, who assisted with the prosecution. The case was investigated by special agents of IRS – Criminal Investigation.
LOS ALAMOS CELEBRATES 50 YEARS SINCE LAUNCH OF 'WATCHMEN'
FROM: LOS ALAMOS NATIONAL LABORATORY
A Golden Anniversary for Space-Based Treaty Verification
Los Alamos celebrates 50-year anniversary of launch of first pair of ‘Watchmen’
LOS ALAMOS, N.M., Oct. 22, 2013—Fifty years ago this month, Los Alamos National Laboratory sensor technology lifted off into space to help verify that world Superpowers were abiding by the newly signed Limited Test Ban Treaty—a pledge by the United States, the former Soviet Union and the United Kingdom to refrain from testing nuclear weapons in the atmosphere, underwater or in space.
“For the past 70 years, Los Alamos National Laboratory has serviced the country and provided technical solutions to the some of biggest national security challenges facing the nation,” said Terry Wallace, Principal Associate Director for Global Security at Los Alamos. “On October 4, 1957, the Soviets launched Sputnik, an event that changed the world. Space became a national-security concern; Los Alamos played the key role in providing a space platform to monitor nuclear weapons testing and treaties, and 50 years later the lab still has this role.
“As we celebrate our golden anniversary of space-based treaty verification, we remember not only our successes in our mission, but also how this mission has enabled scientific discovery,” Wallace said. “Without a focus on national security, we could not continue to produce cutting-edge science; without our commitment to scientific excellence, we could not succeed in our mission. It is this synergy that makes Los Alamos a truly unique national treasure.”
The first pair of Vela satellites launched on Oct. 17, 1963, just one week after the three nations had signed the historic treaty, and barely a year after the U.S. and Soviet Union had faced an extremely tense nuclear standoff during the Cuban Missile Crisis. With the launch of Vela—an abbreviated version of Velador, a colloquial New Mexican word for “night watchman”—a dangerous era of accelerated atmospheric and space-based nuclear weapons testing by the U.S. and Soviet Union subsided, thanks to collaboration between Los Alamos and Sandia national laboratories. One year later, China detonated its first nuclear weapon, underscoring the need for enhanced vigilance in a rapidly changing world.
The success of the Vela program marked the beginning of an enduring space-based treaty verification system that continues to enhance security for America and the rest of the world. Vela’s sensors focused on basic detection of electromagnetic- and energetic-particle emissions associated with open nuclear weapons detonations. But they also enabled serendipitous discoveries of remarkable natural phenomena such as cosmic gamma-ray bursts, X-ray novae and solar wind composition. Modern space-based verification systems rely on sophisticated sensors that have not only helped keep the peace, but also continue to help explain the origins of poorly understood natural events such as terrestrial lightning.
During the past 50 years, some 200 space vehicles have been launched with Los Alamos payloads aboard. Many of these support on-going treaty-monitoring missions, while others are experiments designed to push the boundaries of what is considered state-of-the-art. Notable Los Alamos experimental missions include:
ALEXIS, the Array of Low-Energy X-ray Imaging Sensors, was Los Alamos’s first homemade satellite. Launched in April 1993, this small craft demonstrated and tested new X-ray and radio sensing technology. The satellite was controlled from inside a small room at the Laboratory and remains aloft today.
The FORTÉ, Fast On-orbit Rapid Recording of Transient Events, satellite, launched in August 1997, was a satellite test-bed for nuclear-detonation-detection technologies. Weighing less than 100 pounds and built of graphite-reinforced epoxy (the first of its kind to go into space), the small, long craft was essentially an antenna attached to a capsule-shaped array of solar panels, giving the satellite a distinctive fish-skeleton appearance. The satellite was lauded by Discovery magazine as one of most innovative advancements in aerospace technology, and it explored a 30-year problem of discriminating between electro-magnetic pulses (EMPs) caused by nuclear explosions and those caused by other natural or manmade sources.
The Cibola Flight Experiment, launched in March 2007, tested eight new technologies—among them whether a specially designed supercomputer could survive the rigors of space. Because spacecraft are constantly bombarded by high-energy particles trapped in Earth’s magnetic field, computers and computer equipment can fail in the harsh environment. Moreover, high-powered computing requires a lot of energy, yet space travel requires low weight and small packages. Cibola’s supercomputer is testing new power sources and new strategies for hardening crucial computer components as well as new treaty verification technologies.
In December 2010 Los Alamos scientists launched four satellites known as “cubeSats,” each of which is tiny enough to be held in a human hand. These unique craft, part of the Perseus Program, demonstrated the ability to quickly build and launch a useful, low-cost satellite. They also helped validate a Los Alamos design methodology of using simple, off-the-shelf components to accomplish a specific mission. The tiny spacecraft showcased communication- and data-collection capabilities, as well as a major new space capability for the Laboratory.
In addition to these missions, Los Alamos space technology deployed on scientific satellites has helped scientists worldwide determine the elemental composition of the surface of the moon, including the presence of water; understand the structure and dynamics of the Van Allen radiation belts; characterize the moons of Saturn; study the origin of gamma ray bursts and supernovae; and, most recently, with key instruments aboard the Curiosity Rover, help characterize the Martian landscape.
“The capabilities and technologies we have developed and demonstrated in support of our treaty verification mission have also found wide application in basic space research, enabled our participation in multiple NASA projects and led to a number of important discoveries,” said Kevin Saeger, leader of Los Alamos’s Intelligence and Space Research Division. “It’s a source of great pride to ISR Division employees to be able to support national security and at the same time participate in the human quest for greater knowledge and understanding of the universe.”
An exhibit that includes highlights of Los Alamos National Laboratory’s 50 years of space-based treaty verification, starting with Vela, is on display at U.S. Department of Energy Headquarters in Washington, D.C. The exhibit will next go to the U.S. Air Force’s Space and Missile Systems Center in Los Angeles, and later to Patrick Air Force Base in Florida, key partners in the national program for space-based nuclear detonation detection.
A Golden Anniversary for Space-Based Treaty Verification
Los Alamos celebrates 50-year anniversary of launch of first pair of ‘Watchmen’
LOS ALAMOS, N.M., Oct. 22, 2013—Fifty years ago this month, Los Alamos National Laboratory sensor technology lifted off into space to help verify that world Superpowers were abiding by the newly signed Limited Test Ban Treaty—a pledge by the United States, the former Soviet Union and the United Kingdom to refrain from testing nuclear weapons in the atmosphere, underwater or in space.
“For the past 70 years, Los Alamos National Laboratory has serviced the country and provided technical solutions to the some of biggest national security challenges facing the nation,” said Terry Wallace, Principal Associate Director for Global Security at Los Alamos. “On October 4, 1957, the Soviets launched Sputnik, an event that changed the world. Space became a national-security concern; Los Alamos played the key role in providing a space platform to monitor nuclear weapons testing and treaties, and 50 years later the lab still has this role.
“As we celebrate our golden anniversary of space-based treaty verification, we remember not only our successes in our mission, but also how this mission has enabled scientific discovery,” Wallace said. “Without a focus on national security, we could not continue to produce cutting-edge science; without our commitment to scientific excellence, we could not succeed in our mission. It is this synergy that makes Los Alamos a truly unique national treasure.”
The first pair of Vela satellites launched on Oct. 17, 1963, just one week after the three nations had signed the historic treaty, and barely a year after the U.S. and Soviet Union had faced an extremely tense nuclear standoff during the Cuban Missile Crisis. With the launch of Vela—an abbreviated version of Velador, a colloquial New Mexican word for “night watchman”—a dangerous era of accelerated atmospheric and space-based nuclear weapons testing by the U.S. and Soviet Union subsided, thanks to collaboration between Los Alamos and Sandia national laboratories. One year later, China detonated its first nuclear weapon, underscoring the need for enhanced vigilance in a rapidly changing world.
The success of the Vela program marked the beginning of an enduring space-based treaty verification system that continues to enhance security for America and the rest of the world. Vela’s sensors focused on basic detection of electromagnetic- and energetic-particle emissions associated with open nuclear weapons detonations. But they also enabled serendipitous discoveries of remarkable natural phenomena such as cosmic gamma-ray bursts, X-ray novae and solar wind composition. Modern space-based verification systems rely on sophisticated sensors that have not only helped keep the peace, but also continue to help explain the origins of poorly understood natural events such as terrestrial lightning.
During the past 50 years, some 200 space vehicles have been launched with Los Alamos payloads aboard. Many of these support on-going treaty-monitoring missions, while others are experiments designed to push the boundaries of what is considered state-of-the-art. Notable Los Alamos experimental missions include:
ALEXIS, the Array of Low-Energy X-ray Imaging Sensors, was Los Alamos’s first homemade satellite. Launched in April 1993, this small craft demonstrated and tested new X-ray and radio sensing technology. The satellite was controlled from inside a small room at the Laboratory and remains aloft today.
The FORTÉ, Fast On-orbit Rapid Recording of Transient Events, satellite, launched in August 1997, was a satellite test-bed for nuclear-detonation-detection technologies. Weighing less than 100 pounds and built of graphite-reinforced epoxy (the first of its kind to go into space), the small, long craft was essentially an antenna attached to a capsule-shaped array of solar panels, giving the satellite a distinctive fish-skeleton appearance. The satellite was lauded by Discovery magazine as one of most innovative advancements in aerospace technology, and it explored a 30-year problem of discriminating between electro-magnetic pulses (EMPs) caused by nuclear explosions and those caused by other natural or manmade sources.
The Cibola Flight Experiment, launched in March 2007, tested eight new technologies—among them whether a specially designed supercomputer could survive the rigors of space. Because spacecraft are constantly bombarded by high-energy particles trapped in Earth’s magnetic field, computers and computer equipment can fail in the harsh environment. Moreover, high-powered computing requires a lot of energy, yet space travel requires low weight and small packages. Cibola’s supercomputer is testing new power sources and new strategies for hardening crucial computer components as well as new treaty verification technologies.
In December 2010 Los Alamos scientists launched four satellites known as “cubeSats,” each of which is tiny enough to be held in a human hand. These unique craft, part of the Perseus Program, demonstrated the ability to quickly build and launch a useful, low-cost satellite. They also helped validate a Los Alamos design methodology of using simple, off-the-shelf components to accomplish a specific mission. The tiny spacecraft showcased communication- and data-collection capabilities, as well as a major new space capability for the Laboratory.
In addition to these missions, Los Alamos space technology deployed on scientific satellites has helped scientists worldwide determine the elemental composition of the surface of the moon, including the presence of water; understand the structure and dynamics of the Van Allen radiation belts; characterize the moons of Saturn; study the origin of gamma ray bursts and supernovae; and, most recently, with key instruments aboard the Curiosity Rover, help characterize the Martian landscape.
“The capabilities and technologies we have developed and demonstrated in support of our treaty verification mission have also found wide application in basic space research, enabled our participation in multiple NASA projects and led to a number of important discoveries,” said Kevin Saeger, leader of Los Alamos’s Intelligence and Space Research Division. “It’s a source of great pride to ISR Division employees to be able to support national security and at the same time participate in the human quest for greater knowledge and understanding of the universe.”
An exhibit that includes highlights of Los Alamos National Laboratory’s 50 years of space-based treaty verification, starting with Vela, is on display at U.S. Department of Energy Headquarters in Washington, D.C. The exhibit will next go to the U.S. Air Force’s Space and Missile Systems Center in Los Angeles, and later to Patrick Air Force Base in Florida, key partners in the national program for space-based nuclear detonation detection.
DEFENSE BUILDING 'IRON MAN SUIT'
FROM: U.S. DEFENSE DEPARTMENT
Special Ops Command Seeks Prototypes for 'Iron Man Suit'
By David Vergun
Army News Service
WASHINGTON, Oct. 18, 2013 - U.S. Special Operations Command wants its operators to be protected with what it informally calls an "Iron Man suit," named after the fictional superhero.
In September, Socom announced it is seeking proposal
As for prototypes of the Tactical Assault Light Operator Suit, or TALOS.
The goal of TALOS is to provide ballistic protection to Special Operations Forces, along with fire-retardant capability, said Michel Fieldson, TALOS lead for Socom.
"We sometimes refer to it as the 'Iron Man' suit, frankly, to attract the attention, imagination and excitement of industry and academia," Fieldson said. "We're hoping to take products we're developing in several technology areas and integrating them into a consolidated suit to provide more protection for the [special operations forces]."
Other technologies include sensors, communications, energy and material that can store and release energy to prevent injuries and increase performance.
Materials that can store and release energy might be similar to the Intrepid Dynamic Exoskeletal Orthosis, now used by some wounded warriors for lower-leg injuries. So TALOS could benefit wounded warriors too, Fieldson said.
The Homeland Security Department and firefighters have expressed an interest in this technology as well, he said, and it eventually might become available for other service members.
"Our goal right now is to try to get the word out and bring industry partners together," Fieldson said. The technologies that will go into the suit's development are varied, he said, so it is unlikely one contractor would be able to specialize in the entire ensemble.
The traditional approach, Fieldson said, was to pick a prime contractor, usually a traditional defense partner, give them the design requirements and let them come up with the solution. That would take a long time, he noted.
"In this case, the government will be the lead integrator, and we'll look to work with traditional or nontraditional partners in industry and academia who are innovative," he said. "We'll leave no stone unturned."
The goal, he said, is to begin integrating capabilities over the next 12 months and have the first suit ready for full field testing in four to five years.
Fieldson thinks TALOS will become a reality because it protects the warfighters and has the backing of Socom's commander, Navy Adm. William H. McRaven.
"I'm very committed to this," McRaven said to industry representatives at a July 8 TALOS demonstration in Tampa, Fla. "I'd like that last operator that we lost to be the last one we ever lose in this fight or the fight of the future, and I think we can get there.
"I'm committed to this," he continued. "At the end of the day, I need you and industry to figure out how you are going to partner with each other to do something that's right for America."
Sunday, October 20, 2013
JUSTICE REPORTS SHUTDOWN OF TAX PREPARATION FIRM FOR IMPROPER REPORTING OF FINANCIAL LOSSES
FROM: U.S. JUSTICE DEPARTMENT
Friday, October 18, 2013
Columbus, Ohio, Tax Return Preparation Firm with Large Portion of Elderly Customers Shut Down
A federal court in Columbus, Ohio, has permanently barred Tobias Elsass and his companies, “Fraud Recovery Group Inc.” and “Sensible Tax Services Inc.,” from preparing federal tax returns, promoting the availability of theft loss deductions, or engaging in any other tax-related business in the future. The Court found that Elsass and Fraud Recovery Group have continually and repeatedly promoted a nationwide scheme falsely informing their customers that they were entitled to claim large theft loss tax deductions, and then preparing the tax returns that improperly claimed such deductions. The civil injunction order was signed yesterday by Judge Peter C. Economus of the U.S. District Court for the Southern District of Ohio.
Elsass serves as president and founder of Fraud Recovery Group and Sensible Tax Services. The district court found that Elsass and his companies promoted a scheme that preyed largely on elderly investors across the United States who had suffered financial losses. Elsass and his companies told the investors that they could deduct their financial losses on their federal income tax returns in an advantaged way and receive large refunds. Under federal tax law, victims of truly fraudulent investment schemes, such as a Ponzi scheme, may properly deduct their financial losses as thefts only if they can substantiate that the losses were, among other things, the product of criminal conduct.
In its opinion, the court concluded that Elsass misled his elderly investor customers into believing that they had valid theft loss deductions, thereby inducing them to pay him and his companies to prepare and file amended tax returns. The opinion notes that hundreds of theft loss deductions claimed on tax returns prepared by Elsass and his companies were improper, because the financial losses they sought to deduct were merely the result of company mismanagement instead of criminal conduct – as Elsass knew. Elsass and his companies were also aware that the Internal Revenue Service (IRS) was disallowing such claims, but filed similar claims for other investor customers in any event, in the hope that the later filings would escape IRS scrutiny. The court found that, as a result of such egregious conduct, Elsass and his companies potentially left their investor customers subject “to audits and scrutiny from the IRS.”
The court also determined that Elsass had intentionally engaged in “incompetent or disreputable” behavior not becoming a tax professional. Based on the record before it, the court found that Elsass seemed “perfectly willing to lie and deceive, even to the extent of possibly committing perjury, in order to advance his own interests.” Accordingly, the “sheer magnitude and variety of the Defendants’ transgressions” made permanent injunctive relief appropriate.
The court directed that FRG be closed and its operations terminated. The court’s injunction order permanently bars Elsass from engaging in any business relating to providing tax advice or the preparation of tax returns. Elsass and his companies are also prohibited from owning any interest in, operating, incorporating, working for or having any other association with any tax-related business in the future, and they must immediately divest any ownership interest they presently have with any such entities. The court’s order also requires Elsass and his companies to advise their existing customers of the injunction’s terms, and to provide the Government with a list of all current customers.
Friday, October 18, 2013
Columbus, Ohio, Tax Return Preparation Firm with Large Portion of Elderly Customers Shut Down
A federal court in Columbus, Ohio, has permanently barred Tobias Elsass and his companies, “Fraud Recovery Group Inc.” and “Sensible Tax Services Inc.,” from preparing federal tax returns, promoting the availability of theft loss deductions, or engaging in any other tax-related business in the future. The Court found that Elsass and Fraud Recovery Group have continually and repeatedly promoted a nationwide scheme falsely informing their customers that they were entitled to claim large theft loss tax deductions, and then preparing the tax returns that improperly claimed such deductions. The civil injunction order was signed yesterday by Judge Peter C. Economus of the U.S. District Court for the Southern District of Ohio.
Elsass serves as president and founder of Fraud Recovery Group and Sensible Tax Services. The district court found that Elsass and his companies promoted a scheme that preyed largely on elderly investors across the United States who had suffered financial losses. Elsass and his companies told the investors that they could deduct their financial losses on their federal income tax returns in an advantaged way and receive large refunds. Under federal tax law, victims of truly fraudulent investment schemes, such as a Ponzi scheme, may properly deduct their financial losses as thefts only if they can substantiate that the losses were, among other things, the product of criminal conduct.
In its opinion, the court concluded that Elsass misled his elderly investor customers into believing that they had valid theft loss deductions, thereby inducing them to pay him and his companies to prepare and file amended tax returns. The opinion notes that hundreds of theft loss deductions claimed on tax returns prepared by Elsass and his companies were improper, because the financial losses they sought to deduct were merely the result of company mismanagement instead of criminal conduct – as Elsass knew. Elsass and his companies were also aware that the Internal Revenue Service (IRS) was disallowing such claims, but filed similar claims for other investor customers in any event, in the hope that the later filings would escape IRS scrutiny. The court found that, as a result of such egregious conduct, Elsass and his companies potentially left their investor customers subject “to audits and scrutiny from the IRS.”
The court also determined that Elsass had intentionally engaged in “incompetent or disreputable” behavior not becoming a tax professional. Based on the record before it, the court found that Elsass seemed “perfectly willing to lie and deceive, even to the extent of possibly committing perjury, in order to advance his own interests.” Accordingly, the “sheer magnitude and variety of the Defendants’ transgressions” made permanent injunctive relief appropriate.
The court directed that FRG be closed and its operations terminated. The court’s injunction order permanently bars Elsass from engaging in any business relating to providing tax advice or the preparation of tax returns. Elsass and his companies are also prohibited from owning any interest in, operating, incorporating, working for or having any other association with any tax-related business in the future, and they must immediately divest any ownership interest they presently have with any such entities. The court’s order also requires Elsass and his companies to advise their existing customers of the injunction’s terms, and to provide the Government with a list of all current customers.
FORMER QUALCOMM EXECUTIVE CHARGED WITH INSIDER TRADING BY SEC
FROM: U.S. SECURITIES AND EXCHANGE COMMISSION
SEC Charges Former Qualcomm Executive and His Financial Advisor with Insider Trading Through Secret Offshore Accounts
The Securities and Exchange Commission today charged a former executive vice president at Qualcomm Inc. and his former financial advisor with insider trading ahead of major announcements by the San Diego-based wireless technology company for more than a quarter-million dollars in profits.
The SEC alleges that Jing Wang, a former executive vice president and president of global business operations at Qualcomm, used a secret offshore brokerage account to make illegal trades based on confidential information that he learned on the job. Gary Yin, a former registered representative at Merrill Lynch, helped Wang set up the account. Yin also created a secret offshore account of his own and traded on the non-public information gleaned from Wang. When Wang eventually realized that insider trading in the offshore accounts still may be discovered by the SEC or other regulators, he concocted a plan to conceal his trading activity by claiming the trades were made by his brother. Wang even convinced Yin to travel to China and go over the account statements with Wang’s brother so he could explain the trades if asked by investigators.
In a parallel action, the U.S. Attorney’s Office for the Southern District of California today announced criminal charges against Wang and Yin.
According to the SEC’s complaint, Wang and Yin became friends in 2005 as members of the same church. When Wang learned that Yin was a financial advisor at Merrill Lynch, he asked Yin to manage his money and opened a number of brokerage accounts at the firm’s San Diego branch office. Each account was disclosed to Qualcomm because, as a company officer, Wang was restricted in his ability to trade Qualcomm stock and required to pre-clear all Qualcomm trades with the company.
The SEC alleges that in early 2006, Wang approached Yin about hiding cash transactions. Yin suggested that Wang create an entity registered in the British Virgin Islands (BVI) and use the name of a non-U.S. citizen family member as the beneficial owner. Then he could open a brokerage account in the newly created entity’s name. Yin then helped Wang set up a secret account in the name of a BVI company called Unicorn Global Enterprises, and Wang’s older brother was listed as the owner. Yin similarly created his own BVI-registered entity named Pacific Rim and put it in his mother-in-law’s name. Yin opened a Merrill Lynch brokerage account for Pacific Rim and used it to hide funds that he was using for investments.
The SEC alleges that Wang and Yin used their secret offshore accounts to trade on material, non-public information that Wang learned as an executive at Qualcomm. In early 2010, Wang was aware that Qualcomm executives were planning a board proposal to increase Qualcomm’s quarterly dividends and request authority to initiate a stock repurchase program. Qualcomm informed Wang and all executives that they would not be permitted to trade Qualcomm stock. On March 1, Wang attended a Qualcomm board meeting where the quarterly dividend increase and stock repurchase were approved. Wang immediately instructed Yin to use all of the funds in the offshore Unicorn account to purchase Qualcomm stock. Yin knew that Wang did not pre-clear these trades and realized that the purchase was out of character for Wang because he previously never purchased Qualcomm stock on the open market in his Merrill Lynch accounts. Within the hour of executing the trades for Wang, Yin himself bought Qualcomm stock on the basis of the material, non-public information. The stock price increased 6.7 percent after Qualcomm publicly announced the quarterly cash dividend and stock repurchase program. Wang and Yin profited when they sold all of their shares.
According to the SEC’s complaint, Wang used the funds from that sale to conduct insider trading again – this time in the shares of San Jose-based Atheros Communications, which was the highly confidential target of a planned acquisition by Qualcomm. Wang was regularly briefed on the transaction internally tabbed as “Project Tango” to protect its confidentiality. Wang instructed Yin to sell all of his Qualcomm stock in the Unicorn account on Dec. 2, 2010, and prepare to buy as many shares of Atheros stock as possible with the funds in that account. He told Yin that he was leaving on a trip to China and would contact him to execute the Atheros trade. On December 6, Wang attended a Qualcomm board meeting in Hong Kong and a resolution was passed to pursue the acquisition. Wang learned that Qualcomm planned to acquire Atheros at $45 per share. Wang and Yin immediately communicated several times through phone calls and a text message, and Wang then purchased the maximum number of shares he could purchase with the existing funds in the Unicorn account at prices between $34 and $35 per share. At Wang’s encouragement, Yin also purchased Atheros stock for himself in his offshore account. When the news became public in early January, Atheros stock increased more than 20 percent. Yin sold all of his Atheros shares in the Pacific Rim account on January 12, and Wang sold his Atheros shares in the Unicorn account on January 25.
According to the SEC’s complaint, Wang took his next insider trading step merely four minutes after selling the Atheros stock, using the proceeds to purchase Qualcomm shares in advance of a company announcement that it would raise its revenue and earnings guidance for the 2011 fiscal year. Wang had learned the confidential information prior to the board meeting he attended in Hong Kong, where Qualcomm’s better-than-expected first quarter financial performance was further discussed. Wang learned that Qualcomm planned to announce its earnings results on January 26, and thus purchased his Qualcomm shares the day before the announcement. After Qualcomm issued a press release to announcing its positive first quarter results, Qualcomm’s stock increased 5.9 percent.
The SEC alleges that Wang made more than $244,000 in illegal profits through the insider trading scheme, and Yin realized gains of more than $27,000. Wang eventually realized that his illegal trading may be detected by Merrill Lynch or others. Wang first asked Yin to delete records of the trades in the Unicorn account, but because they were permanent records in Merrill Lynch’s systems they could not be erased. Around January 2012, Wang directed Yin to establish a new BVI corporation named Clearview Resources and open a new account at Merrill Lynch to which they transferred the insider trading proceeds in the Unicorn account to further distance Wang from the suspicious trades. A few months later, Wang informed Yin that the trades may have been detected because the SEC had subpoenaed his e-mails. So Wang devised a cover story and convinced Yin if ever questioned to say that the Atheros trades were made by Wang’s brother. Because Yin had never communicated with Wang’s brother, Wang instructed him to travel to China with the Unicorn account statements and review the trades with his brother so he could explain the trading if asked. Yin did so in May 2012. To further hide Wang’s ownership of the Unicorn account and his link to the Atheros trades, Yin removed the Unicorn account from Wang’s “household” in Merrill Lynch’s computer system in July 2012. “Householding” is a function used by Merrill Lynch to link related accounts.
The SEC's complaint charges Wang, who lives in Del Mar, Calif., with violating Sections 10(b) and 16(a) of the Securities Exchange Act of 1934 and Rules 10b-5 and 16a-3. Yin, who lives in San Diego, is charged with violating Section 10(b) of the Exchange Act and Rule 10b-5. The SEC’s complaint seeks disgorgement of ill-gotten gains plus prejudgment interest, financial penalties, and permanent injunctions. The SEC also seeks an officer-and-director bar against Wang.
The SEC’s investigation has been conducted by Ann C. Kim, Wendy E. Pearson, Nina Yamamoto, and Finola H. Manvelian of the Los Angeles Regional Office. The SEC’s litigation will be led by Sam Puathasnanon. The SEC appreciates the assistance of the Department of Justice’s Criminal Division, the U.S. Attorney’s Office for the Southern District of California, and the Federal Bureau of Investigation.
SEC Charges Former Qualcomm Executive and His Financial Advisor with Insider Trading Through Secret Offshore Accounts
The Securities and Exchange Commission today charged a former executive vice president at Qualcomm Inc. and his former financial advisor with insider trading ahead of major announcements by the San Diego-based wireless technology company for more than a quarter-million dollars in profits.
The SEC alleges that Jing Wang, a former executive vice president and president of global business operations at Qualcomm, used a secret offshore brokerage account to make illegal trades based on confidential information that he learned on the job. Gary Yin, a former registered representative at Merrill Lynch, helped Wang set up the account. Yin also created a secret offshore account of his own and traded on the non-public information gleaned from Wang. When Wang eventually realized that insider trading in the offshore accounts still may be discovered by the SEC or other regulators, he concocted a plan to conceal his trading activity by claiming the trades were made by his brother. Wang even convinced Yin to travel to China and go over the account statements with Wang’s brother so he could explain the trades if asked by investigators.
In a parallel action, the U.S. Attorney’s Office for the Southern District of California today announced criminal charges against Wang and Yin.
According to the SEC’s complaint, Wang and Yin became friends in 2005 as members of the same church. When Wang learned that Yin was a financial advisor at Merrill Lynch, he asked Yin to manage his money and opened a number of brokerage accounts at the firm’s San Diego branch office. Each account was disclosed to Qualcomm because, as a company officer, Wang was restricted in his ability to trade Qualcomm stock and required to pre-clear all Qualcomm trades with the company.
The SEC alleges that in early 2006, Wang approached Yin about hiding cash transactions. Yin suggested that Wang create an entity registered in the British Virgin Islands (BVI) and use the name of a non-U.S. citizen family member as the beneficial owner. Then he could open a brokerage account in the newly created entity’s name. Yin then helped Wang set up a secret account in the name of a BVI company called Unicorn Global Enterprises, and Wang’s older brother was listed as the owner. Yin similarly created his own BVI-registered entity named Pacific Rim and put it in his mother-in-law’s name. Yin opened a Merrill Lynch brokerage account for Pacific Rim and used it to hide funds that he was using for investments.
The SEC alleges that Wang and Yin used their secret offshore accounts to trade on material, non-public information that Wang learned as an executive at Qualcomm. In early 2010, Wang was aware that Qualcomm executives were planning a board proposal to increase Qualcomm’s quarterly dividends and request authority to initiate a stock repurchase program. Qualcomm informed Wang and all executives that they would not be permitted to trade Qualcomm stock. On March 1, Wang attended a Qualcomm board meeting where the quarterly dividend increase and stock repurchase were approved. Wang immediately instructed Yin to use all of the funds in the offshore Unicorn account to purchase Qualcomm stock. Yin knew that Wang did not pre-clear these trades and realized that the purchase was out of character for Wang because he previously never purchased Qualcomm stock on the open market in his Merrill Lynch accounts. Within the hour of executing the trades for Wang, Yin himself bought Qualcomm stock on the basis of the material, non-public information. The stock price increased 6.7 percent after Qualcomm publicly announced the quarterly cash dividend and stock repurchase program. Wang and Yin profited when they sold all of their shares.
According to the SEC’s complaint, Wang used the funds from that sale to conduct insider trading again – this time in the shares of San Jose-based Atheros Communications, which was the highly confidential target of a planned acquisition by Qualcomm. Wang was regularly briefed on the transaction internally tabbed as “Project Tango” to protect its confidentiality. Wang instructed Yin to sell all of his Qualcomm stock in the Unicorn account on Dec. 2, 2010, and prepare to buy as many shares of Atheros stock as possible with the funds in that account. He told Yin that he was leaving on a trip to China and would contact him to execute the Atheros trade. On December 6, Wang attended a Qualcomm board meeting in Hong Kong and a resolution was passed to pursue the acquisition. Wang learned that Qualcomm planned to acquire Atheros at $45 per share. Wang and Yin immediately communicated several times through phone calls and a text message, and Wang then purchased the maximum number of shares he could purchase with the existing funds in the Unicorn account at prices between $34 and $35 per share. At Wang’s encouragement, Yin also purchased Atheros stock for himself in his offshore account. When the news became public in early January, Atheros stock increased more than 20 percent. Yin sold all of his Atheros shares in the Pacific Rim account on January 12, and Wang sold his Atheros shares in the Unicorn account on January 25.
According to the SEC’s complaint, Wang took his next insider trading step merely four minutes after selling the Atheros stock, using the proceeds to purchase Qualcomm shares in advance of a company announcement that it would raise its revenue and earnings guidance for the 2011 fiscal year. Wang had learned the confidential information prior to the board meeting he attended in Hong Kong, where Qualcomm’s better-than-expected first quarter financial performance was further discussed. Wang learned that Qualcomm planned to announce its earnings results on January 26, and thus purchased his Qualcomm shares the day before the announcement. After Qualcomm issued a press release to announcing its positive first quarter results, Qualcomm’s stock increased 5.9 percent.
The SEC alleges that Wang made more than $244,000 in illegal profits through the insider trading scheme, and Yin realized gains of more than $27,000. Wang eventually realized that his illegal trading may be detected by Merrill Lynch or others. Wang first asked Yin to delete records of the trades in the Unicorn account, but because they were permanent records in Merrill Lynch’s systems they could not be erased. Around January 2012, Wang directed Yin to establish a new BVI corporation named Clearview Resources and open a new account at Merrill Lynch to which they transferred the insider trading proceeds in the Unicorn account to further distance Wang from the suspicious trades. A few months later, Wang informed Yin that the trades may have been detected because the SEC had subpoenaed his e-mails. So Wang devised a cover story and convinced Yin if ever questioned to say that the Atheros trades were made by Wang’s brother. Because Yin had never communicated with Wang’s brother, Wang instructed him to travel to China with the Unicorn account statements and review the trades with his brother so he could explain the trading if asked. Yin did so in May 2012. To further hide Wang’s ownership of the Unicorn account and his link to the Atheros trades, Yin removed the Unicorn account from Wang’s “household” in Merrill Lynch’s computer system in July 2012. “Householding” is a function used by Merrill Lynch to link related accounts.
The SEC's complaint charges Wang, who lives in Del Mar, Calif., with violating Sections 10(b) and 16(a) of the Securities Exchange Act of 1934 and Rules 10b-5 and 16a-3. Yin, who lives in San Diego, is charged with violating Section 10(b) of the Exchange Act and Rule 10b-5. The SEC’s complaint seeks disgorgement of ill-gotten gains plus prejudgment interest, financial penalties, and permanent injunctions. The SEC also seeks an officer-and-director bar against Wang.
The SEC’s investigation has been conducted by Ann C. Kim, Wendy E. Pearson, Nina Yamamoto, and Finola H. Manvelian of the Los Angeles Regional Office. The SEC’s litigation will be led by Sam Puathasnanon. The SEC appreciates the assistance of the Department of Justice’s Criminal Division, the U.S. Attorney’s Office for the Southern District of California, and the Federal Bureau of Investigation.
CDC OFFICIAL'S STATEMENT ON DEATH OF ANTI-SMOKING ACTIVIST NATHAN MOOSE
FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION
Statement from Tim McAfee, Director, CDC’s Office on Smoking and Health on the passing of Nathan Moose, former Tips campaign ad participant.
We are deeply saddened by the passing of Nathan Moose, a valued member of CDC's Tips family. Nathan’s selfless and courageous dedication to ensuring that others would not suffer as he did saved many lives. He was a victim of cigarette smoking, although he never smoked.
Nathan worked for 11 years in a casino that allowed smoking, and the exposure to secondhand smoke permanently damaged his lungs and led to his untimely death. His health problems inspired him to take action to help protect not only his fellow Oglala Sioux, but also all Americans, and he especially wanted his message to impact young people.
In addition to participating in the Tips campaign, Nathan spoke at Pow-Wows, conferences, and schools to make people aware of the dangers of smoking and exposure to secondhand smoke. Nathan was only 54 years old. Our thoughts and prayers go out to Nathan's wife, five children, and three grandchildren.
Tim McAfee, M.D., M.P.H.
Director, CDC’s Office on Smoking and Health
Statement from Tim McAfee, Director, CDC’s Office on Smoking and Health on the passing of Nathan Moose, former Tips campaign ad participant.
We are deeply saddened by the passing of Nathan Moose, a valued member of CDC's Tips family. Nathan’s selfless and courageous dedication to ensuring that others would not suffer as he did saved many lives. He was a victim of cigarette smoking, although he never smoked.
Nathan worked for 11 years in a casino that allowed smoking, and the exposure to secondhand smoke permanently damaged his lungs and led to his untimely death. His health problems inspired him to take action to help protect not only his fellow Oglala Sioux, but also all Americans, and he especially wanted his message to impact young people.
In addition to participating in the Tips campaign, Nathan spoke at Pow-Wows, conferences, and schools to make people aware of the dangers of smoking and exposure to secondhand smoke. Nathan was only 54 years old. Our thoughts and prayers go out to Nathan's wife, five children, and three grandchildren.
Tim McAfee, M.D., M.P.H.
Director, CDC’s Office on Smoking and Health
Saturday, October 19, 2013
PRESIDENT OBAMA'S WEEKLY ADDRESS FOR OCTOBER 19, 2013
FROM: THE WHITE HOUSE
WEEKLY ADDRESS: Working Together on Behalf of the American People
Remarks of President Barack Obama
Weekly Address
The White House
October 19, 2013
Hi everybody. This week, because Democrats and responsible Republicans came together, the government was reopened, and the threat of default was removed from our economy.
There’s been a lot of discussion lately of the politics of this shutdown. But the truth is, there were no winners in this. At a time when our economy needs more growth and more jobs, the manufactured crises of these last few weeks actually harmed jobs and growth. And it’s understandable that your frustration with what goes on in Washington has never been higher.
The way business is done in Washington has to change. Now that these clouds of crisis and uncertainty have lifted, we need to focus on what the majority of Americans sent us here to do – grow the economy, create good jobs, strengthen the middle class, lay the foundation for broad-based prosperity, and get our fiscal house in order for the long haul.
It won’t be easy. But we can make progress. Specifically, there are three places where I believe that Democrats and Republicans can work together right away.
First, we should sit down and pursue a balanced approach to a responsible budget, one that grows our economy faster and shrinks our long-term deficits further. There is no choice between growth and fiscal responsibility – we need both. So we’re making a serious mistake if a budget doesn’t focus on what you’re focused on: creating more good jobs that pay better wages. If we’re going to free up resources for the things that help us grow – education, infrastructure, research – we should cut what we don’t need, and close corporate tax loopholes that don’t help create jobs. This shouldn’t be as difficult as it has been in past years. Remember, our deficits are shrinking – not growing.
Second, we should finish the job of fixing our broken immigration system. There’s already a broad coalition across America that’s behind this effort, from business leaders to faith leaders to law enforcement. It would grow our economy. It would secure our borders. The Senate has already passed a bill with strong bipartisan support. Now the House should, too. The majority of Americans thinks this is the right thing to do. It can and should get done by the end of this year.
Third, we should pass a farm bill – one that America’s farmers and ranchers can depend on, one that protects vulnerable children and adults in times of need, and one that gives rural communities opportunities to grow and the longer-term certainty they deserve.
We won’t suddenly agree on everything now that the cloud of crisis has passed. But we shouldn’t hold back on places where we do agree, just because we don’t think it’s good politics, or just because the extremes in our parties don’t like compromise. I’ll look for willing partners from either party to get important work done. There’s no good reason why we can’t govern responsibly, without lurching from manufactured crisis to manufactured crisis. Because that isn’t governing – it’s just hurting the people we were sent here to serve.
Those of us who have the privilege to serve this country have an obligation to do our job the best we can. We come from different parties, but we’re Americans first. And our obligations to you must compel all of us, Democrats and Republicans, to cooperate, and compromise, and act in the best interests of this country we love.
Thanks everybody, and have a great weekend.
WEEKLY ADDRESS: Working Together on Behalf of the American People
Remarks of President Barack Obama
Weekly Address
The White House
October 19, 2013
Hi everybody. This week, because Democrats and responsible Republicans came together, the government was reopened, and the threat of default was removed from our economy.
There’s been a lot of discussion lately of the politics of this shutdown. But the truth is, there were no winners in this. At a time when our economy needs more growth and more jobs, the manufactured crises of these last few weeks actually harmed jobs and growth. And it’s understandable that your frustration with what goes on in Washington has never been higher.
The way business is done in Washington has to change. Now that these clouds of crisis and uncertainty have lifted, we need to focus on what the majority of Americans sent us here to do – grow the economy, create good jobs, strengthen the middle class, lay the foundation for broad-based prosperity, and get our fiscal house in order for the long haul.
It won’t be easy. But we can make progress. Specifically, there are three places where I believe that Democrats and Republicans can work together right away.
First, we should sit down and pursue a balanced approach to a responsible budget, one that grows our economy faster and shrinks our long-term deficits further. There is no choice between growth and fiscal responsibility – we need both. So we’re making a serious mistake if a budget doesn’t focus on what you’re focused on: creating more good jobs that pay better wages. If we’re going to free up resources for the things that help us grow – education, infrastructure, research – we should cut what we don’t need, and close corporate tax loopholes that don’t help create jobs. This shouldn’t be as difficult as it has been in past years. Remember, our deficits are shrinking – not growing.
Second, we should finish the job of fixing our broken immigration system. There’s already a broad coalition across America that’s behind this effort, from business leaders to faith leaders to law enforcement. It would grow our economy. It would secure our borders. The Senate has already passed a bill with strong bipartisan support. Now the House should, too. The majority of Americans thinks this is the right thing to do. It can and should get done by the end of this year.
Third, we should pass a farm bill – one that America’s farmers and ranchers can depend on, one that protects vulnerable children and adults in times of need, and one that gives rural communities opportunities to grow and the longer-term certainty they deserve.
We won’t suddenly agree on everything now that the cloud of crisis has passed. But we shouldn’t hold back on places where we do agree, just because we don’t think it’s good politics, or just because the extremes in our parties don’t like compromise. I’ll look for willing partners from either party to get important work done. There’s no good reason why we can’t govern responsibly, without lurching from manufactured crisis to manufactured crisis. Because that isn’t governing – it’s just hurting the people we were sent here to serve.
Those of us who have the privilege to serve this country have an obligation to do our job the best we can. We come from different parties, but we’re Americans first. And our obligations to you must compel all of us, Democrats and Republicans, to cooperate, and compromise, and act in the best interests of this country we love.
Thanks everybody, and have a great weekend.
U.S. AND ROMANIA REACH AGREEMENTS THAT ENHANCE PARTNERSHIP
FROM: U.S. DEFENSE DEPARTMENT
Hagel, Romania's Defense Chief Reach Significant Agreements
American Forces Press Service
WASHINGTON, Oct. 18, 2013 - Defense Secretary Chuck Hagel met with Romania's Minister of Defense Mircea Dusa today at the Pentagon, a meeting that produced a number of significant agreements, which Pentagon Spokesman George Little said will enhance the strong and productive partnership the U.S. enjoys with Romania.
Among the agreements reached Little said, is for Romania to support logistics in and out of Afghanistan, including both personnel and cargo movement. "Secretary Hagel praised this agreement, which is particularly important as the U.S. prepares to wind down transit center operations at Manas, Kyrgystan next year," Little said in a statement issued after the meeting. "Secretary Hagel highlighted this agreement as a further testament to Romania's steadfast commitment to the ISAF mission and its commitment to regional and international security," he added.
In addition, Little said Hagel thanked Romania for its decision to host the Aegis Ashore missile defense system, emphasizing that the agreement reaffirms and strengthens the collective defense upon which NATO was founded. "This system represents an important component of the larger European Phased Adaptive Approach and is expected to be operational in 2015." At Hagel's direction, Undersecretary of Defense for Policy Dr. James N. Miller will attend the groundbreaking ceremony for the Aegis Ashore system at Deveselu later this month.
Little said Hagel further praised Romania's decision to purchase 12 F-16 aircraft from Portugal. He added that this significant investment in air superiority capabilities will open the door for greater regional collaboration and will be valuable to future NATO and coalition operations.
"Secretary Hagel reaffirmed that Romania is one of the United States' staunchest allies. The two leaders also agreed to look for ways to expand our strong military cooperation as well as to support Romania's efforts to become a leader in the region and in NATO."
Hagel, Romania's Defense Chief Reach Significant Agreements
American Forces Press Service
WASHINGTON, Oct. 18, 2013 - Defense Secretary Chuck Hagel met with Romania's Minister of Defense Mircea Dusa today at the Pentagon, a meeting that produced a number of significant agreements, which Pentagon Spokesman George Little said will enhance the strong and productive partnership the U.S. enjoys with Romania.
Among the agreements reached Little said, is for Romania to support logistics in and out of Afghanistan, including both personnel and cargo movement. "Secretary Hagel praised this agreement, which is particularly important as the U.S. prepares to wind down transit center operations at Manas, Kyrgystan next year," Little said in a statement issued after the meeting. "Secretary Hagel highlighted this agreement as a further testament to Romania's steadfast commitment to the ISAF mission and its commitment to regional and international security," he added.
In addition, Little said Hagel thanked Romania for its decision to host the Aegis Ashore missile defense system, emphasizing that the agreement reaffirms and strengthens the collective defense upon which NATO was founded. "This system represents an important component of the larger European Phased Adaptive Approach and is expected to be operational in 2015." At Hagel's direction, Undersecretary of Defense for Policy Dr. James N. Miller will attend the groundbreaking ceremony for the Aegis Ashore system at Deveselu later this month.
Little said Hagel further praised Romania's decision to purchase 12 F-16 aircraft from Portugal. He added that this significant investment in air superiority capabilities will open the door for greater regional collaboration and will be valuable to future NATO and coalition operations.
"Secretary Hagel reaffirmed that Romania is one of the United States' staunchest allies. The two leaders also agreed to look for ways to expand our strong military cooperation as well as to support Romania's efforts to become a leader in the region and in NATO."
FDA ANNOUNCES RARE EROSION EVENTS ASSOCIATED WITH CARDIAC IMPLANT DEVICE
FROM: U.S. FOOD AND DRUG ADMINISTRATION
Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)
Date Issued: October 17, 2013
Audience: Pediatric and Adult Interventional Cardiologists; Cardiothoracic Surgeons; Non-Invasive Cardiologists; Referring and follow-up physicians including Pediatricians; and Patients implanted with the device
Medical Specialty: Pediatric and Adult Interventional Cardiology and Cardiothoracic Surgery; and Non-Invasive Cardiology
Device:
The St. Jude Amplatzer Atrial Septal Occluder (ASO) (Figure 1) is a cardiac implant device used in children and adults to treat an abnormal hole between the upper left and right chambers (atria) of the heart, known as an atrial septal defect (ASD). The metal device is put into place through a thin tube (catheter) inserted into a vein. This is considered a minimally invasive method for ASD closure, and is an alternative to open heart surgery.
Purpose: The Food and Drug Administration (FDA) is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.
Summary of Problem and Scope:
Tissue erosion caused by the Amplatzer ASO is rare, but can be life-threatening. Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the St. Jude Amplatzer ASO. During the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device.
The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly.
Immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. Tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. Fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
The FDA has not yet identified risk factors related to the occurrence of erosion. Articles in professional medical journals have discussed the possibility that patients with a lack of tissue in the retro-aortic rim might be at higher risk of erosion events; however, this relationship has not been determined. This type of device failure has not been seen in similar devices used to treat this condition.
Recommendations for Physicians:
Review the updated Instructions For Use disclaimer icon (IFU) for the Amplatzer ASO before implanting the device.
Consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO.
Inform patients that most people implanted with the Amplatzer ASO experience good outcomes and that erosion is a very rare event.
Educate patients implanted with the Amplatzer ASO to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
The FDA does NOT recommend device removal for patients who have the Amplatzer ASO unless physicians determine it is appropriate for their particular patient(s). The risks associated with device removal surgery may be equal to or greater than the risk of erosion.
If erosion is suspected in one of your patients, immediately report this event to St. Jude Medical and the FDA via the established adverse event reporting process in your facilities. Please provide all necessary records, including implant and event images, surgical records, and catheterization reports, so that the FDA has the most complete assessment of the event.
Recommendations for Patients:
Talk to your doctor about the long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO, to determine which treatment option is best for you.
If you have an ASD occluder implant and experience ANY symptoms of erosion you should immediately contact your doctor and go to the emergency room for an echocardiogram (ultrasound of the heart). Symptoms of erosion may include chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
Current recommendations for follow-up with a cardiologist after Amplatzer ASO implantation include the following:
You should have an ultrasound of your heart (echocardiogram) at the following timeframes:
implantation,
one day after implantation,
before hospital discharge, and
one week after implantation.
You should follow-up with your cardiologist at the following timeframes after implantation:
one month,
six months, and
one year.
After the first 12 months, you should follow up with your cardiologist once each year (unless your have symptoms or concerns).
FDA Activities:
To better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion, the FDA is requiring St. Jude to conduct a study of patients who have been recently implanted with the device. The study is designed to estimate the incidence of erosion events within seven days, one month, six months, and 12 months after the implantation of the Amplatzer ASO. The study will also compare patients who experience an erosion event to those who do not, and will identify differences in demographic, clinical, and device characteristics.
The FDA, medical device industry and echocardiography societies are collaborating to develop standardized echocardiographic imaging techniques and guidelines for ASD procedures. These techniques and guidelines will provide needed information toward understanding pre-, peri-, and post-procedural anatomical characteristics of patients with atrial septal defects and the operation of the device in use.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with an atrial septal defect occluder, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
To help the FDA learn as much as possible about the adverse events associated with atrial septal occluders, please include the following information in your reports, if available:
Manufacturer’s Name
Device Name (Brand Name)
Date Device was Manufactured
Implant Duration by providing Date of Implant, Date of Event and/or Date of Explant
Distributor’s Name
Details of Adverse Event and Medical and/or Surgical Interventions (if required)
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at, industry.devices@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.
Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)
Date Issued: October 17, 2013
Audience: Pediatric and Adult Interventional Cardiologists; Cardiothoracic Surgeons; Non-Invasive Cardiologists; Referring and follow-up physicians including Pediatricians; and Patients implanted with the device
Medical Specialty: Pediatric and Adult Interventional Cardiology and Cardiothoracic Surgery; and Non-Invasive Cardiology
Device:
The St. Jude Amplatzer Atrial Septal Occluder (ASO) (Figure 1) is a cardiac implant device used in children and adults to treat an abnormal hole between the upper left and right chambers (atria) of the heart, known as an atrial septal defect (ASD). The metal device is put into place through a thin tube (catheter) inserted into a vein. This is considered a minimally invasive method for ASD closure, and is an alternative to open heart surgery.
Purpose: The Food and Drug Administration (FDA) is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery. According to published estimates, these events occur in approximately 1 to 3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have been 234,103 Amplatzer ASO devices sold worldwide.
Summary of Problem and Scope:
Tissue erosion caused by the Amplatzer ASO is rare, but can be life-threatening. Between 2002 and 2011, the FDA received more than 100 reports of erosions associated with the St. Jude Amplatzer ASO. During the same period, several medical journals contained articles reporting tissue erosion among patients implanted with this device.
The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly.
Immediate open heart surgery may then be necessary to remove the device, close the holes or other defects caused by erosion, and close the original defect the device was meant to treat less invasively. Tissue erosion can also cause fistulas - abnormal scar tissue that connects parts of the heart that were not previously connected. Fistulas are not life-threatening, but do require surgery for treatment and could result in congestive heart failure.
The FDA has not yet identified risk factors related to the occurrence of erosion. Articles in professional medical journals have discussed the possibility that patients with a lack of tissue in the retro-aortic rim might be at higher risk of erosion events; however, this relationship has not been determined. This type of device failure has not been seen in similar devices used to treat this condition.
Recommendations for Physicians:
Review the updated Instructions For Use disclaimer icon (IFU) for the Amplatzer ASO before implanting the device.
Consider the potential for erosion when talking to patients about long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO.
Inform patients that most people implanted with the Amplatzer ASO experience good outcomes and that erosion is a very rare event.
Educate patients implanted with the Amplatzer ASO to seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
The FDA does NOT recommend device removal for patients who have the Amplatzer ASO unless physicians determine it is appropriate for their particular patient(s). The risks associated with device removal surgery may be equal to or greater than the risk of erosion.
If erosion is suspected in one of your patients, immediately report this event to St. Jude Medical and the FDA via the established adverse event reporting process in your facilities. Please provide all necessary records, including implant and event images, surgical records, and catheterization reports, so that the FDA has the most complete assessment of the event.
Recommendations for Patients:
Talk to your doctor about the long- and short-term benefits and risks of treatment options, including implantation with the Amplatzer ASO, to determine which treatment option is best for you.
If you have an ASD occluder implant and experience ANY symptoms of erosion you should immediately contact your doctor and go to the emergency room for an echocardiogram (ultrasound of the heart). Symptoms of erosion may include chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.
Current recommendations for follow-up with a cardiologist after Amplatzer ASO implantation include the following:
You should have an ultrasound of your heart (echocardiogram) at the following timeframes:
implantation,
one day after implantation,
before hospital discharge, and
one week after implantation.
You should follow-up with your cardiologist at the following timeframes after implantation:
one month,
six months, and
one year.
After the first 12 months, you should follow up with your cardiologist once each year (unless your have symptoms or concerns).
FDA Activities:
To better understand how erosion impacts the performance of the Amplatzer ASO and assess potential risk factors related to the occurrence of erosion, the FDA is requiring St. Jude to conduct a study of patients who have been recently implanted with the device. The study is designed to estimate the incidence of erosion events within seven days, one month, six months, and 12 months after the implantation of the Amplatzer ASO. The study will also compare patients who experience an erosion event to those who do not, and will identify differences in demographic, clinical, and device characteristics.
The FDA, medical device industry and echocardiography societies are collaborating to develop standardized echocardiographic imaging techniques and guidelines for ASD procedures. These techniques and guidelines will provide needed information toward understanding pre-, peri-, and post-procedural anatomical characteristics of patients with atrial septal defects and the operation of the device in use.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with an atrial septal defect occluder, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
To help the FDA learn as much as possible about the adverse events associated with atrial septal occluders, please include the following information in your reports, if available:
Manufacturer’s Name
Device Name (Brand Name)
Date Device was Manufactured
Implant Duration by providing Date of Implant, Date of Event and/or Date of Explant
Distributor’s Name
Details of Adverse Event and Medical and/or Surgical Interventions (if required)
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at, industry.devices@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.
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