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Kevin Grandia | September 30, 2009
By Kevin Grandia • Wednesday, September 30, 2009 - 15:08
As the old saying goes: "You can't have your cake and eat it too." Or in the case of Toyota: "You can't have your green and fight it too."
With a well-earned reputation as a leader in the development of fuel efficient cars it boggles my mind that Toyota continues to be a supporter of the US Chamber of Commerce - an organization that is leading the charge against President Obama's clean energy agenda.
Other big supporters of the Chamber of Commerce have been distancing themselves from the organization over their archaic standpoint on the issue of climate change.
Just today we saw Nike relinquish its membership on the US Chamber's board, stating that:
"we fundamentally disagree with the US Chamber of Commerce on the issue of climate change and their recent action challenging the EPA is inconsistent with our view that climate change is an issue in need of urgent action."
And over the last week two other high profile members have quit, including the largest US electric utility company, Exelon. In a press release, Exelon states that:
"Exelon is so committed to climate legislation that Rowe [Exelon's CEO] announced during today's speech that Exelon will not be renewing its membership in the U.S. Chamber of Commerce due to the organization's opposition to climate legislation."
If an energy producer and a shoe company are willing to take such a strong stance, one would reason that Toyota, a company that heavily markets itself as a "sustainable mobility" company, would have led the exodus from the US Chamber. Instead we see all sorts of big green talk from the auto-giant, like:
"We support environmental programs that educate and mobilize people to reduce their environmental footprint."
"At Toyota, our commitment to the environment goes beyond our products."
"As an auto manufacturer, Toyota believes that "sustainable mobility" can be achieved through advanced technologies, key partnerships and creative people who are willing to take on this most important challenge."
It goes on and on like this throughout Toyota's website and I applaud them for putting their money where there mouth is on things like their Together Green program. But it all rings just a little too hollow when you know that at the same time they're doing all this "green" work, they're still a big backer of the US Chamber of Commerce who continues to be a major lobby against action on climate change.
At the least it seems to me to be financially backwards to fund one group that is advancing environmental causes while at the same time funding those opposed to those very same things. At the most, it makes me wonder whether all of Toyota's "green" image in nothing more than a clever ruse.
If Toyota is genuinely committed to sustainability as they say they are, then they can can take their lead from Nike, Exelon and others and stop supporting the US Chamber and their attack on the Obama administration's clean energy and climate change reforms. If they don't leave the US Chamber, then we know where their motivations truly lie.
The only surprise is that the AGW crowd still does not get it
Global Warming alarmism is tired, rickety, no one cares, read the polls.
Good on Toyota. I expect a higher level of science from Asia.
I am surprised that Japan or China has not debunked alarmism
Why let Steve McIntyre show the world that the "Team" is using bogus statistics to alarm the world and cause huge waste of public monies? Why did China not prove the USA was blowing smoke, it would have knocked wind out of the USA ego. Yes, I heard their minister dismiss the US findings, but he was too timid for what is needed to stop this hoax.
Oh well, leave it to an intrepid Canadian.. now where have I heard that before.. oh.. William Stevenson, the real 007 from Winnipeg..
You poor fellow
Your by-line should be Rip Van Winkle if you think that Steve McIntyre is still relevant (or ever was). Everything you have posted here in your little flurry over the past week or so is based on lame, ancient, and completely discredited codswollop from the deniers' camp. The world has moved on. Get over it. Harping on about McIntyre is a dead givaway that you are stuck in the past and haven't been paying attention FOR YEARS.
ad hominum attack is
Just what I would expect on this blog, so why not indulge myself..
AGW is a political ideology, so 30,000,000 people who listen to Beck are being given political ammunition..
That is why AGW is so low on voters lists of priorities that it almost was off the bottom of the chart.
That is why Kerry talks about energy security, not climate change, except to throw it out as a tidbit for the political base at the end of his press comments.
The AGW dog is not hunting!
I am all for an energy policy for the USA. It is long overdue. Just don't try to tax carbon to give money to Al Gore and his 3 billion fund.(OK, we already see the car company Al Gore backs(and invested in?) got 1/2 a billion.
Such greed from the left wing! Of course, Al Gore was rich as his dad owned a big chunk of Occidental petroleum, but hey, it is fun to be rich.. you get to fly private jets, own humungous houses, and to have writers write books based on your babble about science. Better than a real job!
A 100 million here, 100 million there, and pretty soon you have some decent pocket change!(It is very necessary to keep the AGW dog hunting)
Ben Lawson replied on Permalink
Stick to walking your cat
"Ed", you are making a fool of yourself. I understand that as a self-described retiree with a lot of time on your hands you're looking for attention and something to fill the hours, but really, stick to walking your cat.
You've officially become white noise as far as I'm concerned, so this is the last response you'll ever get from me.
I hope to educate more people as well by exposing them to other points of view.
Enough cool aid has been consumed.
I for one want the scientific Journals to live up to scientific standards by requiring the release of data and methods for all published papers.
It should not take 10 years effort on part of so called "deniers" to get access. Then it takes 3 days to debunk the statistics, as S McIntyre did.
If that set of facts bothers you, then you are not at all interested in science, but only your propaganda.
Good riddance to you sir.
it takes three days to make a mockery out of science
…considering that Steve McIntyre did a bit of cherry picking himself:
he replaced one dataset, without testing its validity (just to name one issue: its data does not fit the measured increased surface temperatures close to that area)
He also keeps on claiming the hockeystick-shape is a result of the analysis, but neglects to inform his 'public' of various monovalent measurements (no nasty CPS or PCA needed) showing the SAME hockeystick shape.
The reason deniers should be kept far away from the data is that they either don't know how to deal with it, or deal with it in a scientific dishonest way.
See also http://www.realclimate.org/index.php/archives/2009/09/hey-ya-mal/
sorry but no cigar
realclimate is the biggest cool aid blog around, so much so they do not allow a single post by non cool aid drinkers.
That is not science, that is propaganda. Shame on you for posting ANYTHING from such a blog site.
Please go to the Wattsupwiththat site and post your enlightened thoughts on statistics.. I venture that you would not dare.
Why should I discuss any statistics? It's not about the statistics! And to complain about realclimate as "propaganda" and then refer to WUWT is just plain idiocy. Which, of course, is a recurring theme in your posts here…
now you arem a liar
WUWT allows alternative views and analysis. All statistical arguements are accepted.
Realclimate does not.
Of course, you know that, so you lie when you call WUWT "propaganda.. No, that describes Realclimate, not WUWT.
lie=knowingly mislead through verbal or written means
alternative views?
Of course, WUWT allows alternative views: any and all alternative views that contradict global warming (to various extents). Knowingly trying to mislead me, huh! What does that make you, according to your own claim?
Beck and Hannity.. influence millions of people
And with a bit of truth from Professor Mojib Latif, they fire away.. not pretty reading, but it sure influences people..
BECK: This is the leading climate modeling guy for the IPCC.
GRAY: I got – I got his name here –
BECK: Get his name – Stu will know it.
GRAY: – in just a second.
BECK: And he has backed out now and said, "We were wrong. We're going into 30 years of cooling right now."
GRAY: At least.
BECK: Yeah, at least. And that's not – that's not the sunspot guy. The sunspot is the other – that the – that the Earth is now in its cooling period because the sunspot activity. Do you remember we were with that sunspot guy –
BURGUIERE: Yeah.
BECK: – and had dinner, and do you remember his look in his eyes? He was just was like, my life is over –
BURGUIERE: Yeah.
BECK: – because I – he's like, I'm the leading –
BURGUIERE: Astrophysicist.
BECK: – astrophysicist. I'm one of the leading astrophysicists in the world, and he said I can't get tenure anywhere.
GRAY: Because he was saying it was sunspots.
BECK: Didn't he have a Nobel Prize coming his way or something – he was up for a Nobel Prize?
BURGUIERE: I'm not sure about that, but he's at – he's at Harvard.
GRAY: Well, you'd have to be crazy to say that the sun has something to do with the warming of this planet when you – when we all know it's CO2.
BECK: He said to us – this was like four years ago, five years ago – he's like, it is sunspots, it is solar activity, that's what it is. And he said we're, in a few years, we're gonna go into a relative quiet period of the sun. He said and then it's over.
BURGUIERE: He did say that. That's amazing, you're right.
GRAY: It's Mojib Latif of Germany's Leibniz Institute.
BECK: Mojib Latif.
BURGUIERE: It's my favorite Latif –
GRAY: Mojib Latif.
BECK: You don't know him?
BURGUIERE: – of the Latif brothers.
GRAY: You don't know him?
BECK: He's one of the leading guys for the IPCC.
GRAY: Big proponent. Yeah. Yeah.
BECK: And look him up, Stu. I'm surprised you didn't know him.
BURGUIERE: Off the top of my head the name kind of sounds familiar, but –
GRAY: He says – he says that he's conceded that the Earth has not warmed for nearly a decade and that we are likely entering one or even two decades or more during which temperatures cool. I mean – and then you couple that with the sunspot report that you were just talking about, and it's madness what they're trying to shove down our throats.
And so, they know there's very little time and they've got this Copenhagen thing coming up, and they thought they'd have it all wrapped up by now – if they just had one more searing hot summer.
BECK: They're going to, they're going to, they're going to, they're going to, they're going to, they're going to.
From the September 22 edition of ABC Radio Networks' The Sean Hannity Show:
HANNITY: As a matter of fact, one of Obama's – one of Al Gore's most prominent allies in this global warming hysterical movement has just pulled off – pulled the rug out from the former vice president and now says the world more likely faces decades of global cooling. I guess Gore didn't see this little tidbit that was printed.
Professor Mojib Latif is one of the leading climate modelers in the world, and he's a recipient of several international climate study prizes, lead author of the UN's Intergovernmental Panel on Climate Change. He's now contributed – he's contributed over the years significantly to these reports that have stated unequivocally that manmade greenhouse emissions are causing the planet to warm dangerously.
Last week in Geneva at the UN's World Climate Conference, an annual gathering of the so-called scientific consensus on manmade global warming climate change – oops. He argued that the Earth has not warmed for nearly a decade, and that we are likely entering one or even two decades during which temperatures actually cool. He pointed out that the Atlantic, particularly the North Atlantic, has been cooling in recent years, and it looks set to continue a cooling phase for 24 years.
HANNITY: The science is not unchallenged; it is challenged. And even leading environmental extremists that have been, you know – you know, sending out these dire warnings, they're now contradicting themselves.
for the record:
From Latif's August 31 presentation at the World Climate Conference – 3:
LATIF: What you see here is just the globally averaged temperature during the 20th century. And you can clearly identify the long-term warming trend, and we all believe that this long-term warming trend is anthropogenic in nature, is manmade. However, you see also a lot of fluctuations superimposed on this trend, interannual, as Tim has pointed out, but also decadal scale variations.
For instance, from the '40s to the '70s, the temperatures dropped and some discussion was going on whether or not we are heading towards a new ice age. And most recently, in the recent decades, we had quite a strong increase in temperature. And now the discussion is basically going on whether this reflects some kind of acceleration of global warming.
Now, I have four points I would like to discuss. First of all, why decadal prediction? Second, the mechanisms of decadal variability. Third – oops – what is the potential? What is the decadal predictability potential? And finally, the challenges. What does it need to realize the decadal predictability potential that actually exists?
All right, so, first point: Why decadal prediction? Now, people who know me, at least my German colleagues, know that I do a lot of media work, OK. There is almost no day in the year when I'm not called by some media person, OK. And so, they basically think about global warming as a kind of slowly evolving process and a monotonic process, OK – so each year is warmer than the preceding year.
However, we all know there is variability, OK, and this variability may look like this. This has been actually derived from the 20th century by just removing some exponential fit, and the two, of course, superimposed, OK, and then, the real evolution of the globally averaged temperatures would look like this. And then, you see right away, OK, it may well happen that you enter a decade, or maybe even two, you know, when the temperature cools, all right, relative to the present level, all right.
And then, you know, I know what's going to happen. You know, I will get, you know, millions of phone calls, you know – "What's going on?" "So is global warming disappearing, you know?" "Have you lied on us, you know?" So, and, therefore, this is the reason why we need to address this decadal prediction issue.
LATIF: If we look at the next 100 years, there are different uncertainties, OK. So AR-4, the last IPCC report, basically was the boundary force problem, so, it – the uncertainty arose mostly from the scenario uncertainty and from the model bias, OK. However, if you look at short lead times, right, then you see that the internal variability is really the dominating uncertainty in the climate change forecasts or, slash, projections. And especially on interannual and decadal timescales, this is true.
Now, however, we should also keep in mind that it may happen some unexpected events like volcanic eruptions or anomalous solar radiation, so there is another uncertainty, OK, however, which we probably cannot predict. … We all believe that the long-term trend is anthropogenic in nature.
LATIF: Everybody who knows me is aware of the fact that I am definitely not one of the skeptics, OK. And if my name was not Mojib Latif, my name would be global warming, all right. However, you know, we have to ask the nasty questions ourselves, all right, or some other people will do it.
scientific illiterate
would be the best term to describe you, Hannity, Gray, Burguiere, and Beck.
In his presentation, Latif mentions that there may be periods of 1-2 decades of hardly any warming, he doesn't say it will be this period. In fact, in his articles he proposes that warming will go REALLY fast the next 10 next years (2010 onwards), possibly followed by another decade of slow warming (2020 onwards).
He actually does refer to people like you, who simply are inable to distinguish the natural variability (variation around the mean) of short-term 'climate', versus an underlying warming trend of long-term climate. How to explain it to you? Well, Mojib, don't even try, some people are beyond reason.
RickJames replied on Permalink
Toyota execs are hard to read
Toyota execs are hard to read but Japanese politicians are full on AGW.
They're hoping to get the 2016 Olympics and make it the green Olympics - solar powered everything - interesting - and the Governor in Tokyo also says we're past the point of no return on AGW.
So Asians may be good business men but in terms of AGW politics, they seem to be fully on board with the consensus.
Opps, my hope for Japan is sliding.. what amazing stuff!
I guess the Tokyo mayor was told to drink a few shiploads of kool aid, as it would help to get support for the Olympics.
"It could be that the 2016 Games are the last Olympics in the history of mankind," Ishihara told reporters at a Tokyo 2016 press event ahead of the vote.
"Global warming is getting worse. We have to come up with measures without which Olympic Games could not last long.
"Scientists have said we have passed the point of no return," said Ishihara."
Ignore the following comment
Ignore the following comment by EdB, which is an attempt to deflect from the topic of the post and which has no proper citation. Did you make those quotes up, EdB? Where's your link?
RickJames replied on Permalink
it's from drudge. The mayor
it's from drudge. The mayor or governor or whatever he is - is just all keyed up about trying to get the Olympics for Tokyo and he figures global warming might help the cause - he wants a "green" Olympic games.
No such thing. The only "green" olympics is a canceled olympics. Olympics are about commerce and commerce is about CO2. At least it is at the moment.
DropshipReview replied on Permalink
Global warming
All vehicle manufacturers must adhre to international emission norms. The fuel guzzlers should be discouraged. We can not have two standards for vehicles. -Nancy
Is this either justified or productive?
I`m afraid I`m not following you Kevin - Toyota`s two-faced because of something that it hasn`t done? That something being something that no others in the US Chamber of commerce have done, other than three firms last week?
And is everyone else in AmCham also two-faced? Why does Toyota get special criticism?
While putting pressure on other members of AmCham is a good idea, why not tell us more about who else are members, and a strategy?
I would think that Toyota is unlikely to leave the chamber, but would be interest in pushing for an internal change of direction.
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- BSO Case Number: BS13-08-1267
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- Time: 2:51 p.m.
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Description of Incident:
Broward Sheriff's Office detectives arrested a Dania Beach man who was trying to find someone to kill his wife and her family and was keeping a cache of weapons in case law enforcement came to get him.
BSO detectives arrested Jason Simione, 39, of Dania Beach on Aug. 12. He was charged with three counts of solicitation to commit murder, possession of a destructive device and child abuse. The BSO SWAT team executed a search warrant at his home after the arrest and found 68 rifles, shotguns and handguns, including a .50 caliber sniper rifle, and approximately 60,000 to 70,000 rounds of assorted ammunition inside. The Bureau of Alcohol, Tobacco, Firearms and Explosives assisted. All the guns are legally-owned. They were taken for safekeeping because of a protection order recently obtained by Simione's wife, 28-year-old Megumi Simione. Jason Simione owns Bulldog Tactical Equipment at 3706 S.W. 30 Ave., Fort Lauderdale. Detectives also found the components of a pipe bomb, though they were not assembled.
Megumi Simione told deputies that her husband had been acting oddly recently and had been giving himself injections of an unknown substance. She discovered that Jason Simione concocted a murder-for-hire plot targeting her, her mother and her brother. He offered acquaintances $150,000 for the three deaths. She also said that on August 9, her husband was holding a 9-month-old baby in his arms while he was arguing with an employee. He became very angry and threw the child onto a table. The baby had a cut on his head and a bruise on his face. Jason Simione recently expressed increasingly hostile and paranoid thoughts while stockpiling the ammunition, weapons and bomb-making materials, witnesses said. He expressed distaste for the U.S. government policies and the president and often used racial epithets. Witnesses told detectives Simione had reinforced his residence to prevent breeches by law enforcement. His bond was set at $5 million.
INVESTIGATORS: VCU Det. Libman, Rivera; Sgt. Rubin, CID
Oakland Park, Dania Beach, SWAT, Crime Scene, ATF
- THIS REPORT BY: Dani Moschella/PIO 8/13/13 1400
Posted At: 08/13/2013 04:23 PM
- PIO-13-8-18 BSOPICS - Jason Simione Arrest Date: Monday, August 12, 2013 10:45:00 AM
- pio-13-8-18c
- pio-13-8-18b
- PIO-13-8-18 Simione Warrant
- pio-13-8-18a
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This paper will help you gain a crystal-clear view of MLC costs and cost drivers. Through this view, you can take an insightful approach to optimize MLC spend and make a significant dent in mainframe costs. As a result, you will:
Register now to receive your copy of the complimentary white paper


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Fine Art Galleries in Cannon Beach, ORJuly 16th, 2012 by archcapeinn
The dramatic cliffs and beaches of the Oregon coast are a natural inspiration for creativity. It's not surprising that so many artists call this area home. Even if their artwork doesn't take inspiration directly from the landscape, artists find the coastal community's laid-back atmosphere and slower pace make it a great place to create.
Below we've listed some of the Cannon Beach galleries and artist groups. Most are clustered on or near Hemlock street. For a more complete list including individual artist galleries and studios, please visit Cannon-beach.net (click on "Galleries | Art").
Bronze Coast Gallery
Focused on showcasing and educating the public about bronze cast artwork, this group of over 30 award-winning regional, national and international artists also features fine original paintings, photography and giclee prints. @ 224 N. Hemlock
Cannon Beach Art Gallery / Arts Association
The Cannon Beach Art Gallery is home to the Cannon Beach Arts Association, a community arts organization which "supports, funds, and enhances the arts and artists in the Cannon Beach community through education, events and exhibits." The Art Gallery has monthly rotating exhibits of fine arts and crafts by local and Pacific Northwest artists. Their inviting open space also has a coffee shop for visitors' enjoyment. @ 1064 S. Hemlock
DragonFire Studio & Gallery
DragonFire features contemporary original works in paint, fiber, metal and other media. Read the rest of this entry »


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Red Horizon Martini
Serves 1
Raspberries, strawberries or cherries
4 parts vodka
1 part dry vermouth
1 part orange bitters
Lime twist, to garnish
In a cocktail shaker, muddle a raspberry, strawberry or cherry. Fill with ice. Add vodka, vermouth and orange bitters. Shake well. Strain into a martini glass, then garnish with a lime twist and fresh raspberries, strawberries or cherries.
— The Plant Cafe Organic, Pier 3


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15 Stars: Three Generals Who Saved the American CenturyHistorians/History
They were each created five-star generals when that super-rank was authorized by Congress in December 1944. In the public mind they appeared, in turn, as glamor, integrity, and competence. Presidential talk long hovered about them. But for the twists of circumstance, all three -- rather than only one -- might have occupied the White House.
MacArthur, Marshall, and Eisenhower were each featured on the covers of Time, when that accolade, in a pre-television era, confirmed a sort of eminence.* All three would appear on postage stamps evoking their signature traits. Their immediately recognizable faces were remarkable indices of personality. MacArthur's hawklike granite gaze conveyed his headstrong, contrary tenacity. Marshall's seamed, inscrutable look suggested the austere middle America of portraits by Grant Wood. Eisenhower's ruddy, balding head and familiar grin brought to mind less the Kansas of his boyhood than the Everyman which admirers always saw in him.
Collectively they represented twentieth-century America at its crest. MacArthur was always City: Washington, Manila, Tokyo, and finally New York, where he retired to the thirty-seventh floor of the Waldorf Towers. Marshall was Suburbs, with a small-town upbringing in western Pennsylvania and an unpretentious home twenty miles from the capital in Leesburg, Virgina, where he was devoted to his vegetable garden. Eisenhower was Country, out of the rural Midwest, and ended his years on his manicured swath of model farm near Gettysburg.
Their trajectories, however upward, reflected their differences. Harry Truman's last secretary of state, Dean Acheson, once said of General Marshall,"The title fitted him as though he had been baptized with it." MacArthur, son of a general, was born and bred to be one. However ambitious, Eisenhower had his stars thrust upon him. Yet their military lives intersected for decades. MacArthur and Marshall were young officers in the newly captured Philippines, seized from declining Spain. Eisenhower emerged later, as a junior aide to MacArthur in Washington and again in Manila, until World War II erupted in Europe. The flamboyant MacArthur and the unpretentious Marshall were both colonels in France during World War I, the career of one taking flight there, to brigadier general and beyond, the career of the other plunging afterward to mere postwar captain, then agonizingly creeping back up, but seemingly never far enough. Despite MacArthur's four early stars -- at forty-nine -- when chief of staff, he would keep the future of his contemporary, who still had none in the early 1930s, in frustrating limbo.
Serving fourteen of his thirty-seven years in the army under both men, Eisenhower was an assistant to MacArthur -- invisible, and painfully aware of going nowhere -- and then deputy to Marshall, who rocketed him to responsibility and to prominence. In seven years with MacArthur, laboring in the arid peacetime vineyards, Eisenhower earned a promotion of one grade, from major to lieutenant colonel, changing the oak leaves on his collar from gold to silver. In seven months under Marshall -- under the vastly altered circumstances of global war -- he earned a constellation of stars and a major command.
Each of the three might have coordinated D-Day in Normandy, the most complex and consequential Western military operation in World War II. All three would be army chiefs of staff, Marshall and then Eisenhower becoming in turn the ostensible superior of their onetime boss, MacArthur, who brooked no bosses.
While MacArthur was sweepingly imperial in manner, the ideal viceroy for a postwar Japan where its humiliated emperor was reduced to a symbol, Eisenhower, genial and flexible, proved the exemplary commander of quarrelsome multinational forces. The self-effacing Marshall possessed such intense respect worldwide that when he entered Westminster Abbey, unannounced, to take his seat at the coronation of young Elizabeth II, the entire congregation arose.
*Marshall and Eisenhower would each be "Man of the Year" twice. MacArthur appeared on the cover of Time on December 29, 1941, in the week usually fixed for that accolade but it went the next week instead to President Roosevelt.
Excerpted from 15 Stars by Stanley Weintraub. Copyright © 2007 by Stanley Weintraub. Reprinted by permission from Free Press, a Division of Simon & Schuster, Inc.
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Lawrence Brooks Hughes - 7/7/2007
Alanbrook also reveals Churchill was under pressure from FDR to commence the North African landings prior to the U.S. election of 1942--to help the Democrats. (It was necessary to postpone the landings, however, until just after the election, and the Democrats lost seats in 1942). While easy to guess FDR engaged in this questionable activity, it is important to have the Alanbrook evidence. I don't think Eisenhower or Marshall ever confirmed or denied it. Alanbrook does not allege the 1942 election was a big factor in the decision to invade North Africa in the first place, but it might well have been.
douglas w jacobson - 7/4/2007
Of these three great generals, Eisenhower stands out. It was Ike who was thrown into the breach with no previous field commands. It was Ike who had to hold together the coalition of egos (Churchill, Patton, Montgomery). It was Ike who shunned the limelight and focused on the most difficult task in the history of warfare. For an excellent look at this most remarkable of American military figures, I suggest Stephen Ambrose's THE SUPREME COMMANDER.
Doug Jacobson
George Robert Gaston - 7/2/2007
William Manchester in American Caesar describes the first friction between McArthur and Truman.
Oddly, it was not over Korea, but rather about Truman's decision to provide American ships to move French forces back into Vietnam. McArthur threatened to resign as a result of the decision. Truman, facing election in 1948, dispatched Marshall to convince McArthur to stay in Japan.
Does your research verify this? Are there more details concerning Truman's reasons for supporting the French in reacquiring their Asian colonies?
I am always taken by the degree of anti-colonialism that existed in the U.S. Army during the period of American empire.
George Robert Gaston - 7/2/2007
Alanbrooke seemed to constantly complain about Marshall and Eisenhower, and their "lack of strategic vision". I'm sure Marshall had a fairly good handle on competing British and American interests.
From my reading Eisenhower did not seem to get caught up in grand strategy. His emphasis was in planning the invasion of Europe. In this planning he did not seem to pay too much attention to the tactical details of operations. He did however; pay a great deal of attention to logistics, which is the art of the possible.
There is a maxim in military circles: "Professors study strategy, Amateurs study tactics, Professionals study logistics". Eisenhower was preparing the most difficult military operation ever undertaken. The key factor to getting winning the war in Europe was to move an enormous mass of men and material onto and through Europe. Making such an operation work within a coalition framework is about as close to genius as it gets. He left strategy to his civilian boss.
Vernon Clayson - 7/2/2007
I looked him up but it appears he was basically a faceless presence in the shadow of Churchill despite having a military record of consequence. It also appears he had to work around Churchill's ego, a monumental task for any man, so didn't get the credit he deserved. Whatever their relationship and worth we need men like that today.
Lawrence Brooks Hughes - 7/2/2007
Alanbrook was at Churchill's elbow, selecting and dismissing people like Montgomery. Thanks for calling me studious!
Vernon Clayson - 7/2/2007
Alanbrook? The world heard of Montgomery's disagreements with Eisenhower and, by association, with Marshall, but only the most studious of historians would even recognize the name Alanbrook - Alanbrook's beef may have been that it didn't gain the credit he sought. Not to worry, who recalls the names of generals under Napoleon or, a bit more recent, Pershing in WWI? Alanbrook, we hardly knew ye.
Lawrence Brooks Hughes - 7/1/2007
General Alanbrook, Marshall's counterpart in the UK, shows contempt for the skills of both Eisenhower and Marshall in his recent unexpurgated diary. Most of his interesting wartime opinions were cut from the diary's first printing many years ago.
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A SWINDON man has qualified to be a part of the England Seniors pool side.
Jason Godbeer, who has been playing local, county and tournament pool for 30 years, will now have the chance, at 51, to represent his country.
Known as 'Sonic' amongst Swindon's pool fraternity, Godbeer's path to international recognition has been a long one.
However, following a prolific year, during which he has claimed league, team knockout, doubles and singles titles with the Village Inn team, the current Wiltshire champion has earned his shot at national service.
He said: "Having achieved a trial for England's men's team back in 1996, which wasn't successful, I now would like to make the most of this opportunity representing my country and I'm looking forward to an undoubtedly challenging period ahead of me.
"I would like to thank all the many players from Swindon and Wiltshire over the years because without the table time everybody gives each other, what would we achieve?"


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Mattingly refuses to speculate Puig could be promoted
DENVER -- Matt Kemp is on the disabled list, A.J. Ellis missed his third consecutive game Saturday and Yasiel Puig is now playing center field at Double-A Chattanooga.
But don't ask Dodgers manager Don Mattingly to connect the dots and confirm that the club plans to bring Puig to the big leagues to take over in center field until Kemp returns.
Mattingly just shook his head back and forth when asked if he would talk about the plans.
Ellis said he was able to hit off a tee with no pain in his strained oblique, that it felt better than he thought and he was headed in the right direction. But Mattingly hedged when asked if that meant Ellis didn't need to be moved to the DL.
"We're pretty confident he won't need 15 days," said Mattingly, but "we still don't have to make a decision today, so we won't."
Disabling Ellis would open a spot for Puig or another center fielder. Skip Schumaker started in center for the second consecutive game Saturday.
Mattingly said his reports on Hanley Ramirez's first rehab game with Class A Rancho Cucamonga on Friday night were favorable. Ramirez is expected to continue rehabbing there at least through Sunday.
Ken Gurnick is a reporter for MLB.com. This story was not subject to the approval of Major League Baseball or its clubs.


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The "Clown Prince of Crime" kicks off Sideshow's new DC license...
To insure your action figure collection, get in touch with Collectibles Insurance. Say figures.com to get 5% off your first term premiums.
To get your figures graded, go to ActionFigureAuthority.com.
To buy action figures, take a look at BigBadToyStore.com, BriansToys.com, ToyWiz.com, SmallJoes.com, MonkeyDepot.com, and Urban-Collector.com.
For statues and sculptures, go to CSMooreStudio.com.
For t-shirts, take a look at 80sTees.com.
As reported last month (see our story HERE), Sideshow Collectibles had been awarded the DC Comics license to create a signature line of premium statues, busts and other collectibles. Their first offering is none other than the Clown Prince of Crime - The Joker - as a towering mixed-media Premium Format Figure. Pre-orders for this piece begin tomorrow, Thursday, September 1st, 2011.
Two versions will be sold. The Sideshow Exclusive Joker Premium Format Figure will include a switch-out portrait with hat and will be priced at $349.99. Additionally, the regular version, without the additional switch-out accessory will be available for pre-order priced at $349.99. Both versions of The Joker Premium Format Figure will be sold on a first come, first served basis, and will have the FLEXPay option available as a payment choice.


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Posted 7 years ago
(1 item)
Hi, This lamp was handed down to my mom in 1955 ,from her dad who owned a little antique shop. No stampings or signatures my mom is 86 years old now ,this is mine, She says its a Handel ,,i dont think its tiffany ,,anyone who has info id love to know about this. I love this lamp.


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Owner: Time to Let Vince Young Go - FoxNews.com
More info at Titans Online: Titans Statement on Vince YoungOriginally Posted by Associated PressThis quote is hidden because you are ignoring this member. Show Quote
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Owner: Time to Let Vince Young Go - FoxNews.com
More info at Titans Online: Titans Statement on Vince YoungOriginally Posted by Associated Press
Have to admit I thought Bud was going to lose his mind and choose Vince Young
Damn, I was hoping to get Fisher out of the division.
A week ago we thought all three of them would be gone(Del Rio/Fisher/Kubiak) instead they're all staying.
I think Del Rio and Kubiak are still around because no one is sure what's going to happen with the CBA. As for why Fisher is still there Bud must have more functioning brain cells than Al Davis does.
I hate that the Titans came to their senses. I was really hoping that would be a team we didn't have to worry about if they sent Fisher out the door in favor of Vince Young.
Ahh oh well, a little competition never hurt anyone. Wouldn't be surprised to see Haynesworth back in Tennessee, packaged with McNabb
Am I the only one that thinks Tennessee needs a new coach? Jeff Fisher is a good coach, but I think Tennessee needs something new. I'm not saying I'm siding with Vince Young, but to me Jeff Fisher has run his course in Tennessee.
You're not the only one. Kegboy has been a little suspicious since he realized Fisher has only taken them to the playoffs six times in 17 years.
If the Colts were still in the East with New England how many times would we have won the division?
VY just does not have it upstairs to be a great QB in this league.
People keep throwing out his win percentage, but that is such a fallacy. Football is the ultimate team game so to give VY all of the glory for those wins is a joke. If anything that defense and running game deserves to have all the glory because they made up for a lot of bone head plays VY would make out there.
The guy is just emotionally fragile. Anytime things start to go against him he has some kind of breakdown and how can the players trust him?
I wish Bud would have picked VY over Fisher because it would have made the Colts chances that much better to win the division.
No, it would have been depressing as hell.
He could end up in San Fran or the Vikings


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JACKSONVILLE, Fla. - Channel 4 received an email Tuesday regarding a dangerous intersection near Dupont Middle School, one that people in the area said needs to change before someone gets hurt.
Nearby business owners at the intersection of St. Augustine and Alvarado Road told Channel 4 on Tuesday that they want to see a change at the intersection because they've seen some close calls between fast moving cars and students who are trying to cross the street.
"It's frightening," said a 6th grader at Dupont Middle School. "My mom tells me to look both ways before I go. I do that to try to stay safe."
Channel 4 found dozens of students trying to make a daring attempt at crossing the intersection Tuesday afternoon.
"I think they need like a crossing guard or somebody who can like guide us through the road and stop the cars from coming, so we can get safely across the road," said another Dupont Middle 6th grader.
The owner of Caroll's Meat Shop, John Rose, said he has a front-row seat to the mid-day dart and dash. Rose said he's seen far too many close calls from in front of his shop.
"Anybody could make a bad judgment and have too close of a call, or their friends run across and they try to catch up and they think they can beat it," said Rose. "Yeah, it does scare you."
Channel 4 asked Duval County Public Schools about the intersection. The spokeswoman for the schools, Tia Ford, said Florida law only requires districts to provide crosswalks or crossing guards for elementary schools.
Channel 4 was told a change would have to be made by the city for more safety measures at the intersection to be put in place.
When Channel 4 inquired with the city we received a statement reading, "The City of Jacksonville is willing to conduct a traffic study in the area of St. Augustine and Alvarado to see if something different is needed."
There is a crosswalk a quarter of a mile up the road at St. Augustine and Toledo, and while that crosswalk is a little more of a hike for students, the city is encouraging students to use that area until the traffic study is complete.
Rose said he'll continue to keep an eye out for students and hopes the city moves fast on the issue before someone gets hurt.
"It's right here, we see it daily and it could turn out to be pretty bad," said Rose.
Duval County Schools said they have not received any complaints from parents or students about the dangerous intersection. However, Rose told Channel 4 that he spoke with administrators at Dupont Middle and was waiting to hear if any changes were going to be made.
Copyright 2014 by News4Jax.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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CONTROVERSIAL footballer Nile Ranger will be questioned by Wiltshire Police this week after a CCTV camera allegedly caught him striking a woman three times and kicking down the door at his home in Gordon Gardens.
The footage, which surfaced yesterday, appears to show Ranger aiming three punches at a woman before kicking through a secure door in the car park at the block of flats he lives in.
The police were contacted last Wednesday by a building management company, believed to be Mainstay, which manages the flats in Gordon Gardens in the town centre, to report criminal damage at the address.
The damage allegedly caused by Ranger is said to be worth £2,000 and involved a lift door, wall and glass panel.
Ranger's neighbours spoke of the damage caused to the Adver yesterday.
Pav Szczerkowski, 30, a plumbing and heating engineer, said: "The police were here from Friday through to Saturday. There were two police cars and one BMW X5 police car. We saw them at 4am on Saturday morning.
"My dad was looking after our flat whilst we were away on holiday earlier this month. "He told us the door had been kicked in and glass was lying around everywhere."
Another resident, who chose to remain anonymous, said: "The management company removed the entire door and frame.
"The glass panel had been broken. Once it was broken, it was easy for people to reach through and press the button which releases the door. "It means you don't need your key to get in."
Another neighbour, who also chose to withhold his name, said: "I just came downstairs to go to work on the Monday and saw glass all over the floor.
"The window looked like it had been punched through."
Wiltshire Police said a 23-year-old man would be contacted via his solicitor for interview by appointment.
"Police were contacted on April 23 by a building management company to report criminal damage at a residential address in Gordon Gardens, Swindon," a spokeswoman said.
"The company were visiting to assess damage reported by residents to have happened on April 13 at approximately 4am.
"Damage caused is in the region of £2,000 to a lift door, a wall and a glass panel which was smashed.
"During the course of enquiries the company have supplied the police with a copy of CCTV of the incident which shows a man kicking and smashing the door and lift, and at one point punching a female who was with him.
"Police have been making enquiries to locate the suspect.
"As a result a man, aged 23, from Gordon Gardens in Swindon will be contacted via his solicitor for interview by appointment in connection with the criminal damage and assault.
"Police are keen to hear from the woman who was with the man on April 13 at 4am and would encourage her to come forward and speak to police."
Ranger, who plays as a striker for Swindon Town, has not played for the club since February 14 because of a hamstring injury.


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Moderators: Timko, Fritz, Solty, Booter, Blake_T, Frank Delicious
bents wrote:First, what is the definition of a tunnel shot?
JHern wrote:
The hole below isn't strictly a tunnel because it doesn't have overhanging branches the entire way (only the lone oak branch sticking out half way)...
bents wrote:Ok, so a tunnel has some ceiling, and stuff on both the left and right. If the tunnel curves way left or right (like many tunnels outside of disc golf do), do you still call it a tunnel shot?
bents wrote:For a tunnel curving way left, for example, I'd want something overstable--I don't think this is what most people are talking about when they recommend a buzzz.
bents wrote:Anyway, your picture looks basically like what I'm describing. I'd have trouble getting a roc under that branch and still get much distance...
JHern wrote:This is a tough hole, a little over 400'
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With more and more small-batch spirits on the market these days, it can be hard to keep up. What are the real standouts? We asked 14 bartenders about their favorite small-batch spirits. Here's what they had to say.
About the author: Carey Jones is the former managing editor of Serious Eats. Follow her on Twitter (@careyjones).


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Catch the balloon
Catch the balloon will have children calling out for more as they play this all time favourite birthday party game. Get your kids moving and laughing with this exciting kids activity and join in the fun too. This is a great game for all the family!
Number of players:
What you need:
- balloons
Arrange the children in a circle on the floor and have them count up - eg the first child is one, the child next to them is two, and so on.
Put the highest number in the centre of the circle to act as 'IT'.
'IT' holds a balloon and calls out one of the children's number while dropping the balloon to the floor.
The holder of that number then tries to catch the balloon before it touches the floor. If the player is successful, 'IT' tries another number. If the balloon touches the floor then that player is 'IT'.
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Find more paper craft ideas:
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Fractional share provider Flight Options' business is growing at a healthy clip, the Cleveland, Ohio-based company announced yesterday. "We're definitely seeing a significant increase in hours flown and customer utilization," said Matt Doyle, executive vice president of sales and marketing. "We're seeing folks are much more comfortable using their hours. On the business side, they're using their airplanes to meet customers and clients and expand their business. On the personal side more folks are flying."
Fractional share sales remain the company's strongest product, although its recently launched Jet Membership program is also selling well, Doyle said, with overall sales up 30 percent year-over-year. On the fractional side, during 2012 Flight Options saw a 70-percent increase in "conquest growth"–shares sold to buyers who have left other programs.
Flight Options operates Embraer Phenom 300s and Legacy 600s; Beechjet/Hawker 400s and Hawker 800s; Nextant 400XTs; and Cessna Citation Xs. Buyers of Nextant 400XT shares are looking for value, Doyle said. "The owner coming out of a Beechjet 400 into the 400XT is not only gaining 50-percent more range, but saving about $1,000 an hour on operating costs."
Flight Options also reported that it has been "profitable on an operating basis in each of the last four years."
Steve (not verified)
February 22, 2013 - 4:16pm
If their sales are up why are they down sizing all of their maintenance facilities?
Chad Trautvetter
February 22, 2013 - 5:00pm
Because outsourced maintenance typically costs much less than in-house maintenance–a CEO at another fractional provider told be that outsourced maintenance costs them one-third of what their in-house maintenance does. Not to mention that Flight Options, or any other fleet operator for that matter, has limited resources when it comes to the number and locations of maintenance bases, meaning they have a limited number of bases in concentrated areas. But by using third-party maintenance providers, they have access to a much broader number and more geographically diverse maintenance shops, but without any upfront capital outlay. The real question to ask is why Flight Options didn't outsource most of its maintenance sooner.
topgearz (not verified)
February 25, 2013 - 8:20am
Chad I would say you hit the nail right on the head. With the fleet sitting far and country wide, normal fleet maintenance, never mind unscheduled, is extremely expensive. Yes I understand that costs alone shouldn't be the only issue, but hanger space can be tough to schedule if your company is doing all the work. BTW I made my living with wrenchs, wires and meters for 15 years doing airframe inspections, certifications and repairs. As one would say, been there,done that.


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You are invited to visit the newest branch of The Adirondack Trust Company, located at the corner
of Ruhle and Round Lake Roads, just west of Exit 11, in Ballston Lake, NY.
Our intent is to provide you with the best possible service in a new and relaxing location.
Our new branch features:
• Free Wi-Fi hot spot - bring your tablet, smartphone or laptop and use in our customer lounge area,
• Free coffee and beverage area, enjoy a nice hot cup of coffee or tea,
• 24/7 Drive Up ATM – with image capture, no envelope needed for check or cash deposits,
• Free coin counter for our customer's use, and
• Enjoy our green building and passive solar design including solar panels and abundant natural light.
Using this link you can visit the website that we have created so you can see the solar panel monitoring system. It provides useful information on the daily and cumulative performance of our solar panel system.
To learn more about this branch and the requested features that were asked for please click here.
Please stop by and say "hi" to Ms. Zuzana Kaplan, our Branch Manager, and meet her fine staff.
Day Lobby Drive-Thru
Monday-Wednesday 9:00 a.m. – 3:00 p.m. 7:30 a.m. – 3:00 p.m.
Thursday and Friday 9:00 a.m. – 6:00 p.m. 9:00 a.m. – 6:00 p.m.
Saturday 9:00 a.m. – 1:00 p.m. 9:00 a.m. – 1:00 p.m.
Our commitment is to provide you with excellent customer service and incomparable value at all times. We look forward to maintaining a long and successful relationship with you.
Please call (518) 899-0155 or visit us soon, we'd enjoy seeing you at our new location.


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Pharmaceutical cGMPS for the 21st Century — A Risk-Based Approach: Second Progress Report and Implementation Plan
On February 20, 2003, the Food and Drug Administration (FDA) released its first progress report on a major initiative concerning the regulation of drug product quality. The 2-year initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach (the Pharmaceutical cGMP initiative), which was launched on August 21, 2002, applies to human drug and biological drug products and veterinary drugs and has several objectives:
- To encourage the early adoption of new technological advances by the pharmaceutical industry
- To facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance
- To encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas
- To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science
- To enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the Agency's business processes and regulatory policies concerning review and inspection activities
During an April 2003 inaugural scientific workshop that was held with stakeholders in Washington, DC, FDA received many valuable comments and ideas [workshop summary]. Input from this workshop and other meetings, such as FDA Science Board and Advisory Committee for Pharmaceutical Science, have supported the progression and evolution of the initiative during the past year, enabling the Agency to make substantial progress in its initiative. The Pharmaceutical cGMP initiative was made an important component of the science-based risk management goal in the Agency's August 20, 2003, 5-Part Strategic Action Plan to Protect and Advance America's Health. The progress of the cGMP initiative to date and plans for the future are the focus of this report.
Brief Progress Report on Our Achievements to Date
As a result of the input received at various meetings and of progress made during the past year on the Pharmaceutical cGMP initiative, new working groups have been formed and some of the original working groups have been realigned. These multidisciplinary groups, comprising experts from various areas of scientific and regulatory practice, are shaping and implementing the initiative under the oversight of the FDA cGMP Steering Committee. [Pharmaceutical Working Groups]
The working groups have completed the following 5 guidance documents, which the Agency is announcing with this progress report:
- Part 11, Electronic Records, Electronic Signatures - Scope and Application (final guidance)
- Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (draft guidance)
- Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practices (draft guidance)
- Comparability Protocols - Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information (draft guidance)
- PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (draft guidance)
In addition, the Agency has recently entered into the following collaborations with industry, academia, and another governmental organization. Details of these collaborations are discussed further in this paper.
- Cooperative Research and Development Agreement (CRADA) with Pfizer, Inc.
- Collaboration with the McDonough School of Business (Professor Jeffrey T. Macher, Ph.D.), at Georgetown University, Washington, DC, and the Olin School of Business (Professor Jackson A. Nickerson, Ph.D.), at the Washington University, St. Louis.
- Collaboration with the National Science Foundation's Center for Pharmaceutical Processing Research
These are only initial collaborations and the FDA will be seeking additional opportunities to better focus on the various aspects of the initiative and to enhance our scientific and technical capabilities.
Finally, the Agency has made several important changes to its inspections program:
- The Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) recently signed a memorandum of understanding establishing a Pharmaceutical Inspectorate within ORA. Details of this highly trained staff are discussed later in the report.
- The Preapproval Inspection Compliance Program has been revised to give the field more opportunity to utilize a risk-based approach by allowing greater flexibility in determining whether a preapproval inspection is warranted. This is also discussed in more detail later in the report.
What follows is a progress report on Agency activities related to our Pharmaceutical cGMP initiative and future plans for achieving the objectives outlined in August 2002 as well as in the recently announced 5-Part Strategic Action Plan.
21 CFR Part 11 - Electronic Records Requirements
The final guidance for industry Part 11, Electronic Records, Electronic Signatures - Scope and Application clarifies the scope and application of the Part 11 regulation and provides for enforcement discretion in certain areas. The final guidance addresses the comments received during the comment period, including those concerning enforcement discretion, time stamps, and legacy systems. The guidance explains the goals of this initiative and removes barriers to scientific and technological advances and encourages the use of risk-based approaches. The Agency intends to begin rulemaking to revise Part 11, to provide further clarifications and adjustments consistent with the principles and enforcement policies described in this guidance document.
Implementation of aTechnical Dispute Resolution Process for CGMP Disputes
The draft guidance Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP is intended to provide recommendations to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes about scientific and technical issues relating to current good manufacturing practice (CGMP) regulations. Disputes related to scientific and technical issues may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements or during the Agency's assessment of corrective actions undertaken as a result of such inspections. Because these disputes may involve complex scientific and technical issues, it is important to have a process in place that encourages open, prompt discussions and leads to dispute resolution. Once finalized, the Dispute Resolution guidance will describe procedures for raising such disputes to the Office of Regulatory Affairs (ORA) and Agency centers and for requesting review by the Dispute Resolution Panel for Scientific and Technical Issues Related to Pharmaceutical cGMPs.
By January 1, 2004, the Agency intends to initiate a 12-month domestic pilot program consistent with the guidance document. The publication of the final guidance is targeted for January 2005 and will reflect the completion and evaluation of the pilot as well as the review of any comments received.
Science-Based Policies and Procedures to Facilitate Innovation Within the Existing Regulatory Framework
Aseptic Processing Guidance Undergoing Revision
Once finalized, the draft guidance Sterile Drug Products Produced by Aseptic Processing -- Current Good Manufacturing Practice will replace the 1987 Guideline on Sterile Drug Products Produced by Aseptic Processing and provide recommendations on how to build quality into products using science-based facility, equipment, and systems design. There are two risk-related themes in the draft guidance:
- Ensure that operational and raw material inputs are predictable through adequate quality control and quality assurance
- Ensure reliable and robust product protection through adequate design and control.
These objectives are consistent with modern manufacturing trends. In particular, the draft guidance underscores the advantages that automation and isolation concepts offer in protecting the exposed sterile drug product during its aseptic manufacture.
Sterile drug products are a high priority in our current risk-based inspectional program. These drug products are generally of high therapeutic significance, and our proactive efforts to enhance CGMP understanding in this area are intended to promote CGMP compliance and ensure a steady supply of these medically necessary products to the U.S. consumer.
In issuing this guidance, FDA is trying to clarify regulatory expectations. We believe that clarifying relevant regulatory standards for sterile drug products will help reduce the incidence of manufacturing problems with this class of pharmaceuticals, which are often a major cause of drug shortages. The guidance also is consistent with Agency efforts to harmonize with international regulatory standards and develop more science-based guidance documents.
Preapproval Inspection Priorities Revised
FDA has revised and reduced the number of inspection categories that would automatically prompt an inspection when a drug application or supplement is reviewed by the Agency. To implement the change, the Agency has revised this section of the Preapproval Inspection Compliance Program [PDF] and notified ORA district preapproval managers and Agency personnel conducting preapproval inspections (PAIs) of the changes.
By reducing the number of mandatory inspection categories, ORA field offices have greater flexibility in determining if a preapproval inspection is warranted. This change is effective immediately and has been incorporated into the Compliance Program for Preapproval Inspections/Investigations, CP 7346.832. These changes will help reduce the number of preapproval inspections being carried out, providing additional resources for more high-risk preapproval and postapproval CGMP inspection coverage. Additional changes to provide more flexibility in assigning preapproval inspections consistent with our risk-based approach are under consideration.
Comparability Protocols Offered as an Option
The draft guidance Comparability Protocols Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information, describes recommendations for preparing and using pre-defined change evaluation plans, generally referred to as comparability protocols, to implement postapproval manufacturing changes. Once finalized, the guidance will apply to protein-based human and veterinary drug products and biological products. Under appropriate circumstances, use of an approved comparability protocol can allow manufacturers to implement some changes without submission of a prior approval supplement. Having information and data in the protocol will enable the Agency to ensure that regulatory requirements appropriately target the risk that a manufacturing change will adversely affect product quality. We also plan to finalize in early 2004 the February 2003 draft guidance pertaining to nonprotein human and veterinary drugs.
In addition, we are planning an evaluation of existing data on prior approval changes with the goal of identifying opportunities for reducing application submission and filing requirements. Throughout 2004, ongoing postapproval activities will be evaluated to identify opportunities for improving coordination between review and inspection activities to identify and implement opportunities for managing manufacturing changes without the need for prior FDA review or approval.
PAT - a New Framework to Encourage Manufacturing Innovation
The draft guidance PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance is intended to describe a regulatory framework that should encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance technologies. Working with existing regulations, the Agency has developed a new, innovative approach for helping the pharmaceutical industry address the technical and regulatory issues and questions anticipated during the introduction of such technologies.
The scientific, risk-based framework outlined in this guidance, Process Analytical Technology or PAT, should help pharmaceutical manufacturers design, develop, and implement new efficient tools for use during product manufacture and quality assurance while maintaining or improving the current level of product quality assurance. The framework we have developed has two general components:
- A set of scientific principles and tools supporting innovation
- A new regulatory strategy for accommodating innovation
Among other things, the regulatory implementation strategy includes the creation of a PAT Team approach to CMC review and CGMP inspections and joint training and certification of PAT review and inspection staff. Together with the recommendations in this guidance, our new strategy should alleviate any concern among manufacturers that introducing new manufacturing technologies will result in a regulatory impasse. Indeed, the Agency is encouraging manufacturers to use the PAT framework described in this guidance to develop and implement new pharmaceutical manufacturing and quality assurance technologies.
The PAT guidance has been written for a broad industry audience comprising different organizational units and scientific disciplines. Because it highlights technological opportunities and regulatory approaches that will encourage innovation, the PAT guidance is not a typical Agency guidance. It was developed through a collaborative effort involving CDER, the Center for Veterinary Medicine (CVM), and Office of Regulatory Affairs (ORA). Collaborative activities also included public discussions, PAT team building activities, joint training and certification, and research. An integral part of this process was the extensive public discussions at the FDA Science Board, the Advisory Committee for Pharmaceutical Science (ACPS), and the PAT-Subcommittee of the ACPS, as well as several scientific workshops. FDA plans to explore the possibility of expanding the scope of the PAT guidance to biological products.
Focus Placed on the Science of Manufacturing
The Manufacturing Science working group, which was established at the launch of the Pharmaceutical cGMPs for the 21st Century initiative, is involved in identifying efficient approaches for characterizing and controlling critical manufacturing process parameters and quality assurance. The primary focus of its activities is to find new ways to use the knowledge acquired during pharmaceutical development, scale-up, optimization, and production during regulatory risk-based decisions. The Manufacturing Science working group will work with the PAT team in a number of efforts. First, efforts are underway to develop a broad regulatory strategy that ensures that existing application review and CGMP programs are based on sound state-of-the-art scientific and engineering knowledge. We hope the new regulatory strategy will encourage manufacturers to develop and implement the latest technologies in pharmaceutical manufacturing processes.
The PAT guidance, described above, emphasizes the importance of understanding processes. The guidance discusses a range of flexible options for qualifying and justifying new technologies, such as modern on-line process analyzers intended to measure and control physical and/or chemical attributes of materials to achieve real time release. By emphasizing the importance of understanding manufacturing processes, the Agency hopes to create win-win approaches for enhancing the use of product and process development knowledge throughout the life-cycle of a product. It is our goal to encourage industry to explore new, efficient pharmaceutical manufacturing technologies with the assurance that we are working to develop new regulatory paths to address the technical and regulatory issues and questions anticipated during the introduction of such new technologies. We believe that a focus on process understanding will facilitate risk-based regulatory decisions and innovation as well as the use of appropriate risk identification, management, and control methodologies.
Second, we have planned several scientific workshops domestically and overseas during the latter part of 2003 and the early part of 2004 for the purpose of exploring, identifying, and discussing innovative scientific risk-based approaches that will help us reach several of the goals of the Pharmaceutical cGMPs initiative.
Next, we are also announcing today that we will be collaborating with the National Science Foundation's Center for Pharmaceutical Processing Research in support of the objectives of the PAT and Pharmaceutical cGMPs initiatives. This collaboration is also intended to expand the Agency's scientific foundation in the area of innovative pharmaceutical manufacturing technology. We believe this collaboration will help the Agency develop and implement sound, science-based policies with regard to the review and inspection of current and innovative systems for monitoring and controlling pharmaceutical manufacturing.
Finally, we have established a cooperative research and development agreement (CRADA) with Pfizer, Inc. to research chemical imaging applications in pharmaceutical manufacturing and quality assurance. Recent advances in chemical imaging technology make it possible to acquire and analyze high-resolution chemical images rapidly. Chemical imaging can now be applied to process monitoring and control. Such modern chemical-imaging tools can offer novel, efficient approaches to ensuring pharmaceutical quality.
Emphasizing a Risk-Based Approach
Even though the Pharmaceutical cGMPs initiative and related activities broadly address risk-based approaches, certain aspects of the initiative focus primarily on implementing specific risk-based approaches. To ensure that a risk management approach is applied to allocating FDA inspectional resources, the Agency is developing a quantitative risk-based site-selection model for use in choosing sites for inspection. This model will be piloted for human drugs (CDER) in October 2004. The model will help the Agency predict where its inspections are most likely to achieve the greatest public health impact. The model will include risk factors relating to the facility (such as the compliance history) and to the type of drugs manufactured at the facility. The model will also include risk factors relating to the manufacturing processes and the level of process understanding.
The Agency also has developed action plans for the review and revision of field compliance programs to incorporate risk-based approaches to improve transparency and guide FDA investigators in conducting inspections. For example, the Agency will revise the sterile products compliance program (for CDER products) upon finalization of the aseptic processing guidance. The Center for Veterinary Medicine (CVM) and ORA will be adopting a more systems based compliance program for its CGMP inspections to more closely parallel CDER's current compliance program on this subject. CDER and ORA have identified other compliance programs for revision toward a more risk-based approach, including the preapproval inspection program and active pharmaceutical ingredients (API) program.
To better understand which factors lead to superior manufacturing performance in the pharmaceutical industry, the Agency has signed a material transfer agreement with Professors Macher and Nickerson of Georgetown University and Washington University in St. Louis, respectively. The study they perform should help the Agency identify the factors that predict manufacturing performance to further refine our risk-based site selection model for CGMP inspections as well as other efforts to better target identified risks to pharmaceutical quality. Ultimately, our risk-based approach should decrease the likelihood of adverse inspection outcomes, product recalls, and drug shortages. The risk-based approach we are developing should help FDA and industry to better focus activities and resources and improve product quality.
Improved Integration of the Preapproval and CGMP Inspection Programs
The Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) signed a memorandum of understanding (MOU) on August 22, 2003, establishing the Pharmaceutical Inspectorate PI Frequently Asked Questions. The PI is a staff of highly trained individuals within ORA who will devote most of their time to conducting human drug quality inspections on prescription drug manufacturers and other complex or high-risk pharmaceutical operations. The PI will also conduct preapproval inspections and may conduct or assist in investigations that require their expertise. The establishment of the PI will foster a close working relationship between the individuals in the field and CDER, working toward ensuring quality products. FDA expects to begin designating these individuals during fiscal year 2004. To serve as a member of the PI, an investigator will have to obtain and maintain a Level III Drug Certification. A Level III Drug Certification signifies that an individual has received extensive training on advanced technology in the pharmaceutical manufacturing process and on how those technologies are evaluated during an inspection. A Level III Drug Certification Board has been established to review certification packages, select candidates for membership into the PI, and develop, update, and maintain the curriculum for the Level III Drug Certification program.
We also plan to increase the use of product specialists to help ensure that submission reviews and CGMP inspections are coordinated and synergistic and that consistency in regulatory decisions is strengthened. Product specialists are individuals with specialized expertise in specific scientific/technical areas. These individuals can be reviewers, center compliance officers, or field investigators. The use of specialists is already established within the Agency, specifically within programs resident at the Center for Biologics Evaluation and Research (CBER) and also for the evolving technology-based PAT Initiative.
Recognizing the value of interaction with other components of the CGMP initiative, the Product Specialist on Inspection Teams working group, which was established at the August 2002 launch of the Pharmaceutical cGMP initiative, is interacting and coordinating its activities with other working groups (see the diagram Potential Use of `Specialists"- An Evolving Team[PDF]).
The PAT Team approach for CMC review and CGMP inspections outlined in the PAT guidance will serve as a pilot for the use of specialists on inspections. The PAT Review and Inspection team is completing their training and certification program fall of 2003. The experience gained and lessons learned from PAT Team building and training programs will be used along with the experience gained from the Team Biologics program to structure further development of this program
Changed Procedures for Drug CGMP Warning Letters
FDA has revised the regulatory procedure it uses for determining when to issue warning letters in response to noncompliance with current good manufacturing practice requirements. Since March 1, 2003, all proposals to issue a warning letter have been reviewed by the centers with product jurisdiction. The appropriate center will determine whether the letter can be issued. A single office authority for the approval of all letters will ensure that requirements are applied consistently.
A warning letter is an official notice to a regulated business establishment that objectionable conditions or practices have been identified in their operations, that corrections are expected, and that failure to correct the deficiencies may result in further FDA actions. Warning letters contain details of conditions and practices that are evaluated from data and other scientific information. Incorporating a center role in the process will ensure that adverse findings will be based on the best science available and will enhance communication and coordination between the field and centers and help identify possible program inconsistencies for resolution before the issuance of a warning letter. During the fall of 2003, an internal assessment will be performed to evaluate the new procedures.
Continuing International Cooperation
One of the guiding principles of this initiative has been international cooperation, including collaboration with other regulatory authorities, via the International Conference on Harmonisation (ICH) and other opportunities. Greater harmonization of international scientific standards on drug product quality will promote technological innovation for enhanced public health protection.
During the most recent ICH meeting, held in July 2003 in Brussels, agreement was reached on a common vision and approach for developing an international plan for a harmonized pharmaceutical quality system that would be applicable across the life cycle of a product. [ICH Press Release] The plan will emphasize an integrated approach to risk management and science. Several actions were outlined to implement this vision. An expert working group (EWG) will be established on pharmaceutical development, which will incorporate elements of risk and quality by design throughout the life cycle of the product. A second EWG was established to better define the principles by which risk management will be integrated into decisions regarding quality, including CGMP compliance both by the regulators and industry. This group will develop a risk management framework intended to lead to more consistent science-based decision-making across the life cycle of a product. These two expert working groups will work in parallel and exchange information on a regular basis.
The industry representatives to ICH have agreed to produce a quality systems scoping document, which will include CGMPs as a subset. This document will address areas of perceived differences in the three ICH regions and make proposals for future areas of collaboration.
All related ICH topics will be developed and discussed further during the November 2003 ICH expert working group meeting in Osaka, Japan, with the intent of developing consensus draft documents, with the possibility of release toward the end of 2004.
Quality Management Systems
The Agency has begun the complex process of designing an integrated Agency-wide, risk-based quality management system. As a first step toward enhancing the Agency's quality management system, the Steering Committee is developing a definition of quality in the context of pharmaceutical quality for the purposes of this initiative.
The original Quality Systems Working Group, formed at the launch of the initiative, was dedicated to enhancing the consistency and predictability of FDA's approach to production quality and safety assurance among our centers and field components. The original Quality Systems Working Group has been disbanded and replaced with new working groups (WGs): the Quality Systems Framework WG, the Quality Systems Guidance Development WG, and the CGMP Harmonization Analysis WG. Another working group has been established that will develop a mechanism similar to CDER's CGMP Notes that, consistent with good guidance practices, can quickly communicate FDA decisions and interpretations related to CGMPs and FDA inspectional findings to the public.
The Quality Systems Framework WG will be developing a framework that enhances and integrates the Agency's existing quality systems. This quality systems framework will be implemented in the involved centers and the field to ensure quality and consistency of reviews and inspections. To achieve greater consistency across the Agency, the framework will provide a common vocabulary and component description. The framework or model will include basic components, such as ensuring that there are process plans with written procedures; well-trained staff; record keeping and review; knowledge sharing and coordination and continuous process improvement. The working group expects to have a draft white paper for internal FDA review by October 31, 2003. The draft will then be made available for public comment by December 1, 2003.
The Quality Systems Guidance Development WG is developing new educational guidance documents to encourage the use of quality system principles. As a first step, the group is studying modern quality systems principles from various sources so that the guidance that is developed can reflect the most modern principles of quality systems and quality management. The guidance will map these modern principles against the CGMP requirements, reinforcing the very quality system principles they were founded on. The first guidance is expected to be released for comment by August 2004.
Also specific to this particular component of the initiative, FDA expects a report in March 2004 on the contract that it awarded in March 2003 on Effective Quality System Practices. This project is intended to help improve the practices and policies of the FDA units involved in the regulation of pharmaceuticals by reviewing effective quality and regulatory system practices from other public or private organizations. As discussed in the next section, an educational series on this topic has been developed for FDA staff during the fall and winter 2003.
Finally, FDA has created a CGMP Harmonization Analysis working group that is analyzing internal and external GMP requirements, including those related to quality systems. Regulations to be reviewed include 21 CFR 210 and 211, European Union CGMPs, PIC/S1 and other Agency-wide CGMP regulations. The differences between these regulations will be highlighted, and the Steering Committee will use an analysis of these differences to determine the value of revising 21 CFR 210 and 211. Opportunities for harmonization will be identified and prioritized. An interim report will be provided to the Steering Committee in November 2003. The working group expects to have a final analysis completed in May 2004.
Training Related to the Initiative
Six organizations have been identified that have expertise in quality systems and/or risk management approaches. They will be providing a series of presentations to FDA staff to share their lessons learned and approaches. This lecture series will provide FDA staff with current thinking in the quality systems and risk management areas and will offer FDA staff the opportunity to ask questions and learn about alternatives used by other organizations that may be applicable to this initiative.
In addition to the lecture series described above, a curriculum is being developed for investigators to become experts and potential members of the Pharmaceutical Inspectorate. The curriculum will include courses on risk management, the science underlying drug manufacturing, the FDA regulation of product quality, technology involved in manufacturing, enforcement processes, and team building. It is anticipated that the classroom courses in combination with on-the-job training will provide an enhanced science base for the inspectional process.
Evaluation Planned
We are continuing to refine our plans for evaluation of this initiative. In general, we expect to achieve gains of increasing quality or process efficiency. Our evaluation approach will include both quantitative and qualitative methods that are applicable to the different Agency activities and objectives included in this initiative.
Comments on the initiative and the implementation plan may be submitted to Docket number 03N-0059. However, comments on the 5 guidances should be submitted to their respective docket numbers.
1 Pharmaceutical inspection cooperation scheme (PIC/S).


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An inquisitive group of girls have turned sleuth as they investigate the science of how their bodies function with a series of experiments.
Over several weeks, the Brownies of the 1st Ogbourne pack have been recording their pulse rate before and after exercise, seeing the effects of pressure with foot impressions on soft or hard surfaces and learning about teeth.
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