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Members Profile
- Profession :
- Mediocre Linguist
- Education :
- Various
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About Me : I like to write. Simple. My life is rather interesting. Uhm... I have trust issues but lets not get into that. Your welcome. Im very symbolic and I loooooooovvvvvveeeee ... more »
Activities | Date |
Poems Rated | |
Latest 5 Poems of Søren Valentine
- 11/27/2013 La Moribunda (The Withered One)
- 4/25/2013 Passively Tearing Me Asunder
- 4/11/2013 Cambre and Arielle (...
- 4/4/2013 Arielle's Awakening
- 2/26/2013 Verdant Blade - A Haiku
Friends of Søren Valentine
Søren Valentine's last comments on poems and poets
POEM: How many times have i counted the stars by Nathan Barkley
Oi mate this is really good! I like the picture of counting the stars, they are special to me.
Also, I absolutely love the imagery of flower petals floating ever so gently on a river of pain knowing that is isn't gentle at all. Every ripple that petal causes will bring so much back, and like you mentioned, those petals come back later on.
I really liked this! -
POEM: And melt into nothingness by Nathan Barkley
Hmm. This poem is very good. It is only the second one I've read and I already know you are a great writer. Therefore, you have much potential.
I'll probably find the answer to this enquiry as I read on, but have you tried writing without rhyming? I think you'd be good at it. But what do I know?
Thanks for sharing.
Sorry if I seem too abrasive. I'm just honest... not to cause offence.
Anyway, sigues escribiendo!
þakka þér! -
POEM: Graffiti by Aria Siren
... must you torture us so? Brilliant, simply brilliant.
Søren Valentine's comments on forums
Søren Valentine
Post reply
Hello :) ,
I've just posted some poems I wrote recently that I would love to get some different opinions on. Thanks in advance! -
Søren Valentine
Post reply
I would love for you guys to read my new poem
The Unraveling
and my poems entitled " Fallen Raven" and " Autumnal Love"
Thanks in advance for your time!
P.S. If you leave comments (which I hope you do, I want to get different opinions on my poetry) PLEASE be completely honest. If you didn't like it, tell me!
That's why I want different opinions :) -
Søren Valentine
Post reply
Hello Everyone,
I'm not exactly new to this site. but I am new to much of its features, (I don't get on the computer much)
anyhow, I would very much appreciate some of your thoughts on my poems, your views, interpretations and opinions.
And please don't hold back your thoughts or try to " spare my feelings" as others have in the past. I'm a very straight forward person and I like to hear (or read) people's honest opinions, specially on my poetry. Anyway, thanks so much for your time!

subset: commoncrawl


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From Wikipedia, the free encyclopedia - View original article
"Mama Told Me Not to Come" | |
Song by Eric Burdon & The Animals from the album Eric Is Here | |
Released | March 1967 |
Genre | Rock |
Label | MGM |
Writer | Randy Newman |
Producer | Tom Wilson |
"Mama Told Me Not to Come" | |
Song by Eric Burdon & The Animals from the album Eric Is Here | |
Released | March 1967 |
Genre | Rock |
Label | MGM |
Writer | Randy Newman |
Producer | Tom Wilson |
"Mama Told Me (Not to Come)" is a song by American singer-songwriter Randy Newman written for Eric Burdon's first solo album in 1966. Three Dog Night's 1970 pop rock cover of the song topped the U.S. pop singles charts. Tom Jones's cover also hit number four on the U.K. Singles Chart in 2000.
Newman says that the song was inspired by his own lighthearted reflection on the Los Angeles, California music scene of the late 1960s. As with most Newman songs, he assumes a character - in "Mama..." the narrator is a sheltered and extraordinarily straight-laced young man, who recounts what is presumably his first "wild" party in the big city, is shocked and appalled by cigarette-smoking, whiskey-drinking, and loud music) and — in the chorus of the song — he recalls his "mama told [him] not to come."
The first recording of "Mama Told Me Not to Come" was cut by Eric Burdon & The Animals. A scheduled single-release of September 1966 was withdrawn,[1] but the song was eventually included on their 1967 album Eric Is Here.
Newman's own version of his song was released on the 1970 album 12 Songs, and was characterized by Newman's mid-tempo, rollicking piano accompaniment, as well as Ry Cooder's understated slide guitar part, both of which give the song the feel of a bluesy Ray Charles-style rhythm and blues number.
"Mama Told Me (Not to Come)" | ||||
Single by Three Dog Night | ||||
from the album It Ain't Easy | ||||
B-side | "Rock & Roll Widow" | |||
Released | May 1970[2] | |||
Format | 7" 45 RPM | |||
Recorded | 1969-1970 at American Recording Company[2] | |||
Genre | Rock | |||
Length | 2:59 (45 version) | |||
Label | Dunhill | |||
Writer(s) | Randy Newman | |||
Producer(s) | Richard Podolor[2] | |||
Certification | Gold (RIAA)[3] | |||
Three Dog Night singles chronology | ||||
Also in 1970, Three Dog Night released a longer, rock 'n roll and funk-inspired version (titled "Mama Told Me (Not to Come)") on It Ain't Easy.
Three Dog Night's version had the same 3/4 by 2/4 time change as Eric Burdon's version and featured Cory Wells singing lead in an almost humorous vocal-style,[4] Jimmy Greenspoon playing a Wurlitzer electric piano, and Michael Allsup playing his guitar, which sounds like a violin on the recording.[5]
Chart (1970) | Peak position |
Canadian Top Singles[6] | 2 |
Germany (Media Control Charts)[7] | 12 |
Netherlands (Single Top 100)[8] | 14 |
UK Singles (Official Charts Company)[9] | 3 |
US Billboard Hot 100[10] | 1 |
Billboard ranked the record as the No. 11 song of 1970.[11] The single was certified gold by the Recording Industry Association of America on July 14, 1970, the same day that It Ain't Easy was certified gold.[3]
This was the very first #1 song played on the July 4, 1970 broadcast of American Top 40.
Tom Jones & Stereophonics' treatment of the song reached number four on the U.K. Singles Chart in 2000. This version was produced by Steve Bush and Marshall Bird (AKA "Bird & Bush"). Singer Kelly Jones shared in the vocals with Tom Jones, with the song featuring a somewhat livelier, punchier sound than the aforementioned Three Dog Night version. The video featured an appearance from Welsh actor Rhys Ifans.
P. J. Proby recorded one of the earliest versions of the song in 1967,[12] followed by Three Dog Night's 1970 hit. It has also been recorded by a diverse range of artists, including Wilson Pickett,[12] Lou Rawls,[12] The Wolfgang Press,[12] Yo La Tengo, Helmut Zerlett, The Slackers, and Paul Frees (as W.C. Fields) accompanied by The Animals. Lazlo Bane. Jazz singer Roseanna Vitro included it in her 2010 collection The Music of Randy Newman. A 1970 cover by The Jackson 5 was released on Come and Get It: The Rare Pearls.
Tea Leaf Green[13] and Widespread Panic[14] have performed this song live. In 1971, the comic singer Patrick Topaloff released a French version named Maman, viens me chercher. A German version, entitled Das War So Doch Nicht Geplant, was published in 2005 by the German soul singer Stefan Gwildis.
Three Dog Night's version would later appear in Terry Gilliam's 1998 movie adaptation of Hunter S. Thompson's 1972 gonzo novel Fear and Loathing in Las Vegas. Due to the song's upbeat, paranoid mood, it was used for the scene of obsessively drug-using protagonists Raoul Duke and Dr. Gonzo escaping a "District Attorneys convention on narcotics and dangerous drugs". It also appears as the last song in the movie's G-rated trailer, mainly accompanying Duke's wild car ride to have Dr. Gonzo catch a plane in time, a scene where in the R-rated trailer and in the actual film, Viva Las Vegas by Dead Kennedys was used instead.
The Three Dog Night version was also used in the 1997 films GI Jane (played over a montage of scenes showing Jordan O'Neill (Demi Moore) conditioning herself for the extreme physical demands of SEAL training) and Boogie Nights.
Also used in the movie The Sweetest Thing (2002), when Cameron Diaz is walking up the street.
Preceded by "The Love You Save" by The Jackson 5 | Billboard Hot 100 number one single (Three Dog Night version) July 11, 1970 (two weeks) | Succeeded by "(They Long to Be) Close to You" by The Carpenters |


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Sixteen candidates apply for vacant school board seat
Sixteen people are in the running to replace former District 196 School Board member Bruce Endler.
Endler, a Rosemount resident, vacated the seat he'd held for 13 years on Dec. 10. The application period for District 196 residents interested in taking his place ended Jan. 31.
Board members will hold a special meeting following their Feb. 25 regular meeting to interview finalists. The person they choose will serve the two years remaining on Endler's term.


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I passed the NCLEX-RN at 254 in one attempt---I'm a Filipina Nurse..... - page 4
Hello everyone…..I would like to share my good news with you-----I passed the NCLEX exam that I took just 2 days ago! I am very happy with the results and I want to thank all the people who gave me... Read More
0Jul 12, '07 by Want2bcomeAnRNhi to everyone!
Just like to share here......i just bought a reviewer published by mosby's entitled...Prioritization,Delegation and Assignment, it's a good book. The questions are very challenging, you have to analyze thoroughly the questions to figure out the answer. Unlike some reviewers that some of the answers are obvious. The book is just thin, contains only 200+ pages but it's amazing. -
0Jul 12, '07 by Want2bcomeAnRNOh! congratulations by the way to the thread starter........:smiley_aa
0Nov 28, '07 by koala_beartry kaplan, their questions require more critical thinking which is what you essentially have to do to pass the boards


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- Russian Motorcycles.
- These motorcycles aren't great - they're cheap.
You have to love messing around with engines to enjoy owning one.
The clients problem?
He couldn't persuade dealers to stock them. And he was a year away from calling it quits because he was haemorrhaging money. It seems nobody wants a big piece of machinery that will carry them at 100 mph up a dual carriage way to be a bargain. Who knew?
Our problem was a tiny budget (we were his last resort).
Our solution was to imbue the Uralmoto range with a personality derived from its WWII heritage and appeal to bike enthusiasts by running these ads in specialist biker magazines. After all, this was a product for an authentic biker — someone with oil beneath his fingernails.
The ads should look cheap — they should look like they came from the manual — and they should appear to have absolutely no sophistication in the design.
After the campaign ran our client no longer had to cold-call dealers, they were calling him.
Legible copy is below each ad.
The Hitler–Stalin pact was a marriage of convenience that ended with war between Mother Russia and the Fatherland. Born and bred in battle, the Roustabout served with distinction. And now after some minor improvements (like electronic start) the Roustabout is again ready and willing to take you across Europe in any weather and over any terrain. But comrade, things aren't what they used to be — these days you need a passport.
The Roustabout £4425 on the road, any road.- NASA spent a decade and $12 billion developing a pen that worked in zero gravity.
The Russians used a pencil.
750cc Wolf
What's the point in frivolous extras? They're as useful as an ashtray on a bike. But hey, you do get an electronic start. Are we Russians going soft? Nyet, get real.
The Siberian Wolf. £3895 on the road. - To make it more appealing to the ladies, we removed the machine gun mount.
The Roustabout
We Russians don't make a fuss about the extras you get. We ditched 7000 rounds of armour piercing ammunition (along with the gun) to give you extra speed. If you really want them back, you'll have to join the Russian army. Don't be so fussy though, you can still take a ride through any country. The Roustabout, £4425 on the road, as well as off. - When you have Joe Stalin looking over your shoulder, you make sure
you produce a bloody reliable motorbike.
The Roustabout
In 1941 Uncle Joe requested that we build a bike with just one design specification. Total victory. We produced a bike that could take anything a heavily armoured Panzer division could throw at it. Today, we even reckon it could take on anything the British weather could throw at it. Brave words you might say, but tovarich once you've tried it, you'll want to take on anything. The Roustabout £4425 on the road. - Vorsprung durch technik [ as they never said in Stalingrad ]
The Dalesman
Developed in 1941. Early competition against Hitler's army group central. Victory.
So much for the history lesson, what about the future?
After a few improvements (electric start for one), ready and willing to do battle.
Have fun comrade.
The Dalesman, £4,625 on the autobahn.


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The Lover's Leap | 7b+ | ||
A short sport route through the roof to the left of the upper section of Little Plum. It can be gained by the bottom pitch of Little Plum, free or with aid. © ROCKFAX Make your way to the break by whatever means. Follow the glue trail up the scabby overhang to a rope trashing belay. The moves just about make for a worthwhile outing. Mark Pretty 2002 Submit a new photo of this climb. | |||


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Mar 01, 2011, 11:04 PM | |
Latest blog entry: How To Update your DragonLink Firmware
Mar 02, 2011, 09:26 AM | |
Phoenix, Arizona
Joined Apr 2009
256 Posts
I covered the flap hinge gap with 10mil mylar and it works perfectly, flexing upward when the flaps reflex fully upward with the ailerons and laying flat otherwise. I found the mylar on a 3-ring notebook cover (transparent) at Staples. Just cut 1" strips and LIGHTLY glue them about 1/2" from the edge of the gap. Leave 1/4" unglued in front of the gap to allow flex. It works quite well.
Mar 02, 2011, 12:15 PM | |
If this is your first DLG build I would look at the DVDs from Radio Carbon Arts on building DLGs. I have 3 of them and got so much out of then. The TS2 was first REAL DLG build and it wouldn't have turned out half as good as it did if not for the info I got from the DVDs. On the first test glide with a gentle hand toss the plane flow away dead strait and level with NO TRIM needed and landed 40 yards away. This was first time I ever maidened a pane that didn't even need one clik of trim. I have taken the tips from these DVDs and use them in all builds now, even if it's a sport plane, 3D, giant gasser or whatever.
http://www.radiocarbonart.com/produc...3-DVD-Set.html Rick |
Mar 02, 2011, 12:18 PM | ||
Anyone got a used DLG building one they want to sell? I spent all my cash on the DLG!!! |
Mar 02, 2011, 01:58 PM | ||
Joined Aug 2010
359 Posts
Mar 02, 2011, 02:39 PM | |
United States, CA, Palo Alto
Joined Dec 2007
653 Posts
Putting the battery in the battery compartment doesn't provide the manual's recommended 70 mm CG location for most people; it makes the real CG more like 77mm. To get 70mm you would need to move the battery forward, almost all the way out of the battery compartment. You would need to measure yours to see if this is true for you also, and experiment to see what CG you prefer. A lot of people like the further-back CG.
Mar 02, 2011, 06:53 PM | ||
Either something Seriously wrong with your Pro or something..Is there a oz of glue on your nose or something? lol At 70mm, where is your Battery located to? All the ways in the hole,50% out etc...? 77mm came from Me!!! A few pages ago i wrote my Bit about how i come too have it at 77mm. Back when the Pro came out there was only a few of us first owners here.. this tread has Grow To big. Crazy that ive read every Page/post. |
Latest blog entry: How To Update your DragonLink Firmware
Mar 02, 2011, 10:00 PM | |
United States, NV, North Las Vegas
Joined Sep 2009
1,075 Posts
Quick question... I'm building up a Radian Pro from parts... I received everything today BUT the carbon fiber spar!!! I figured it would be with the wing set Horizon does not list the spar as a separate piece.
Anyway, I need a spar... is there anything special about the spar? any reason I can't go to my local kite shop(he sells us airplane guys carbon fiber out of the back door) and buy a 10mm tube? It looks to be nothing more than a straight tube in the manual. I'm going to call horizon and ask about the spar in the morning but I don't think they will have me one by the weekend... if I can just go buy a 10mm tube I can fly it this weekend John |
Mar 02, 2011, 10:16 PM | ||
LI, New York, USA
Joined Mar 2003
24,829 Posts
Thread Tools | |
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Doug Havens, supervisor at the town's skate park approached board members about the possibility of a erecting a tube run somewhere in the township.
"There's not much to do around the village in the winter," Havens said.
Havens had a vision and explained what he thought would be ideal. He suggested a seven-lane run with three people staffing it. The run would need a winch system therefore electricity would be needed. The purchase of 50 tubes would be a good start, he said. He felt the area would also need a concession stand and a few picnic tables.
He suggested the run be open on weekends, holidays and winter break. He said the town could charge $5 for an all-day lift ticket or $100 for a season pass.
Havens said there is property behind his house on Port Street that would be ideal.
"There's a pond there and we could pump water for an outdoor ice rink," Havens said. "It's really fun to get out there on the ice."
Tubing, ice skating, hockey and broomball could be held there during the village's annual SnowBlast event, he said.
"I feel it would be a great investment for the town," Havens said. "It could be a family-oriented activity."
"I'm enthused by your commitment, anything to get kids outside," said Grace Rapasadi. "You don't see kids outside anymore."
Town Supervisor Rocco DiVeronica has envisioned a tube run for the town for some time now and actually suggested it last year.
"The problem is, the area you are talking about belongs to the village," DiVeronica said.
Anthony Palamara suggested the town look into an inter-municipal agreement with the village, to lease or buy the property.
DiVeronica said if not there could be other locations available.
Because Havens did not have estimates on how much it would cost, the board gave him the go ahead to pursue it.
"Right now it's a tube run without a home," Rapasadi said.
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Be inspired to create a sleek, contemporary kitchen; take a look through our gallery of 20 of the best modern kitchen designs.
1. The black-stained timber panelling borders cabinetry doors and blends with the black glass Miele ovens.
>>Melbourne townhouse design
>>20 best modern bathrooms
>>20 best modern bedrooms
A historic retreat in the Southern Highlands that combines...


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Tracy Broughton: We're excited to welcome Ms. America 2011 Tracy Broughton to our show! Tracy has been a fighter since day one. She was born pre-mature, at age 3 she was kidnapped, and in Oct. of 1991 she was involved in a serious car accident which left her wheel chair bound. Today, Tracy stands victorious as the winner of 2011's Ms. America contest and a National speaker!!
Jamison: One of the most talented R&B singer/songwriters Jamison drops by the Conversation to show off his musical talents. Jamison is bring back old school R&B!!!
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Alison Flint is an associate attorney in the Rocky Mountain regional office.
We have these federal environmental laws for a reason, and it's that agencies need to consider all the impacts of their decisions. So if they're going to authorize aggressive oil and gas development, then they need to look at impacts to wildlife, impacts to wilderness lands, impacts to human health and air quality.
"No End to Legal Battle Over Forest Road, Fish." Associated Press. November 12, 2012.


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Smokin' White Hot Chocolate
With Thanksgiving behind us, Christmas looms closer. One of my family traditions is to take my children to a tree farm to pick the perfect Christmas tree. After the right tree is brought home, we start decorating both the tree and the house with Christmas music playing in the background and this recipe for hot chocolate. The cayenne pepper gives it a little zip.
Smokin' White Hot Chocolate
4 cups milk, 2 percent
8 ounces white chocolate chips
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Wooden Baby Growth & Milestone Chart
Monday, March 10, 2014
Since I had lots of room, I included boxes to mark other interesting milestones and firsts for her. The type of things that I might forget if I didn't write down and she might find interesting: countries + cities visited, halloween costumes, first words, schools, books read, etc. I tried not to make them too baby centric so the board stays relevant for more than just the first few years.
I added a coat of Danish oil thinking it would darken up the wood but I don't love how it highlighted the grain. I probably should have just left it bare or stained it prior to writing on it but live and learn.
26 comments:
I've seen growth charts done before, but THIS is amazing! From the fonts to the milestone boxes. I am in love with this project.
ReplyDeleteWish you would sell these on Etsy! Love the fonts. This seems so much more personable than the things I've being seeing.
ReplyDeleteThat looks so nice..I'm interested what stuff you all write down? What does the big numbers 0 to 5 mean? Or could you tell all sections?
ReplyDeleteRepliesThe numbers are for photos of her at each age. (you can see i haven't gotten around to putting those on). The rest of the sections are:
Milestones: First crawls, steps, walks, first day home, first words, etc.
Adventures: Countries and cities visited, first plane/train/boat ride, amusement parks, etc
Education: School name, date, etc, first book read, first scribbles, etc
Celebrations: Santa sightings, halloween costumes, birthday parties
I'd love to hear what you think. I ♥ comments.
If you are asking a question, please be sure to type in your email address so I can respond directly to you.


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Here is a comparsion of the Sig 238 recoil spring and the Mustang recoil spring which will work in the Sig.
The Mustang spring is on the top...notice that it's a double spring.
I had a problem with FTE with my Sig 238 and Sig is sending a new recoil spring. Here is a guy who they sent a new spring to....notice the size difference....
The new spring sent is on the bottom....he said he only had about 200 rds through the gun. I think they see that the orginal springs are a problem. The Mustang spring is a 12 #.
Going to be interested in which they send me.


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Growing collaboration between US Cyber Command, DHS
The outgoing chief of staff for U.S. Cyber Command said recently the military's professional cyber corps has strong, diverse capabilities.
New leader for Navy cyber command
The Navy's cyber command will welcome a new leader as it approaches its one-year anniversary since declaring full operational capability.
DoD Cyber Command to get new senior leaders
Rear Adm. Sean Filipowski will take over from Rear Adm. Jan Tighe as the deputy director of operations at Cyber Command.
GAO: DoD cybersecurity falls short
The Government Accountability Office says the Defense Department needs to step up its cybersecurity training.
Lockheed attack highlights rise in cyber espionage
This cyber attack didn't go after people playing war games on their PlayStations. It targeted a company that helps the U.S. military do the real thing.
Ft. Meade commander sees more growth after BRAC
In a column for Federal News Radio, Ft. Meade Commander Col. Dan Thomas says, "By this fall, the official worker population of Fort Meade will have grown to more than 48,000. This is 13,000 more personnel than we had three years ago - you do the math: if BRAC growth is 5,400, who are all these other people?"
Navy realigns cyber command
The Deputy commander of Navy Fleet cyber command Rear Admiral Bill Leigher explains the significance of this realignment.
Cyber Command, NSA tout benefits of cloud computing
The head of U.S. Cyber Command says cloud computing is part of his plan for staying ahead of the cyber threats that face the Defense Department. "A year from now we should be well on our way to having a hardened architecture proven and in place, which provides a new level of cybersecurity," said General [...]
Cyber Command priorities announced
Gen. Keith Alexander has outlined a series of next steps to be pursued by the six-month-old U.S. Cyber Command.
DoD wants common cyber picture
The Cyber Command is focused on achieving real-time capabilities, but the director of current operations said they still have serious work to do. He appealed to industry leaders for help designing a sufficient platform.
Navy to track cyber attacks in real-time
The Navy's cyber command will soon be able to see a real-time view of penetration attempts into the service's IT systems, the command's number two officer said Thursday.
Agencies spend too much time on cyber defensive
An event this week sponsored by Potomac Institute in Arlington, Va., evaluates government's cyber spending priorities.
Defense expands cyber DMZs
DoD is expanding the use of demilitarized zones to improve security of its unclassified network. Over the next two years, DISA require all service applications to go through these buffer zones.
Navy activates real-time view of networks
The Navy's Fleet Cyber Command said a lack of real-time visibility into their computer networks is a problem. A new operations center opening this week at Ft. Meade will let technicians see cyber attacks as they are happening.
Cyber Command plans offensive actions
Fully operational last week, the Cyber Command is already planning offensive actions for cybersecurity.
DoD Cyber Command fully operational
DoD's Cyber Command is now fully operational.
Army Cyber Command must find right balance
Maj. Gen. Hernandez took over the new organization Oct. 1. He tells Federal News Radio his goals include making sure the workforce has the capabilities it needs and to better understand the Army's situational awareness.
Army Cyber Command must find right balance
Maj. Gen. Hernandez took over the new organization Oct. 1. He tells Federal News Radio his goals include making sure the workforce has the capabilities it needs and to better understand the Army's situational awareness.
Cyber Command misses operational deadline
The Defense Department announced that Cyber Command did not achieve its October 1st deadline for being fully operational.
General Alexander takes on new cyber hat
Federal Security Spotlight examines the stand-up of the new DoD Cyber Command, to be lead by General Keith Alexander. This week, we bring you a portion of a House Armed Services Committee hearing where Alexander testified.
September 30, 2010


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Strafford County Committee on Aging met in April
Thursday, May 9, 2013
DOVER — Members of the Strafford County Committee on Aging met on April 23 at the Community Center, Dover Housing at Niles Park. Members are still working to revise and re-organize the SCCOA to better serve and meet the needs of the area Seniors. A tentative revised Mission statement was discussed with revisions to be included on the agenda for the May meeting for approval.
Currently, the membership of the Strafford County Committee on Aging is mostly area service providers with a few faithful seniors regularly attending. We are strongly encouraging seniors who want to be involved and informed to join our monthly meetings. The next meeting is scheduled on May 28 at 12 to 1:30 p.m. at the Frisbie Educational Conference Center, York Room, in Rochester. For more information call Linda Nylund at (603) 335-1770. Please join SCCOA and let your voice be heard.


text: No recent wiki edits to this page. Team Origins Fighting an Elephant The Girl Commandos was led by Pat Parker who was also known as War Nurse. The team was consisted of members Mei-Ling from china, Tanya from Russia , and Ellen and Penny from England. The Girl Commandos were unique in convention and for comics of there time and even today. For example Ellen was an over weight hero and Mei-Ling was a Chinese member depicted as an equal of the group. The Girl Commandos fought to until the end of the war.


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Please enter your details to make it easier for us to help you further.
Many years ago I was given a bottle of Laphroaig as a special treat .after trying a glass I put it in my. Drinks cupboard.It is still there.Forty years on.I really disliked the taste I like grouse etc but I found this unpalatable. I will now go and try a drop.Despite being tee total for the last two rears
4th March 2014
Every child of mine born will have a bottle of this bought for them so they can open on their 21st birthdays as a special occasion.
1st March 2014


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Welcome to the Muppet Central Forum!
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Sesame Street Special: The Cookie Thief
Discuss "The Cookie Thief", an all-new one-hour Sesame Street special. "The Cookie Thief" also features the farewell performance of veteran Muppeteer Fran Brill.
"Crash and Bernstein" puppet show debuts on Disney XD
Discussion in 'Puppet News' started by snichols1973, Oct 8, 2012.
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Loading... A Weekend with Mr. Darcy (edition 2011)by Victoria Connelly
Work detailsA Weekend with Mr. Darcy by Victoria Connelly
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Sign up for LibraryThing to find out whether you'll like this book. No current Talk conversations about this book. Good, enjoyable, light read. This was a fun, quick read with lots of Jane Austen and her books in it. The love interests were cute, their relationships moved very fast but it was fun to read about it! I have only read Pride and Prejudice, so I was only familiar with those references. Any die hard Jane Austen fans would absolutely love this. I will be reading the next book to see how everything plays out with the couples. :)" a little surprise mystery adding to this FuN read... just begun. happy to continue ") oooo ") deliteful! humorous amorous as each change of scene encouraged me to read on... a very 'now' setting juxtaposed against Jane Austen's historicity. well played, Victoria! thanks for keeping me reading ") missing it now that i've had to put it down! and eagerly awaiting the next Victoria Connelly delivery... UK author,Victoria Connelly , has done a great job at connecting a reader of today with the person of Jane Austen. She places us right into Jane's home turf. her life at home, in her village, at her church~ with today's characters entirely real, believable and enjoyable {as well as frustrating!} In fact, i liked it so much, i'm on the library wait list for her entire selection of books! Victoria's blog site has excellent pictures of Jane's life setting as well as her own writings A book that kept me riveted! Many thanks to you, Victoria, for keeping me occupied so enjoyably ")) Any JA fans looking for a deliteful summer read? here's a 'don't miss' choice ! This book was a fun, super quick, light read. It was pretty (very) predictable, but all the Jane Austen references made up for it mostly. The thing that irritated me the most was how quickly the characters would tell their romantic interests that they loved them. Obviously the book wasn't meant to be realistic, but still. Fully grown adults with established careers just don't say such things within one day of meeting a person. Anyway, I did enjoy the idea behind the story of Katherine and her love interest. I am planning on reading the related books but am not expecting to be blown away. no reviews | add a review
References to this work on external resources. Wikipedia in EnglishNone No descriptions found. During a Jane Austen Addicts weekend in England, Dr. Katherine Roberts, a Jane Austen lecturer, discovers that the author of the racy Regency novels she loves is actually a man who has been waiting to declare his feelings for her. (summary from another edition) |
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text: Idea Exchange: Switch needles to ease vaccine administration Nov 01, 2010 By dvm360.com staff VETERINARY MEDICINE Getty Images When I administer a vaccine to my patients, especially cats and small dogs, I use the original needle on the syringe only to withdraw the liquid from the diluent vial, inject it into the vaccine vial, and withdraw the vaccine. This process makes the needle blunt, so I replace the needle with a new one of the appropriate gauge. I find that this process makes the injection easier and smoother for the patient and me. Dr. Amirreza Amerinaeini Dr. Amirreza Amerinaeini Tehran, Iran Related linksRead more Idea Exchange tipsHow safe are your vaccine procedures? Hot topics on dvm360Veterinarians: Your clients are going to Google with these cat questions Vetcetera: The complex topic of canine fear-related aggression Reality TV and the veterinarian: Discussing mainstream dog training advice with clients Blog: Election results pose obstacles for veterinary prescription law 7 steps to a better relationship between veterinarians and rescue groups


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In its Pathway to Product Safety the U.S. Food and Drug Administration (FDA) emphasizes the importance of operating as a "truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders" (FDA, 2011b, p. 3). To this end, the agency must bridge the many gaps within regulatory systems abroad. In this chapter, the committee recommends actions the FDA and other U.S. government agencies can take to increase the efficiency of their own operations while improving the systems of their counterpart agencies abroad.
Chapter 4 describes the committee's strategy in forming its recommendations and emphasizes that the FDA should let risk guide its efforts to build food and medical product regulatory systems abroad. In keeping with its focus on risk, the committee recommends that the FDA divide its limited resources according to risk. An understanding of risk will allow the FDA to choose what problems are its highest priorities.
There are tradeoffs implicit in all decision making. Especially in capacity building, managers need to choose between different risks affecting different populations. When working across many countries, choosing to work with one population means less attention for others. Through the use of an enterprise risk management framework, the FDA can determine which risks are the most serious and have an objective way to rank its priorities.
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OCR for page 193
Domestic Action
In its Pathway to Product Safety the U.S. Food and Drug Adminis-
tration (FDA) emphasizes the importance of operating as a "truly global
agency fully prepared for a regulatory environment in which product safety
and quality know no borders" (FDA, 2011b, p. 3). To this end, the agency
must bridge the many gaps within regulatory systems abroad. In this chap-
ter, the committee recommends actions the FDA and other U.S. government
agencies can take to increase the efficiency of their own operations while
improving the systems of their counterpart agencies abroad.
Chapter 4 describes the committee's strategy in forming its recom-
mendations and emphasizes that the FDA should let risk guide its efforts
to build food and medical product regulatory systems abroad. In keeping
with its focus on risk, the committee recommends that the FDA divide its
limited resources according to risk. An understanding of risk will allow the
FDA to choose what problems are its highest priorities.
There are tradeoffs implicit in all decision making. Especially in capacity
building, managers need to choose between different risks affecting differ-
ent populations. When working across many countries, choosing to work
with one population means less attention for others. Through the use of an
enterprise risk management framework, the FDA can determine which risks
are the most serious and have an objective way to rank its priorities.
OCR for page 193
Recommendation 6-1: FDA should use enterprise risk management1 to
inform its inspection, training, regulatory cooperation, and surveillance
efforts. Enterprise risk management should apply to the agency's entire
operation, and it should incorporate a number of set criteria such as
country of manufacture or production, volume and type of product,
facility inspection history, and trends or data shared from other regula-
tory authorities.
The FDA's implementation of an enterprise risk management system
will be the best measure of this recommendation. The FDA's allocation of
resources in a way that reflects decisions grounded in enterprise risk man-
agement will also be a measure of this recommendation. The FDA will also
have to select which statistics best measure the impact of its inspections,
trainings, and surveillance efforts. Choosing which metrics to monitor most
closely will be part of the assessment. The timetable on which the FDA col-
lects these data is up to the agency's management, but it should be frequent,
perhaps every quarter, but at least every 6 months.
Should the results of an enterprise risk management analysis suggest
full reorganization of the FDA, such a process would take time. In order to
work toward this change promptly, the FDA needs to conduct enterprise-
wide risk assessment, analysis, and evaluation. If its results suggest an
inefficient or unscientific allocation of resources in the agency's current
operations, as one expects they will, then the FDA will need, at that time,
to lobby Congress for permission to revise its operations.
The agency has more freedom in running its capacity building pro-
grams. Therefore, an enterprise risk management assessment, analysis, and
evaluation can be used to reorganize international programs in the next 3
to 5 years.
Enterprise-wide Risk Management
Multinational food and medical product companies have been using
enterprise risk management for some time (see Box 6-1). Even the most
profitable business cannot afford to monitor every transaction on its supply
chain with the same diligence. Instead, multinational companies develop a
hierarchy of risk and devote resources to the highest risks in the hierarchy.
These companies may have a broader data set to inform their estimates
than the FDA would have. Nevertheless, the FDA has to work with the
1 Enterprise risk management is a discipline by which an organization "assesses, controls,
exploits, finances, and monitors risks from all sources for the purpose of increasing the
organization's short- and long-term value to its stakeholders" (Casualty Actuarial Society-
Enterprise Risk Management Committee, 2003, p.8).
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E nterprise Risk Management
Risk is the potential any action or inaction has to result in an undesir-
able outcome. The concept of enterprise risk management comes from
the financial services industry, but has been adapted for use in a variety
of businesses, as well as in running governments and universities. The
Committee of Sponsoring Organizations of the Treadway Commission
defined enterprise risk management as "a process, effected by an entity's
board of directors, management and other personnel, applied in strategy
setting and across the enterprise, designed to identify potential events
that may affect the entity, and manage risk to be within its risk appetite,
to provide reasonable assurance regarding the achievement of entity
objectives" (COSO, 2004, p. 2).
The principles of enterprise risk management allow any type of
organization to assess areas where it has exposure to harm and evaluate
the extent of the danger. Assessing mitigation strategies is an important
part of enterprise risk management, as is financial and administrative
planning against the organization's risk profile. The advantage of an
enterprise-wide risk management assessment (as opposed to a func-
tional or discipline-based assessment) is that the organization's man-
agement gains a framework that presents the connected relationships
between decisions and then allows it to integrate their responses to
multiple threats (COSO, 2004). The use of enterprise risk management
can guide staffing and training decisions. Over time, the use of enterprise
risk management can help the organization transition from a culture of
responding to crises when they happen to predicting and preventing
them (Protiviti Inc., 2006).
data available. Over time the agency may develop data sharing relationships
with its counterpart agencies abroad. The FDA may also want to collabo-
rate to develop its own risk assessment tool.
A number of organizations have supported a risk-based approach to
food and medical product regulatory strategy. The Pew Health Group
encouraged using risk to guide inspections (Pew Health Group, 2011), as
have industry spokespeople (Vijay, 2011). The committee's recommenda-
tion is also consistent with the 2010 Institute of Medicine report Enhancing
Food Safety that argued for consistency in applying a risk-based food safety
system (IOM, 2010).
In understanding the committee's emphasis on enterprise risk manage-
ment it is important to consider that this is a way to manage the agency's
enterprise. That is to say, a way to manage everything the agency does.
Enterprise risk management is a strategic perspective to set priorities for the
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agency, not a tactical perspective applied to any subfunction of the enter-
prise, such as food safety or medical device safety. Many of the systematic
steps in risk management at the enterprise level and at the subordinate
levels can be described in similar terms. At the level of the organization's
leadership, concerns over specific product lines or countries need to be
reconciled with the entire risk and opportunity profile the FDA needs to
address. Food, drug, vaccine, and medical device safety must be reconciled
with each other and with other FDA responsibilities. Enterprise risk man-
agement can reconcile an array of risks at the agency level. The goal is for
the FDA to optimally balance its limited resources with the full array of
risks the agency needs to control.
This committee recommends an enterprise-wide risk assessment be used
to inform the FDA's capacity building projects and all its routine work. An
enterprise-wide assessment will help the FDA allocate its staffing, trainings,
and operations to the highest risk, highest priority activities, not just the
inspections. The FDA has, for some time, been working to base inspections
on a risk assessment paradigm. In 2007 the FDA was already using a risk-
based process to rank foreign manufactures according to the urgency of the
need for inspection (GAO, 2007). In a speech to the Partnership for Safe
Medicines, the FDA commissioner explained that the agency has systemati-
cally ranked more than 1,000 active pharmaceutical ingredients according
to respective risk of economically motivated adulteration (Hamburg, 2010).
Clearly, the FDA has a strong foundation on which to build its enterprise
risk management system. Its use of risk to guide foreign inspections is
exemplary. The challenge to the agency now is to persuade others that it
can better protect consumers if it allocates more of its resources, not just
inspections, based on modern risk management.
The use of enterprise risk management will be especially valuable
to the FDA given the poor economy and fiscal austerity. The agency has
been underfunded for years. The fiscal year 2010 budget was relatively
generous to the FDA. This, combined with modest increases in fiscal years
2008 and 2009, brought the agency's budget back to 1994 levels (see
Figure 6-1) (McCain, 2011). At the same time, the agency's responsibilities
have increased dramatically. The increasing number of foreign food facility
inspections demanded by the Food Safety Modernization Act (about 19,200
by 2016) cannot be reasonably managed by an agency that, according to
a 2007 GAO report, operates on about one-seventh of its required budget
(GAO, 2007; McCain, 2011). The committee believes that enterprise risk
management will help the FDA triage its funding, which, especially during
the 2012 election cycle, will likely be "hijacked and delayed by political
maneuvering" (Semeniuk, 2011).
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Full-time equivalents
1994 1996 1998 2000 2002 2004 2006 2008 2010
Fiscal Year
Full-time equivalents supported by congressional appropriations, from fiscal year 1994
to fiscal year 2010.
SOURCE: McCain, 2011.
Implementing Enterprise Risk Management at the FDA
The committee recognizes that implementing an enterprise-wide risk
management program is challenging for any large organization. Fortu-
nately, the International Organization of Standardization and other enter-
prise risk management experts publish guidance on implementing enterprise
risk management strategies (COSO, 2004; ISO, 2009; Protiviti Inc., 2006).
These sources all emphasize that the risk management framework is
different for every organization. The committee agrees; this report does not
dictate what the FDA's strategy will be. Such a level of prescription would
be inappropriate and impossible: it would require analysis of the agency's
internal data and consideration of internal contextual factors of which
expert committees have no knowledge. Instead of dictating the agency's
plan, the committee recommends that the FDA undertake an enterprise-
wide risk assessment in keeping with its objectives and the Department of
Health and Human Services' (HHS') goals as explained in its Global Health
Strategy (HHS, 2011). The Global Health Strategy provides a framework
in which to evaluate all of the FDA's activities and consider their risks. The
department's goals are protecting the health of Americans through global
health action; advancing American interests in diplomacy, development,
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and security through global health action; and leading in science, policy,
and programs that advance global health (HHS, 2011). The FDA's enter-
prise risk assessment will need to consider these goals and identify where
the biggest risks are in relation to meeting them.
The FDA's risk management framework will define the processes, staff-
ing, timelines, and budgeting needed to manage its risks. First, the FDA
will undertake a thorough risk assessment. This will include identifying
the risks it faces and evaluating its response options. In this phase the FDA
will need to define how risks will be measured and when, and also how it
will determine the level of the risks identified (ISO, 2009). Input from all
stakeholders will be important to this process, especially as the FDA tries to
determine if there are likely combinations of risk (ISO, 2009). The frame-
work will mandate the schedule on which the FDA revisits its priorities to
keep pace with changing risks.
The next step will be a risk analysis that accounts for the sources and
causes of risk as well as their consequences and likelihood of reoccurring.
The risk analysis step may include analyzing internal data and running
simulations of different crises. The last step is risk evaluation, which ana-
lyzes the identified risks against pre-determined criteria to guide decisions.
In risk evaluation, the FDA will consider the costs, effort, and benefits of
all actions. A well-executed risk evaluation will provide the FDA's leaders
with the information they need to develop their capacity building priorities.
Implementation in the Short-Term Should Focus on FDA Activities
Outside the United States
There are many restrictions on the FDA's authority to allocate its
resources domestically. Therefore, especially in the next 3 to 5 years, the
committee sees promise in using enterprise-wide risk management to orga-
nize the FDA's foreign operations.
Enterprise risk management depends on ongoing assessment of current
and potential future risks. The FDA can use its data and, when confidential-
ity agreements allow, reliable data from its counterpart agencies abroad to
inform its understanding of product risks. These risks are always changing;
the product lines and suppliers considered highest risk a decade ago are dif-
ferent from those that are highest risk today. The FDA is best positioned to
know which countries are increasing their exports to the United States. It
should better define which countries are increasing their high-risk exports
or which product lines are increasing in risk. Once it has identified these
trends, it can allocate its resources accordingly. The FDA should also target
its capacity building efforts to the countries and regions that export the
highest risk products. The committee recommends that the FDA focus its
resources on high-risk suppliers abroad for the next 3 to 5 years.
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Enterprise risk management assessments should inform the FDA's deci-
sions on where to put its overseas staff, which overseas offices to scale up,
and the best use of its overseas staff's time. The FDA should devote the
most energy to training people in countries that are exporting high-risk
products. For example, holding workshops on food safety for regulators
in the Middle East and North Africa, as the FDA did in 2010, does not
appear to be a decision grounded in risk management (FDA, 2011a). Arab
countries export little food to the United States or anywhere else; they
are net food importers (World Bank, 2009). The implementation of a risk
management system to all FDA work might better empower the staff of
the Office of Technical Cooperation and Capacity Building to choose more
useful topics and audiences for capacity building programs.
Implementation in the Longer-Term Should Be FDA Activities in
Both Domestic and International Markets
The results of these assessments should also inform the FDA's inspec-
tions in the United States. There are some firms in the United States that
have never failed inspection, yet Congress demands that the FDA revisit the
sites every 2 years. The FDA is surely better aware than anyone that this
is not an efficient use of its inspectors' time, yet it is bound by dated laws.
An enterprise risk management system would allow the FDA to reallocate
its resources to give more attention to inspections abroad.
The committee recognizes that the FDA will need to work with Con-
gress to change the laws governing it if it is to fully revise its domestic
work based on risk. It is important to remember that the existing laws were
designed for a time when most foods and medical products were produced
domestically. Nowadays, much of the food and pharmaceutical supply
comes from abroad. This shift demands a complementary shift in the al-
location of fixed resources to ensure product safety.
The Food Safety Modernization Act requires the FDA to inspect at
least 600 foreign facilities in 2011 and double those inspections every year
until 2016.2 The FDA will struggle to meet these requirements, especially
if Congress does not increase its funding (Stewart and Gostin, 2011). If
the agency were able to reallocate its domestic staffing, then it could give
more attention to needs overseas. This does not mean that the FDA should
neglect inspection and product safety responsibilities in the United States.
The Salmonella-tainted egg crisis of 2010 and persistent quality control
problems at Johnson & Johnson are a reminder that American companies
can also prove to be high risk (Kavilanz, 2010; Silverman, 2011; Un oeuf
is enough, 2010).
2 21 USC 350(j)(a)(2)(D).
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The committee's recommendation of a modern systemic risk manage-
ment system depends on upgrades to the FDA's information technology
system. A series of recent Government Accountability Office (GAO) re-
ports have highlighted inaccuracies in the FDA's foreign supplier database
and problems with its data management system (GAO, 2008, 2010a, b,
2011). The FDA science review committee recommended in 2007 that the
agency "enhance the program to monitor performance metrics and put
the appropriate [information technology] infrastructure in place to track
the evolution of those metrics" (FDA, 2007, p. 42). The committee sees
efficient use of modern information technology as indispensible to a risk-
based regulatory system. The proper use of such a system could improve
cooperation and communication among regulatory agencies. Information
technology holds great promise to enhance surveillance. The results drawn
from reliable data management systems will give the public and legislators
a better understanding of product safety threats.
Recommendation 6-2: FDA should develop an information and infor-
matics strategy that will allow it to do risk-based analysis, monitor
performance metrics, and move toward paperless systems. In the next
3 to 5 years, the FDA should propose, in all its international harmoni-
zation activities, a standardized vocabulary, a minimum data set to be
collected, and the frequency of data collection.
This recommendation can be measured when the FDA releases a stan-
dardized vocabulary for data collection, a codebook of the minimum data
required from all points on the supply chain, and a timetable explaining
how often these data should be collected.
As with the implementation of enterprise risk management, there are
aspects of this recommendation that will take a decade to execute. A full
overhaul of the FDA informatics and information strategy will take at
least 10 years. However, in the next 3 to 5 years, the FDA can work out
a standardized vocabulary and data collection protocols to propose for
international use.
Information and Informatics Strategies
For the purposes of this report, information strategies are ways to
ensure that all data about food and medical products are accurately col-
lected, well annotated, recorded in permanent electronic media, and securely
shared with authorized personnel for better information management. The
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committee uses the term informatics strategies to describe how the data
are cleaned of errors, transformed to proper formats, analyzed, and shared
promptly with regulatory agents for better decision making.
Modern information management uses networked computing infra-
structure across national borders. Information management lays the foun-
dation for computer-assisted automated information extraction. Without
such data, risk modeling would be impossible. The strategy outlined in
this report also emphasizes the need to share information across inter-
national borders. The committee feels that the FDA should promote the
development of secure and open protocols for electronic data capture,
computerized data management, electronic data sharing, and decentral-
ized data exchange. It is suitable that the FDA provide leadership in this
international endeavor.
A good architecture for storing, collecting, and exchanging information
is key to reliable, modern food and medical product regulation, although
the importance of such a system, especially in developing countries, is not
always obvious. A regulatory agency has to access data and information
about drug registration, facility inspections, and surveillance from dispa-
rate data sources and in varying formats on an ongoing basis. In develop-
ing countries much of these data is still stored as paper documents. This
severely decreases the productivity of the already thinly staffed regulatory
agencies. A functional informatics system thus has the ability to enhance the
productivity of regulatory agencies in developing countries. Well-defined
data architectures and topologies can allow the multiple agencies regulat-
ing food and medical products to coordinate their work and reduce redun-
dancy. In addition to sharing across different agencies within a country,
common data architectures and good systems for information sharing can
also facilitate better international harmonization. For example, the use of a
reliable information system can allow the FDA to share inspection reports
with its counterpart agencies in developing countries and vice versa.
Collecting data in common formats can also lay the groundwork for
developing tools that will make regulatory agencies more productive.
Pharmacovigilance and postmarket surveillance are two areas that could
greatly improve with informatics tools that allow for simpler data collection
and analysis. The path to having modern informatics tools in developing
country regulatory agencies depends on the FDA leading in defining com-
mon standards, which will enable data collection, sharing, and (at some
time in the more distant future) advanced decision support. The committee
believes that moderate investments in informatics and information technol-
ogy will yield significant long-term benefits in the quality of food and drug
OCR for page 193
Used with the permission of Dwayne Powell and Creators Syndicate. All rights reserved.
Challenges in Implementation
The committee recognizes that implementing an information and in-
formatics strategy will be difficult, especially in developing countries. First
of all, the data sharing that it recommends requires collecting information
from many sources at different agencies. For example, border rejection
data, public safety breakout events, regulated product safety recall records,
assessment reports of export and import companies, and product ingredi-
ent tracking information all need to be collected and linked. There is also
room for misunderstanding when many people are responsible for data
collection. Field staff may have different interpretations of questions that
can lead to inconsistencies in the data. Attempts to work with the European
Union (EU) border rejection data, described in Appendix G, made it clear
that worker inconsistency is a threat to data quality. Additionally, all large
data analysis projects must deal with missing data and attempt to control
for human error as much as possible.
International survey and data collection experts in academia have ex-
pertise in standardizing data collection across many different languages.
Standardizing questions and response categories are challenging, but not
impossible, especially for people who have worked on similar problems
before. Programmers can easily adapt decision-making algorithms to tablet
OCR for page 193
computers and mobile phones, tools that would be accessible to field staff.
Using such an algorithm, even minimally educated staff could be trained to
collect and transmit standard data.
The FDA's informatics strategy should aim to produce reports that will
be compatible with reports produced by its counterpart agencies abroad.
As Chapter 2 explains, the committee sees collaboration with the FDA's
counterpart agencies abroad as fundamental to ensuring product safety. In
a report on drug safety the GAO also encouraged such collaborations. The
FDA should ensure that its information strategy uses the same measurement
conventions or has an accurate way to adjust for different conventions.
Most of all, the FDA's information and informatics strategy will need to
protect confidential information. The committee understands that willing-
ness to share data may be minimal at first, especially in developing countries
with a history of deficits in this area. De-identified or aggregated data can
still be useful, however.
Models for Implementation
The biomedical research and financial services industries use modern
information sharing, and the FDA might do well to study lessons learned
from these sectors. All of them define a minimal set of XML-based files for
information sharing. The data elements, semantics, and structure of such
data sharing reports can be jointly determined in international standard
setting committees. These committees would do well to draw on expertise
at the World Wide Web Consortium and the Institute of Electrical and Elec-
tronics Engineers. Participating countries should agree to minimal data re-
porting elements. Experts need to identify the key minimal data set that will
allow for the best communication among regulators and the best product
safety assurances. Information management tools such as Protégé are based
on ontologies, explicit definitions categories, and sub-categories of informa-
tion and the relationships between them (Noy and Mcguinness, 2000). The
use of Protégé and systems like it promotes a common understanding of
the concepts and data being captured among different organizations. Over
time, a shared ontology can facilitate adherence to basic standards and
improve standards (Pisanelli et al., 1999).
The committee proposes that the FDA encourage its counterparts in
developed countries to develop similar information sharing and informatics
strategies. Ideally, all agencies can agree on standardized data collection and
information sharing practices from the start. Eventually, developed coun-
try regulatory authorities can expand the system to include developing
country regulatory authorities (GAO, 2011). The FDA should demonstrate
how information and informatics strategies can improve its logistics and
risk management in both domestic and export markets.
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This evaluation should be focused on scaling-up to include food producers
and more drug firms.
End-to-end supply chain visibility for food and medical products is the
best insurance against safety lapses. The committee recommends that FDA
evaluate the results from the Secure Supply Chain pilot for the technical and
operational feasibility of scaling. A full-scale program should then be insti-
tuted in which all interested manufacturers are enthusiastically encouraged
to participate. In order to reduce the risk of non-compliance of these incen-
tives programs with WTO law, FDA should develop these food and drug
importer incentive programs in close consultation with U.S. trade officials
and ensure participation is voluntary and pursuant to objective criteria that
do not favor applicants of any one country over those of another.
Promising Initiatives
Globalization has dramatically altered where food and medical prod-
ucts come from. The FDA cannot inspect all of the import lines to the
United States or all foreign manufacturers exporting to the United States
(GAO, 2008). Even if it could, the GAO pointed out that, "relying solely
on inspections is insufficient to secure the drug supply chain" (GAO, 2010a,
p. 29). The same is true of relying exclusively on end product testing and
food safety inspections to ensure food safety (Young, 2011). There need to
be other ways to ensure the safety of import lines.
Market incentives drive food safety in the United States (Thomsen
and McKenzie, 2001). The Food Safety Modernization Act requires the
traceability of the food supply chain and holds suppliers accountable for
ensuring HACCP compliance. The ability to assess the safety of ingredients
produced overseas, in places where the FDA has no authority, is a challenge
(FDA, 2009a). By expanding incentives programs, the FDA could help en-
courage foreign producers to adhere to international standards and work
to produce higher-quality products. The Food Safety Inspection Service has
a program in place to ensure the quality of imported meat. This is not an
incentives program, but it is a good example of bilateral coordination to
facilitate trade (Box 6-3).
The Secure Supply Chain program promotes drug safety. In this pro-
gram, foreign firms voluntarily provide the same information FDA requires
of American firms (FDA, 2009b). The pilot program includes 100 firms;
each firm can include up to five drugs. To be eligible firms must be able to
trace their products from manufacture through entry to the United States.
They also need a plan for recalling the drug or active ingredient. Qualify-
ing firms receive expedited entry of select products through customs (FDA,
2009b). The FDA and U.S. Customs and Border Protection agency are
currently defining how to expedite entry. The solution will make use of the
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The Food Safety Inspection Service
The Food Safety and Inspection Service (FSIS) is the office within
the USDA "responsible for ensuring that domestic and imported meat,
poultry, and egg products are safe, wholesome, and accurately labeled"
(FSIS, 2009). Meat imported into the United States must meet the same
safety, quality, and labeling standards required of domestically produced
meat. In order to assure this, the FSIS only allows importation of meat
that has gone through its rigorous approval protocol that covers the
entire import process (FSIS, 2009).
Any country that wants to export meat to the United States must
undergo an FSIS inspection and certification process called an equiva-
lence determination process. This certification evaluates the meat inspec-
tion processes of the exporting country. If the export inspection protocol
in place is deemed equivalent to U.S. domestic inspection protocol, the
country may be granted eligibility. By setting the standard at equiva-
lence, the FSIS ensures products of equal quality without requiring that
exporting countries conform to exact U.S. inspection procedures. Within
a country, each producer wishing to export meat to the United States
must undergo a similar certification. The evaluation process includes
both offsite assessment of written protocols and procedures and an
onsite inspection by an FSIS team. Both elements stress five primary
categories of risk assessment as established by the FSIS: animal disease
controls, sanitation controls, residue controls, slaughter and processing
controls, and controls for enforcement. Countries and sites are periodi-
cally reevaluated to ensure ongoing safety and equivalence. Countries
and specific producers may lose eligibility, often temporarily, because
of an outbreak of a disease affecting livestock or other adverse health
conditions (FSIS, 2009, 2011).
After the appropriate export country inspection paperwork has been
filed, meat is re-inspected by an FSIS inspector before it is allowed past
the port of entry. Products that are approved during this second inspec-
tion are allowed into the United States for sale and are treated no dif-
ferently than domestically produced products from that point forward
Equivalent inspection practices, rather than identical ones, must
be accepted by importing countries under the guidelines set forth by
the WTO, specifically the Sanitary and Phytosanitary Measures (SPS)
agreement. The SPS agreement concerns the international trade in food,
animal, and plant products. As with all WTO agreements, the SPS agree-
ment seeks to limit barriers to international trade, in part by ensuring that
developing countries, often using less technologically advanced equip-
ment, are not unfairly discriminated against. Regardless of the exact
measures in place, if exports are of a suitable standard, then they must
be treated as such (WTO, 2012).
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Customs-Trade Partnership Against Terrorism program, which offers prior-
ity processing for products from companies with secure supply chains. The
Secure Supply Chain pilot aims to enable FDA to determine the practicality
of using a secure supply chain program to prevent importing sub-standard
drugs (FDA, 2009b). The committee suggests that this program be evalu-
ated immediately after its pilot phase and implemented and expanded, if
successful, to include a greater number of importers and to food.
Appendix B describes how the civil liability system, so essential to
product safety in the United States, is flawed in low- and middle income
countries, and so does not deter faulty manufacturing.
Recommendation 6-8: Over the next 10 years, U.S. government agen-
cies should work to strengthen the ability of those harmed by unsafe
food and medical products to hold foreign producers and importers
liable in civil lawsuits.
The establishment of mechanisms that increase liability will measure
this recommendation. This process will be slow, and it will require major
revisions to the status quo that involves multiple government agencies. It is
unlikely these changes could be made in less than 10 years.
Product Liability in Developed Countries
The U.S. legal system has two ways to ensure food and medical product
safety. The first way is the regulatory framework built around the Federal
Food, Drug, and Cosmetic Act; regulatory framework is the primary focus
of the current report. Recent legislation has provided the FDA with a vari-
ety of new tools with which to enforce this regulatory framework for both
foods and medical products. If there is a sufficient likelihood that food is
adulterated or misbranded, the FDA may administratively detain products
or mandate a recall if there is reasonable probability that food will cause
"serious adverse health consequences or death to humans or animals."13
Food production facilities must register with the FDA in order to intro-
duce their products into U.S. interstate commerce; the FDA can suspend
that registration if there is reasonable probability that the food from that
facility will harm humans or animals.14 The Food and Drug Administra-
tion Amendments Act of 2007 also expanded the legal tools FDA uses to
13 21 USC 350(l).
14 21 U.S.C. 350(d)(a).
OCR for page 193
ensure drug and vaccine safety. The FDA may withdraw approval from
a marketed drug or biologic,15 order labeling changes or the inclusion of
package inserts about new safety information and recommendations,16
mandate postmarket observational studies or clinical trials to assess risks,17
and require sponsors to have strategies to ensure that the benefits of a drug
will outweigh its risks.18 In general, most violations of the Federal Food,
Drug, and Cosmetic Act are also subject to criminal enforcement, but few
are subject to civil enforcement (Hutt et al., 2007).
The second way that the U.S. legal system ensures food and medical
product safety in the United States is product liability. Entities involved in
the manufacture, distribution, and marketing of a food or drug product to
the public are obligated under U.S. common law and, in some cases, U.S.
federal and state statutes to ensure the safety of that product. Individuals
that suffer harm from that food or drug product in the United States may
bring a civil lawsuit against the manufacturers, importers, distributors, and
marketers of that product. Any entity with significant contacts with the
United States is potentially subject to the jurisdiction of U.S. courts. Redress
is typically monetary compensation to cover the damages incurred by the
injured party, but it may also involve punitive damages.
Product liability plays an essential role in ensuring food and drug safety
in the United States. The volume of commerce in FDA-regulated food and
medical products far exceeds the resources and legal authority that FDA
has to monitor and enforce the safety of those products. The threat of
product liability suits, high litigation costs, and reputational damage help
fill the gap by providing a significant economic incentive to companies to
maintain and improve the safety of their products. Ultimately, it is retailers
and manufacturers that are best able to ensure the safety of their products.
There are limits to the role of product liability in imports. First of all,
the FDA does not have jurisdiction in foreign markets, and even when its
staff is permitted to inspect foreign establishments there are practical chal-
lenges to working in a new country and in a different language. Further-
more, U.S. plaintiffs have limited ability to litigate and enforce judgments
against foreign firms with few U.S. contacts or assets. It is difficult for
Americans to bring lawsuits against foreign firms in foreign country courts
for injuries that occurred in the United States (Appendix B). U.S.-based
importers and distributors may be able to avoid product liability when
there is doubt that they knew or should have known about their suppliers'
actions (Bamberger and Guzman, 2008). It may be difficult for consumers
15 21 USC 355(e).
16 21 USC 355 (o) and 21 USC 355(r).
17 21 USC 355 (k)(3).
OCR for page 193
to establish accountability for unsafe products when the supply chain is so
complicated (Bamberger and Guzman, 2008). With the possibility of more
limited liability, manufacturers and distributors of imported products may
not have the same market incentives as their U.S. counterparts for continual
improvement in consumer safety.
Congress and U.S. government agencies (including, but not limited to,
the Department of Justice, the Department of the Treasury, and the U.S.
Trade Representative) should consider measures to strengthen the ability
of those harmed by unsafe food and medical products to hold foreign pro-
ducers, exporters to the United States, and U.S. importers of foreign prod-
ucts liable. Congress could increase appropriations for criminal enforcement
of the Federal Food, Drug, and Cosmetic Act or amend it to make violations
subject to civil penalties. The FDA could issue more stringent guidance for
high-risk drugs and foods, such as requiring importers to maintain a staff
person at each foreign production facility for high-risk products (Bollyky,
2009). Scholars have made other thoughtful proposals to increase liability.
The issuing of bonded warranties would oblige sellers to pay statutory dam-
ages to people injured by unsafe products (Baker and Moss, 2009). Another
option would be using discriminatory strict liability with damages based on
the risk posed by the product and by the importer's history (Bamberger and
Guzman, 2008). Finally, developing country governments seeking to im-
prove the safety of their food and drug production should consider measures
to facilitate the ability of domestic consumers to hold firms accountable in
civil suits for the harms caused by unsafe products (Appendix B).
During its meetings, the committee heard from FDA staff about the
agency's current work in capacity building and the challenges it faces in
protecting the U.S. food and medical products supply. The committee com-
mends FDA on its work, but sees some areas where it might improve its
operations. First, it should use an enterprise risk management system to
identify its most important priorities. That is, it should use risk to inform
all its staffing and training decisions, not just its inspections. In the next 3
to 5 years, the FDA should use enterprise risk management to inform its
work abroad, but eventually the committee recommends that it use this tool
to plan its domestic work as well. The committee recognizes that Congress
might need to revise the laws governing FDA for this to happen.
The agency's use of risk will depend on reliable data collection. A
modern information and informatics strategy will allow the agency to col-
lect and analyze data promptly. The FDA's PREDICT system is a step in
the right direction. The committee believes that in the next 10 years the
agency should work toward a paperless system in its own operations and
OCR for page 193
in its dealings with its counterpart agencies abroad. The first step toward
this system would be the development of a standard data format and vo-
cabulary, which could be developed in 3 to 5 years.
Regulators around the world need training on how to respond to the
challenges of globalization. FDA has the technical depth and international
presence to contribute to an ongoing, standing regulatory science and policy
college, but developing this college will take a decade. In the meantime, the
agency can work with universities and through existing training networks
to make better training opportunities available. The FDA's staff college is
an exemplary training center that should be a model for an international
regulatory science and policy college. In the next 3 to 5 years, FDA could
require their staff to take courses on the international implementation of
and compliance with American regulations. In the longer term, that is, in
the next decade, FDA could work to develop a training program like the
CDC's Field Epidemiology Training Program. Involving industry and aca-
demia in these efforts will also set a valuable example.
The United States could also lead by example in its consistent use of
international product standards. Harmonized standards make the market
more predictable for foreign investors and exporters. USAID and other
agencies can demonstrate U.S. commitment to harmonized standards by
empowering scientists in low- and middle-income countries to participate
actively in standard setting meetings. Over the next decade, product safety
objectives should be fully integrated into U.S. foreign policy.
The United States could also set a powerful example for industry and
government around the world by expanding the one-up, one-back, track
and trace requirements for food and medical products. The committee real -
izes that this would be complicated, but believes that the FDA could make
progress by holding a public workshop on expanding one-up, one-back
in the next year. This workshop should include international stakeholders
from government, industry, and academia.
There is great potential for innovation in American universities. The
government should, starting in the next 2 years, encourage research into
simple and elegant technology that will help small-scale producers prevent
fraud and control their supply chains. Similarly, the government can im-
prove supply chain management by giving market incentives that reward
supply chain management. The committee is especially impressed by the
FDA's Secure Supply Chain pilot program. The 2014 evaluation for this
pilot should consider how to best expand this program to include a greater
number of producers.
Market incentives can do much to improve the safety of the food and
medical products used around the world. The committee also sees value in
increasing civil liabilities on foreign importers over the next 10 years.
OCR for page 193
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Agent: Proctor will play somewhere next season
PALM CITY — Scott Proctor should have no problem finding work for next season.
The only question is, where he will play.
Proctor currently is finishing up a one-year contract with the Doosan Bears of the Korea Baseball Organization. He's posted 32 saves in 51 appearances and his ERA has hovered around 2.00 all season.
"Scott has pitched very well over there," said Mark Rodgers, Proctor's Palm City-based agent. "I know this — he'll have a job. It's been exciting to some extent to see how he has reestablished his ability to get guys out in late innings. We always knew he had it, but he struggled there for a bit.
"He's going to be employed, the only question is where. I'd like him to get a multi-year contract. He's a free agent. He won't have a contract, but the team in Korea has his rights over there. But that doesn't mean we can't take him to Japan."
Rodgers said he has received interest from multiple teams in Japan and believes Doosan would like to bring Proctor back.
Major league teams also could be interested.
"We've had enough clubs approach us about Scott that he's going to pitch somewhere," Rodgers said. "It's not like we're approaching them asking if they're interested. They're coming to us."
Rodgers cautioned that teams in Japan will not be in a hurry to get something done. The franchises are very deliberate and, with a limited number of spots open to foreign players, cannot afford to make a mistake.
If Proctor decided to return to Korea, Doosan retains his rights.
"I think we'll have something done before Christmas," Rodgers said. "That's the beginning of the major league free agent period and we'll see who's re-signing where."
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