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Mystical Brain reveals the exploratory work of a team from the University of Montreal who seek to understand the states of grace experienced by mystics and those who meditate. Filmmaker Isabelle Raynauld offers up scientific research, which proposes that mystical ecstasy is a transformative experience and could to contribute to people’s psychic and physical health, treat depression and speed up the healing process when combined with conventional medicine. In French with English subtitles.
practicality stfu!
Technology anthropologist Stefana Broadbent analyzes how we text, IM and talk. Today, she says these new methods of communication are helping us break out of old institutions and bringing us closer together than ever before. She’s speaking with a backdrop of constantly refreshing, beautiful black and white portraits, always of two people seated together. She explains that in each picture is someone she interviewed and the person the communicate with most in the world, whether it be their significant other, parent, grandparent or sibling, along with the communication tools they use — by and large, these are cell phones.
She says that although we may have many people on our Facebook friend lists (120 on average) and in our cell phone directories, we typically use these technologies to interact with a small core group of people. The typical cell phone user makes 80 percent of their calls to just four people, and the average Facebook user exchanges most of their messages with only five or six friends. So these technologies are not networking us with more people, but reinforcing our communication with our inner circle.
Even more interesting, she says that we are now seeing the democratization of intimacy. As more communication technologies are written, and can therefore fly under the radar more easily in a workplace, the boss is not the only one that can keep in touch with their family and friends during working hours. She finds companies’ restrictions on Facebook and schools’ restrictions on texting appalling. We always lived with work and family together, she explains, this compartmentalization of our lives only began 150 or so years ago with the Industrial Revolution. Broadbent is glad to see that cleavage ending.
can’t gt the vid to embed
check the link
http://staging.democracynow.org/2009/10/22/cia_invests_in_software_firm_monitoring
LISTEN
WATCH
JUAN GONZALEZ: “America’s spy agencies want to read your blog posts, keep track of your Twitter updates—even check out your book reviews on Amazon.” That’s the lead sentence to a new article on the website of Wired magazine titled “US Spies Buy Stake in Firm that Monitors Blogs, Tweets.”
The article reveals how the investment arm of the Central Intelligence Agency has invested in a software firm called Visible Technologies that specializes in monitoring social media sites, including blogs, Flickr, YouTube, Twitter and Amazon.
AMY GOODMAN: Noah Shachtman joins us here in our firehouse studio. He broke the story. He’s a contributing editor at Wired and editor of “Danger Room,” the magazine’s national security blog.
OK, lay it out for us, Noah. What did you find?
NOAH SHACHTMAN: So, the CIA, in 1999, set up an investment arm called In-Q-Tel that sort of makes investments in technologies that the spy agencies would like to see grow. And their latest investment is in this company called Visible, which basically takes blog posts and takes Twitter updates and takes comments on YouTube videos and sort of sorts them out and decides which people have the most weight in the blogosphere, which people are the most influential, and also filters out, you know, certain key words, decides whether certain posts are hostile or positive. And it’s basically a way for them to sort of keep track on what’s going on in Twitter, on the blogs, etc., etc.
JUAN GONZALEZ: And who does this firm normally supply this information to?
NOAH SHACHTMAN: Usually to companies like Microsoft. Right now they’re tracking the buzz on their Windows 7 release. They also do the work for Hormel, the processed meat company. When PETA was going after Hormel for some of their business practices, they kept track on the sort of anti-processed food activists. So it’s usually corporate clients, although there’s sort of a political spin to some of the work they do, as well.
JUAN GONZALEZ: So, in essence, they’re sort of like an intelligence operation for the corporate world on a normal—
NOAH SHACHTMAN: Yeah. They would say they try to spot trends and keep tabs on things, yeah.
AMY GOODMAN: But In-Q-Tel, you say, is the investment arm of the CIA. I think a lot of people would just be surprised by the CIA having an investment arm.
NOAH SHACHTMAN: Yeah, that’s right. In 1999, the CIA set up this sort of separate agency that would make investments on behalf of the intelligence agencies. It was a way to sort of develop certain technologies without going through the formal contracting process. Remember, back in 1999, that was like sort of the height of the dotcom boom. And there were a lot of these business incubators that were growing small businesses into something bigger. And In-Q-Tel was the CIA’s attempt to do the same thing.
JUAN GONZALEZ: Is it reporting it’s making money for the government?
NOAH SHACHTMAN: I don’t—it’s a not-for-profit—
JUAN GONZALEZ: Oh, not-for-profit, I see.
NOAH SHACHTMAN: —company, but I do believe that it has—many of its investments have panned out.
AMY GOODMAN: So, explain how Visible works. You talk about how it crawls over half a million web 2.0 sites a day.
NOAH SHACHTMAN: Mm-hmm.
AMY GOODMAN: Explain exactly. And then, how do people protect their privacy?
NOAH SHACHTMAN: Well, first they protect their privacy by not tweeting or not blogging. I mean, that’s the way they would have to protect their privacy, or to do it within a closed password-protected system. If you leave it out there, not only is the government going to read it, but Microsoft and Google just signed deals with Twitter and Facebook yesterday, where all the—all your tweets and all your blog updates will be very easily searchable by either Microsoft’s Bing search engine or by Google.
AMY GOODMAN: What’s the deal?
NOAH SHACHTMAN: The deal is basically that all your Facebook updates will be sort of fed into Microsoft’s new search engine, and people will be able to see what you post on Facebook or Twitter, or what have you.
JUAN GONZALEZ: And, of course, for the CIA, given the fact—the recent reports of how tweets and other social networking are used around the world sometimes to give advance notice on popular insurrections or—
NOAH SHACHTMAN: Mm-hmm.
JUAN GONZALEZ: For the CIA, this would be a sort of a normal direction for them to take, if they want to collect more intelligence.
NOAH SHACHTMAN: It would be. They’re probably already doing so, but just in a less elegant way. So this is probably—for them, they view it as a smarter way to get information they’re already interested in. The question is whether it’s aimed out at international audiences or whether it’s aimed in at domestic ones.
AMY GOODMAN: Noah Shachtman, you’ve also written about the US military using a fleet of unmanned spy blimps to keep tabs on would-be enemies in Afghanistan and Iraq.
NOAH SHACHTMAN: Mm-hmm.
AMY GOODMAN: Explain.
NOAH SHACHTMAN: Well, you know, the US military in Afghanistan—I just got back from there in September—is very interested in what’s called ISR—Intelligence, Surveillance and Reconnaissance. The idea is to see as much of what’s going on in Afghanistan as possible and to hear as much of what’s going on in cell phone conversations, or what have you. And so, these blimps are another tool to do it. There’d be cameras and listening equipment installed in these blimps in Afghanistan. It’s another way to kind of keep tabs on what’s going on.
AMY GOODMAN: And tell us what’s going on in New Jersey. In New Jersey, you have written about the Naval Air Warfare Center Aircraft Division in Lakehurst.
NOAH SHACHTMAN: Oh, oh, yeah, right, right, right. So, in New Jersey, there is a—the Navy’s got a sort of R&D arm, and they’re looking to upgrade what’s in those spy blimps and really kind of update the surveillance equipment, make it much more powerful.
JUAN GONZALEZ: I’d like to get back for a second to this—you just happened to mention that remark that depending on whether this is being done, the social networking intelligence is being mined, internationally or domestically. Can the CIA conduct surveillance of Americans at home here, in terms of their communications?
NOAH SHACHTMAN: Well, they’re not supposed to. But, I mean, given the recent history of the US intelligence agencies looking inward as well as outward, it’s tough to imagine they wouldn’t. Also, remember, on the internet, it’s very tough to discern whether it’s a purely international conversation or whether a purely domestic conversation.
AMY GOODMAN: I mean, you say, “In-Q-Tel says it wants Visible to keep track of foreign social media, and give spooks ‘early-warning detection on how issues are playing internationally,’” but that tool can just be used inward?
NOAH SHACHTMAN: I mean, obviously, right? It’s the internet. There’s no—there’s no hard national borders, and all this stuff is already out in the public. So it’s a little hard to fathom that there wouldn’t at least be the temptation to use it domestically.
AMY GOODMAN: What’s the military’s policy on soldiers using Twitter?
NOAH SHACHTMAN: The policy right now is up for grabs, but there should be a declared policy in the next, I would say, two to three weeks. And surprisingly, the Pentagon looks to be having a fairly liberal policy when it comes to Twitter and Facebook and other social networks. There was a lot of confusion over the years about whether soldiers could use it or not. Some commands banned it, others allowed it to happen. But it looks like the Pentagon is actually going to come out with something that says, “Hey, look, use YouTube and use Twitter, but just do it smart.”
JUAN GONZALEZ: But that has, certainly during the Iraq war and the Afghanistan war now, opened up a whole new level of communication that didn’t exist before, of ordinary soldiers being able to get information out to their family or to people here in the United States that normally would not happened in previous wars.
NOAH SHACHTMAN: Yeah, that’s absolutely true. And in this period of confusion where it wasn’t clear what the regulations were, a lot of times insecure commanders would sort of slap down their soldiers if they printed something that maybe was a little bit subversive or, you know, didn’t quite hew to the party line. But hopefully these new regulations are going to sort that out, and you really should be able to have those soldiers take to YouTube, take to Twitter, you know, with a great deal of freedom.
AMY GOODMAN: Back to what you said at the beginning, saying the uses for Visible before, Visible tracking animal rights activists’ online campaigns against the company that was Hormel?
NOAH SHACHTMAN: Mm-hmm.
AMY GOODMAN: When it was working for Hormel. So, I see here you’ve got trillions of dollars being spent on the wars in Iraq and Afghanistan, actually trillions. And it seems like it’s very ripe and open money that can’t be tracked. It can also develop the spy technology under the guise of just war.
NOAH SHACHTMAN: That’s true, although the Pentagon also has plenty of money to—independent of the war costs, to develop spy technology. And the intelligence agencies, remember, their budgets are largely a black box. We don’t know how much they spend. And so, you know, there’s plenty of places where money for spy technology can be funded out of.
AMY GOODMAN: And this issue of how Hormel used Visible, now In-Q-Tel buying into it?
NOAH SHACHTMAN: Mm-hmm. Well, I mean, I don’t know too much more than the fact that they used it. I don’t have a lot of details. But, you know, the way Visible works is it kind of grabs all the blogs and all the tweets out there, then it sorts for certain key words, it sorts for a sentiment about whether things are positive or negative, and then it also sorts based on which bloggers and which tweeters are really important or not. And you can sort of see over time how a conversation develops. Technology then allows companies or the government to respond directly within a blog or within a Facebook page to those people. So, who knows? The commenter—the next commenter on your blog might be the CIA.
AMY GOODMAN: Well, we will leave it there. Noah Shachtman, I want to thank you for being with us. Noah Shachtman is a contributing editor at Wired magazine, and he’s editor of “Danger Room,” the magazine’s national security blog.
“We Are All Connected” was made from sampling The History Channel’s Universe series, Carl Sagan’s Cosmos, Richard Feynman’s 1983 interviews, Neil deGrasse Tyson’s cosmic sermon, and Bill Nye’s Eyes of Nye Series, plus added visuals from The Elegant Universe (NOVA), Stephen Hawking’s Universe, Cosmos and more.
[deGrasse Tyson]
We are all connected;
To each other, biologically
To the earth, chemically
To the rest of the universe atomically
[Feynman]
I think nature’s imagination
Is so much greater than man’s
She’s never going to let us relax
[Sagan]
We live in an in-between universe
Where things change all right
But according to patterns, rules,
Or as we call them, laws of nature
[Nye]
I’m this guy standing on a planet
Really I’m just a speck
Compared with a star, the planet is just another speck
To think about all of this
To think about the vast emptiness of space
There’s billions and billions of stars
Billions and billions of specks
[Sagan]
The beauty of a living thing is not the atoms that go into it
But the way those atoms are put together
The cosmos is also within us
We’re made of star stuff
We are a way for the cosmos to know itself
Across the sea of space
The stars are other suns
We have traveled this way before
And there is much to be learned
I find it elevating and exhilarating
To discover that we live in a universe
Which permits the evolution of molecular machines
As intricate and subtle as we
[deGrasse Tyson]
I know that the molecules in my body are traceable
To phenomena in the cosmos
That makes me want to grab people in the street
And say, have you heard this??
(Richard Feynman on hand drums and chanting)
[Feynman]
There’s this tremendous mess
Of waves all over in space
Which is the light bouncing around the room
And going from one thing to the other
And it’s all really there
But you gotta stop and think about it
About the complexity to really get the pleasure
And it’s all really there
The inconceivable nature of nature
-
and of course
another excuse to post this
“A Glorious Dawn” is crafted from sampling Carl Sagan’s 1980 PBS Documentary Cosmos and Stephen Hawking’s 1997 PBS cosmology documentary series Stephen Hawking’s Universe. Cosmos is available to watch for free on Hulu, and many parts of Stephen Hawking’s Universe can be found on Youtube and various other video sites online.
[Sagan]
If you wish to make an apple pie from scratch
You must first invent the universe
Space is filled with a network of wormholes
You might emerge somewhere else in space
Some when-else in time
The sky calls to us
If we do not destroy ourselves
We will one day venture to the stars
A still more glorious dawn awaits
Not a sunrise, but a galaxy rise
A morning filled with 400 billion suns
The rising of the milky way
The Cosmos is full beyond measure of elegant truths
Of exquisite interrelationships
Of the awesome machinery of nature
I believe our future depends powerfully
On how well we understand this cosmos
In which we float like a mote of dust
In the morning sky
But the brain does much more than just recollect
It inter-compares, it synthesizes, it analyzes
it generates abstractions
The simplest thought like the concept of the number one
Has an elaborate logical underpinning
The brain has it’s own language
For testing the structure and consistency of the world
[Hawking]
For thousands of years
People have wondered about the universe
Did it stretch out forever
Or was there a limit
From the big bang to black holes
From dark matter to a possible big crunch
Our image of the universe today
Is full of strange sounding ideas
[Sagan]
How lucky we are to live in this time
The first moment in human history
When we are in fact visiting other worlds
The surface of the earth is the shore of the cosmic ocean
Recently we’ve waded a little way out
And the water seems inviting
nice
i mean NICE doc on “this subject”
angles
ideas
perspectives
vid will mostlikely not play here
but will open to the tudou page proper
http://www.tudou.com/programs/view/W6Rjkr3Olvk
Interest in the Mayan Long Count Calendar and 2012 end-of-the-world prophecies is increasing rapidly with about four years left to the target date of December 21, 2012 (or thereabouts).
A significant number of new books, as well as reprints of older ones, on the topic of 2012 are being published, some becoming legitimate bestsellers, including: Apocalypse 2012: A Scientific Investigation into Civilization’s End by Lawrence E. Joseph; Maya Cosmogenesis 2012 by John Major Jenkins; and 2012: The Return of Quetzalcoatl by Daniel Pinchbeck.
On the fiction front, Whitley Strieber’s latest novel, 2012: The War for Souls, is slated to be a Michael Bay-produced (and possibly directed) film at Warner Bros. Pictures.
An increasing number of mainstream publications are writing about 2012. The New York Times Magazine ran a feature on the topic, focusing on John Major Jenkins, in its July 1, 2007 edition; USA Today published an article entitled “Does Maya calendar predict 2012 apocalypse?” on March 28, 2007; and Publishers Weekly ran a story about the large number of new books on the topic on March 26, 2007. A second PW story ran in the September 3, 2007 edition with a quote from a well-known editor saying that 2012 “has practically become its own category” of books; and proving that the trend is only strengthening, a year later the September 22, 2008 issue of PW in its cover story stated “publishers agree that New Age readers can’t get enough prophetic 2012 literature,” and “sales on this topic have been through the roof.”
Perhaps most significantly from a mainstream awareness perspective, Roland Emmerich (Independence Day, Day After Tomorrow, 10,000 BC) is directing a new tent-pole film for Sony Pictures entitled 2012. It is set for wide theatrical release in July, 2009.
The Disinformation Company specializes in publishing articles on topics surfacing in the culture on its popular website at www.disinfo.com and publishes books by authors writing in this and related fields. (For instance, Disinformation author Graham Hancock’s bestselling book Fingerprints of the Gods was one of the first to focus on the Mayan calendar and its end date in 2012, and will be one of the bases for the Roland Emmerich movie.) Of course, in addition to its publishing division, The Disinformation Company also produces and distributes documentary films.
Producer Gary Baddeley recognized that interest in 2012 was on a fast track into the zeitgeist in 2007 and initiated the process of planning and producing 2012: Science Or Superstition with director Nimrod Erez. The Disinformation team, including co-producer Ralph Bernardo, contacted and arranged interviews with multiple experts, often obtaining speedy access due to more than ten years of working with them or colleagues in their fields.
Interviews were conducted in New York, Los Angeles, San Diego, Palenque and also shot on location in Mexico and Egypt. Co-producer Bernardo worked with NASA to obtain illuminating footage of our solar system and galaxy and was able to locate leading astronomy professor Anthony Aveni, a cornerstone of the film’s balanced approach. Director Nimrod Erez worked closely with animators to illustrate the sometimes complicated concepts discussed in the film, allowing the viewer to see visually, the hard to grasp phenomenon of precession.
In accord with the Disinformation style of documentary filmmaking and publishing, the producers attempted to highlight multiple views of the subject matter and to interview experts who address the issues from varying and sometimes conflicting perspectives. The goal was to present the viewer with a balanced look at the 2012 phenomenon, allowing him or her to form an independent opinion on the debate about what the December 21, 2012 date means to all of us.
Peppers and People
Join intrepid host Dave DeWitt as he explores the story of chile peppers throughout human history. Episode One explores how chile peppers changed our world by influencing science, diets, and absurd human behavior. Approximate Running Time: English: 45 minutes
From Seed to Salsa
Dave “the Pope of Peppers” DeWitt is back on the chile pepper trail. Episode Two shows how peppers are grown, harvested, processed and sold, as Dave embarks on a quest to find the elusive chile pepper shrine in southern Florida. Approximate Running Time: English: 45 minutes
Hot Plates
Treat yourself to a traveling feast with hungry host Dave DeWitt. Episode Three focuses on the culinary delights of hot and spicy food. From Miami to Los Angeles, f
Please contemplate the following ten questions as they relate to your relationships with others and, perhaps more importantly, with yourself.
- Do you know what values, standards, or guidelines control your thinking and feelings in your relationships?
- What principles or beliefs determine your ‘world view’?
- Do you know how to improve yourself in whatever you do?
- Do you think/feel you could learn to use your intelligence more intelligently, and your creativity more creatively?
- What do you know for sure?
- How do you know what you know, and how do you know what you know is so?
- Do you judge yourself based on the high standards by which you judge others?
- Do you know how to go about creating more satisfying relationships with yourself, others, and your environment?
- Are you aware of times when you acted as if what you knew – or thought you knew – was all there was to know; when you were certain beyond a doubt … and later proved wrong?
- Do you take responsibility for the meanings you give to what you see, hear, read and experience?
I wrote these articles based on my interpretation of what I have read of Alfred Korzybski and others. My intent is to help others — and myself — apply the principles of general semantics and modify our habitual ways of thinking-behaving to improve our human understanding and relationships.
A Story About Stories From a Story-telling Form of Life
One way we could describe our species is that we are, among other characteristics, a story-telling form of life. Other life forms, in their own way, “tell stories”, but few of us believe these to be anywhere near as extensive, as varied and as fanciful as the stories we tell. We tell ourselves stories about ourselves – sometimes distressing ourselves with our own stories. We tell others stories about our children, our marriage, our pets, our fears, hopes, beliefs, vacations, and so on. We also make up and tell each other stories about other story-tellers. We repeat others’ stories, sometimes in an admiring way, sometimes to discredit them.
Politicians tell stories they think we want to hear, hoping that we will believe their stories and elect them to office. Advertisers use words, images, music, etc., to tell us stories extolling the virtues of their clients’ products and services. Revolutionaries tell stories about the good life to come after present leaders are removed. Scientists tell us stories about their discoveries of some relationships they have explored. Theologians and religious leaders tell us stories purportedly about God and His/Her relationship with the world, and about how we shoud behave toward each other. Philosophers tell us stories, purportedly about the nature of reality, values, meanings, and so on. Authors, playwrights, poets, and others, tell us stories which we sometimes fail to perceive as stories about ourselves.
Now, all these story-tellers do not usually introduce their stories by saying “This is my story …” Could it be that they/we suspect that we/others would ‘listen’ differently? In my story, I visualize a society with an evolved education system, where teachers at all levels would recognize their roles as “story-tellers”. They would help students evaluate what they read and hear in terms of “degrees of fantasy” and “degrees of accurate representation”. They would advise students to become more aware of the stories they tell themselves, and the stories they tell to others. They would also remind students that there are times to reserve judgment on a story.
When we hear the word “story”, among the images that might pop up are those of a parent telling a child a story; children listening attentively to stories in a classroom; stories we read in books; myths, and so on. We also tend to think of stories as fictional – not factual – but fanciful and made up. It is part of my story that we all make up stuff. Our everyday conversations, news reports, books and articles we write, documentaries, etc., are all made up – and as such, they also qualify as stories. In my story, I suggest that we would greatly improve our understanding of ourselves, others, situations we find ourselves in, and the world around us, if we considered the following:
- Anything we read, hear, think, feel, believe, say, write, etc., qualifies as a story. The stories we make up about someone else’s story is not their story – it is our story, about their story. Stories are not objective reports. Stories will unavoidably be slanted in terms of an individual’s age, experiences, state of mind, beliefs, concerns, motives, world view, values, social standing, and so on.
- Whatever else a story is about, it is also a story about the story-teller. It reflects his/her thoughts, feelings, experiences, understanding, etc.
- Individuals in the ’same’ situation will have different stories to tell.
- There are unavoidable gaps in our awareness. Therefore no story tells the truth, the whole truth, and nothing but the truth. No story is ever the whole ’story’.
- Since we depend on light waves, sound waves, electrochemical impulses etc., for information about ourselves and about the outside world, our stories will always be out of synch with their referents.
- Things were going on before our arrival. In a sense we are always ‘late’ on the scene.
- Stories constituted of relatively static words will necessarily be more or less inaccurate as an account of a world of change, process and multi-interactions.
- As maps are not the territories they represent, as words are not the processes they stand for, stories made up of words and images are not their referents. Stories are about referents, both inside and outside one’s head.
- Stories are sometimes presented to us as opinions, facts, truths, insights, intuitions, gut feelings, revelations, news, etc.
- Our stories have endings. We end our stories. But that’s not the end of the ’story’. Happenings do not start or end exactly where our stories start and end.
- In terms of Heisenberg’s Uncertainty Principle and the observer-observed interaction, we sometimes affect, to some degree, the situations our stories are about. (Listen carefully to what we call ” news”).
- Metaphors and similes embellish our stories. For clearer understanding, it helps if we don’t confuse metaphors and similes with descriptions and facts.
- We benefit a great deal when we take responsibility for the meanings we give to the stories that we read and hear.
[yuotube=http://www.youtube.com/watch?v=LCEpxlFtlRY]
September 29th, 2009 by paulbradshaw
http://onlinejournalismblog.com/2009/09/29/the-end-of-objectivity-web-2-0-version
This week a new nail was driven into the coffin of the notion of journalistic objectivity. The culprit? The Washington Post’s leaked social media policy.
The policy is aimed at preserving the appearance of objectivity rather than its actual existence. It focuses on what journalists are perceived to be, rather than what they actually do.
And in doing so, it hits upon the very reason why their attempt is doomed from the start:
“Our online data trails reflect on our professional reputations and those of The Washington Post. Be sure that your pattern of use does not suggest, for example, that you are interested only in people with one particular view of a topic or issue.”
Our behaviour as journalists is now measurable. And measurability gives the lie to the pretence that journalists behave like scientists, impartially observing the petri dish of society.
That pretence has been crumbling for years. In 1976 the Glasgow Media Group’s Bad News study demonstrated how TV news favoured powerful groups by measuring a number of factors in news coverage. Dozens of other studies have followed a similar vein, using the measurability of journalistic output as their barometer. Meanwhile, depending where you sit politically, you’ll find a right-wing or left-wing media conspiracy to believe in.
Objectivity was always a phantom conjured by publishers to appeal to maximum audiences and advertisers [see comments fleshing out objectivity as method vs style]. Regulators then helped by requiring objectivity to broadcast in a limited bandwidth spectrum. The first nail in its coffin came with the end of those limits. As Dan Gillmor explained in The End of Objectivity:
“Objectivity is a construct of recent times. One reason for its rise in the journalism sphere has been the consolidation of newspapers and television into monopolies and oligopolies in the past half-century. If one voice overwhelms all the others, there is a public interest in playing stories as straight as possible — not favoring one side over the other (or others, to be more precise, as there are rarely just two sides to any issue).
“There were good business reasons to be “objective,” too, not least that a newspaper didn’t want to make large parts of its community angry. And, no doubt, libel law has played a role, too. If a publication could say it “got both sides,” perhaps a libel plaintiff would have more trouble winning.”
It was also born from 19th century beliefs in the scientific method and the search for abstract ‘truth’. But society is not a petri dish; and journalists are no scientists: their methodologies are flawed by the need for narrative and the rhythm of the deadline. And most don’t understand scientific methods at all.
So when you can not only measure the lack of balance in journalistic output, but also the lack of balance in journalists’ behaviour and relationships online, the game is well and truly up.
Imagine you’re a trainee journalist who has grown up in a Web 2.0 world: a member of countless Facebook groups; signatory to a dozen online petitions; tagged in Flickr galleries of protests and rallies. Oh, and your profile tells us not only your gender, but your ethnicity, religion, relationship status and sexuality. Will an offer of a job on the Washington Post now come with the request that you cut all ties to your previous life and wipe all records of your former existence as you join the monastic seclusion of Journalistic Objectivity?
Yes, journalists have opinions. And friends. And they rely on easily accessible sources.
Well, hold the front page.
So there lies the problem - but also the solution. Transparency is hastening the demise of the already crumbling notion of journalistic objectivity; but it also represents the best hope for journalistic integrity – and ultimately, for many journalists that was what the pursuit of objectivity was about.
As David Weinberger argues:
“Transparency subsumes objectivity. Anyone who claims objectivity should be willing to back that assertion up by letting us look at sources, disagreements, and the personal assumptions and values supposedly bracketed out of the report.
“Objectivity without transparency increasingly will look like arrogance. And then foolishness. Why should we trust what one person — with the best of intentions — insists is true when we instead could have a web of evidence, ideas, and argument?”
So keep your social media profiles, and make yourself available to a thousand potential sources rather than relying on the dozen in your contacts book. Link to your raw material and let people comment on the holes in your narrative. Engage with online communities if you expect them to engage with you.And stop thinking about the PR of how you look and focus on the journalism of what you do.
Written by Paul Bradshaw – Visit Website
m pretty close to obsessed with my pair of KSO
i only get giddy and idolatrous over very few products and objects
Tabasco
Parmigiano-Reggiano
Sativa strains
Am Appy
idk
i feel like im doin it right in these
The typical human foot is an anatomical marvel of evolution with 26 bones, 33 joints, 20 muscles, and hundreds of sensory receptors, tendons and ligaments. Like the rest of the body, to keep our feet healthy, they need to be stimulated and exercised.
That’s why we recommend wearing FiveFingers for exercise, play, and for fun. Stimulating the muscles in your feet and lower legs will not only make you stronger and healthier, it improves your balance, agility and proprioception.
When we first introduced Vibram FiveFingers® to the world, it was the beginning of a revolution.
For the first time, active outdoor athletes and fitness professionals were able to experience the sensation and freedom of going barefoot with the protection and sure-footed grip of a Vibram sole. Their response exceeded our wildest expectations.
Some customers told us they felt more connected to the earth and more in tune with their bodies. Others discovered an increased sense of balance and greater agility. And many reported health benefits like improved posture and less back pain. All were generous with their praise and their ideas, often suggesting new and creative uses for FiveFingers.
With the new 2009 Vibram FiveFingers collection, our patented barefooting concept continues to evolve.
Now you can choose from a variety of designs to cover the wide range of activities you would rather do barefoot; everything from fitness training and yoga, to running and trekking, to kayaking and sailing. Clearly, the barefooting revolution is alive and well.
When you go barefoot, your movements become the movements of a child—playful and sensitive, yet purposeful and confident. You experience the unbound joy of stepping, hopping, and running across any surface on earth, simply to get from here to there.
Vibram FiveFingers® allow you to relive that sensation. Unlike conventional shoes that insulate you from your surroundings, FiveFingers footwear deepens your connection to the earth and your surroundings. FiveFingers enhance your sense of touch and feel, while improving foot strength, balance, agility, and range of motion. Because wearing Vibram FiveFingers is so close to going barefoot, you’ll enjoy the health and performance benefits of barefooting without some of the risks.
Outdoor enthusiasts have found FiveFingers to be the ideal crossover shoe for multiple sports and activities—from ChiRunning and bouldering to kayaking and windsurfing. Fitness enthusiasts use FiveFingers for core strength training, yoga and Pilates. Our customers continually discover new and creative uses for our alternative performance footwear.
http://www.vibramfivefingers.com
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Vibram FiveFingers is perfect for people who want the benefits of barefoot walking or running without the consequences of going barefoot in modern urban society. There are 4 different product lines that Vibram offer which accommodate a variety of activities and users.
FiveFingers Classic – no frills simple version of the FiveFingers design. Dries quickly and perfect for Running, Fitness Training, Martial Arts, Yoga, Pilates, Travel.
FiveFingers Sprint – extra loop and hook enclosures add additional fit and snugness making it great for a variety of activities like Light Trekking, Climbing, Canyoneering, Running, Fitness Training, Martial Arts, Yoga, Pilates, Sailing, Boating, Kayaking, Canoeing, Surfing, Flats Fishing, Travel.
FiveFingers FLOW – extra covering on top of shoe provides additional insulation for cold weather envrionments which makes it great for Cold Weather Running, Light Trekking, Climbing, Canyoneering, Sailing, Boating, Kayaking, Canoeing, Surfing, Flats Fishing.
FiveFingers KSO – the KSO stands for “keep stuff out” and that’s what it was intended to do. The extra mesh on the top of the shoe keep out dirt, gravel, and other nasties and make it good for Light Trekking, Climbing, Canyoneering, Running, Fitness Training, Martial Arts, Yoga, Pilates, Sailing, Boating, Kayaking, Canoeing, Surfing, Flats Fishing, Travel.
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Plastic Gorilla Feet Give You Twinkle Toes
Minutes after wiggling my feet into these five-toed monstrosities I was creeping across a coworker’s desk like Spider-man. Sadly, Vibram FiveFingers don’t actually let you stick to walls and ceilings, but they are wickedly fun to wear.
Vibram FiveFingers are little more than flexible plastic soles with just enough cloth to hold them snugly on your feet. They have little individual pockets for each toe, making the FiveFingers into a sort of foot glove. The resulting footwear feel less like shoes and more like tougher, more invulnerable versions of your feet.
Traction is incredibly good, due to the grippy material, the separation of the toes, and the addition of siping, or tiny zigzag cuts etched into the soles that expand into little treads as the sole flexes.
The VFFs are also surprisingly comfortable. Each toe is snuggled inside its own little pocket, which is not only cozy, it also gives your feet a surprising amount of feedback about the ground you’re standing on. Your toes, freed from their typical leather prisons, act like a tiny topography sensor array.
Running in FiveFingers is much like running barefoot, except without the mincing “Ow-ow-ow!” moments as you hit a patch of gravel or sun-baked asphalt. You have to use the same stride (and the same, probably atrophied, calf and arch muscles) as you do when running with naked feet. The end result is good: By forcing me into a more efficient stride, the VFFs helped subtract nearly a minute from my admittedly slow per-mile pace. Also, a growing body of research suggests that minimal or no footwear will result in fewer running injuries. But it takes some getting used to if you’ve never run barefoot before. Start with very short runs, and work up gradually.
Vibram offers four different models of its FiveFingers line; I tested two. The Classic offers as clean a line as you’re going to get from such freaky footwear, but the KSO (short for “Keep Stuff Out”) is more practical for running, with webbing on the top to keep debris from sneaking in and a single strap for snugging the shoes more firmly onto your feet.
Vibram FiveFingers will make you look like you have plastic gorilla feet. They’ll draw curious, often appalled stares from strangers and mockery from your family. But by making you run as if barefoot, Vibram FiveFingers might just make you a stronger, faster and less-injured runner.
WIRED Just like going barefoot, except without the cuts, abrasions and icky stuff between your toes. Excellent traction on a variety of surfaces. Surprisingly comfortable.
TIRED Ugly as a bucket of vomit. Just looking at the shoes is a one way ticket to the uncanny valley. Slightly time-consuming to put on. Sizing is extremely fickle. -http://www.wired.com/reviews/product/pr_vibram_fivefingers_kso
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http://www.weathersealed.com/2009/09/22/where-the-buffalo-roamed
Where The Buffalo Roamed
This summer, cruising down the I-5 through California’s Central Valley to the Los Angeles Basin, I unwittingly stumbled upon a most exasperating development: the country strip mall. First, let me state that I don’t hate. I’ve got nothing against Petco, Starbucks, OfficeMax, et al. When overcome by the desire for a cubic yard of kitty litter, a carafe of pre-Columbian frappasmoochino, or fifty gross of pink highlighter pens, I’m there in a jiffy!
But, Mr. Real Estate Tycoon, did you have to plop your shopping center smack dab in the middle of what was previously nowhere? Okay, the land was cheap. And yes, you did traffic studies and proved that the interstate and distant suburbs would drench whatever you built in a raging torrent of eager consumerism. But your retail monstrosity drains the wildness from the countryside for twenty miles in every direction! Sure, you can’t see it from everywhere – but once you know it’s there, you feel it. In the rural drawl of a neighboring rancher, that flat-out sucks!
Which begs the question: just how far away can you get from our world of generic convenience? And how would you figure that out?
As I hurtled down the highway, a pair of golden arches crept over the horizon, and the proverbial lightbulb smacked me in the forehead. To gauge the creep of cookie-cutter commercialism, there’s no better barometer than McDonald’s – ubiquitous fast food chain and inaugural megacorporate colonizer of small towns nationwide.
So, I set out to determine the farthest point from a Micky Dee’s – in the lower 48 states, at least. This endeavor required information, and the nice folks at AggData were kind enough to provide it to me: a complete list of all 13,000-or-so U.S. restaurants, in CSV format, geolocated for maximum convenience. From there, a bit of software engineering gymnastics, and…
Behold, a visualization of the contiguous United States, colored by distance to the nearest domestic McDonald’s!
The contiguous United States, visualized by distance to the nearest McDonald’s. Click on the image for a larger version!
You can download a bigger, wallpaper-ready version of the visualization, too!
As expected, McDonald’s cluster at the population centers and hug the highway grid. East of the Mississippi, there’s wall-to-wall coverage, except for a handful of meager gaps centered on the Adirondacks, inland Maine, the Everglades, and outlying West Virginia.
For maximum McSparseness, we look westward, towards the deepest, darkest holes in our map: the barren deserts of central Nevada, the arid hills of southeastern Oregon, the rugged wilderness of Idaho’s Salmon River Mountains, and the conspicuous well of blackness on the high plains of northwestern South Dakota. There, in a patch of rolling grassland, loosely hemmed in by Bismarck, Dickinson, Pierre, and the greater Rapid City-Spearfish-Sturgis metropolitan area, we find our answer.
Between the tiny Dakotan hamlets of Meadow and Glad Valley lies the McFarthest Spot: 107 miles distant from the nearest McDonald’s, as the crow flies, and 145 miles by car!
Suffer a Big Mac Attack out there, and you’re hurtin’ for certain! For a coupla hours, at least, unless graced by the tender blessings of “manna from heaven” – that is, a fast food air drop from the Medi-Copter.
10 part high quality film piece
http://www.nytimes.com/2009/09/20/magazine/20jung-t.html?_r=1&pagewanted=1&ref=magazine
This is a story about a nearly 100-year-old book, bound in red leather, which has spent the last quarter century secreted away in a bank vault in Switzerland. The book is big and heavy and its spine is etched with gold letters that say “Liber Novus,” which is Latin for “New Book.” Its pages are made from thick cream-colored parchment and filled with paintings of otherworldly creatures and handwritten dialogues with gods and devils. If you didn’t know the book’s vintage, you might confuse it for a lost medieval tome.
And yet between the book’s heavy covers, a very modern story unfolds. It goes as follows: Man skids into midlife and loses his soul. Man goes looking for soul. After a lot of instructive hardship and adventure — taking place entirely in his head — he finds it again.
Some people feel that nobody should read the book, and some feel that everybody should read it. The truth is, nobody really knows. Most of what has been said about the book — what it is, what it means — is the product of guesswork, because from the time it was begun in 1914 in a smallish town in Switzerland, it seems that only about two dozen people have managed to read or even have much of a look at it.
Of those who did see it, at least one person, an educated Englishwoman who was allowed to read some of the book in the 1920s, thought it held infinite wisdom — “There are people in my country who would read it from cover to cover without stopping to breathe scarcely,” she wrote — while another, a well-known literary type who glimpsed it shortly after, deemed it both fascinating and worrisome, concluding that it was the work of a psychotic.
So for the better part of the past century, despite the fact that it is thought to be the pivotal work of one of the era’s great thinkers, the book has existed mostly just as a rumor, cosseted behind the skeins of its own legend — revered and puzzled over only from a great distance.
Which is why one rainy November night in 2007, I boarded a flight in Boston and rode the clouds until I woke up in Zurich, pulling up to the airport gate at about the same hour that the main branch of the United Bank of Switzerland, located on the city’s swanky Bahnhofstrasse, across from Tommy Hilfiger and close to Cartier, was opening its doors for the day. A change was under way: the book, which had spent the past 23 years locked inside a safe deposit box in one of the bank’s underground vaults, was just then being wrapped in black cloth and loaded into a discreet-looking padded suitcase on wheels. It was then rolled past the guards, out into the sunlight and clear, cold air, where it was loaded into a waiting car and whisked away.
THIS COULD SOUND, I realize, like the start of a spy novel or a Hollywood bank caper, but it is rather a story about genius and madness, as well as possession and obsession, with one object — this old, unusual book — skating among those things. Also, there are a lot of Jungians involved, a species of thinkers who subscribe to the theories of Carl Jung, the Swiss psychiatrist and author of the big red leather book. And Jungians, almost by definition, tend to get enthused anytime something previously hidden reveals itself, when whatever’s been underground finally makes it to the surface.
Carl Jung founded the field of analytical psychology and, along with Sigmund Freud, was responsible for popularizing the idea that a person’s interior life merited not just attention but dedicated exploration — a notion that has since propelled tens of millions of people into psychotherapy. Freud, who started as Jung’s mentor and later became his rival, generally viewed the unconscious mind as a warehouse for repressed desires, which could then be codified and pathologized and treated. Jung, over time, came to see the psyche as an inherently more spiritual and fluid place, an ocean that could be fished for enlightenment and healing.
Whether or not he would have wanted it this way, Jung — who regarded himself as a scientist — is today remembered more as a countercultural icon, a proponent of spirituality outside religion and the ultimate champion of dreamers and seekers everywhere, which has earned him both posthumous respect and posthumous ridicule. Jung’s ideas laid the foundation for the widely used Myers-Briggs personality test and influenced the creation of Alcoholics Anonymous. His central tenets — the existence of a collective unconscious and the power of archetypes — have seeped into the larger domain of New Age thinking while remaining more at the fringes of mainstream psychology.
A big man with wire-rimmed glasses, a booming laugh and a penchant for the experimental, Jung was interested in the psychological aspects of séances, of astrology, of witchcraft. He could be jocular and also impatient. He was a dynamic speaker, an empathic listener. He had a famously magnetic appeal with women. Working at Zurich’s Burghölzli psychiatric hospital, Jung listened intently to the ravings of schizophrenics, believing they held clues to both personal and universal truths. At home, in his spare time, he pored over Dante, Goethe, Swedenborg and Nietzsche. He began to study mythology and world cultures, applying what he learned to the live feed from the unconscious — claiming that dreams offered a rich and symbolic narrative coming from the depths of the psyche. Somewhere along the way, he started to view the human soul — not just the mind and the body — as requiring specific care and development, an idea that pushed him into a province long occupied by poets and priests but not so much by medical doctors and empirical scientists.
Jung soon found himself in opposition not just to Freud but also to most of his field, the psychiatrists who constituted the dominant culture at the time, speaking the clinical language of symptom and diagnosis behind the deadbolts of asylum wards. Separation was not easy. As his convictions began to crystallize, Jung, who was at that point an outwardly successful and ambitious man with a young family, a thriving private practice and a big, elegant house on the shores of Lake Zurich, felt his own psyche starting to teeter and slide, until finally he was dumped into what would become a life-altering crisis.
What happened next to Carl Jung has become, among Jungians and other scholars, the topic of enduring legend and controversy. It has been characterized variously as a creative illness, a descent into the underworld, a bout with insanity, a narcissistic self-deification, a transcendence, a midlife breakdown and an inner disturbance mirroring the upheaval of World War I. Whatever the case, in 1913, Jung, who was then 38, got lost in the soup of his own psyche. He was haunted by troubling visions and heard inner voices. Grappling with the horror of some of what he saw, he worried in moments that he was, in his own words, “menaced by a psychosis” or “doing a schizophrenia.”
He later would compare this period of his life — this “confrontation with the unconscious,” as he called it — to a mescaline experiment. He described his visions as coming in an “incessant stream.” He likened them to rocks falling on his head, to thunderstorms, to molten lava. “I often had to cling to the table,” he recalled, “so as not to fall apart.”
Had he been a psychiatric patient, Jung might well have been told he had a nervous disorder and encouraged to ignore the circus going on in his head. But as a psychiatrist, and one with a decidedly maverick streak, he tried instead to tear down the wall between his rational self and his psyche. For about six years, Jung worked to prevent his conscious mind from blocking out what his unconscious mind wanted to show him. Between appointments with patients, after dinner with his wife and children, whenever there was a spare hour or two, Jung sat in a book-lined office on the second floor of his home and actually induced hallucinations — what he called “active imaginations.” “In order to grasp the fantasies which were stirring in me ‘underground,’ ” Jung wrote later in his book “Memories, Dreams, Reflections,” “I knew that I had to let myself plummet down into them.” He found himself in a liminal place, as full of creative abundance as it was of potential ruin, believing it to be the same borderlands traveled by both lunatics and great artists.
Jung recorded it all. First taking notes in a series of small, black journals, he then expounded upon and analyzed his fantasies, writing in a regal, prophetic tone in the big red-leather book. The book detailed an unabashedly psychedelic voyage through his own mind, a vaguely Homeric progression of encounters with strange people taking place in a curious, shifting dreamscape. Writing in German, he filled 205 oversize pages with elaborate calligraphy and with richly hued, staggeringly detailed paintings.
What he wrote did not belong to his previous canon of dispassionate, academic essays on psychiatry. Nor was it a straightforward diary. It did not mention his wife, or his children, or his colleagues, nor for that matter did it use any psychiatric language at all. Instead, the book was a kind of phantasmagoric morality play, driven by Jung’s own wish not just to chart a course out of the mangrove swamp of his inner world but also to take some of its riches with him. It was this last part — the idea that a person might move beneficially between the poles of the rational and irrational, the light and the dark, the conscious and the unconscious — that provided the germ for his later work and for what analytical psychology would become.
The book tells the story of Jung trying to face down his own demons as they emerged from the shadows. The results are humiliating, sometimes unsavory. In it, Jung travels the land of the dead, falls in love with a woman he later realizes is his sister, gets squeezed by a giant serpent and, in one terrifying moment, eats the liver of a little child. (“I swallow with desperate efforts — it is impossible — once again and once again — I almost faint — it is done.”) At one point, even the devil criticizes Jung as hateful.
He worked on his red book — and he called it just that, the Red Book — on and off for about 16 years, long after his personal crisis had passed, but he never managed to finish it. He actively fretted over it, wondering whether to have it published and face ridicule from his scientifically oriented peers or to put it in a drawer and forget it. Regarding the significance of what the book contained, however, Jung was unequivocal. “All my works, all my creative activity,” he would recall later, “has come from those initial fantasies and dreams.”
Jung evidently kept the Red Book locked in a cupboard in his house in the Zurich suburb of Küsnacht. When he died in 1961, he left no specific instructions about what to do with it. His son, Franz, an architect and the third of Jung’s five children, took over running the house and chose to leave the book, with its strange musings and elaborate paintings, where it was. Later, in 1984, the family transferred it to the bank, where since then it has fulminated as both an asset and a liability.
Anytime someone did ask to see the Red Book, family members said, without hesitation and sometimes without decorum, no. The book was private, they asserted, an intensely personal work. In 1989, an American analyst named Stephen Martin, who was then the editor of a Jungian journal and now directs a Jungian nonprofit foundation, visited Jung’s son (his other four children were daughters) and inquired about the Red Book. The question was met with a vehemence that surprised him. “Franz Jung, an otherwise genial and gracious man, reacted sharply, nearly with anger,” Martin later wrote in his foundation’s newsletter, saying “in no uncertain terms” that Martin could not “see the Red Book, nor could he ever imagine that it would be published.”
And yet, Carl Jung’s secret Red Book — scanned, translated and footnoted — will be in stores early next month, published by W. W. Norton and billed as the “most influential unpublished work in the history of psychology.” Surely it is a victory for someone, but it is too early yet to say for whom.
STEPHEN MARTIN IS a compact, bearded man of 57. He has a buoyant, irreverent wit and what feels like a fully intact sense of wonder. If you happen to have a conversation with him anytime before, say, 10 a.m., he will ask his first question — “How did you sleep?” — and likely follow it with a second one — “Did you dream?” Because for Martin, as it is for all Jungian analysts, dreaming offers a barometric reading of the psyche. At his house in a leafy suburb of Philadelphia, Martin keeps five thick books filled with notations on and interpretations of all the dreams he had while studying to be an analyst 30 years ago in Zurich, under the tutelage of a Swiss analyst then in her 70s named Liliane Frey-Rohn. These days, Martin stores his dreams on his computer, but his dream life is — as he says everybody’s dream life should be — as involving as ever.
Even as some of his peers in the Jungian world are cautious about regarding Carl Jung as a sage — a history of anti-Semitic remarks and his sometimes patriarchal views of women have caused some to distance themselves — Martin is unapologetically reverential. He keeps Jung’s 20 volumes of collected works on a shelf at home. He rereads “Memories, Dreams, Reflections” at least twice a year. Many years ago, when one of his daughters interviewed him as part of a school project and asked what his religion was, Martin, a nonobservant Jew, answered, “Oh, honey, I’m a Jungian.”
The first time I met him, at the train station in Ardmore, Pa., Martin shook my hand and thoughtfully took my suitcase. “Come,” he said. “I’ll take you to see the holy hankie.” We then walked several blocks to the office where Martin sees clients. The room was cozy and cavelike, with a thick rug and walls painted a deep, handsome shade of blue. There was a Mission-style sofa and two upholstered chairs and an espresso machine in one corner.
Several mounted vintage posters of Zurich hung on the walls, along with framed photographs of Carl Jung, looking wise and white-haired, and Liliane Frey-Rohn, a round-faced woman smiling maternally from behind a pair of severe glasses.
Martin tenderly lifted several first-edition books by Jung from a shelf, opening them so I could see how they had been inscribed to Frey-Rohn, who later bequeathed them to Martin. Finally, we found ourselves standing in front of a square frame hung on the room’s far wall, another gift from his former analyst and the centerpiece of Martin’s Jung arcana. Inside the frame was a delicate linen square, its crispness worn away by age — a folded handkerchief with the letters “CGJ” embroidered neatly in one corner in gray. Martin pointed. “There you have it,” he said with exaggerated pomp, “the holy hankie, the sacred nasal shroud of C. G. Jung.”
In addition to practicing as an analyst, Martin is the director of the Philemon Foundation, which focuses on preparing the unpublished works of Carl Jung for publication, with the Red Book as its central project. He has spent the last several years aggressively, sometimes evangelistically, raising money in the Jungian community to support his foundation. The foundation, in turn, helped pay for the translating of the book and the addition of a scholarly apparatus — a lengthy introduction and vast network of footnotes — written by a London-based historian named Sonu Shamdasani, who serves as the foundation’s general editor and who spent about three years persuading the family to endorse the publication of the book and to allow him access to it.
Given the Philemon Foundation’s aim to excavate and make public C. G. Jung’s old papers — lectures he delivered at Zurich’s Psychological Club or unpublished letters, for example — both Martin and Shamdasani, who started the foundation in 2003, have worked to develop a relationship with the Jung family, the owners and notoriously protective gatekeepers of Jung’s works. Martin echoed what nearly everybody I met subsequently would tell me about working with Jung’s descendants. “It’s sometimes delicate,” he said, adding by way of explanation, “They are very Swiss.”
What he likely meant by this was that the members of the Jung family who work most actively on maintaining Jung’s estate tend to do things carefully and with an emphasis on privacy and decorum and are on occasion taken aback by the relatively brazen and totally informal way that American Jungians — who it is safe to say are the most ardent of all Jungians — inject themselves into the family’s business. There are Americans knocking unannounced on the door of the family home in Küsnacht; Americans scaling the fence at Bollingen, the stone tower Jung built as a summer residence farther south on the shore of Lake Zurich. Americans pepper Ulrich Hoerni, one of Jung’s grandsons who manages Jung’s editorial and archival matters through a family foundation, almost weekly with requests for various permissions. The relationship between the Jungs and the people who are inspired by Jung is, almost by necessity, a complex symbiosis. The Red Book — which on one hand described Jung’s self-analysis and became the genesis for the Jungian method and on the other was just strange enough to possibly embarrass the family — held a certain electrical charge. Martin recognized the descendants’ quandary. “They own it, but they haven’t lived it,” he said, describing Jung’s legacy. “It’s very consternating for them because we all feel like we own it.” Even the old psychiatrist himself seemed to recognize the tension. “Thank God I am Jung,” he is rumored once to have said, “and not a Jungian.”
“This guy, he was a bodhisattva,” Martin said to me that day. “This is the greatest psychic explorer of the 20th century, and this book tells the story of his inner life.” He added, “It gives me goose bumps just thinking about it.” He had at that point yet to lay eyes on the book, but for him that made it all the more tantalizing. His hope was that the Red Book would “reinvigorate” Jungian psychology, or at the very least bring himself personally closer to Jung. “Will I understand it?” he said. “Probably not. Will it disappoint? Probably. Will it inspire? How could it not?” He paused a moment, seeming to think it through. “I want to be transformed by it,” he said finally. “That’s all there is.”
IN ORDER TO UNDERSTAND and decode the Red Book — a process he says required more than five years of concentrated work — Sonu Shamdasani took long, rambling walks on London’s Hampstead Heath. He would translate the book in the morning, then walk miles in the park in the afternoon, his mind trying to follow the rabbit’s path Jung had forged through his own mind.
Shamdasani is 46. He has thick black hair, a punctilious eye for detail and an understated, even somnolent, way of speaking. He is friendly but not particularly given to small talk. If Stephen Martin is — in Jungian terms — a “feeling type,” then Shamdasani, who teaches at the University College London’s Wellcome Trust Center for the History of Medicine and keeps a book by the ancient Greek playwright Aeschylus by his sofa for light reading, is a “thinking type.” He has studied Jungian psychology for more than 15 years and is particularly drawn to the breadth of Jung’s psychology and his knowledge of Eastern thought, as well as the historical richness of his era, a period when visionary writing was more common, when science and art were more entwined and when Europe was slipping into the psychic upheaval of war. He tends to be suspicious of interpretive thinking that’s not anchored by hard fact — and has, in fact, made a habit of attacking anybody he deems guilty of sloppy scholarship — and also maintains a generally unsentimental attitude toward Jung. Both of these qualities make him, at times, awkward company among both Jungians and Jungs.
The relationship between historians and the families of history’s luminaries is, almost by nature, one of mutual disenchantment. One side works to extract; the other to protect. One pushes; one pulls. Stephen Joyce, James Joyce’s literary executor and last living heir, has compared scholars and biographers to “rats and lice.” Vladimir Nabokov’s son Dmitri recently told an interviewer that he considered destroying his father’s last known novel in order to rescue it from the “monstrous nincompoops” who had already picked over his father’s life and works. T. S. Eliot’s widow, Valerie Fletcher, has actively kept his papers out of the hands of biographers, and Anna Freud was, during her lifetime, notoriously selective about who was allowed to read and quote from her father’s archives.
Even against this backdrop, the Jungs, led by Ulrich Hoerni, the chief literary administrator, have distinguished themselves with their custodial vigor. Over the years, they have tried to interfere with the publication of books perceived to be negative or inaccurate (including one by the award-winning biographer Deirdre Bair), engaged in legal standoffs with Jungians and other academics over rights to Jung’s work and maintained a state of high agitation concerning the way C. G. Jung is portrayed. Shamdasani was initially cautious with Jung’s heirs. “They had a retinue of people coming to them and asking to see the crown jewels,” he told me in London this summer. “And the standard reply was, ‘Get lost.’ ”
Shamdasani first approached the family with a proposal to edit and eventually publish the Red Book in 1997, which turned out to be an opportune moment. Franz Jung, a vehement opponent of exposing Jung’s private side, had recently died, and the family was reeling from the publication of two controversial and widely discussed books by an American psychologist named Richard Noll, who proposed that Jung was a philandering, self-appointed prophet of a sun-worshiping Aryan cult and that several of his central ideas were either plagiarized or based upon falsified research.
While the attacks by Noll might have normally propelled the family to more vociferously guard the Red Book, Shamdasani showed up with the right bargaining chips — two partial typed draft manuscripts (without illustrations) of the Red Book he had dug up elsewhere. One was sitting on a bookshelf in a house in southern Switzerland, at the home of the elderly daughter of a woman who once worked as a transcriptionist and translator for Jung. The second he found at Yale University’s Beinecke Library, in an uncataloged box of papers belonging to a well-known German publisher. The fact that there were partial copies of the Red Book signified two things — one, that Jung had distributed it to at least a few friends, presumably soliciting feedback for publication; and two, that the book, so long considered private and inaccessible, was in fact findable. The specter of Richard Noll and anybody else who, they feared, might want to taint Jung by quoting selectively from the book loomed large. With or without the family’s blessing, the Red Book — or at least parts of it — would likely become public at some point soon, “probably,” Shamdasani wrote ominously in a report to the family, “in sensationalistic form.”
For about two years, Shamdasani flew back and forth to Zurich, making his case to Jung’s heirs. He had lunches and coffees and delivered a lecture. Finally, after what were by all accounts tense deliberations inside the family, Shamdasani was given a small salary and a color copy of the original book and was granted permission to proceed in preparing it for publication, though he was bound by a strict confidentiality agreement. When money ran short in 2003, the Philemon Foundation was created to finance Shamdasani’s research.
Having lived more or less alone with the book for almost a decade, Shamdasani — who is a lover of fine wine and the intricacies of jazz — these days has the slightly stunned aspect of someone who has only very recently found his way out of an enormous maze. When I visited him this summer in the book-stuffed duplex overlooking the heath, he was just adding his 1,051st footnote to the Red Book.
The footnotes map both Shamdasani’s journey and Jung’s. They include references to Faust, Keats, Ovid, the Norse gods Odin and Thor, the Egyptian deities Isis and Osiris, the Greek goddess Hecate, ancient Gnostic texts, Greek Hyperboreans, King Herod, the Old Testament, the New Testament, Nietzsche’s Zarathustra, astrology, the artist Giacometti and the alchemical formulation of gold. And that’s just naming a few. The central premise of the book, Shamdasani told me, was that Jung had become disillusioned with scientific rationalism — what he called “the spirit of the times” — and over the course of many quixotic encounters with his own soul and with other inner figures, he comes to know and appreciate “the spirit of the depths,” a field that makes room for magic, coincidence and the mythological metaphors delivered by dreams.
“It is the nuclear reactor for all his works,” Shamdasani said, noting that Jung’s more well-known concepts — including his belief that humanity shares a pool of ancient wisdom that he called the collective unconscious and the thought that personalities have both male and female components (animus and anima) — have their roots in the Red Book. Creating the book also led Jung to reformulate how he worked with clients, as evidenced by an entry Shamdasani found in a self-published book written by a former client, in which she recalls Jung’s advice for processing what went on in the deeper and sometimes frightening parts of her mind.
“I should advise you to put it all down as beautifully as you can — in some beautifully bound book,” Jung instructed. “It will seem as if you were making the visions banal — but then you need to do that — then you are freed from the power of them. . . . Then when these things are in some precious book you can go to the book & turn over the pages & for you it will be your church — your cathedral — the silent places of your spirit where you will find renewal. If anyone tells you that it is morbid or neurotic and you listen to them — then you will lose your soul — for in that book is your soul.”
ZURICH IS, IF NOTHING ELSE, one of Europe’s more purposeful cities. Its church bells clang precisely; its trains glide in and out on a flawless schedule. There are crowded fondue restaurants and chocolatiers and rosy-cheeked natives breezily pedaling their bicycles over the stone bridges that span the Limmat River. In summer, white-sailed yachts puff around Lake Zurich; in winter, the Alps glitter on the horizon. And during the lunch hour year-round, squads of young bankers stride the Bahnhofstrasse in their power suits and high-end watches, appearing eternally mindful of the fact that beneath everyone’s feet lie labyrinthine vaults stuffed with a dazzling and disproportionate amount of the world’s wealth.
But there, too, ventilating the city’s material splendor with their devotion to dreams, are the Jungians. Some 100 Jungian analysts practice in and around Zurich, examining their clients’ dreams in sessions held in small offices tucked inside buildings around the city. Another few hundred analysts in training can be found studying at one of the two Jungian institutes in the area. More than once, I have been told that, in addition to being a fantastic tourist destination and a good place to hide money, Zurich is an excellent city for dreaming.
Jungians are accustomed to being in the minority pretty much everywhere they go, but here, inside a city of 370,000, they have found a certain quiet purchase. Zurich, for Jungians, is spiritually loaded. It’s a kind of Jerusalem, the place where C. G. Jung began his career, held seminars, cultivated an inner circle of disciples, developed his theories of the psyche and eventually grew old. Many of the people who enroll in the institutes are Swiss, American, British or German, but some are from places like Japan and South Africa and Brazil. Though there are other Jungian institutes in other cities around the world offering diploma programs, learning the techniques of dream analysis in Zurich is a little bit like learning to hit a baseball in Yankee Stadium. For a believer, the place alone conveys a talismanic grace.
Just as I had, Stephen Martin flew to Zurich the week the Red Book was taken from its bank-vault home and moved to a small photo studio near the opera house to be scanned, page by page, for publication. (A separate English translation along with Shamdasani’s introduction and footnotes will be included at the back of the book.) Martin already made a habit of visiting Zurich a few times a year for “bratwurst and renewal” and to attend to Philemon Foundation business. My first morning there, we walked around the older parts of Zurich, before going to see the book. Zurich made Martin nostalgic. It was here that he met his wife, Charlotte, and here that he developed the almost equally important relationship with his analyst, Frey-Rohn, carrying himself and his dreams to her office two or three times weekly for several years.
Undergoing analysis is a central, learn-by-doing part of Jungian training, which usually takes about five years and also involves taking courses in folklore, mythology, comparative religion and psychopathology, among others. It is, Martin says, very much a “mentor-based discipline.” He is fond of pointing out his own conferred pedigree, because Frey-Rohn was herself analyzed by C. G. Jung. Most analysts seem to know their bloodlines. That morning, Martin and I were passing a cafe when he spotted another American analyst, someone he knew in school and who has since settled in Switzerland. “Oh, there’s Bob,” Martin said merrily, making his way toward the man. “Bob trained with Liliane,” he explained to me, “and that makes us kind of like brothers.”
Jungian analysis revolves largely around writing down your dreams (or drawing them) and bringing them to the analyst — someone who is patently good with both symbols and people — to be scoured for personal and archetypal meaning. Borrowing from Jung’s own experiences, analysts often encourage clients to experiment on their own with active imagination, to summon a waking dreamscape and to interact with whatever, or whoever, surfaces there. Analysis is considered to be a form of psychotherapy, and many analysts are in fact trained also as psychotherapists, but in its purist form, a Jungian analyst eschews clinical talk of diagnoses and recovery in favor of broader (and some might say fuzzier) goals of self-discovery and wholeness — a maturation process Jung himself referred to as “individuation.” Perhaps as a result, Jungian analysis has a distinct appeal to people in midlife. “The purpose of analysis is not treatment,” Martin explained to me. “That’s the purpose of psychotherapy. The purpose of analysis,” he added, a touch grandly, “is to give life back to someone who’s lost it.”
Later that day, we went to the photo studio where the work on the book was already under way. The room was a charmless space with concrete floors and black walls. Its hushed atmosphere and glaring lights added a slightly surgical aspect. There was the editor from Norton in a tweedy sport coat. There was an art director hired by Norton and two technicians from a company called DigitalFusion, who had flown to Zurich from Southern California with what looked to be a half-ton of computer and camera equipment.
Shamdasani arrived ahead of us. And so did Ulrich Hoerni, who, along with his cousin Peter Jung, had become a cautious supporter of Shamdasani, working to build consensus inside the family to allow the book out into the world. Hoerni was the one to fetch the book from the bank and was now standing by, his brow furrowed, appearing somewhat tortured. To talk to Jung’s heirs is to understand that nearly four decades after his death, they continue to reel inside the psychic tornado Jung created during his lifetime, caught between the opposing forces of his admirers and critics and between their own filial loyalties and history’s pressing tendency to judge and rejudge its own playmakers. Hoerni would later tell me that Shamdasani’s discovery of the stray copies of the Red Book surprised him, that even today he’s not entirely clear about whether Carl Jung ever intended for the Red Book to be published. “He left it an open question,” he said. “One might think he would have taken some of his children aside and said, ‘This is what it is and what I want done with it,’ but he didn’t.” It was a burden Hoerni seemed to wear heavily. He had shown up at the photo studio not just with the Red Book in its special padded suitcase but also with a bedroll and a toothbrush, since after the day’s work was wrapped, he would be spending the night curled up near the book — “a necessary insurance measure,” he would explain.
And finally, there sunbathing under the lights, sat Carl Jung’s Red Book, splayed open to Page 37. One side of the open page showed an intricate mosaic painting of a giant holding an ax, surrounded by winged serpents and crocodiles. The other side was filled with a cramped German calligraphy that seemed at once controlled and also, just given the number of words on the page, created the impression of something written feverishly, cathartically. Above the book a 10,200-pixel scanner suspended on a dolly clicked and whirred, capturing the book one-tenth of a millimeter at a time and uploading the images into a computer.
The Red Book had an undeniable beauty. Its colors seemed almost to pulse, its writing almost to crawl. Shamdasani’s relief was palpable, as was Hoerni’s anxiety. Everyone in the room seemed frozen in a kind of awe, especially Stephen Martin, who stood about eight feet away from the book but then finally, after a few minutes, began to inch closer to it. When the art director called for a break, Martin leaned in, tilting his head to read some of the German on the page. Whether he understood it or not, he didn’t say. He only looked up and smiled.
ONE AFTERNOON I took a break from the scanning and visited Andreas Jung, who lives with his wife, Vreni, in C. G. Jung’s old house at 228 Seestrasse in the town of Küsnacht. The house — a 5,000-square-foot, 1908 baroque-style home, designed by the psychiatrist and financed largely with his wife, Emma’s, inheritance — sits on an expanse between the road and the lake. Two rows of trimmed, towering topiary trees create a narrow passage to the entrance. The house faces the white-capped lake, a set of manicured gardens and, in one corner, an anomalous, unruly patch of bamboo.
Andreas is a tall man with a quiet demeanor and a gentlemanly way of dressing. At 64, he resembles a thinner, milder version of his famous grandfather, whom he refers to as “C. G.” Among Jung’s five children (all but one are dead) and 19 grandchildren (all but five are still living), he is one of the youngest and also known as the most accommodating to curious outsiders. It is an uneasy kind of celebrity. He and Vreni make tea and politely serve cookies and dispense little anecdotes about Jung to those courteous enough to make an advance appointment. “People want to talk to me and sometimes even touch me,” Andreas told me, seeming both amused and a little sheepish. “But it is not at all because of me, of course. It is because of my grandfather.” He mentioned that the gardeners who trim the trees are often perplexed when they encounter strangers — usually foreigners — snapping pictures of the house. “In Switzerland, C. G. Jung is not thought to be so important,” he said. “They don’t see the point of it.”
Jung, who was born in the mountain village of Kesswil, was a lifelong outsider in Zurich, even as in his adult years he seeded the city with his followers and became — along with Paul Klee and Karl Barth — one of the best-known Swissmen of his era. Perhaps his marginalization stemmed in part from the offbeat nature of his ideas. (He was mocked, for example, for publishing a book in the late 1950s that examined the psychological phenomenon of flying saucers.) Maybe it was his well-documented abrasiveness toward people he found uninteresting. Or maybe it was connected to the fact that he broke with the established ranks of his profession. (During the troubled period when he began writing the Red Book, Jung resigned from his position at Burghölzli, never to return.) Most likely, too, it had something to do with the unconventional, unhidden, 40-something-year affair he conducted with a shy but intellectually forbidding woman named Toni Wolff, one of Jung’s former analysands who went on to become an analyst as well as Jung’s close professional collaborator and a frequent, if not fully welcome, fixture at the Jung family dinner table.
“The life of C. G. Jung was not easy,” Andreas said. “For the family, it was not easy at all.” As a young man, Andreas had sometimes gone and found his grandfather’s Red Book in the cupboard and paged through it, just for fun. Knowing its author personally, he said, “It was not strange to me at all.”
For the family, C. G. Jung became more of a puzzle after his death, having left behind a large amount of unpublished work and an audience eager to get its hands on it. “There were big fights,” Andreas told me when I visited him again this summer. Andreas, who was 19 when his grandfather died, recalled family debates over whether or not to allow some of Jung’s private letters to be published. When the extended family gathered for the annual Christmas party in Küsnacht, Jung’s children would disappear into a room and have heated discussions about what to do with what he had left behind while his grandchildren played in another room. “My cousins and brothers and I, we thought they were silly to argue over these things,” Andreas said, with a light laugh. “But later when our parents died, we found ourselves having those same arguments.”
Even Jung’s great-grandchildren felt his presence. “He was omnipresent,” Daniel Baumann, whose grandmother was Jung’s daughter Gret, would tell me when I met him later. He described his own childhood with a mix of bitterness and sympathy directed at the older generations. “It was, ‘Jung said this,’ and ‘Jung did that,’ and ‘Jung thought that.’ When you did something, he was always present somehow. He just continued to live on. He was with us. He is still with us,” Baumann said. Baumann is an architect and also the president of the board of the C. G. Jung Institute in Küsnacht. He deals with Jungians all the time, and for them, he said, it was the same. Jung was both there and not there. “It’s sort of like a hologram,” he said. “Everyone projects something in the space, and Jung begins to be a real person again.”
ONE NIGHT DURING the week of the scanning in Zurich, I had a big dream. A big dream, the Jungians tell me, is a departure from all your regular dreams, which in my case meant this dream was not about falling off a cliff or missing an exam. This dream was about an elephant — a dead elephant with its head cut off. The head was on a grill at a suburban-style barbecue, and I was holding the spatula. Everybody milled around with cocktails; the head sizzled over the flames. I was angry at my daughter’s kindergarten teacher because she was supposed to be grilling the elephant head at the barbecue, but she hadn’t bothered to show up. And so the job fell to me. Then I woke up.
At the hotel breakfast buffet, I bumped into Stephen Martin and a Californian analyst named Nancy Furlotti, who is the vice president on the board of the Philemon Foundation and was at that moment having tea and muesli.
“How are you?” Martin said.
“Did you dream?” Furlotti asked
“What do elephants mean to you?” Martin asked after I relayed my dream.
“I like elephants,” I said. “I admire elephants.”
“There’s Ganesha,” Furlotti said, more to Martin than to me. “Ganesha is an Indian god of wisdom.”
“Elephants are maternal,” Martin offered, “very caring.”
They spent a few minutes puzzling over the archetypal role of the kindergarten teacher. “How do you feel about her?” “Would you say she is more like a mother figure or more like a witch?”
Giving a dream to a Jungian analyst is a little bit like feeding a complex quadratic equation to someone who really enjoys math. It takes time. The process itself is to be savored. The solution is not always immediately evident. In the following months, I told my dream to several more analysts, and each one circled around similar symbolic concepts about femininity and wisdom. One day I was in the office of Murray Stein, an American analyst who lives in Switzerland and serves as the president of the International School of Analytical Psychology, talking about the Red Book. Stein was telling me about how some Jungian analysts he knew were worried about the publication — worried specifically that it was a private document and would be apprehended as the work of a crazy person, which then reminded me of my crazy dream. I related it to him, saying that the very thought of eating an elephant’s head struck me as grotesque and embarrassing and possibly a sign there was something deeply wrong with my psyche. Stein assured me that eating is a symbol for integration. “Don’t worry,” he said soothingly. “It’s horrifying on a naturalistic level, but symbolically it is good.”
It turned out that nearly everybody around the Red Book was dreaming that week. Nancy Furlotti dreamed that we were all sitting at a table drinking amber liquid from glass globes and talking about death. (Was the scanning of the book a death? Wasn’t death followed by rebirth?) Sonu Shamdasani dreamed that he came upon Hoerni sleeping in the garden of a museum. Stephen Martin was sure that he had felt some invisible hand patting him on the back while he slept. And Hugh Milstein, one of the digital techs scanning the book, passed a tormented night watching a ghostly, white-faced child flash on a computer screen. (Furlotti and Martin debated: could that be Mercurius? The god of travelers at a crossroads?)
Early one morning we were standing around the photo studio discussing our various dreams when Ulrich Hoerni trudged through the door, having deputized his nephew Felix to spend the previous night next to the Red Book. Felix had done his job; the Red Book lay sleeping with its cover closed on the table. But Hoerni, appearing weary, seemed to be taking an extra hard look at the book. The Jungians greeted him. “How are you? Did you dream last night?”
“Yes,” Hoerni said quietly, not moving his gaze from the table. “I dreamed the book was on fire.”
ABOUT HALFWAY THROUGH the Red Book — after he has traversed a desert, scrambled up mountains, carried God on his back, committed murder, visited hell; and after he has had long and inconclusive talks with his guru, Philemon, a man with bullhorns and a long beard who flaps around on kingfisher wings — Jung is feeling understandably tired and insane. This is when his soul, a female figure who surfaces periodically throughout the book, shows up again. She tells him not to fear madness but to accept it, even to tap into it as a source of creativity. “If you want to find paths, you should also not spurn madness, since it makes up such a great part of your nature.”
The Red Book is not an easy journey — it wasn’t for Jung, it wasn’t for his family, nor for Shamdasani, and neither will it be for readers. The book is bombastic, baroque and like so much else about Carl Jung, a willful oddity, synched with an antediluvian and mystical reality. The text is dense, often poetic, always strange. The art is arresting and also strange. Even today, its publication feels risky, like an exposure. But then again, it is possible Jung intended it as such. In 1959, after having left the book more or less untouched for 30 or so years, he penned a brief epilogue, acknowledging the central dilemma in considering the book’s fate. “To the superficial observer,” he wrote, “it will appear like madness.” Yet the very fact he wrote an epilogue seems to indicate that he trusted his words would someday find the right audience.
Shamdasani figures that the Red Book’s contents will ignite both Jung’s fans and his critics. Already there are Jungians planning conferences and lectures devoted to the Red Book, something that Shamdasani finds amusing. Recalling that it took him years to feel as if he understood anything about the book, he’s curious to know what people will be saying about it just months after it is published. As far as he is concerned, once the book sees daylight, it will become a major and unignorable piece of Jung’s history, the gateway into Carl Jung’s most inner of inner experiences. “Once it’s published, there will be a ‘before’ and ‘after’ in Jungian scholarship,” he told me, adding, “it will wipe out all the biographies, just for starters.” What about the rest of us, the people who aren’t Jungians, I wondered. Was there something in the Red Book for us? “Absolutely, there is a human story here,” Shamdasani said. “The basic message he’s sending is ‘Value your inner life.’ ”
After it was scanned, the book went back to its bank-vault home, but it will move again — this time to New York, accompanied by a number of Jung’s descendents. For the next few months it will be on display at the Rubin Museum of Art. Ulrich Hoerni told me this summer that he assumed the book would generate “criticism and gossip,” but by bringing it out they were potentially rescuing future generations of Jungs from some of the struggles of the past. If another generation inherited the Red Book, he said, “the question would again have to be asked, ‘What do we do with it?’ ”
Stephen Martin too will be on hand for the book’s arrival in New York. He is already sensing that it will shed positive light on Jung — this thanks to a dream he had recently about an “inexpressively sublime” dawn breaking over the Swiss Alps — even as others are not so certain.
In the Red Book, after Jung’s soul urges him to embrace the madness, Jung is still doubtful. Then suddenly, as happens in dreams, his soul turns into “a fat, little professor,” who expresses a kind of paternal concern for Jung.
Jung says: “I too believe that I’ve completely lost myself. Am I really crazy? It’s all terribly confusing.”
The professor responds: “Have patience, everything will work out. Anyway, sleep well.”
This article has been revised to reflect the following correction:
Correction: September 20, 2009
An article on Page 34 this weekend about Carl Jung and a book he wrote about struggling with his own demons misspells the name of a street in Zurich where, before it was published, the book was held for years in a bank safe-deposit box, and a correction in this space on Saturday also misspelled the name. It is Bahnhofstrasse, not Banhofstrasse or Banhoffstrasse. The article also misstates the location of Bollingen, the town where Jung built a stone tower as a summer residence. While it is on the north shore of Lake Zurich, it is south of the Jung family home in Küsnacht.
Sen. Tom Coburn’s (R-Okla.) Chief of Staff: ‘All Pornography Is Homosexual Pornography’
By David Weigel 9/20/09 1:54 PM
One of the final events of the Values Voter Summit was a Saturday breakout session on “the new masculinity,” a wide-ranging topic that one speaker used to explain how any and all pornography could lead young people into homosexual lifestyles. That speaker was Sen. Tom Coburn’s (R-Okla.) chief of staff Michael Schwartz, a longtime conservative activist who has worked for the senator since 2005.
“Pornography is a blight,” Schwartz told an audience in a crowded room of the Omni Shoreham hotel. “It is a disaster. It is one of those silent diseases in our society that we haven’t been able to overcome very well. Now, I may be getting politically incorrect here. And it’s been a few years, but not that many, since I was closely associated with pre-adolescent boys, boys around 10 years of age. But it is my observation that boys of that age have less tolerance for homosexuality than just about any other class of people. They speak badly about homosexuality. And that’s because they don’t want to be that way. They don’t want to fall into it.”
Schwartz told the crowd about Jim Johnson, a friend of his who turned an old hotel into a hospice for gay men dying of AIDS. “One of the things he said to me,” said Schwartz, “that I think is an astonishingly insightful remark… he said ‘All pornography is homosexual pornography, because all pornography turns your sexual drive inwards.”
There were murmurs and gasps from the crowd. “Now, think about that,” said Schwartz. “And if you tell an 11-year-old boy about that, do you think he’s going to want to get a copy of Playboy? I’m pretty sure he’ll lose interest. That’s the last thing he wants! You know, that’s a good comment, it’s a good point, and it’s a good thing to teach young people.”
Here’s the final portion of Schwartz’s remarks.
so…
basically internalized or introverted sexuality equals homosexuality
same thing
?
oh
and that’s a bad thing
!Luh ah ah Jik!
the first vid in a 17 part series made by AronRa
check out his youtube page for the series and more of his work
http://www.youtube.com/AronRa
http://darwinwasright.homestead.com/1stFFoC.html
The U.S. population seems pretty evenly divided over whether the human species is biologically related to other animals or whether we were “specially-created” as part of a flurry of miracles. Even our collective politicians -seemingly all of them- are wrapped up in this controversy. Yet its hard to find even one of them who knows what its about. Why is it that there is such concern in so many grade schools (K thru 12) about teaching evolution, yet there is still a complete consensus among scientists all over America and the rest of the world -that evolution is the backbone of modern biology, and a demonstrable reality historically as well?
Most people really don’t understand science; what it is, how it works, what hypotheses and theories are, or even the purpose behind it. Sadly even those on your school faculty or state Board of Education often need an education themselves before they can be trusted to govern how or what our kids will be taught, and that’s why I thought I should speak up and do what I can to help.
To adequately understand evolution, you not only have to understand how to be scientific, (which is the real trick for most people) but you also have to know something about cellular biology, genetics, and anatomy, geology, particularly paleontology, as well as environmental systems, tectonics, atomic chemistry, and especially taxonomy, which most people don’t know squat about at all. Most people who accept evolution also tend to know a whole lot about cosmology, geography, history, sociology, politics, and of course, religion.
But to believe in creationism, you don’t have to know anything about anything, and its better if you don’t! Because creationism relies on ignorance. It is not honest research! It is a scam, a con job exploiting the common folk, and preying on their deepest beliefs and fears. Creationist apologetics depends on misrepresented data and misquoted authorities, out-of-date and out-of-context, and uses distorted definitions if it uses definitions at all.
There are basically two types of creationists; the professional or political creationists; these are the activists who lead the movement and who will regularly deliberately lie to promote their propaganda; and the second type which are the innocently-deceived followers commonly known as “sheep”. I know lots of intellectual Christians, but I can’t get any of them to actually watch the tele-evangelists, because they either already know how phony they are, or they don’t want to find out. But that only allows a radical fringe to claim support from they masses they now also claim to represent. So there’s nothing to stop them. Professional creationists are making money hand over fist with faith-healing scams or bilking little old ladies out of prayer donations, or selling books and videos at their circus-like seminars where they have undeserved respect as powerful leaders. All of them feign knowledge they can’t really possess, and some of them claim degrees they’ve never actually earned.
“You are a scientist, correct?”
“That’s right; I have a PhD in truthology from Christian Tech.”
Were it not for this con, they’d have to go back to selling used cars, wonder drugs, and multi-level marketing schemes. They will never change their minds no matter what it costs anyone else. So it is obviously the “sheep” whom I’m attempting to reach with this speech –so that they might not be sheep anymore, and will stop feeding fuel into that manipulative movement. Because its one thing to believe in something that might be true (like God in general or Christianity specifically) even though neither can be substantiated or tested in any objective way. But it is a whole other matter to willfully deceive others into believing things which are definitely not true -like creationism, especially when we can also prove that those doing this know their assorted arguments are bogus, and know they’re lying to our children, and that they hope to continue doing so under the guise of “education”.
Creationism extorts support through peer-pressure, prejudice, and paranoid propaganda, and sells itself with short, simplistic slogans which appeal to those who don’t want to think too much, or are afraid to question their own beliefs. Worst of all, it actually forbids critical inquiry, and promotes anti-intellectualism, and it is based on at least a dozen foundational falsehoods. First and foremost among them is the idea that accepting evolution requires the rejection of theism, if not all other religious or spiritual beliefs as well.
For decades those behind the creationism movement have tried very hard to portray the illusion that one cannot accept evolution and still believe in God. They know better, but they still want you to believe that evolution is atheist, and that it is either evolution without God, or God creating without evolution. That’s been their central claim since the creationism movement began. But this supposed controversy never was about whether or not there is a god. Most people believe there is a god, and they believe he is in control of all the seemingly-random events of our lives. This is true of most of the people who accept evolution also. Most of them believe in God as well, and they believe that God is in control of evolution; that evolution, like every other system in nature, is part of God’s design.
Of the couple hundred different, and often violently-conflicting denominations of Christianity, the largest of them by far is Catholicism followed by Orthodoxy. Both of these have stated support of evolution and denounced creationism. Pope Benedict recently described evolution as an “enriching reality” and described creationist contests against it as “absurd”. Both of the popes before him advised Christians ‘round the world to consider evolution to be “more than an hypothesis” and not to fear acceptance of that as being any challenge to their faith in Christ.
The early pioneers of evolutionary science were all initially Christian, (including Darwin) and many leading proponents of modern evolutionary science are still Christian today. For example, microbiologist Dr. Ken Miller, (who testified against intelligent design creationism in Kitzmiller v. Dover) -is a Catholic. Another outspoken proponent of evolution, Dr. Robert T. Bakker, (who has PhDs from both Harvard and Yale) is not only one of the leading, and most recognizable paleontologists in the world today, but he also happens to be a Bible-believing Pentecostal preacher; though he interprets Genesis differently than literalists would. In his book, Bones, Bibles and Creation, he says that to treat the Bible as though it were common history is to degrade its eternal meaning. One of the earliest geneticists, Theodosius Dobzhansky was an Orthodox Christian who many times professed his belief that life was created by God, but that nothing in biology made sense except in light of evolution. All these men agree that even if there really is a god, and even if that god is the Christian god, and even if that god created the universe and everything in it, =which they all believe- evolution would still be at least mostly true, and creationism would still be completely wrong.
Of all the developed nations throughout Christendom, only the United States has a significant number of creationists, and they’re the minority even here! Every other predominantly-Christian country tends to regard creationism as an incredulous, (if not insane) radical fringe movement which is an almost exclusively American phenomenon, and not taken seriously anywhere else. Poll after poll continues to reveal that, around the world, most “evolutionists” are Christian, and most Christians are evolutionists. So evolution is not synonymous with atheism, and creationism isn’t synonymous with Christianity either. Most creationists aren’t even Christians! There are millions more Muslim and Hindu creationists than Christian ones.
Regardless which religion they claim, creationism can be collectively defined as the fraction of religious believers who reject science, not just the conclusions of science, but its methods as well, and I mean all of them, from uniformitarianism and methodological naturalism to the peer review process and requirement that all positive claims be based on testable evidence. These people rely instead on blind faith in the assumed authority of their favored fables. In all cases, creationism is an obstinate and dogmatic superstitious belief which holds that members of most seemingly-related taxonomic groups did not evolve naturally, but were created magically, -that plants and animals were literally poofed out of nothing fully-formed, in their current state, unrelated to anything else –despite all indications to the contrary.
Creationists may side with western Abrahamic religions, (being the Judeo-Christian/Islamic mythos) in which there are conflicting versions of the same tales. Or creationists may belong to one of many eastern religions where the sacred stories of creation are much older, completely different, and dedicated to other gods and pantheons. But in every case, the proposed “creator” is supernatural, meaning that it is not a part of perceptible reality. Therefore it is undetectable by any testable means, and can only be assumed to exist for subjective emotional reasons, or as a result of cultural indoctrination, rather than because of any measurable evidence or logical rationale. In other words, there’s no way to say if its really there. Worst of all, there’s also no way to distinguish anyone’s gods or ghosts from the imaginary beings some primitive folks just made up either. This doesn’t mean no god exists. But it does mean that science can’t say anything about them. Because even if gods are real, they still don’t appear to be, and apparently don’t want to –since all the holy books demand they be believed on faith alone. As there is nothing anyone can verify and thus actually know to be correct about gods, then science is unable to make any comment about them at all. Because science can only ever investigate things with demonstrable evidence can be tested or measured.
From the creationist’s perspective, the method or mechanism of creation which these mystical beings use is nothing more than a golem spell where clay statues are animated with an enchantment. Or its an incantation in which complex modern plants and animals are “spoken” into being. That’s right, magic words which cause fully-developed adult animals to be conjured out of thin air. Or a god simply wishes them to exist; so they do. That’s it! There really is nothing more to it than that; pure freakin’ magic –by definition. Remember that the next time you hear anything from a creation “scientist”.
So for those who believe in God, the question really is how God created, and whether it was by one of many inextricably integrated natural systems he seemingly designed, or whether he simply blinked, wiggled his nose, wished upon a star and said “abra-cadabera”.
The 1st Falsehood of creationism:
“evolution = atheism”
seriously
https://www.accu-chek.com/data/born/index.html
it has an american flag on it!
couldnt pull the vid alone
but got the whole page flash
can’t really run it bigger than this though
facts as 0f 2007 via the international diabetes foundation
-Up to 80% of type 2 diabetes is preventable by adopting a healthy diet and increasing physical activity.
-Diabetes is the fourth leading cause of global death by disease.
-Type 2 diabetes has become the most frequent condition in people with kidney failure in countries of the Western world. The reported incidence varies between 30% and 40% in countries such as Germany and the USA.
ol boy has a helmet that can…
yeah
just watch
the helmet is in the intro to the lecture itself
i like to listen to this guy speak
his voice
his logic
searchin out more of his work now
kinda curious as to why im ignorant of him given the work n all
“christians” or christ likin folk should pay attention to the 36:45 min mark up until 39:00
and the info presented on rauvolfia
then his remarks on synergism
this is one h.a.i.r.y. fella
47:45 is another buena vista!
this…
“thing”
IS ridiculous
http://www.4degreez.com/misc/personality_disorder_test.mv
wow
there are even forums you can go to to seek help for your disorders!
tha fuck??!!
there are 14 yr old kids on there proclaiming fear and despair over being “diagnosed” by this test
oh wow
i cant even answer most of these loaded questions
shit
its structured to where if you have an emotion it has to place you in one of the categories lke “you’re doin it wrong”
so many of the forum post are about folk being afraid of the disorders and searchin for help
shit
psychology is either absolutely proper or disastrously wrong
sort of like reggae music
seriously
i mean
seriously
LOGIC!
anyways
yeah
reminds me of third grade
didn’t have as many laughs then though
i have no idea what any of these people are tryin to accomplish in this vid
now i assume and project the main goal is proselytizing and righteous herd identification
on all 3 sides
even the police
that’s about all i can gather and deduce as far as ends
but the means…
WTF
the cops were the only ones doin it right
fuck i just typed that
but yeah
they won and converted most of the folk to their civil order paradigm
as well as accomplishing both herds lookin to them as answerable authority
so i’ve really been tryin to empathize with this bill
see if i can find the logic play
and how this is a means to an end
i did some extensive and exhausted web searches and most of what i’m herain and seein is a bunch of left leanin libbys cryin on how mommy and daddy are raisin them
how wrong it is that hey are tellin them what to eat
idk
i really want to slap them and say
“quit bitchin about the paradigm you created!”
“you made the bed, lie in it”
“KARMA”
here’s some of the propaganda i’ve received and come across
http://www.federaljack.com/index.php?s=organic <-where is that first vid from? and how scary are they tryin to be in their bullshit boo!
http://www.change.org/ideas/6133/view_blog/hr_875s_425_farm_to_fork_food_fascism_comes_to_america
http://www.opencongress.org/bill/111-h875/show
http://www.facebook.com/group.php?gid=59474562131
http://www.thenhf.com/press_releases/pr_26_mar_2009.html
http://boards.straightdope.com/sdmb/showthread.php?t=511973
http://www.opednews.com/articles/Response-to-Myths-and-Fac-by-Aaron-Lucich-090315-298.html
http://www.opednews.com/articles/CODEX-is-in-HR-875–learn-by-Abu-Ahmad-090511-625.html
http://www.opednews.com/populum/search.php?mode=AR&pg=30&from=183&to=0&search_requested=hr+875&submit=Site
idk
my utopian fairy tale would be that these folk said
“ok gub’ment”
“but we are responsible for our own life”
“we dont need nor want for you to do for us”
but again it dawns on me
that is a right sided logic
not left
right now the entity that thinks it owns and runs me has already told me what i can and can’t grow in my garden
they just said i was wrong for a garden of beautiful purple flowers last year
there are hundreds of plants/fruits/veggies that this authoritative entity tells me not to grow
so what does one do now?
what will you do?
the entire bill is listed below
but i’ve taken time to pull ou the prohibitive acts section here
i read that it’s not that organic farming is to become illegal like i keep hearin
and it seems to be focused on interstate commerce more so
even in the penalties section it is focused on businesses of people not their private use
but there is the lack of responsibility in the regulation and inspection by the government(although i wonder if that is only for interstate commerce as well
ya
responsibility is the only issue i see
imo
liberal dems fel entitled for someone to do for them and everyone else
in the projected solipsism of my way is the best way
then they bitch when the folk doin for them arent doin it the way they want
a libertarian rep wuld rather do it his way for him and bitch at himself if he does it wrong
SEC. 401. PROHIBITED ACTS.
It is prohibited–
(1) to manufacture, introduce, deliver for introduction, or receive in interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate commerce;
(3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
(4) to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);
(5) to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);
(6) to refuse to permit entry to or inspection of a food establishment as required under section 205;
(7) to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);
(8) to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;
(9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;
(10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;
(11) to fail to comply with a recall or other order under section 403; or
(12) to otherwise violate the food safety law.
Text of H.R. 875: Food Safety Modernization Act of 2009
111th CONGRESS
1st Session
H. R. 875
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
February 4, 2009
Ms. DELAURO (for herself, Ms. ESHOO, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. ENGEL, Ms. CASTOR of Florida, Mr. MURPHY of Connecticut, Ms. SUTTON, Mrs. LOWEY, Ms. SLAUGHTER, Mr. HINCHEY, Mr. MCGOVERN, Ms. WASSERMAN SCHULTZ, Ms. HIRONO, Mr. GRIJALVA, Mr. SCHAUER, Mr. NADLER of New York, Mr. BISHOP of New York, Ms. LINDA T. SANCHEZ of California, Mr. MCDERMOTT, Mr. RYAN of Ohio, Ms. GIFFORDS, Mr. FILNER, Mr. HALL of New York, Ms. LEE of California, Ms. PINGREE of Maine, Ms. KAPTUR, Mr. BISHOP of Georgia, Ms. MOORE of Wisconsin, and Mr. DEFAZIO) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the ‘Food Safety Modernization Act of 2009’.
(b) Table of Contents- The table of contents of this Act is as follows:
TITLE I–ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
TITLE II–ADMINISTRATION OF FOOD SAFETY PROGRAM
TITLE III–RESEARCH AND EDUCATION
TITLE IV–ENFORCEMENT
TITLE V–IMPLEMENTATION
SEC. 2. FINDINGS; PURPOSES.
(a) Findings- Congress finds that–
(1) the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation’s economy;
(2) lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce and international trade;
(3) recent ongoing events demonstrate that the food safety program at the Food and Drug Administration is not effective in controlling hazards in food coming from farms and factories in the United States and food and food ingredients coming from foreign countries, and these events have adversely affected consumer confidence;
(4) the safety and security of the food supply require a systemwide approach to prevent food-borne illness involving the integrated efforts of Federal, State and local agencies; a thorough, broad-based, and coordinated approach to basic and applied science; and intensive, effective, and efficient management of the Nation’s food safety program;
(5) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to–
(A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
(B) the threat of intentional contamination of the food supply;
(C) a growing number of people at high risk for food-borne illnesses, including an increasing population of aging and immune-compromised consumers, together with infants and children;
(D) an increasing volume of imported food, without adequate monitoring, inspection, and systems for prevention of food safety problems; and
(E) maintenance of rigorous inspection of the domestic food processing and food service industries;
(6) Federal food safety standard setting, inspection, enforcement, and research efforts should be based on the best available science and public health considerations, and food safety resources should be systematically deployed in ways that most effectively prevent food-borne illness;
(7) the Food and Drug Administration, an agency within the Department of Health and Human Services, has regulatory jurisdiction over the safety and labeling of 80 percent of the American food supply, encompassing all foods except meat, poultry, and egg products, as well as drugs, medical devices, and biologics;
(8) rapid technological advance and the expansion and globalization of industries in all areas of Food and Drug Administration jurisdiction present challenges and require leadership beyond the capacity of any one agency or agency head to provide;
(9) in the food safety area, the Food and Drug Administration implements provisions of the Federal Food, Drug, and Cosmetic Act that are 70 years old and that antiquated law limits the Food and Drug Administration’s role largely to reacting to and correcting food safety problems after they occur, rather than working with the food industry to systematically prevent problems;
(10) the Food and Drug Administration’s effectiveness is further impaired by fragmentation of leadership and management within the Administration, as major food safety responsibilities are dispersed across the Administration’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and Office of Regulatory Affairs;
(11) there is no official with the full-time responsibility and budget authority for food safety at the Food and Drug Administration and food safety competes unsuccessfully with the drug and medical device programs for senior agency management attention and resources; and
(12) improving Federal oversight of food safety requires a modern food safety mandate, clear authorities, and a dedicated official within the Department of Health and Human Services with budget authority to manage an integrated organizational structure and report directly to the Secretary.
(b) Purposes- The purposes of this Act are–
(1) to establish an agency within the Department of Health and Human Services to be known as the ‘Food Safety Administration’ to–
(A) regulate food safety and labeling to strengthen the protection of the public health;
(B) ensure that food establishments fulfill their responsibility to process, store, hold, and transport food in a manner that protects the public health of all people in the United States;
(C) lead an integrated, systemwide approach to food safety and to make more effective and efficient use of resources to prevent food-borne illness;
(D) provide a single focal point within the Department of Health and Human Services for food safety leadership, both nationally and internationally; and
(E) provide an integrated food safety research capability, including internally generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments;
(2) to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the date of the enactment of this Act, are performed by various components of the Food and Drug Administration and the National Oceanic and Atmospheric Administration;
(3) to modernize and strengthen the Federal food safety law to ensure more effective application and efficient management of the laws for the protection and improvement of public health; and
(4) to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements of this law.
SEC. 3. DEFINITIONS.
In this Act:
(1) ADMINISTRATION- The term ‘Administration’ means the Food Safety Administration established under section 101(a)(1).
(2) ADMINISTRATOR- The term ‘Administrator’ means the Administrator of Food Safety appointed under section 101(a)(2).
(3) ADULTERATED-
(A) IN GENERAL- The term ‘adulterated’ has the meaning given that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
(B) INCLUSION- The term ‘adulterated’ includes bearing or containing a contaminant that causes illness or death among sensitive populations.
(4) AGENCY- The term ‘agency’ has the meaning given that term in section 551 of title 5, United States Code.
(5) CATEGORY 1 FOOD ESTABLISHMENT- The term ‘category 1 food establishment’ means a food establishment (other than a seafood processing establishment) that slaughters, for the purpose of producing food, animals that are not subject to inspection under the Federal Meat Inspection Act or poultry that are not subject to inspection under the Poultry Products Inspection Act.
(6) CATEGORY 2 FOOD ESTABLISHMENT- The term ‘category 2 food establishment’ means a seafood processing establishment or other food establishment (other than a category 1 establishment) not subject to inspection under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, that processes raw seafood or other raw animal products, whether fresh or frozen, or other products that the Administrator determines by regulation to pose a significant risk of hazardous contamination.
(7) CATEGORY 3 FOOD ESTABLISHMENT- The term ‘category 3 food establishment’ means a food establishment (other than a category 1 or category 2 establishment) that processes cooked, pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-to-eat raw form, or other products that pose a risk of hazardous contamination.
(8) CATEGORY 4 FOOD ESTABLISHMENT- The term ‘category 4 food establishment’ means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).
(9) CATEGORY 5 FOOD ESTABLISHMENT- The term ‘category 5 food establishment’ means a food establishment that stores, holds, or transports food products prior to delivery for retail sale.
(10) CONTAMINANT- The term ‘contaminant’ includes a bacterium, chemical, natural toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.
(11) HAZARDOUS CONTAMINATION- The term ‘hazardous contamination’ refers to the presence of a contaminant in food at levels that pose a risk of human illness, injury, or death or are capable of reaching levels that pose such risk during the shelf life of the product.
(12) FOOD- The term ‘food’ means a product intended to be used for food or drink for a human or an animal and components thereof.
(13) FOOD ESTABLISHMENT-
(A) IN GENERAL- The term ‘food establishment’ means a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.
(B) EXCLUSIONS- For the purposes of registration, the term ‘food establishment’ does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).
(14) FOOD PRODUCTION FACILITY- The term ‘food production facility’ means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.
(15) FOOD SAFETY LAW- The term ‘food safety law’ means–
(A) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, quality, nutritional composition, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food;
(B) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any other Acts that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;
(C) the provisions of the Public Health Service Act that relate in any way to studying, surveying, containing, or preventing food-borne illness; and
(D) the provisions of this Act.
(16) FOREIGN FOOD ESTABLISHMENT- The term ‘foreign food establishment’ means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.
(17) INTERSTATE COMMERCE- The term ‘interstate commerce’ has the meaning given that term in section 201(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
(18) MISBRANDED- The term ‘misbranded’ has the meaning given that term in section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
(19) PROCESS- The term ‘process’ or ‘processing’ means the commercial slaughter, packing, preparation, or manufacture of food.
(20) STATE- The term ‘State’ means–
(A) a State;
(B) the District of Columbia;
(C) the Commonwealth of Puerto Rico; and
(D) any other territory or possession of the United States.
TITLE I–ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.
(a) Establishment-
(1) IN GENERAL- There is established in the Department of Health and Human Services an agency to be known as the ‘Food Safety Administration’.
(2) HEAD OF THE ADMINISTRATION- The Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate, for a term of 5 years, and who may be reappointed.
(3) DELEGATION- All the authorities and responsibilities assigned to the Secretary of Health and Human Services in the food safety law are hereby assigned to the Administrator.
(b) Duties of Administrator- The Administrator shall–
(1) administer and enforce the food safety law;
(2) serve as the food safety leader within the Department of Health and Human Services and coordinator of all Department activities related to ensuring the safety, quality, and proper labeling of the food supply;
(3) represent the United States in relevant international food safety bodies and discussions;
(4) promulgate regulations to ensure the safety and security of the food supply from all forms of contamination, including intentional contamination; and
(5) oversee within the Department of Health and Human Services–
(A) in consultation with the Director of the Centers for Disease Control and Prevention, all activities related to foodborne illness surveillance and investigation of foodborne illness outbreaks;
(B) implementation of food safety inspection, enforcement, and research efforts to protect the public health;
(C) development of consistent and science-based standards for safe food;
(D) coordination and prioritization of food safety research and education programs with other Federal agencies;
(E) prioritization of food safety efforts and deployment of food safety resources to achieve the greatest possible benefit in reducing food-borne illness;
(F) coordination of the response to food-borne illness outbreaks with other Federal and State agencies; and
(G) integration of food safety activities with State and local agencies.
SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.
(a) Transfer of Functions and Resources- For each component of the Department of Health and Human Services or the Department of Commerce specified in subsection (b), there are transferred to the Administration all functions, personnel, and assets (including facilities and financial resources) of those components as of the day before the date of the enactment of this Act (including all related functions of any officer or employee of the component) that relate to administration or enforcement of the food safety law, as determined by the President.
(b) Transferred Functions and Resources- The components referred to in subsection (a) are–
(1) the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;
(2) the Center for Veterinary Medicine of the Food and Drug Administration;
(3) the National Center for Toxicological Research of the Food and Drug Administration;
(4) the personnel and assets of the Office of Regulatory Affairs of the Food and Drug Administration used to administer and conduct inspections of food establishments and imports and conduct laboratory analyses and other investigations relating to food safety and enforcement of the food safety law;
(5) the personnel and assets of the Office of the Commissioner of Food and Drugs used to support–
(A) the Center for Food Safety and Applied Nutrition;
(B) the Center for Veterinary Medicine;
(C) the National Center for Toxicological Research; and
(D) the personnel and assets of the Office of Regulatory Affairs described in paragraph (4); and
(6) the personnel and assets of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce used to administer the seafood inspection program.
(c) Renaming and Reservation of Agency Identity- The Food and Drug Administration in the Department of Health and Human Services is hereby renamed the Federal Drug and Device Administration and may be referred to as ‘FDA’.
(d) Sharing of Facilities and Resources- The Food Safety Administration and the Federal Drug and Device Administration shall enter into such agreements concerning the sharing of facilities and other resources as may be appropriate to make efficient use of such facilities and resources and achieve their respective missions.
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.
(a) Officers and Employees- The Administrator may–
(1) appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and
(2) fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.
(b) Experts and Consultants- The Administrator may–
(1) procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and
(2) pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.
(c) Bureaus, Offices, and Divisions- The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.
(d) Advisory Committees-
(1) IN GENERAL- The Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.
(2) DUTIES- The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of new processes, research, communications, performance standards, and inspection.
TITLE II–ADMINISTRATION OF FOOD SAFETY PROGRAM
SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.
(a) In General- The Administrator shall–
(1) develop, administer, and annually update a national food safety program (referred to in this section as the ‘program’) to protect public health; and
(2) ensure that persons who produce, process, or distribute food meet their responsibility to prevent or minimize food safety hazards related to their products.
(b) Comprehensive Analysis- The program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of–
(1) the severity of the potential health risks;
(2) the sources of potentially hazardous contamination or practices extending from the farm or ranch to the consumer that may increase the risk of food-borne illness;
(3) the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;
(4) the potential for hazardous contamination to have cumulative toxic effects, multigenerational effects, or effects on specific categories of consumers;
(5) opportunities across the food production, processing, distribution, and retail system to reduce potential health risks; and
(6) opportunities for intentional contamination of food or food ingredients.
(c) Program Elements- In carrying out the program, the Administrator shall–
(1) adopt and implement a national system for the registration of food establishments and foreign food establishments, as provided in section 202 of this Act;
(2) adopt and implement a national system for regular unannounced inspection of food establishments;
(3) require and enforce the adoption of preventive process controls in food establishments, based on the best available scientific and public health considerations and best available technologies;
(4) establish and enforce science-based standards for–
(A) potentially hazardous substances that may contaminate food; and
(B) safety and sanitation in the processing and handling of food;
(5) implement a statistically valid sampling program with the stringency and frequency to independently monitor that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the standards established under this Act;
(6) implement appropriate surveillance procedures and requirements to ensure the safety and security of imported food;
(7) coordinate and collaborate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;
(8) implement a national system to identify the food products posing the greatest public health risk and to analyze the effectiveness of existing food safety programs, in conjunction with the Centers for Disease Control and Prevention and other Federal agencies;
(9) develop public education, risk communication, and advisory programs;
(10) implement an applied research program to further the purposes of this Act;
(11) coordinate and prioritize food safety research and educational programs with other Federal agencies and with State and local governments; and
(12) provide technical assistance to farmers and food establishments that are small business concerns (meeting the requirements of section 3(a) of the Small Business Act and the regulations promulgated thereunder) to assist with compliance with the requirements of this Act.
SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND FOREIGN FOOD ESTABLISHMENTS.
(a) In General- Any food establishment or foreign food establishment engaged in manufacturing, processing, packing, or holding food for consumption in the United States shall register annually with the Administrator.
(b) Registration Requirements-
(1) IN GENERAL- To be registered under subsection (a), a food establishment shall submit a registration or reregistration to the Administrator.
(2) REGISTRATION- Registration under this section shall begin within 90 days of the enactment of this Act. Each such registration shall be submitted to the Secretary through an electronic portal and shall contain such information as the Secretary, by guidance, determines to be appropriate. Such registration shall contain the following information:
(A) The name, address, and emergency contact information of each domestic food establishment or foreign food establishment that the registrant owns or operates under this Act and all trade names under which the registrant conducts business in the United States relating to food.
(B) The primary purpose and business activity of each domestic food establishment or foreign food establishment, including the dates of operation if the domestic food establishment or foreign food establishment is seasonal.
(C) The types of food processed or sold at each domestic food establishment or, for foreign food establishments selling food for consumption in the United States, the specific food categories of that food as listed under section 170.3(n) of title 21, Code of Federal Regulations, or such other categories as the Administrator may designate in guidance, action level, or regulations for evaluating potential threats to food protection.
(D) The name, address, and 24-hour emergency contact information of the United States distribution agent for each domestic food establishment or foreign food establishment, who shall maintain information on the distribution of food, including lot information, and wholesaler and retailer distribution.
(E) An assurance that the registrant will notify the Administrator of any change in the products, function, or legal status of the domestic food establishment or foreign food establishment (including cessation of business activities) not later than 30 days after such change.
(3) PROCEDURE- Upon receipt of a completed registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, designate each establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration number to each domestic food establishment and foreign food establishment.
(4) LIST- The Administrator shall annually compile a list of domestic food establishments and a list of foreign food establishments that are registered under this section. The Administrator may establish the manner of and any fees required for reregistration and any circumstances by which either such list may be shared with other governmental authorities. The Administrator may remove from either list the name of any establishment that fails to reregister, and such delisting shall be treated as a suspension.
(5) DISCLOSURE EXEMPTION- The disclosure requirements under section 552 of title 5, United States Code, shall not apply to–
(A) the list compiled under paragraph (4); and
(B) information derived from the list under paragraph (4), to the extent that it discloses the identity or location of a specific person.
(6) SUSPENSION OF REGISTRATION-
(A) IN GENERAL- The Administrator may suspend the registration of a domestic food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law that is either repeated or could result in serious adverse health consequences or death to humans or animals.
(B) NOTICE AND OPPORTUNITY FOR HEARING- The Administrator shall provide notice of an intent to suspend the registration of an establishment under this paragraph to a registrant and provide the registrant with an opportunity for an administrative hearing within 3 days. The Administrator may issue a written order of suspension following the hearing, if the Administrator finds that a violation described in subparagraph (A) has occurred.
(C) JUDICIAL REVIEW- The issuance of an order of suspension under subparagraph (B) shall be considered to be a final agency action subject to judicial review in accordance with the provisions of chapter 7 of title 5, United States Code.
(7) REINSTATEMENT- A registration that is suspended under this section may be reinstated based on a showing that adequate process controls have been instituted that would prevent future violations and there are assurances from the registrant that the violations will not be repeated.
(c) Transitional Provision- During the 6-month period following the date of the enactment of this Act, a food establishment is deemed to be registered in accordance with this section if the establishment is registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d).
(d) Repeal- Effective at the end of the 6-month period following the date of the enactment of this Act, section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is repealed.
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION OF FOOD.
(a) In General- The Administrator shall, upon the basis of best available public health, scientific, and technological data, promulgate regulations to ensure that food establishments carry out their responsibilities under the food safety law.
(b) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations that require all food establishments, within time frames determined by the Administrator–
(1) to adopt preventive process controls that–
(A) reflect the standards and procedures recognized by relevant authoritative bodies;
(B) are adequate to protect the public health;
(C) meet relevant regulatory and food safety standards;
(D) limit the presence and growth of contaminants in food prepared in a food establishment using the best reasonably available techniques and technologies; and
(E) are tailored to the hazards and processes in particular establishments or environments;
(2) to establish a sanitation plan and program that meets standards set by the Administrator;
(3) to meet performance standards for hazardous contamination established under section 204;
(4) to implement recordkeeping to monitor compliance with regulatory requirements;
(5) to implement recordkeeping and labeling of all food and food ingredients to facilitate their identification and traceability in the event of a recall or market removal;
(6) to implement product and environmental sampling at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that regulatory standards are being met;
(7) to label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy microbial contaminants; and
(8) to provide for agency access to records kept by the food establishments and submission of copies of records to the Administrator, as the Administrator determines appropriate.
(c) Specific Hazard Controls- The Administrator may require any person with responsibility for or control over food or food ingredients to adopt specific hazard controls, if such controls are needed to ensure the protection of the public health.
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.
(a) In General- To protect the public health, the Administrator shall establish by guidance document, action level, or regulation and enforce performance standards that define, with respect to specific foods and contaminants in food, the level of food safety performance that a person responsible for producing, processing, or selling food shall meet.
(b) Identification of Contaminants; Performance Standards-
(1) LIST OF CONTAMINANTS- Not later than 6 months after the date of the enactment of this Act, the Administrator shall publish in the Federal Register a list of the contaminants in foods that have the greatest adverse impact on public health in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act. Where appropriate, the Administrator shall indicate whether the risk posed by a contaminant is generalized or specific to particular foods or ingredients.
(2) PERFORMANCE STANDARDS-
(A) ESTABLISHMENT- The Administrator shall establish by guidance document, action level, or regulation a performance standard for each contaminant in the list under paragraph (1) at levels appropriate to protect against the potential adverse health effects of the contaminant.
(B) TIMING- The Administrator shall establish a performance standard under subparagraph (A) for each contaminant in the list under paragraph (1)–
(i) as soon as practicable; or
(ii) in the case of a contaminant described in subparagraph (C), by the date described in such subparagraph.
(C) SIGNIFICANT CONTAMINANTS- The list under paragraph (1) (and any revision thereto) shall identify the 5 most significant contaminants in the list (in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act). Not later than 3 years after a contaminant is so identified, the Administrator shall promulgate a performance standard under subparagraph (A) for the contaminant.
(3) REVIEW; REVISION- Not less than every 3 years, the Administrator shall review and, if necessary, revise–
(A) the list of contaminants under paragraph (1); and
(B) each performance standard established under paragraph (2).
(c) Performance Standards-
(1) IN GENERAL- The performance standards established under this section may include–
(A) health-based standards that set the level of a contaminant that can safely and lawfully be present in food;
(B) zero tolerances, including any zero tolerance performance standards in effect on the day before the date of the enactment of this Act, when necessary to protect against significant adverse health outcomes;
(C) process standards, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; and
(D) in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance on the basis of reliable information on the best reasonably achievable performance, using best available technologies, interventions, and practices.
(2) BEST REASONABLY ACHIEVABLE PERFORMANCE STANDARDS- In developing best reasonably achievable performance standards under paragraph (1)(D), the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.
(3) REVOCATION BY ADMINISTRATOR- All performance standards, tolerances, action levels, or other similar standards in effect on the date of the enactment of this Act shall remain in effect until revised or revoked by the Administrator.
(d) Enforcement-
(1) IN GENERAL- In conjunction with the establishment of a performance standard under this section, the Administrator shall develop a statistically valid sampling program with the stringency and frequency sufficient to independently monitor whether food establishments are complying with the performance standard and implement the program within 1 year of the promulgation of the standard.
(2) INSPECTIONS- If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, the Administrator shall, as appropriate–
(A) detain, seize, or condemn food from the food establishment under section 402;
(B) order a recall of food from the food establishment under section 403;
(C) increase the inspection frequency for the food establishment;
(D) withdraw the mark of inspection from the food establishment, if in use; or
(E) take other appropriate enforcement action concerning the food establishment, including withdrawal of registration.
(e) Newly Identified Contaminants- Notwithstanding any other provision of this section, the Administrator shall establish interim performance standards for newly identified contaminants as necessary to protect the public health.
SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.
(a) In General- The Administrator shall establish an inspection program, which shall include statistically valid sampling of food and facilities to enforce performance standards. The inspection program shall be designed to determine if each food establishment–
(1) is operated in a sanitary manner;
(2) has continuous preventive control systems, interventions, and processes in place to minimize or eliminate contaminants in food;
(3) is in compliance with applicable performance standards established under section 204, and other regulatory requirements;
(4) is processing food that is not adulterated or misbranded;
(5) maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and
(6) is otherwise in compliance with the requirements of the food safety law.
(b) Establishment Categories and Inspection Frequencies- The resource plan required under section 209, including the description of resources required to carry out inspections of food establishments, shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):
(1) CATEGORY 1 FOOD ESTABLISHMENTS- A category 1 food establishment shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that–
(A) diseased animals are not offered for slaughter;
(B) the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; and
(C) applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
(2) CATEGORY 2 FOOD ESTABLISHMENTS- A category 2 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least weekly.
(3) CATEGORY 3 FOOD ESTABLISHMENTS- A category 3 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least monthly.
(4) CATEGORY 4 FOOD ESTABLISHMENTS- A category 4 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least quarterly.
(5) CATEGORY 5 FOOD ESTABLISHMENTS- A category 5 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least annually.
(c) Establishment of Inspection Procedures- The Administrator shall establish procedures under which inspectors shall take random samples, photographs, and copies of records in food establishments.
(d) Alternative Inspection Frequencies- With respect to a subcategory of food establishment under category 2, 3, 4, or 5, the Administrator may establish alternative increasing or decreasing inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources. Before establishing an alternative inspection frequency for a subcategory of food establishments or individual establishments, the Administrator shall take into consideration the evidence described in paragraph (2)(D) and the overall record of compliance described in paragraph (2)(E) for such subcategory. In establishing alternative inspection frequencies under this subsection, the Administrator shall comply with the following criteria and procedures:
(1) Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).
(2) In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider–
(A) the nature of the food products being processed, stored, or transported;
(B) the manner in which food products are processed, stored, or transported;
(C) the inherent likelihood that the products will contribute to the risk of food-borne illness;
(D) the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the proposed subcategory of establishments; and
(E) the overall record of compliance with food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
(3) The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment and shall annually publish a list of establishments subject to alternative inspections.
(4) In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider–
(A) the criteria in paragraph (2), together with any evidence submitted from the individual food establishment supporting a request for an alternative inspection frequency, including the establishment’s record for implementing effective preventive process control systems;
(B) whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and
(C) the establishment’s record of compliance with food safety law, including compliance with applicable performance standards and the frequency of recalls.
(e) Effective Date- The inspection mandates shall go into effect 2 years after the date of the enactment of this Act.
(f) Maintenance and Inspection of Records-
(1) IN GENERAL-
(A) RECORDS- A food establishment shall–
(i) maintain such records as the Administrator shall require by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and
(ii) permit the Administrator, in addition to any authority transferred to the Administrator pursuant to section 102, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–
(I) to determine whether the food is contaminated or not in compliance with the food safety law; or
(II) to track the food in commerce.
(B) REQUIRED DISCLOSURE- A food establishment shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant.
(2) MAINTENANCE OF RECORDS- The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.
(3) REQUIREMENTS- The records in paragraph (1) shall include records describing–
(A) the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
(B) the identity and quantity of ingredients used in the food;
(C) the processing of the food;
(D) the results of laboratory, sanitation, or other tests performed on the food or in the food establishment;
(E) consumer complaints concerning the food or packaging of the food;
(F) the production codes, open date codes, and locations of food production; and
(G) other matters reasonably related to whether food is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
(g) Protection of Sensitive Information-
(1) IN GENERAL- The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or commercially valuable confidential information obtained by the Administrator.
(2) LIMITATION- The requirements under this subsection and subsection (f) do not–
(A) limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act;
(B) have any legal effect on section 1905 of title 18, United States Code;
(C) extend to any food recipe, financial data, pricing data, or personnel data;
(D) limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403; or
(E) limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.
(h) Bribery of or Gifts to Inspector or Other Officers and Acceptance of Gifts- Any person or agent or employee thereof that gives, pays, or offers, directly or indirectly, to the Administrator or any employee or other designee thereof authorized to perform any duty under the food safety law any money or other thing of value, with intent to influence the discharge of any duty under such law, shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both. Any Administrator, employee, or other designee that solicits or accepts any money or other thing of value from any person, with intent to influence the discharge of any duty under the food safety law, shall be summarily discharged from office and imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
SEC. 206. FOOD PRODUCTION FACILITIES.
(a) Authorities- In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to–
(1) visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;
(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;
(3) set good practice standards to protect the public and animal health and promote food safety;
(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and
(5) collect and maintain information relevant to public health and farm practices.
(b) Inspection of Records- A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–
(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or
(2) to track the food in commerce.
(c) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall–
(1) consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;
(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;
(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water;
(4) include, with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;
(5) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;
(6) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and
(7) include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.
(d) Variances- States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c). A request shall–
(1) be in writing;
(2) describe the reasons the variance is necessary;
(3) describe the procedures, processes, and practices that will be followed under the variance to ensure produce is not adulterated; and
(4) contain any other information required by the Administrator.
(e) Approval or Disapproval of Variances- If the Administrator determines after review of a request under subsection (d) that the requested variance provides equivalent protections to those promulgated under subsection (c), the Administrator may approve the request. The Administrator shall deny a request if it is–
(1) not sufficiently detailed to permit a determination;
(2) fails to cite sufficient grounds for allowing a variance; or
(3) does not provide reasonable assurances that the produce will not be adulterated.
(f) Enforcement- The Administrator may coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.
(g) Imported Produce- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations to ensure that raw agricultural commodities and minimally processed produce imported into the United States can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to such commodities and produce produced in the United States.
SEC. 207. FEDERAL AND STATE COOPERATION.
(a) In General-
(1) AUTHORITY- The Administrator shall strengthen and expand food-borne illness surveillance systems to–
(A) inform and evaluate efforts to prevent food-borne illness; and
(B) enhance the identification and investigation of, and response to, food-borne illness outbreaks.
(2) FOOD-BORNE ILLNESS OUTBREAK- For purposes of this section, the term ‘foodborne illness outbreak’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a common food.
(b) Food-Borne Illness Surveillance Systems- The Administrator, in collaboration with the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by–
(1) coordinating food-borne illness surveillance systems, including complaint systems, in order to–
(A) produce better information on illnesses associated with foods, including sources and risk factors for infections by emerging pathogens; and
(B) facilitate sharing of data acquisition and findings on a more timely basis among governmental agencies, including the Food Safety Administration, the Food Safety and Inspection Service, and State and local agencies, and with the public;
(2) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;
(3) developing improved epidemiological tools for obtaining quality exposure data, microbiological methods for classifying cases and detecting clusters, and improved tracebacks to rapidly and specifically identify contaminated food products;
(4) expanding capacity of such systems for implementation of fingerprinting strategies for food-borne infectious agents, including parasites and hepatitis A, in order to increase pathogen discovery efforts to identify new or rarely documented causes of food-borne illness;
(5) allowing timely public access to de-identified, aggregate surveillance data;
(6) at least annually, publishing current reports on findings from such systems;
(7) exploring establishment of registries for long-term case follow-up to better characterize late complications of food-borne illness;
(8) increasing participation in national networks of public health and food regulatory agencies and laboratories to–
(A) allow public health officials at the Federal, State, and local levels to share and accept laboratory analytic findings; and
(B) identify food-borne illness outbreaks and attribute such outbreaks to specific foods through submission of standardized molecular subtypes (also known as ‘fingerprints’) of food-borne illness pathogens to a centralized database; and
(9) establishing a flexible mechanism for rapidly supporting scientific research by academic centers of excellence, which may include staff representing academic clinical researchers, food microbiologists, animal and plant disease specialists, ecologists, and other allied disciplines.
(c) Improving State Surveillance Capacity- The Administrator, in collaboration with the Director of the Centers for Disease Control and Prevention, shall improve capacity for surveillance in the States by–
(1) supporting outbreak investigations with needed specialty expertise, including epidemiological, microbiological, and environmental expertise, to assist identification of underlying common sources and contributing factors;
(2) identifying, disseminating, and supporting implementation of model practices at the State and local level for–
(A) facilitating rapid shipment of clinical isolates from clinical laboratories to State public health laboratories to avoid delays in testing;
(B) conducting rapid and more standardized interviewing of cases associated with major enteric pathogens, including prior to designation of clusters as food-borne illness outbreaks;
(C) conducting and evaluating rapid and standardized interviews of healthy control persons;
(D) sharing information on a timely basis–
(i) within public health and food regulatory agencies;
(ii) among such agencies;
(iii) with the food industry;
(iv) with healthcare providers; and
(v) with the public;
(3) developing, regularly updating, and disseminating training curricula on food-borne illness surveillance investigations, including standard sampling methods and laboratory procedures;
(4) integrating new molecular diagnostic tools for parasites into web-based consultation services for parasitic infections to accelerate the identification of these food-borne infectious agents;
(5) supporting research to develop and deploy new subtyping methods for salmonella, E. coli, campylobacter, and other pathogens, to increase the speed and accuracy of diagnoses;
(6) determining minimum core competencies for public health laboratories, and developing self-evaluation and proficiency-testing tools for such laboratories;
(7) facilitating regional public health laboratory partnerships to leverage resources, including equipment and physical space, and increase surge capacity;
(8) providing technical assistance, which may include the detailing of officers and employees of the Administrator, to State and local public health and food regulatory agencies;
(9) partnering with the Food Safety Administration to increase communication, coordination, and integration of food-borne illness surveillance and outbreak investigation activities; and
(10) developing and periodically updating response and interview procedures so that such procedures are standardized and tested.
(d) Program Activities- The Administrator shall carry out activities to support core food safety functions of State and local public health laboratories, including–
(1) establishing fellowships, stipends, and scholarships to address critical workforce shortages;
(2) training and coordination of State and local personnel;
(3) establishing partnerships between private and public laboratories to facilitate sharing of positive enteric specimens and improve surge capacity;
(4) strengthening capacity to participate in existing or new food-borne illness surveillance systems; and
(5) purchasing and maintaining data systems hardware and software and laboratory equipment.
(e) Plan To Improve Food Safety Capacity at the State and Local Level-
(1) GOALS- The Administrator shall leverage and enhance the food safety capacity and roles of State and local agencies and integrate State and local agencies as fully as possible into national food safety efforts, in order to achieve the following goals:
(A) Improve food-borne illness outbreak response and containment.
(B) Improve the contribution of food-borne illness surveillance and investigation to the prevention of food-borne illness.
(C) Strengthen oversight of food safety at the retail level.
(D) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards in food processing establishments, as part of a national strategy and plan to provide an adequate level of inspection and achieve compliance with safety standards in such establishments.
(E) Make more effective use of the Nation’s combined food safety resources to reduce the burden of food-borne illness.
(2) SURVEY- In preparation for development of the plan required by paragraph (3), the Administrator shall, not later than 1 year after the date of enactment of this part, complete a survey of State and local capacities, and needs for enhancement, with respect to–
(A) staffing levels and expertise available to perform food safety functions;
(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;
(C) information systems to support data management and sharing of food safety information among State and local agencies and with counterparts at the Federal level;
(D) legal authorities of State and local agencies to support the roles of such agencies in a national food safety system; and
(E) organizational arrangements for managing and coordinating food safety activities.
(3) PLAN- Taking into account the goals established in paragraph (1), results from the survey required in paragraph (2), and consultations with State and local agencies and other food safety stakeholders, the Administrator shall, not later than 2 years after the date of enactment of this part, develop, publish, and begin implementation of a plan that includes the following elements:
(A) Criteria for assessing the adequacy of State and local capacity to perform food safety functions as part of a national food safety system.
(B) Priorities for enhancing the capacity of State and local agencies.
(C) Action plans for meeting the highest priority capacity needs, including budget requirements and financing plans that take into account Federal, State, and local resources.
(D) Improved coordination and information flow among Federal, State, and local agencies to strengthen food-borne illness surveillance, outbreak response, and investigation and to ensure that agencies at all levels have the information on origins and causes of food-borne illness that such agencies need to plan preventive measures.
(E) Integration of the inspection and compliance programs in food processing establishments of the Food Safety Administration and State and local agencies, including–
(i) joint planning and priority setting to ensure that the collective effort has the greatest possible impact on achieving compliance with food safety standards and reducing food-borne illness;
(ii) elimination of barriers to the free flow of information among the Food Safety Administration and State and local agencies with respect to inspection and compliance programs and integration of State and Federal inspection and laboratory data systems;
(iii) steps to expand, and ensure the vigor and consistency of, State inspection of processing establishments under contract to the Food Safety Administration; and
(iv) reliance by the Food Safety Administration on State inspection and food sample analyses in Federal enforcement activities.
(4) FOOD SAFETY CAPACITY BUILDING GRANTS- The Administrator shall make grants to State and local agencies to enhance State and local food safety capacity and programs and support achievement of the goals established in paragraph (1). In awarding such grants, the Administrator shall take into account the criteria and priorities established by the Administrator under paragraph (3).
(5) REPORT TO CONGRESS- Not later than 1 year after the date of enactment of this part, and on an annual basis thereafter, the Administrator shall submit to Congress a report that describes–
(A) progress made in implementing this section, including any obstacles to such implementation; and
(B) any legislative recommendations or additional resources needed for full implementation.
(f) Service Agreements-
(1) IN GENERAL- The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the qualified personnel and services of those agencies in carrying out this Act.
(2) TRAINING- Agreements with a State under this subsection shall provide for training of State employees.
(3) MAINTENANCE OF AGREEMENTS- The Administrator shall maintain any agreement described in paragraph (1) that is in effect on the day before the date of the enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.
(4) COMMISSIONING- Where necessary and appropriate to fulfill the provisions of this Act or other food safety law, the Administrator shall, as part of any service agreement, commission qualified State and local regulatory officials and inspectors to assist the Administrator in carrying out the food safety law and accord such commissioned officials and inspectors access to information in possession of the Administrator as if they were Federal employees.
SEC. 208. IMPORTS.
(a) In General- All imported food under this Act shall meet requirements for food safety, inspection, labeling, and consumer protection that are at least equal to those applicable to food grown, manufactured, processed, packed, or held for consumption in the United States.
(b) Certification System- Not later than 2 years after the date of the enactment of this Act, the Administrator shall establish a system under which food products offered for importation into the United States shall be certified by the accredited foreign government in the country of export or by an accredited certifying agent meeting all applicable standards under this section.
(1) Category 1, 2, and 3 food establishments shall secure certification of products from the accredited foreign government in the country where the products are produced and must enter the United States through ports designated by the Administrator.
(2) Category 4 and 5 food establishments shall be certified either by–
(A) the accredited foreign government in the country where the products are produced; or
(B) a certifying agent that has been accredited under subsection (c).
(3) Beginning not later than 5 years after the date of the enactment of this Act, food from category 4 and 5 food establishments that is not certified by an accredited entity described in subsection (c) shall not enter the United States except through ports of entry that are located in a metropolitan area with an accredited food testing laboratory.
(c) Certification Standard-
(1) IN GENERAL- A foreign government or third party agent requesting accreditation to certify food for entry into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of the foreign government or third party agent, respectively, can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to food produced in the United States.
(2) REQUEST BY FOREIGN GOVERNMENT- Prior to accrediting a foreign government, the Administrator shall–
(A) review and audit the food safety program of the requesting foreign government (including all statutes, regulations, and inspection authority); and
(B) determine that the exporting country–
(i) administers a food control program that requires food exporters to implement hazard control measures for physical, chemical, and biological contaminants;
(ii) ensures sanitary operations of facilities;
(iii) utilizes testing and verification programs; and
(iv) administers an effective enforcement program.
(3) REQUEST BY A CERTIFYING AGENT- Prior to accrediting a certifying agent, the Administrator shall–
(A) review the training and qualifications of auditors and other employees used by the agent;
(B) ensure that any such auditors have completed such training as may be required by the Administrator for the conduct of food safety inspections; and
(C) conduct reviews of internal systems and such other investigation as the Administrator deems necessary to determine that the certifying agent is capable of auditing food establishments–
(i) to assess the adequacy of systems and standards in use; and
(ii) to ensure that food approved by the agent for import to the United States meets the requirements of this Act.
(4) CERTIFICATION TO ACCOMPANY EACH SHIPMENT- As a condition of accrediting any foreign government or certifying agent, such government or agent shall agree to issue a written and electronic certification to accompany each shipment intended for import to the United States from any food establishment which the government or agent certifies, subject to requirements set forth by the Administrator.
(d) Audits; Inspections- Following any accreditation under subsection (c), the Administrator may at any time–
(1) conduct an on-site audit of any food establishment registered under section 202, with or without the certifying agent; or
(2) require a certifying agent to submit an onsite audit report and any other reports or documents which the agent requires as part of the audit process, including documentation that the food establishment is in compliance with registration requirements and prior notice requirements for food imported to the United States.
(e) Limitation- A foreign government or other certifying agent accredited by the Administrator to certify food for import to the United States under this section may certify only the food products or food categories for importation to the United States that are specified in the grant of accreditation.
(f) Withdrawal of Accreditation- The Administrator may withdraw accreditation from a foreign government or certifying agent–
(1) if food approved by the foreign government or certifying agent is linked to an outbreak of human illness;
(2) following an investigation and finding by the Administrator that the programs of the foreign government, or a foreign food establishment certified by the certifying agent, are no longer equal to those applied to food grown, manufactured, processed, packed, or held in the United States; or
(3) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements of this section.
(g) Renewal of Accreditation- The Administrator shall audit foreign governments and certifying agents whenever needed, but no less than once every 3 years, to ensure the continued compliance with the requirements set forth in this section. Renewal of accreditation shall occur following each satisfactory audit.
(h) Required Routine Inspection- The Administrator shall routinely inspect food before or at entry into the United States to ensure ongoing compliance with food safety law and where appropriate, as part of the audit of any certifying entity.
(i) Enforcement- The Administrator may–
(1) deny importation of food from any foreign country if the government of such country does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill requirements under this section;
(2) deny importation of food from any foreign country or foreign food establishment that does not consent to a timely investigation by the Administration when food from that foreign country or foreign food establishment is linked to a food-borne illness outbreak or is otherwise found to be adulterated or misbranded;
(3) promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the requirements of this Act; and
(4) establish such fees as are necessary to carry out the implementation of the accreditation and inspection programs required under this section.
(j) Detention and Seizure- Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402 or recalled pursuant to section 403.
(k) Certifying Agents- Entities eligible for accreditation as a certifying agent under subsection (c) may include–
(1) a State or regional food authority; or
(2) a foreign or domestic cooperative that aggregates the products of growers or processors for importation.
(l) Avoiding Conflicts of Interest With Certifying Agents-
(1) IN GENERAL- To be eligible for accreditation under subsection (c), a certifying agent shall–
(A) not be owned, managed, or controlled by any person that owns or operates an establishment whose products are to be certified by such agent;
(B) have procedures to ensure against the use, in carrying out audits of food establishments under this section, of any officer or employee of such agent that has a financial conflict of interest regarding an establishment whose products are to be certified by such agent; and
(C) annually make available to the Secretary, disclosures of the extent to which such agent, and the officers and employees of such agent, have maintained compliance with subparagraphs (A) and (B) relating to financial conflicts of interest.
(2) REGULATIONS- The Secretary shall promulgate regulations not later than 18 months after the date of the enactment of this Act to ensure that there are protections against conflicts of interest between a certifying agent and the establishments whose products are to be certified by such agent. Such regulations shall include–
(A) requiring that domestic audits performed under this section be unannounced;
(B) a structure, including timing and public disclosure, for fees paid by food establishments to certifying agents to decrease the potential for conflicts of interest; and
(C) appropriate limits on financial affiliations between a certifying agent and any person that owns or operates an establishment whose products are to be certified by such agent.
SEC. 209. RESOURCE PLAN.
(a) In General- The Administrator shall prepare and update annually a resource plan describing the resources required, in the best professional judgment of the Administrator, to develop and fully implement the national food safety program established under this Act.
(b) Contents of Plan- The resource plan shall–
(1) describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of this Act;
(2) allocate inspection resources in a manner reflecting the distribution of risk and opportunities to reduce risk across the food supply to the extent feasible based on the best available information, and subject to section 205; and
(3) describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities, at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205 and food production facilities under section 206–
(A) in foreign establishments and production facilities; and
(B) at the point of importation.
(c) Grants- The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities and inspections of food establishments and food production facilities and include resources to audit such programs.
(d) Submission of Plan- The Administrator shall submit annually to the Committee on Appropriations of the Senate, the Committee on Appropriations of the House of Representatives, and other relevant committees of Congress, the resource plan required under this section.
SEC. 210. TRACEBACK REQUIREMENTS.
(a) In General- The Administrator, in order to protect the public health, shall establish a national traceability system that enables the Administrator to retrieve the history, use, and location of an article of food through all stages of its production, processing, and distribution.
(b) Applicability- Traceability requirements under this section shall apply to food from food production facilities, food establishments, and foreign food establishments.
(c) Requirements-
(1) STANDARDS- The Administrator shall establish standards for the type of information, format, and timeframe for food production facilities and food establishments to submit records to aid the Administrator in effectively retrieving the history, use, and location of an item of food.
(2) RULE OF CONSTRUCTION- Nothing in this section shall be construed as requiring the Administrator to prescribe a specific technology for the maintenance of records or labeling of food to carry out the requirements of this section.
(3) AVAILABILITY OF RECORDS FOR INSPECTION- Any records that are required by the Administrator under this section shall be available for inspection by the Administrator upon oral or written request.
(4) DEMONSTRATION OF ABILITY- The Administrator, during any inspection, may require a food establishment to demonstrate its ability to trace an item of food and submit the information in the format and timeframe required under paragraph (1).
(d) Relationship to Other Requirements-
(1) CONSISTENCY WITH EXISTING STATUTES AND REGULATIONS- To the extent possible, the Administrator should establish the national traceability system under this section to be consistent with existing statutes and regulations that require recordkeeping or labeling for identifying the origin or history of food or food animals.
(2) EXISTING LAWS- For purposes of this subsection, the Administrator should review the following:
(A) Country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
(B) The Perishable Agricultural Commodities Act of 1930 (7 U.S.C. 499a-t).
(C) Country of origin labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).
(D) The National Animal Identification System as authorized by the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.).
(3) CERTAIN REQUIREMENTS- Nothing contained in this section prevents or interferes with implementation of the country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
SEC. 211. ACCREDITED LABORATORIES.
(a) Establishment of Program- The Administrator shall establish a program for accrediting laboratories to perform sampling and testing for purposes of this Act. Such program shall include–
(1) standards for appropriate sampling and analytical procedures;
(2) training and experience qualification levels for individuals who conduct sampling and analysis;
(3) annual onsite visits to audit the performance of an accredited laboratory; and
(4) such additional requirements as the Administrator determines to be appropriate.
(b) Requirements- To be accredited under this section, a laboratory shall–
(1) prepare and submit an application for accreditation to the Administrator;
(2) meet required tests and standards established by the Administrator; and
(3) comply with such terms and conditions as are determined necessary by the Administrator.
(c) Accrediting Bodies- The Administrator may approve State agencies or private, nonprofit entities as accrediting bodies to act on behalf of the Administrator in accrediting laboratories under this section. The Administrator shall–
(1) in making such approvals–
(A) oversee and review the performance of any accrediting body acting on behalf of the Administrator to ensure that such accrediting body is in compliance with the requirements of this section; and
(B) have the right to obtain from an accrediting body acting on behalf of the Administrator and from any laboratory that may be certified by such a body all records and materials that may be necessary for the oversight and review required by subparagraph (A);
(2) reevaluate accreditation bodies approved under paragraph (1) whenever–
(A) the Administrator determines a laboratory accredited by the accrediting body is no longer in compliance with this section;
(B) the Administrator determines the accrediting body is no longer in compliance with the requirements of this section; or
(C) no less than once every 5 years; and
(3) promptly revoke the approval of any accreditation body found not to be in compliance with the requirements of this section.
(d) Revocation of Accreditation- The Administrator shall revoke the accreditation of any laboratory that fails to meet the requirements this section.
TITLE III–RESEARCH AND EDUCATION
SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.
(a) In General- The Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with food safety and research programs of the Department of Agriculture, shall–
(1) identify on an ongoing basis the priorities for collection of epidemiological data and for other food safety research and data collection that are most important to implementing the food safety law and reducing the public health burden of food-borne illness;
(2) have full access for purposes of implementing the food safety law to the applicable data and data systems of the Centers for Disease Control and Prevention, including data made available to the Centers by a State;
(3) provide appropriate support and input on the design and implementation by the Centers for Disease Control and Prevention and the States of an active surveillance system that provides information on the incidence and causes of food-borne illness which is timely, detailed, and representative of the population of the United States;
(4) based on data and information obtained from the Centers for Disease Control and Prevention, the States, and other sources, assess the incidence, distribution, public health impact, and causes of human illness in the United States associated with the consumption of food, and conduct research and analysis to devise effective and feasible interventions to reduce food-borne illness;
(5) maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment; and
(6) utilize surveillance data created by means of monitoring and statistical studies conducted as part of its own inspection.
(b) Public Health Sampling-
(1) IN GENERAL- Not later than 1 year after the enactment of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food–
(A) to assist the Administrator in carrying out this Act; and
(B) to assess the nature, frequency of occurrence, and quantities of contaminants in food.
(2) REQUIREMENTS- The sampling system described in paragraph (1) shall provide–
(A) statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and
(B) at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.
(c) Assessment of Health Hazards-
(1) IN GENERAL- Through the surveillance system and analyses referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall–
(A) rank food categories based on the hazard to human health presented by the food category and specific chemical and microbiological hazards associated with foods in those categories;
(B) identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and
(C) assess the conditions affecting the likelihood that emerging pathogens and diseases, including zoonosis, will affect the safety of the food supply and possible strategies for minimizing the potential risk to public health associated with emerging pathogens and diseases.
(2) COMPONENTS OF ANALYSIS- The analysis under subsection (b)(1) may include–
(A) a comparison of the safety of commercial processing with the health hazards associated with food that is harvested for recreational or subsistence purposes and prepared noncommercially;
(B) a comparison of the safety of food that is domestically processed with the health hazards associated with food that is processed outside the United States;
(C) a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and
(D) use of comparative risk assessments.
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education-
(1) IN GENERAL- The Administrator, in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, shall establish a national public education program on food safety.
(2) REQUIREMENTS- The program shall provide–
(A) information to the public regarding Federal standards and best practices, and promotion of public awareness and understanding of those standards and practices;
(B) information for health professionals–
(i) to improve diagnosis and treatment of food-related illness; and
(ii) to advise individuals at special risk for food-related illnesses; and
(C) such other information or advice, including on safe food handling practices, to consumers and other persons as the Administrator determines will promote the purposes of this Act.
(b) Health Advisories- The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities–
(1) to develop and distribute regional and national advisories concerning food safety;
(2) to develop standardized formats for written and broadcast advisories;
(3) to incorporate State and local advisories into the national public education program established under subsection (a); and
(4) to present prompt, specific information regarding food found to pose a threat to the public health, including by identifying the retailers and food establishments where such food has been sold.
SEC. 303. RESEARCH.
(a) In General- The Administrator shall conduct research to carry out this Act, including studies to–
(1) improve sanitation and food safety practices in the processing of food;
(2) develop improved techniques to monitor and inspect food;
(3) develop efficient, rapid, and sensitive methods to detect contaminants in food;
(4) determine the sources of contamination of contaminated food;
(5) develop food consumption data;
(6) identify ways that animal production techniques could improve the safety of the food supply;
(7) draw upon research and educational programs that exist at the State and local level;
(8) utilize the DNA matching system and other processes to identify and control pathogens;
(9) address common and emerging zoonotic diseases;
(10) develop methods to reduce or destroy harmful pathogens before, during, and after processing;
(11) analyze the incidence of antibiotic resistence as it pertains to the food supply and develop new methods to reduce the transfer of antibiotic resistance to humans; and
(12) conduct other research that supports the purposes of this Act.
(b) Contract Authority- The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.
SEC. 304. WORKING GROUP ON IMPROVING FOODBORNE ILLNESS SURVEILLANCE.
Not later than 180 days after the date of enactment of this Act, the Administrator shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, consumer organizations, and academia. Such working group shall provide the Administrator, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of food-borne illness surveillance, including advice and recommendations on–
(1) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on food-borne illness and its causes that can be used to prevent food-borne illness;
(2) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;
(3) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to food-borne illness surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;
(4) key barriers to improvement in food-borne illness surveillance and its utility for preventing food-borne illness at Federal, State, and local levels; and
(5) specific actions to reduce barriers to such improvement, implement the working group’s recommendations, with measurable objectives and timelines, and identification of resource and staffing needs.
SEC. 305. CAREER-SPANNING TRAINING FOR FOOD INSPECTORS.
(a) In General- The Administrator shall make a grant to an entity described in subsection (c) to provide training to Federal, State, and local food inspectors.
(b) Use of Funds- The Administrator may make a grant under this section to an applicant only if the applicant agrees to use the grant to provide regular, standardized, graduated, career-spanning training, based on a curriculum developed by the Association of Food and Drug Officials, to Federal, State, and local food inspectors.
(c) Eligible Entity- An entity described in this subsection is an entity that–
(1) is described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3));
(2) has the capability to train not less than 1,000 food inspectors per year; and
(3) offers both on-site and off-site training for food inspectors.
SEC. 306. FOOD-BORNE ILLNESS HEALTH REGISTRY.
(a) Purpose- The purpose of the registry under subsection (b) is to stimulate research on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.
(b) Registry- For the purpose described in subsection (a), the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall develop and maintain a registry, to be known as the Food-Borne Illness Health Registry, consisting of data on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.
SEC. 307. STUDY ON FEDERAL RESOURCES.
Not later than one year after the date of the enactment of this Act, the Comptroller General of the United States shall complete a study on the Federal resources being dedicated to food-borne illness and food safety research and submit a report on the results of such study to the Congress.
TITLE IV–ENFORCEMENT
SEC. 401. PROHIBITED ACTS.
It is prohibited–
(1) to manufacture, introduce, deliver for introduction, or receive in interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate commerce;
(3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
(4) to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);
(5) to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);
(6) to refuse to permit entry to or inspection of a food establishment as required under section 205;
(7) to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);
(8) to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;
(9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;
(10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;
(11) to fail to comply with a recall or other order under section 403; or
(12) to otherwise violate the food safety law.
SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNATION.
(a) Administrative Detention of Food-
(1) EXPANDED AUTHORITY- The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food regulated under this Act that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
(2) DETENTION AUTHORITY- If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this the food safety law, the officer, employee, or agent may order the food detained.
(3) PERIOD OF DETENTION-
(A) IN GENERAL- A food may be detained under paragraph (1) or (2) for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action.
(B) PERISHABLE FOOD- The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.
(4) SECURITY OF DETAINED FOOD-
(A) IN GENERAL- A detention order under this subsection–
(i) may require that the food be labeled or marked as detained; and
(ii) shall require that the food be removed to a secure facility, if appropriate.
(B) FOOD SUBJECT TO AN ORDER- A food subject to a detention order under this subsection shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.
(C) DELIVERY OF FOOD- This subsection does not authorize the delivery of a food in accordance with execution of a bond while the article is subject to the order.
(b) Appeal of Detention Order-
(1) IN GENERAL- A person who would be entitled to be a claimant for a food subject to a detention order under subsection (a) if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334), may appeal the order to the Administrator.
(2) ACTION BY THE ADMINISTRATOR- Not later than 5 days after an appeal is filed under paragraph (1), the Administrator, after providing an opportunity for an informal hearing, shall confirm, modify, or terminate the order involved.
(3) FINAL AGENCY ACTION- Confirmation, modification, or termination by the Administrator under paragraph (2) shall be considered a final agency action for purposes of section 702 of title 5, United States Code.
(4) TERMINATION- A detention order under subsection (a) shall be considered to be terminated if, after 5 days, the Administrator has failed–
(A) to provide an opportunity for an informal hearing; or
(B) to confirm, modify, or terminate the order.
(5) EFFECT OF INSTITUTING COURT ACTION- If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or section 304(a) of that Act (21 U.S.C. 334(a)) for a food subject to a detention order under subsection (a), the process for the appeal of the detention order with respect to such food shall terminate.
(c) Condemnation of Food-
(1) IN GENERAL- After confirming a detention order, the Administrator may order the food condemned.
(2) DESTRUCTION OF FOOD- Any food condemned shall be destroyed under the supervision of the Administrator.
(3) RELEASE OF FOOD- If the Administrator determines that, through reprocessing, relabeling, or other action, a detained food can be brought into compliance with this Act, the food may be released following a determination by the Administrator that the relabeling or other action as specified by the Administrator has been performed.
(d) Temporary Holds at Ports of Entry-
(1) IN GENERAL- If an officer or qualified employee of the Administration has reason to believe that a food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, and the officer or qualified employee is unable to inspect, examine, or investigate the food when the food is offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Homeland Security to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, to enable the Administrator to inspect or investigate the food as appropriate.
(2) REMOVAL TO SECURE FACILITY- The Administrator shall work in coordination with the Secretary of Homeland Security to remove a food held in accordance with paragraph (1) to a secure facility as appropriate.
(3) PROHIBITION ON TRANSFER- During the period in which food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.
(4) DELIVERY IN ACCORDANCE WITH A BOND- The delivery of the food in accordance with the execution of a bond while the food is held is not authorized.
(5) PROHIBITION ON REEXPORT- A food found unfit for human or animal consumption shall be prohibited from reexport without further processing to remove the contamination and reinspection by the Administration.
SEC. 403. NOTIFICATION AND RECALL.
(a) Notice to Administrator of Violation-
(1) IN GENERAL- A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Administrator of the identity and location of the food.
(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.
(b) Recall and Consumer Notification-
(1) VOLUNTARY ACTIONS- If the Administrator determines that food is in violation of the food safety law when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Administrator, the Administrator shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity to–
(A) cease distribution of the food;
(B) notify all persons–
(i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
(ii) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;
(C) recall the food;
(D) in conjunction with the Administrator, provide notice of the finding of the Administrator–
(i) to consumers to whom the food was, or may have been, distributed; and
(ii) to State and local public health officials; or
(E) take any combination of the measures described in this paragraph, as determined by the Administrator to be appropriate in the circumstances.
(2) MANDATORY ACTIONS- If a person referred to in paragraph (1) refuses to or does not adequately carry out the actions described in that paragraph within the time period and in the manner prescribed by the Administrator, the Administrator shall–
(A) have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator–
(i) at the expense of the food establishment; or
(ii) in an emergency (as determined by the Administrator), at the expense of the Administration; and
(B) by order, require, as the Administrator determines to be necessary, the person to immediately–
(i) cease distribution of the food; and
(ii) notify all persons–
(I) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
(II) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
(3) NOTIFICATION TO CONSUMERS BY ADMINISTRATOR- The Administrator shall, as the Administrator determines to be necessary–
(A) provide notice of the finding of the Administrator under paragraph (1)–
(i) to consumers to whom the food was, or may have been, distributed; and
(ii) to State and local public health officials; and
(B) provide notice to the public of the names and addresses of retail locations at which recalled food products were available for sale.
(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food.
(5) AVAILABILITY OF RECORDS TO ADMINISTRATOR- Each person referred to in paragraph (1) that processed, distributed, or otherwise handled food shall make available to the Administrator information necessary to carry out this subsection, as determined by the Administrator, regarding–
(A) persons that processed, distributed, or otherwise handled the food; and
(B) persons to which the food has been transported, sold, distributed, or otherwise handled.
(c) Informal Hearings on Orders-
(1) IN GENERAL- The Administrator shall provide any person subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order.
(2) SCOPE OF THE HEARING- In a hearing under paragraph (1), the Administrator shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled.
(d) Post-Hearing Recall Orders-
(1) AMENDMENT OF ORDER- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that there is a reasonable probability that the food that is the subject of an order under subsection (b), if consumed, would present a threat to the public health, the Administrator, as the Administrator determines to be necessary, may–
(A) amend the order to require recall of the food or other appropriate action;
(B) specify a timetable in which the recall shall occur;
(C) require periodic reports to the Administrator describing the progress of the recall; and
(D) provide notice of the recall to consumers to whom the food was, or may have been, distributed.
(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the order, the Administrator shall vacate the order.
(e) Remedies Not Exclusive- The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.
SEC. 404. INJUNCTION PROCEEDINGS.
(a) Jurisdiction- The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 208, or 401 (or a regulation promulgated thereunder).
(b) Trial- In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.
SEC. 405. CIVIL AND CRIMINAL PENALTIES.
(a) Civil Sanctions-
(1) CIVIL PENALTY-
(A) IN GENERAL- Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under the food safety law) may be assessed a civil penalty by the Administrator of not more than $1,000,000 for each such act.
(B) SEPARATE OFFENSE- Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
(2) OTHER REQUIREMENTS-
(A) WRITTEN ORDER- The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.
(B) AMOUNT OF PENALTY- Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering–
(i) the gravity of the violation;
(ii) the degree of culpability of the person;
(iii) the size and type of the business of the person; and
(iv) any history of prior offenses by the person under the food safety law.
(C) REVIEW OF ORDER- The order may be reviewed only in accordance with subsection (c).
(b) Criminal Sanctions-
(1) OFFENSE RESULTING IN SERIOUS ILLNESS- Notwithstanding section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of any provision of section 301 of such Act (21 U.S.C. 301) with respect to an adulterated or misbranded food results in serious illness, the person committing the violation shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
(2) OFFENSE RESULTING IN DEATH- Notwithstanding section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of any provision of section 301 of such Act (21 U.S.C. 331) with respect to an adulterated or misbranded food results in death, the person committing the violation shall be imprisoned for not more than 10 years, fined in accordance with title 18, United States Code, or both.
(c) Judicial Review-
(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be a final order unless the person–
(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and
(B) simultaneously serves a copy of the petition by certified mail to the Administrator.
(2) FILING OF RECORD- Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.
(3) STANDARD OF REVIEW- The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
(d) Collection Actions for Failure To Pay-
(1) IN GENERAL- If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.
(2) LIMITATION ON REVIEW- In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.
(e) Penalties Paid Into Account- The Administrator–
(1) shall deposit penalties collected under this section in an account in the Treasury; and
(2) may use the funds in the account, without further appropriation or fiscal year limitation–
(A) to carry out enforcement activities under the food safety law; or
(B) to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
(f) Discretion of the Administrator To Prosecute- Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.
(g) Remedies Not Exclusive- The remedies provided in this section are in addition to, and not exclusive of, other remedies that may be available.
SEC. 406. PRESUMPTION.
In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.
SEC. 407. WHISTLEBLOWER PROTECTION.
(a) In General-
(1) PROHIBITION- No Federal employee, employee of a Federal contractor or subcontractor, or covered individual may be discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against, because of any lawful act done by the employee or covered individual to–
(A) provide information, cause information to be provided, or otherwise assist in an investigation regarding any conduct that the covered individual reasonably believes constitutes a violation of any law, rule, or regulation, or that the covered individual reasonably believes constitutes a threat to the public health, when the information or assistance is provided to, or the investigation is conducted by–
(i) a Federal regulatory or law enforcement agency;
(ii) a Member or committee of Congress; or
(iii) a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct);
(B) file, cause to be filed, testify, participate in, or otherwise assist in a proceeding or action filed or about to be filed relating to a violation of any law, rule, or regulation; or
(C) refused to violate or assist in the violation of any law, rule, or regulation.
(2) DEFINITION- For the purposes of this section, the term ‘covered individual’ means an individual who is an employee of–
(A) a food establishment;
(B) a food production facility;
(C) a restaurant;
(D) a retail food establishment other than a restaurant;
(E) a nonprofit food establishment in which food is prepared for or served directly to the consumer;
(F) a fishing vessel; or
(G) an agent of any of the above.
(b) Enforcement Action-
(1) IN GENERAL- A covered individual who alleges discharge or other discrimination by any person in violation of subsection (a) may seek relief under subsection (c) by filing a complaint with the Secretary of Labor. If the Secretary of Labor has not issued a final decision within 180 days after the date on which the complaint is filed and there is no showing that such delay is due to the bad faith of the claimant, the claimant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy.
(2) PROCEDURE-
(A) IN GENERAL- An action under paragraph (1) shall be governed under the rules and procedures set forth in section 42121(b) of title 49, United States Code.
(B) EXCEPTION- Notification under section 42121(b)(1) of title 49, United States Code, shall be made to the person named in the complaint and to the person’s employer.
(C) BURDENS OF PROOF- An action brought under paragraph (1) shall be governed by the legal burdens of proof set forth in section 42121(b) of title 49, United States Code.
(D) STATUTE OF LIMITATIONS- An action under paragraph (1) shall be commenced not later than 90 days after the date on which the violation occurs.
(c) Remedies-
(1) IN GENERAL- A covered individual prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the covered individual whole.
(2) COMPENSATORY DAMAGES- Relief for any action described in paragraph (1) shall include–
(A) reinstatement with the same seniority status that the covered individual would have had, but for the discrimination;
(B) the amount of any back pay, with interest; and
(C) compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.
(d) Rights Retained by the Covered Individual- Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any covered individual under any Federal or State law, or under any collective bargaining agreement.
SEC. 408. ADMINISTRATION AND ENFORCEMENT.
(a) In General- For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.
(b) Inquiries and Actions-
(1) IN GENERAL- The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.
(2) POWERS- The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.
SEC. 409. CITIZEN CIVIL ACTIONS.
(a) Civil Actions- A person may commence a civil action against–
(1) a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or
(2) the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.
(b) Court- In an action commenced under this section:
(1) IN GENERAL- The action shall be commenced–
(A) in the case of a civil action against a person, the United States district court for the district in which the defendant resides, is found, or has an agent; and
(B) in the case of a civil action against the Administrator, any United States district court.
(2) JURISDICTION- The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.
(3) DAMAGES- The court may–
(A) award damages, in the amount of damages actually sustained; and
(B) if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.
(c) Remedies Not Exclusive- The remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available.
TITLE V–IMPLEMENTATION
SEC. 501. REORGANIZATION PLAN.
(a) Submission of Plan- Not later than 180 days after the enactment of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:
(1) The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.
(2) Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.
(b) Plan Elements- The plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:
(1) The timetable for transfer and identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred promptly to the Administration under the plan.
(2) Specification of the steps to be taken by the Administrator to organize the Administration, including the delegation or assignment of functions transferred to the Administration among the officers of the Administration in order to permit the Administration to carry out the functions transferred under the plan.
(3) Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.
(4) Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.
(5) Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.
(6) Specification of the proposed allocations within the Administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food.
(c) Modification of Plan- The President may, on the basis of consultations with the appropriate congressional committees, modify or revise any part of the plan until that part of the plan becomes effective in accordance with subsection (d).
(d) Effective Date-
(1) IN GENERAL- The reorganization plan described in this section, including any modifications or revisions of the plan under subsection (c), shall become effective for an agency on the earlier of–
(A) the date specified in the plan (or the plan as modified pursuant to subsection (c)), except that such date may not be earlier than 90 days after the date the President has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection (a); or
(B) the end of the 12-month period beginning on the date of the enactment of this Act.
(2) STATUTORY CONSTRUCTION- Nothing in this subsection may be construed to require the transfer of functions, personnel, records, balances of appropriations, or other assets of an agency on a single date.
(3) SUPERSEDES EXISTING LAW- Paragraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.
SEC. 502. TRANSITIONAL AUTHORITIES.
(a) Provision of Assistance by Officials- Until the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the date of the enactment of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.
(b) Services and Personnel- During the transition period, upon the request of the Administrator, the head of any executive agency may provide services or detail personnel to assist with the transition.
(c) Acting Officials-
(1) IN GENERAL- During the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the date of the enactment of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.
(2) COMPENSATION- While acting pursuant to paragraph (1), such officers shall receive compensation at the higher of–
(A) the rates provided by this Act for the respective offices in which they act; or
(B) the rates provided for the offices held at the time of designation.
(3) LIMITATION- Nothing in this Act shall be construed to require the advice and consent of the Senate to the appointment by the President to a position in the Administration of any officer whose agency is transferred to the Administration pursuant to this Act and whose duties following such transfer are germane to those performed before such transfer.
(d) Transfer of Personnel, Assets, Obligations, and Function-
(1) IN GENERAL- Consistent with section 1531 of title 31, United States Code, the personnel, assets, liabilities, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds that relate to the functions transferred under subsection (a) from a Federal agency shall be transferred to the Administration.
(2) UNEXPENDED FUNDS- Unexpended funds transferred under this subsection shall be used by the Administration only for the purposes for which the funds were originally authorized and appropriated.
SEC. 503. SAVINGS PROVISIONS.
(a) Completed Administrative Actions- The enactment of this Act or the transfer of functions under this Act shall not affect any order, determination, rule, regulation, tolerance, guidance, permit, personnel action, agreement, grant, contract, certificate, license, registration, user fees, privilege, or other administrative action issued, made, granted, or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions.
(b) Pending Proceedings- Subject to the authority of the Administrator under this Act–
(1) pending proceedings in an agency, including notices of proposed rulemaking, and applications for licenses, permits, certificates, grants, and financial assistance, shall continue notwithstanding the enactment of this Act or the transfer of the agency to the Administration, unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance or modification could have occurred if such enactment or transfer had not occurred; and
(2) orders issued in such proceedings, and appeals therefrom, and payments made pursuant to such orders, shall issue in the same manner on the same terms as if this Act had not been enacted or the agency had not been transferred, and any such order shall continue in effect until amended, modified, superseded, terminated, set aside, or revoked by an officer of the United States or a court of competent jurisdiction, or by operation of law.
(c) Pending Civil Actions- Subject to the authority of the Administrator under this Act, any civil action commenced with regard to that agency pending before that agency on the day before the transfer date with respect to the transferred functions shall continue notwithstanding the enactment of this Act or the transfer of an agency to the Administration.
(d) References-
(1) IN GENERAL- After the transfer of functions from a Federal agency under this Act, any reference in any other Federal law, Executive order, rule, regulation, directive, document, or other material to that Federal agency or the head of that agency in connection with the administration or enforcement of the food safety law shall be deemed to be a reference to the Administration or the Administrator, respectively.
(2) STATUTORY REPORTING REQUIREMENTS- Statutory reporting requirements that applied in relation to such an agency immediately before the date of the enactment of this Act shall continue to apply following such transfer if they refer to the agency by name.
SEC. 504. CONFORMING AMENDMENTS.
(a) Executive Schedule- Section 5313 of title 5, United States Code, is amended by inserting at the end the following new item: ‘Administrator of Food Safety.’.
SEC. 505. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.
Not later than 60 days after the submission of the reorganization plan under section 501, the President shall prepare and submit proposed legislation to Congress containing necessary and appropriate technical and conforming amendments to the Acts listed in section 3(15) of this Act to reflect the changes made by this Act.
SEC. 506. REGULATIONS.
The Administrator may promulgate such regulations as the Administrator determines are necessary or appropriate to perform the duties of the Administrator.
SEC. 507. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are necessary to carry out this Act.
SEC. 508. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.
For the fiscal year that includes the date of the enactment of this Act, the amount authorized to be appropriated to carry out this Act shall not exceed–
(1) the amount appropriated for that fiscal year for the Federal agencies identified in section 102(b) for the purpose of administering or enforcing the food safety law; or
(2) the amount appropriated for those agencies for that purpose for the preceding fiscal year, if, as of the date of the enactment of this Act, appropriations for those agencies for the fiscal year that includes such date have not yet been made.
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Text of S. 425: Food Safety and Tracking Improvement Act
S 425 IS
111th CONGRESS
1st Session
S. 425
To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.
IN THE SENATE OF THE UNITED STATES
February 12, 2009
Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the Food Safety and Tracking Improvement Act.
(b) Table of Contents- The table of contents for this Act is as follows:
TITLE II–ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
TITLE I–TRACEABILITY OF FOOD
SEC. 101. TRACEABILITY OF FOOD.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended–
(1) in section 301, by inserting at the end the following:
‘(oo) The failure to comply with any requirement of section 414A (relating to the traceability of food).’; and
(2) in chapter IV, by inserting after section 414 the following:
‘SEC. 414A. TRACEABILITY OF FOOD.
‘(a) Establishment of System- Not later than 3 years after the date of the enactment of this section, the Secretary shall establish a traceability system described in subsection (b) for all stages of manufacturing, processing, packaging, and distribution of food.
‘(b) Description of System- The traceability system required by subsection (a) shall require each article of food shipped in interstate commerce to be identified in a manner that enables the Secretary to retrieve the history, use, and location of the article through a recordkeeping and audit system, a secure, online database, or registered identification.
‘(c) Records-
‘(1) IN GENERAL- The Secretary may require that each person required to identify an article of food pursuant to subsection (b) maintain accurate records, as prescribed by the Secretary, regarding the purchase, sale, and identification of the article.
‘(2) ACCESS- Each person described in paragraph (1) shall, at all reasonable times, on notice by a duly authorized representative of the Secretary, allow the representative to access each place of business of the person to examine and copy the records described in paragraph (1).
‘(3) DURATION- Each person described in paragraph (1) shall maintain records as required under this subsection for such period of time as the Secretary prescribes.
‘(d) False Information- No person shall falsify or misrepresent to any other person or to the Secretary, any information as to any location at which any article of food was held.
‘(e) Alteration or Destruction of Records- No person shall, without authorization from the Secretary, alter, detach, or destroy any records or other means of identification prescribed by the Secretary for use in determining the location at which any article of food was held.
‘(f) Advisory Committee-
‘(1) IN GENERAL- In order to assist the Secretary in implementing the traceability system under subsection (a), the Secretary shall convene an advisory committee (referred to in this subsection as the ‘Committee’).
‘(2) MEMBERSHIP- The Committee shall consist of 13 members appointed by the Secretary which shall include–
‘(A) an equitable number of food safety and tracking technology experts, representatives of the food industry, and consumer advocates; and
‘(B) officials from the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs of the Food and Drug Administration and the Agriculture Marketing Service of the Department of Agriculture.
‘(3) CHAIRPERSON- The Secretary shall appoint a Chairperson of the Committee.
‘(4) MEETING- The Committee shall convene not later than 180 days after the date of enactment of this section and periodically thereafter at the call of the Chairperson.
‘(5) REPORT OF COMMITTEE-
‘(A) IN GENERAL- Not later than 1 year after the date of enactment of this section, the Committee shall submit to the Secretary and the Office of the Commissioner a report that describes the recommendations regarding the most practicable approach to providing for the traceability of food, including the most efficient means of implementing the traceback of contaminated foods.
‘(B) CONSIDERATIONS- In developing the report under subparagraph (A), the Committee shall consider the following approaches to providing for the traceability of food:
‘(i) A national database or registry operated by the Food and Drug Administration.
‘(ii) Electronic records identifying each prior sale, purchase, or trade of the food and its ingredients, and establishing that the food and its ingredients were grown, prepared, handled, manufactured, processed, distributed, shipped, warehoused, imported, and conveyed under conditions that ensure the safety of the food. The records should include an electronic statement with the date of, and the names and addresses of all parties to, each prior sale, purchase, or trade, and any other information as appropriate.
‘(iii) Standardized tracking numbers on all shipments. These numbers would identify the country of origin, the unique facility registration number, date of production, and lot number (if applicable).
‘(iv) Recall performance standards for each food or commodity type.
‘(v) Safeguards for the combining, repacking, or otherwise mixing of items of food, particularly fresh produce.
‘(vi) Other approaches that enable the reliable tracking of food and food products.
‘(g) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $40,000,000 for the period of fiscal years 2010 through 2012.’.
TITLE II–ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
SEC. 201. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT FOOD PRODUCTS.
(a) In General- The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended–
(1) by redesignating section 411 (21 U.S.C. 680) as section 414; and
(2) by inserting after section 410 (21 U.S.C. 679a) the following:
‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any carcass, part of a carcass, meat, or meat food product of an amenable species (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local public health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall;
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed; or
‘(D) take any combination of actions described in subparagraphs (A) through (C).
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under title I with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 401), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under title I, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 413. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 411 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under title I of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 411 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
(b) Conforming Amendments-
(1) Section 1 of the Federal Meat Inspection Act (21 U.S.C. 601) is amended by adding at the end the following:
‘(x) Person- The term ‘person’ means any individual, partnership, corporation, association, or other business unit.’.
(2) The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended–
(A) by striking ‘person, firm, or corporation’ each place it appears and inserting ‘person’;
(B) by striking ‘persons, firms, and corporations’ each place it appears and inserting ‘persons’; and
(C) by striking ‘persons, firms, or corporations’ each place it appears and inserting ‘persons’.
SEC. 202. FOOD SAFETY ENFORCEMENT FOR POULTRY AND POULTRY FOOD PRODUCTS.
(a) In General- The Poultry Products Inspection Act (21 U.S.C. 451 et seq.) is amended by adding at the end the following:
‘SEC. 32. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any poultry or poultry product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 33. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18(a)), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 34. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 32 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 32 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
(b) Conforming Amendments- Section 5(c)(1) of the Poultry Products Inspection Act (21 U.S.C. 454(c)(1)) is amended in the first sentence–
(1) by striking ‘, by thirty days prior to the expiration of two years after enactment of the Wholesome Poultry Products Act,’; and
(2) by striking ‘sections 1-4, 6-10, and 12-22 of this Act’ and inserting ‘sections 1 through 4, 6 through 10, 12 through 22, and 32 through 34’; and
SEC. 203. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.
The Egg Products Inspection Act is amended by inserting after section 20 (21 U.S.C. 1049) the following:
‘SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any egg or egg product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 20B. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 20C. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 20A (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 20A in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
SEC. 204. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.
(a) Prohibited Acts- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
‘(pp)(1) The failure to notify the Secretary in violation of section 311(a).
‘(2) The failure to comply with–
‘(A) an order issued under section 311(b) following any hearing requested under section 311(c); or
‘(B) an amended order issued under section 311(d)(1).’.
(b) Notification, Nondistribution, and Recall of Adulterated or Misbranded Articles of Food; Civil Penalties Relating to Foods- Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end the following:
‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer or other individual who is the intended consumer of an article of food) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury (as determined by the Secretary), the Secretary shall provide all appropriate persons (including the manufacturer, importer, distributor, or retailer of the article) with an opportunity (as determined by the Secretary)–
‘(A) to cease distribution of the article;
‘(B) to notify all persons–
‘(i) that produce, manufacture, pack, process, prepare, treat, package, distribute, or hold the article, to cease immediately those activities with respect to the article; or
‘(ii) to which the article has been distributed, transported, or sold, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed and to appropriate State and local health officials; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(c) Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for a hearing on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article of food that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that commits an act prohibited by section 301(pp) a civil penalty for each such act of not more than–
‘(A) $100,000, in the case of an individual; and
‘(B) $500,000, in the case of any other person.
‘(2) SEPARATE OFFENSES- Each prohibited act and each day during which the act continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(3) STANDARD OF REVIEW- The findings of the Secretary relating to the order shall be set aside only if the findings are found to be unsupported by substantial evidence on the record as a whole.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary may refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Penalties Deposited in Treasury- All amounts collected as civil penalties under this section shall be deposited in the Treasury of the United States.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of any libel or injunction proceeding, any violation of section 301(pp) in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
The Pharmacratic Inquisition DVD – Official Online Edition
1:51:19
How deep does the rabbit hole go? Gnostic Media is proud to present the official online edition of The Pharmacratic Inquisition 2007. If you enjoyed “Zeitgeist – The Movie”, you will love this video; the creators of this video are listed as one of the sources for the Zeitgeist Movie. The Pharmacratic Inquisition 2007 is a video version of the book, “Astrotheology & Shamanism” by Jan Irvin & Andrew Rutajit. The painstakingly detailed and heavily footnoted research in the book comes to life in this video and is now available to you for FREE! For further research of the claims made in this video, please read AstroTheology & Shamanism – this book is available to order as a combo with the DVD. Thousands of years ago, in the pre monarchic era, sacred plants and other entheogenic substances where politically correct and highly respected for their ability to bring forth the divine, Yahweh, God, The Great Spirit, etc., by the many cultures who used them. Often the entire tribe or community would partake in the entheogenic rites and rituals. These rites were often used in initiation into adulthood, for healing, to help guide the community in the decision process, and to bring the direct religious experience to anyone seeking it. In the pre literate world, the knowledge of psychedelic sacraments, as well as fertility rites and astronomical knowledge surrounding the sun, stars, and zodiac, known as astrotheology, were anthropomorphized into a character or a deity; consequently, their stories and practices could easily be passed down for generations. Weather changes over millenniums caused environmental changes that altered the available foods and plant sacraments available in the local vicinity. If a tribe lost its shamanic El-der (El – God), all of the tribe’s knowledge of their plant sacraments as well as astronomical knowledge would be lost. The Church’s inquisitions extracted this sacred knowledge from the local Shamans who were then exterminated…It is time to recognize the fact that this Pharmacratic Inquisition is still intact and destroy it.
In this one-off documentary, David Malone looks at four brilliant mathematicians – Georg Cantor, Ludwig Boltzmann, Kurt Gödel and Alan Turing – whose genius has profoundly affected us, but which tragically drove them insane and eventually led to them all committing suicide.
September 8, 2009
Listen to the Story
All Things Considered [5 min 20 sec]
“Retarded” used to be a garden-variety insult, but it may be the next candidate for prime-time bleeping.
E. Duff Wrobbel never gave the word much thought — until his daughter was born with Down syndrome. When she was just a baby, Wrobbel was driving with her when another car cut them off.
“And I actually said that word,” says Wrobbel, who is a professor of speech communications. “And then I stopped my car and got teary. And I thought, ‘Oh my gosh, I can’t believe I just said that.’ “
Now, Wrobbel has joined other activists who campaign against the word “retard.” To them, it’s not a hilarious put-down; it’s hate speech. (The word has been retired by medical and social service organizations, which prefer the term “intellectual disabilities” instead.) They petition TV networks and comedians, and organize against movies like last summer’s hit film Tropic Thunder, which coined the term “full retard” to describe a certain kind of unsuccessful Oscar-baiting role.
While the Tropic Thunder protests did little but provide publicity, there are signs that the word’s status may be changing. Earlier this summer, film critic Eric D. Snider was reviewing a DVD called Miss March. It’s a stinker of an insult comedy uniformly hated by critics when it came out in theaters last spring. Snider noticed that in the DVD version, actors’ lips were clearly saying “retard” repeatedly, but the word was dubbed out and replaced with “stupid” or “crackhead.” (He wrote about it here.)
It’s not just movies rethinking “retard” as an easy laugh. The Black Eyed Peas recorded a “clean” version of their song “Let’s Get Retarded” that changed that line to “Let’s Get It Started.” And a few months ago, popular sex advice columnist Dan Savage renounced his use of the word.
“You know, I just sat down to write the column, and I’d used the word ‘retard’ in a column recently,” he explained. “And there was a handful of letters taking me to task and I thought, ‘OK, I won’t use it anymore. I’ll use a new word. I hope you like this one better.’ “
The new word was “leotard.” As in, “You’re being totally leotarded.”
“Frankly, I’ve heard people using the ‘r-word,’ ” Savage says, “and it just seems so pansy-assed, if I may use that phrase.”
Savage is gay and brings a specific knowledge to that phrase. According to Oxford English Dictionary editor Jesse Sheidlower, “gay” and “retard” occupy parallel linguistic positions when it comes to schoolyard trash talk. They mean the same thing — “stupid” or “bad.”
Sheidlower can trace the use of “retard” as an insult back to the late 1950s. The first reference he could find was in a book about jazz. In a reference to Playboy magazine, a character says, “that Hefner jazz is for retarded jockstraps.”
“Retarded,” like “gay,” functions as an all-purpose put-down, says Sheidlower. If you say, “Stop being so gay,” or “That movie was retarded,” it’s not meant to be taken literally — as in “Stop being so homosexual,” or “That movie was intellectually disabled.” That differentiates those words from racist slurs. Ta-Nehisi Coates has written on the topic in his column in The Atlantic.
Coates says that in order for hateful language to become socially unacceptable, it needs to be linked with the kind of bigoted behavior no one wants to be associated with. And he suggests that there needs to be a fundamental cultural shift in empathy.
“As a young man, I used the word ‘chink’ all the time,” he says. “We referred to the corner store as ‘the chink store’ and thought nothing of it. What happens is, if you’re lucky, you come to understand those words describe actual human beings.”
Until then, “retard” will continue as a commonplace zinger.
-
re⋅tard
/rɪˈtɑrd, for 1–3, 5; ˈritɑrd for 4/ Show Spelled Pronunciation [ri-tahrd, for 1–3, 5; ree-tahrd for 4]
–verb (used with object)
1. to make slow; delay the development or progress of (an action, process, etc.); hinder or impede.
–verb (used without object)
2. to be delayed.
–noun
3. a slowing down, diminution, or hindrance, as in a machine.
4. Slang: Disparaging.
a. a mentally retarded person.
b. a person who is stupid, obtuse, or ineffective in some way: a hopeless social retard.
5. Automotive, Machinery. an adjustment made in the setting of the distributor of an internal-combustion engine so that the spark for ignition in each cylinder is generated later in the cycle.
Compare advance.
Origin:
1480–90; < L retardāre to delay, protract, equiv. to re- re- + tardāre to loiter, be slow, deriv. of tardus slow; see tardy
Related forms:
re⋅tard⋅ing⋅ly, adverb
Synonyms:
1. obstruct, check.
Antonyms:
1. accelerate.
Dictionary.com Unabridged
Based on the Random House Dictionary, © Random House, Inc. 2009.
“Persistence Hunt” of a Male Kudu, by tribesman of the San on the Kalahari Desert of Africa.
http://e-cognitive-enhancers.blogspot.com/
Dopaminergics
Dopaminergics are substances that affect the neurotransmitter dopamine or the components of the nervous system that use dopamine. Dopamine is produced in the synthesis of all catecholamine neurotransmitters, and is the rate limiting step for this synthesis. Dopaminergic nootropics include dopamine precursors and cofactors (vitamin C and vitamin B6), and dopamine reuptake inhibitors:
* Mucuna pruriens – Seed powder which contains high concentrations of levodopa (L-dopa),[28] a direct precursor of the neurotransmitter dopamine.
* Tyrosine (requires Vitamin B6 and Vitamin C) – Amino acid. Precursor to dopamine, anti-depressant, sleep reducer.
* Lazabemide – a MAO-B inhibitor and has potent membrane lipid antioxidant activity. The antioxidant effects of lazabemide are attributed to its chemical structure and direct physicochemical interactions with the membrane lipid bilayer. It is a potent antioxidant, even more powerful than selegiline (deprenyl) or vitamin E, and is used to treat Alzheimer’s disease.[29]
* L-dopa – Prescription drug and dietary supplement. Precursor to the neurotransmitter dopamine, anti-depressant.
* Phenylalanine (requires Vitamin B6 and Vitamin C) – Essential amino acid. Precursor to dopamine, anti-depressant, sleep reducer.
* Selegiline – L-deprenyl is an irreversible MAO-B inhibitor, an enzyme that breaks down dopamine. Thus, it is used to treat Parkinson’s disease, and has been tested as a treatment for Alzheimer’s disease.[30] It protects against the genotoxin AraC, provides neuroprotection against growth factor withdrawal in PC12 cells, protects against oxidative stress in mesencephalatic neurons, and delays neuronal cell death in the hippocampus after global ischemia.[31]
* Tolcapone – Inhibits COMT (an enzyme that breaks down the neurotransmitters dopamine, epinephrine, and norepinephrine) and increases performance in tasks depending on working memory in individuals with the val/val and val/met genotype of the val158Met polymorphism of the catechol-O-methyltransferase gene, while decreasing it in presence of the met/met version. Tolcapone presents the risk of deadly side effects.
* Yohimbe – Bark. Aphrodisiac. Boosts dopamine levels,[citation needed] though how it does this is not yet understood. Supplements are likely to have no yohimbe in them.[32] Yohimbe poses some health risks through its side-effects: it is a neuro-paralytic which slows down breathing and induces acidosis, some symptoms of which are malaise, nausea, and vomiting. Contraindicated for users of megadoses of acidic vitamins or nutrients.
* Theanine – Found in tea. Increases serotonin and dopamine levels in the brain. Increases alpha-wave based alert relaxation.
Publicat de health victorro la 04:23 0 comentarii
Etichete: Dopaminergics
Cholinergics
Cholinergics are substances that affect the neurotransmitter acetylcholine or the components of the nervous system that use acetylcholine. Acetylcholine facilitates memory, concentration, focus, and high-order thought processes (abstract thought, calculation, innovation, etc.).[citation needed] Increasing the availability of this neurotransmitter in the brain may improve these functions and increase the duration in which they may be engaged without slowing down or stopping. Oversupplying the brain with acetylcholine may have the opposite effect, temporarily reducing rather than improving mental performance.[citation needed] Cholinergic nootropics include acetylcholine precursors and cofactors, and acetylcholinesterase inhibitors:
Piracetam
Main article: Piracetam
Piracetam (Nootropil) is the original[15] and most commonly taken[16][15] nootropic supplement. It is a cholinergic agent synergistic with DMAE, Centrophenoxine, choline, Alpha-GPC and Hydergine. It increases brain cell metabolism and energy levels,[17][15] and speeds up interhemispheric flow of information (left-right brain hemisphere communication). It increases alertness,[12] improves concentration, and enhances memory. Protects neurons from hypoxia,[15] and stimulates growth of acetylcholine receptors.[citation needed] It may also cause nerves to regenerate.[citation needed] Piracetam markedly decreases the formation of neuronal lipofuscin.[18] It improves posture in elderly people.[19] It is not regulated in the US.[citation needed] It is a pyrrolidone derivative.
Aniracetam
Main article: Aniracetam
Aniracetam is a pyrrolidone derivative drug, analogous of piracetam, and considered more potent[citation needed]. Like piracetam, aniracetam protects against some memory impairing chemicals, such as diethyldithiocarbamate and clonidine.[20] Also like piracetam, aniracetam may enhance memory in aging adults by increasing levels of brain biogenic monoamines, which are beneficial to learning and memory.[13] Both racetams have possible therapeutic use in treating fetal alcohol syndrome.[21] Aniracetam increases vigilance.[12] Aniracetam has shown to positively potentiate AMPA receptors.
Other cholinergics
This section needs additional citations for verification.
Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (December 2007)
* Acetyl-L-carnitine (ALCAR) – Amino acid. Precursor of acetylcholine (donating the acetyl portion to the acetylcholine molecule). It is synergistic with lipoic acid.[22] Inhibits lipofuscin formation.
* Choline – precursor to acetylcholine (an essential component of the acetylcholine molecule).
o Alpha-GPC (L-alpha glycerylphosphorylcholine, Choline alfoscerate) – most effective choline precursor, readily crosses the blood-brain barrier.
o Citicoline – less expensive and similar in effect to Alpha GPC. Appears effective in rats.[23][24]
o Choline bitartrate – precursor of acetylcholine, anti-depressant.
o Choline citrate – precursor of the neurotransmitter acetylcholine, anti-depressant.[citation needed]
* DMAE – approved treatment for ADD/ADHD[citation needed], precursor of acetylcholine, cholinergic agent, removes lipofuscin from the brain, anti-depressant.
* Galantamine – acetylcholinesterase inhibitor made from chemical synthesis or extract from plants such as Red Spider Lily (Lycoris radiata).
* Huperzine A – potent acetylcholinesterase inhibitor derived from Chinese club-moss. Recent Cochrane review concluded that it appears to have beneficial cognitive effects with limited side-effects, but more evidence is needed.[25]
* Ispronicline – recently developed selective α4β2 partial agonist
* Lecithin – contains phosphatidylcholine, precursor of acetylcholine.
* Other pyrrolidone derivatives:
o Etiracetam – It increases vigilance.[12]
o Nefiracetam – Drug. Analog of piracetam, and facilitates hippocampal neurotransmission.[26]
o Oxiracetam – Drug. Analog of piracetam, and 2 to 4 times stronger. Improves memory, concentration, and vigilance. When fed to pregnant rats, the offspring of those rats were more intelligent than the offspring of rats fed a saline solution placebo.
o Pramiracetam – Drug. Analog of piracetam.
o In animal studies, nootropics such as piracetam, oxiracetam and aniracetam are known to facilitate the formation of long term memory traces and to restore object recognition in aging rats.[27] There is evidence that the beneficial effect of racetams may result from an interaction with the central glutamatergic receptor function. [27]
* Vitamin B5 – cofactor in the conversion of choline into acetylcholine, cholinergic agent, increases stamina (including mental stamina).[citation needed]
Excess acetylcholine is considered by many to be potentially harmful; see acetylcholinesterase inhibitor.
Acetylcholinesterase inhibitors
Acetylcholinesterase inhibitors function by inhibiting the cholinesterase enzyme which breaks down the neurotransmitter acetylcholine. They exist in the form of poisons and have been used as weapons, but they are also used to treat Alzheimer’s patients. Donepezil, galantamine, and Huperzine A are notable among these.
Publicat de health victorro la 04:21 0 comentarii
Etichete: Cholinergics
Replenishing and increasing neurotransmitters
As the brain ages, its ability to produce and maintain youthful levels of neurotransmitters declines.[13] There are various reasons for such an insufficiency. For instance, there might be a lack of enzymes involved in the neurotransmitter synthesis. Nevertheless, in many cases, providing the brain with ample raw materials necessary to make neurotransmitters can restore them to more youthful levels and thus help maintain cognitive function at vigorous youthful levels.[citation needed] Furthermore, there are declines in immune and endocrine functioning.[14] Certain nootropics enhance immune and endocrine functioning.
Publicat de health victorro la 04:21 0 comentarii
Etichete: neurotransmitters
Stimulants
Stimulants are often seen as smart drugs. Their effects are non-specific with similar results seen in children and adults with and without ADHD. One finds improved concentration and behavior in all.[6][7][8][9] Due to their non-specific activity, stimulants have been used by writers to increase productivity,[10] as well as by the United States Air Force to improve effectiveness in combat.[11] Some scientists recommend wide spread use (of Ritalin and Adderall) by the general population to increase brain power.[4]
This section needs additional citations for verification.
Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (January 2008)
* Adrafinil (Olmifon) – Drug.
* Caffeine – Drug. Improves concentration, idea production, but hinders memory encoding. Large amounts produce the jitters. Caffeine is the most widely used psychoactive substance in the world, and may be susceptible to strong levels of tolerance.
* Coffee – Bean. Contains caffeine; brewed coffee is high in antioxidants.
* Nicergoline – Drug. Nicergoline is an ergoloid mesylate derivative used to treat senile dementia. It has also been found to increase mental agility and enhance clarity and perception. It increases vigilance.[12] Increases arterial flow and use of oxygen and glucose in the brain.
* Nicotine – stimulus barrier (aids in concentration). Stimulus barrier rebound effect (an unpleasant side effect).
* Cocaine – Drug. Schedule II. Increase extracellular dopamine and serotonin levels resulting in increased alertness and arousal.
* Methylphenidate (Ritalin) – aids in concentration, focus and stamina. Prescribed for ADHD.
* Dextroamphetamine – (Adderall, Dexedrine) – aids in concentration, focus and stamina. Prescribed for ADHD.
* Modafinil – (Provigil) – Drug.
* Phenibut -
* Theophylline -
* Amphetamines – aids in concentration, focus and stamina. Prescribed for ADHD.
* Carphedon (Phenotropil) -
Publicat de health victorro la 04:19 0 comentarii
Etichete: cognitive, enhancers, Stimulants
Availability
Currently there are several drugs on the market that improve memory, concentration, planning and reduce impulsive behavior. Many more are in different stages of development.[3] The most commonly used class of drug are the stimulants.[4]
These drugs are used primarily to treat people with cognitive difficulties: Alzheimer’s disease, Parkinson’s disease, ADHD. However, more widespread use is being recommended by some researchers.[5] These drugs have a variety of human enhancement applications as well and are marketed heavily on the World Wide Web. Nevertheless, intense marketing may not correlate with efficacy; while scientific studies support some of the claimed benefits, it is worth noting that many of the claims attributed to most nootropics have not been formally tested.
i normally dont care for his logic play
and find it loaded and slippery at times
i did find this perspective very curious and foreign
http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?currentPage=all
Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.
By Steve Silberman 
08.24.09
08.24.09
Photo: Nick Veasey
Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn’t introduced a truly new product in three years, and its stock price was plummeting.
In interviews with the press, Edward Scolnick, Merck’s research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company’s reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. “To remain dominant in the future,” he told Forbes, “we need to dominate the central nervous system.”
His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive’s dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.
Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people’s health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.
Ultimately, Merck’s foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.
MK-869 wasn’t the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.
The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn’s disease, an intestinal ailment, citing an “unusually high” response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.
It’s not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late ’90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.
It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.
The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today’s economy, the fate of a long-established company can hang on the outcome of a handful of tests.
Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body’s innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.
The roots of the placebo problem can be traced to a lie told by an Army nurse during World War II as Allied forces stormed the beaches of southern Italy. The nurse was assisting an anesthetist named Henry Beecher, who was tending to US troops under heavy German bombardment. When the morphine supply ran low, the nurse assured a wounded soldier that he was getting a shot of potent painkiller, though her syringe contained only salt water. Amazingly, the bogus injection relieved the soldier’s agony and prevented the onset of shock.
Returning to his post at Harvard after the war, Beecher became one of the nation’s leading medical reformers. Inspired by the nurse’s healing act of deception, he launched a crusade to promote a method of testing new medicines to find out whether they were truly effective. At the time, the process for vetting drugs was sloppy at best: Pharmaceutical companies would simply dose volunteers with an experimental agent until the side effects swamped the presumed benefits. Beecher proposed that if test subjects could be compared to a group that received a placebo, health officials would finally have an impartial way to determine whether a medicine was actually responsible for making a patient better.
In a 1955 paper titled “The Powerful Placebo,” published in The Journal of the American Medical Association, Beecher described how the placebo effect had undermined the results of more than a dozen trials by causing improvement that was mistakenly attributed to the drugs being tested. He demonstrated that trial volunteers who got real medication were also subject to placebo effects; the act of taking a pill was itself somehow therapeutic, boosting the curative power of the medicine. Only by subtracting the improvement in a placebo control group could the actual value of the drug be calculated.
The article caused a sensation. By 1962, reeling from news of birth defects caused by a drug called thalidomide, Congress amended the Food, Drug, and Cosmetic Act, requiring trials to include enhanced safety testing and placebo control groups. Volunteers would be assigned randomly to receive either medicine or a sugar pill, and neither doctor nor patient would know the difference until the trial was over. Beecher’s double-blind, placebo-controlled, randomized clinical trial—or RCT—was enshrined as the gold standard of the emerging pharmaceutical industry. Today, to win FDA approval, a new medication must beat placebo in at least two authenticated trials.
Beecher’s prescription helped cure the medical establishment of outright quackery, but it had an insidious side effect. By casting placebo as the villain in RCTs, he ended up stigmatizing one of his most important discoveries. The fact that even dummy capsules can kick-start the body’s recovery engine became a problem for drug developers to overcome, rather than a phenomenon that could guide doctors toward a better understanding of the healing process and how to drive it most effectively.
In his eagerness to promote his template for clinical trials, Beecher also overreached by seeing the placebo effect at work in curing ailments like the common cold, which wane with no intervention at all. But the triumph of Beecher’s gold standard was a generation of safer medications that worked for nearly everyone. Anthracyclines don’t require an oncologist with a genial bedside manner to slow the growth of tumors.
What Beecher didn’t foresee, however, was the explosive growth of the pharmaceutical industry. The blockbuster success of mood drugs in the ’80s and ’90s emboldened Big Pharma to promote remedies for a growing panoply of disorders that are intimately related to higher brain function. By attempting to dominate the central nervous system, Big Pharma gambled its future on treating ailments that have turned out to be particularly susceptible to the placebo effect.
The tall, rusty-haired son of a country doctor, William Potter, 64, has spent most of his life treating mental illness—first as a psychiatrist at the National Institute of Mental Health and then as a drug developer. A decade ago, he took a job at Lilly’s neuroscience labs. There, working on new antidepressants and antianxiety meds, he became one of the first researchers to glimpse the approaching storm.
To test products internally, pharmaceutical companies routinely run trials in which a long-established medication and an experimental one compete against each other as well as against a placebo. As head of Lilly’s early-stage psychiatric drug development in the late ’90s, Potter saw that even durable warhorses like Prozac, which had been on the market for years, were being overtaken by dummy pills in more recent tests. The company’s next-generation antidepressants were faring badly, too, doing no better than placebo in seven out of 10 trials.
As a psychiatrist, Potter knew that some patients really do seem to get healthier for reasons that have more to do with a doctor’s empathy than with the contents of a pill. But it baffled him that drugs he’d been prescribing for years seemed to be struggling to prove their effectiveness. Thinking that something crucial may have been overlooked, Potter tapped an IT geek named David DeBrota to help him comb through the Lilly database of published and unpublished trials—including those that the company had kept secret because of high placebo response. They aggregated the findings from decades of antidepressant trials, looking for patterns and trying to see what was changing over time. What they found challenged some of the industry’s basic assumptions about its drug-vetting process.
Assumption number one was that if a trial were managed correctly, a medication would perform as well or badly in a Phoenix hospital as in a Bangalore clinic. Potter discovered, however, that geographic location alone could determine whether a drug bested placebo or crossed the futility boundary. By the late ’90s, for example, the classic antianxiety drug diazepam (also known as Valium) was still beating placebo in France and Belgium. But when the drug was tested in the US, it was likely to fail. Conversely, Prozac performed better in America than it did in western Europe and South Africa. It was an unsettling prospect: FDA approval could hinge on where the company chose to conduct a trial.
Mistaken assumption number two was that the standard tests used to gauge volunteers’ improvement in trials yielded consistent results. Potter and his colleagues discovered that ratings by trial observers varied significantly from one testing site to another. It was like finding out that the judges in a tight race each had a different idea about the placement of the finish line.
Potter and DeBrota’s data-mining also revealed that even superbly managed trials were subject to runaway placebo effects. But exactly why any of this was happening remained elusive. “We were able to identify many of the core issues in play,” Potter says. “But there was no clear answer to the problem.” Convinced that what Lilly was facing was too complex for any one pharmaceutical house to unravel on its own, he came up with a plan to break down the firewalls between researchers across the industry, enabling them to share data in “pre-competitive space.”
After prodding by Potter and others, the NIH focused on the issue in 2000, hosting a three-day conference in Washington. For the first time in medical history, more than 500 drug developers, doctors, academics, and trial designers put their heads together to examine the role of the placebo effect in clinical trials and healing in general.
Potter’s ambitious plan for a collaborative approach to the problem eventually ran into its own futility boundary: No one would pay for it. And drug companies don’t share data, they hoard it. But the NIH conference launched a new wave of placebo research in academic labs in the US and Italy that would make significant progress toward solving the mystery of what was happening in clinical trials.
Visitors to Fabrizio Benedetti’s clinic at the University of Turin are asked never to say the P-word around the med students who sign up for his experiments. For all the volunteers know, the trim, soft-spoken neuroscientist is hard at work concocting analgesic skin creams and methods for enhancing athletic performance.
One recent afternoon in his lab, a young soccer player grimaced with exertion while doing leg curls on a weight machine. Benedetti and his colleagues were exploring the potential of using Pavlovian conditioning to give athletes a competitive edge undetectable by anti-doping authorities. A player would receive doses of a performance-enhancing drug for weeks and then a jolt of placebo just before competition.
Benedetti, 53, first became interested in placebos in the mid-’90s, while researching pain. He was surprised that some of the test subjects in his placebo groups seemed to suffer less than those on active drugs. But scientific interest in this phenomenon, and the money to research it, were hard to come by. “The placebo effect was considered little more than a nuisance,” he recalls. “Drug companies, physicians, and clinicians were not interested in understanding its mechanisms. They were concerned only with figuring out whether their drugs worked better.”
Part of the problem was that response to placebo was considered a psychological trait related to neurosis and gullibility rather than a physiological phenomenon that could be scrutinized in the lab and manipulated for therapeutic benefit. But then Benedetti came across a study, done years earlier, that suggested the placebo effect had a neurological foundation. US scientists had found that a drug called naloxone blocks the pain-relieving power of placebo treatments. The brain produces its own analgesic compounds called opioids, released under conditions of stress, and naloxone blocks the action of these natural painkillers and their synthetic analogs. The study gave Benedetti the lead he needed to pursue his own research while running small clinical trials for drug companies.
Now, after 15 years of experimentation, he has succeeded in mapping many of the biochemical reactions responsible for the placebo effect, uncovering a broad repertoire of self-healing responses. Placebo-activated opioids, for example, not only relieve pain; they also modulate heart rate and respiration. The neurotransmitter dopamine, when released by placebo treatment, helps improve motor function in Parkinson’s patients. Mechanisms like these can elevate mood, sharpen cognitive ability, alleviate digestive disorders, relieve insomnia, and limit the secretion of stress-related hormones like insulin and cortisol.
In one study, Benedetti found that Alzheimer’s patients with impaired cognitive function get less pain relief from analgesic drugs than normal volunteers do. Using advanced methods of EEG analysis, he discovered that the connections between the patients’ prefrontal lobes and their opioid systems had been damaged. Healthy volunteers feel the benefit of medication plus a placebo boost. Patients who are unable to formulate ideas about the future because of cortical deficits, however, feel only the effect of the drug itself. The experiment suggests that because Alzheimer’s patients don’t get the benefits of anticipating the treatment, they require higher doses of painkillers to experience normal levels of relief.
Benedetti often uses the phrase “placebo response” instead of placebo effect. By definition, inert pills have no effect, but under the right conditions they can act as a catalyst for what he calls the body’s “endogenous health care system.” Like any other internal network, the placebo response has limits. It can ease the discomfort of chemotherapy, but it won’t stop the growth of tumors. It also works in reverse to produce the placebo’s evil twin, the nocebo effect. For example, men taking a commonly prescribed prostate drug who were informed that the medication may cause sexual dysfunction were twice as likely to become impotent.
Further research by Benedetti and others showed that the promise of treatment activates areas of the brain involved in weighing the significance of events and the seriousness of threats. “If a fire alarm goes off and you see smoke, you know something bad is going to happen and you get ready to escape,” explains Tor Wager, a neuroscientist at Columbia University. “Expectations about pain and pain relief work in a similar way. Placebo treatments tap into this system and orchestrate the responses in your brain and body accordingly.”
In other words, one way that placebo aids recovery is by hacking the mind’s ability to predict the future. We are constantly parsing the reactions of those around us—such as the tone a doctor uses to deliver a diagnosis—to generate more-accurate estimations of our fate. One of the most powerful placebogenic triggers is watching someone else experience the benefits of an alleged drug. Researchers call these social aspects of medicine the therapeutic ritual.
In a study last year, Harvard Medical School researcher Ted Kaptchuk devised a clever strategy for testing his volunteers’ response to varying levels of therapeutic ritual. The study focused on irritable bowel syndrome, a painful disorder that costs more than $40 billion a year worldwide to treat. First the volunteers were placed randomly in one of three groups. One group was simply put on a waiting list; researchers know that some patients get better just because they sign up for a trial. Another group received placebo treatment from a clinician who declined to engage in small talk. Volunteers in the third group got the same sham treatment from a clinician who asked them questions about symptoms, outlined the causes of IBS, and displayed optimism about their condition.
Rx for Success
What turns a dummy pill into a catalyst for relieving pain, anxiety, depression, sexual dysfunction, or the tremors of Parkinson’s disease? The brain’s own healing mechanisms, unleashed by the belief that a phony medication is the real thing. The most important ingredient in any placebo is the doctor’s bedside manner, but according to research, the color of a tablet can boost the effectiveness even of genuine meds—or help convince a patient that a placebo is a potent remedy.—Steve Silberman
Yellow pills
make the most effective antidepressants, like little doses of pharmaceutical sunshine.
Red pillscan give you a more stimulating kick. Wake up, Neo.
The color greenreduces anxiety, adding more chill to the pill.
White tablets—particularly those labeled “antacid”—are superior for soothing ulcers, even when they contain nothing but lactose.
More is better,scientists say. Placebos taken four times a day deliver greater relief than those taken twice daily.
Branding matters.Placebos stamped or packaged with widely recognized trademarks are more effective than “generic” placebos.
Clever namescan add a placebo boost to the physiological punch in real drugs. Viagra implies both vitality and an unstoppable Niagara of sexy.
Not surprisingly, the health of those in the third group improved most. In fact, just by participating in the trial, volunteers in this high-interaction group got as much relief as did people taking the two leading prescription drugs for IBS. And the benefits of their bogus treatment persisted for weeks afterward, contrary to the belief—widespread in the pharmaceutical industry—that the placebo response is short-lived.
Studies like this open the door to hybrid treatment strategies that exploit the placebo effect to make real drugs safer and more effective. Cancer patients undergoing rounds of chemotherapy often suffer from debilitating nocebo effects—such as anticipatory nausea—conditioned by their past experiences with the drugs. A team of German researchers has shown that these associations can be unlearned through the administration of placebo, making chemo easier to bear.
Meanwhile, the classic use of placebos in medicine—to boost the confidence of anxious patients—has been employed tacitly for ages. Nearly half of the doctors polled in a 2007 survey in Chicago admitted to prescribing medications they knew were ineffective for a patient’s condition—or prescribing effective drugs in doses too low to produce actual benefit—in order to provoke a placebo response.
The main objections to more widespread placebo use in clinical practice are ethical, but the solutions to these conundrums can be surprisingly simple. Investigators told volunteers in one placebo study that the pills they were taking were “known to significantly reduce pain in some patients.” The researchers weren’t lying.
These new findings tell us that the body’s response to certain types of medication is in constant flux, affected by expectations of treatment, conditioning, beliefs, and social cues.
For instance, the geographic variations in trial outcome that Potter uncovered begin to make sense in light of discoveries that the placebo response is highly sensitive to cultural differences. Anthropologist Daniel Moerman found that Germans are high placebo reactors in trials of ulcer drugs but low in trials of drugs for hypertension—an undertreated condition in Germany, where many people pop pills for herzinsuffizienz, or low blood pressure. Moreover, a pill’s shape, size, branding, and price all influence its effects on the body. Soothing blue capsules make more effective tranquilizers than angry red ones, except among Italian men, for whom the color blue is associated with their national soccer team—Forza Azzurri!
But why would the placebo effect seem to be getting stronger worldwide? Part of the answer may be found in the drug industry’s own success in marketing its products.
Potential trial volunteers in the US have been deluged with ads for prescription medications since 1997, when the FDA amended its policy on direct-to-consumer advertising. The secret of running an effective campaign, Saatchi & Saatchi’s Jim Joseph told a trade journal last year, is associating a particular brand-name medication with other aspects of life that promote peace of mind: “Is it time with your children? Is it a good book curled up on the couch? Is it your favorite television show? Is it a little purple pill that helps you get rid of acid reflux?” By evoking such uplifting associations, researchers say, the ads set up the kind of expectations that induce a formidable placebo response.
The success of those ads in selling blockbuster drugs like antidepressants and statins also pushed trials offshore as therapeutic virgins—potential volunteers who were not already medicated with one or another drug—became harder to find. The contractors that manage trials for Big Pharma have moved aggressively into Africa, India, China, and the former Soviet Union. In these places, however, cultural dynamics can boost the placebo response in other ways. Doctors in these countries are paid to fill up trial rosters quickly, which may motivate them to recruit patients with milder forms of illness that yield more readily to placebo treatment. Furthermore, a patient’s hope of getting better and expectation of expert care—the primary placebo triggers in the brain—are particularly acute in societies where volunteers are clamoring to gain access to the most basic forms of medicine. “The quality of care that placebo patients get in trials is far superior to the best insurance you get in America,” says psychiatrist Arif Khan, principal investigator in hundreds of trials for companies like Pfizer and Bristol-Myers Squibb. “It’s basically luxury care.”
Big Pharma faces additional problems in beating placebo when it comes to psychiatric drugs. One is to accurately define the nature of mental illness. The litmus test of drug efficacy in antidepressant trials is a questionnaire called the Hamilton Depression Rating Scale. The HAM-D was created nearly 50 years ago based on a study of major depressive disorder in patients confined to asylums. Few trial volunteers now suffer from that level of illness. In fact, many experts are starting to wonder if what drug companies now call depression is even the same disease that the HAM-D was designed to diagnose.
Existing tests also may not be appropriate for diagnosing disorders like social anxiety and premenstrual dysphoria—the very types of chronic, fuzzily defined conditions that the drug industry started targeting in the ’90s, when the placebo problem began escalating. The neurological foundation of these illnesses is still being debated, making it even harder for drug companies to come up with effective treatments.
What all of these disorders have in common, however, is that they engage the higher cortical centers that generate beliefs and expectations, interpret social cues, and anticipate rewards. So do chronic pain, sexual dysfunction, Parkinson’s, and many other ailments that respond robustly to placebo treatment. To avoid investing in failure, researchers say, pharmaceutical companies will need to adopt new ways of vetting drugs that route around the brain’s own centralized network for healing.
Ten years and billions of R&D dollars after William Potter first sounded the alarm about the placebo effect, his message has finally gotten through. In the spring, Potter, who is now a VP at Merck, helped rev up a massive data-gathering effort called the Placebo Response Drug Trials Survey.
Under the auspices of the NIH, Potter and his colleagues are acquiring decades of trial data—including blood and DNA samples—to determine which variables are responsible for the apparent rise in the placebo effect. Merck, Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi-Aventis, Johnson & Johnson, and other major firms are funding the study, and the process of scrubbing volunteers’ names and other personal information from the database is about to begin.
In typically secretive industry fashion, the existence of the project itself is being kept under wraps. NIH staffers are willing to talk about it only anonymously, concerned about offending the companies paying for it.
For Potter, who used to ride along with his father on house calls in Indiana, the significance of the survey goes beyond Big Pharma’s finally admitting it has a placebo problem. It also marks the twilight of an era when the drug industry was confident that its products were strong enough to cure illness by themselves.
“Before I routinely prescribed antidepressants, I would do more psychotherapy for mildly depressed patients,” says the veteran of hundreds of drug trials. “Today we would say I was trying to engage components of the placebo response—and those patients got better. To really do the best for your patients, you want the best placebo response plus the best drug response.”
The pharma crisis has also finally brought together the two parallel streams of placebo research—academic and industrial. Pfizer has asked Fabrizio Benedetti to help the company figure out why two of its pain drugs keep failing. Ted Kaptchuk is developing ways to distinguish drug response more clearly from placebo response for another pharma house that he declines to name. Both are exploring innovative trial models that treat the placebo effect as more than just statistical noise competing with the active drug.
Benedetti has helped design a protocol for minimizing volunteers’ expectations that he calls “open/hidden.” In standard trials, the act of taking a pill or receiving an injection activates the placebo response. In open/hidden trials, drugs and placebos are given to some test subjects in the usual way and to others at random intervals through an IV line controlled by a concealed computer. Drugs that work only when the patient knows they’re being administered are placebos themselves.
Ironically, Big Pharma’s attempt to dominate the central nervous system has ended up revealing how powerful the brain really is. The placebo response doesn’t care if the catalyst for healing is a triumph of pharmacology, a compassionate therapist, or a syringe of salt water. All it requires is a reasonable expectation of getting better. That’s potent medicine.
Contributing editor Steve Silberman (steve@stevesilberman.com) wrote about the hunt for Jim Gray in issue 15.08.
Health Insurers Own Tobacco Stocks Worth Nearly $4.5 Billion
By Carey Alexander, 10:00 AM on Sat Jun 6 2009, 14,059 views
http://consumerist.com/5281026/health-insurers-own-tobacco-stocks-worth-nearly-45-billion
Major health insurance companies own nearly $4.5 billion worth of stock in tobacco companies, according to a Harvard University study. It kinda makes sense: health insurers know tobacco sickens people, and so as long as people are smoking, why not profit from the killer? It’s what David Himmelstein, a co-author of the study, calls “the combined taxidermist and veterinarian approach: either way you get your dog back.”
The largest tobacco investor on the list, the 160-year old Prudential company with branches in the US and the UK, has more than $1.5 billion invested in tobacco stocks. The runner-up was Toronto-based Sun Life Financial, which apparently holds over $1 billion in Philip Morris (Altria) and other tobacco stocks. In total, seven companies that sell life, health, disability, or long-term care insurance, have major holdings in tobacco stock.
Why is it a big deal? “If you own a billion dollars [of tobacco stock], then you don’t want to see it go down,” says Himmelstein, “You are less likely to join anti-tobacco coalitions, endorse anti-tobacco legislation, basically, anything most health companies would want to participate in.”
Sun Life Financial denies that they hold any tobacco stock, a claim Himmelstein delicately called a lie.
It’s just another thing to keep in mind this summer as Congress debates whether we can continue trusting our private health insurers to look out for our best interests.
Health insurers want you to keep smoking, Harvard doctors say [Scientific American]
(Photo: Kevin Dean)
