What is wrong with HR2749 after reading it

The following is an excellent analysis of HR2749.

Written in response to a blog elsewhere that states the latest version isn't so bad...

I believe I have the last copy of HR2749 in my lap; it was “ordered to be printed” yesterday. I have a number of concerns still.
1. It gives the Federal government jurisdiction over interstate commerce, still, which violates the Constitution. There is no exemption for farmers, homesteaders or small processors who sell only in their own states.
2. The exemption for those who sell over 50% direct to the public will of course require some of us to PROVE the mix of our business, which means government inspection of our paperwork, farms, etc anyway. I own a small local food store. I am the sole owner and the sole employee and currently have nothing of my own in the store other than tomatoes and cucumbers, but will have goat meat within the month and eggs and bread as soon as my egg processing room and kitchen are licensed. Now you’d THINK since I am sole owner, this would be direct to the public, but since I have a storefront instead of a farm stand, it is not. Complying with HR2749 would make my tiny 9 acre farm cost me more money and heartache than it is worth. Those folks who sell at a farmers market and at a retail store or establishment will have to watch their sales very, very carefully and keep their records for years, just in case. I know someone who underreports farm market sales because the market takes a percentage and he thinks that is so unfair even though he signed a contract. This person will pay eventually, but to the Feds rather than to the market he’s cheating, because he also sells to a restaurant. There goes his more than 50% direct!

Read the rest here at Localvore Oregon


I

Swallow Peanuts but Choke on Raw Milk - Excellent Article

Tim Rowland

Swallow peanuts, but choke on raw milk?

February 22, 2009

It's rich to hear state health departments and the federal Food and Drug Administration shake a warning finger at the Maryland General Assembly over the dangers of raw milk.

It is equally quaint to hear the farm bureaus raise the same complaints, considering that many of their dairy-farmer members grew up drinking the stuff.

The message is that any milk that hasn't been cooked beyond recognition under the watchful eye of government regulators is unfit for human consumption - and as regulators guard the front door with shotguns to prevent a dairy breaking and entering, tons of bacterially poisoned peanut butter are slipping in through the back, which should be proof enough that it's the producer, not the product, that makes the difference. [read the rest here]

But before you go....buy my book. Or look at it anyway. Click through on the right sidebar. It is an excellent resource for people who don't know about NAIS, and, if I might say so, a very good read. Signed copies still available, drop me an email.

Oh, Vanity! Death be thy name

Cure yourself of the affliction of caring how you appear to others. Concern yourself only with how you appear before God, concern yourself only with the idea that God may have of you. ~Miguel De Unamuno

FDA approves Allergan's drug for longer eyelashes

BOSTON (Reuters) - Allergan Inc, the maker of Botox, said on Friday that the U.S. Food and Drug Administration has approved its eyelash-thickening drug Latisse.

Latisse is designed to treat a condition known as hypotrichosis of the eyelashes, which means a person does not have enough eyelashes.

The active ingredient in Latisse is bimatroprost, the same ingredient that is in Allergan's glaucoma treatment Lumigan. Patients taking Lumigan found a side effect of the drug to be eyelash growth, prompting Allergan to study it for the new use. Read the rest here.

How many people will line up to get this product? Honestly, what is wrong with this world? Have you see then television ad for "prescription strength deoderant"? It helps keep your underarms soft. Gosh. What kind of a world are our young women coming into where they think they might be judged for sparse eyelashes and rough underarms?

FDA/USDA sez melamine contaminated products at "levels calculated to be safe to consume."

Give me a break! No level of melamine can be considered anything but poisonous. The FDA and USDA are failing miserably and now, to cover their butts, are trying to tell people that the levels are safe to consume.

This is the link for their MELAMINE AND ANALOGUES SAFETY/RISK ASSESSMENT.

Within that risk assessment is this little nugget:

The assessment notes that melamine is not metabolized, and is rapidly excreted in the urine. Thus, it is not believed to accumulate in the body of animals.

I mean, I'm no scientist, but logically, if that statement were true how then did all those pets die? And, the numbers of pet deaths were severly under reported in the media.

How long can they keep lying?

I'm so glad I eat my own chickens and pork. You wouldn't catch me buying either in the grocery store.

FDA News

FOR IMMEDIATE RELEASE P07-82 May 7, 2007

Media Inquiries: FDA Press Office: 301-827-6242 USDA Press Office: 202-720-4623 Consumer Inquiries: 888-INFO-FDA

FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans
from Food Containing Melamine
USDA Releases Some Swine and Poultry for Processing

There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.

In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe. In other words, it was well below any level of public health concern.

The risk assessment is an important new science-based component of the continuing federal joint investigation into imported wheat gluten and rice protein concentrate from China that contained melamine and melamine-related compounds.

The risk assessment was conducted by scientists from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services (HHS), the Environmental Protection Agency (EPA), U.S. Customs and Border Protection (CBP) of the Department of Homeland Security (DHS) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). This team is now compiling a scientific assessment of the risk to animal health associated with ingestion of animal feed containing melamine and its compounds.

FDA and USDA are in the process of identifying a group of experts to convene a scientific advisory board that would be charged with reviewing the risk assessment. This group would also be asked to contribute to future scientific analysis related to the risk of melamine and its compounds to humans and animals.

In the course of the investigation, it was discovered that pet food was contaminated by wheat gluten and rice protein concentrate that contained melamine and its compounds. Subsequently, scraps of contaminated pet food that contained only low levels of melamine were distributed to farms in a limited number of states and added to the feed consumed by swine and poultry. These scraps constituted only a small percentage of the farm animal rations. In addition, melamine is known to be excreted in animal urine. When exposure levels are much higher, as was the case with cats and dogs, the melamine and its compounds appear to cause the formation of crystals in the kidney systems, resulting in kidney damage. There was no indication of kidney damage in hogs. Both hogs and chickens known to have been fed contaminated feed appear to be healthy.

This dilution factor was an important piece of data considered in the multi-agency science-based human risk analysis and helps to support the conclusion that there is very low risk to human health from eating meat from animals that were fed the contaminated product. This conclusion supports the decision announced on April 28 not to recall meat from animals that were fed contaminated product.

Currently, swine and poultry on farms suspected of receiving contaminated feed are being held under state quarantine or voluntarily by the owners. In several cases, feed samples have tested negative for melamine and related compounds. These tests were conducted by federal laboratories or state laboratories using approved methods. It is assumed that because only small amounts of the contaminated feed were mixed with other rations, the melamine and related compounds were no longer detectable. USDA has concluded that, based on the human risk assessment and the inability to detect melamine in the feed samples, these animals no longer need to be quarantined or withheld from processing.

In other cases, feed samples have tested positive for melamine and related compounds; feed samples were not available; or feed samples have not yet been submitted for testing. These animals continue to be withheld from processing, but are not yet being culled, pending the results of the animal risk assessment. This assessment is expected to be completed within one week. At that time, USDA will determine whether these animals can be released for inspection and further processing.

USDA and FDA continue to conduct a full and comprehensive investigation. As additional information is confirmed, updates will be provided and decisions will be made using the best available science to protect the public's health.

To ensure no further contaminated products enter the U.S., the federal government will continue to monitor imported wheat and corn gluten as well as rice protein concentrate and isolates arriving from all countries destined for human and animal consumption. The FDA import alert for these products sourced from China remains in effect and U.S. Customs and Border Protection will continue laboratory testing of the products as they enter the U.S. The inspections are a precautionary measure to ensure the safety of products entering at U.S. ports of entry. There is no evidence to suggest products bound for the human food supply are contaminated.

For additional information about the pet food and contaminated feed investigation, go to www.fda.gov or www.usda.gov. The human safety/risk assessment will be available online upon completion of an executive summary.

A biblical answer for USDA/APHIS and Mike Johanns

Proverbs 12:11

11 He who works his land will have abundant food,
but he who chases fantasies lacks judgment.

USDA, Mike Johanns, all you all, you are chasing a fantasy of food safety and disease tracking by the methods you are pursuing. You will never get full voluntary compliance for NAIS. You've got it all backwards. The real enemy of food, besides USDA and FDA are the CAFOs, importation of foreign, not inspected meat that doesn't have to meet the same NAIS obligations that you are trying and lying so hard to cram down our throats and the bogus USDA "organic standard". Don't you think it is time to re-evaluate and scrap your plans?

Here is Proverb 12 in full. It is a wise man who works to rightly divide the word of God. There is much profit in these words.

Proverbs 12

1 Whoever loves discipline loves knowledge,
but he who hates correction is stupid.

2 A good man obtains favor from the LORD,
but the LORD condemns a crafty man.

3 A man cannot be established through wickedness,
but the righteous cannot be uprooted.

4 A wife of noble character is her husband's crown,
but a disgraceful wife is like decay in his bones.

5 The plans of the righteous are just,
but the advice of the wicked is deceitful.

6 The words of the wicked lie in wait for blood,
but the speech of the upright rescues them.

7 Wicked men are overthrown and are no more,
but the house of the righteous stands firm.

8 A man is praised according to his wisdom,
but men with warped minds are despised.

9 Better to be a nobody and yet have a servant
than pretend to be somebody and have no food.

10 A righteous man cares for the needs of his animal,
but the kindest acts of the wicked are cruel.

11 He who works his land will have abundant food,
but he who chases fantasies lacks judgment.

12 The wicked desire the plunder of evil men,
but the root of the righteous flourishes.

13 An evil man is trapped by his sinful talk,
but a righteous man escapes trouble.

14 From the fruit of his lips a man is filled with good things
as surely as the work of his hands rewards him.

15 The way of a fool seems right to him,
but a wise man listens to advice.

16 A fool shows his annoyance at once,
but a prudent man overlooks an insult.

17 A truthful witness gives honest testimony,
but a false witness tells lies.

18 Reckless words pierce like a sword,
but the tongue of the wise brings healing.

19 Truthful lips endure forever,
but a lying tongue lasts only a moment.

20 There is deceit in the hearts of those who plot evil,
but joy for those who promote peace.

21 No harm befalls the righteous,
but the wicked have their fill of trouble.

22 The LORD detests lying lips,
but he delights in men who are truthful.

23 A prudent man keeps his knowledge to himself,
but the heart of fools blurts out folly.

24 Diligent hands will rule,
but laziness ends in slave labor.

25 An anxious heart weighs a man down,
but a kind word cheers him up.

26 A righteous man is cautious in friendship, ^[a]
but the way of the wicked leads them astray.

27 The lazy man does not roast ^[b] his game,
but the diligent man prizes his possessions.

28 In the way of righteousness there is life;
along that path is immortality.

Footnotes:

1. Proverbs 12:26 Or man is a guide to his neighbor
2. Proverbs 12:27 The meaning of the Hebrew for this word is uncertain.

Comment promoted to an entry so I can reply

Obewan said...

You guys are still looking for pet food contaminations (sic)........much of this gluten is food grade...this means we have been eating this melamine for many many years in very small quantities. Have you not seen the light that no one can be trusted? [Yes, I know no one in the food industry can be trusted.] Clearly Americans would not poison Americans. If you are that far away in China...how are you going to get me? Your (sic) not.... they are not a democracy and have no laws like ours..... am I the only one that sees the bigger picture here? [No, Obewan, you aren't the only one. If you have read through my blog at all you would know that I am one of the awake ones.] The Chinese use melamine as a common practice to cut the gluten and have been doing it for the past 15 years. The melamine is a poison...animals died! Have you not seen chronic diseases skyrocket around you and in your family? [This is another area I have tried to enlighten others about. As the food supply becomes more corrupt, the more diseases we see, more obesity, more drugs need to be sold, etc. It drives me nuts, really, that the populace can't seem to connect the dots.] All imported processed foods from anywhere out side this country need to stop coming into this country immediately [We are in 100% agreement.] .....the products can not be trusted....should I say this again? Systematic auto immune chronic disease means lots....no tons of money for the drug companies who are dealing with this intentional poisoning of Americans and their pets. You were not suppose to find out that they were cutting the food with a poison.....like a crack dealer gone bad!
Obewan

Thanks for your comments, we are on the same page. We need people like you, obviously awake to what is happening, to help us wake others up. Events in this country are happening faster and faster. It is frustrating that the majority of the citizens won't stand up and make a loud noise.

Imported food rarely inspected

Again, time and time again, FDA and USDA fail miserably at their jobs of making sure our food supply is not compromised. It is time for the FDA and USDA to be audited because it is clear they are not doing the job of protecting the country from foreign-borne diseases.

I don't know whose idea it was to globalize, but that person deserves a huge head-spank for it. So far nothing good has come of it. We have lost jobs here in America, we have given a huge amount of money to the UN and for what, the quality of overseas products is substantially inferior to what America used to make, on and on I could go with that rant. Time to pull in! Go back to being for America first.

Write to your legislators in Congress and demand an audit of the FDA and USDA.

-----------------------------------
Imported food rarely inspected

By ANDREW BRIDGES, Associated Press Writer

WASHINGTON - Just 1.3 percent of imported fish, vegetables, fruit and other foods are inspected — yet those government inspections regularly reveal food unfit for human consumption.

Frozen catfish from China, beans from Belgium, jalapenos from Peru, blackberries from Guatemala, baked goods from Canada, India and the Philippines — the list of tainted food detained at the border by the Food and Drug Administration stretches on.

Add to that the contaminated Chinese wheat gluten that poisoned cats and dogs nationwide and led to a massive pet food recall, and you've got a real international pickle. Does the United States have the wherewithal to ensure the food it imports is safe?

Food safety experts say no.

With only a minuscule percentage of shipments inspected, they say the nation is vulnerable to harm from abroad, where rules and regulations governing food production are often more lax than they are at home.

"FDA doesn't have enough resources or control over this situation presently," said Mike Doyle (news, bio, voting record), director of the University of Georgia's Center for Food Safety, which works with industry to improve safety.

Last month alone, FDA detained nearly 850 shipments of grains, fish, vegetables, nuts, spice, oils and other imported foods for issues ranging from filth to unsafe food coloring to contamination with pesticides to salmonella.

And that's with just 1.3 percent of the imports inspected. As for the other 98.7 percent, it's not inspected, much less detained, and goes to feed the nation's growing appetite for imported foods.

Each year, the average American eats about 260 pounds of imported foods, including processed, ready-to-eat products and single ingredients. Imports account for about 13 percent of the annual diet.

"Never before in history have we had the sort of system that we have now, meaning a globalization of the food supply," said Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition.

FDA inspections focus on foods known to be at risk for contamination, including fish, shellfish, fruit and vegetables. Food from countries or producers previously shown to be problematic also are flagged for a closer look.

Consider this list of Chinese products detained by the FDA just in the last month: frozen catfish tainted with illegal veterinary drugs, fresh ginger polluted with pesticides, melon seeds contaminated with a cancer-causing toxin and filthy dried dates.

But even foods expected to be safe can harbor unexpected perils. Take wheat gluten: Grains and grain byproducts like it are rarely eaten raw and generally pose few health risks, since cooking kills bacteria and other pathogens.

Even so, the FDA can't say for sure whether the ingredient used in the pet foods was inspected after it arrived from China. And if the wheat gluten was, officials said, it wouldn't have been tested for melamine. Even though the chemical isn't allowed in food for pets or people, in any quantity, it previously wasn't believed toxic.

How did the melamine wind up in the wheat gluten? Investigators still don't know. Meanwhile, China is struggling to overhaul its food system and improve safety standards, but still faces major hurdles.

Farmers use pesticides and chemical fertilizers to build produce yields and antibiotics are used on seafood and livestock. Heavy metals also can be introduced into the food chain by widespread industrial pollution.

Increasingly, those foods are sold in a now global marketplace.

While the European Union, Canada and Mexico still top the list of food exporters to the U.S., China is coming up fast. Since 1997, the value of Chinese food imports, including commodities like wheat gluten, has more than tripled, to $2.1 billion from $644 million, according to Agriculture Department statistics. It accounts for 3.3 percent of the total food the U.S. buys abroad.

For suspect imported products — and wheat gluten is now one of them — the FDA issues alerts to its inspectors. The FDA flags Chinese food and other imported products it regulates, like cosmetics, for that extra scrutiny more than any other country except Mexico.

To safeguard its export business, China is looking at separating foods by their ultimate destination, domestic or foreign, according to Michiel Keyzer, director of the Center for World Food Studies at Amsterdam's Vrije Universiteit.

U.S. government statistics suggest China still has a way to go.

The FDA has been stopping Chinese food import shipments at the rate of about 200 per month this year. Shippers have the right to appeal the detentions, after which the government can order products returned or destroyed.

How do you know the origin of the food you eat? The 2002 Farm Act called for fish, fruit and vegetable imports to be labeled by country of origin, though implementation for the latter two foods has been delayed.

Meanwhile, the U.S. imports more and more, though the increase in value is partially due to the weaker dollar.

All told, the U.S. is expected to import a record $70 billion in agricultural products for the 12 months ending in September, according to an Agriculture Department forecast. The value of those imports will be about double the nearly $36 billion purchased overseas in 1997.

Contributing to that growth are the fresh fruits and vegetables imported during the offseason, when domestic production dwindles or ends.

About one-quarter of our fruit, both fresh and frozen, is imported. For tree nuts, it's about half. And for fish and shellfish, more than two-thirds come from overseas.

Even as the amount of imported food increased, the percentage of FDA inspections declined — from 1.8 percent in 2003 to 1.3 percent this year to an expected 1.1 percent next year.

"Inspections have a very important role but they're not the solution. They are the verification," FDA commissioner Dr. Andrew von Eschenbach said.

The FDA and the USDA have adopted a "risk-based" inspection philosophy, focusing on specific foods, sources or producers that they believe represent the largest potential risk to the public's health.

"The public at large is not at any increased risk," said Craig Henry, senior vice president and chief operating officer for scientific and regulatory affairs of the Grocery Manufacturers-Food Products Association, an industry group.

Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest, an advocacy group, countered that "risk-based" is just shorthand for "reduced resources."

"Whenever they say 'risk-based approach,' it often means they don't have enough staff to actually do the job. They're doing triage. They're trying to hit what's most important to inspect but they're missing a lot," DeWaal said.

Groups lobbying to increase the FDA's budget say its spending on food safety has languished, despite the agency's outsized role in ensuring the safety of the nation's food supply.

A recent Government Accountability Office report noted that most of the $1.7 billion the federal government allocates to food safety goes to the USDA, which is responsible for regulating about 20 percent of the food supply. The FDA, responsible for most of the other 80 percent, gets about 24 percent of the total spent on food safety.

Unlike the FDA, the USDA requires foreign inspection certificates to accompany all products it regulates, which include meat and poultry. Those imports are then reinspected at each port of entry before they are allowed into this country — something that doesn't happen to all FDA-regulated imports.

Under the Bioterrorism Act of 2002, anyone importing food into the United States is required to notify the FDA of the shipment before it arrives by land, air or sea. That allows the FDA to intercept contaminated products before they reach the marketplace, though agency officials acknowledge it doesn't always work that way.

"We have better control than we did a few years ago but it is largely the responsibility of the importer to make sure those products are safe," said Stephen Sundlof, the FDA's top veterinarian.

ChemNutra Inc., the Las Vegas importer of the tainted wheat gluten, said it was "particularly troubled" that its supplier did not disclose it contained melamine.

Doyle, of the University of Georgia, warned the contaminated pet food could be an unsavory taste of what's to come.

"This is not the first and will not be the last but it certainly is a wakeup call for the public to get a better appreciation for where this country is going with imports and imported foods," Doyle said.

Brackett, the FDA official, said the globalization of the food supply means the agency is going to have to be more creative and strategic in ensuring its safety. "I am not quite sure how we're going to do that yet," he said, "except to know that that's the direction that we're going to be heading."

FDA Rules Override Warnings About Drug

[As I was googling for the source of the following article, I came across this site: People over Profits. It looks like an interesting Grass roots activist site, though I haven't researched who is behind them.]

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.



The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.



Echoing those concerns, the FDA's advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.



Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh the threats to human health posed by proposed new animal drugs.



The wording of "Guidance for Industry #152" was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to pharmaceutical companies than is recommended by the World Health Organization.Cefquinome's seemingly inexorable march to market shows how a few words in an obscure regulatory document can sway the government's approach to protecting public health.Industry representatives say they trust Guidance #152's calculation that cefquinome should be approved. "There is reasonable certainty of no harm to public health," Carl Johnson, InterVet's director of product development, told the FDA last fall.



Others say Guidance #152 makes it too difficult for the FDA to say no to some drugs.



"The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use,' " said Edward Belongia, an epidemiologist at the Marshfield Clinic Research Foundation in Wisconsin. "But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open."



The FDA knows how hard it can be to close that door. In the mid-1990s, overriding the objections of public health experts from the Centers for Disease Control and Prevention (CDC), the drug agency approved the marketing of two drugs, Baytril and SaraFlox, for use in poultry. Both are fluoroquinolones, a class of drugs important for their ability to fight the bioterror bacterium that causes anthrax and a food-borne bacterium called campylobacter, which causes a serious diarrheal disease in people.



Before long, doctors began finding fluoroquinolone-resistant strains of campylobacter in patients hospitalized with severe diarrhea. When studies showed a link to poultry, the FDA sought a ban. But while Abbott Laboratories, which made SaraFlox, pulled its product, Baytril's manufacturer, Bayer Corp., pushed back.



"They fought this tooth and nail. It took years," said Kirk Smith, an epidemiologist at the Minnesota Department of Health.



Finally, late in 2005, Bayer gave up, but not before fluoroquinolone resistance had spread even further.


A Question of Resistance


Microbes are constantly mutating, and some of those mutations happen to confer immunity to one drug or another. Exacerbating the problem, bacteria constantly exchange bits of DNA with each other, spreading that resistance.


Given those realities, experts agree that all antibiotics should be used judiciously.



"If a drug is used less, then less resistance emerges," said Patricia Griffin, chief of intestinal disease epidemiology for the CDC.



Prudence is especially important for medicines of last resort, which is why the cefquinome application stirred such a storm.



Cefquinome is a fourth-generation cephalosporin, the most recent of several steadily improving versions of the cephalosporin family of antibiotics. Only one medicine from that family has been approved in the United States -- a powerful human drug called cefepime (brand name Maxipime), which is the only effective treatment for serious infections in cancer patients and a reliable lifesaver against several other nearly invincible infections.



InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. Recognizing the potential public health implications of using a close cousin of cefepime in animals, the FDA's Center for Veterinary Medicine, which oversees animal drug approvals, convened its expert advisers in September.



One of the first things the group learned was that more than a dozen medicines are already on the market for the respiratory syndrome, and all are still effective.



"If we have no susceptibility problem, why do we need one more new drug?" asked James E. Leggett Jr., a professor of medicine at Oregon Health & Science University, whom the FDA brought in as a consultant on the cefquinome question.



The panel also learned that the disease would be a relatively minor issue but for the stressful conditions under which U.S. cattle are raised, including high-density living spaces and routine shipment on crowded trains for hundreds or thousands of miles. Those "production dynamics" suppress the animals' immune systems, explained feedlot consultant Kelly Lechtenberg of Oakland, Neb., and virtually guarantee that bovine respiratory disease will be a major problem.



Yet Stephen Sundlof, head of the FDA's Veterinary Medicine Center, told the panel members that under agency rules they should ignore those issues and consider only the language in Guidance #152.


Flaws Seen in Rules


Guidance #152 is essentially a checklist of points to consider when weighing the potential human impact of a new animal drug.



After the Baytril debacle, the public health community embraced the idea of a guidance document. A formalized risk-assessment process promised to minimize the chances of making a bad regulatory call.



But a struggle ensued when the FDA hosted meetings to spell out the criteria to be used for measuring risk, often with veterinarians and veterinary drug companies on one side and doctors and public health experts on the other.



When differences could not be resolved after repeated drafts and months of work, the agency sidestepped some tough issues and adopted language that both sides agree can block approval of the most worrisome drugs -- those such as Baytril that are put in animal feed or water, and so are easily overused. But public health experts say the wording tilts the playing field toward industry for other kinds of drugs. They want to see it revised.



Most glaring, they say, is that the guidance makes it almost impossible to say no to a new animal drug unless it is likely to threaten the effectiveness of an antibiotic that is a critical player against food-borne illnesses. By contrast, the World Health Organization recommends saying no if approval would spur resistance to any antibiotic that is important for fighting "serious human disease" -- not just food-borne illnesses.



Cefquinome's primary threat is that it may undermine the usefulness of the closely related human drug, cefepime. But as it turns out, the FDA does not consider cefepime a front-line drug against food-borne infections. So although it is a highly important drug in human medicine generally -- and although the Infectious Diseases Society of America even recommends it against some food-borne bacteria -- that risk does not count under the terms of Guidance #152.



A related problem is that the guidance's definition of "food-borne" is conservative, said Margaret Mellon of the Union of Concerned Scientists, a science policy advocacy group. For example, most urinary tract infections are caused by intestinal bacteria acquired from food, and cefepime is prescribed for those infections. If the FDA counted those infections as food-borne, then the guidance's formula would call for rejecting cefquinome for cattle.



"But FDA didn't do that," Mellon said. "That restricted the analysis right there."



Moreover, the guidance does not take into account that when microbes become resistant to fourth-generation cephalosporins, they often gain resistance to third-generation versions, too.



Third-generation cephalosporins are among the only effective therapies for serious gastrointestinal diseases in children and are the sole therapies for many cases of meningitis. That means the emergence of resistance to fourth-generation cephalosporins "could have a much more far-reaching effect" than is considered under the terms of Guidance #152, John H. Powers, a medical officer at the FDA's Center for Drug Evaluation and Research, told the agency's panel of experts.


How Great a Risk?



Richard Carnevale, vice president for scientific and regulatory affairs at the Animal Health Institute, which represents veterinary drugmakers, said critics should not presume that a dozen drugs effective against bovine respiratory syndrome are enough.



"It's not a question of whether there is a need or not," Carnevale said. "The answer is, there's always a need."



The institute contends that the risk to human health posed by animal antibiotics has been overblown.



Officials at InterVet declined several requests to be interviewed. In a statement, the company said it "fully supports the prudent use of antibiotics in animals."



The statement also said that in Europe, fourth-generation cephalosporins similar to cefquinome have been used in animals for the past decade "without compromising the interests of public health."



Yet recent European data indicate that resistance against this class of antibiotics is on the rise.



An analysis of E. coli bacteria in pigs and other animals in Spain, published in December, found high levels of the resistance that renders fourth-generation cephalosporins useless. A January report from Britain documented similar resistance patterns emerging at 10 farms.



Microbes resistant to fourth-generation cephalosporins have also begun to pop up in European patients. Such resistance is virtually unknown in the United States, where fourth-generation cefepime has been used in patients since 1997. That suggests that the resistance emerging in Europe is a result of veterinary use, said Steve Roach of the Food Animal Concerns Trust, a Chicago public interest group.



Roach says he is concerned that history is about to repeat itself. U.S. cattle were free of bacteria resistant to third-generation cephalosporins in 1997, but by 2003 one of every five samples was resistant. "This is exactly what should be avoided with cefquinome," he said.


Merely Suggestions



At the FDA advisory meeting in September, the agency's experts defied Guidance #152 and voted 6 to 4 against approval of cefquinome. But that day, and in follow-up interviews, Sundlof, the agency's veterinary chief, made it plain that the vote was "not binding."



"I think we all agreed . . . that Guidance for Industry #152 would be the criteria against which we would base our decisions on safety," Sundlof said at the meeting.



Concerned that the FDA is poised to approve cefquinome, Congress's only microbiologist recently wrote to the agency.



"Given the recent outbreaks of E. coli and other food borne illnesses across the nation, it is hardly the time to ignore the advice of scientists, and potentially impair our ability to treat deadly infections," wrote Rep. Louise M. Slaughter (D-N.Y.), who chairs the House Rules Committee.



Yet, being realists, the FDA advisers in September said more than just no. They told the FDA that if it approves cefquinome, then it should at least impose limits to minimize the potential consequences. One suggestion was to explicitly preclude "off label" use of the drug -- that is, to tell veterinarians that it can be used only for bovine respiratory disease.



But Sundlof said that, under FDA rules, those decisions must be left up to veterinarians unless there is clear evidence that wider use is causing harm.



"We have to take a fairly legal interpretation," Sundlof said in an interview. "If we have no evidence of a problem, or sparse evidence, we would not be able to make the prohibition prior to approval."



However, raising a point that opponents do not find very reassuring, he noted: "As soon as we have the first glimpse of evidence that off-label use of a drug is causing resistance, we have the authority to prohibit off-label use."



The advisers also urged that as a condition of approval, the FDA should demand that InterVet provide annual reports on how much cefquinome was used and in which animals -- data that would help scientists detect links between the drug's use and patterns of resistance that emerge in people.



"Without reliable, meaningful data on the quantity of use, the purpose of use, the type, number and location of animals treated, it will be exceedingly difficult to interpret fluctuations in rates of resistance," said Susan Prolman of the Union of Concerned Scientists.



But Sundlof offered little hope for that outcome.



"That is information that would be useful to have," he said. But the agency does not have the authority to demand it.


By Rick Weiss
Washington Post Staff Writer

A good news Friday! Part 1

Major British grocers to boycott meat from cloned animals

By Pete Hisey on 1/12/2007 for Meatingplace.com

Reacting to reports that a cloned cow from the United States has birthed a calf on a British farm, virtually all major British grocery chains have pledged to boycott meat from clones or their offspring. Tesco, Wal-Mart's Asda chain, Morrisons and Marks & Spencer were among the chains participating in the boycott, which would include meat, milk or "anything else from clones or their offspring," according to an Asda spokesperson. British law prohibits the sale of meat or milk from cloned animals, but makes no mention of the offspring of clones. According to The Daily Mail, the British Food Standards Agency is in emergency talks with European Union officials about the gap in regulations that allows products from clone offspring to be sold. The Food and Drug Administration is in the process of approving the sale of meat from clones and their offspring in the United States, and has received strong criticism from consumers' groups. On Thursday, a major dairy processor, Petaluma, Calif.-based Clover Stornetta, announced that it will not accept milk from cloned animals.

Cloned animals is a dead end to evolution

Here's something else to think about in regard to cloned animals. My friend wrote to me and said, " ...one other thing on the cloned food issue. The health is an unknown, and since it isn't necessary I simply would personally avoid it. But there is another issue. As a farmer and breeder I have no interest cloned animals. They are evolutionarily dead ends. They are not perfect and they will show no improvement. We are constantly looking to improve our livestock generation to generation. We want to adapt it to our local climate, improve the meat, improve the feed efficiency, temperment, play with the color, etc.

Cloned Cow Owner’s Fiscal Plight Unchanged By FDA Decision

HAGERSTOWN, Md. (AP)--The financially strapped owner of two cloned dairy cows said Thursday he’s still in a bind, despite the Food and Drug Administration’s decision Thursday that food from cloned animals is safe to eat.

Williamsport farmer Gregory C. Wiles said the slow pace of federal rule-making will prevent him from benefiting in a timely fashion from the policy change.

The FDA will take several months to gather public comments on its proposal to allow sales of milk and meat from cloned livestock without special labeling. Meanwhile, the food industry’s voluntary ban on such products remains in effect.

Wiles, who faces eviction in a family business dispute, said that if he can’t find a new home for his cloned cows and their offspring within weeks, he’ll probably sell them for use in the human food chain despite the informal ban. For nearly four years, Wiles has poured milk from his cloned cows, Genesis and Cyagra, down the drain in compliance with the voluntary ban.

“My goal is to hopefully find a facility where we can continue to milk the cows and keep these animals out of the food chain, but nobody’s found a solution yet other than to continue down the path whereby these animals will be put into the slaughterhouse,“ Wiles said.

He said he expects to get an eviction notice Jan. 9 that would give him 30 days to remove the animals from the 200-acre farm owned by his father, Charles. Wiles runs the farm but hasn’t paid rent in several months. Wiles has gotten offers to have the cows placed in an animal sanctuary, and his father has said they should be killed and buried.

But Wiles said the cows are part of the collateral for a farm loan and therefore have monetary value that should be realized -- as either milk or hamburger. Barb Glenn of the Biotechnology Industry Association, which favors using cloned livestock primarily for breeding instead of meat, said Wednesday that Wiles should respect the voluntary ban. “We support what he’s done up ’til now. He’ll have to continue to withhold food (made) from these animals,“ Glenn said.

Comments from Let Andy try it

Four comments to one entry, that's a first.

Tony says:

this is the first time
I've seriously felt like
giving up meat. For some reason,
the idea of not knowing
whether the meat I'm eating is
cloned makes me more queasy
than any slaughter house
documentary or e-coli pandemic.
I see an immediate crash in
hamburger consumption

I say, Tony, don't give up meat. Better for you if you locate a local grass farmer and buy sustainable meat and produce that way. The meat from the grocery store, cloned meat aside, comes from Concentrated Animal Feeding Operations (CAFOs) where the cows are fed corn which ruins the pH of their rumins. When the pH of the rumins is put out of balance the animal gets sick and needs to be given antibiotics and other drugs. The meat that comes from the grocery store is filled with the drugs they give the animals. It boggles my mind that the mainstream media who is always trying to help us get healthy never, ever advises that people should stop shopping at the grocery store. Check out SlowFoodUSA.

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These next two comments had the ip address and name server of the FDA

150.148.0.0 - 150.148.255.255

Anonymous said... i guess ignorance reigns on this blog; once it has been cloned, it's an animal, stupid, no different from any other. It's like saying you won't let your kids play with the neighbors kid created through IVF, because we still don't know, maybe they carry disease..

and, Grandma, virtually indistinguishable means just that, no conspiracy here; two hamburgers from cattle procreated by AI (cows and bulls don't have sex on farms BTW) are also virtually indistinguishable, they are not the "same" since they are two different hamburgers

I am ignorant because I have an immediate emotional reaction to the idea of cloning?
A public servant has called me ignorant and stupid right to my face. That is very rude. You shouldn't be rude to me, rather you should try to learn from me.

Comment number 2 from the FDA.

Anonymous said... can you read?!? try this again, when the hot flashes subside:To produce a clone, the nucleus of a donor egg is removed and replaced with the DNA of a cow, pig or other animal. [Wait a minute. What did FDA say cloning didn't involve? "Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence." DNA is added or it isn't? ]

The DNA is moved into the nucleus, it is not altered and nothing is added or deleted

If you take the nucleus (contains DNA, right?) out of an egg, that is the same as deleting it, right? Then you replace the DNA with some other DNA, isn't that the same as adding it? So the egg is altered, right? See above.

Mr or Ms FDA Person, let me ask you...would YOU sit down to a nice beefy piece of cloned meat? Would you take the milk from a cloned cow straight or would you stir in some Ovaltine?

God is going to pay all you bureaucrats back for tinkering with nature.
---------------------------------


The next one isn't from the FDA.

Anonymous said... Why will they not label it! Then people can decide if they want to eat cloned or GMO.

Dear Anon,

Your food that you buy in the grocery store contains a high amount of GMO ingredients and they are not labeled. Some reports say that 60 - 70% of ingredients in prepared or canned foods are GMO. Here is a list from True Food Now that lists gmo and non-gmo products. You might want to read Omnivore's Dilemma by Michael Pollan. When you find out all tht GMO corn is made into you will be shocked.

We need to get the FDA to mandate truth in labeling.

Let Andy try it first

Andrew von Eschenbach, Commissioner of the FDA, that is. He should have to eat cloned meat for 10 years, at every meal and with GMO veggies on the side. He's got the job permanently, so he can be a captive cloned meat tester.

FDA: Cloned livestock is safe to eat
[My comments are added.]

WASHINGTON (AP) -- The government declared Thursday that food from cloned animals is safe to eat.

After more than five years of study, the Food and Drug Administration concluded that cloned livestock is "virtually indistinguishable" from conventional livestock. [There's that word "virtually" which seems to mean something other than what it used to mean.]

FDA believes "that meat and milk from cattle, swine and goat clones is as safe to eat as the food we eat every day," said Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine.

Officials said they don't think special labels are needed, although a decision on labeling is pending. [Well, that should come as no surprise. They aren't labeling GMOs or irradiated foods. Why should clones be any different?}

Because scientists concluded there is no difference between food from clones and food from other animals, "it would be unlikely that FDA would require labeling in those cases," Sundlof said. [Which scientists? I am going to research who they are. Can't believe they are scientists who have no financial arrangements with industry.]

Final approval is still months away; the agency will accept comments from the public for the next three months. [FDA is seeking comments from the public on the three documents for the next 90 days. To submit electronic comments on the three documents, visit http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Written comments may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must be received by Apr. 2, 2007 and should include the docket number 2003N-0573.]

Critics of cloning say the verdict is still out on the safety of food from cloned animals. [How about the ethics?]

"Consumers are going to be having a product that has potential safety issues and has a whole load of ethical issues tied to it, without any labeling," said Joseph Mendelson, legal director of the Center for Food Safety.

Carol Tucker Foreman, director of food policy at the Consumer Federation of America, said the FDA is ignoring research that shows cloning results in more deaths and deformed animals than other reproductive technologies. [Of course they are ignoring the results. They don't care about results, they only care about making more money for their corporate buddies. It is just the same in USDA/NIAA. Wake up!]

The consumer federation will ask food companies and supermarkets to refuse to sell food from clones, she said.

"Meat and milk from cloned animals have no benefit for consumers, and consumers don't want them in their foods," Foreman said.

However, FDA scientists said that by the time clones reached 6 to 18 months of age, they are virtually indistinguishable from conventionally bred animals. [Virtually again.]

Labels should only be used if the health characteristics of a food are significantly altered by how it is produced, said Barb Glenn of the Biotechnology Industry Organization. [So says a spokesperson for an industry organization. GMOs are proving to have altered health consquenses and yet no labeling is required for them.]

"The bottom line is, we don't want to misinform consumers with some sort of implied message of difference," Glenn said. "There is no difference. These foods are as safe as foods from animals that are raised conventionally." [Misinform consumers. It's being done all the time. FDA has a terrible track record of not informing the public with the truth. Look at the Zero grams of Transfats labeling lie. I don't trust the FDA.]

Those in favor of the technology say it would be used primarily for breeding and not for steak or pork tenderloin.

Cloning lets farmers and ranchers make copies of exceptional animals, such as pigs that fatten rapidly or cows that are superior milk producers.

"It's not a genetically engineered animal; no genes have been changed or moved or deleted," Glenn said. "It's simply a genetic twin that we can then use for future matings to improve the overall health and well-being of the herd." [From FDA: An animal clone is a genetic copy of a donor animal, similar to identical twins but born at different times. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence.]

Thus, consumers would mostly get food from their offspring and not the clones themselves, Glenn said.

Still, some clones would eventually end up in the food supply. As with conventional livestock, a cloned bull or cow that outlived its usefulness would probably wind up at a hamburger plant, and a cloned dairy cow would be milked during her breeding years. [I wonder if they have to be registered with NAIS tags.]

That's unlikely to happen soon, because FDA officials have asked farmers and cloning companies since 2001 to voluntarily keep clones and their offspring out of the food supply. The informal ban would remain in place for several months while FDA accepts comments from the public.

Approval of cloned livestock has taken five years because of pressure from big food companies nervous that consumers might reject milk and meat from cloned animals. [Who is going to consume anything from cloned animals? Only those forced to do so; prisoners, school children, WIC program families. Keep an eye on this one if your child eats a school lunch.]

To produce a clone, the nucleus of a donor egg is removed and replaced with the DNA of a cow, pig or other animal. [Wait a minute. What did FDA say cloning didn't involve? "Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence." DNA is added or it isn't? ] A tiny electric shock coaxes the egg to grow into a copy of the original animal. Cloning companies say it's just another reproductive technology, such as artificial insemination, yet there can be differences between the two because of chance and environmental influences.

Some surveys have shown people to be uncomfortable with food from cloned animals; 64 percent said they were uncomfortable with such food in a September poll by the Pew Initiative on Food and Biotechnology, a nonpartisan research group.

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Here's the link for FDA's A Risk-Based Approach to Evaluate Animal Clones and Their Progeny - DRAFT