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11/19
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Senate Lurches Ahead On Food Safety Bill, But Hurdles Remain
Source: http://www.npr.org/blogs/health/2010/11/18/131407187/senate-lurches-ahead-on-food-safety-bill-but-hurdles-remain
09:57 am
November 18, 2010
by April Fulton
More than a year after the House passed a bill to strengthen food safety, the Senate voted overwhelmingly Wednesday to move ahead with its version.
But, as is just about always the case with the Senate, it¡¯s just not moving very fast. Senate Majority Leader Harry Reid (D-NV) said Thursday the bill "has to get done" and threatened to keep senators in Washington this weekend to work on it. "Nobody in America should have to worry that their salad or sandwich is going to kill them," he said in an opening speech on the Senate floor today.
Recent food-related outbreaks of illness and nationwide recalls involving lettuce and half a billion eggs have upped the pressure on lawmakers to get something done quickly. The bill, like the one passed by the House already, would give the Food and Drug Administration more power to regulate food and food producers.
One key stumbling block has been removed. Sen. Dianne Feinstein (D-CA) dropped her efforts to include a ban on the controversial plastics ingredient known as BPA in the bill. Still, there's plenty of other legislative sausage-making happening behind closed doors right now.
If there's an agreement on how to deal with an earmark ban, which is now tied to the Senate food bill, the legislation could pass by the end of this week.
But if the Senate passes it, that's not the end of the story. The House would need to weigh in by either passing the Senate bill as is or calling for a conference to reconcile it with the House's more generous version.
First, the BPA update. Feinstein worked for months to get a ban on the chemical from sippy cups and baby bottles attached to the food safety bill now being considered by the Senate. But she relented Wednesday afternoon when it became clear the chemical industry would get Republicans to block it.
"The chemical council says no and I guess the other side of the aisle bows," she said in a floor speech Wednesday night, announcing the end of her efforts. "There is no good reason to expose our children to this chemical."
But she vowed to keep fighting. More than 200 reports have linked extensive exposure to BPA to health problems ranging from cancer to early puberty, and it has been banned in several states, she said. Exactly how risky the chemical is hasn't been officially decided, however, and the FDA is still figuring out what to do about it.
The American Chemistry Council told us in an e-mail that it doesn't support any bans that would interfere with the FDA¡¯s process or authority:
Throughout this process we have been constructively engaged with Congress, and have consistently advocated for respecting the scientific assessment of the experts at FDA who have the capacity and expertise to make food safety contact decisions. ACC relies on the consensus of 11 government agencies across the world that current exposures to BPA are 1,000 times below levels established as safe.
Another sticking point that seems to be on the way to a fix is an exemption from some regulatory requirements for small farmers. Sen. Jon Tester (D-MT) has been pushing for an amendment to the bill that would exempt farmers who sell directly to consumers within a 400 mile radius and who make less than $500,000 a year.
But he says he's willing to compromise on those numbers to get a provision inserted in the bill, and talks continue. "We're working on that," Tester told Shots Wednesday. "In fact, I don¡¯t have a problem bringing those miles down at all, it's a matter of getting the votes. I don¡¯t have a problem bringing that dollar figure down. It¡¯s a matter of getting those votes."
Bill substance aside, unrelated political issues could still delay the bill. Sen. Tom Coburn (R-OK), who has held up the food safety bill in the past, has vowed to fight to get an amendment attached to this bill that would ban earmarks.
According to Feinstein, the Senate Democratic leadership is seeking a deal to prevent any amendments to the food safety bill, in order to move it more quickly. That, in fact, is part of why she surrendered on BPA. Leadership sources didn't confirm this strategy late last night.
But Democrats would surely like to claim a victory on something ? even a bipartisan bill containing lots of compromises ? before their Hill reign, for all practical purposes, comes to an end.
UPDATE: Senator Tester announced Thursday morning that a deal has been reached on incorporating his small producers amendment into the food safety bill. It would exempt small farmers who earn less than $500,000 and sell directly to consumers within 275 miles from some federal requirements.
It would also allow FDA to override the exemption if a small grower is connected with an outbreak.

Irradiation¡¯s future potential
The technology is slowly making inroads
MeatPoultry.com, November 10, 2010

by Keith Nunes
Source: http://www.meatpoultry.com/
Meat and poultry irradiation in the U.S. may not be as active as it was earlier this decade when electron-beam treatment of ground beef began moving from the East Coast westward thanks to the technology of the now defunct SureBeam Corp., but food irradiation in the U.S. nevertheless continues at a healthy pace.
¡°Omaha Steaks and Schwan¡¯s irradiate 100% of their raw ground beef items and have done so since 2000,¡± says Ronald Eustice, executive director of the Minnesota Beef Council and a long-time advocate of food irradiation. ¡°Both companies have seen beef sales rise, however, the increase is not necessarily due to irradiation. But one can conclude that the fact that they sell irradiated product has not been a negative.¡±
In fact, Omaha Steaks has seen its ground-beef sales double in recent years, Eustice said.
¡°Wegmans Food Markets, Rochester, N.Y., proudly offers irradiated fresh-ground beef in chubs and has done so for many years,¡± he added. ¡°They position irradiated ground beef as a value-added product.¡±
The Wegmans Web site describes irradiated ground beef as follows ? A Rare Opportunity: The technology that irradiates this product uses electron-beam energy to reduce harmful bacteria like E. coli. Now juicy, great-tasting burgers can be yours! Remember, your satisfaction is always guaranteed with Wegmans brand products. Signed: The Wegmans Family.¡±
Colorado Boxed Beef, Auburndale, Fla., also offers irradiated frozen patties through Publix in the Southeastern US. As for the availability of treated ground beef at retail outlets in the U.S., Eustice said, ¡°Omaha Steaks has about 100 retail stores in 25 states; Wegmans is at about 85 stores in New York, Pennsylvania, Maryland, Virginia and New Jersey; and Publix has stores in the Southeast.¡± In the foodservice segment, Eustice said he¡¯s unaware of any operator serving irradiated ground beef.
Perception is still reality and the consensus in the U.S. meat industry regarding the use of e-beam, gamma or x-ray technology as a food-safety measure remains lukewarm at best. ¡°Generally, the mood can be described as cautious,¡± Eustice says. ¡°Beef-industry research is focused on pre-harvest interventions, such as vaccines, antimicrobial sprays and bacteriophage, etc. None of these interventions is as effective as irradiation, which at doses commonly used will reduce pathogenic bacteria such as E. coli by 5 logs [99.999%].¡±
Last year, the American Meat Institute petitioned for the use of carcass irradiation as a food-safety surface treatment. ¡°Several other petitions are also languishing in government bureaucracy, including the ¡°Ready to Eat¡± foods petition from the Grocery Manufacturers of America,¡± Eustice said.
During its heyday, SureBeam was driving the U.S. food irradiation movement and was making great headway. ¡°Today, Food Technology Services Inc., Mulberry, Fla., and Sadex, Sioux City, Iowa, are the country¡¯s two main irradiation service providers,¡± Eustice said.
¡°Omaha Steaks, Schwan¡¯s and Wegmans are the most aggressive marketers [of irradiated meat],¡± he added.
However, the volume of irradiated foods being marketed in the U.S. at retail is rising because of imported exotic produce. ¡°Mangoes from India and Mexico, guavas from Mexico, lychee and rambutan from Thailand, various items from Vietnam, purple sweet potatoes from Hawaii and several domestically grown items are arriving at supermarkets daily,¡± Eustice said. ¡°The annual volume of irradiated produce exceeds 30 million pounds and has tripled since 2008.¡±
A ¡®non-issue¡¯
Consumer acceptance is a non-issue in the minds of those who are actively marketing irradiated food items, Eustice claimed. ¡°The sale and construction of irradiators are being actively promoted by Canadian-based Nordion and GRAY*STAR, a firm in New Jersey,¡± Eustice added.
While the amount of irradiated meat and poultry sold in the U.S. has remained relatively steady at around 15 million pounds annually, the quantity of irradiated produce sold at retail has tripled during the past two years and now stands at 35 million pounds, Eustice said. ¡°Currently, about 175 million pounds of irradiated spices are also being sold and distributed in the U.S. annually [which is about one-third of total annual spice usage in U.S.] and that quantity is expected to grow as a result of recent recalls and food borne illness outbreaks caused by meat products that were contaminated by non-irradiated spices,¡± he added. ¡°The alternative technology [ethylene oxide] does not seem to be as effective as irradiation.¡±
Also, millions of pounds of pet treats are irradiated and marketed annually at many well-known retail and pet stores. ¡°This is a very significant and rapidly growing use of irradiation,¡± Eustice said.
¡°Those companies that market irradiated food items have not seen consumer reluctance to purchase,¡± he added. ¡°The key to consumer acceptance is ¡®education, education, education¡¯ combined with advertising and promotion.¡±
Looking ahead, Eustice predicted food irradiation will become a routine food-safety and disinfestation technology in the U.S. ¡°Unfortunately, many sick children, lawsuits and bankruptcies will have to occur before irradiation takes its rightful place as the fourth pillar of public health along with pasteurization, immunization and chlorination,¡± Eustice added. ¡°The greatest opportunity may be in the area of shelf-life extension to allow sea shipments instead of air. Irradiation will at least double the shelf-life of many food items.¡±

Food Fight: Will the Food Safety Modernization Act better protect us from contaminated food?

Source: http://www.grist.org/article/2010-11-11-food-fight-food-safety-modernization-act-better-protect-us
Will the Food Safety Modernization Act now before the Senate improve our protection from contaminated food, in particular, from the large-scale outbreaks of the type we've recently seen in eggs and peanut butter?
Tom Philpott, Grist senior food writer: Well, obviously no single bill can address all the issues we've raised. I guess my answer is: Maybe. The best we can hope for from it is a step, probably a small one, in the right direction. It won't affect the meat supply, for example, which is one of the prime sources of hazard in the food system.
Then there's the fact that the bill has industry support. Call me perverse, but I am repelled by the fact that legislation needs the support of the industry it regulates if it has any hope of passing. I realize that's the way things stand, but if the Grocery Manufacturers of America supports the bill, as it does, than I suspect that it is overly friendly to the huge players that need the most oversight. In her analysis of the bill on Grist, Food & Water Watch's Elanor Starmer writes: "S. 510 requires the FDA to inspect high-risk food processors -- think the Peanut Corporation of America -- only once every five years, and low-risk processors every seven years. That wouldn't have caught the salmonella that spread like ... well, creamy peanut butter, out of PCA's Georgia facility in 2006, 2007, and 2008."
So in that regard, the bill seems a bit toothless. The bill would increases inspections -- if still to a too-low level -- and give the FDA authority to declare mandatory recalls, when now "the agency can only ask nicely," as Elanor puts it. So, small step in the right direction.
Michael Bulger, master's candidate in food studies at New York University: It will improve our protection from large-scale outbreaks. We won't be in the clear, but outbreaks will be prevented.
S. 510 says that facilities identified as high-risk would be required to be inspected more frequently than they are currently being inspected. I think we can agree on that. This will increase the chances that inspectors will catch a problem before it develops into something more serious. If a facility has a history of poor safety standards, that facility will be considered more risky and should be inspected more often.
Foreign inspections will also increase, with the goal being an annual increase in the number of foreign facilities inspected. Imported food will also be checked at the port of entry, with priority being given to companies and countries with poor compliance histories.
Under S. 510, in the event of an outbreak or identification of contaminated food, the FDA will have improved resources for communicating the danger to the public.
S. 510 will provide more inspectors, they will be better trained, and they will be doing more inspections. The laws of probability say that this will prevent outbreaks in the future.
Judith McGeary, founder and executive director of the Farm and Ranch Freedom Alliance: I'll echo Tom and say "maybe." Moreover, unless the Tester amendment is adopted, the bill is likely to drive the small-scale local producers out of business, which would deprive consumers of the option to buy food that is not part of the flawed industrial food system. [Editor's note: More on this topic later.]
One would expect that increased inspections would improve the food safety system. But it's not quite as simple as "more inspectors and more inspections mean safer food." What will be inspected? How often? Will the inspectors be willing to crack down on big industry players or will they turn a blind eye to warning signs of problems?
S. 510 directs FDA to categorize facilities as "high risk" and allocate its resources for inspections based on a list of five factors and "any other criteria deemed necessary and appropriate." After checking the various cross-references, the factors in classifying facilities as high risk are:

The "risk of the food"
The facility's compliance history for food safety violations
How good the facility's HACCP paperwork is
Whether the food is at high risk for intentional adulteration
Whether imported food has gone through a qualification or certification program
The factors do NOT include:

The size of the facility or the scope of distribution
The level of commingling
The degree of processing, length of transportation, duration of storage, etc.
Environmental violations, such as those at the Wright County egg facilities
The effectiveness of the inspections will depend on whether FDA uses the catch-all "any other criteria" to truly identify high-risk facilities, namely the large-scale processors who commingle ingredients from a variety of producers and then transport them long distances to a wide range of consumers. Or will FDA continue its current track record of avoiding crackdowns on the big players, while wasting resources on inspections of the thousands of small-scale producers who do not actually pose a high risk of foodborne illness?
Unfortunately, since the bill does nothing to address the consolidation of the food supply in the hands of a few large entities, or the capture of the agency by those industry interests, the outlook is not encouraging.
More fundamentally, the bill fails to address the underlying causes of food-borne illnesses. As Mark Kastel has already pointed out in the last post, the CAFOs and E.coli 0157:H7 are the elephants in the room. I think that issue and many others stem from a fundamental lack of understanding of biological systems. Food has become viewed as an industrial commodity capable of being produced in factories, essentially no different from cars or stoves. When there is a problem in the production system, both the industry and the government look for a technical fix for that problem and ignore the underlying biological reason that the problem arose.
Related to that view of food is the view of food safety in which the regulators and industry seek to treat food as an artificial product rather than a biological one. They can mandate chlorine baths, irradiation, pasteurization, and other kill steps, but the reality is that food does not start out sterile and it can never end up sterile. The latest science supports the understanding that bacteria can play a significant role in supporting our immune system function and that the critical issues are in the interactions at the microbial level. But the food industry and the regulators continue to ignore the science in favor of the flawed technological model that that large-scale industrial food system is built upon.
Ferd Hoefner, policy director for the National Sustainable Agriculture Coalition: I too am in the maybe camp. Some elements of the bill will clearly help, others might. But Judith has just done an excellent job laying out some of the fundamental false premises and left-out elements that will keep the bill from being a greater success.
Those very substantial flaws notwithstanding, I hope Michael is right that some/many large-scale outbreaks will be prevented. But let me hasten to add that it is not actually true that under S. 510 FDA will have added resources for more inspectors and more inspections. One might think so listening to much of the debate, but this bill is an authorizing bill. The added resources will only come later, if at all, through appropriations bills in future Congresses.
In light of the current climate of fiscal restraint, this is no insignificant matter, and it puts a huge premium on making sure whatever current or extra future funding does come along gets spent on the most significant problems. We do not have time or space in this exchange to get into details, but suffice it to say it is very clear to me that trying to find funding for FDA to inspect the hundreds of thousands of farms that under current FDA regulations are considered food facilities would be misguided and in these budget times impossible in any event.
On the farm side, there are two ways out of this dilemma. One is contained in the manager's amendment to the bill and would require FDA to rewrite (and hopefully narrow via risk analysis) those regulations. The other is to take whatever new money can be had and focus it on bigger bang for the buck activities including farmer training, education, and group certification.
Bulger: I think that everyone here agrees that some substantial changes need to take place within our food system to make it more safe. Still, if we all wait for the silver bullet to be delivered, I'm going to go from being the youngest member of the panel to being the oldest.
I feel that Jill Richardson did a good job of illustrating a key fracture in the debate over S. 510. In September, Jill wrote that where you stand on the bill boils down to how much you trust the government.
In the current political climate, you have ample company if you want to distrust government. It's simple to cast the FDA as the lapdog of Big Ag. It makes it romantic to be an advocate of small, sustainable food, and it relieves the responsibility to try to work to change the current system. After all, it's totally hopeless, isn't it?
These sensational outbreaks and the loss in sales has the major food companies realizing it might be better to be regulated than to lose sales every time a competitor causes an outbreak. It's time for the advocates to stand up and call their bet. The language in this bill is very clear in its intent to protect the viability of small businesses. If S. 510 can pass and make it to the rule-making period, I see a tremendous chance to engage the FDA and hold them to the intent of Congress.
I believe sustainable food advocates can make the most of this point in our history and set us on a path to a better system. Ten years ago, there wasn't the movement that we see today. The momentum is real and the public is open to changing our food system.
Patty Lovera, assistant director of Food & Water Watch: Sorry to be the last one to join in. Y'all have raised a lot of important points so far, and I just have a couple thoughts to add.
Food & Water Watch has been calling for a couple things that we think would make 510 more effective. The Tester amendment has already been mentioned here and we agree that it's needed. [Editor's note: Not quite -- more later on this.] But we also think 510 could use some beefing up in one of its core functions -- spelling out how often FDA inspects food-processing facilities (and we agree that there's work to do in defining facilities). Right now, the bill calls for facilities to get inspected once every five years if they are classified as high risk, and once every seven years if they are classified as low risk. While this would be an improvement over what the agency averages now, it's not a big enough change to fix what is one of the most frustrating things about FDA -- they are set up to react to food safety problems, not prevent them.
That said, we get it that we need to make sure that what they think of as prevention doesn't amount to technological fixes or crazy paperwork schemes dreamed up by consultants who get paid by the hour. Which is where the provisions in 510 that require consideration of impact on small-scale, organic, etc. and the Tester amendment come in and why they are so important. And it's why the implementation phase of anything on food safety will be critical, so FDA gets the details right (including their definition of "risk") and the programs are workable.
In these discussions, I always end up coming back to the bigger context of what is happening in food safety beyond this legislation. S. 510 has provisions requiring the agency to think about small-scale production, technical assistance, etc. The requirements that grocery stores put on farmers don't. Nor does the "leafy greens" industry proposal to regulate itself through a marketing agreement. Nor the produce industry's proposal for traceability.
Legislation may not make those things go away. But they exist because FDA is not getting the job done on food safety, which is why so many groups have been pushing so long for legislation.
Russell Libby, executive director of the Maine Organic Farmers and Gardeners Association: S. 510 by itself isn't going to do anything. It's the combination of the legislation with the implementation that may make a difference. The food system is far too fragmented to actually think that just passing legislation will protect the public from contaminated food. We've had laws for decades that supposedly accomplish this.
The bill gives FDA a few tools that will make it easier for them to enforce standards that are already in place. However, there is a presumption that more legislation, or more rules, or marketing orders, will make our food supply safer. And if safer food is the goal, there are as many solutions as there are problems. This is the challenge of the bill, and this approach. The food-safety training embedded in the bill may make more difference than anything else.
It will be years before the concepts in the bill are fully implemented. Meanwhile, we all need to be thinking about what's really going to produce safer food -- more reliance on large and concentrated food processors and distributors who have full-time food safety compliance officers keeping up with the paperwork, or a widely dispersed network of farmers around the country, supplying their local and regional markets.
That's the real conversation that S. 510 can't, and won't, address.
Kathleen Chrismer, food-safety victims' advocate: I agree with Michael, the issue of food-safety reform has been put aside for far too long.

There has never been a piece of legislation on any issue that has been perfect. You can't make everyone happy, yet we all have the right to express our point of view, that's the beauty of democracy. However, in terms of food safety, S. 510 is the closest we've gotten in over 20 years to acceptable food safety reform that will prevent contaminated food from entering the marketplace, instead of forcing producers and FDA to scramble to react in the aftermath of a major outbreak.
So far, nobody has addressed the issue of science-based testing and mandatory reporting of test results that show contamination. These key provisions are part of H.R. 2749, the House food-safety bill which passed in August 2009, and will provide for quicker identification of a potential problem before a product enters the food supply.
Additionally, should a contaminated product make its way into the marketplace, the testing and reporting measures will aid FDA in pinpointing the source of the problem, essentially saving producers from having to destroy their similar product or suffer losses due to consumer fear. Hopefully, once S. 510 passes in the Senate, these provisions will be incorporated into a final bill in Conference.
There has been a lot of discussion and focus on farmers, eggs, and produce, but we need to remember that those are not the only products that fall under FDA authority. Spices, canned goods, frozen foods, etc. fall under the FDA umbrella as well. The tea you drank this morning or the garden-burger you had for lunch, really anything you find on your grocer's shelf, is a product that has been through some type of production or packaging process and is therefore a potential candidate for contamination.
As much as we would all like to only eat locally grown foods from farmers we know and trust and limit our consumption of processed foods, the reality is that in today's society it's not always possible. There are not enough small-scale farmers to feed the 310 million people in the United States. I live in an area with limited access to truly "local" produce, the farmer's market three blocks from my home has vegetables that have traveled all the way from Stockton, Calif. While I enjoy the products they sell, I don't consider the vendor part of my community.
This bill is not about the big bad government taking over or squeezing out the local farmer, it's about preventing the 5,000 deaths that occur each year as a result of the unknowing consumption of food-borne pathogens.
Bulger: I agree with Kathleen that this is an essential part of the legislation. The Senate bill asks facilities to develop hazard analysis and risk-based control plans (HARCP). [Such plans are also called HACCP, for Hazard Analysis & Critical Control Points.] Basically this consists of identifying points in the processing system (refrigerated holding, employee handling) that could be potentially dangerous, and then developing controls that can be implemented at those points (checking temperatures daily, washing hands).
The small facilities have longer to comply and the FDA has the power to exempt small facilities from this HARCP plan if they are deemed a low-risk operation. For those that do fall under the new regulations, S. 510 says that FDA must "provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food-processing facility co-located on a farm."
Many larger operations already test for microbial pathogens. As of today, they are only required to disclose limited information about test results to inspectors. If they test positive for a pathogen, they can quietly attempt to clean up and if the FDA asks for test results the company can claim they are private. This happens more often then we would hope and it contributes to the feeling that FDA is turning a blind eye to large processors, when much of the time the FDA is being kept in the dark.
Under the Senate's version of the Food Safety Modernization Act, the companies will no longer be able to claim proprietary rights to their test results when the FDA comes knocking. Section 418(h) of the bill states the last two years of test results have to be made available to the FDA whenever a request is made by an official.
Libby: Obviously, if all the provisions of S. 510 are implemented, there will be improved protection. Who will be producing food under the standards is another question.
The assumption that the 210,000 produce farmers in the country are all going to be putting together HAACP plans is troublesome. It's compounded by including all the farmers who supply all the food exporters who ship to this country. Is this what will make our food supply safer? A HACCP plan, or GAP certification, may be parts of the solution, but they are not the entire answer.
The carve-outs for flexibility in S. 510 are the result of over a year of work from the National Sustainable Agriculture Coalition and others. Many of them were initially opposed by the consumer groups, but are critical to having a bill that doesn't make the problem worse rather than better, at least in terms of the impact on the farm side.
Farmers, at least the small family farms who produce the food that you buy at farmers' markets or in a CSA, don't see themselves as food processors. Yet under the Food Bioterrorism Act of 2002, and FDA's interpretation of that law through regulations, washing, and packing the produce and sending it to a wholesale market can turn the farm into a regulated processor.
Is FDA going to have the resources to visit all of these farms, even on a five-year cycle? No. Then why write legislation that's too inclusive instead of clarifying the areas where FDA does need both authority and focus? That's where much of the conflict about this bill arises.
Jean Halloran, director of food policy initiatives at Consumer Union (publisher of Consumer Reports): The question posed wasn't whether this bill will solve all our food-safety problems, or if it is the best possible food safety bill -- it certainly isn't everything that consumer groups wanted. But the question is whether it will improve safety, particularly with regard to preventing major serious outbreaks like we've seen in peanut butter. I think the answer is absolutely yes -- just requiring food processors to register that they exist is a major improvement. FDA didn't even know that Peanut Corp was making peanut butter, and would likely have visited it sooner, following the Conagra outbreak, if it did.
Giving FDA mandatory recall authority so they don't have to wheedle and cajole companies into cooperating is also a significant major step.
Libby: Here's where one of my fundamental concerns still lies, and I'll address it more in the third question. The definition of facility embedded in the rules for the Food Bioterrorism Act of 2002, and relied upon in S. 510, makes many farms into facilities. Any transformation of product does it -- and then you jump back out of being a facility by selling at least 50.1% of your product directly to individual consumers.
Unless, of course, you produce a product of concern -- sprouts, juice and juice products, or, as seems likely, leafy greens, tomatoes, and melons -- and then maybe you're back in for that part of your farm, and potentially out for the rest. Most of the 210,000 produce farmers in the U.S. (2007 Census) grow at least one of those three vegetable crops, particularly if they are selling directly to consumers. Are they facilities, or are they not?
Bonnie Azab Powell, Grist food editor and Food Fight moderator: Let's stop here, as that sets us up for our next questions, about (3) whether S. 510 unfairly burdens small and medium-size farmers and producers (and whether the Tester amendment mitigates that sufficiently), and (4) whether it gives the FDA too much power -- or not enough.

Bacteria Adapt: The Battle Rages On
Source: http://www.foodsafetynews.com/2010/11/antibiotic-resistance-the-battle-rages-on/
by Cookson Beecher | Nov 15, 2010
Antibiotics have been used so widely and for so long that the bacteria the antibiotics are designed to kill have adapted to them, thus making them less effective, according to the Centers for Disease Control and Prevention.
Worse yet, in some cases, the microorganisms have become so resistant that there are no effective antibiotics against them.
To understand this biological phenomenon, it helps to think of a battle between two enemies. On one side are the powerful and mighty antibiotics -- the "Wonder Drugs" of history.
On the other side are the bacteria, one-celled guerilla fighters, powerful in their own right, that can cause infectious diseases such as pneumonia, tuberculosis, meningitis, cholera, and typhoid, which before the advent of antibiotics 70 or so years ago killed countless people across the globe.
In battle after battle, the antibiotics prevailed, exerting a powerful blow against illnesses and death from infectious diseases.
But as time went on, some of the bacteria began to "figure out" how to wage war against their adversaries. In some cases, that was accomplished by "stealing" genetic information from other types of bacteria that had the power to withstand the onslaught of antibiotics.
In other cases, if not enough of the antibiotics were sent into battle, or if they were pulled out of battle before they had been able to vanquish the enemy, the bacteria learned how to adapt and survive the next attack.
It's the stuff of video games except that it's real -- sometimes "deadly" real. It goes by the name of "antibiotic resistance."
"It comes down to which one is winning -- the bug (bacteria) or the antibiotic," said Robert Stanley, a pharmacist in Burlington, WA. "The more the bug is exposed to the antibiotic, the tougher it gets."
A CDC overview of antibiotic resistance explains why this is such a threat to human health:
"People infected with drug-resistant organisms are more likely to have longer and more expensive hospital stays and may be more likely to die as a result of the infection," says the overview.
For information about diseases and pathogens associated with antibiotic resistance, go to the CDC's site.

Bacteriophages Eyed as Antibiotic Alternatives
Source: http://www.foodsafetynews.com/2010/11/natural-disease-fighters-eyed-as-antibiotic-alternatives/
by Cookson Beecher | Nov 16, 2010
In the battle against antibiotic resistance in animal agriculture, researchers from Washington and New York states are hoping to help pave the way for U.S. approval of a promising biological therapy that has the potential to not only treat sick cows, but also save human lives threatened by infectious diseases that no longer respond to antibiotics.
The "weapons" in this battle -- bacteriophages, or phages for short -- are microscopic beings that live everywhere on Earth -- inside of us, on our skin, in the soil, inside and on the outside of plants and animals, and even in the ocean. This summer, researchers in the United States and Australia reported that humans have 10 trillion or so bacteria in their gastrointestinal tracts and more than 10 times that amount of bacteriophages residing and "working" there.
Bacteriophages -- so named when they were first discovered because they appear to eat bacteria -- are naturally occurring viruses that can infect and kill bacteria. That's important because it's different forms of bacteria that cause dread diseases such as typhoid, leprosy, cholera, TB and meningitis, as well as foodborne illnesses such as E. coli, Listeria and Campylobacter.
Bacteriophages were discovered in 1915 by British bacteriologist Frederick Twort, and independently 2 years later by Canadian Felix d'Herelle, at the Pasteur Institute in Paris.
Their first medical success was realized in 1919 when they were used to treat severe cases of bacterial dysentery, which would otherwise have been a fatal infection, in 4 children in Paris. All of the children recovered.
The way phages work is nothing short of amazing. They typically have hollow heads, where their DNA or RNA is stored. At the other end of their tiny beings they sport tails that could be compared to tunnels. The tips of these tails can "dock" onto molecules on the surface of the specific bacteria they're targeting.
With that mission accomplished, they begin shooting their viral DNA through their tails into the targeted cell. Once inside, the DNA takes over and starts directing the production of progeny phages -- often more than a hundred in a mere 30 minutes. These "young phage-warriors" then burst out of the host cell, killing it in the process, and eagerly head off in search of more bacteria to infect and kill.
Yet as powerful as phages are against bacteria, they're nontoxic to mammals and the environment. That's because they require the specialized form of cellular machinery found only in bacteria to multiply. Another plus is that no genetic engineering is required. There's no need for that, say scientists, simply because bacteriophages are so plentiful that it's not difficult to combine them into cocktails that can be highly effective against bacteria.
This is not pie-in-the-sky science fiction. Before the advent of antibiotics, phage therapy was used with varying degrees of success against a range of bacterial diseases.
But with the advent of "miracle" antibiotics during World War II, interest in phage therapy plummeted. One of the main reasons for that downward spiral is based on how bacteriophages work. In contrast to antibiotics, which can be effective against a wide range of different bacteria, bacteriophages target specific bacteria. That means the bacteriophage that works against a specific bacteria needs to be isolated, which in earlier times was far more challenging than it is today.
Then, too, technologies that are now available, such as the electron microscope and computers, weren't available during the early stages of phage research. In fact, until the electron microscope was invented in 1940, these bacteriophages couldn't even be seen as anything but a clear spot under a regular microscope.
"In a flash, I had understood: what caused my clear spots was in fact an invisible microbe ... a virus parasitic on bacteria," D'Herelle wrote while he was investigating an outbreak of dysentery in Paris.
Fast forward to the present, where an increasing number of bacteria strains -- often referred to as "super bugs" -- are becoming resistant to antibiotics typically used against them. The fear of seeing human medical science being hurled back into a pre-antibiotic era is ever present.
This is not an overblown fear. In a letter last November to the presidents of the United States and the European Union, the Infectious Disease Society of America described antibiotic resistance as one of the world's greatest health threats.
The IDSA has collected patient stories describing how antibiotic resistance has affected them and their loved ones, some of whom died for the lack of an effective antibiotic to treat the disease they had contracted.
A report done by a task force co-chaired by the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, warned that "the world may soon be faced with previously treatable diseases that have again become untreatable, as in the pre-antibiotic era."
With thousands of people dying each year from bacterial diseases that have grown resistant to antibiotics, interest in alternatives to antibiotics has propelled bacteriophages back onto the medical stage. Some scientists say their time has come -- once again.
But because they aren't approved for human use by the FDA, much of the research is directed toward animal agriculture. The hope is that successes there will serve as an "end run" around FDA and prompt the agency to move forward on policies and regulations pertaining to phage therapy in human health.
In Washington and New York states, researchers are working on developing bacteriophage "cocktails" that will be able to treat some serious dairy cattle diseases -- postpartum uterine infections caused primarily by E. coli, and Salmonella-related diarrhea in calves -- that are typically treated by antibiotics in their severe stages. They have achieved success in the laboratory and now want to see how effective these "cocktails" will be when used on cows.
According to information on a Cornell website, researchers Rodrigo Carvalho Bicalho, Peter Frazier, and Thorsten Joachims will isolate and evaluate new bacteriophages and develop mathematical models to optimize a phage cocktail.
"In short, the right match has to be made," said computer scientist Joachims. "We are using genetic data about phages and bacteria to predict which phage will effectively treat which bacterium."
The study, which will be conducted along with researchers Mike Paros, Elizabeth Kutter and Andrew Brabban, all of The Evergreen State College in Washington state, as well as researchers from Washington State University, will culminate in a clinical trial on 900 dairy cows.
One of the goals of the research project is to come up with an economic model for evaluating the cost-effectiveness of phage therapy for commercial dairy farms.
But more than that, the research promises to harness the antibacterial power of bacteriophages, replacing antibiotics for the treatment of common bovine diseases -- and may eventually lead to phage therapies for human diseases, according to the Cornell website.
Bicalho, one of the project's research scientists, refers to the growing interest in bacteriophage research as "a renaissance."
"We're coming out of the dark ages," he told Food Safety News. "More and more people are becoming interested in it because of the rise of antibiotics resistance. It's on people's minds. Everyone who goes into surgery is worried about it." As he works on this research project, he has his eye on the future. "My major objective is to prove it works in animals," Bicalho said. "But my biggest hope is that it will help open the world's eyes to this as an alternative to antibiotics for humans."
Phage biologist Elizabeth Kutter, who has been doing research on bacteriophages at The Evergreen State College for about 40 years, agrees, saying that ever since her first visit to Tbilisi, in the former Soviet Republic of Georgia, in 1990, where she saw phages being used therapeutically for humans, she has had a "very strong sense that eventually this was going to be the wave of the future."
To share some history about Tbilisi, even after the Western world embraced antibiotics, bacteriophage therapy was used broadly in the Soviet Union, particularly in the Republic of Georgia, which has been the global center of phage-therapy expertise for more than 80 years.
According to the Phage Therapy Center's website, the Tbilisi center provides an effective treatment solution for patients who have bacterial infections that don't respond to conventional antibiotic therapies.
Also, according to the website, although the center does not anticipate that phages will replace antibiotics as the first-line, general antibacterial therapy in major Western countries, it does see a promising role for phages in situations where antibiotics alone are not sufficient.
The center is currently accepting patients with diabetic foot ulcers, urinary infections, tropic ulcers, bed sores, sinusitus, and osteomyelitis -- including those with infections that are drug-resistant.
Kutter has her own success stories to share about phage therapy at Tbilisi. One involves a musician who was facing amputation of his foot in 2001 due to a serious infection that just wouldn't respond to antibiotics. His doctors told him that without amputation, he would be dead within a year. Thanks to phage therapy he received at Tbilisi, he didn't have to have his foot amputated and was able to resume activities such as playing his bass in bands and playing with his kids.
In the conclusion of the story she wrote about the musician, Kutter says that "hopefully there will be more routine mechanisms in place before long for others to follow in his footsteps -- and eventually phage therapy will be available around the world for all who need it so desperately."
Kutter can tick off a list of advances that phage therapy has made in agriculture in this country.
A good example is OmniLytics, a Utah-based company whose website proclaims: "Bacteriophage: The Good Virus."
On the food-safety front, the company has been granted a federal "no objection" for a bacteriophage product that when applied as a mist, wash or spray on live animals can reduce Salmonella before the animals are slaughtered. Another product used in the same way can reduce E.coli O157:H7 before the animals are slaughtered.
The company's AgriPhage product line gives organic vegetable growers the opportunity to use what the company describes as "a natural, safe, effective bacteria-control solution."
That benefit translates into worker safety as well. The Environmental Protection Agency has approved a label amendment for the AgriPhage products that reduces to zero the amount of time before workers can re-enter the fields after the products are applied to crops. That's in contrast with the substantial time intervals required when pesticides are used.
The AgriPhage products also eliminate the need for workers to wear personal protective equipment.
Another company success is the use of bacteriophages to protect tomato plants from tomato spot, a disease that has developed resistance to widely used antibiotic and chemical sprays.
Intralytix, a Baltimore-based company, offers another example of advances being made in phage therapy. It says one of its products reduces or eliminates Listeria contamination when sprayed on ready-to-eat foods. And it says another product is highly effective in reducing E. coli O157:H7 contamination of various foods, among them ground beef, fruits, and vegetables.
According to the company, both of these products are 100 percent natural, contain no preservatives or any known, potentially allergenic substances.
Intralytix says it has also developed and licensed bacteriophage-based animal health-care products effective against two bacterial diseases and has two human therapeutic products in various stages of production. One of the company's prototype phage preparations for treating infected wounds was recently used during a human clinical trial in Lubbock, TX, with an outcome the company describes as "very favorable."
On the academic scene, a new book published by The American Society for Microbiology, "Bacteriophages in the Control of Food- and Waterborne Pathogens," looks at the use of bacteriophages in detecting and controlling foodborne bacteria pathogens - both in the production of plants and animals and in food processing. (Kutter wrote the introduction.)
Meanwhile, medical tourism has kicked into gear on a global scale, with patients suffering from chronic, drug-resistant or difficult-to-treat infections heading for the Phage Therapy Center in Tbilisi. There's even a lab in New York that tests patients' samples and sends the results to the center ahead of time so the appropriate treatment can be decided upon in advance.
Other countries are taking note. Kutter said that people in China are importing bacteriophage products from Tbilisi. And phage conferences were held last year in such far-flung places as Paris, Australia, and Bogota, Columbia.
Trials have also taken place in Brussels and London.
"It's exciting to see things like this happen in other countries," Kutter said, adding that it's unfortunate that the United States is one of the last countries to be going forward on phage therapy in human health.
Kutter said the biggest hurdle is money.
"Everything costs so much when you're trying to get to the position where FDA is willing to look at it," she said.
But cost may also be on the side of bacteriophage therapy. Although bacteria may develop resistance to phages, it is far easier to find new phages that will work against the problem bacteria than develop new antibiotics.
Generally, it only takes several weeks to find new phages for an emerging strain of resistant bacteria compared with the 7 to 12 years it takes to discover and develop a new antibiotic and get it approved by the FDA.
Even so, Kutter said phage therapy is not the panacea. "It generally needs to be used in conjunction with good surgical techniques, antibiotics to deal with secondary infectious agents not targeted by the phage cocktail, and other therapies," she said.

Food and Ag Groups Rally Against Tester Amendment
Source: http://www.foodsafetynews.com/2010/11/food-and-ag-groups-rally-against-tester-amendment/
by Helena Bottemiller | Nov 16, 2010
As the Senate gears up to vote on a motion to limit debate and move the pending food safety bill forward on Wednesday, interest groups are kicking into high gear to lobby for and against key amendments.
Monday a group of 30 meat, pet food, and fresh produce industry groups sent a letter to the Health, Education, Labor, and Pensions Committee chairman and ranking members, Senators Tom Harkin (D-IA) and Michael Enzi (R-WY), respectively, urging key staff and lawmakers working on the bill to oppose a measure to exempt small farms and producers from the crux of the legislation.
"We believe an operation's size, the growing practices used, or its proximity to customers does not determine whether the food offered is safe," read the letter, which was signed by the American Meat Institute, the United Fresh Produce Association, and the United Egg Producers.
"What matters is that the operation implements prudent product safety practices, whether the product is purchased at a roadside stand, a farmers' market, or a large supermarket," continues the letter. "We support FDA food safety programs developed through a scientific, risk-based approach and that benefit public health."
As the food safety bill, which would increase the U.S. Food and Drug Administration's authority and mandate over the food supply, has languished, an amendment by Sen. Jon Tester (D-MT), now also backed by Sen. Kay Hagan (D-NC), has gained widespread support. The measure would ease the regulatory burden on small farmers and producers.
The National Sustainable Agriculture Coalition (NSAC) and several other sustainable ag groups have been issuing a last round of action alerts to rally support for the Tester amendment.
"The bill takes important steps to improve corporate food safety rules but it is not appropriate for small farms and processors that sell to restaurants, food coops, groceries, schools, wholesalers and at farm stands and farmers markets," said NSAC in its alert late last week.
NSAC asked its supporters to call Senators in support of the Tester provision to prevent "one-size-fits-all" regulations from being created.
Though the details are still being worked out, insiders expect the Tester amendment to garner enough support to be added to the bill. The FDA Food Safety Modernization Act, also known as S. 510, is also expected to pass, with bipartisan support, this week.

Cargill: E. coli cattle vaccine promising
Source: http://www.denverpost.com/business/ci_16623151/
By Kyle Glazier
The Denver Post

Posted: 11/16/2010 01:00:00 AM MST
The fight to make food safer continues at a microscopic level with locally produced beef yielding encouraging early data about the effectiveness of a vaccination against dangerous E. coli bacteria.
International food marketer Cargill announced Monday the initial results of a trial for the new vaccine, a test involving 85,000 cattle at the company's Fort Morgan beef-processing facility.
"We are pleased with the preliminary results," said Dan Schaefer, Cargill's assistant vice president for beef research and development, to a committee of the U.S. Animal Health Association.
Schaefer said Cargill was awaiting results from other researchers across the nation but that the company had plans to conduct a second trial next summer at a Midwest processing plant. The cattle had no negative reaction to the vaccine, Schaefer said.
He said the vaccinated Fort Morgan animals showed positive immune system response and low levels of the strain of E. coli bacteria that can sicken and kill human beings if consumed. But Schaefer said nonvaccinated cattle at Fort Morgan also showed low levels of E. coli. A variety of factors influence E. coli levels in cattle, Schaefer said, including weather, living conditions and vaccine dosage.
"The scientist in me tells me much more research remains to be conducted before we can draw any meaningful conclusions," Schaefer said.
Minnesota-based pharmaceutical company Epitopix developed the vaccine used in the trial. It received initial testing approval from the Food and Drug Administration and the U.S. Department of Agriculture in February 2009.
Other Colorado beef producers are conducting similar trials. JBS USA spokesman Chandler Keys said the company, which operates a facility in Greeley, is in the final stages of a trial involving 200,000 vaccinated cattle and would have results as soon as next month.
According to the national Centers for Disease Control and Prevention, more than 73,000 infections occur annually in the U.S. from this strain of E. coli, resulting in more than 600 deaths. An E. coli outbreak linked to gouda and gorgonzola cheeses sold in Costco stores led to a state health-department recall this month.
"The potential success of a vaccine should be viewed as another possible measure in the beef industry's food-safety toolbox," Schaefer said. "We believe people have the right to expect safe food."

Great quote from Eric Schlosser and Michael Pollan on S 510 - FDA Food Safety Act
Source: http://www.marlerblog.com/lawyer-oped/great-quote-from-eric-schlosser-and-michael-pollan-on-s-510---fda-food-safety-act/
Posted by Bill Marler on November 16, 2010
"S 510 is the most important food safety legislation in a generation. The Tester Amendment will make it even more effective, strengthening food safety rules while protecting small farmers and producers. We both think this is the right thing to do." Eric Schlosser & Michael Pollan
This is from Food Safety News this morning:
The National Sustainable Agriculture Coalition (NSAC) and several other sustainable ag groups have been issuing a last round of action alerts to rally support for the Tester amendment.
"The bill takes important steps to improve corporate food safety rules but it is not appropriate for small farms and processors that sell to restaurants, food coops, groceries, schools, wholesalers and at farm stands and farmers markets," said NSAC in its alert late last week.
NSAC asked its supporters to call Senators in support of the Tester provision to prevent "one-size-fits-all" regulations from being created.
The Senate is supposed to take up S 510 Wednesday morning (supported by a number of consumer groups, "Big ag" and grocery interests - arguably problematic). My bet is that if S 510 passes it is not going to pass without the Tester Amendment. However, with the Tester Amendment, the House is never going to take it up before the end of the year because of how broad the exclusion are and because S 510 does not have funding in it either. The House version does not have the former, but does have the later.
I supported the Tester Amendment (see link - October 1, The Tester - Hagen Amendment to S. 510 protects food safety and small farmers) as a mechanism to get the bill moved forward before the election when there actually was a real chance for passage by both Houses and a signature by the President. However, I have very strong reservations about the Amendment on food safety grounds.
Both the House and Senate bills already exclude sales ¡°to restaurants, food coops, groceries, ... and at farm stand and farmers markets¡± from most of the provisions of the bills that primarily relate to large manufacturers. Excluding sales to schools and wholesalers really makes no sense at all. Setting schools aside for a moment (although I think we all should care about the safety of the food our kid¡¯s get), excluding sales to wholesalers is a huge food safety loophole.
It was selling spinach wholesale from a small, organic farm that caused the 2006 spinach outbreak. Twenty-five acres of an organic spinach farm sold to a wholesaler, who sold to a manufacturer. The fecal contamination with E. coli O157:H7 was introduced at the spinach farm and amplified at manufacturer.
My feeling is that if a farm seller (small or large) puts his or her product into the wholesale market, they have to play by the same food safety rules as the large players. When it comes to food safety ? ¡°one size should fit all.¡±
We missed a once in a decade opportunity. Once the Republicans take control of the House in January, food safety legislation is, well, toast.

Cheese E. coli outbreak: a study in good epidemiology
Source: http://www.foodpoisonjournal.com/2010/11/articles/foodborne-illness-outbreaks/cheese-e-coli-outbreak-a-study-in-good-epidemiology/
Posted on November 17, 2010 by Drew Falkenstein
It may be only a rarity that a widely contaminated food product distributed to a major grocery chain all over an entire region of the country does not cause many severe illnesses. Even though there are at least 37 confirmed illnesses in the cheese E. coli outbreak, many people probably escaped severe illness under some relatively difficult epidemiological circumstances. It is important to recognize an ongoing, collaborative job very well done by local, state and federal health organizations involved in the investigation.
Sick people in the outbreak purchased or ate Bravo Farms gouda cheese at many different Costco locations in a number of major metropolitan areas throughout a 5 state region, including California, Arizona, New Mexico, Colorado, and Nevada. Important to also note that the cheese was not only sold to consumers, but also tasted by them at sampling stations. If people's food recall is bad with major items that they may have eaten, what's it like with items that are merely sampled as a shopper walks by?
Nevertheless, health agencies from affected states, together with CDC and PulseNet, recognized the pattern of matching E. coli illnesses and didn't hesitate to call the outbreak when they saw it. Their work has resulted in detection of the outbreak strain in multiple packages of opened Bravo Farms gouda cheese. And the CDC stated yesterday that the New Mexico Department of Health isolated the outbreak strain of E. coli in an unopened (intact) package of cheese. And it certainly doesn't hurt that Denver/Boulder and New Mexico are FoodNet sites, which is a collaborative epidemiological project with the CDC and several states and metro areas. Also, although Arizona and Maricopa County are not FoodNet members, they are particularly aggressive in investigating reported cases of foodborne pathogens.
But still, questions remain. What was the precise cause of the outbreak? Was the raw milk used to make the gouda cheese from a reputable producer (I think we know it was the milk)? Or was it CAFO-style milk from somebody who had no business supplying product for human consumption. Was the mandatory 60 day aging period for raw milk-based cheeses adhered to? Does it even matter if the answer is yes? Or is the 60 day period really an insufficient prophylactic against contamination, given the nature of the raw material used to produce the cheese. And what was the production environment like? FDA is at the Bravo Farms facility testing environmental and product samples; we'll publish the results when they are released.





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