Remarks prepared for delivery by Dr. Richard Raymond, Under Secretary for Food Safety, to the Food Safety Conference, "Who's Minding the Store? The Current State of Food Safety and How it Can be Improved," April 11, 2008, Seattle, Washington.

Notes: Slides are available in an attached PDF document; individual pages are linked within the text. Links to organizations outside USDA open in a second window.

Introduction
(Slide 1) It is great to be here. Thank you, Dean Testy, for your welcome and introduction, and thank you as well to Barbara Kowalcyk, who has turned a family's grief into a force for good. We may not agree on every issue, but we share a passion to improve the safety of the food we regulate. I want to express my respect and appreciation, Barbara, for your tireless efforts on behalf of food safety, and while I have the highest regard for the skills and dedication to the public health of FSIS employees, it's good to have concerned citizens keeping an eye on what their government is doing and ready to speak out.

Basics
Before I begin let's whip through a few basics, although I'm confident 90% of this audience is fully up to speed on everything I'm about to say.

(Slide 2) As the Under Secretary for Food Safety, I oversee the Food Safety and Inspection Service, which carries out USDA's food safety regulatory program, as well as important public health outreach and education activities focused on enhancing the safety of the U.S. food supply.

It's the "AND" in FSIS that I wasn't aware of before taking this job. I can tell you though that we do much more than just inspect and regulate.

Our mission is to ensure the safety and wholesomeness of the nation's commercial supply of meat, poultry and egg products. It doesn't matter if those products are imported to, or exported from, the United States.

We're also dedicated to fostering safer food handling habits among all types of food handlers, and developing science-based policies to improve our food safety and defense systems.

Acts and Authorizing Statutes
(Slide 3) Our vital food safety activities are conducted under a number of federal acts and authorizing statutes. The three that most clearly define our role in food safety are the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970. They provide the basis for FSIS' ability to perform as a public health agency. Another key mandate is the Humane Methods of Slaughter Act of 1958, which requires that all livestock be slaughtered by humane methods.

I'm not going to go into the details of these acts. Most of you are probably familiar with them already. That's something that can be found on our Web site. But I do want to point out that each statute requires that meat or poultry products must be wholesome, unadulterated and properly marked, labeled and packaged.

In addition, one of the requirements is that we have a daily inspection presence in each establishment, as well as a carcass by carcass inspection. Nearly all of FSIS' activities focus around one or more of these vital mandates.

(Slide 4) FSIS' sister agency, the Department of Health and Human Services' Food and Drug Administration (FDA), is responsible for all other food products not under FSIS' jurisdiction. This can include fresh produce, ice cream, and seafood. FDA does not fall under the same statutes as we do, and does not face the same responsibilities, such as daily inspection.

So, that's the line up of who does what.

Hallmark/Westland Meat Packing Co. Recall
(Slide 5) First let me directly address the Hallmark/Westland recall. As I'm sure you are all aware, Hallmark/Westland Meat Packing Co. was the subject of an undercover video by The Humane Society of the United States that depicted alleged humane handling violations.

After the video was released to the media and USDA, we initiated an investigation, which is still ongoing and being led by our Office of Inspector General. Through the investigation, FSIS has obtained evidence that the establishment had the practice of occasionally slaughtering cattle that had already passed ante-mortem inspection but became non-ambulatory prior to entering the slaughter operation without notifying our Public Health Veterinarian. This practice is not compliant with FSIS regulations.

Therefore, FSIS determined that their products are unfit for human food because the cattle did not receive complete and proper inspection.

Based on this noncompliance with FSIS regulations, Hallmark/Westland Meat Packing Co. voluntarily recalled 143 million pounds of raw and frozen beef products produced since February 1, 2006. FSIS issued a Class II recall on February 17, 2008.

A point I want to stress is that this is not a food safety issue. This meat was recalled because the plant violated our regulations and therefore the meat is considered unfit for sale — unfit, but not unsafe.

I've heard a lot of concern and fear about getting mad cow disease from this meat. It's important to remember, again, that all of the animals involved passed pre-slaughter inspection by an FSIS veterinarian on the same day of slaughter, a veterinarian who was keeping an eye out for, among other things, evidence of central nervous system disorders such as mad cow.

In fact, our workforce condemned 592 non-ambulatory disabled dairy cattle at Hallmark in 2007. That's 0.48% of the total there, substantially more than the national average of 0.29%. [7,200 out of 2.5 million.]

Had the plant notified the FSIS veterinarian when the animals later went down, the vet would have been able to make a case by case determination that the animals had sustained an acute injury and would have been permitted into the food supply.

(Slide 6) The safety of our food supply is protected from exposure to the prions that cause BSE in cattle and vCJD in humans because of the strong interlocking system of controls to protect the beef supply and prevent downer cattle with signs of central nervous system disorders from entering the food supply.

1. FDA's feed ban preventing the feeding of ruminant to ruminant has been in place since 1997;
2. SRM rule and prohibition of non-ambulatory disabled cattle in 2004;
3. Post-slaughter inspection by FSIS veterinarians are able to identify chronic illnesses and signs of central nervous system disorders which take time to develop, and the animals would not have passed pre-slaughter inspection; and
4. USDA surveillance testing: since June 1, 2004, more than 759,000 animals have been tested and to date, only two animals have tested positive for BSE under the program.

Thanks to these four safeguards, although the risk of getting mad cow from this recalled meat is not zero in mathematical terms, it is essentially impossible to get mad cow from it in practical, real-world terms.

Now there has been some misreporting about this that I want to clear up. Some have said that the ban on downer cattle entering the food supply has only been active since 2007. In fact, it's been in place since June 2004.

E. coli Meeting
(Slide 7) Something that is a food safety issue, and a very timely and pertinent one, is E. coli O157:H7 (which I'll just call E. coli for short from now on). I'm proud to report that we have just had a very successful meeting on it that ended yesterday, what I hope will prove to be a watershed moment in food safety. Over 200 people attended, from government, industry, academia, consumer groups, and elsewhere, including a representative from a certain high-powered law firm located right here in Seattle.

We laid out some bold proposals that I believe and hope will make a substantial difference. I think the discussions we had were very frank, and I'm hopeful that we can rally industry around these new ideas just as we did with HACCP and the principle that public health is not a competitive issue.

We're seeing some good news as well, as shown by CDC in the most recent Morbidity and Mortality Weekly Report, which is officially released today.

May Conference
We'll also have a two day meeting May 15-16 in St. Louis, Missouri to focus on improving coordination during foodborne illness outbreak investigations and response. This is part of our follow up on the issue of recalls and foodborne illness outbreaks from last year going up somewhat. After hard work and a close look, we realized with each outbreak that there was something we could have done better. We're working to get better and I'm appreciative of what Caroline Smith DeWaal is doing to help us prepare for that meeting.

Participants include

• AFDO, the Association of Food and Drug Officials,
• APHL, the Association of Public Health Laboratories,
• ASTHO, the Association of State and Territorial Health Officials,
• CSTE, the Council of State and Territorial Epidemiologists,
• NACCHO, the National Association of County and City Health Officials,
• NEHA, the National Environmental Health Association,
• FDA, CDC, consumer groups, and industry.

Import Safety
(Slide 8) Let me turn now to another issue, import safety. I'd like to clarify the situation after seeing some alarmism about imports tripling while our workforce stagnates, and so on. That's simply not true of FSIS.

One reason FDA has had to deal with a tripling of imports is that people now want fresh fruits and vegetables in winter rather than just canned or jarred goods. However, our level of imports has been stable.

On the issue of employment, we have more full time employees and Import Surveillance Liaison Officers to handle what we've imported. As a result, in our 140 import inspection houses, we've gone from 36,000 pounds of product removed from commerce in 2005 to over 2.1 million pounds in 2007.

We have rigorous steps in place to ensure that the imported products we regulate are just as safe as products produced in the United States.

(Slide 9) Our three-part system consists of, first, establishing the initial equivalence of the meat, poultry and processed egg products inspection system of a country wishing to export to the United States.

In this step, an FSIS audit team evaluates, during an on-site review, all the aspects of a country's inspection program, from the headquarters of the inspection system to regional offices and local offices, and ultimately to individual establishments within the country and to laboratories that will be testing product destined for the United States from 34 countries.

Secondly, we verify the continuing equivalence of foreign systems through annual audits.

If a country fails an audit, FSIS can suspend imports from that country, from individual plants, or of specific products. In fact, FSIS has taken just those kinds of steps in the past to ensure the safety of the U.S. supply of meat and poultry products.

Finally, we provide 100 percent re-inspection, with a few exceptions, when products enter the country.

In addition to the initial re-inspection of product entering the United States, FSIS performs intensive random re-inspection on approximately 10 percent of the shipments of meat, poultry and egg products. More intensive re-inspection is automatically applied to future shipments of product from the foreign establishment when a product fails re-inspection. Approximately four percent of shipments of imported meat and poultry products receive microbiological and chemical verification testing.

Our system of equivalence and working closely with governments in improving countries works especially well for higher risk product and was recognized by the president's Interagency Working Group on Import Safety.

Fighting Pathogens
Now I want to share with you the challenges we faced in 2007, the ongoing and upcoming initiatives that we're using to combat pathogens like E. coli, and our plans for the future.

Listeria. We have taken a risk based approach to battling pathogens that cause foodborne illness. For example, we've instituted risk based sampling for Listeria monocytogenes. (Slide 10) Since 1998, the percentage of regulatory samples of meat and poultry products that tested positive for Lm has fallen by almost 80 percent.

(Slide 11) As you can see, as the percentage of positive regulatory samples declined, so have the number of illnesses attributed to Listeria monocytogenes, but we still have work to do to meet the Healthy People 2010 goal.

Salmonella. (Slide 12) When I started this job, the news on Salmonella was not encouraging, as the rates were going up.

However, after announcing our targeted 11-point Salmonella reduction plan in February 2006, we've seen consistent declines in product positive rates.

(Slide 13) For example, in broilers we've seen the numbers go from more than 16 percent of samples testing positive for the pathogen in 2005 down to single digits.

(Slide 14) On March 28 we began publicly listing plants by category, making it clear to everyone — the news media, business partners, and ordinary consumers — which ones are poorly performing. We've started with young broilers, but are considering other product categories as well.

E. coli. (Slide 15) Over the long haul, we've made some tremendous progress in controlling E. coli. Between 2002 and 2006, as you know, FSIS testing shows the percentage of samples testing positive for E. coli declined by 80 percent. Maybe not the best indicator of prevalence, but certainly an indicator of trends and increasing industry control of this bug — until recently.

FSIS' Data Analysis and Integration Group has worked hard on improving attribution, and has calculated that 34% of E. coli illnesses come from consuming ground beef. New data like that will help a great deal in future efforts to control this bug.

The Agency's E. coli O157:H7 initiatives and industry's collective response in 2002 helped drive the rates of positive samples down in 2002, 2003 and 2004 — and these rates remained at 0.17 percent for 2005 and 2006. But in 2007, the rate increased to 0.23 percent. To put that percentage into perspective, out of 12,000 samples taken in 2007, only 27 — a miniscule amount — were positive for E. coli O157:H7.

So, we improved in the long run, but unfortunately we "plateaued" for three years and slipped a little lately.

(Slide 16) But the bottom line isn't product testing — it's human illness, and the numbers rose in 2005, from a low in 2004, and then higher yet in 2006. Foodborne illness data from 2007 are officially due out today in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report. I hope it isn't further bad news, but we only have to look at the trends in illness and product testing to know it's time for bold steps to be taken.

Last year, we also experienced an increase in the number of recalls related to E. coli O157:H7 — 21 recalls, with 10 due to reported illnesses.

(Slide 17) But to put this in perspective, from 2002 to 2006, the number of recalls of ground beef due to E. coli O157:H7 had decreased significantly. This was not through chance or luck, but rather through our collective efforts and commitment to control this pathogen and lower the risk of foodborne illness to consumers. Here's the breakout:

• 2002 - 21 recalls, 2 with reported illness
• 2003 - 12 recalls, 5 with reported illness
• 2004 - 6 recalls, 3 with reported illness
• 2005 - 5 recalls, 4 with reported illness
• 2006 - 8 recalls, none illness-associated
• 2007 - 21 recalls, 10 with reported illness

I don't think anyone has become complacent in the last year or two. What may have changed is the ecology of the bug, or the prevalence of the bug, or the concentrations of the bug on hides or in the gut of the herd. We don't yet know what has caused the disconcerting upward trends in recalls, positive samples, and human illnesses. And until we do, so we can attack the problem at the pre-harvest stage, we must do everything possible to reverse the trends and protect public health. That is our collective responsibility and we must take it on together.

Two days ago I challenged the participants at our public meeting on E. coli to outline how they would change so as to make this happen. FSIS has proposed some bold steps... It's already caused some pushback but I'm determined to that we stay on top of this problem.

Change We Support … And Oppose
(Slide 18) As my tenure as Under Secretary goes into its final year, I want to put forth three common sense changes:

First, public health / risk-based inspection; basically, putting inspectors where and when they will do the most good and where they are most needed. It makes little sense to assign as many police officers to watch the church as stringently as we do the bar (and I assure you I meant the beverage kind of bar, not the fine bar association here in Washington State — unless you know something I don't). We are laying the foundation now of our new system by improving how we collect and analyze data. Although I expect to be gone when this is implemented by a new Under Secretary, we are looking to the beginning of implementation in the third quarter of 2009.

Second, letting consumers know the specific name of the stores which have sold recalled product, so everyone can more easily identify what they have and find the product they should discard or return. Right now we give out good information, but it's not as easy as it could be for someone to open up their freezer and based on what we're allowed to tell them, determine whether they can eat what they're holding. I feel strongly that this needs to change.

Third, creating a practical solution to how we handle E. coli positive boxed beef and carcasses. Something big and bold has to change here, and we want to foster intensive discussions with the goal of a practical solution, soon.

(Slide 19) But there are also changes being talked about that I oppose. One is so-called mandatory recall authority. The phrase overlooks the fact that if a company ignores our recommendation to institute a recall, we can seize and detain its product.

I would like to emphasize also that no company, in the 101 years of the FMIA, has ever refused our request to do a voluntary recall.

Also, the proposed statutes that I've seen for so-called mandatory recall all include a "due process." For example, a bill introduced by Sen. Kohl actually says the plant does not have to recall for ten days while we do a public hearing. All that does is slow us down.

By contrast, with our current, voluntary system, the massive, record Hallmark recall happened four hours after we picked up the phone and called the company.

The second proposed change we oppose is to jam USDA, FDA, and who knows who else into a giant, monolithic, single food safety bureaucracy.

I believe smaller can be better, and in this case is better. Smaller helps us be more nimble, more responsive, quicker and less burdened by big bureaucracy. And that is exactly what is necessary in dealing with a food safety emergency.

We know animal husbandry; our FDA friends know canned fruits and vegetables. We cooperate closely but also deal with very different situations and statutes. Letting each of us do what we do best is, I think, a better approach.

Closing
(Slide 20) The state of public health is constantly evolving, and we can't allow ourselves to stagnate. I've often said it's like riding a bicycle; if you're not moving forward you're going to fall down. We know we can and must improve, but when we look at what we've done since 2004; the progress we made has flattened out. What can we do in the second half of this decade to repeat the successes of the first?

I'm here to listen for the entire meeting, as opposed to the usual thing of giving a speech and leaving. This is important stuff, multiple views and ideas will be expressed. I'm impressed with the agenda, and I'm here to listen and learn. I look forward to hearing your views.