USDA RULING ON E. COLI & STEC IS ONE MORE STEP IN THE RIGHT DIRECTION...STILL LEAVES MUCH TO BE DESIRED FOR THE FOOD SAFETY COMMUNITY...

Big News But: USDA Bans “Other” E. coli Strains

By Maryn McKenna  

September 13, 2011 |
8:27 pm |






Good news, but not excellent news, today from the US Department of Agriculture: It has agreed that, starting in March 2012, six more strains of E. coli will be considered “adulterants,” putting them in the same regulatory category as the much-feared E. coli O157:H7.

It is a big step, to do this. Those six bacterial bad actors — technically, E. coli O26, O45, O103, O111, O121, and O145 — are now responsible for the majority of foodborne illness caused by E.coli in the United States, causing almost twice as much illness each year as O157 does.

                                      

                                                Declaring a substance to be an adulterant means that it cannot legally be distributed in food, and that therefore food processors can legally be held to account for products that contain it. 

O157 was declared an adulterant in 1994, one year after it killed four children and sickened hundreds more in an outbreak centered on Jack-in-the-Box hamburgers.

 Because of that ruling, meat processors were forced to detect the pathogen and work to suppress it. 

And they did: As you can see from the chart (cribbed from a CDC presentation archived here), there is less E. coli O157 than there was. 

It does not show up because O157 can reach people from other sources, including raw produce that has been exposed to manure in the field. But there is a lot less, and the adulterant declaration is responsible.

That’s a significant achievement not just because O157 still causes more than 90,000 cases per year, but also because they are such bad cases. 

O157 is what’s called an STEC — a Shiga toxin-producing E. coli — and the toxins it produced cause not only diarrhea, but red blood cell damage, kidney failure, and death.

     

                                                                                                    However: All the other “non-O157s” are STECs also, and they also cause illness, hospitalization and death — about 112,000 cases per year, USDA Secretary Tom Vilsack said in a media briefing today. (There’s no transcript online that I can see. It was a frustrating briefing, because it was billed for 30 minutes but lasted only 15, leaving many reporters including me hanging in the phone queue waiting to ask our questions.)

The non-O157’s incidence has been rising, as captured by this chart (also cribbed from a CDC presentation, this one archived here). 

For more than a decade — as excellently summarized in June by Michele Simon at Food Safety News — the non-O157s have been causing significant outbreaks in the US, and the federal government has been dithering over what to do about it. 

 Dithering, that is, despite assessments by its own experts that”Non-O157 Shiga toxin-producing E. coli have emerged as a significant public health issue” and “overall, the non-O157 STEC, in particular strains O26, O55, O103, O111, and O145, are just as prevalent and clinically significant as E. coli O157 in the US,” to quote an internal USDA report from 2007.

Under the measure announced today, the additional six STECS will be barred from commercial sale. That’s definitely progress. But here’s where the “buts” begin:

First, this rule applies only to raw ground beef and in the scraps or “trim” that are collected in processing plants to be made into ground beef. (And only trim will be tested initially, on the argument that it becomes ground beef. Choosing trim means the testing can be carried out at larger processors that may be better able to afford it.) It does not apply to any other meats, though STECs have been found in chicken and turkey.

         

                                                                                            It also will not apply to any other organism. So if this rule had been in effect this year, for instance, it still would not have prevented the contamination of ground turkey with antibiotic-resistantSalmonella Heidelberg that caused 36 million pounds to be recalled. 

For food-safety campaigners, this is probably the biggest disappointment: The Consumer Federation of America and the Center for Science in the Public Interest today both urged the USDA to enact a ban on resistant Salmonella. You can see in this chart (from this CDC paper) how many other problematic foodborne pathogens there are.

Finally, it doesn’t take care of all the STECs out there. 

This summer’s Europe-wide outbreak of thousands of cases of E. coli spread by fenugreek seeds was caused by a serotype dubbed O104 — which is not one of the six covered by today’s rule.

Still, it’s important to recognize that today’s action is a big step. You can tell that, in part, because the meat industry opposes it; in a statement emailed to reporters now online here, the American Meat Institute said, “USDA’s announcement today declaring six strains of naturally occurring STEC to be adulterants in ground beef is premised upon the notion that the government can make products safe simply by banning a pathogen. 

This new policy is not supported by science and likely will not benefit public health.” (The AMI sued the government in 1994 to prevent the O157 regulation from taking effect, and failed.)

It’s equally important though to look to the next steps, which would be to take the USDA’s Food Safety and Inspection Service to where its sister agency the Food and Drug Administration already is. At the FDA, any pathogen in food is an adulterant.

Food-safety attorney Bill Marler, who has been one of the chief campaigners for changing the regulations on STECs (and filed a petition to get the USDA to pay attention) thinks that’s the way to go. He told me in an email a few hours ago: “Hagen’s action today is a great first step in recognizing that pathogens have no place in our food supply. I look forward to the day when FSIS deems all pathogens in meat (beef, turkey, chicken and lamb) as adulterants just like FDA does for all other foods.”

See Also:
The biggest foodborne-disease threat may not be addressed by the …
E. coli: What we know and need to
Resistant Salmonella: Deadly Yet Somehow Not Illegal
Multi-Drug Resistant Staph in 1 in 4 Meat Samples
E. coli: A Risk for 3 More Years From Who Knows Where

Flickr/JoshBousel/CC


Maryn McKenna is a journalist for national magazines and the author of SUPERBUG and BEATING BACK THE DEVIL. She finds emerging diseases strangely exciting.

Follow @marynmck on Twitter.

VOLUNTARY FOOD SAFETY PROGRAMS (GLOBALGAP & GFSI) ABOUT TO BECOME MANDATORY...

Food Importers Required to Beef Up Food Safety Programs
JAN 04





President Obama signed into law a new food safety bill (HR2751: The FDA Food


Safety Modernization Act’’) that gives FDA mandatory recall authority and requires food companies and their suppliers (including importers) to expand their food safety programs and in particular their documentation of what they do and why.




The following is a summary of the act from the perspective of a food safety scientist who is NOT a legal expert. This is therefore not a legal interpretation of the act and its requirements, and you should not rely on this for the basis of any actions.




Responsibilities for food companies that are identified in the new law:




1. Have a food safety plan that incorporates at least the following:




a. A hazard analysis that are reasonably likely to occur (varies by facility)

b. Put into place effective controls (have to work) and back up why they are adequate

c. Monitor that they are working correctly and if not take corrective actions and document why and what was done (DOCUMENTATION is CRITICAL at inspection time)

d. Verification activities – including both environmental and finished product testing - FDA can go back as far as records are kept (required to keep for 2 years)

e. Redo at least every 3 years

f. All records incl. food safety plan are available to FDA

g. Some differences for animal foods/pet foods




2. Have adequate and documented controls for the following: sanitation, training of personnel, environmental monitoring program including listeria, salmonella, etc, food allergen control program (a lot of specifics in the law on undeclared allergens),recall plans (basic parameters are already established in 21CFR), GMPs (prerequisite controls) and supplier verification programs




3. Supply chain management must include monitoring and control. Companies must know who they are and have a plan to ensure adherence. Companies must– ensure that the food (and ingredients used in the food) aren’t adulterated or misbranded (including undeclared food allergens).




4. The law also specifies new record keeping requirements and provides FDA with expanded access to the records. Maintain Documentation throughout it manufacturing processes and all documentation must now be available to FDA inspectors. This documentation includes the food safety plan, all monitoring, all testing, all corrective actions and the rationale for why the company has done what it is doing and why it isn’t doing other things.




5. Exemptions are allowed only for very small companies, with a small radius of product distribution (still have some requirements)




6. Warehouses are exempted from most of the requirements.




7. Biennial registration is required. The registration changes from essentially a directory to a “license” to sell foods that FDA can suspend for food safety reasons.




8. Includes safety standards for fresh fruits and vegetables.




9. Traceability of ingredients is addressed but this provision will not be implemented in the first phases.






Imported ingredients and foods




Companies must have a foreign supplier verification program that is risk -ased for ingredients, intermediate or final product. The program must include packaging. It will be prohibited for US owner or consignee to import a product that is not compliant with this section of the new law. It now becomes a basis to deny importation if there isn’t a compliant foreign supplier program in place. Ultimately it is the US owner, or consignee who is responsible.




Depending upon contractual arrangements custom brokers/distributors could be responsible. The US company is responsible for ensuring that its suppliers and products from those suppliers are in compliance. and must show that it is as safe as domestically produced food (referencing the food safety plan and address critical control points, misbranding, etc. Each company will have to have a unique plan based on the foods, regulatory system in the location from which the food comes, tailored to the situation. Types of verification that may be needed include: monitoring of records, lot certification, annual onsite inspections, checking HACCP program, periodic testing and sampling, etc. There are exemptions for small quantities of product specifically designated for research or validation, for samples or for personal consumption. Records from the foreign suppliermust be maintained for 2 years and available to FDA on request (e.g. from US company).




Time frame: guidance from FDA within 1 year of enactment (this time next year), (promulgate regulations by then), provision kicks in within 2 years of enactment (2 years from January 4, 2011 even if FDA doesn’t put forth regulations.




If FDA decides there is a problem it can require certification from an accredited auditor (agencies of foreign government, persons accredited under 3rd party certification. The law specifies several types of audits and specifies penalties for auditors who make errors (or reach faulty conclusions). There are requirements for using accredited laboratories and a requirement that under certain circumstances the laboratory test results are to go directly from the laboratory to the FDA.




Enhanced enforcement powers




FDA inspections will increase for both domestic and international facilities and fees will be levied on firms whose food safety programs are such that FDA needs to increase its inspections further. FDA now has mandatory recall authority. However firms can avoid the fees and associated issues by agreeing to a voluntary recall.




The law implements a registration system that will allow FDA to simply suspend registration and make it illegal for the company to operate (e.g. withdraw license temporarily).




Until now FDA has needed credible evidence to detain product. The law will now allow detentions if there is reasonable evidence that it is adulterated or misbranded . (Most states already had this provision).

The law has some new fees including the re-inspection fee noted above, an export ceritifcation fee and in the future a “fast lane” fee.




The law doesn’t include civil money penalties unless you defy the recall, quarantine authority or subpoena or remote access to records. The FDA will have to come to the facility.




Timetable: Small and very small companies have longer time frames but basically:




• 18 months for food safety plans

• 24 months for foreign supplier verification

• Will become effective with or without FDA guidance/regulations

• Registration begins in 2012




RIGHT NOW most companies need to get started on food safety plans, supply chain management – especially foreign supplier verification programs, records maintenance and access plans and testing of ingredients and finished products.

15% OF MEXICAN PAPAYAS CONTAMINATED WITH SALMONELA...GIVES "CALIDAD SUPREMA"...A BLACK EYE...COULD SPILL OVER TO OTHER MEXICAN ITEMS...INCLUDING MANGOES...

Salmonella fears spur ban of Mexican papayas in U.S.
Investigation shows 15 percent of fruit contaminated; shipments halted at border




By JoNel AlecciaHealth writer

msnbc.com

updated 58 minutes ago

The federal Food and Drug Administration is banning imports of all papayas grown in Mexico because of widespread and ongoing salmonella contamination, the agency announced Thursday.



More than 15 percent of fresh papayas entering the U.S. from Mexico were contaminated with the foodborne bacteria, an FDA investigation between May 12 and Aug. 18 found. That included papayas from 28 different firms and included all the major papaya-producing regions in Mexico.

The investigation followed an outbreak of salmonella Agona infections earlier this year that sickened 100 people in 23 states, and sent at least 10 victims to the hospital, according to the Centers for Disease Control and Prevention. 

Those papayas were imported via Agromod Produce Inc., a distributor in McAllen, Tex.

All raw fresh and raw fresh refrigerated papaya may be halted at the U.S. border, unless the items are on a exempted list, the FDA import alert said. Papaya producers will have to prove that shipments of the fruit are free of salmonella contamination with a third-party laboratory analysis to gain future entry. FDA may consider five consecutive salmonella-free shipments over a period of time to allow re-entry.

The U.S. is a main source for papaya growers, with imports of nearly 345 million pounds of fresh papaya in worldwide in 2009, according to the U.S. Department of Commerce. About 275 million pounds of those papayas come from Mexico, making that country a chief supplier.

FDA officials said that the U.S. and Mexico would continue to work together to address the problem.

"Collaboration between FDA and the Mexican government in the management of food safety problems is essential to fulfilling our responsibility to consumers in our respective countries," said Michael R. Taylor, the FDA's deputy commissioner for foods, in a statement.

Enrique Sanchez Cruz, director in chief for the National Service for Agroalimentary Public Health, Safety and Quality, said the move would reduce the risks of contaminated produce moving across the international borders.

© 2011 msnbc.com 

LEARNING FROM THE DEADLY E. COLI OUTBREAK THIS SUMMER...52 DEATHS LATER...

August 16, 2011




German E. coli outbreak: After the outbreak the learning begins - Sponsored by Zetes



The German E. coli contamination that has killed more than 50 people is now officially over, according to health officials. 




But the scale of this event ensures a lengthy aftermath.

It is telling that a week after officials stated that the E. coli outbreak in Germany was over, just-food is reporting an outbreak of salmonella in the US which has killed one person and made another 70 ill.

What does this suggest to us? 




That such food scares are more prevalent? 




Some would say yes and may point to industrialised food production and intensified agriculture as the cause. 




Others would counter by saying that we need mass-produced food and the science that has made it possible has concurrently contributed to making large-scale food production ever safer.

On that debate, you can pay your money and take your choice.

However, the quick succession of these two events definitely reminds us that such contaminations - while technically avoidable and therefore not 'inevitable' - do happen. 




It is an apparent and regrettable truth that the one we are currently dealing with - or reporting on - will not be the last.





In all, 52 people died from the German E. coli outbreak, which is a chilling statistic when compared with other large-scale contaminations. 




The outbreak of E. coli in spinach in the US in 2007, which was considered a major contamination at the time, only resulted in three deaths. 




The salmonella in peanuts contamination two years later, also in the US, resulted in nine deaths.




 Some 4,300 people became ill as a result of the German outbreak, compared with around 200 in the 2007 outbreak and 700Only tweak in 2009.

But, the personal tragedy these figures represent can also spawn technological and procedural improvements which can reduce the risk of something similar happening.

Given that the outbreak first began in May and it was some weeks before it was accurately traced to fenugreek seeds imported from Egypt into Germany, with Spanish cucumbers initially blamed in error, questions have been asked as to whether mistakes were made at that vital early stage.

For just-food's full coverage of the outbreak and its recently published analysis of the aftermath, click here.

Until next time...

Dean Best
Managing Editor
Web: http://www.just-food.com
Email: editor@just-food.com
Twitter: http://twitter.com/just_food