Sunland Knowingly Shipped Contaminated Peanut Butter

“Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella. The following is a list of products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm’s internal testing program, and were at least partially distributed by your firm.”

– FDA Form 483, issued October 29, 2012

It’s Peanut Corporation of America all over again.

Earlier today, FDA released a series of Enterprise Inspection Reports and Form 483 reports issued following inspections of Sunland Inc.‘s production facilities in Portales, New Mexico from as long ago as 2007.

The company, whose peanut butter was definitively linked to an outbreak of Salmonella Bredeney that sickened at least 41 people from 20 states, has known about its Salmonella contamination problems since at least June 2009. Somehow, this information escaped the notice of the company’s customers – including Trader Joe’s – its third party auditors, and FDA inspectors for more than 2 years.

According to company records reviewed by FDA, Sunland found Salmonella contamination in its nut butters (peanut and almond) on more than 20 occasions, including findings of Salmonella Newport in 2009, Salmonella Dallgow in 2010, Salmonella Dallgow, Salmonella Arapahoe, Salmonella Teddington, Salmonella Cerro, Salmonella Mbandaka and Salmonella Kubacha in 2011, and Salmonella Bredeney and Salmonella Meleagridis in 2012.

FDA’s own in-depth inspection – carried out in September and October 2012 after epidemiologists pointed to Sunland’s peanut butter as the likely source of an outbreak of Salmonella Bredeney – found Salmonella Bredeney in samples of peanut butter, as well as Salmonella Senftenberg, Salmonella Montevideo, Salmonella Bredeney, Salmonella Mbandaka, Salmonella Meleagridis, and Salmonella Anatum in the production plant environment.

That’s more strains of Salmonella than many labs maintain in their reference collection!

In addition to turning a blind eye to the contamination that pervaded its operations since 2009, Sunland’s management ignored standard Good Manufacturing Practices, as evidenced by the following litany of “Observations” reported by FDA in October 2012:

Observation 1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.

Observation 2: Failure to handle equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination.

Specifically, the production and packaging lines of equipment in the Peanut Butter Plant were not cleaned after each time Salmonella was isolated from peanut and nut butter products between 2009 and 2012.

The … packaging equipment in the small packaging room of the Peanut Plant is not effectively cleaned between raw and roasted peanuts. Cleaning consists of wiping off non-food contact surfaces with dry paper towels, sweeping underneath and around equipment, as well as vacuuming excess dust.

Tote mesh bags utilized by your firm for storing bulk peanuts are not effectively cleaned between storage o f raw and treated (roasted and/or brined) peanuts. The tote bags are considered multi-use, and re-used for both raw and roasted peanuts.

Firm does not clean production and packaging equipment between runs of various allergen-containing products.

Observation 3: Food contact surfaces used for manufacturing low-moisture food were wet at time of use.

Observation 4: The design and workmanship of equipment does not allow proper cleaning.

Observation 5: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles, dirt, and organic matter and the opportunity for growth of microorganisms.

Observation 6: Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.

Observation 7: Plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant.

Observation 8: The plant is not constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair.

Observation 9: Failure to store raw materials in a manner that protects against contamination.

From 9/17112-10/2112, raw, in-shell peanuts were observed outside in uncovered trailers and open to the elements. Birds too numerous to count were observed flying over, and landing on peanuts in the trailers.

On 9/28/12, [FDA inspectors] observed the weather as overcast and rainy, seven open trailers filled with peanuts were observed stored uncovered on the front of [the] property exposed to moisture from the weather.

Observation 10: Effective measures are not being taken to exclude pests from the processing areas.

As for the company’s compliance history, consider the following:

In 2003, FDA cited the following problems: (1) the firm’s plumbing constitutes a source of contamination to food; (2) effective measures were not being taken to protect against the contamination of food on the premises by pests; (3) the firm failed to provide adequate screening or other protection against pests; (4) the firm failed to hold rework materials in bulk or in suitable containers so as to protect against contamination; and (5) the firm failed to maintain the buildings in repair sufficient to prevent food from becoming adulterated.

In 2007, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination; (2) the firm failed to take reasonable precautions to ensure that production procedures do not contribute contamination from any source; (3) employees were observed not washing and sanitizing hands thoroughly in an adequate hand washing facility before starting work and after each absence from the work station; (4) effective measures were not being taken by the firm to protect against the contamination of food on the premises by pest (a repeat observation); (5) the firm failed to store raw materials in a manner that protects against contamination; and (6) the firm failed to maintain buildings in repair sufficient to prevent food from becoming adulterated (a repeat observation).

In 2009, FDA cited the following problems: (1) the firm failed to manufacture foods under conditions and controls necessary to minimize the potential of microorganisms and contamination (a repeat observation); (2) the firm failed to take all reasonable precautions to ensure that production procedures did not contribute contamination from any source (a repeat observation); (3) failure to take all reasonable measures and precautions to ensure personnel cleanliness by utilizing effective hair restraints and ensuring that beard covers were worn in an effective manner; (4) failure to ensure employees washed/sanitized their hands properly when returning from the work station (a repeat observation); (5) failure to maintain equipment used to hold food ingredients in a manner that protects them from contamination. Also, FDA found Salmonella in an environmental sample taken during its 2009 inspection.

In 2010, FDA cited the following problems: (1) All reasonable precautions are not taken to ensure that production · procedures do not contribute contamination from any source; (2) Effective measures are not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests; (3) The plant is not constructed in such a manner as to allow floors to be kept in good repair; (4) Failure to wear beard covers in an effective manner; (5) The design and construction of equipment and utensils fails to preclude the adulteration of food with contaminants.

In 2011, FDA cited the following problems: (1) Failure to store raw materials in a manner that protects against contamination; (2) Failure to provide adequate screening or other protection against pests.

Am I the only one who doesn’t understand what’s going on here?

Where were the company’s customers? Did they never visit the production plant?

Where was Silliker Laboratories, the company’s third party auditor? Did they ever visit the production plant or review the company’s internal lab results?

AND WHERE THE HELL WAS FDA? Why did the agency not review Sunland’s internal lab results and production/distribution records until after the company’s negligence resulted in a food poisoning outbreak?

If this is an example of “Food Safety Modernization” in action, please give me the Good Old Days.

Tardy Testing Endangers Consumers

Once upon a time, a routine E. coli O157:H7 presence/absence test required at least two days to complete.

Once upon a time, a routine Salmonella presence/absence test took at least four days to complete.

Once upon a time, a routine Listeria monocytogenes presence/absence test required at least four days.

Today, all of these analyses can be performed in 24 hours or less, using recognized, readily available rapid test kits.

So, why are we still seeing recall notices that state “…the bacterium was discovered during routine sampling?“

On August 22, 2012, Spence & Co. Ltd. (Brockton, MA) recalled approximately 635 pounds of Wellsley Farms brand Nova Lox and Smoked Salmon Trim. The recall was initiated after routine sampling detected Listeria monocytogenes in the product. The products already were in circulation for two months at the time of the recall. No illnesses were reported, according to the recall notice.

Did the company learn from this? You can bet your life it did NOT! On November 9, 2012, Spence issued a second recall notice, this time for approximately 390 pounds of New York Style Nova Lox that were distributed – you guessed it – more than one month earlier. This time, Spence’s Lox may be responsible for two cases of listeriosis.

With affordable rapid testing kits readily available, there is no justification for releasing untested products – even highly perishable products – into the retail marketplace.

I am the first to acknowledge that finished product testing isn’t foolproof. A proper microbiological testing program must include ingredient testing and environmental monitoring in addition to finished product tests. Nevertheless, the retail distribution of a product without any testing whatsoever is unconscionable, especially when that same product already has a history of Listeria monocytogenes contamination.

Consumers have every right to expect that the food they purchase has been processed and handled in a safe manner – and that manufacturers have taken every reasonable precaution to ensure that this is so.

It’s time to make “test and hold” a standard food industry practice.

Investigation: USDA Quietly Eliminated 60 Percent of Foreign Inspections

The following article first appeared on Food Safety News, and is reposted with permission.

Investigation: USDA Quietly Eliminated 60 Percent of Foreign Meat Inspections

Agency also lacks foreign audit transparency

BY HELENA BOTTEMILLER | NOVEMBER 1, 2012

Sending U.S. Department of Agriculture officials overseas to inspect meat and poultry plants whose products are destined for American consumers has long been a bedrock of our modern import safety system, but an investigation by Food Safety News found, the number of countries audited by U.S. officials each year has declined by more than 60 percent since 2008.

The USDA’s Food Safety and Inspection Service has also become less transparent. The agency has failed to make audit reports public in a timely fashion and only revealed which countries have been audited in the past two years this week following multiple inquiries by Food Safety News and a blog post by former Under Secretary for Food Safety Richard Raymond questioning the lack of online records.

With an increasingly global food system – around 17 percent of the U.S. food supply is now imported – U.S. consumers are directly impacted by food safety practices and regulatory systems abroad.

Just last month, a massive E. coli O157:H7 beef recall from XL Foods in Alberta, Canada, affected 2.5 million pounds of beef that had been shipped to U.S. meat processors and grocery chains. According to the Centers for Disease Control and Prevention, there are no known illnesses linked to XL Foods in the United States, but at least 16 Canadians have fallen ill.

The XL Foods recall, the largest in Canadian history, might never have happened if FSIS border inspectors in Sweetgrass, Montana hadn’t found E. coliO157:H7 in multiple samples of the imported beef and raised the issue with the Canadian Food Inspection Agency (CFIA). Food safety advocates say the incident highlights the importance of a strong border inspection system, but also raises critical questions about whether FSIS has taken a more hands-off approach in regulating foreign countries sending meat and poultry products to the U.S.

Canadian media reported this month that FSIS was preparing to audit the Canadian meat safety system. The audit had been planned and was not prompted by the XL Foods recall, according to both CFIA and FSIS officials, but the reports noted that FSIS had not audited Canada, a major meat trading partner, since 2009.

Food safety experts and consumer advocates have started wondering: Why aren’t these food safety check-ups happening annually like they used to? Some worry that budgetary pressures are forcing a reduction in the number of audits, or worse, that the reductions are part of an effort to liberalize trade at the expense of public health.

In-country audits are part of what the agency often calls a “triad of protection” for imported meat and poultry. First, USDA must establish “equivalency,” determining that the importing country has a food safety system in place that’s on par with the U.S. system. Once a country is given the go-ahead (only 34 countries are currently approved), the USDA’s Food Safety and Inspection Service continually monitors the safety of imported products through strict re-inspection at the port of entry, by testing for dangerous pathogens, and by conducting “ongoing audits” to ensure the countries are living up to their equivalency designation.

Dr. Richard Raymond, the former Under Secretary for Food Safety, who led FSIS under the Bush administration, went public with his concerns about reducing the frequency of foreign audits this week. In a Meatingplace op-ed published Monday, Raymond questioned whether regular foreign audits were a casualty of tough budgetary times.

“I’ve always considered our foreign inspection program one of the crown jewels of our food safety system,” Raymond told Food Safety News. “Frequent audits are important. Without them, people cut corners – it’s human nature.”

Data show steep drop in foreign inspections

During the Bush administration, in-country audits generally happened annually, but, according to data provided to Food Safety News by FSIS earlier this month (which were posted online Wednesday), the number of in-country audits has dropped dramatically under the Obama administration.

Online documents show that from 2001 to 2008 FSIS inspectors were routinely evaluating, in-person, the foreign plants processing meat for American consumers. The number of countries audited annually, with only one exception (in 2006 there was a large drop in audits), was between 25 and 32, so FSIS was auditing an average of 26.4 countries per year. From 2009 to 2012, however, the number of countries audited annually dropped to between 3 and 20, so FSIS was auditing an average of 9.8 countries per year.

INFOGRAPHIC: A look at country audits conducted by FSIS 2001 to 2012.

The number of foreign countries audited started to decline significantly in 2009, to only 21 audits, but the in-country inspections that year still covered many of the major meat importers, including Australia, Brazil, Canada and Mexico.

In 2010, FSIS only audited 6 countries – Brazil, China, Honduras, Korea, Spain, and Uruguay – a third of what the agency had done the year before.

By 2011, the number of countries audited by FSIS was down to just 3: Australia, New Zealand and Poland.

So far in 2012, the agency has completed 10 audits, but the agency began auditing Canada on Oct. 22, so presumably that brings the total to 11. FSIS officials would not say how many more audits, if any, were scheduled through the end of the calendar year.

As of Monday, FSIS had not posted audit reports for all of the countries it audited in 2010, nor had it posted any information about which countries were audited in 2011 and 2012, telling Food Safety News that the reports were still under review. Sometime in 2009 the agency also stopped including plant audits in the reports posted online. On Wednesday, the agency updated its foreign audit page to include a handful of draft country audit reports as well as notes about which audit reports are still pending.

One former FSIS employee from the International Affairs Office told Food Safety News they could not imagine why the agency had stopped posting audit reports online in a timely manner.

“In past years, those audit reports would get posted within 60 days,” they said. “I’m surprised that FSIS isn’t being as transparent as we want them to be.”

A new approach to foreign inspection

According to interviews with former and current FSIS officials, the agency has, since 2008, been quietly changing its approach to foreign audits, making in-country visits far less frequent.

Though FSIS officials object to calling the new approach “risk-based” – they refer to the new approach as “systems-based” – internal agency documents obtained by Food Safety News clearly show that FSIS has shifted to a “risk-based” system that relies more heavily on paperwork than annual in-country inspections.

What’s particularly curious about this apparent policy shift, according to several stakeholders and consumer advocates, is that it was never made public.

Laurie Bryant, the executive director of the Meat Import Council of America, for example, told Food Safety News he was not aware that the agency had been reducing the frequency of in-country audits or that there had been a significant change in policy.

“If they’re going to make major changes to our foreign inspection program, the criteria for doing so should be made public,” said Tony Corbo, a lobbyist for Food & Water Watch. “They’ve never announced or explained this new approach. We’ve been kept in the dark on this.”

Gary Weber, who used to serve as the director of regulatory affairs at the National Cattlemen’s Beef Association and now runs his own food safety consulting company, expressed concern about scaling back in-country audits.

“Audits are critical to protecting both consumer confidence and public health,” said Weber. “It’s a privilege to be able to export meat to our country.”

There is no official explanation for the significant policy change, but one official did acknowledge they “dropped the ball” by not announcing it.

Agency officials told Food Safety News they “intended to announce it in a Federal Register notice,” but haven’t because they’ve been busy issuing other policy changes. The agency said it’s “preparing the documentation around this” and intends to explain the new approach.

FSIS officials argue that the new system is more sophisticated and replaces the old “cookie cutter” audits.

The agency now uses a self reporting tool, known as SRT, that allows countries to self-report information to FSIS. Foreign inspectors provide information to the agency on things like preventive controls, microbiological and chemical testing, sanitation and government oversight. The self reporting tool has been supplementing in-country audits since 2010, according to the agency.

“We get more information from countries on an ongoing basis,” said a FSIS official. “We’re going to do less in-country audits.”

“This is more of a document approach,” said one former FSIS official, adding that SRT is more cost-effective than extensive onsite audits. “It doesn’t make sense to keep going back to the countries that don’t have problems.”

The agency is already using a tiered approach to rank countries based on risk – they look at SRT submissions, past problems and the results of FSIS’ re-inspection testing at the ports of entry. The criteria have not been made public.

Budget and transparency concerns

There is some disagreement about what motivated FSIS to adopt a new approach to foreign inspection.

Agency officials insist that budget constraints were not the reason for scaling back in-country visits. House Appropriations Committee staff confirmed that FSIS has received appropriations on par with what they’ve requested.

But a former FSIS official from the Office of International Affairs told Food Safety News that budgetary pressures were a major factor in the change.

“The budget restrictions had pretty much forced the agency to re-evaluate the most cost-effective way to do audits,” they said, noting that the agency is trying to transition to a more risk-based approach across the board.

FSIS said the new approach was suggested by the National Advisory Committee on Meat and Poultry Inspection (NACMPI) in August 2008, but consumer advocates dispute the claim.

One of the recommendation documents from the meeting states that the “length of time between audits can be based more on risk and compliance history in the foreign country,” and that “a three-tiered system may be appropriate,” but the documents don’t get much more specific.

“I don’t see anything in the document that says, ‘It’s fine for you to go three years without auditing a country’s system,’” said longtime consumer advocate Carol Tucker-Foreman, who served as Assistant Secretary of Agriculture for Food and Consumer Services under the Carter administration. “I’ve never seen anything that outlines the grounds for such an approach.”

“FSIS hasn’t provided any data showing that imported meat and poultry products are safer than those made in the U.S,” said Tucker-Foreman. “Perhaps [the White House Office of Management and Budget] wants even more cuts in the FSIS budget; perhaps pleasing our trading partners now trumps public health; perhaps it is a little of both. Whatever the cause, we think it is bad public policy.”

Pat Buck, the director of outreach and education at the Center for Foodborne Illness Research and Prevention echoed similar concerns.

“It is concerning that Canada, which is America’s largest supplier of imported beef, is not audited every year. It would seem prudent for USDA to conduct an annual audit for those countries — Canada, Australia, New Zealand and Uruguay — that account for the bulk of America’s imported beef products,” said Buck. “It is not clear what caused this policy change.”

The agency insists it has not backed off foreign inspection; it’s just being smarter about targeting audits to where the potential problems are. Plus, FSIS points out, in-country inspections are just one part of the “triad of protection” for imports.

Nevertheless, the agency responded to follow up questions Wednesday by saying it would take a second look at its protocols regarding foreign audits: “FSIS is evaluating our process of updating audits to be more transparent and responsive to requests from our stakeholders.”

Infographic with data from FSIS contributed by James Andrews.