Food Policy & Regulation

ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., today pleaded guilty to a criminal misdemeanor charge alleging the shipment of contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of salmonellosis, or salmonella poisoning, the Department of Justice announced today.  Following its guilty plea, the company was sentenced to pay an $8 million criminal fine and forfeit an additional $3.2 million in assets.  The sentence represents the largest fine ever paid in a food safety case.  ConAgra Grocery Products LLC is based in Omaha, Nebraska, with a manufacturing facility in Sylvester, Georgia.

The company pleaded guilty pursuant to a plea agreement filed last year in federal district court in the Middle District of Georgia.  Senior U.S. District Court Judge W. Louis Sands accepted the company’s guilty plea and imposed the sentence proposed in the plea agreement.  In pleading guilty to violating the federal Food, Drug and Cosmetic Act, the company admitted that it introduced Peter Pan and private label peanut butter contaminated with salmonella into interstate commerce during the salmonellosis outbreak.

“This case demonstrates companies – both large and small – must be vigilant about food safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.  “We rely every day on food processors and handlers to meet the high standards required to keep our food free of harmful contamination.”

In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Peter Pan and private label peanut butter produced and shipped from the company’s Sylvester, Georgia, peanut butter plant.  The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004.  The CDC eventually identified more than 700 cases of salmonellosis linked to the outbreak with illness onset dates beginning in August 2006.  The CDC estimated that thousands of additional related cases went unreported.  The CDC did not identify any deaths related to the outbreak.

The criminal information specifically alleged that on or about Dec. 7, 2006, the company shipped from Georgia to Texas peanut butter that was adulterated, in that it contained salmonella and had been prepared under conditions whereby it may have become contaminated with salmonella.  The company admitted in the plea agreement that samples obtained after the recall showed that peanut butter made at the Sylvester plant on nine different dates between Aug. 4, 2006, and Jan. 29, 2007, was contaminated with salmonella.  Environmental testing conducted after the recall identified the same strain of salmonella in at least nine locations throughout the Sylvester plant.

“Consumers are at the mercy of food merchants when it comes to the wholesomeness and healthiness of the food we consume and, as the result, a great responsibility is imposed by law on those merchants and manufacturers,” said U.S. Attorney G. F. “Pete” Peterman III for the Middle District of Georgia.  “Likewise, agriculture is Georgia’s largest industry and peanuts and peanut products are a major factor in the health of that industry.  While ConAgra did take corrective action eventually, by failing to timely recognize and rectify the problem of salmonella contamination, this company damaged the health of both public consumers and of the agricultural industry overall.  I commend my staff, that of the Consumer Protection Branch of the Civil Division of the U.S. Department of Justice, and the investigators of the FDA, for the excellent work by all in bringing this incident to this conclusion and I hope that it will serve as a reminder to others in the industry of the high cost of failing to protect the public that relies on them to properly meet this responsibility.”

As part of the plea agreement, the company admitted that it had previously been aware of some risk of salmonella contamination in peanut butter.  On two dates in October 2004, routine testing at the Sylvester plant revealed what later was confirmed to be salmonella in samples of finished peanut butter.  Company employees attempting to locate the cause of the contamination identified several potential contributing factors, including an old peanut roaster that was not uniformly heating raw peanuts, a storm-damaged sugar silo, and a leaky roof that allowed moisture into the plant and airflow that could allow potential contaminants to move around the plant.  As stated in the plea agreement, while efforts to address some of these issues had occurred or were underway, the company did not fully correct these conditions until after the 2006 through 2007 outbreak.  In public statements after the 2007 recall, company officials hypothesized that moisture entered the production process and enabled the growth of salmonella present in the raw peanuts or peanut dust.

The company also admitted in the plea agreement that between October 2004 and February 2007, employees charged with analyzing finished product tests at the Sylvester plant failed to detect salmonella in the peanut butter, and that the company was unaware some of the employees did not know how to properly interpret the results of the tests.

“Product safety has to be a high priority for every manufacturer of foods sold in the United States” says Stephen M. Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at the FDA. “FDA is working with food producers to promote compliance with food safety requirements, but if problems occur and are willfully ignored, we will use all available resources to protect American consumers from unsafe food.”

Following the outbreak and shutdown, the company made significant upgrades to the Sylvester plant to address conditions the company identified after the 2004 incident as potential factors that could contribute to salmonella contamination.  The company also instituted new and enhanced safety protocols and procedures regarding manufacturing, testing and sanitation, which it affirmed in the plea agreement it would continue to follow.

The case was prosecuted by the U.S. Attorney’s Office of the Middle District of Georgia and the Civil Division’s Consumer Protection Branch.  This matter was investigated by the FDA’s Office of Criminal Investigations.

If the Smooties do not get you, the employee will!

Anyone who ate at the Tropical Smoothie Café in Gainesville beween July 28 and Aug. 18 may have been exposed to hepatitis A, according to the Prince William Health Department.

An employee of the restaurant at 8069 Stonewall Shops Square was diagnosed this week with the virus.

The case is apart of an ongoing investigation into a cluster of hepatitis A cases associated with smoothies from Tropical Smoothie Café restaurants in Virginia.

Anyone who ate or drank anything from the Tropical Smoothie in Gainesville between Aug. 12-13 and Aug. 15-18 may have been exposed and could benefit from a vaccine or immune globulin to prevent hepatitis A. The medication is effective within two weeks of exposure.

Sound familiar?  Read on:

Editor’s Note: This opinion piece by Bill Marler was first published in the Honolulu Star-Advertiser on Aug. 7.

In a state dependent on tourism, foodservice workers should be vaccinated against Hepatitis A.

My bet is Baskins-Robbins, Sushi Shiono, Taco Bell, Costco, Chili’s, Hawaiian Airlines and Tamashiro Market would now agree.

According to the Hawaii Department of Health (HDOH), employees at Baskins-Robbins, Sushi Shiono, Taco Bell, Costco, Chili’s, Hawaiian Airlines and Tamashiro Market have been diagnosed with Hepatitis A. These restaurants and airline are NOT the source of the 135 people sickened with the as-yet-unsolved outbreak sweeping the island of Oahu — they are seven of the victims., because those foodservice workers worked while likely contagious, the HDOH is urging “all persons who have consumed food or drink products from these businesses during the identified dates of service should contact their healthcare provider for advice and possible preventive care” – a Hepatitis A vaccine.

Hepatitis A is a communicable disease that spreads from person-to-person. It is spread almost exclusively through fecal-oral contact, generally from person-to-person, or via contaminated food or water. Hepatitis A is the only foodborne illness that is preventable with vaccination.

The Centers for Disease Control and Prevention estimates that 83,000 cases of Hepatitis A occur in the United States every year, and that many of these cases are related to food-borne transmission. In 1999, more than 10,000 people were hospitalized due to Hepatitis A infection, and 83 people died.

As more children have been vaccinated for Hepatitis A as part of routine vaccination programs, those overall numbers have fallen. However, hardly a month passes without a warning from a health department somewhere that an infected food handler is the source of yet another potential Hepatitis A outbreak. Absent vaccinations of food handlers, combined with an effective and rigorous hand-washing policy, there will continue to be more Hepatitis A scares and outbreaks. And, in a state like Hawaii that is dependent on tourism, the impact can be even more concerning.

Although CDC has not yet called for mandatory vaccination of foodservice workers, it has repeatedly pointed out that the consumption of worker-contaminated food is a major cause of foodborne illness in the U.S.

Vaccinations cost about $50 per person. The major economic excuse for these preventive shots not being given is the high turnover rate of foodservice employees.

According to CDC, the costs associated with Hepatitis A are substantial. Between 11 percent and 22 percent of people who have Hepatitis A require hospitalization. Adults who become ill lose an average of 27 days of work. Health departments incur substantial costs in providing post-exposure vaccines to an average of 11 contacts per case. Average costs – direct and indirect – of Hepatitis A range from $1,817 to $2,459 per case for adults and from $433 to $1,492 per case for children younger than 18. A CDC report shows that, in 2010, slightly more than 10 percent of people between ages 19 and 49 got a Hepatitis A shot.

If the foodservice industry will not step up to protect its customers and itself, it is time for health departments to require vaccinations of foodservice workers, especially those who serve the very young, the elderly and immune-compromised.

It is moral to protect customers from an illness that can cause serious complications and death. Vaccines also protect businesses from the multimillion-dollar fallout that can result if people become ill or if thousands are forced to stand in line to be vaccinated to prevent a more serious problem.

Vaccinating employees make sense — especially in a state so dependent on tourism. It is time to step up.

Data Sharing Plan Will Promote Transparency for Consumers and Further Improve Food Safety at Meat and Poultry Facilities

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced that it will soon begin sharing new levels of food safety data specific to slaughter and processing facilities in the United States, on The agency has detailed its framework for releasing this data in its Establishment-Specific Data Release Plan, which the agency anticipates will allow consumers to make more informed choices, motivate individual establishments to improve performance, and lead to industry-wide improvements in food safety by providing better insights into strengths and weaknesses of different practices.

“FSIS’ food safety inspectors collect vast amounts of data at food producing facilities every day, which we analyze on an ongoing basis to detect emerging public health risks and create better policies to prevent foodborne illness,” said USDA Deputy Under Secretary for Food Safety Al Almanza. “Consumers want more information about the foods they are purchasing, and sharing these details can give them better insight into food production and inspection, and help them make informed purchasing decisions.”

FSIS employs roughly 7,500 food safety inspectors who work in more than 6,000 meat, poultry and processed egg facilities across the country and more than 120 ports of entry every day. Over the past seven years, the agency has taken an increasingly data-driven approach to identifying and preventing food safety concerns, and the data these men and women collect in regulated facilities every day have made it possible for FSIS to implement significant food safety changes since 2009. More information about these efforts to modernize food safety inspection can be found at Between 2009 and 2015, this work led to a 12 percent drop in foodborne illness associated with FSIS-regulated products.

The new datasets will begin to publish on on a quarterly basis starting 90 days after publication in the Federal Register. Initially, FSIS will share information on the processes used at each facility, giving more detail than is currently listed in the searchable establishment directory, as well as a code for each facility that will make it easier to sort and combine future datasets by facility. Additionally, FSIS will release results for Listeria monocytogenes (Lm) and Salmonella in ready-to-eat (RTE) products and processed egg products.

On a quarterly basis, FSIS will then begin to share other datasets, including results for Shiga Toxin-producing Escherichia coli(STEC) and Salmonella in raw, non-intact beef products; results for Salmonella and Campylobacter in young chickens and young turkeys, comminuted poultry, and chicken parts; routine chemical residue testing data in meat and poultry products; and advanced meat recovery testing data.

Criteria such as data availability and possible impact on public health will be considered by FSIS to determine which datasets are best suited for future public release. User guides that provide context to the data will be included with each dataset.

“This plan is another step toward better engagement with our stakeholders and they will now have quality information on an ongoing basis,” stated USDA Deputy Under Secretary for Food Safety Al Almanza.

The Establishment-Specific Data Release Plan was developed in response to the President Obama’s call for increased data sharing and greater transparency under the Open Government Plan by the Office of Management and Budget (OMB). Beginning in 2010, FSIS consulted with various stakeholder groups, including the National Advisory Committee on Meat and Poultry Inspection Subcommittee on Data Collection, Analysis, and Transparency and the National Research Council on this issue. With the expertise of these organizations, FSIS developed its plan that will not only provide consumers with the opportunity to make more informed choices, but make data publicly available that could yield valuable insights that go beyond the regulatory uses for which the data were collected.

Over the past seven years, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has instituted some of the most significant updates to our country’s food safety system since the 1950s, leading to a 12 percent drop in foodborne illness associated with meat, poultry and processed egg products from 2009 to 2015. Throughout July, at the height of summer grilling season, USDA will be highlighting these changes, introducing Americans to the men and women who are enacting them, and demonstrating the positive impacts for public health.

“The United States has the strongest food safety system in the world, and over the past seven years it has grown even stronger. We’re better now at keeping unsafe food out of commerce, whether it’s made unsafe because of dangerous bacteria, or because of an allergen, like peanuts or wheat,” said Agriculture Secretary Tom Vilsack. “Over the course of this Administration, we have tightened our regulatory requirements for the meat and poultry industry, enhanced consumer engagement around safe food handling practices, and made smart changes to our own operations, ultimately moving the needle on the number of foodborne illness cases attributed to products that we regulate.”

USDA has a role to play in ensuring the safety of virtually all foods produced and eaten in America, but its most direct responsibility is through FSIS, the public health agency charged with ensuring America’s supply of meat, poultry and processed egg products is safe, wholesome, and correctly labeled and packaged. Through its Agricultural Marketing Service and research agencies, however, USDA is also working to help America’s fruit, vegetable and grain producers comply with the landmark Food Safety Modernization Act (FSMA), and is making groundbreaking discoveries that can lead to safer food production methods.

USDA’s modernization efforts are bringing down the number of foodborne illnesses in USDA-regulated products. Advanced testing methods, greater focus on mislabeling, and more rigorous scientific processes are building a stronger overall safety net to detect pathogens and mislabeled product before they reach consumers.

Here are five of the top food safety changes FSIS has made since 2009:

1.  Prohibiting STECs: In the 1990’s, USDA took historic action by declaring that beef contaminated with shiga-toxin producing E. coli O157:H7 was adulterated and therefore illegal to be sold in America. Prior to this Administration, other strains of shiga-toxin producing E. coli, or STECs, were considered to be a rare public health concern and therefore were not given the same illegal and unsafe status as O157:H7. In 2011, armed with new information about the prevalence of other STECs from our partners at the Centers for Disease Control and Prevention, USDA established a zero tolerance policy for raw beef products that contain E. coli O26, O103, O45, O111, O121 and O145, collectively known as the “Big Six” strains of STEC.

2.  Labeling Mechanically Tenderized Meat: Beginning this summer, USDA is requiring meat companies to disclose on packages of beef steak and other whole cuts if a product has been “mechanically tenderized,” meaning the meat was pierced with needles or small blades to break up tissue and make it tenderer. The blades or needles can introduce pathogens from the surface of the beef to the interior, making proper cooking very important. However, mechanically tenderized products look no different than meat that has not been treated this way, so without disclosure on the label, consumers may not know about this higher food safety risk. Home cooks, restaurants and other food service facilities now have more information about the products they are buying, as well as useful cooking instructions so they know how to safely prepare them.

3.  Targeting Commonly Purchased Items: In February 2016, FSIS finalized the first-ever pathogen reduction standards for poultry parts, like breasts and wings. FSIS implemented performance standards for whole chickens in 1996 but has since learned that Salmonella levels increase as chicken is further processed into parts. Poultry parts like represent 80 percent of the chicken available for Americans to purchase. By creating a standard for chicken parts, and by performing regulatory testing at a point closer to the final product, FSIS can greatly reduce consumer exposure to Salmonella and Campylobacter. These new standards are expected to prevent 50,000 cases of foodborne illness annually.

4.  Modernizing Poultry Food Safety Inspections: In August 2014, USDA finalized the most significant update to poultry food safety inspections since 1957, requiring for the first time ever that that all poultry facilities create a plan to prevent contamination with Salmonella and Campylobacter, rather than addressing contamination after it occurs. Under this update, poultry companies now have to collect samples at two points on their production line and have them tested to show control of enteric pathogens, which is done in addition to USDA’s own improved testing strategy in poultry plants. This same update introduced the New Poultry Inspection System, a science-based inspection system that, while optional for poultry companies, positions food safety inspectors in a smarter way so that they can have maximum food safety oversight.

5.  Testing and Holding Policy: In 2012, USDA began requiring meat and poultry companies to hold all product that is undergoing laboratory analysis until the agency’s microbial and chemical tests for harmful hazards are fully complete. This “test and hold” policy will significantly reduce consumer exposure to unsafe meat products, and it could have prevented 44 recalls of unsafe foods between 2007 and 2009 if it had been in place at the time.

Today, USDA published  Chapter Seven: Safer Food and Greater Consumer Confidence to its year-long USDA Results project on The latest chapter includes audio testimony from USDA food safety stakeholders, information about scientific breakthroughs such as a process to remove allergens from peanuts, and more.

June 8, 2016
John Mackey, Co-Chief Executive Officer
Walter Robb, Co-Chief Executive Officer
Whole Foods Markets Inc.
550 Bowie Street
Austin, TX 78703
Dear Mr. Mackey & Mr. Robb:
The U.S. Food and Drug Administration (FDA) inspected your multiple food manufacturing facility, Whole Foods Market North Atlantic Kitchen, 9 Commercial St, Suite 300, Everett, MA 02149-5506, on February 10, 11, 16, 18, & 26, 2016. The inspection found serious violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code(U.S.C.) § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page at
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, issued to Mr. Brian Corbley, Facility Team Leader at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
1.    Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 21 CFR 110.80(b)(2). Specifically, we observed:
  • On February 10, 2016, you were mixing ready to eat pesto pasta directly under an area in the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
  • On February 16, 2016, you were storing an uncovered rack of ready to eat mushroom quesadilla in the same area of the Assembly Room where condensate from ceiling joints was dripping onto the surface below.
  • On February 10, 2016, your employee transported uncovered ready to eat vegetables through a doorway, from the Veg Prep Room into the Prepared Veg Cooler. A significant amount of condensate had formed above the doorway and was dripping onto the surface below.
  • On February 10, 2016, your employee was cutting chives and beets on a work surface directly underneath a leaking condensate drainage pipe in the Veg Prep Room.
  • On February 16, 2016, you were holding uncovered ready to eat egg salad in large white barrels that were placed in an area below the condenser. Condensate was observed to be dripping at a rate of approximately once per second from the condenser fan bolts in the K8/K9 Room.
  • On February 16, 2016, your employee transported uncovered ready to eat couscous through an area in the K8/K9 Room where condensate was dripping from an area around the condenser fan bolts at a rate of approximately once per second.
  • On February 10, 16, & 18, 2016, you were holding ready to eat vegetables, utensils such as cutting boards, mandolins, stainless colanders and yellow plastic totes in close proximity to hand a washing station in the Veg Prep Room. The hand washing station does not have splash guards and is foot operated releasing water from the faucets with significant pressure causing water to splash outside the sink while employees were observed washing soiled hands. Water splashed onto covered and uncovered ready to eat vegetables, utensils and food containers.
  • On February 16, 2016, your employee measured the strength of peracetic acid from the faucet in the Veg Prep Room with an (b)(4) Peracetic Acid test strip that indicated its strength over 160 ppm (maximum level on the test strip). This concentration exceeds the maximum level recommended by the (b)(4) product information sheet and the maximum level allowed under 21 CFR Part 173.315(a) (5) for use of peracetic acid for surface treatment and soaking and rinsing of vegetables.
  • On February 16, 2016, your employee was performing multiple tasks in the Pre-Pack Room including filling and weighing ready to eat egg salad in retail packs. The employee was observed cleaning and directly contacting work surfaces and then packaging and handling exposed product without hand washing or changing gloves in between tasks.
  • On February 16, 2016, your employee in the Bulk-Pack Room was observed assembling bulk cartons while also packaging exposed ready to eat quinoa cakes without hand washing or changing gloves in between tasks.
  • On February 16, 2016, your employee in the Pre-Pack Room was spraying (b)(4) quaternary ammonium based sanitizer to clean work surfaces while another employee in close proximity was packaging exposed ready to eat mesculin salad. This resulted in the sanitizer being sprayed onto an open colander of salad leafy greens.
  • On February 16, 2016, your employee’s unprotected upper sleeves were frequently touching ready to eat leafy salad greens as leafy salad greens were packaged into retail packs in the Pre-Pack Room.
2.    Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing as required by 21 CFR 110.80(b)(1). Specifically, on February 10, 2016 we collected an environmental sample (INV 911932), which consisted of one hundred (100) swabs/subs, from food contact and non-food contact surfaces throughout your manufacturing facility. FDA laboratory analysis of these subs confirmed the presence of non-pathogenic bacteria Listeria welshimeri in swab #39. Swab #39 was collected from the internal rotating drum portion, a food contact surface, of the (b)(4) vegetable chopping machine located in the Veg Prep Room. The presence of Listeria spp., such as the non-pathogenic Listeria welshimeri, detected on a food contact surface in your manufacturing facility is specifically used as an indicator for the probable presence of Listeria monocytogenes in your processing environment. This finding demonstrates that conditions exist in and on your equipment that would support the presence and growth of Listeria monocytogenes and indicates that your cleaning and sanitation practices may not be adequate. Your firm should consider improving your environmental monitoring program to verify the adequacy of your cleaning and sanitation operation.
3.    Your firm failed to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned as required by21 CFR 110.35(d)(1). Specifically,
  • On February 16, 2016, you filled the dip tank for soaking sheet pans (used for raw meats and ready to eat in process and finished products) with a quaternary ammonium based sanitizing agent. You measured the sanitizer strength using a color based test strip which indicated the sanitizer strength at 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
  • On February 16, 2016, you measured the sanitizer strength on the spray nozzle located in the dish washing room that is used for filling the dip tank and for sanitizing larger portable equipment such as the rotating blades of (b)(4) machine and Ribbon Blender parts. The color based test strip indicated the sanitizer strength to be 100ppm. This strength is not adequate for sanitizing foodcontact surfaces and the manufacturer recommended limit of the sanitizing product you were using was identified as 200-400ppm.
  • On February 16, 2016, you did not clean and sanitize the semi-permanent divider curtain in the K8/K9 Room after using a high pressure spray hose to clean and sanitize the ribbon blender and the walls and floors surrounding the ribbon blender.
  • On February 10, 2016, you were storing various utensils and equipment parts inside containers and on rolling carts that had pooling water in or on them.
4.    Your firm failed to take proper precautions to protect food and food-contact surfaces from contamination with chemicals, filth and extraneous materials due to deficiencies in plant design as required by21 CFR 110.20(b)(2). Specifically, we observed:
  • You failed to keep soiled dishes separate from ready to eat products and you are using portable divider curtains and semi-permanent divider curtains to segregate areas between the dishwashing room entrance/exit doors and the Assembly Room where ready to eat products are assembled. Soiled and insanitary equipment from various preparation processes including holding of raw chicken and turkey were observed touching both sides of the portable divider curtains.
  • On February 10 & 16, 2016, your employees in the K8/K9 Room used high pressure hoses to clean the ribbon blender and the semi-permanent divider curtains, causing water and aerosolized spray from the cleaning activity to go beyond the portable divider curtains and the semi-permanent divider curtains into areas where ready to eat food such as couscous and salad dressings were being prepared.  The portable and semi- permanent divider curtains did not provide adequate protection of ready to eat food when high pressure hoses are used to clean and sanitize clean-in-place equipment and the portable and semi-permanent divider curtains.
  • On February 10 & 16, 2016, soiled/unclean equipment , utensils and food containers had accumulated beyond the entrance of the dish washing room and portable divider curtains separating the dish washing room and the Assembly Area. This resulted in soiled/unclean equipment, utensils and food containers to be held for an indefinite period of time in close proximity to ready to eat manufacturing activities such as making of enchiladas, mixing of pesto pasta and quesadillas.
5.    Your firm’s hand-washing facilities lack running water of a suitable temperature as required by 21 CFR 110.37(e). Specifically, on February 16, 2016 the hand washing station located at the entrance of the K8/K9 Room did not have warm/hot water. Your employees returning from break and other non-food related tasks continued to use this tagged “out of service, no hot water, 2/16/16” hand washing sink before returning to preparing and handling ready to eat foods.
6.    Your firm failed to properly identify toxic sanitizing agents in a manner that protects against contamination of food as required by 21 CFR 110.35(b)(2). Specifically, we observed an unmarked drum of an unidentified chemical that was connected to the vegetable preparation sink in the Veg Prep Room. It was verbally identified as peracetic acid to be used to soak vegetables.
The above is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure your establishment is in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective actions may subject your firm and products to further actions, such as injunction, or seizure.
Further, Section 743 of the Act, 21 U.S.C. § 379j-31, authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
We acknowledge receipt of your March 17, 2016 written response to the FDA Form-483 Inspectional Observations, issued to your firm on February 26, 2016. This response states that your firm takes these observations seriously and that your senior leadership is committed to take all the necessary measures to correct all the deficiencies. Despite this, FDA has serious concerns that our investigators found your firm operating under these conditions. Further, your response includes retraining of employees as a corrective action for most of the observed violations but you failed to mention adequate supervision over your specialized food processing operations and how retraining will ensure sustained compliance. We do not consider your response acceptable because you failed to provide documentation for our review, which demonstrates that all your noted corrective actions have been effectively implemented. This documentation may include photographs, invoices, work orders, voluntary destruction records of any affected products, certification of actions performed by contractors, and/or any other useful information that would assist us in evaluating your corrections.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at
Joseph Matrisciano Jr.
District Director
New England District

A new USDA analysis of the Food and Drug Administration’s (FDA) import refusals report reveals that from 2005 to 2013 the FDA rejected nearly 18,000 imported seafood shipments because they were unfit for human consumption.

According to the FDA, these shipments were refused entry into the United States for containing unsafe levels of “filth,” veterinary drug residues and Salmonella, which is responsible for thousand hospitalizations per year and hundreds of deaths. “Filth” is a catchall term used to describe anything that shouldn’t be in food—like rat feces, parasites, illegal antibiotics and glass shards.

The USDA summarized their findings by saying: “The safety of imported seafood clearly continues to be of significant concern, based on the number of shipments refused by FDA.”

Currently, the majority of all food refusals are seafood products; while the FDA is responsible for ensuring the safety of any food imported from foreign countries, they only have the manpower to inspect less than 1 per cent of the 1.2 billion pounds of shrimp entering into the country each year.

The American Shrimp Processors Association (ASPA), a group representing the US Gulf and Southeast Atlantic Coast shrimp fishing industry, has expressed great concern over the findings.

ASPA President Dr. David Veal pointed out: “This issue goes beyond the FDA; I don’t think it’s unreasonable to expect food suppliers to take some responsibility for the health and safety of their products. We hope shrimp exporters will take a more proactive role in assuring that suppliers adhere to laws designed to protect the people who buy their products.”

Shrimp is the most popular seafood in the United States, with the average person consuming more than four pounds of shrimp per year. Worryingly, 90 per cent, or 3.6 of those pounds, will be imports from countries like China, Indonesia and Thailand, who routinely distribute shrimp that the FDA ends up refusing.

According to the report, Indonesia and Thailand account for about a fifth of shrimp refusals, and they are also two of the largest exporters of shrimp to the United States.

Moreover, while the report contains information through 2013, in more recent years other countries like India have greatly increased the amount of shrimp they export; in 2015, 297 million pounds of Indian shrimp was turned away.

While information is unavailable on the total number of FDA seafood inspections performed yearly, it is safe to assume that with the extremely low rates of inspection, Americans are consuming imported shrimp that is fundamentally unfit for consumption.

Given the above, ASDA encourages Americans to purchase wild-caught domestic shrimp, which has demonstrably fewer bacterial and chemical contaminants, and is an important historic industry supporting millions of jobs in the country.

madcowThe U.S. Food and Drug Administration today issued a rule finalizing three previously-issued interim final rules designed to further reduce the potential risk of bovine spongiform encephalopathy (BSE), sometimes referred to as “mad cow disease,” in human food.

The final rule provides definitions for prohibited cattle materials and prohibits their use in human food, dietary supplements, and cosmetics, to address the potential risk of BSE. These materials include:

  • Specified risk materials (SRMs ): brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle.
  • The small intestine from all cattle unless the distal ileum has been properly removed,
  • Material from nonambulatory disabled cattle,
  • Material from cattle not inspected and passed, or mechanically separated (MS) (Beef).

The rule additionally confirms that milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, and tallow derivatives are not prohibited cattle materials. The FDA also finalized the process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics.

Finally, the rule provides a definition of gelatin and clarifies that gelatin is not considered a prohibited cattle material if it is manufactured using the customary industry processes specified. Gelatin was never considered a prohibited cattle material, but FDA had never specifically defined gelatin in past IFRs.

The FDA is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. It is important to note that the U.S. has long had measures in place to prevent the introduction and spread of BSE, including those affirmed in this rule; therefore the risk of human exposure to the BSE agent from FDA-regulated human food and cosmetics is negligible.

This rule finalizes three interim rules from 20042005, and 2008.

New Standards to Help Prevent an Estimated 50,000 Illnesses Annually

WASHINGTON, Feb. 4, 2016 — The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced the finalization of new federal standards to reduce Salmonella and Campylobacter in ground chicken and turkey products, as well as in raw chicken breasts, legs, and wings. Based on scientific risk assessments, FSIS estimates that implementation of these standards will lead to an average of 50,000 prevented illnesses annually.

As part of this move to make chicken and turkey items that Americans frequently purchase safer to eat, FSIS has also updated its microbial testing schedule at poultry facilities and will soon begin posting more information online about individual companies’ food safety performance.

“Over the past seven years, USDA has put in place tighter and more strategic food safety measures than ever before for meat and poultry products. We have made strides in modernizing every aspect of food safety inspection, from company record keeping, to labeling requirements, to the way we perform testing in our labs,” said Agriculture Secretary Tom Vilsack. “These new standards, in combination with greater transparency about poultry companies’ food safety performance and better testing procedures, will help prevent tens of thousands of foodborne illnesses every year, reaching our Healthy People 2020 goals.”

FSIS uses pathogen reduction performance standards to assess the food safety performance of establishments that prepare meat and poultry products. By making the standards for ground poultry tougher to meet, ground poultry products nationwide will have less contamination and therefore result in fewer foodborne illnesses. FSIS implemented performance standards for whole chickens in 1996 but has since learned that Salmonella levels increase as chicken is further processed into parts. Poultry parts like breasts, wings and others represent 80 percent of the chicken available for Americans to purchase. By creating a standard for chicken parts, and by performing regulatory testing at a point closer to the final product, FSIS can greatly reduce consumer exposure to Salmonella and Campylobacter.

“This approach to poultry inspection is based on science, supported by strong data, and will truly improve public health,” said USDA Deputy Under Secretary for Food Safety Al Almanza. “The new performance standards will complement the many other proactive, prevention-based food policies that we’ve put in place in recent years to make America’s supply of meat and poultry safer to eat.”

For chicken parts, ground chicken, and ground turkey, FSIS is finalizing a pathogen reduction performance standard designed to achieve at least a 30 percent reduction in illnesses from Salmonella. For chicken parts and ground chicken, FSIS is finalizing a pathogen reduction performance standard designed to achieve at least a 32 percent reduction in illnesses from Campylobacter. Because FSIS has found the prevalence for Campylobacter in ground turkey to be already low, the reduction for this product is estimated to be 19 percent.

After these standards were proposed in early 2015, FSIS began to use routine sampling throughout the year rather than infrequent sampling on consecutive days to assess whether establishments’ processes are effectively addressing Salmonella and Campylobacter. Once establishments have completed a full set of testing under the new standards, the agency will also begin posting online which facilities pass, meet or fail the new standards.

An estimated 1.2 million foodborne illnesses are thought to be caused every year by Salmonella, with approximately one-third or 360,000 of those illnesses attributed to FSIS-regulated products. In 2013, the agency released a Salmonella Action Plan, which created a blueprint for the agency to address this pathogen of significant public health concern. Today’s announcement fulfills the major steps that FSIS had outlined in its plan.

Over the past six years, USDA has collaborated extensively with other federal partners to safeguard America’s food supply, prevent foodborne illnesses and improve consumers’ knowledge about the food they eat. USDA’s FSIS is working to strengthen federal food safety efforts and develop strategies that emphasize a three-dimensional approach to prevent foodborne illness: prioritizing prevention; strengthening surveillance and enforcement; and improving response and recovery.

Some of the other steps taken to improve the safety of meat and poultry include adopting a zero-tolerance policy for raw beef products containing six additional strains of shiga-toxin producing E. coli; ensuring that beef products that have been mechanically tenderized are labeled as such and include validated cooking instructions; implementing a new “test and hold” policy in 2012, which significantly reduces consumer exposure to unsafe meat products; and working closely with FDA and CDC to collectively form the Interagency Food Safety Analytics Collaboration (IFSAC), which focuses on projects related to foodborne illness source attribution and will try to improve the classification of foods implicated in foodborne disease outbreaks.

Really, not a question that you want to be asked or to answer.

CBS News just reported that the Department of Justice has started an investigation into Blue Bell after their ice cream was linked to a deadly Listeria outbreak earlier this year that killed three people. Sources told CBS News that the Department of Justice is trying to determine what Blue Bell management knew about potentially deadly hazards in their plants, and when they knew it.

622x350-300x200Last May I wrote, “Paul Kruse, President and CEO of Blue Bell Ice Cream – My Advice, Get a Good Criminal Lawyer.” Seems like I was on the money.

After watching the Blue Bell Listeria Outbreak unfold over the last months – especially after reading the FDA’s 483’s, I think it is time for the President and CEO of Blue Bell to consult with criminal counsel.  True, perhaps he did not know that his Broken Arrow Plant had Listeria positives going back over years, but knowledge is not necessary for the FDA and a US Attorney to prosecute – just ask the Jensens and DeCosters.

Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

The legal jargon aside, if you are a producer of food and knowingly or not sell adulterated food, you can (and should) face fines and jail time.  Mr. Kruse, I know you are a lawyer, but you should get another one.

The inspection observations of the most recent completed FDA inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Okla., and Sylacauga, Ala. are available:

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced a new measure that will improve the agency’s ability to determine the source of foodborne illnesses linked to ground beef, stopping foodborne illness outbreaks sooner when they occur.  Based on lessons learned from previous outbreak investigations, FSIS is requiring that all makers of raw ground beef products keep adequate records of the source material, so that the agency can quickly work with the suppliers to recall contaminated product.

Outbreak investigations can be hindered when retail stores produce ground beef by mixing product from various sources but fail to keep clear records that would allow investigators to determine which supplier produced the unsafe product. This new requirement complements expedited traceback and traceforward procedures announced in August 2014 that enhance the agency’s ability to quickly and broadly investigate food safety breakdowns in the event of an outbreak connected to ground beef.

“This is a common-sense step that can prevent foodborne illness and increase consumer confidence when they purchase ground beef,” said Deputy Under Secretary for Food Safety Al Almanza. “In the event that unsafe product does make it into commerce, these new procedures will give us the information we need to act much more effectively to keep families across the country safe.”

Under the new final rule, FSIS is amending its recordkeeping regulations to require that all official establishments and retail stores that grind raw beef products maintain the following records: the establishment numbers of establishments supplying material used to prepare each lot of raw ground beef product; all supplier lot numbers and production dates; the names of the supplied materials, including beef components and any materials carried over from one production lot to the next; the date and time each lot of raw ground beef product is produced; and the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized. These requirements also apply to raw beef products that are ground at an individual customer’s request when new source materials are used.

“The traceback mechanism provided for in this final rule will facilitate recall efforts that could stop outbreaks and prevent additional foodborne illnesses,” said Deputy Under Secretary for Food Safety Brian Ronholm. “USDA is committed to providing resources and assistance to makers of ground beef to ensure they can be a part of this important and essential new public health measure.”

Retail stores regularly produce raw ground beef for consumer sales by mixing cuts of beef from various sources. A 2011 Salmonella outbreak in Maine and parts of the northeastern region of the United States resulted in illnesses that could have been prevented if establishments had kept records of suppliers on file. As a result of this outbreak, on July 22, 2014, FSIS published a proposed rule (79 FR 42464) to require official establishments and retail stores to maintain records of their suppliers and source materials received. After receiving and considering comments, FSIS is announcing this final recordkeeping rule that ensures that public health officials have the ability to quickly search records to identify the exact source of the raw beef products during outbreak investigations.

The final rule can be viewed at: