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New Study by USDA, FDA Aims to Enhance Food Safety in Retail Delis – Risk Assessment Targets Listeria monocytogenes (Lm)

Posted By Bruce Clark on May 10, 2013

To help minimize the public health burden of listeriosis, USDA’s Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) have conducted a major study to better understand the risk of foodborne illness associated with eating certain foods prepared in retail delicatessens and developed recommendations for changes in current practices that may improve the safety of those products.

The study, a quantitative risk assessment, provides a scientific evaluation of the risk of listeriosis associated with consumption of meats, cheeses and other ready-to-eat foods prepared in retail delis. It also examines interventions that limit the survival, growth or transmission of Listeria monocytogenes (Lm), the bacteria that causes listeriosis.

Control of Lm has long been an objective of the public health community. The Centers for Disease Control and Prevention estimates that infections with Lm cause about 1,600 illnesses, 1,500 hospitalizations and 260 deaths in the United States each year. Listeriosis is rare, but its fatality rate is very high (i.e., about 16 percent, compared with 0.5 percent for either Salmonella or E. coli O157:H7). It primarily affects older adults, pregnant women, newborns and adults with weakened immune systems.

“The risk assessment will be a tremendous asset in our efforts to reduce the 1,600 illnesses and 260 deaths attributed to this pathogen annually,” USDA Under Secretary for Food Safety Dr. Elisabeth Hagen said. “Essential information has been gained from these findings, including the fact that once Lm enters a retail environment, it has the potential to spread due to cross contamination. This assessment highlights the importance of our work to prevent Lm from entering the retail environment in the first place, and provides a significant tool towards this effort to protect consumers and prevent foodborne illness.”

The U.S.-focused study is the first of its kind. It quantitatively links retail deli practices to predicted public health outcomes, which has never been done before. The study is based on observations of deli employees’ work routines; concentrations of Lm on incoming products and in the deli environment; simulations of the bacteria’s transmission, such as from slicer to food; and dose-response modeling. The study was designed to apply to a range of deli establishments, from small independent operations to the deli departments in large supermarkets.

The study also reinforces the importance of FDA’s Food Code recommendations to operators of retail delis. State, local and tribal jurisdictions can do their part to reduce listeriosis by enforcing all relevant provisions of the Food Code as part of their own food safety requirements.

No single intervention will put an end to Lm in food sold at retail delis, the study found. Instead, there are many steps that retail deli operators and their suppliers can take to help reduce listeriosis. The study’s key findings include:

  • Storage temperature. If all refrigerated, ready-to-eat foods are stored at 41 degrees Fahrenheit or below, as the FDA Food Code recommends, at least 9 of every 100 cases of listeriosis caused by contaminated deli products could be prevented.
  • Growth inhibitors. If all deli products that support Lm growth were reformulated to include growth inhibitor, 96 of every 100 cases of listeriosis caused by contaminated deli products could be prevented. While this finding is significant, the actual benefit may be smaller in part because growth inhibitor may be used in concentrations not effective throughout the shelf life of a food, and it can affect the flavor.
  • Cross contamination. The predicted risk of listeriosis dramatically increases in retail delis as a result of cross contamination, with slicers remaining a particular challenge. Cross contamination is particularly difficult to eliminate, but the study shows proper cleaning and personal hygiene makes a difference.
  • Contamination of Incoming Product. If current levels of Lm in ready-to-eat foods received by the retail deli from processing establishments were reduced by half, 22 of every 100 cases of listeriosis caused by contaminated deli products could be prevented. This finding suggests that continued efforts to prevent low levels of Lm contamination during processing, even on products that do not support growth of the pathogen, reduces the risk from these products and other ready-to-eat foods that can be subsequently cross contaminated in the retail delicatessens.

FDA and FSIS have taken many steps to enhance retail food safety in an effort to reduce listeriosis and other foodborne illnesses. For instance, since its initial release in 1993, the FDA Food Code has been revised to target Lm prevention, including more stringent temperature controls for refrigerated foods and limits on how long such foods can be retained after opening or preparation.

In addition, FDA has created educational materials in recent years to support foodservice operators, including guidance on how to keep deli slicers properly cleaned and sanitized, a handbook on employee health and personal hygiene, food-safety posters in nine languages, and video testimonials designed as training aids. FSIS is planning to provide outreach materials to retailers where ready-to-eat meat and poultry products are sliced, prepared, or packaged for consumption in the home. These materials will highlight risky practices based on the results of the interagency risk assessment and help retail establishments to adopt best practices that could decrease the potential for Lm growth or cross contamination.

Consumers, too, have a role to play in reducing listeriosis. For advice on keeping refrigerated foods cold, cleaning one’s refrigerator regularly, and cleaning hands and kitchen surfaces often, visit foodsafety.gov. To further minimize any risk of listeriosis, FDA and FSIS recommend that older adults, pregnant women and adults with weakened immune systems reheat hot dogs and lunchmeats until steaming hot.

The study was published today and can be read in its entirety on either the FDA or FSIS web sites. A public meeting to discuss the study and its findings will be held at USDA’s Jefferson Auditorium at 1400 Independence Avenue, Southwest, Washington, D.C., on May 22nd, from 8:15 a.m. to 4:15 p.m. People who plan to attend the meeting are asked to register in advance at FSIS’ website.

Class Action Lawsuit to be filed against West Village Restaurant Linked to Hepatitis A Scare

Posted By Bill Marler on April 10, 2013

Marler Clark, the nation’s leading law firm representing victims of foodborne illness outbreaks, and Underberg & Kessler filed a class action lawsuit today against Alta Restaurant.  The lawsuit was filed in New York County Superior Court on behalf of named plaintiff Michael Piacente and other restaurant patrons who received hepatitis A vaccinations after alleged exposure to the hepatitis A virus at Alta Restaurant between March 23 and April 2, 2013.

On April 5, the New York City Department of Health and Mental Hygiene advised Alta Restaurant patrons who had eaten dessert purchased from the restaurant between March 23 and April 2, 2013 to seek vaccination against hepatitis A, a communicable disease that is often transmitted through food-contamination.  According to multiple news reports, a pastry chef who works at the restaurant had recently returned from Mexico and contracted the virus.  Because symptoms of infection do not appear for roughly 2 weeks after exposure, the Alta Restaurant worker prepared food while infectious, but before exhibiting symptoms illness, which include jaundice (yellowing of the skin and eyes) and fatigue.

The Health Department encouraged Alta Restaurant customers to contact a healthcare provider for vaccination or to visit one of three vaccination clinics the public health agency offered.  According to the complaint, Michael Piacente obtained the appropriate vaccination against hepatitis A from his private physician.  He also had blood drawn so a sample could be tested for hepatitis A.

“I’ve seen this situation play out time and again,” said William Marler, attorney for the plaintiffs.  “If restaurants would require workers to be vaccinated—or better yet, pay for vaccinations—they could go a long way toward preventing these public health scares and the loss of business that naturally goes with them.”

BACKGROUND:  Marler Clark has represented hundreds of people who contracted hepatitis A after eating contaminated food.  The law firm has represented thousands who received hepatitis A vaccine or immune globulin injections to prevent infection.

New York City Health Department Warns Patrons of Alta Restaurant Of Possible Exposure To Hepatitis A

Posted By Bill Marler on April 5, 2013

Anyone Who Ate Dessert at Alta Restaurant (64 W 10th St) Between From March 23 To April 2 Should Get Hepatitis A Vaccine as a Precautionary Measure

Patrons Should See Their Doctor or Visit Health Department Clinic

In response to a case of Hepatitis A in a food handler at Alta restaurant in the West Village, the Health Department today urges patrons who ate dessert at the restaurant between March 23rd and April 2nd to get Hepatitis A vaccination as a precautionary measure. Hepatitis A is spread by putting something in your mouth (even though it might look clean) that has been contaminated with traces of fecal matter from an infected person. Symptoms include jaundice (yellowing of eyes and skin), fatigue, abdominal pain, nausea, and diarrhea.

Any patron who ate dessert at Alta from March 23rd – April 2nd is considered at risk and is recommended to receive a preventive vaccine. The Health Department is working with the restaurant to obtain as many names as possible of people who may have been exposed and will contact each of them directly. Patrons can also call 311 for more information.

The restaurant owners, who are cooperating fully with the Health Department, estimate that about 3,000 people may have visited on these nights with about 15% having eaten dessert. No additional cases of illness have been identified.

People can visit their regular doctor to receive this shot. Pregnant women are urged to consult with their doctor to discuss whether to receive vaccine or a different preventive treatment. The Health Department will also offer free Hepatitis A vaccinations to patrons starting tomorrow at the Chelsea Health Center, 303 Ninth Avenue, 1st Floor in Manhattan at the following times:

Saturday, April 6: 2 p.m. – 6 p.m.

Sunday, April 7: 2 p.m. – 6 p.m.

Monday, April 8: 9 a.m. – 5 p.m.

People who were exposed but have already received two doses of Hepatitis A vaccine sometime in their life do not need another shot; all others should be vaccinated.

“We are asking these restaurant patrons to get this vaccination as a precautionary measure,” said Health Commissioner Dr. Thomas Farley. “If people experience symptoms, they should see a doctor immediately. This incident serves as an important reminder to always wash your hands thoroughly to prevent the spread of disease.”

“We are working closely with the Health Department to ensure the safety of our customers,” said Christopher Chesnutt, owner of Alta restaurant. “This is an isolated incident and the infected employee is no longer on premises.”

About Hepatitis

Hepatitis type A is a liver disease caused by a virus. It is spread from person to person by putting something in the mouth (even though it might look clean) that has been contaminated with traces of fecal matter from an infected person. There are no special medicines or antibiotics that can be used to treat a person once the symptoms appear. While some people who have chronic liver disease or a weakened immune system could experience more severe illness and require hospitalization, hepatitis A is rarely fatal (fewer than 1% of cases).

In order for the vaccine to be most effective, people who have been exposed to Hepatitis A should be vaccinated within 14 days. The earlier the vaccine is given, the more effective it is in preventing the disease.

About the Investigation

The Health Department investigates all cases of Hepatitis A in New York City. The Department was notified of this case on April 4, began the investigation, and inspected the restaurant yesterday. An average of 65 cases of Hepatitis A occur in New York City each year, with 1-2 occurring in food handlers.

Hepatitis A:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Hepatitis A outbreaks. The Hepatitis A lawyers of Marler Clark have represented thousands of victims of Hepatitis A and other foodborne illness outbreaks and have recovered over $600 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Hepatitis A lawyers have litigated Hepatitis A cases stemming from outbreaks traced to a variety of sources, such as green onions, lettuce and restaurant food.  The law firm has brought Hepatitis A lawsuits against such companies as Subway, McDonald’s, Chipotle, Quiznos and Carl’s Jr.

OIG to FSIS: Test more Beef for E. coli

Posted By Bill Marler on March 30, 2013

The Office of Inspector General (OIG) audited Food Safety Inspection Service (FSIS) to determine how effectively the agency was testing boxed beef items that downstream processors used for ground beef production.

Finding 1: FSIS Needs to Ensure that All Components of Ground Beef are Included in the Agency’s E. coli Testing Program

The OIG found that FSIS needs to re-evaluate its E. coli testing methodology, as it relates to the downstream processing of boxed beef products.  FSIS tests product designated as ground beef or likely to become ground beef, but they do not sample all boxed beef product. Some downstream processors grind such boxes of unsampled cuts of beef without sampling it for E. coli prior to grinding.

Finding 2: FSIS Needs to Improve How It Oversees the Grinding of Bench Trim at Retail Exempt Establishments

Similarly, “retail exempt establishments”—grocery stores, butcher shops, etc.— potentially grind their own ground beef; but unlike Federally inspected plants, FSIS does not sample and test bench trim at these establishments for E. coli. FSIS does have a program for periodically testing the final ground beef products at downstream processors and retail exempt establishments before it enters commerce.

Finding 3: FSIS Does Not Sample Tenderized Meat Products for E. coli Testing

FSIS is not testing tenderized meat products for E. coli despite several recent recalls.

Finding 4: FSIS Needs to Ensure PHIS Contains Accurate Data, so that Establishments are Correctly Sampling Beef for E. coli Testing

FSIS has recently transitioned to their new Public Health Information System (PHIS), which relies, in part; on correct profile information to accomplish such tasks as sending inspectors E. coli sampling requests. However, we found some establishments had incorrect profile information, resulting in incorrect requests for sampling. This profile error caused FSIS not to sample one establishment’s “other ground beef components” for over 4 years. However, FSIS did sample the ground product before it left the plant.

Finding 5: FSIS Needs to Ensure Processors Maintain Sufficient Records for Trace Back and Recall Purposes

Lastly, not all plants we reviewed had adequate records for tracing source material back to the originating slaughter establishment. Such information is crucial during a recall.

And, my favorite part (OIG citing sources):

Online Articles and Blogs: We reviewed sources, such as foodsafetynews.com and meatingplace.com, to stay current on relevant industry issues.

See Full OIG Audit and FSIS Response.

Chu Minh Tofu Company loses food-processing license, fined $17,800

Posted By Bill Marler on March 11, 2013

The Washington State Department of Agriculture (WSDA) has revoked the food-processing license of Chu Minh Corp., which produces tofu and other soy products, after several inspections found on-going sanitation problems with the Seattle business.

In addition to revoking the company’s license to process food, WSDA also assessed a civil penalty of $17,800 against the company and required all products at the facility to be destroyed. Notices about the license revocation are being sent to all retail outlets and restaurants that have purchased or carry Chu Minh products.

As a result of these actions, the company cannot process any food at this location. Chu Minh has 10 days to appeal and request agency reconsideration of the order, but it cannot operate as a food processing operation during that appeal period.

This enforcement action follows several visits to Chu Minh where WSDA inspectors consistently found problems with unsanitary conditions, poor sanitation practices by employees, pest infestations and a general failure to protect food products from contamination.

During the most recent inspection on March 6, inspectors noted many of the same problems observed during earlier inspections.

WSDA’s Food Safety and Consumer Services Division typically tries to work with businesses to correct problems when violations of the state food production and handling requirements are discovered. When these education efforts fail to improve conditions, WSDA has the authority to suspend licenses or assess civil penalties.

In this case, WSDA had twice issued orders to suspend Chu Minh Corps.’ processing license. Both times, the company signed settlement agreements in which they promised to meet food-processing requirements. The most recent agreement was in October 2012.

However, the continued violations of food processing standards and the failure to fully pay earlier fines associated with previous violations led to the decision to revoke Chu Minh’s food processing license.

Consumers who purchased Chu Minh products are advised to dispose of them. For questions, contact WSDA’s Food Safety and Consumer Services Division at foodsafety@agr.wa.gov or 800-843-7890.

Parnell Faces 754 Years in Prison for Salmonella Outbreak

Posted By Bill Marler on February 28, 2013

AP reports today that Peanut Corporation of America owner Stewart Parnell, his food broker brother Michael Parnell, Georgia plant manager Samuel Lightsey and Georgia plant quality assurance manager Mary Wilkerson entered pleas of not guilty in Georgia federal court.  Among the various charges are conspiracy, mail fraud, wire fraud and the introduction of adulterated and misbranded food into interstate commerce with the intent to defraud or mislead.  A fifth defendant, Daniel Kilgore, another plant manager, has already plead guilty.

U.S. Magistrate Judge Thomas Langstaff set bond at $100,000 each for the Parnell brothers, $50,000 for Lightsey and $25,000 for Wilkerson. The defendants and their family members, who attended Thursday’s hearing, did not speak to reporters.

Assistant U.S. Attorney Kenneth Dasher told the court that Stewart Parnell faces a maximum 754 years in prison and $17 million in fines if convicted. His brother Michael faces a maximum 437 years and $10 million.

Over 700 people were sickened and nine died as a result of the 2009 Salmonella outbreak and massive recall.

FDA Issues International Food Safety Capacity-Building Plan under the Food Safety Modernization Act

Posted By Bill Marler on February 28, 2013

In 2011, Congress enacted the FDA Food Safety Modernization Act (FSMA), recognizing the unique challenges faced by FDA in the area of food safety in the 21st century. FSMA directs FDA to build a new food safety system based on the public health principle of comprehensive prevention, an enhanced focus on risk-based resource allocation, and partnerships across the public and private sectors to minimize hazards from farm to table.  In addition, Section 305 of FSMA calls on FDA to develop a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments and their respective food industries in countries that export foods to the United States (the “Plan”). This Plan meets the Section 305 requirement, and does so by incorporating FSMA’s principles of comprehensive prevention, risk-based resource allocation, and partnering.

This Plan provides a strategic framework for FDA’s international food safety capacity-building activities. It outlines goals, objectives, and key actions that will provide a framework for the FDA in setting priorities and managing international food safety capacity building programs.

The Plan will also enable all stakeholders to see the breadth of food safety capacity-building efforts on the part of FDA.   It charts a direction for how FDA will prioritize its capacity-building efforts based on risk, coordinate with other partners to avoid duplication of efforts, and to broaden the reach of technical assistance and capacity-building efforts.   FDA will use data to develop strategies, allowing the agency to make decisions about capacity-building based on identifiable needs, while also allowing the agency to measure the impact of its efforts.

The plan addresses the six elements required by Section 305 of FSMA by incorporating them into four key goals and objectives, as supplemented by additional themes. The Plan’s key goals and objectives are:

  • Ensure efficiency across the FDA Foods and Veterinary Medicine Program
  • Increase effectiveness through evidence-based decision making
  • Support the exchange of information between FDA and other foreign government agencies or other entities
  • Enhance technical assistance and capacity-building in food

Building International Capacity with Respect to Food Safety

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on January 4, 2011 enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. Specifically, the legislation significantly enhances FDA’s ability to oversee the millions of food products that come into the United States from other countries each year. An estimated 15 percent of the U.S. food supply is imported, including 60 percent of fresh fruits and vegetables and 80 percent of seafood.

The law gives FDA important new tools to hold imported foods to the same standards as domestic foods. With these new tools, FDA can better ensure that imported products meet U.S. standards and are safe for U.S. consumers.

Full Text of the Law Relating to International Capacity Building

FDA’s International Food Safety Capacity-Building Plan

Section 305 of FSMA requires FDA to develop a comprehensive plan to expand technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries from which foods are exported to the United States. Further, FDA is required to develop the capacity-building plan in consultation with certain stakeholders, including representatives of the food industry, officials from other federal agencies, foreign government officials, non-governmental organizations that represent the interests of consumers, and other stakeholders. The capacity-building plan shall include, as appropriate:

  1. Recommendations for bilateral and multilateral arrangements and agreements, including providing for responsibilities of exporting countries to ensure food safety;
  2. Provisions for secure electronic data sharing;
  3. Provisions for mutual recognition of inspection reports;
  4. Training of foreign governments and food producers on U.S. requirements for safe food;
  5. Recommendations on whether and how to harmonize requirements under the Codex Alimentarius; and
  6. Provisions for multilateral acceptance of laboratory methods and testing and detection techniques.

View FDA’s International Food Safety Capacity-Building Plan (PDF: 5.7MB), February 2013.

Public Meeting

FDA hosted a one-day public meeting entitled “International Capacity Building with Respect to Food Safety” on June 19, 2012 in Washington, DC. The purpose of this public meeting was to provide interested persons a forum to learn about FDA’s current thinking on the international capacity building plan and offer an opportunity for the public to provide comments. See more information on the upcoming public meeting.

FDA to Hold Additional Public Meetings on Two Major FSMA Proposed Rules

Posted By Bill Marler on February 12, 2013

The U.S. Food and Drug Administration (FDA) is announcing two additional public meetings on the Food Safety Modernization Act (FSMA): Proposed Rules for Produce Safety and for the Preventive Controls for Human Food. These meetings are the second and third in a series of public meetings announced in the January 31, 2013 Federal Register Notice and on FDA’s FSMA website. The first meeting will be held February 28-March 1, 2013, at the U.S. Department of Agriculture in Washington, DC.

The purpose of the public meetings is to discuss the proposed rules to establish standards for growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls for human food proposed rule). They are the first of five proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act. The meetings are also designed to solicit oral and public comments from stakeholders on the proposed rules, inform the public about the rulemaking process (including how to submit comments, data and other information to the rulemaking dockets), and respond to questions about the proposed rules. 
Specific information for the Chicago, IL and Portland, OR Public Meetings is provided below.

  • Public Meeting attendees are encouraged to register on-line or contact: Courtney Treece, Planning Professionals, Ltd., 1210 W. McDermott, Suite 111, Allen, TX 75013, telephone: 704-258-4983, fax: 469-854-6992, e-mail: ctreece@planningprofessionals.com.
  • For general questions about the meetings or to request special accommodations due to a disability, contact: Juanita Yates, FDA, Center for Food Safety and Applied Nutrition, telephone: 240-402-1731, e-mail: juanita.yates@fda.hhs.gov.

Additional Information and registration:

Please note the following important dates:

March 11-12, 2013 Meeting in Chicago, IL

  • February 21, 2013: Closing date for request to make oral comment
  • February 21, 2013: Closing date to request special accommodation due to a disability
  • March 1, 2013: Closing date for advance registration
  • May 16, 2013: closing Date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Preventive Controls see Docket No. FDA-2011-N-0920 and for the proposed rule on Produce Safety Standards see Docket No. FDA-2011-N-0921

March 27-28, 2013 Meeting in Portland, OR

  • March 8, 2013: Closing date for request to make oral comment
  • March 8, 2013: Closing date to request special accommodation due to a disability
  • March 18, 2013: Closing date for advance registration

May 16, 2013: closing Date to submit either electronic or written comments to FDA’s Division of Dockets Management; for the proposed rule on Preventive Controls see Docket No. FDA-2011-N-0920 and for the proposed rule on Produce Safety Standards see Docket No. FDA-2011-N-0921

FDA Publishes Risk Assessment for Listeria and Cheese

Posted By Patti Waller on February 9, 2013

The U.S. Food and Drug Administration announced a draft quantitative assessment of the risk of listeriosis from soft-ripened cheese consumption in the United States and Canada. The risk assessment is a joint effort between FDA and Health Canada. View the Federal Register Notice for the assessment.

The new FDA/Health Canada draft risk assessment found that the risk of listeriosis from soft-ripened cheeses made with raw milk is estimated to be 50 to 160 times higher than that from soft-ripened cheese made with pasteurized milk. This finding is consistent with the fact that consuming raw milk and raw milk products generally poses a higher risk from pathogens than do pasteurized milk and its products.

While raw milk and raw milk products put all consumers at risk, the bacteria they may contain can be especially dangerous to people with weakened immune systems, older adults, pregnant women and children. View guidelines for avoiding illness by choosing milk and milk products carefully.

FDA invites comments that can help FDA and Health Canada improve:

  • the approach used;
  • the assumptions made;
  • the modeling techniques;
  • the data used; and
  • the clarity and transparency of the draft quantitative risk assessment documentation.

To submit comments electronically, go to docket FDA-2012-N-1182 on regulations.gov. The comment period opens February 11, 2013 for 75 days.

FDA Listeria Warning Letter to Gioia Cheese Co., Inc.

Posted By Drew Falkenstein on February 6, 2013

The U.S. Food and Drug Administration (FDA) inspected your cheese manufacturing facility, located at 1605 Potrero Ave., South El Monte, CA 91733-3018, from August 22 through 29, 2012. During our inspection, FDA collected environmental samples from multiple areas in your processing facility as well as ricotta cheese product samples. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen. In addition, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. These CGMP violations and our findings of L. monocytogenes in your processing facility cause your ready-to-eat cheese products to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Laboratory findings from the August 2012 inspection represent the third time since 2010 that FDA has detected L. monocytogenes at your facility. Two environmental swabs collected from your facility in July 2010 and five environmental swabs collected in February 2011 tested positive for L. monocytogenes. The July 2010 swabs testing positive for L. monocytogenes were collected from the floor around the floor drain underneath the brine tank and the floor around the wheel of the brine tank. Swabs collected in February 2011 from your facility testing positive for L. monocytogenes were collected from the floor directly underneath soak tank # 2 in the southeast corner of the main processing room, the floor underneath the weighing table located on the southeast side of the main processing room, the surface of the floor drain located directly underneath the brine tank on the southeast side of the main processing room, the floor and under surface of the floor mat placed underneath the weighing table in the southeast corner of the main processing room, and the underneath surface of a white plastic bucket placed directly under the weighing table in the main processing room near the south wall.

Adding to the past findings of L. monocytogenes at your facility, three swabs collected in August 2012 from your facility tested positive for L. monocytogenes. These swabs were collected from the wheels and west side of mozzarella holding table located near a drain, underneath the north drain grate, and the floor mat near the packing table.

Pulsed-field gel electrophoresis (PFGE) testing results determined that the two environmental swabs from July 2010 and the five environmental swabs from February 2011 had a PFGE pattern that was indistinguishable from the three positive environmental swabs collected in August 2012. The PFGE results suggest that L. monocytogenes may have been transported throughout your facility and may have established niche areas to colonize. The presence of persistent L. monocytogenes in your facility over time is significant in that it demonstrates that your sanitation efforts are inadequate to effectively control pathogens in your facility and prevent the contamination of food. Once established in a production area, humans or machinery can facilitate the pathogen’s movement to and contamination of food-contact surfaces and finished product.

FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:

1. You firm failed to handle work-in-progress in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5).

Specifically, an employee was observed to be spraying water with a high-pressure hose onto the floor and into a drain in the pasteurization room in close proximity to a rack holding in-process, exposed ricotta cheese.

2. Your firm failed to handle and maintain equipment, containers, and utensils used to convey, hold, or store food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7).

Specifically, an employee was observed holding a bucket of stretched mozzarella with his/her bare arms in direct contact with the outer surface of the bucket. Subsequently, the bucket was dipped directly into a cooling table and used to transfer water to another cooling table containing mozzarella.

3. Your firm failed to adequately install and maintain plumbing so that it is not a source of contamination to water supplies, as required by 21 CFR 110.37(b)(3).

Specifically, a discharge hose was observed to be submerged under water in a cooling table containing in-process mozzarella. To prevent contamination of in-process food and to protect your water supply against backflow and back siphonage, your firm must install a backflow prevention device on the hose and/or water line. You must also take steps to ensure that the discharge hose is no longer submerged in or otherwise in contact with the water in the cooling table in a manner that can allow for cross-contamination to food.

We acknowledge receipt of your letter dated October 1, 2012, in response to FDA’s positive L. monocytogenes environmental swabs. Your letter indicates that you are currently updating your food defense practices to include a comprehensive L. monocytogenes testing program and that you are working closely with a food safety company with dairy and sanitation expertise. Your letter also indicates that you are implementing an environmental program that will include weekly monitoring for L. monocytogenes. Your response does not address the CGMP deviations identified in this letter.

In updating your food defense practices, it is essential to identify all areas of your facility where L. monocytogenes is able to grow and survive (niche areas) and to take such corrective actions as necessary to control the organism. We note that a second, nonpathogenic species of Listeria, L. seeligeri, was found in your cheese products that were sampled in 2009 and again during the August 2012 inspection. These findings further demonstrate that your cheese products are manufactured under conditions that may reasonably allow food to be contaminated with Listeria species, including pathogens. As such, FDA recommends that your sanitation controls include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L. monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.