FDA Rapid Response Team Pilot Project: Improving Food Emergency Response Capabilities

CDC estimates published in 2011better define the burden of foodborne disease in the United States. Roughly 1 in 6 Americans (or 48 million people) get sick each year, 128,000 are hospitalized, and 3,000 die of foodborne diseases. Ongoing multi-state outbreaks and food/feed recalls provide powerful evidence that local, state, and federal agencies will be judged by their ability to mount a credible response to foodborne outbreaks and other food emergencies.

Multiple initiatives have been launched to help agencies improve outbreak response team capabilities. Examples include the Guidelines for Foodborne Disease Outbreak Response by the Council to Improve Foodborne Outbreak Response (CIFOR), National Voluntary Retail Food Program Standards, National Environmental Health association’s Epi-Ready Training Program, and the U.S. Food and Drug administration’s (FDA) Rapid Response Team (RRT) Pilot Project.

This presentation highlights some of the resources developed by the RRT Pilot Project that environmental health professionals can use to improve the efficiency and effectiveness of their agency’s foodborne illness response team. The RRT Pilot Project is a series of multi-year cooperative agreements between FDA and nine states: California, Florida, Massachusetts, Michigan, Minnesota, North Carolina, Texas, Virginia, and Washington. The RRTs completed a nationally reviewed, seven-chapter manual of best practices in 2011. The manual shares concepts and tools that the RRTs found to be key to effective food/feed emergency responses. Chapter topics include multiagency coordination, training programs, multi-agency inspections, communication, food emergency response planning, traceback investigations, and the use of Incident Command System (ICS) concepts. Finally, this presentation will explore strategies that agencies can use for long-term sustainability of food emergency response capabilities during tight budget times.

Drug Residues in Milk and Milk Products Risk Assessment

Over the years, concern has been raised over the possibility of drug residues in dairy foods, such as fluid milk. The requirement to test milk and milk products for drug residues, is limited to only the Beta lactam drugs and has not changed over the past twenty years. For this reason, the National Conference on Interstate Milk Shipments (NCIMS) Drug Residue Committee has requested that FDA perform a risk assessment on potential drug residues in milk and milk products produced in the United States to re-evaluate the National Drug Residue Milk Monitoring Program. This symposium will describe the potential drug residue problem in milk and milk products and the approach utilized in analyzing this issue. The Drug Residues in Milk Risk Assessment Work Group consists of scientific and dairy experts from FDA, Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) working together to develop a risk assessment on drug residues in raw milk and milk products.

Scores and More: Can you be sued for giving a restaurant a good grade?

The City of Sunnyvale was rocked when news broke that patrons of the Greasy Spoon had become ill with E. coli infections. Despite its name, the restaurant had the reputation of having the cleanest kitchen in town and had received an A+ on its most recent inspection, which was posted on the City’s Website just days before the outbreak. In fact, Sunnyvale Environmental Health regularly held its annual End of the Year party at the Greasy Spoon because of its stellar reputation. The outbreak investigation took weeks to conduct, but the Sunnyvale Health Department and Sunnyvale Environmental Health final outbreak report pointed to cross-contamination between raw ground beef and fresh (irradiated) mango in the restaurant kitchen. Hours after the report was issued, Greasy Spoon owners, management, and staff appeared on local television to apologize for the outbreak and express their concern for victims. Meanwhile, Sunnyvale Environmental Health was served with a lawsuit filed by a plaintiff whose 3-year-old son had been hospitalized for 3 weeks with HUS. In an interview with a local TV station, the plaintiff explained that he was suing Sunnyvale Environmental Health rather than the meat producer or the Greasy Spoon because he had relied on the City’s posted restaurant inspection what he was led to believe was a safe place to take his son to dinner. He claimed he never ate anywhere that had received less than an A+ on an inspection and that the health department’s failure to prevent cross-contamination at the restaurant led to his son’s illness.

Sunnyvale Environmental Health’s restaurant inspectors were left scratching their heads. Did giving the Greasy Spoon a perfect score just days before the cross-contamination happened constitute a failure of some sort that left the City open to lawsuits? Food safety attorney Bill Marler will address this question and more.

Food Safety Allergen Training for Food Service Employees

Early in 2011 the Minnesota Food Code Rule Revision Committee voted overwhelmingly to adopt the Food and Drug Administration food allergen recommendations. The committee agreed to adopt language regarding training:

"Employees are properly trained in food safety, including food allergy awareness, as it relates to their assigned duties."

The Food Allergen Subcommittee encouraged Minnesota Department of Agriculture, Minnesota Department of Health, and the University of Minnesota, to develop training to address food allergen issues. Taking a proactive approach, our team decided to develop an online food allergen training course. We worked in consultation with an advisory group representing industry, regulatory, academia, and food service employees.

The course is approximately one hour in length and provides interactive activities, real life situations, decision making and application of concepts. By the end of the course, learners will be able to make informed decisions and provide safe food to the people they serve.

The Role of Rapid Cycle Improvement in addressing recurrent critical violations in restaurants

Through a grant from The Ohio Voluntary Accreditation Team (OVAT)The Food Protection Program staff assessed the strengths and weaknesses of the food inspection program. A weakness identified during the assessment was re-inspection time spent by the sanitarian in restaurants due to reoccurring critical violations. CCBH staff was spending just under 1,800 hours conducting re-inspections of food services with re-occurring CDC risk factor critical violations. Though re-inspections are a routine part of the food safety inspection program, this amount of time seemed excessive. A continuous quality improvement team was assembled and this issue was discussed with possible solutions to be measured. A Pareto chart was created to assess which facilities in the CCBH jurisdiction were taking the most time to inspect. The inspection reports showed that recurring critical risk factor violations were being documented during the re-inspections, but were not improving. This seemed to be a weakness in the program because there was no written protocol that would assist sanitarians in decreasing recurring violations. The rapid cycle improvement tool was chosen because we could conduct a pilot study to a limited amount of facilities and track results that can be analyzed within a short period of time. The rapid turnover of interventions and testing would give CCBH results to see what intervention would affect recurrent critical violations in restaurants.

Reducing agricultural food contamination risk and increasing farm worker health and safety opportunities through implementation of an Agricultural Field Toilet Inspection Program

Unsanitary or improperly equipped field toilets are one of many sources that can contribute to Escherichia coli contamination of agricultural products. This public health risk can lead to unsafe field worker conditions, food borne illness, and substantial economic impacts to the agricultural industry. In 2005 and 2006, United States Food and Drug Administration investigations of food-borne illnesses linked outbreaks to fresh-cut lettuce and spinach grown in the Salinas Valley, California. Monterey County Health Department’s Environmental Health Bureau (MCEH) launched an array of potential source mitigations, one of which was an Agricultural Field Toilet Inspection Program (AFTIP) to register, monitor, and enforce sanitary practices. From project launch in late 2007 to the December 31 2009, MCEH inspectors permitted more than 7,500 field toilet units, estimated to likely be nearly all of the units that existed in Monterey County. From the first fully-operational program year (2008) to the second program year (2009), total violations decreased from 1,502 to 315 and of those, the number of violations requiring immediate correction decreased from 244 to 8. These results suggest a decreased probability of crop contamination, food-borne illness, and economic loss for Monterey County agricultural products due to field toilet sources. The study describes MCEH’s rigorously-maintained process to adhere to public health egulations and standards with relatively minor impact on resources, and provides a local health policy, procedures, and materials (forms, tools) to assist other counties in enacting similar policies and cost effective programs. Adoptions of similar practices by other local health departments throughout the U.S. are expected to provide similar results and benefits within those counties. However, because agricultural workers and farming equipment (machinery, trucks, tools, toilet units, etc.) are seasonally transported across county and state boundaries, possibilities of contamination will exist due to differentials in inspections and regulations between counties. Yet implementing AFTIP in California counties would give researchers the opportunity to compare findings, thereby providing further recommendations for greater protections.

Pets in Retail Food Outlets: A Literature Review

The presence of service animals in restaurants as allowed under the 1990 Americans with Disabilities Act, coupled with the resurging popularity of tea cup dogs and portable exotic pets, raises questions about the environmental health and safety implications of animals in patronage areas within retail food outlets. To provide the evidence base for informed policy and practice, the authors conducted a search of public health journals and medical publications with the aim to aggregate and summarize literature germane to this issue. A range of potential zoonotic diseases was identified among common household pets, including those that are parasitic, bacterial, and viral in origin.  At the same time, the relative risk associated with specific pet-human interactions has yet to be established in a clear and consistent manner. The U.S. Centers for Disease Control and Prevention reported approximately 100 disease outbreaks involving animals in public settings for the time period of 1996-2008, though most were rooted in petting zoos. Existing literature largely failed to recognize the potential significance of aeroallergens, which the authors believe may present the single most significant animal-related risk to the dining public.  Public policy developers should consider vulnerable populations such as children, pregnant women and their fetuses, asthmatics, and the immune-compromised.  Preventive measures and best practices include signage, installation and maintenance of suitable building materials, adherence to applicable ventilation standards, staff training and hygiene, and aggressive animal management systems.  There is a paucity of published scientific literature directly related to risk factors associated with animals in restaurant seating areas. Environmental health professionals are encouraged to stay abreast of emerging literature related to the hospitality industry.

The Role of Public Health in Promoting a Food System that is Safe, Secure, and Sustainable: S3.

Public health and safety considerations are an integral component to local food systems policy. A healthy food system should ensure the well being of consumers. To achieve that goal, local food systems policy should ensure that food is Safe, Secure, and Sustainable (S3) by supporting and encouraging healthy production of food for all.  Nothing in food systems policy should undermine the public’s health, especially the health of our vulnerable populations including our children, the elderly, or those who are immunecompromised.  Over time, our food system has become more centralized, decreasing reliance on local farmers and backyard gardens to feed the Country. Convenience foods became core to our diets and unfortunately have resulted in heart disease, diabetes, and childhood obesity among other things. In addition, taking better care of our environment is also on people’s minds.  There are many food systems lessons that have been learned over time. These lessons must not be overlooked when reformulating local policy. In fact, the lessons learned should be reflected upon and risk-based interventions integrated into new food systems policy that are protective of public health and the environment, making our local food system in San Diego County Safe, Secure, and Sustainable: (S3).

The Military/ Civilian Disaster Strategy: A National Emergency Food Protection Practicum

The Military/ Civilian Disaster Strategy: A National Emergency Food Protection Practicum Food and water protection is at the intersection of many of public health’s greatest challenges: pandemic disease preparedness, agriculture and bio-terrorism, emerging infectious disease, food security, and climate change. Moving between traditional environmental health, epidemiology, and all-hazards preparedness tracks, the Wright State University Master of Public Health Program, through the National Center for Medical Readiness, partnered with the US Air Force School of Aerospace Medicine located at Wright-Patterson Air Force Base to develop a novel, national training schedule for military and civilian food safety inspectors focused on realistic scenarios they could face during times of emergency.

This unique and intensive, two-day training program is based upon the Food and Drug Administration Model Food Code, a proven military food defense program, and (the soon-to-be-implemented) 2011 Food Safety Modernization Act. The course is a field practicum, taught by United States Air Force instructors and Wright State University academicians, and tested in a mobile food establishment designed for contingency situations. Training content tests the trainee’s ability to make sound judgment in the face of a real-time emergency. Knowledge of food microbiology/ toxicology, ionizing radiation, disease vectors, food storage and salvage, and detection equipment, is tested “hands on” in a mock food establishment that is an emergency simulator. Scenarios include: failed food holding units (stocked with perishable foods), vector infestations, flood waters, failed structural and mechanical systems, and many other tests of technical training competencies.

Trainees will be videotaped and graded according to performance. Successful candidates receive emergency training certification, issued jointly by Wright State University and the United States Air Force. Presenters will discuss expected training outcomes and proposals for future national training criteria augmentation and expansion.

NOTE: This Information is the property of the United States Air Force and Wright State University: confidential until selection for presentation.

Food Handler Training under the Microscope

As food-borne illnesses continue to garner national attention, it is critical that health departments reevaluate their retail food handler food safety training protocols.  Although many of the serious outbreaks are linked to food production or processing, an analysis of 2006 CDC data indicated that in that year 52% of food-borne disease outbreaks were attributed to food service establishments.  Although it is unknown what percentage of these illnesses were due to inappropriate food safety procedures and behaviors at the food establishment, it is becoming increasingly important to the public to know that employees in the food service industry have the food safety knowledge to minimize their risk of contacting food-borne illness. 

This session will briefly summarize the research literature on food safety training for hourly workers in the retail food service work force, present an overview of health department practices around the country, and compare differing modalities of training. It is proposed that the author of this abstract bring together a panel of 4-5 individuals, representing environmental health personnel in departments that offer food handler training, as well as individuals involved in academic research of food handler training and behaviors.  This will allow the audience to hear information based on a range of experiences, participate in discussion, and receive input to their questions as they evaluate the direction of their department with regard to food handler/food safety training.

Data will also be presented on a study currently being conducted in collaboration with the Utah County Health Department evaluating operator perception of food handler training. Of critical interest will be an evaluation of the movement from classroom training to online food safety training.  Variables to be discussed include financial impact, relative value of the training vs. the testing component, issues related to fraud prevention and detection, learning styles, alternative guidelines for evaluating comprehension, and the evaluation of quality of training options.

New Deli Slicer Standards in Food Safety

All newly manufactured and certified Deli Style Slicers comply with the sanitation requirements of the NSF standard.  However, over time, and with constant use and regular cleaning, seals can deteriorate, creating vulnerable points of bacterial harborage that have been associated with specific food borne illness outbreaks.  Regular inspection and routine maintenance has been shown as the most effective way to minimize this problem, especially for older equipment.

This presentation will focus on the key parts of the Deli Style Slicer that have shown deterioration with use over time.  This presentation will describe what  food safety professionals should monitor closely during routine sanitation inspections. We then will present recommendations on when to service equipment, or when to take  units out of service altogether.  The presentation will focus on the key findings of foodborne illness outbreak investigations specific to the Deli Style Slicers which led to the recommendation to revise  the NSF/ANSI standard pertaining to these products. We will then further look at the research and the science that formed the foundation for the revisions to the American National Standard.

The science behind the recommended changes to the revised NSF/ANSI standard has resulted in a necessary re-engineering of the design and construction of the Deli Style Slicer as we know it today. These changes  should result in the improvement of both the serviceability and food safety associated with this very common piece of food service equipment.  The presentation will focus on and describe several of the specific new requirements found in the revised standard.

An Introduction to the CORE Network: FDA’s New Approach to Managing Foodborne Outbreak Surveillance, Response and Post-Response Efforts

This presentation is intended to illustrate how the new Coordinated Outbreak Response and Evaluation (CORE) Network coordinates, conducts, and has improved FDA’s preparedness, response, and post-response efforts involving human and animal foodborne outbreaks of illness, both within the Agency and in collaboration with our partners. In April 2010, FDA Commissioner Hamburg announced the intent to streamline the foodborne outbreak process within FDA to better work with our partners. Subsequent to this announcement, FDA formed a small group of subject matter experts to design, analyze, develop, and implement the new process.  In July 2011, the CORE Network launched,  addressing outbreak signals, response, and post-response activities, and improving the way we work with other operational areas of FDA, with the field staff, with our stakeholders, with other federal agencies, even with the public in promoting food safety education. 

The CORE Network builds upon FDA’s established best practices, incorporating lessons learned, expanding FDA’s monitoring and post-response capabilities, investigates and documents underlying causes, to drive prevention-based food safety policies.

Passing Parasites: A Rare Foodborne Giardiasis Outbreak at a Restaurant

Over a five-week period in 2010, five individuals diagnosed with giardiasis were reported to the Alexandria (VA) Health Department. Patronage at a specific restaurant between March and August was the only commonality. A review of the foods consumed did not identify any commonalities.  An Epi-Ready-trained multidisciplinary team conducted an investigation to assess possible sources of Giardia lamblia. An EH evaluation of the restaurant was

performed, focusing on food sources, backflow prevention and employee hygiene.  No food source or backflow prevention problems were identified. Many instances of inadequate handwashing and bare-hand contact with ready-to-eat-foods were observed. The restaurant had an unofficial employee health policy, but many employees were not aware of it.  Steps were taken to identify infected employees through antigen testing of stool specimens. Due to possible intermittent shedding, two specimens were collected from staff. Testing initially focused on kitchen staff, but was expanded following early results to include bartenders and wait staff. In total, 13 (28%) of 46 employees were positive for G. lamblia; only two reported symptoms within the past six months. Four of these employees cooked, the others were wait staff and bartenders.

A meeting with restaurant management established appropriate control measures.  To avoid closure, the restaurant agreed to develop a written risk control plan, an employee health policy and to require employee training. The risk control plan included strict hand washing, gloving, restriction of some employees, and paid sick leave for excluded employees. Also, the restaurant paid for lab tests.  Treatment of infected food workers was coordinated through the health department.  Frequent EH evaluations and strict control measures were key to controlling this outbreak. These included identification of infected food service workers, restriction or exclusion of positive employees, and hygiene training for restaurant staff.

Do restaurant food handler knowledge gaps predict violations identified during inspections?

Approximately half of the foodborne outbreaks reported to the CDC are associated with restaurants or delicatessens. Periodic restaurant inspection by the local health authority helps to assess food handling behaviors but it is not designed to identify gaps in knowledge related to food safety. Therefore, the combination of measuring food handler knowledge and review of restaurant inspection scores allows a more complete understanding of the restaurant food handler.  To determine food safety knowledge gaps, we interviewed 729 suburban Chicago food handlers in 211 participating restaurants.  A 50 question survey was administered in English or Spanish during June 2009 through January 2010. 

The reports for inspections performed just prior to conducting the surveys were reviewed and violations were quantified.  Participants scored an average of 72% on the survey, with substantial knowledge gaps related to cross contamination, cooking temperatures and thawing and storage of food. The mean score for certified food managers was 79%.  Restaurants had an overall mean inspection score of 90.6 and the number of violations ranged from 0 to 19.  Among the most commonly reported violations, two were critical; one for the failure to maintain temperature requirements of potentially hazardous food (29%) and the other for inadequate food protection from potential cross-contamination (28%).  No significant correlation was observed between overall inspection score and certified food manager knowledge score as a result of regression analysis.  In general, knowledge gaps were not directly correlated with food safety citations in practice. However, there was a significant association between an inspection with a violation related to food handler hygiene and employing at least one certified food manager who missed at least one hand hygiene question, on the knowledge survey (RR=1.96, p=0.05). The results of this study suggest that restaurant inspection reports do not correlate well with certified food manager knowledge. Interpretation of these results should consider that some violations may be corrected during the inspection and not recorded on the report form.  Future research should focus on enhancing restaurant manager knowledge and determining what factors may motivate restaurant managers to ensure compliance with food safety policies that inspections are intended to monitor.         

Serving Up An Education: Online Food Safety Training

Washington State requires all food workers to complete a basic course on food safety.  Tacoma-Pierce County Health Department inspectors have taught food worker classes since the 1950’s.  Recently, in response to consumer demand, the department began searching for a more convenient way food workers could obtain the State required training.  

In January 2011, Tacoma-Pierce County Health Department launched the State’s first web based food safety training and testing program.  The interactive program offers users a 30 minute course on food safety in 8 different languages and closed captioning.  Upon completion of the course users take a test, pay for the course with a debit or credit card and print a copy of their food worker card.  

The online food worker class has been a success.  Nearly 80% of Pierce County’s food worker cards are now issued online.  Seventeen additional counties participate in the program, and more than 10,000 cards are issued monthly to food workers in those counties.  User surveys show a high rate of satisfaction with the class and significant time and travel savings. 

Participating health departments have realized cost savings and other incidental benefits. The development and launch of this online food safety program presented many challenges as well as opportunities.  This presentation will discuss the challenges, lessons learned, and benefits realized by both food workers and participating local health jurisdictions.

Handwashing: The Game-Changing Scale For Success in 2012

Poor hand hygiene has become the entrenched industry standard. Inability to implement broad risk-based interventions has resulted in hand hygiene being the  perennial winner of the title for "Single-most cited contributing factor in foodborne outbreaks." Year after year acceptance of poor handwashing behaviors has calcified the issue with a trail of frustration and repetitious trials of failing programs.  The common factor is the lack of measurement and the inability to sustain temporary enhancements. Everything routinely tried is rich in the sciences except for behavioral science and its attendant math. Think about changing your weight. First there is the commitment and then a scale to monitor success. Do you know anybody who has successfully dieted without a scale?  That is where we are at with hand hygiene.

Jerold R. Mande, USDA Former Deputy Under Secretary for Food Safety put it this way What doesn't get measured doesn't get done. Food workers first need measurable objectives to understand expectations and build everyday confidence and professionalism. They need to know where they are at on the scale of success.

The PIC, Person-In-Charge, addition to the Model Food Code is a major success yet it appears to have done little to resolve the number one problem – poor hand hygiene. PICs need tools to measure, document and manage.  This is a call to all operators and their 30,000+ inspectors to be open to change and onboard in creating an environment of innovation in kitchens across the country. Start small. Pick the easiest first step. Inspectors are asked to bring their full compliment of coaching skills and help operators build a hand cleanliness culture tailored to the establishment.  This presentation serves up a menu of three easy to adopt measures to improve hand hygiene standards. It starts with a new way to look at raising the handwashing priority for the workers. Second, is a series of examples of successful compliance monitoring techniques. Finally, a case is made to measure surface cleanliness – for those surfaces most likely to contaminate hands and the food prepared and served.

FDA’s perspective on an environmental assessment of a cantaloupe-growing farm linked to a multi-state Listeria monocytogenes outbreak, 2011.

In early September 2011, the U.S. Food and Drug Administration (FDA) learned of a multi-state outbreak of Listeria monocytogenes associated with exposure to fresh cantaloupe marketed from the Rocky Ford growing region of Colorado. A majority of illnesses were traced back to a single producer, Jensen Farms of Holly, CO. Following the firm’s voluntary recall of its cantaloupes, FDA’s Coordinated Outbreak Response and Evaluation (CORE) network, working with state and federal regulatory partners, visited 3 different Jensen Farms cantaloupe-growing sites to conduct an environmental assessment (EA) to try to determine the source of (or contributing factors to) the outbreak. Agricultural production practices, and harvest and post-harvest operations were evaluated to identify potential areas of concern that may have fostered pathogen introduction and / or proliferation. The EA identified factors that may have contributed to the contamination of whole, fresh cantaloupe that caused the outbreak.

Bridging the Food Safety Gap: Increasing Communication and Collaboration among Federal Agencies

On March 14, 2009, President Barack Obama announced the creation of a new Food Safety Working Group (FSWG) to advise him on how to upgrade the U.S. food safety system.  Since then, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has begun a number of initiatives with the U.S. Department of Health and Human Service’s Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to coordinate food safety projects and programs more effectively with each other.  One of them, “Strengthening Federal Coordination to Address Cross-Cutting Problems” will be examined.  Questions that will be addressed include:  “What are the catalysts for the creation of the FSWG?  What federal food safety initiatives are currently taking place?  And, how will these agencies respond to future

challenges?