Two unlucky diners found a dead bat in their Fresh Express salad mix
Source : http://mashable.com/2017/04/09/dead-bat-salad-mix-fresh-express-recall/#nxCcAbGC2kq9
By MARIA GALLUCCI (Apr 10, 2014)
Two diners in Florida were munching on a prepackaged salad, perhaps enjoying the crispy crunch of lettuce, when they stumbled upon a strange ingredient. A weird crouton? No. Some ultra-GMO vegetable? You wish.
It was a bat. A dead bat. A dead bat was in their salad.
Fresh Express recently recalled some salad mixes sold at Walmart stores after the unlucky customers found a winged creature plopped among the leafy greens.
SEE ALSO: Bed bugs were blood-sucking pests even 11,000 years ago
The pair had already started eating some of the salad before they found the bat. Not gross enough? Well, turns out the bat was in such deteriorated condition that when U.S. health officials tried to test it in the lab, they couldn't definitively determine if that bat had rabies, the Centers for Disease Control and Prevention (CDC) said on Saturday.
As if finding a decomposing creature in your food wasn't bad enough, the two people were advised to start post-exposure rabies treatment. Fortunately, the CDC said both people reported being in good health, and neither had any signs of rabies.
Apparently, it's extremely uncommon to get rabies by eating a rabid animal (pro tip!) and the virus doesn't survive very long outside of the infected animal, the health agency said.
Orlando-based Fresh Express on Saturday announced a precautionary recall of its 5-ounce Organic Marketside Spring Mix. The recalled salads came in a clear container with a best-if-used-by date of April 14. They were only distributed to Walmart stores in the southeastern region of the United States.
No other Fresh Express or Marketside salads were included in the recall. Fresh Express said that Walmart acted quickly to remove the spring mix product from its store shelves.
Experts from the CDC are working with the U.S. Food and Drug Administration and the Florida Department of Health to crack this particularly unsettling food safety case.
Food Allergies Can Be Life-Threatening
Source : https://foodpoisoningbulletin.com/2017/food-allergies-can-be-life-threatening/
By Linda Larsen (Apr 7, 2017)
Food Poisoning Bulletin is constantly search and publishing information about food and drink recalls for potential food allergens, and with good reason. According to the FDA, anaphylaxis to food causes 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths in this country every year.
Anaphylaxis is caused by a severe reaction to one of the eight major food allergens, which include milk, wheat, eggs, soy, fish, shellfish, tree nuts, and peanuts. More than 150 other foods can cause allergic reactions in people allergic to them, But those top eight cause 90% of food allergic reactions. While most allergies start in childhood, and while some children can “outgrow” their allergies, anyone can develop an allergy to anything at any time throughout life.
The Food Allergen Labeling and Consumer Protection Act of 2004 is enforced by the FDA. This Act guides the labeling of foods regulated by the FDA, which includes all foods except poultry, most meats, certain egg products, and most alcoholic beverages that are regulated by other agencies. Food labels must “clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.”
The name of the food source of a major food allergen must appear either in parentheses following the name of the ingredient, such as “lecithin (soy)” or “whey (milk)”, or immediately after or next to the list of ingredients in a “contains” statement. Examples of that use include “Contains Wheat, Milk, and Soy.”
Anaphylaxis causes constricted airways in the lungs, severe lowering of blood pressure and shock, or anaphylactic shock, and suffocation since the throat swells up. Administration of epinephrine by an auto injector can prevent serious consequences.
Mild symptoms can quickly become a serious threat to life. A person may have mild symptoms at first, but they can quickly escalate to anaphylaxis. The initial symptoms of an allergic reaction occur within a few minutes to 2 hours after consumption of an allergen. They may include hives, flushed skin or a rash, tingling or itchy sensation in the mouth, and face, tongue, or lip swelling. More serious reactions include vomiting and/or diarrhea, abdominal cramps, coughing or wheezing, dizziness and/or lightheadedness, swelling of the throat or vocal cords, difficulty breathing, and loss of consciousness.
There is no cure for food allergies; the person affected must learn to avoid that food. Learn to read labels and avoid problematic foods. Also learn to recognize early signs of an allergic reaction, and carry an epinephrine auto injector. If symptoms progress, go to an emergency room.
You can report a problem with food to the FDA. Report a problem or labeling issue, such as a potential misuse of “gluten-free” claims, for instance, to the FDA by contacting Medwatch. You can also contact the consumer complaint coordinator in your area. The FDA maintains a list of consumer complaint coordinators in each state.
Building an Integrated Food Safety System One Brick at a Time
Source : https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2017/building-an-integrated-food-safety-system-one-brick-at-a-time/
By Joe Corby and Steve Mandernach
Abraham Lincoln was once quoted as saying, “Things may come to those who wait, but only the things left by those who hustle.” You must be wondering how long you have to wait before you begin to see the integrated food safety
system that government agencies have been promoting. Are there target dates, timelines and plans? Who are the ones who “hustle” while we wait?
Actually, food safety stakeholders should now be able to recognize with some clarity that the vision of an integrated food safety system (IFSS) is currently being implemented, and it is beginning to illustrate great promise. An IFSS really isn’t anything new, as it has been employed for some time now. Let’s look back to 1937.
The Elixir Sulfanilamide
Government’s response to the sulfanilamide episode in 1937 may have been the first truly integrated effort in food and drug safety control efforts. It was an exceptional effort that clearly saved lives. Not only were federal, state and local agencies involved, but doctors, pharmacists and the news media played roles as well.
During September and October 1937, sulfanilamide was responsible for the deaths of more than 100 people in 15 states, many of whom were children. This incident led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act), which increased the authority of the U.S. Food and Drug Administration (FDA) to regulate drugs.
Sulfanilamide was used to treat streptococcal infections and had been used safely for some time in tablet and powder form. In June 1937, S.E. Massengill Co. found that sulfanilamide would dissolve in diethylene glycol, and after testing it for flavor and appearance, began to market the product in liquid form. The company sent 633 shipments all over the country.
When deaths started to be reported, FDA set out to retrieve all shipments of the drug by utilizing their entire field staff of 239 inspectors and chemists. State and local health officials joined in the search as well.
This was not the easiest task as FDA had to track down the company’s 200 salesmen and review approximately 20,000 sales slips.
Without anyone really recognizing it, this entire response effort was, perhaps, the first instance of a fully national integrated system that included the coordination and persistence of multi-jurisdictional health agencies, along with the effective actions of the medical community and the news media. As a result, most of the elixir was recovered. Of 240 gallons manufactured and distributed, 234 gallons and 1 pint were retrieved; the remainder that had been consumed caused the deaths of the victims. Imagine how many lives would have been lost without an integrated response.
This event did more than hasten enactment of the FD&C Act. It also clearly demonstrated how food and drug safety is a national concern best addressed through a nationally recognized rule and a nationally integrated system designed to prevent such tragedies.
Early Efforts in Federal-State Coordination
Early efforts to improve federal and state coordination are marked by clear intentions. Seldom would anyone use the term “integration,” instead referring to “contracts,” “partnership” and “leveraging.” There were plenty of milestones that expanded the idea of the need for closer federal, state and local collaboration. Some of those milestones can be seen in the illustrated timeline.
While many federal statutes and regulations preceded the creation of the Food Safety Modernization Act (FSMA), it was this act that directed FDA to better coordinate food safety resources with its partners at the state, local, territorial and tribal levels. FSMA has had a huge impact on the IFSS effort. All previous visions and hopes of an IFSS were weakened and difficult to advance without the strength of a congressional mandate. Because of FSMA, the country could now truly begin to develop that IFSS aspired to by so many for so long.
Partnership for Food Protection (PFP)
The PFP is a group of dedicated professionals from federal, state and local governments with roles in protecting the food supply and public health. It is the structure used to coordinate activities by representatives with expertise in food, feed, epidemiology, laboratory science, animal health, environment and public health, and helps develop and implement the IFSS.
The PFP is a volunteer organization; its members dedicate their expertise, in addition to their regular job duties, because of their belief and support for an IFSS. Members enjoy the opportunity to work on collaborative public health projects with multi-jurisdictional officials and with representatives of the Association of Food & Drug Officials (AFDO), the National Association of State Departments of Agriculture, the National Environmental Health Association, the Association of State and Territorial Health Officials and the Association of Public Health Laboratories. Many working relationships have developed within the PFP, and they have been helpful when responding to a foodborne outbreak investigation, or simply in obtaining input on inspections, work planning or training activities.
Since its establishment, the PFP has utilized its workgroup structure to develop and implement procedures, best practices and other work products that would advance an IFSS. There are seven PFP workgroups: Compliance and Enforcement, Information Technology, Laboratory Science, Outreach, Surveillance, Response and Post-Response Training and Certification, Work Planning and Inspections.
The PFP has also established a strategic plan covering a 6-year period from fiscal year (FY) 2015 through FY2020. The plan focuses primarily on integrating functions related to domestically manufactured human and animal food. It is reviewed every 2 years to allow for adjustments. Although the focus for an IFSS is currently domestic, PFP principles and resource documents may be shared with foreign government partners to promote a global approach.
PFP Resource Documents
PFP workgroups have developed a number of resource documents that are shared with regulatory agencies nationally, including the following:
• Quick Start Food Emergency Response Job Aids: These aids facilitate communication, coordination and planning among government agencies early on when an outbreak or food contamination is initially suspected or detected. The job aids include three flow diagrams that highlight key general, epidemiological and environmental tasks in the early stages of notification to promote an integrated response approach.
• Best Practices for Improving FDA State Communications Recalls: This guidance document is intended to encourage and enhance timely, reciprocal communication of recall information among FDA, state and local government agencies during class I recalls and outbreaks. The goal of this document is to increase recall transparency, communication and sharing of information without unduly impacting the high workload of partner agencies’ recall staff.
• Best Practices for the Use of FoodSHIELD during Food and Feed Incidents: These were created by the PFP Surveillance, Response and Post-Response workgroup as a guide to facilitate information sharing and communication for FDA, state and local food safety officials responding to a food or feed safety incident. FoodSHIELD is a secure, web-based communication, coordination, education and training platform for food safety and defense. Agencies use FoodSHIELD during response efforts to share information with stakeholders. This document provides instructions for utilizing the FoodSHIELD web-based system to share response information in real time. It provides instructions for building and managing a workgroup and recommends using a consistent nomenclature for naming files and documents while sharing information within the system.
• Food/Feed Testing Laboratories Best Practices Manual: This manual addresses national standard laboratory practices to promote consistent and meaningful data from environmental and food/feed samples for compliance and surveillance.
• National Program Standards Crosswalk Resource Paper: This document compiles information on standards and requirements that apply to food regulatory programs in four program areas: Grade A Milk and Milk Products, Manufactured Foods (excluding meat and poultry), Retail Food Protection and Molluscan Shellfish. It identifies commonalities and differences among the existing program standards.
• Model for Local Federal/State Planning and Coordination of Field Operations and Training: This model and the effective communication between FDA and its multi-jurisdictional counterparts with overlapping jurisdictions are critical components of an IFSS. These activities facilitate the efficient use of limited government resources and promote the safety and security of the food supply. Planning and coordination of field operations as referenced in this document relate to the scheduling of inspections, sample collection and analysis, and the execution of assignments, response activities and compliance/enforcement actions. Best practices for planning and coordination of field operations as well as associated training serve as a basis for this document.
To successfully advance an IFSS, the importance of training has never been greater. Having a high-quality, skilled food protection staff requires agencies to maintain a comprehensive employee-training development program. In addition to the internal agency training conducted, food protection officials can take advantage of the training opportunities inside and outside government. Many of these opportunities are presented at an annual training summit FDA has sponsored since 2015.
In 2016, the Regulatory and Public Health Partner Training Summits brought together over 120 stakeholders. They represented regulatory associations and alliances, industry education foundations, academia, localities, states, international agencies (representing Mexico and Canada) and federal agencies ranging from the U.S. Department of Defense to FDA. They meet to collaborate on an unprecedented level to develop the concept of a National Curriculum Standard (NCS) and support the attainment of a competent workforce performing comparable work. Training Summit 2015 was organized around “Thinking Differently,” as the event was used to introduce an innovative approach to an NCS while meeting the Office of Regulatory Affairs (ORA) Executive and PFP Training and Certification workgroups’ goals.
The new approach to curriculum construction blends learner competencies and training content to build a unique, multidimensional curriculum framework. The framework not only involves competency development but also offers a ready-made training needs analysis, a barometer to measure the effectiveness of learning events and a learner pathway from entry into the organization through leadership positions. Training Summit 2016 continued introducing more detail to the NCS approach. It provided updates on progress made over the year and offered extensive engagement with participants to give them a hands-on perspective on the approach. To date, multiple frameworks have been created, representing retail and manufactured food, animal food and laboratory competencies needed by regulatory enforcement professionals. Establishing an NCS gets us one step closer to a competent workforce doing comparable work across all strategic partners.
Regulatory Program Standards
Regulatory program standards establish a uniform foundation for the design and management of multi-jurisdictional programs responsible for regulating human and animal food. There are three sets of standards for manufactured food, animal feed and retail food regulatory programs. The goals of the standards are to leverage resources and share common successes to build systems within regulatory food programs. Collaboration is fostered with regulatory partners by:
• Encouraging programs to adopt the best practices and continuous improvement models contained within nationally recognized regulatory program standards and codes
• Utilizing performance measures and metrics to identify priorities and measure effectiveness
• Fostering partnerships through food protection task forces, technical support, program evaluation, funding, training and information technology
• Enhancing laboratory services by promoting national program standards and accreditation
• Conducting outreach programs to enhance food safety and public health
• Promoting capacity building, accountability, cost efficiency, transparency and exchange of best practices
• Facilitating enhanced communication and collaboration between internal and external stakeholders
• Advancing a nationally integrated approach to food safety and public health
The Manufactured Food Regulatory Program Standards (MFRPS) are a critical component in establishing a national IFSS. The goal of the MFRPS is to implement a nationally integrated, risk-based food safety system. The MFRPS establishes a uniform basis for measuring and improving the performance of prevention, intervention and response activities of manufactured food regulatory programs in the United States. The development and implementation of the standards will help federal and state programs better direct their regulatory activities toward reducing foodborne illness.
The Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) define what constitutes a highly effective and responsive program for the regulation of foodservice and retail food establishments. They begin by providing a foundation and system upon which all regulatory programs can be built through a continuous improvement process. The Retail Program Standards encourage regulatory agencies to improve and build upon existing programs. Further, they provide a framework designed to accommodate both traditional and emerging approaches to food safety. They are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulators and industry to focus on the factors that cause and contribute to foodborne illness.
In support of this goal, FDA works cooperatively with multi-jurisdictional partners using a risk-based approach to leverage limited resources. The Retail Program Standards represent an important component of a comprehensive strategic approach to help ensure the safety and security of the food supply at the retail level.
The Animal Feed Regulatory Program Standards (AFRPS) were developed in 2011 by FDA and the Association of American Feed Control Officials. The standards establish a uniform foundation for the design and management of state programs responsible for regulating animal feed. By implementing the AFRPS, a state program will be better able to achieve and maintain programmatic improvements that help ensure the safety and integrity of the U.S. animal feed supply. A state’s implementation of the AFRPS also helps ensure a uniform and consistent approach to feed regulation among jurisdictions.
The IFSS Toolkit was developed by the International Food Protection Training Institute in conjunction with AFDO and FDA. The toolkit is specifically designed for all stakeholders involved in food safety and food defense. It can be used within an organization or by an interdisciplinary workgroup with knowledge and practical experience in food safety and food defense. Use of the IFSS Toolkit will provide a broader context for assessing an organization’s current integration efforts and identify potential areas for improvement, especially with respect to cross-agency/cross-discipline activities.
By using the IFSS Toolkit, stakeholders become more familiar with the roles and responsibilities of others, which can allow them to facilitate better communication and engender team building in the process. There are three basic goals of the toolkit:
1. Better understanding of current integration efforts in their jurisdiction
2. Identification of specific IFSS practices and activities that will improve the integration performance of all stakeholders
3. Making of plans to im-plement those activities
Although the interdisciplinary workgroup is an ideal target audience, the IFSS Toolkit can be used by persons from a single program, agency or discipline, or even a single person within an agency who acts as a “champion” for the cause. Because integration is a team effort, however, such an approach is more limited in scope and might best be viewed as the initial steps that could later involve others.
The toolkit promotes a process in which users prioritize areas of integration (called focus areas) that are most important to the user’s organization and then systematically undertake three steps for each prioritized focus area:
1. Describe current activities and procedures in the focus area and identify those in need of improvement.
2. Prioritize recommendations to address needed improvements.
3. Make plans to implement prioritized recommendations.
This approach allows workgroups to focus efforts and identify changes to improve integration that are most appropriate to effectively use limited resources within the program/agency/jurisdiction/organization/company.
The IFSS Toolkit can offer concrete ways to achieve compliance with many of the regulatory program standards and should be considered a resource by agencies involved in meeting the standards. For example, FDA’s MFRPS and the Retail Program Standards require that participating programs take many steps related to integration.
The IFSS Toolkit integration activities have been divided into six major focus areas (Figure 1): Communication, Roles and Responsibilities, Integration of Legal Authority, Resources, Emergency Response and Global Activities.
FDA’s ORA and Office of Partnerships (FDA ORA/OP) promotes the increased quality of state and local government regulatory programs to improve overall consistency and confidence in the work by these agencies. FDA ORA/OP has made great investments in state and local agencies through contracts and cooperative agreements. For example, in FY2016, FDA ORA/OP invested $15.4 million to execute 93 contracts for state human and animal food inspections and $82.2 million to 592 grants/cooperative agreement awardees to support and advance state and local programs in the areas of program standards, rapid response teams (RRTs), laboratory accreditation and emergency response activities.
While these investments have proven successful, there are a number of conclusions that can be made as the IFSS is built, including the following:
• States will need more time for human and animal food preventive control regulations adoption, outreach and internal training/external education.
• The Produce rule is a game changer and will require significant inspectional and cultural shifts in mindsets and protocols.
• There remains a great deal of work to do and this work must be performed collaboratively to improve efficiencies and reduce duplication of effort.
• Staff for federal, state and local agencies must maintain their expertise to perform important functions.
• Stakeholders must recognize that flexibility is key in advancing a national system and that one size does not fit all.
• Flexible, risk-based, multi-year work plans between FDA and state partners must be implemented.
• Joint compliance actions should be piloted and considered for national implementation.
• Multiple funding models that account for differences between state programs should be adopted and implemented.
• Collecting and sharing data electronically between FDA and state programs should not have insurmountable restrictions.
• A means to measure the effectiveness of inspections and value of integration must be devised.
Much can be made, however, of the commitment of state and local programs to advancing an IFSS. States learn from pilots and successes that currently exist in other states. The following successful state activities have been employed to advance an IFSS:
Maryland Office of Food Protection
The Office of Food Protection in the Maryland Department of Health and Mental Hygiene comprises four expertise centers: Center for Food Processing; Center for Milk and Dairy Product Safety; Center for Facility and Process Review; and Center for Food Defense & Emergency Planning, Preparedness and Response.
The centers manage all regulatory aspects of food processing in Maryland, have oversight of local health departments’ foodservice programs and work closely with the Maryland Department of Agriculture on the farming-related activities of the food supply chain.
For the past 5 years, the Center for Food Processing has been supported in part by an MFRPS award from FDA. This funding has been used to support and enhance the functioning of the Office of Food Protection by:
• Adopting and implementing the best practices encompassed in the MFRPS program
• Installing a Food Processing Standardization Officer
• Supporting the training of staff as specialist courses become available
• Supporting and developing an office-wide database system to track food facility licensing, inspections and history, and to provide a tool for management of office activities
• Introducing the field use of computers by the staff during the course of inspections and investigations at food processing facilities and allowing the direct electronic storage and remote transfer of information to the office database
Over the same period, the Center for Food Defense & Emergency Planning, Preparedness and Response has been supported in part by an RRT award from FDA. The funding has been utilized to support the establishment of the State of Maryland RRT (SMarRRT). Maryland is a relatively small state with only a medium-size, in-state food industry. Consequently, a full-time, fully staffed RRT could not be supported. The model for SMarRRT that was adopted was to use the funding to establish two dedicated full-time staff in the Office of Food Protection: the SMarRRT Coordinator and the SMarRRT Communications Coordinator. The remainder of SMarRRT comprises an epidemiologist from the state epidemiologist’s office, an analyst from the state laboratory administration and a specialist from the Maryland Department of Agriculture. Each member of this group acts as a part-time member of SMarRRT and not only contributes their individual expertise to SMarRRT but is charged with acting as the gateway to other expertise in their parent group. This group together with the two dedicated SMarRRT members comprises the core of SMarRRT for all incidents.
Except in very small events, the core SMarRRT has insufficient resources to adequately respond to an incident. SMarRRT resources are therefore enhanced as needed by utilizing staff from the Office of Food Protection and local health departments. In addition to extra manpower, this approach brings specialist knowledge from the dairy, shellfish and retail programs as needed. To facilitate this surge capacity, SMarRRT has used FDA funding to provide additional RRT training to staff in both the Office of Food Protection and local health departments. Additionally, SMarRRT emergency Standard Operating Procedures (SOPs) have been built into the SOPs for all staff in the office and provided to the local health departments.
Currently, SMarRRT is developing the use of geographic information system technology for emergency response applications, including foodborne illness outbreak tracking, traceback investigations, storm surge flooding, power outages, airborne plume events and waterborne contamination.
Much of what has been accomplished has also been used to help improve the local programs responsible for inspecting all retail foodservice facilities. Training has been provided and the state now corresponds daily with local authorities to inform them of recalls, outbreaks, etc.
Wisconsin Department of Agriculture, Trade & Consumer Protection (WDATCP)
WDATCP and the FDA Minneapolis District Office (MN-DO) have been developing a good process for sharing inspection reports, work plans and establishment inventories over the past 4 years. This has dramatically reduced duplicative or too closely scheduled state and federal inspections and assisted in verifying establishment inventories for each agency.
The collaboration markedly decreased the number and rate of duplication of routine inspections. This saves time and resources that can be redirected elsewhere and minimizes the burden on businesses.
As a component of this, FDA has been sharing unredacted establishment inspection reports (EIRs), which help serve as a baseline for WDATCP inspections. Wisconsin has built the ability to protect FDA information (reports) from state open-records laws. As an additional benefit, Wisconsin has utilized FDA inspections conducted in-state to be utilized toward meeting state inspection goals during severe staff shortages.
The FDA MN-DO investigations branch work plan was shared with WDATCP at the beginning of the fiscal year to allow WDATCP to insert “FDA placeholders” in their inspection work plan database. This indicates to state inspectors that FDA will be conducting an inspection at those businesses this year, so a WDATCP routine inspection is not needed. In addition, to account for the large number of FDA ad hoc inspections, a simple inspection query is run, and the results are provided to WDATCP approximately every 3 weeks, showing recent inspection accomplishments. This allows WDATCP to position additional placeholders for any inspected companies that weren’t originally identified on the FDA work plan, again reducing the number of duplicative inspections a company might see. In return, Wisconsin provides FDA with a quarterly report of the inspections the state has conducted, to help ensure businesses are not inspected sooner than 6 months between agency inspections. Business inventories are routinely shared to identify and match similar businesses and identify businesses unique to each inventory.
In FY2017, nine joint inspections were conducted (two of which were companies that were in the compliance process for both agencies). WDATCP shared voluntary compliance agreements with FDA, and FDA shared unredacted warning letters with WDATCP.
All of this has provided a solid foundation for an excellent working partnership between these two agencies, which benefits them both, as well as the industries they regulate.
Washington State Department of Agriculture (WSDA)
WSDA has been an active partner in several innovative partnerships that emphasize integration of the food/feed safety system. For example, WSDA is an active participant in various PFP workgroups and continues to be a recipient of RRT, Food Protection Task Force, MFRPS and AFRPS cooperative agreements granted by FDA. Due to the close working relationship and multi-jurisdictional collaboration experienced by these workgroups in these agreements, WSDA has met the implementation requirements of three AFRPS standards during the first year of a 5-year renewable agreement. As an example, compliance with the requirements of Standard 5 of AFRPS (Feed Related Illnesses or Death and Emergency Response), WSDA as a lead agency was well prepared to respond in a very coordinated and timely manner with several federal, state and local agencies in a recent event where a large number of mink deaths were potentially associated with an adulterated feed. This included informing other authorities, coordinating collection and submission of product samples, dissemination of results, investigations/inspections and stoppage of the activities.
The integration of multiple layers of government partners is not limited just to times of emergency responses. In August 2016, the Washington RRT created, coordinated and hosted a webinar symposium entitled “Radiation and Food/Feed Emergency Response.” The overarching goal of the symposium was to increase multi-jurisdictional awareness around roles and responsibilities of partners in the event where radiation has affected the safety of human and animal food.
Another active demonstration of Washington State’s ongoing integrated food/feed safety system work is the Washington State Food Protection Task Force (FPTF). Created in 2012, the FPTF meets throughout the year with federal, state and local public health partners to facilitate collaboration and communication, and promote educational opportunities among the partners.
The FPTF Recall Audit Improvement committee consisting of state agriculture, state health and local health representatives came together to develop a multi-jurisdictional recall response guide to improve communication between agencies. This guide contains a one-page description of the agencies in Washington that have a role in recall audit checks and public health protection. It also provides a field guide that has a standardized glossary of terms for recalls and tips on what recall information is helpful to share between agencies. The guide is expected to enhance communication between agencies, limit duplication of efforts and enhance efforts to protect public health.
Thanks to the WSDA Recall Coordinator housed in the Feed/RRT Program, FPTF also maintains a website that contains food and feed information that is available to the public.
New York State Department of Agriculture & Markets (NYSDAM)
There are two components of New York State’s food protection program that forge innovative, cutting-edge partnerships with FDA and serve as models for other states. NYSDAM’s Integrated Food Safety System Partnership program with FDA’s New York District Office and their “Imported Food Initiative” agreement with FDA’s Import Operations are most noteworthy.
The purpose of the Integrated Food Safety Partnership is to establish an agreement that coordinates the food protection efforts of NYSDAM’s Division of Food Safety and Inspection and the FDA’s New York District Office. This agreement reduces consumer risk, eliminates duplication, defines regulatory roles and improves channels of communication. It covers all manufacturing food establishments and food storage facilities licensed or inspected by NYSDAM. The agreement has demonstrated the effectiveness of integrating federal/state responsibility for the food manufacturing and storage industries.
The partnership includes data and information sharing, training, recalls and enforcement strategies. It also allows FDA and NYSDAM to share each other’s resources and authorities when necessary.
The Imported Food Initiative is a nationally recognized collaborative project for dealing with the overwhelming burden of imported foods. While the number of food products imported into this country has increased dramatically, FDA’s ability to handle this surge remains limited. The Imported Food Initiative, however, allows FDA and NYSDAM to work more collaboratively on imported-food oversight. This effort is considered essential to New York because of the number of imports that enter the country through this state and then, because of its diverse population, are marketed there. The domestic marketing channels include food warehouses, processing plants and retailers for which state and local food safety regulators are primarily responsible.
Although New York is a major entry point, food of imported origin offered for sale at state wholesale/retail establishments can, and does, enter the U.S. via more than 400 ports of entry nationwide. NYSDAM’s surveillance of foods of imported origin at the wholesale/retail level not only protects consumers in New York but also provides valuable information to FDA regarding how the national import program is working. Subsequent joint investigations of food products in violation enable FDA to determine why the violative food was not detected and detained, and take affirmative steps to do so in the future. A good illustration of the dilemma for state agencies with imported foods is depicted in Table 1. Of the 4,531 food recalls coordinated in New York since 2000, 3,234 of these (or 71%) involved foods of foreign origin. Of that amount, 2,710 (or 84%) were categorized as class I or class II.
With the Imported Food Initiative, NYSDAM and FDA have developed a better understanding of the laws and the authority each agency has over imported foods, and they merge and utilize them wherever necessary to control violative food imports. Both agencies share resources and will work jointly with foods of imported origin to make better decisions on products to be detained for examination at the border. In addition, both agencies share any intelligence and information they may have that relates to food of imported origin in domestic commerce.
Integrated Information Technology Systems
In 2010, the Pennsylvania Department of Agriculture (PDA) in conjunction with 55 local health departments, implemented a new food safety inspection and licensing system, “USAFoodSafety.” The PDA recognized not only that they had this need but also that other states could benefit from this endeavor. Pennsylvania has made the solution available to other state/local governments through the National Agribusiness Technology Center (NATC). The NATC is a nonprofit entity that facilitates various activities such as enhancement requests and collaboration across the states. Since all development is done by a single software company, the enhancements are available at no additional cost to all states using the system.
Currently, 13 state food safety programs have implemented this solution, but more importantly, they have leveraged limited development funds to add several features and modules to the system. Many of the states were able to fund implementation and enhancement development by securing funds from FDA cooperative agreements and grants. The system helps states conform to FDA’s program standards.
Several states have developed modules in USAFoodSafety and they are made available to all states using the solution. For example, the Minnesota Department of Agriculture implemented tracebacks and recall functionality. The Iowa Department of Inspections and Appeals began to provide licensees uniform guidance documents associated with inspections, automated inspection report dissemination based on chain or owner, violation trends by chain or owner, a public-facing mobile app and an executive dashboard with broad search and summary ability of real-time data analytics for licensing, inspection, complaint and violations data. The dashboard received the AFDO’s Elliot O. Grosvenor Food Safety Award in 2016.
USAFoodSafety includes many functions for industry stakeholders as well as transparency for the public. There is an online system that allows management to automatically receive emails of all completed inspection reports for their brand and portals for facilities to electronically apply/renew their licenses. There also are portals for citizens to review inspection reports, giving them robust access to information. The adoption and collaboration of the USAFoodSafety solution between states leverages best practices in the food safety industry. This has allowed for increased communication, consistency and joint development for more uniform inspection methods and greater comparability of data analytics. The states also participate in user-group meetings that focus on setting priorities for the system, prioritizing development based on best practices in the industry and identifying potential areas for improvement and collaboration.
The next step of this process is working to build consistency in manufactured food inspections to allow for data exchange with FDA. Initial exchanges are scheduled to occur in mid-2017. The vendor is working with FDA and six states to pilot the National Food Safety Data Exchange, which will highlight the following capabilities between FDA and the states:
• State-to-FDA Electronic Transmission: (Submitting) Contracted inspection results
• FDA-to-State Electronic Transmission: (Receiving) Firm data
• State-to-State Electronic Transmission: (Requesting, receiving and sending) Facility search
State and local government food safety regulations and programs remain a mainstay in protecting the U.S. food supply. An IFSS would allow for resource leveraging, minimize duplication of effort and improve agency response effectiveness. With the inclusion of oversight, regulatory program standards, FDA audits of state and local programs and federal funding, many of the barriers to implementation have been resolved. Even expected resistance to change and cultural barriers seem less of an issue now. It appears that the country is ready for an IFSS, and it is being built brick by brick.
The authors wish to thank Alan Taylor, Maryland State Department of Health & Mental Hygiene; Peter J. Haase, WDATCP; Randy Treadwell, WSDA; Stephen Stich, NYSDAM; and Julianna Wittig, FDA, for their helpful contributions to the article.
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Go Feed the Animals
Source : https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2017/go-feed-the-animals/
By Jeff Strout and Nick Price
Have you ever had a pet that has gotten sick from eating its own food? Or how about a child who has gotten sick from sampling the dog’s food from the bowl? Even if you haven’t known a dog or a child to get sick from eating pet food, this is a very common occurrence and not fun for anyone. It has been estimated by the U.S. Centers for Disease Control and Prevention that about 1,500 humans have been infected by Salmonella through pet food sources.
The U.S. Food and Drug Administration (FDA) and the U.S. Congress have taken action to try to prevent these types of scenarios. The action is known as the Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals and is part of the recent implementation of the Food Safety Modernization Act (FSMA), which was established to provide a more preventive stance for our food industry (pet and animal food included).
According to FDA, “The Food Safety Modernization Act, the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
The final Preventive Controls for Animal Food rule, published in September 2015, has also since been established to “build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.” Although many throughout the industry are anxious and a bit nervous about the implications of this new rule, a majority are glad to see science and risk being brought into the new design of the food safety system for all pets and animals.
If you’re like us (and let’s face it, there’s a good chance you are), your pet’s safety is as important to you as your child’s. For this reason alone, the new guideline released in 2015 has had tremendous support. The American Pet Products Association estimates that approximately 65 percent of households in the U.S. spend over $62 billion each year on family pets.
The Animal Food Rule
The recalls for pet food and the potential human contamination risk led Congress to establish legislation to help FDA create key regulations to help identify hazards around pet food and animal food. This legislation will support pet food companies as they work to improve their food safety systems and thus lower the risk for pet food-related illnesses and the risk for human illness through pet food. However, this final rule also includes the food safety controls for other animal food. Why does regulation reference all animals instead of just pets?
Imagine a chicken farm. Because chickens must eat, what would happen if their feed was contaminated with Salmonella? What are the odds, do you think, that the Salmonella would be transferred to the chicken dinner later served? If a hen lays an egg after she eats feed that is contaminated with Salmonella, would there be a higher risk for Salmonella to the end consumer? Salmonella-contaminated chicken feed can lead to an enormous risk for various end consumers. By controlling the risk of hazards throughout the entire food chain, the overall opportunity for contamination getting into our food supply is significantly reduced.
Thankfully, there are regulations in place designed to protect animals in our food chain, our pets and fellow humans from hazards that might affect the food and feed that are consumed. The big question often heard is: “When do we have to comply?”
In September 2015, the final Preventive Controls for Animal Food rule was established with compliance dates dependent on company size (Table 1).
What Does It Mean?
Now, for the first time in the animal and pet food industry, there is a requirement to comply with the new Current Good Manufacturing Practices (CGMPs) for any location that must comply with the final rule mentioned above. This requirement states:
Any employees who handle, manufacture, process, pack or hold animal foods have rules and practices to follow in order to protect the products and packaging materials from contamination.
For some companies, this may be a completely new process, whereas others will just have to “tweak” their current systems to comply.
Additionally, any animal food company must ensure all its workers (seasonal and temporary) receive training in the principles of animal hygiene and animal food safety if they supervise or perform manufacturing, processing, packing or holding duties in the company. Auditors often ask the production crew making a product on a line, “What is the law or regulation requirements for making this product?” They usually receive deer-in-the-headlights looks from the workers, supervisors and managers. Most of the people could answer only basic GMP requirements like washing hands or clean clothing or not being ill when working with food. Not many individuals could fully explain how they know the products they make meet all of the law requirements or could explain how the company’s designed system ensures they meet the regulatory requirements. Could you answer that question? What about your employees?
The system is supposed to work as follows:
1. The company establishes a system of policies, Standard Operating Procedures and work instructions.
2. The people writing these documents ensure that all the requirements from the many laws (federal, state and local) as well as any other requirements (such as a Global Food Safety Initiative audit, customer requirements and company-specific requirements) are added to the policy, procedure or work instruction.
3. The company designs a training system to train the employees at the right time using an effective method and the right training message.
4. The company establishes an internal audit function to evaluate the effectiveness of the workers for following the company policies, procedures and work instructions (thus showing proof that they are following the current regulations). Usually, a finding on audits is a disconnect between what was done on the production floor and what was written in the instruction documents.
Animal food workers must know the rules for implementing food safety practices into the manufacturing, processing, packing and holding of any animal food. This doesn’t mean just when they are first hired but also periodically throughout their career. FDA expects companies to determine all refresher courses needed to implement up-to-date training schedules. Internal audits will help evaluate this process and answer the question “Is our training program working the way we need it to work?” If a company organizes its internal audit to be the most difficult audit to pass, it will find its noncompliance issues before anyone else and have an opportunity to shine during an external audit (regulatory, customer or third party).
Preventive Controls-Qualified Individuals
If you remember one thing from all your training, it’s that the policies, procedures, work instructions and GMPs should be based on the hazards identified at the facility. The processes a company implements should always be a reflection of the findings of the on-site food safety team. With FSMA, companies must design their food safety plan using an accurate facility- and process-specific Hazard Analysis, which requires a facility to identify a Preventive Controls-Qualified Individual (PCQI) for each facility.
A PCQI is required to be trained and have experience in how to effectively manufacture, process, pack and carry the products being produced. This person also must fully understand the requirements of the final Preventive Controls for Animal Food rule. The most efficient method used to show an FDA inspector that a PCQI meets all federal requirements is to produce a certificate of completion for a PCQI-approved course for animal food. This certificate is not required, but FDA inspectors accept it as evidence of meeting the requirement of the final rule. If you choose not to show the certificate, you would have to show proof of how you were trained, have the experience required to do the job and know the FSMA rule. How long would that take to show an FDA inspector?
There has been a widely used unwritten rule throughout the industry: Get the auditor in, give them what they need and get them out of the facility as quickly as possible. An FDA inspector will expect to talk to the PCQI and the person in charge while visiting the facility. He/she will probably want to see the Hazard Analysis and associated food safety plan that was performed to see what hazards exist within the facility’s processes.
Animal-Specific Hazard Analysis
While performing a Hazard Analysis for pet and animal food, it is important to fully understand the animals consuming the food, their specific nutritional needs and any possible food components that could possibly cause harm. For example, if sheep ingest too much copper with their food, they can develop copper toxicity poisoning, which is when copper builds in the liver and causes the liver cells to die and disperse copper into the bloodstream. Once this happens, sheep become lethargic and anemic, and death usually occurs within 1–2 days.
If a company makes sheep food, the amount of copper in that food becomes a potential hazard that will require an analytical process—the most critical part of the Preventive Controls for Animal Food rule. It is important to have the right people involved in the Hazard Analysis process; a cross-section of workers (production, quality, maintenance, sanitation, warehouse, purchasing, human relations, etc.) is recommended.
When identifying hazards and determining the associated risk of each hazard, don’t forget to determine which controls are already in place and successfully being implemented. During a Hazard Analysis process, be sure to properly examine the following:
1. Formulation of the animal food
2. Condition, function and design of the facility and equipment
3. All raw materials, ingredients and processing aids
4. Normal transportation practices and procedures
5. Manufacturing and processing procedures
6. Packaging and labeling activities
7. Storage and distribution procedures
8. Intended use vs. reasonably foreseeable use
9. Sanitation and employee hygiene
10. Other factors related to the food (such as seasonal issues, weather issues, humidity, etc.)
Every identified hazard must have the amount of risk determined while considering the probability and severity of the hazard. A rubric or matrix is not required, but may be found helpful, when determining this risk.
Many resources are available to help determine the probability and severity of hazards. Some resources are provided in Table 2.
The Need for Preventive Controls
Once a food safety team has properly determined and identified the hazards and risks in your process, it is time to assess whether there is a need to implement preventive controls. The final rule defines a “preventive control” as “a known or reasonably foreseeable hazard for which a person manufacturing, processing, packing or holding animal food would, based on the outcome of a Hazard Analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of a preventive control), establish one or more preventive controls to significantly minimize or prevent the hazard in an animal food and components to manage those controls as appropriate to the animal food.”
Basically, if you don’t control the hazard, it will result in illness for the animals that consume it.
Three basic types of preventive controls are described in the final rule: process preventive controls, sanitation preventive controls and supply chain preventive controls. However, the process preventive controls will be the most often used in a pet food or animal food facility. This control is used to ensure the control of parameters (defined later) during the manufacturing or processing of the animal food.
The processes that benefit most from the implementation of any of the three preventive controls include extrusion, flushing or sequencing procedures. The process preventive controls will often include heat processing, irradiating or refrigerating animal or pet foods. The controls used here were at one time referred to as Critical Control Points (CCPs) under the Hazard Analysis and Critical Control Points system; because of this, companies may choose to keep calling them CCPs or begin using the newer term: process preventive controls.
Every preventive control established in a facility must have four components implemented and managed to be compliant with the final rule.
2. Corrective actions and corrections
3. Verification (including validation)
Once a food safety team identifies a hazard requiring a preventive control, the PCQI should create a recall plan as part of the food safety plan; although this is not required by law, it is considered a best practice. We will discuss the recall plan later in the article.
To understand if a preventive control is successful, it is crucial to have a grasp of what renders the hazard controlled. For instance, if there is a raw meat, like chicken, being extruded and put into a kibble for a dog food, there are time and temperature constraints at which any potential Salmonella in the chicken will die and no longer be a biological hazard for the product. That time and temperature is known as a parameter (critical limit or value) for the preventive control. Once that limit is determined through research, a challenge study or a process validation, then a food safety team can establish a monitoring system to ensure that all products being extruded in the same process meet the parameter. The monitoring process lets you know you have safe products for that hazard.
If an established parameter is not achieved, the product may be unsafe.
If you have unsafe product, then the food safety team must determine the corrections and corrective actions that must be taken to ensure that no adulterated product is shipped out. These corrective actions and corrections should be in writing before the entire process begins so everyone is aware of what to do if the values are not achieved.
The final rule defines a “correction” as an action taken to identify and correct a problem that occurred during the production of animal food. A “corrective action” is an action taken to reduce the likelihood that the problem will reoccur or to evaluate the affected animal food for safety and to prevent it from entering commerce. Corrective actions might also include performing a root-cause analysis to determine the root causes of the problem so appropriate corrective actions can be implemented against them.
Preventive controls must also be verified to ensure the monitoring, corrections and corrective actions, and record-keeping practices are being carried out as designed to guarantee no adulterated product enters commerce. Verification should include certifying the parameters are being achieved as required for a safe product. The parameters must be validated to make sure they are actually controlling the hazard. For example, does 165 °F for 1 second actually reduce the particles of Salmonella in the product or process down to safe levels for our animal customers? The temperature and time (the heating process) must be validated—in addition to the equipment used in your facility. That is, can your equipment get your product to the required time and temperature?
Controls for Sanitation Hazards
Animal food and pet food facilities will often have prerequisite controls for sanitation hazards. These are designed to control the environment where ready-to-eat animal food is processed or packaged and may be exposed to environmental hazards (such as Salmonella and Listeria). The prerequisite program controls are also used for many identified supply chain hazards. This could include an ingredient or raw material that is received without being treated for a potential hazard and then added to the company’s finished product after a heat treatment step. The total risk for the hazard is placed on the incoming material since there is no additional control in place for that material or finished product. The company can choose to control the new hazard through supply chain control, placing the control with the supplier to show that the hazard was effectively controlled. Supply chain control can be either a prerequisite program or a preventive control. Either way, the identified hazard must be controlled, as it is unlawful to ship out a product that is known to be adulterated or contaminated in any way or where it might be contaminated.
Preparing a Recall Plan
As mentioned earlier, once a food safety team has identified a hazard that requires a preventive control, a recall plan becomes part of the food safety plan. If there is a risk for a hazard requiring a preventive control getting into the product, the facility must have the capability to recall that product if needed.
The recall plan should define the three classes of recall.
Class 1 — Reasonable probability of serious adverse health consequences or death
Class 2 — May cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote
Class 3 — Not likely to cause adverse health consequences
The recall plan should also cover team members’ roles and responsibilities, emergency contact lists for proper notification of regulators (federal, state and local as required), customers, suppliers and the public/media. There should be specific procedures for determining the lot numbers affected and the methods for determining the effectiveness of the recall throughout the recall operation. There should also be procedures to determine the disposition of the products based on the hazards identified and where the product is located. For example, class 1 recalls should not just be thrown away due to the risk for other animals going into dumpsters and consuming the affected products. These products should instead be destroyed with a completed certificate of destruction. All recalls must be properly documented, as FDA inspectors and other outside auditors will very likely review all recall documentation.
As you can see, a lot of work is involved in making sure that pet and animal food is safe for consumption. The entire supply chain is affected, and it is important to have all pieces in the process work together to produce a safe product. You do not want a pet or child sick from the food created in your company.
Food Safety Testing Market Report 2017-2027
Source : http://finance.yahoo.com/news/food-safety-testing-market-report-205900841.html By PR Newswire (Apr 7, 2017)
Forecasts by Contaminant (Pathogen, Genetically Modified Organisms (GMOs), Pesticides, Toxins, Other), by Food Tested (Meat & Poultry, Dairy Products, Processed Foods, Fruit & Vegetables, other) by Technology (Traditional, Rapid, Others) and by Region Plus Examination of Top Companies Developing Technologies Such as PCR, Biosensors & Chromatography
Download the full report: https://www.reportbuyer.com/product/4814611/
Visiongain's comprehensive new food industry report reveals that the food safety testing market will achieve revenues of $13.1bn in 2017.
Are you involved in the food supply chain of more specifically the food safety testing market? If so, then you must read this report
It's vital that you keep your knowledge up to date. You need this report.
Market scope: The Food Safety Testing reports provides insight into the large and ever growing food testing market and also examines the different testing technologies adopted worldwide. With outbreaks and contaminations such as salmonella, E. coli, listeria, and many more, the food testing market has grown at a rapid pace. Testing concerns as well as the rapidly growing international trade in food has stimulated the demand for more food safety testing all over the world and has led to technological innovation in areas such as rapid testing and new test technologies such as PCR, Biosensors and Chromatography, etc.
The Food Safety Testing Market Report 2017-2027 responds to your need for definitive market data:
Who are the leading food safety testing companies?
- See analysis of competitive positioning, capabilities, product portfolios, R&D activity, services, focus, strategies, M&A activity, and future outlook.
- AsureQuality Ltd
- ALS Ltd
- BioMérieux SA
- Bio-Rad Laboratories Inc,
- Bureau Veritas SA
- Eurofins Scientific
- Intertek Group PLC,
- LabCorp Holdings
- SGS SA
Where are the food safety testing market opportunities?
- 100 tables, charts, and graphs reveal market data allowing you to target your strategy more effectively
When will the food safety testing market grow?
- Global, regional and food safety testing submarket forecasts and analysis from 2017-2027 illustrate the market progression
Which food safety testing by contaminant type will evolve from 2017-2027?
- Genetically Modified Organisms (GMOs)
Which food safety testing submarket by food tested will flourish from 2017-2027?
- Meat & Poultry
- Dairy Products
- Processed Foods
- Fruit & Vegetables
Which food safety testing submarket by technology will thrive from 2017-2027?
Where are the regional food safety testing market opportunities from 2017-2027?
- Focused regional forecasts and analysis explore the future opportunities
North America food safety testing forecast 2017-2027
- US forecast 2017-2027
- Canada forecast 2017-2027
- Mexico forecast 2017-2027
Europe food safety testing forecast 2017-2027
- France forecast 2017-2027
- Germany forecast 2017-2027
- UK forecast 2017-2027
- Italy forecast 2017-2027
- Spain forecast 2017-2027
- Rest of Europe forecast 2017-2027
Asia Pacific food safety testing forecast 2017-2027
- China forecast 2017-2027
- Japan forecast 2017-2027
- India forecast 2017-2027
- Australia forecast 2017-2027
- Rest of Asia Pacific forecast 2017-2027
Rest of the World (RoW) food safety testing forecast 2017-2027
- Brazil forecast 2017-2027
- South Africa forecast 2017-2027
- Others forecast 2017-2027
What are the factors influencing food safety testing market dynamics?
- Porter's Five Forces Analysis explores the factors.
- The evolving challenge of food safety risks and threats
- Technological issues and constraints.
- Supply and demand dynamics
- Advances in testing speed
- Growing consumer demands for safer food
Who should read this report?
- Anyone within the food supply chain including
- Food testing equipment companies
- Specialist food testing laboratories
- Ingredients suppliers
- Agricultural companies
- Food manufacturers
- Food wholesalers
- Food retailers
- Food standards agencies
- Food scientists
- Business development managers
- Marketing managers
- R&D staff
- Other government agencies
Get our report today Food Safety Testing Market Report 2017-2027: Forecasts by Contaminant (Pathogen, Genetically Modified Organisms (GMOs), Pesticides, Toxins, Other), by Food Tested (Meat & Poultry, Dairy Products, Processed Foods, Fruit & Vegetables, other) by Technology (Traditional, Rapid, Others) and by Region Plus Examination of Top Companies Developing Technologies Such as PCR, Biosensors & Chromatography. Avoid missing out – order our report now.
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Only a handful of food questions during Gottlieb’s FDA hearing
Source : http://www.foodsafetynews.com/2017/04/only-a-handful-of-food-questions-during-gottliebs-fda-hearing/#.WOroldKLSUl
BY DAN FLYNN (Apr 6, 2017)
It was an hour and 57 minutes into the confirmation hearing for the next Food and Drug Administration commissioner before Scott Gottlieb drew a question about food.
Perhaps to be expected, it came from Sen. Pat Roberts, R-KS, who wanted to know if Gottlieb would favor setting some priorities for enforcement of the Food Safety Modernization Act (FSMA) and coordinate with the U.S. Department of Agriculture so that changes to nutrition labeling could occur at approximately the same time.
Roberts chairs the Senate Agriculture Committee.
Sen. Lisa Murkowski, R-AK, also had some questions about food for Gottlieb. With her constituents in Alaska still smarting from FDA’s 2015 approval of genetically modified salmon, Murkowski wanted to know if Gottlieb would re-visit the issue. She was critical of FDA for not only the approval, but for also deciding no special labeling is required for the product.
Gottlieb said he is willing to study the issue and work on it with Murkowski.
Murkowski also asked Gottlieb about FDA guidance issued in January, urging consumers to limit their in-take of certain fish because of mercury concerns. She said FDA did not take into account a “net value” study that shows people are better off eating more fish than less.
Gottlieb said he was willing to study that issue too, and work on it with Murkowski.
The confirmation hearing before the Senate Committee on Health, Education, Labor, and Pensions consumed two hours and 39 minutes. Chairman Lamar Alexander, R-TN, said additional written questions for Gottlieb must be turned in by Friday. The committee record will remain open for 10 days.
The “mark-up” session to send Gottlieb’s nomination to the full Senate for the confirmation vote won’t occur until the Senate returns from its spring break on April 24.
Alexander also announced Gottlieb’s nomination has the endorsement of Robert M. Califf and Margaret Hamburg, the FDA commissioners who served during the Obama Administration. He also said the committee has received seven letters with endorsements for Gottlieb from 29 professional organizations.
If confirmed, Gottlieb has agreed to resign from 13 boards and divest from about 20 different funds that are concentrated in pharmaceuticals and medical investments. Ethics officials have signed off on Gottlieb’s divestiture plan.
Several Democrats on the committee, especially Sen. Elizabeth Warren, D-MA, and Sen. Patty Murray, D-WA, spent much of their time picking apartment Gottlieb’s finances and his “big pharma” connections.
However, Republicans saw Gottlieb’s past experience with industries regulated by FDA as a plus, not a minus. Sen. Orin Hatch, R-UT, said he did not understand why Gottlieb is willing to give up so much to take the job, but that FDA will benefit greatly from the depth of his experience.
Gottlieb, a medical doctor and cancer survivor, was joined by his wife, daughters and his parents at the hearing. His father is also medical doctor. He served and was wounded in Vietnam.
Several times during the hearing, Gottlieb was asked what he would do if he was being opposed by the Trump White House. For example, FDA’s need to staff up to offset retirements in FSMA may be running counter to the administration’s hiring freeze. Gottlieb said he could be counted on to fight for what’s best for FDA.
Focus on opioid crisis
Much of the questioning was focused on the nation’s opioid crisis, including an exchange that began with Alexander asking Gottlieb about the promise of the 21st Century Cures Act and the possibility of developing non-addictive pain medicines in the near future.
“Dr. Collins, the head of the National Institutes of Health, has predicted a number of medical miracles over the next ten years. One of the most important would be the possibility of discovering non-addictive pain medicines which would make the opioid epidemic much less of a problem by providing a substitute,… ” Alexander said. “What could you do, as commissioner of the FDA, working with Dr. Collins, the president, and others in the administration, and with us, to be forward leaning on accelerating finding a discovery of non-addictive pain medicines, which might do more than anything to relieve the opioid epidemic?”
Gottlieb responded: “Thank you, Senator. The opioid epidemic in this country is having staggering human consequences. I think this is the biggest crisis facing the agency and is going to require dramatic action on the part of whoever steps into the agency. And I hope the Senate confirms me to take on this challenge.
“I think it’s going to require an all of the above approach. I think there are some things that we’re going to have to do to really push the boundaries of the policy framework in this area, and that does include reevaluating the framework for how we can develop alternatives to opioid drugs. I think it also includes looking at the device alternatives to opioid drugs and looking at devices in the context of drugs, and I would also add to that, looking at medically assisted therapy to help people live a life of sobriety after they have become addicted.”
If confirmed, Gottlieb will return to FDA for a third time. He was there as associate commissioner during the administration of George W. Bush. Since his last stint, the opioid crisis has engulfed the U.S., including many rural areas. Gottlieb said the opioid crisis is a public health emergency as much as Ebola or AIDS and must be given the same degree of attention.
Hong Kong announces latest food safety report
Source : http://www.foodsafetynews.com/2017/04/hong-kong-announces-latest-food-safety-report/#.WOrpVNKLSUl
BY NEWS DESK (Apr 5, 2017)
The Center for Food Safety (CFS) of Hong Kong’s Food and Environmental Hygiene Department has released the findings of its food safety report for February. The results of about 9,200 food samples tested were found to be satisfactory except for four unsatisfactory samples which were announced earlier. The overall satisfactory rate was 99.9 per cent.
A CFS spokesman said about 900 food samples were collected for microbiological tests, some 1,600 samples were taken for chemical tests and the remaining 6,700 (including about 6,400 taken from food imported from Japan) were collected to test radiation levels.
The microbiological tests covered pathogens and hygienic indicators, while the chemical tests aimed at detecting pesticides, preservatives, metallic contaminants, coloring matters, veterinary drug residues and others.
The samples included about 2,400 samples of vegetables and fruit and their products; 500 samples of meat and poultry and their products; 1,400 samples of aquatic and related products; 400 samples of milk, milk products and frozen confections; 400 samples of cereals, grains and their products; and 4,100 samples of other food commodities, including beverages, bakery products and snacks.
The four unsatisfactory samples were two vegetable samples detected with pesticide residues exceeding the legal limits; a mud crab sample found to contain a veterinary drug, chloramphenicol; and a roast beef sample suspected to be contaminated with Listeria monocytogenes.
The CFS has taken follow-up action on the unsatisfactory samples including informing the vendors concerned of the test results, instructing them to stop selling the affected food items and tracing the sources of the food items in question.
Since the Pesticide Residues in Food Regulation (Cap 132CM) came into effect on Aug. 1, 2014, as of Feb. 28 this year, the CFS had taken over 97,600 food samples at import, wholesale and retail levels for testing for pesticide residues. The overall unsatisfactory rate is less than 0.2 per cent.
The spokesman added that excessive pesticide residues in food may arise from the trade not observing Good Agricultural Practices, e.g. using excessive pesticides and/or not allowing sufficient time for pesticides to decompose before harvesting.
The maximum residue limit (MRL) of pesticide residues in food is not a safety indicator. It is the maximum concentration of pesticide residues to be permitted in a food commodity under Good Agricultural Practices when applying pesticides. Consumption of food with pesticide residues higher than the MRL will not necessarily lead to any adverse health effects.
Listeria monocytogenes can be easily destroyed by cooking but can survive and multiply at refrigerator temperatures. Most healthy individuals do not develop symptoms or only have mild symptoms like fever, muscle pain, headache, nausea, vomiting or diarrhea when infected.
However, severe complications such as septicemia, meningitis or even death may occur in newborns, the elderly and those with a weaker immune system. Although infected pregnant women may just experience mild symptoms generally, the infection of Listeria monocytogenes may cause miscarriage, infant death, preterm birth, or severe infection in the newborns.
The CFS spokesman reminded the food trade to ensure that food is fit for human consumption and meets legal requirements. Consumers should patronize reliable shops when buying food and maintain a balanced diet to minimize food risks.
Food Integrity: Innovation, Transparency and Trust
Source : http://www.foodsafetymagazine.com/enewsletter/food-integrity-innovation-transparency-and-trust/
By Brian Sterling (Apr 4, 2017)
In the first of this series of articles, we introduced food protection as a concept at the foundation of the goal we called food integrity. We proposed a model to help us investigate the interplay of food safety, food security, food defense and food sustainability on food integrity. In the second article, we started to explore how they interact, which required a definition for each of these terms. The hypothesis was that the four aspects of food protection each contribute and interact in their own way as the means to achieve the goal of food integrity.
We placed food security prominently in our model, because it is a fundamental need for people. It connects with the other three aspects of food protection. In this context, we take into account food security when we make decisions and take action on food safety and as we build a food safety culture into our organizations. Food security influences and is influenced by each of the others. Food security guides the efficiency and effectiveness of food safety. In turn, food safety strengthens food security; it informs the practical ways of inspiring confidence in the food we eat, lowering or eliminating foodborne illness.
Food sustainability is tougher to consider because it is fraught with baggage. How is this so? We said that food sustainability is the result obtained from all activities in the food system, so that food enhances a community’s environmental, economic and social well-being. Why is this so challenging?
It is partly due to the byzantine network of steps that bring food from farm to fork; however, there are other systemic reasons. There is close interplay between the physical aspects of producing food and the financial realities of business; there are also the political and cultural (even religious) realities of food production and consumption, along with the impact that producing food has on our environment. Finally yet importantly, there are the very genuine personal physiological and psychological impacts that food has on us all. With so many perspectives, it is understandable that food sustainability becomes complicated and complex to us.
At a pragmatic level, what does this all mean in terms of our food integrity model? If the value of food sustainability is that it is the operational result of food safety, food defense and food security, then the other three elements directly influence it. In a real way, they are said to operationalize, or bring into being, food sustainability. This suggests a solution to our confusion.
We said that food safety and defense drive the efficiency of food sustainability efforts; they are the means to align our need for safe food with confidence in the food we eat. Food security, on the other hand, drives the impact or the effectiveness of food sustainability; food security directs how our food system fits within a larger world and our view of it. How does this affect the actions of a farmer, or food distributor or manufacturer, or food service outlet? How does it impact the food system?
When considered through this lens, it is no longer be surprising that food sustainability has become a cacophony of programs, stratagems and actions. Our model tells us that sustainability is an outcome of all the stream of activities in the other areas. Therefore, it stands to reason that the more we understand the interrelationship and collaboration of activities in those elements, the more efficient and effective will be efforts to improve food sustainability. As alignment strengthens, the ‘higher’ we rise up the model towards our goal of food integrity.
What happens when we act in ways where these actions do not align? Our model says we lose efficiency and effectiveness—and operationalization suffers. It takes more energy, material, labor and money: more of many scarce resources, to build food sustainability. Sound familiar? For example, we know waste is a major crisis facing the food system. Between now and 2050, it is projected that the food system must produce 70 percent more than currently. How is this possible when we now waste more than 30 percent of what we produce? Now we can see that waste is directed impacted by food safety, food defense and food security. So we need to advance on all three in alignment to be most efficient and effective.
The strongest step we can take is to stop considering each element of food integrity in isolation and start acting in more collaborative ways on food safety, food defense and food security. While resources always are needed, we really require more innovation, more transparency and more trust to achieve our goal. In short, we need more of the things that are infinitely available. The actors in the system must expand their perspective and way of thinking to realize improved results.
To achieve food integrity, we know we must become more efficient and effective. Regulators, businesses and other stakeholders within the food system—from farm to fork—must act collaboratively through the various elements in our model. This will be the most positive way to succeed. Without innovation, transparency and trust, we will fall short; we will suboptimize food integrity and continue with a less efficient and effective system. We no longer can afford to do so.
States need $100M more for Food Safety Modernization Act
Source : http://www.foodsafetynews.com/2017/04/states-need-100m-more-for-food-safety-modernization-act/#.WOrpkdKLSUl
By DAN FLYNN (Apr 4, 2017)
President Trump may have proposed a “skinny budget” for most domestic spending, including food and agricultural program for the next fiscal year, but nobody is taking it seriously. Congress always reacts to presidential budgets with the same three words: “Dead on Arrival.”
For more serious guide posts, it’s always better to look at what the serious organizations —the ones involved with federal spending — are up to. For food and agricultural programs, including food safety, the National Association of State Departments of Agriculture (NASDA) stays in the thick of the federal budget.
NASDA, a bipartisan organization built around the appointed and elected state agricultural directors an commissioners, is out with a letter to congressional budget leadership that lays down some markers on spending needs when the next federal fiscal year begins Oct. 1.
In the letter, NASDA says state governments need an annual additional $100 million a year for “sufficient funding” for Food Safety Modernization Act (FSMA) implementation.
“While FDA is charged with writing the rules, significant implementation and enforcement activities under FSMA are the primary responsibilities of state agencies,” NASDA’s letter to budget writers says.
“It is crucial that Congress provide sufficient resources so as to avoid unfunded mandates on the states and to ensure farmers have the tools and education necessary to comply with these new federal requirements.”
NASDA also says it “continues to insist that FDA get the rules right. The combination of problematic elements of these regulations coupled with inadequate funding for their implementation will ultimately subject producers to inconsistent and arbitrary enforcement, putting their farms in economic jeopardy while doing little, if anything to enhance food safety. Funding to ensure parity between imported and domestic food is also necessary.”
State agricultural directors and commissioners see the additional $100 million annually as necessary to “ensure the systematic and timely implementation of the elements of FSMA for which state have primary responsibility.”
“To date, funding for states has focused on implementing the Produce Safety Rule, but funding is also necessary for the development and operation of programs associated with the Preventive Controls: Human Food and Preventive Controls: Animal Food rules.”
NASDA estimates the following funding levels for state programs are necessary:
Produce Safety $40 million annually for state programs
Preventive Controls for animal food $20 million annually for state programs
Preventive Controls for human food $40 million annually for state programs
In another food safety area, NASDA wants the budget prohibitions on USDA horse meat inspections removed and $63 million for state Food Safety and Inspection restored. The letter says the funding is “critical for states that provide state meat inspections under a variety of programs regulated by USDA’s Food Safety and Inspection Service (FSIS).”
On horse meat, they want an end to the use of on again, off again budget provision to prevent USDA from equine inspections. The letter points to a 2011 GAO study that found removal of USDA from horse meat inspections resulted in widespread starvation, abandonment of horses and unnecessary suffering of horses and horses becoming unwanted and being shipped to farther processing plants in Canada and Mexico.
No horse meat slaughter or processing remains in the United States, and during the last period when USDA could have provided inspections, a handful of proposals for such facilities fell through for a variety of reasons.
The Trump proposal cuts USDA by about $4.7 billion as part of about $54 billion the president wants to shift from domestic to defense programs without raising taxes. Many of those domestic cuts, however, would come out of international programs. USDA, for example, is being asked to “zero out” the bipartisan McGovern-Dole program for funding international school lunch programs.
Auditor credential program added to Food Safety Summit
Source : http://www.foodsafetynews.com/2017/04/auditor-credential-program-added-to-food-safety-summit/#.WOrp9NKLSUl
By CORAL BEACH (Apr 3, 2017)
Professionals in the food safety auditing arena are exercising practical application of the old adage if you’re not part of the solution, you’re part of the problem with the launch of a credentialing program.
The course work and independent exam have been in the work for six years and will debut at the 2017 Food Safety Summit next month. It’s a classic example of industry policing itself.
“One of the biggest complaints in the food industry about auditors is that it’s been like playing whack a mole to get rid of the bad ones,” said Patricia Wester, a former auditor who now owns PA Wester Consulting. “You identify them at a company and get them out, only to find they have gone to work at another company. They just keep popping back up.”
Wester, who started out in the meat industry before moving into the auditing sector, is one of two instructors for food safety auditor training certification course being offered May 8 and 9 at the Food Safety Summit in the Stephens Convention Center in the Chicago suburb of Rosemont.
Along with Wester, Robert Thrash, president of Process Management Consulting, is scheduled to provide instruction during the auditor training course.
The course curriculum was developed by the National Environmental Health Association (NEHA), an 80-year-old non-profit organization dedicated to improving professional standards in environmental health and therefore enhancing public health.
“One reason it’s taken six years to develop is because it’s complex and there is not a lot of material already out there to draw from,” said TJay Gerber, credentialing manager for NEHA.
Wester said while the Food Safety Modernization Act signed into law in 2011 includes auditors in its preventive approach to improving the nation’s food safety, federal law is short on specifics. Federal code defines an auditor as a “qualified individual… who has the education, training, or experience — or a combination thereof — necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties.
She said it’s not realistic to think that the Food and Drug Administration could conduct the audits similar to the way the USDA’s Food Safety and Inspection Service has inspectors on duty in every single slaughter operation.
“Meat has thousands of facilities,” Wester said, “but the FDA has hundreds of thousands of registered food facilities. There’s really no way for FDA to fund site auditors for all of them.”
The credentialing program from NEHA includes two tiers:
Certified in Food Safety Supplier Audits (CFSSA) status will prepare individuals for first- and second-party audits and can be a career path to becoming a third-party auditor; and
Registered Food Safety Auditor (RFSA) status is for more experienced food safety professionals, who are one of the last lines of defense in the complex global food supply chain.
Certificates of completion, which will be given to everyone completing the auditor training course at the Food Safety Summit, are from the new Association for Food Safety Auditing Professionals Auditor Academy.
People who complete the course at the summit have the option to take the NEHA credential exam on May 10 at the summit, if they apply by April 10. Wester said some people may prefer to take the course and then log real-world experience before taking the exam.
The exam, developed by NEHA with the help of professional test developers, is a proctored exam that takes three hours.
The CFSSA credential is awarded for a period of two years. To remain certified, credential holders must meet the renewal requirements. Renewal requirements are based on the philosophy of continued competence, and as such, credential holders must meet the renewal requirements. Credential holders must:
Earn and submit a minimum of 24 hours of continuing education every two years; and
Submit renewal fees for your credential every two years, which are $145 for members and $365 for non-members; and
Agree to continue to abide by and uphold the Code of Ethics and Professional Conduct Policy and the policies of the credential program, which includes continued appropriate and authorized use of the certificate, logo, and marks.
Early-bird registration discounts for the Food Safety Summit are available until April 15.
Anyone interested in taking the NEHA exam for the Certified in Food Safety Supplier Audits credential at the summit but apply by April 10. To apply to take the exam, should visit the NEHA website for additional application details.
Rep. DeLauro Applauds FDA for Closing Dixie Dew Products
Source : https://foodpoisoningbulletin.com/2017/rep-delauro-applauds-fda-for-closing-dixie-dew-products/
By News Desk (Apr 3, 2017)
Congresswoman Rosa DeLauro (D-CT) is applauding the FDA for closing the Dixie Dew Products processing plant, which is the contract manufacturer for The SoyNut Butter Company. I.M. Healthy SoyNut Butter products, made by The SoyNut Butter Company, are linked to an E. coli O157:H7 HUS outbreak that has sickened at least 29 people in 12 states.
The FDA’s investigations at the plant in Erlanger, Kentucky revealed that food safety violations at that facility go back at least 15 years. Some violations included broken temperature control equipment, an infestation of flies and larva, production machines that have not been cleaned since 2015, and no hot water in hand-washing sinks for the last two years.
DeLauro said in a statement, “Dixie Dew’s gross negligence is sickening dozens of Americans and leaving thousands more at risk of falling seriously ill. With fifteen years of food safety violations, I am outraged that it took 29 Americans falling sick before the Dixie Dew plant closed. Not only did Dixie Dew fail to take action to prevent contamination of its products, we do not even know all of the names and locations of where the recalled products were sold.
“While the FDA made the right decision in shutting down the Dixie Dew plant, the agency should take another step forward and reverse its policy of withholding the names and locations of stores and schools where recalled food products are sold. As we have seen with Dixie Dew, it is irresponsible and insufficient to rely on the good faith of food corporations to provide all the necessary recall information. Americans deserve to know these details to ensure their health and safety.”
In March, DeLauro wrote to the FDA, asking them to reverse its policy on withholding names and locations of stores and schools where the recalled I.M. Healthy products were sold. The FDA has not responded to DeLauro’s letter. [Food Poisoning Bulletin has a partial list of grocery store chains that sold those products.
The CDC’s latest update on the outbreak, posted on March 30, 2017, states that twelve of the twenty-nine patients have been hospitalized, and nine of them have developed hemolytic uremic syndrome (HUS), a type of kidney failure. Most of the patients, 24, or 83%, are under the age of 18.
Young children are more likely to develop HUS after a Shiga toxin-producing E. coli (STEC) infection, which explains why the rate of this complication is so high in this outbreak. In most E. coli outbreaks, only about 5 to 10% of patients develop HUS.
The symptoms of an E. coli O157:H7 infection include severe and painful abdominal and stomach cramps, diarrhea that is usually bloody and/or watery, and a mild fever. The symptoms of hemolytic uremic syndrome include little or no urine output, lethargy, pale skin, unexplained bruises, a rash, and bleeding from the nose and mouth. Anyone experiencing any of these symptoms should see a doctor immediately.
Pritzker Hageman, America’s food safety law firm, successfully represents people harmed by adulterated food products in outbreaks throughout the United States. Its lawyers have won hundreds of millions of dollars for survivors of foodborne illness, including the largest verdict in American history for a person harmed by coli and hemolytic uremic syndrome. The firm also publishes the E-news site, Food Poisoning Bulletin, a respected source for food safety news and information. Pritzker Hageman lawyers are regularly interviewed by major news outlets including the New York Times, CNN, and the Wall Street Journal. In addition, the firm represents people harmed by pathogenic microorganisms in Legionnaires‘ disease, surgical site infection and product liability cases.
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