Tag Archives: FDA

Standards for Animal Food Ingredients

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The U.S. Food and Drug Administration has announced a strategy to establish ingredient definitions and standards for animal food in order to increase transparency and affirm the safety of the animal food supply, as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

As part of the strategy, FDA will review the list of animal food ingredient definitions used by industry and state regulators, which is contained in Association of American Feed Control Officials’ (AAFCO) Official Publication. AAFCO is a voluntary membership organization that includes regulatory officials of U.S. state and federal government agencies. AAFCO provides a forum for these regulatory officials to provide guidance and recommendations to ensure that the regulation of animal feeds is as uniform as possible from state to state.

The Official Publication includes FDA-approved food additives and ingredients that are generally recognized as safe (GRAS), as well as AAFCO-established definitions for other ingredients. The FDA intends to align AAFCO ingredient listings with the agency’s regulatory process and requirements.

The agency has identified the following steps for animal food ingredients:

  • FDA intends to publish a proposed rule establishing as the agency’s standards and definitions for animal food ingredients the AAFCO definitions for those ingredients that are recognized as GRAS or approved by the agency as food additives. This proposed rule will be open for public comment, and the agency will consider those comments before issuing a final rule.
  • FDA scientists will evaluate the remaining animal food ingredients listed in the AAFCO Official Publication that are currently not FDA-approved food additives or regcognized as GRAS.
    • In cases where the scientific literature supports a GRAS determination, the FDA will publish the supporting information in the Federal Register for public comment before affirming the ingredient as GRAS.
    • In cases where the data and information support a finding that the ingredient meets the food additive approval standard, the FDA intends to approve the ingredient as a food additive.
    • In cases where the FDA does not currently have data to make a GRAS determination or to approve the ingredient as a food additive, the agency will require manufacturers of these ingredients to submit a food additive petition in order to allow continued legal use of the product in animal food.

Although animal food ingredient definitions and standards generally do not vary widely across the industry, and consumers can be confident in their accuracy, FDA’s strategy will formalize definitions and standards to meet federal laws and regulations.

The agency intends to work closely with industry during this transition to minimize disruption to animal food production and ensure transparency and clarity for both manufacturers and the public.

InstantLabs Launches DNA-based Atlantic and Coho Salmon SpeciesID Test Kits to Combat Seafood Mislabeling

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The company has broadened species identification product line created in partnership with University of Guelph and plans to release additional test kits during the year.

InstantLabs announced today the expansion of its SpeciesID product line by offering DNA-based tests for Atlantic and Coho salmon. InstantLabs SpeciesID™ tests provide accurate DNA verification in under two hours.

The launch of the salmon test kits highlights InstantLabs’ efforts to meet market demand by expanding the affordable, simple-to-use InstantID™ product line. The company already offers kits to identify Atlantic Blue Crab, pork and horse meat. The InstantLabs’ system gives food wholesalers, processors and inspectors a fast and reliable option for product tests.

The two new products were created in partnership with the University of Guelph, an international leader in agricultural and food science. The InstantID test kits for Atlantic (Salmo salar) and Coho salmon (Oncorhynchus kisutch) are the first of four salmon assays planned for release during 2015. InstantLabs will launch InstantID™ for Chinook (Oncorhynchus tshawytscha) and Sockeye (Oncorhynchus nerka) salmon later this year.

Expanding its presence in the high-demand seafood market, the Baltimore-based manufacturer of the Hunter® system expects to also release InstantID™ kits for snapper, catfish, grouper, and tilapia.

“Producers, wholesalers and government entities needs robust tools to combat seafood fraud,” said Steven Guterman, chief executive officer of InstantLabs. “InstantLabs’ real-time PCR testing systems and reagent kits can become an integral part in a testing program to verify labeling accuracy.”

InstantLabs’ Hunter® Real-Time PCR instrument combines accuracy, speed, and ease-of-operation into a compact portable system. The Hunter system is designed for use at points-of-need to detect and analyze a wide variety of food samples by targeting DNA. Results delivered quickly allow seamless integration into food industry firms’ processes and facilities.

Dr. Robert Hanner, Ph. D., has directed the University of Guelph’s research in conjunction with InstantLabs. “This collaboration has been essential in commercializing DNA-based food authentication tests for the seafood industry,” said Dr. Hanner, associate professor at the Center of Biodiversity Genomics. “This technology will help safeguard against existing supply chain vulnerabilities, protecting both businesses and consumers from food fraud.”

InstantLabs identification tests are designed for use on the Hunter, a real-time PCR system developed by the company, and are also available for use with other PCR instruments.

Seafood industry reports continue to highlight concerns about fraud, species substitution and consumer preferences to use sustainable fish stocks. Approximately one-third of all fish sold in the U.S. was mislabeled, reported a recent survey from Oceana. The U.S. Food and Drug Administration identifies a range of lower valued fish regularly substituted for 20 higher-priced species. InstantLabs will provide critical tool sets needed by the industry to ensure the integrity of the supply chain.

ABOUT INSTANTLABS:

InstantLabs, a molecular diagnostic device company, developed and markets the Hunter® Accelerated-PCR system, a fully-integrated, easy-to-use, portable and affordable real-time polymerase chain reaction (RT-PCR) platform for rapid, accurate pathogen detection. InstantLabs Medical Diagnostics Corp., the legal entity, offers the Hunter® system for use with several food-borne pathogen test kits for the global food industry. The Hunter® system is especially well suited for use at points-of-care and points-of-need to detect and analyze a wide variety of common and problematic pathogens. InstantLabs’ growing worldwide customer base includes some of the world’s leading food companies. InstantLabs is also developing products for additional markets, including medical diagnostics where gold-standard accuracy, combined with Ease-of-use and rapid results, are critical. Founded in 2008, InstantLabs is located in Baltimore, MD. For more information please visit www.instantlabs.com.

ABOUT THE UNIVERSITY OF GUELPH:

Acknowledged as one of the leading public research universities, the University has 39 Canada Research chairs in natural sciences, energy, health services and social sciences. With a commitment to student learning and innovative research, University leaders are dedicated to cultivating the essentials for our quality of life – water, food, environment, animal and human health, community, commerce, culture and learning. The University community also shares a profound sense of social responsibility, an obligation to address global issues and a concern for international development. Learn more at www.uoguelph.ca.

Additional resources on seafood fraud:

GM Apples and Potatoes are ‘Safe’: FDA

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Arctic Apples have ‘silenced’ genes that prevent them from turning brown when bruised, while genetic modification of Innate potatoes reduces the activity of genes that cause tubers to turn brown.

The U.S. Food and Drug Administration has completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are “as safe and nutritious as their conventional counterparts.”

Okanagan’s Granny Smith and Golden Delicious varieties of apples, known collectively by the trade name “Arctic Apples,” are genetically engineered to resist browning associated with cuts and bruises by reducing levels of enzymes that can cause browning.

Simplot’s varieties of Ranger Russet, Russet Burbank and Atlantic potatoes are collectively known by the trade name “Innate” and are genetically engineered to reduce the formation of black spot bruises by lowering the levels of certain enzymes in the potatoes. In addition, they are engineered to produce less acrylamide by lowering the levels of an amino acid called asparagine and by lowering the levels of reducing-sugars. Acrylamide is a chemical that can form in some foods during high-temperature cooking, such as frying, and has been found to be carcinogenic in rodents.

Foods derived from genetically engineered plants must meet the same legal standards, including safety standards, as foods derived from traditional plant breeding methods. Though producers of genetically engineered foods are not compelled to submit their products for FDA approval, both Okanagan, of British Columbia, Canada, and Simplot, of Boise, Idaho, submitted to FDA a summary of their safety and nutritional assessments.

“The consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties,” said Dennis Keefe, Ph.D., director of the FDA’s Office of Food Additive Safety. “This case-by-case safety evaluation ensures that food safety issues are resolved prior to commercial distribution.”

The changes are expected to make the produce healthier, more palatable and easier to transport and sell without spoilage, and hence result in less food waste. But the approval is expected to spark controversy among critics who argue that genetically modified foods will introduce potentially dangerous unknowns into the American food supply. Okanagan and Simplot may label their products as GMO, something that many consumer groups have advocated for.

Source: FDA.gov

CAPA and Root Cause Analysis for the Food Industry

By Dr. Bob Strong
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A thorough and effective CAPA can provide many benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections.

Why do a Root Cause Analysis? Because unless you identify the root cause of a problem, you cannot resolve it. You need to find out what went wrong, how the problem was not detected, or what has changed.

Often times, it may seem that a Correction conceived on the fly solves the nonconformity. However, manufacturing processes—especially in the food industry—can involve a huge number of variables. As a result, problems that arise can involve multiple levels of causal relationships that must be followed in order to locate the true root cause of a nonconformity. This is why performing an RCA is essential; we may think we’re addressing the root cause of a non-conformity with a Correction, but in fact, we are only treating a symptom of a larger (and often more costly) issue.

Without an RCA, it’s anyone’s guess whether a Correction will hold. The nonconformity might be solved, or it might come back—and bring with it other issues related to the root cause.In any case, guessing is not sound strategy for dealing with non-conformities. This is why it is essential for organizations to be disciplined in their approach to investigating non-conformities. Sure, performing an RCA takes time, and nobody wants to waste time on something unnecessary. Nevertheless, organizations should understand that identifying the root cause of a nonconformity early could save a great deal of time and expense in the long run. Of course, you won’t know unless you perform the RCA, so it is always a better practice to invest time into an RCA upfront rather than get exposed to a more serious nonconformity at a later date that could threaten the safety and/or quality of product being produced or handled.

Who should perform the RCA?

Though it may be possible for a single person to perform an RCA, it is always better to have a team of minds working on the problem—people who are familiar with the relevant products, processes, equipment, and challenges of the working environment. A team also brings a greater pool of experience, knowledge, and perspectives, which can be extremely helpful in the investigative process of an RCA. It also makes sense for your RCA team to be comprised of people who canhelp represent the resulting CA or PA plan to other areas of the organization and help facilitate buy-in, consensus, and execution of the plan

CAPA: The process unpacked

A new white paper, published by SAI Global Assurance Services, describes in detail the various steps involved in CAPA. Broadly, these have been described as:

  1. Identify the problem: Before you can solve the problem, you must identify it plainly and clearly.
  2. Evaluate /Review: How big is the problem? What are the implications? What is the severity of the consequences?
  3. Investigate: Make a plan to research the problem.
  4. Analyze: Identify all possible causes using different methodologies such as It is/ It is not analysis, the 5 Why’s Method, and The Fishbone Diagram
  5. The Action Plan: Narrow the list of possible causes.
  6. Implement: Execute the action plan
  7. Review: Verify and assess effectiveness

CAPA benefits

A thorough and effective CAPA provides a lot of benefits such as providing long-term solutions, preventing recurrences, fostering continuous improvement, improving customer satisfaction, improving profitability, and having the ability to influence FDA and FSMA inspections, frequency of which will be based on on the robustness of your food safety programs.

This article is an excerpt from a white paper prepared by SAI Global Assurance Services, and has been published in Food Safety Tech with permission. Click here to download the white paper in its entirety.

Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
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While HACCP has been highly successful and truly promoted seafood safety and consumer confidence in these products, there are several useful lessons that may make your transition to FSMA compliance easier.

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods.

Since the requirement for preventive controls is about to be extended to all foods regulated by FDA, it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

1. Unnecessary CCPs. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry. Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans. Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.

2. Mixing sanitation controls with HACCP controls. The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls. A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.

3. Monitoring need to be available in their original form in an organized fashion. Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators. If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.

4. If a new product is introduced to your processing operation the HACCP plan should be amended immediately. Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same. Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.

5. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator. For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.

6. Generic HACCP plans should not be used. In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis. This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis. Not doing so could result in a serious charge.

This article originally appeared in EAS-e-News, March 2015 edition. 

 

Getting Ready for FSMA: How a Laboratory Information Management System Can Help

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Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required by FSMA.

Do you know where your food comes from? How sure are you that it was grown, processed or produced with your safety as the priority? Increasingly this issue is headline news as we struggle with managing the outbreak of food-borne illnesses caused by the very stuff of our daily lives: salmonella contaminated peanut butter; e-coli contaminated beef and pork; contaminated spinach, lettuce and strawberries; melamine in milk.

In each instance, the grower or producer had inadequate methods in place to trace the original source of the contamination. The Mexican tomato business was devastated in 2009 when tomatoes were wrongly blamed for an outbreak of salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to know the contamination source. Several people died, many more became ill and a major business was destroyed for lack of information. The ultimate price for those food producers is that not only have they lost revenue due to product recalls, but, more importantly, they have also lost the trust of the buying public – and governments around the world have taken notice.

In the United States, the oversight of food had fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fell under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contained a combination of meat, dairy and produce fell under the oversight of the Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections had been low compared to the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public.

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The result of this legislation for consumers should be greater safety of their grown and produced foods. The impact for food producers will be mandates for upgraded business and operations plans, investments in instrumentation, software and manpower, and a safer food supply chain. This white paper discusses how to respond to FSMA, the role that traceability plays in it, and how leading food producers have implemented best practice solutions.

Employing a LIMS to meet the demanding FSMA requirements

The most important common thread throughout the FSMA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

  • Automated data collection from testing and delivering the records of proof that are required for regulatory compliance;
  • A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;
  • A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;
  • Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation; and
  • Assurance that all (standard, fast turnaround and condition sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, while recording that data for any subsequent inspection. Auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS whenever required to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning systems.

For some food testing laboratories, commercial LIMS have been too costly for the business to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. The new legislation will put enormous strain on these labs to remain compliant. Investing in a LIMS will give food testing labs, growers, producers and manufacturers the traceability they need to keep their products safe from contamination and to conform to the stricter regulations and reporting required of the FSMA.

Case Studies: LIMS providing traceability for food worldwide

Chr. Hansen is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in the United States, Denmark, France and Germany to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data, and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system, so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities technicians and laboratory administrators.

Molkerei Alois Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory. The Müller UK labs focus mainly on production Quality Control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller UK selected Thermo Scientific LIMS to manage their QC data for raw materials, in -process, and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies, and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements for food exports to countries including the United States. The LIMS has helped laboratory managers achieve faster assembly, collation, and review of information and data relating to QA/QC activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

This article has been adapted from a white paper presented by Thermo Fisher Scientific. Click here to access the white paper. For More Information about Thermo Scientific informatics solutions for the food and beverage industry, visit: www.thermoscientific.com/foodsafetyresources.

Millennials Are Changing the Food Industry

By Chelsey Davis
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Millennials are definitely changing the landscape of the food industry. What do they care about when it comes to food, and what does this mean for food manufacturers?

TraceGains_Millennials1

We’ve all heard the latest trends regarding that hard-to-reach audience we’ve dubbed the Millennials (those born roughly between the years 1980 and the early 2000s). And with so many how-to articles out there, it’s hard to really understand who these folks are and what they want. Here are just a few fun facts about this generation: 50 percent consider themselves politically unaffiliated, they have the highest average number of Facebook friends, 55 percent have posted a selfie or two to social media sites, and there are roughly 80 million of them. This makes Millennials the biggest generation thus far. And one thing is for certain, based on research, they are definitely changing the landscape of the food industry. So what do Millennials care about when it comes to food?

Millennials care about quality and sustainability

According to a 2014 study by the International Food Council (IFC), Millennials have the highest level of awareness out of any age group when it comes to food sustainability, and they are willing to pay more for it. And when it comes to quality vs. price, Millennials are more apt to be loyal to a brand deemed to have quality products as opposed to a brand that has a better price point.

Quality versus price for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Quality versus price for Millennials (Image courtesy of Business Insider via Goldman Sachs)

Take McDonald’s for example. In August of 2013, the fast-food chain reported a 13 percent decline in consumption for people between the ages of 19-21 since 2011. And while Millennials are still dinning out, they are opting for franchises like Chipotle and Five Guys. Why? These chains pride themselves on using local producers and sustainable food items, which makes paying that extra $2.00 for guacamole not so bad to this generation.

Additionally, Millennials are more apt to choose products that are socially responsible and produce lower carbon footprints. For example, Millennials are now paying attention to how much energy, water and effort it takes to grow, manufacture and transport food, including the packaging process. And as this environmentally friendly generation matures and moves into prime spending age, manufacturers will need to evolve the packaging of food products to ensure they are created with eco-friendly and recyclable materials if they wish to appeal to these folks.

Millennials care about their health

This generation, as research states, is more aware of their health than any other generation thus far, especially when it comes to what goes into their bodies. Locally grown, cage-free, all-natural, organic—these are all terms Millennials tend to gravitate towards when making food choices. As a result, organic coffee shops are popping up everywhere, farm-to-table restaurants are all the rage, and even private label brands are seeing increases in sales, with Millennials opting for those over national brands due to the perception that these labels are more innovative.

Millennials are also reading labels and are more aware of what the items on the labels mean—they understand the ingredients and what goes into their food more so than their parents and grandparents. As a result, we’re seeing an increase in natural and organic claims as we navigate through the grocery aisles.

Graphic showing wellness stats for Millennials (Image courtesy of Bushiness Insider via Goldman Sachs)
Graphic showing wellness stats for Millennials
(Image courtesy of Bushiness Insider via Goldman Sachs)

What this means for food manufacturers

Food manufacturers have an interesting challenge ahead, but also a great opportunity. The ones that will ultimately gain popularity among Millennials will be those that are willing to innovate while staying authentic. Millennials not only value the transparency of brands, they are also aware of shortcomings when it comes to unsubstantiated claims. Food manufacturers must now walk the line between making all-natural and sustainable product claims, and being 100 percent truthful in their statements. When it comes down to it, Millennials will do the research, read the labels and uncover the truth.

So how do you appeal to Millennials, while also mitigating the risks when it comes to labeling your product natural, organic or GMO-free? To answer tough questions like this, TraceGains got the inside scoop from Attorney Antonio Gallegos, who advises on compliance with regulations administered by the FDA, FTC, USDA and similar state-level agencies, and co-produced a guidance report. Use this free Natural Labeling Guidance Report to help you make informed decisions in the future for your products. Do you have additional tips for reaching Millennials? Leave a comment below and let us know!

No Industry Fees for FSMA – Food Groups Write to Congress

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A coalition of nearly 60 food groups, has now written to the Congress, urging the Senate and House of Representatives to fund the Food and Drug Administration without introducing new fees to the food industry.

The Obama administration budget proposal for fiscal year 2016 includes a proposal to impose a food facility registration and inspection fee to fund agency activities related to the Food Safety Modernization Act. The agency projects it would collect $60 million in fiscal year 2016. A food import fee was also proposed, with projected revenues of $103 million in FY 2016.

A coalition of nearly 60 food groups, has now written to the Congress, urging the Senate and House of Representatives to fund the Food and Drug Administration without introducing new fees to the food industry. The group — including the United Fresh Produce Association, the Food Marketing Institute and the American Farm Bureau Federation — is arguing that the new fees will hurt food producers and consumers.

Delivered before the March 4 House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations subcommittee hearing, the letter explained that Congress has previously rejected efforts to impose new regulatory fees on food makers and distributors to fund FDA’s food safety programs and should do so again.

“We believe if FDA requires additional funds in FY 2016 to support food inspection activities and implementation of the Food Safety Modernization Act, the administration should seek all such funding through the Congressional budget and appropriations process, rather than asking for authorization of new regulatory taxes that Congress has repeatedly rejected,” the letter said.

Top 3 Things to Know about President Obama’s FY 2016 Food Safety Budget Proposal

By Miranda Peguese
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Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

Food safety funding has been a major focal point for the FY 2016 budget proposed by President Obama. Primarily due in support of the fact that all major Food Safety Modernization Act (FSMA) rules are scheduled to take effect by the end of FY 2016, the increased focus will impact each of the agencies governing food safety within the US and all entities which fall under their jurisdiction.

Here are three things to know about the proposed food safety funding allocation for FY 2016:

1. There will be a sizeable increase in the allocation of food safety funding.

President Obama’s $3.99 trillion FY 2016 budget proposal allocates $1.6 billion for food safety, a significant increase in food safety funding over previous years. This would include increases of $301 million for the U.S. Food and Drug Administration (FDA) to support new measures under the Food Safety Modernization Act (FSMA), resulting in a $109 million increase over the previous year as well as an additional $2.1 million increase to the Centers for Disease Control and Prevention (CDC) over FY 2015’s $48 million allocation going towards food safety.

USDA budget requests would decrease slightly for FY 2016, requesting $1.012 billion vs. $1.016 billion for the previous year’s budget as a result of program related cost savings and correlated efficiencies and expects that a portion of the $2.9 billion for agricultural research and extension activities would support additional food safety requirements set forth by FSMA.

2. The proposed increase in food safety funds would include a prioritized food safety spending plan.

The increases to the allocated funding for food safety do not come without guidance. The funding increase includes a detailed plan for spending to include the following allocation:

  • $32 million for Nation Integrated Food Safety System
  • $25.5 million for New Import Safety Systems
  • $25 million for Inspection Modernization Training
  • $11.5 million for Industry Education and Technical Assistance
  • $4.5 million for Risk Analytics and Evaluation
  • $4 million for Technical Staffing and Guidance Development

The top three funding allocations noted are for integration, import, and inspection. These allotments directly reflect the directives set forth in FSMA

3. The plan also includes a proposed single food safety regulatory entity.

In addition to the increase in funding, the new plan outlined by President Obama also asks for Congress to combine several programs overseeing US food safety into a single agency under the Department of Health and Human Services (HHS). Advocates of the plan state that the combination would provide “focused, centralized leadership, a primary voice on food safety standards and compliance with those standards, and clear lines of responsibility and accountability”, citing the current food safety system as being fragmented and outdated. Currently, a total of 12 agencies enforce 30 different laws. An alternate proposal has also been put forth by two members of congress which would suggest the formation of a new food safety agency independent of HHS.

How does this affect your facility? Knowing the government’s increased focus on food safety means companies must continually be audit ready with program sustainability as a focus for management and employees alike. Commitment to food safety and a sound preparation plan is key for facilities as they navigate through the increasing food safety regulatory oversight.

To learn more about the food safety allocations within the proposed FY 2016 budget, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm432576.htm and http://www.usda.gov/wps/portal/usda/usdahome?navid=BUDGET.

Food Safety Agencies Introduce New Model to Better Identify Foodborne Illness Sources

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FDA, CDC and the USDA’s FSIS have jointly released a report on the new method for analyzing outbreak data to identify better foods that are responsible for illness related to four major foodborne bacteria.

Titled “Foodborne Illness Source Attribution Estimates forSalmonella, Escherichia coli O157 (E. coliO157), Listeria monocytogenes (Lm), and Campylobacter using Outbreak Surveillance Data,” the report was produced by the Interagency Food Safety Analytics Collaboration (IFSAC).

FSTNewsNewModelforOutbreaks For the new model, IFSAC analyzed data from nearly 1,000 outbreaks that occurred between 1998 and 2012, excluding those that involved multiple pathogens, those for which no food vehicle was identified, and those attributed to food containing multiple ingredients, to assess which categories of foods were most responsible for making people sick with Salmonella, E. coli O157, Listeria, and Campylobacter.

The pathogens were chosen because of the frequency or severity of the illnesses they cause, and because targeted interventions can have a significant impact in reducing them. Some of the findings include:

  • More than 80 percent of E. coli O157 illnesses were attributed to beef and vegetable row crops, such as leafy vegetables.
  • Salmonella illnesses were broadly attributed across food commodities, with 77 percent of illnesses related to seeded vegetables (such as tomatoes), eggs, fruits, chicken, beef, sprouts and pork.
  • Nearly 75 percent of Campylobacter illnesses were attributed to dairy (66 percent) and chicken (8 percent). Most of the dairy outbreaks used in the analysis were related to raw milk or cheese produced from raw milk, such as unpasteurized queso fresco.
  • More than 80 percent of Listeria illnesses were attributed to fruit (50 percent) and dairy (31 percent). Data were sparse for Listeria, and the estimate for fruit reflects the impact of a single large outbreak linked to cantaloupes in 2011.

The new model using data from the resulting 952 outbreaks differs from previous methods by using a categorization of foods updated to align with the regulatory framework of FDA and FSIS. The model focuses more on recent outbreaks by giving less weight to data from 1998 through 2007, and decreasing the bias that potentially results from very large outbreaks.

“This suggests interventions designed to reduce foodborne salmonellosis need to include a variety of approaches,” IFSAC’s report states. “For [Listeria monocytogenes], the limited number of outbreaks and wide credibility intervals dictate caution in interpreting the attribution percentages for fruit and dairy,” the report notes.

The report also noted that “Lm outbreaks have been frequently linked to the Dairy category, specifically with the consumption of soft cheeses by pregnant women and persons with weakened immune systems. Although the wide credibility interval for the Fruit category substantially limits interpretation, the analysis does suggest vigilance in seeking unrecognized sources of outbreaks and illnesses in this food category.”