Tag Archives: FDA

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.”

Dietary Supplements: Verifying Label Claims “By Input” Unacceptable

By Tara Lin Couch, Ph.D.
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FDA issued more than 400 Warning Letter citations for inappropriate specifications in dietary supplement during 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications, but recent citations have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants.

Criteria used to establish that these requirements are met are supposed to be provided in a Finished Product Specification developed by the dietary supplement company. FDA issued more than 400 Warning Letter citations for inappropriate specifications in 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications at all, but recent Warning Letters have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The input of a dietary supplement alone is not a scientifically valid analytical test method for determining the strength of a dietary ingredient in a finished product. Chemical testing of the ingredient should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, the testing may be exempted provided dietary ingredient raw material testing, in-process testing, other finished product testing, process controls, and additional information can support that the strength of the dietary ingredient can be verified without testing, as allowed in 21 CFR 111.75(d)(1).

The incoming dietary ingredient raw material must be verified to meet quality requirements for identity, purity, strength, and the lack of potential contaminants. Warehouse controls must then ensure that the material is held in a condition in which its quality is not altered. The material must be formulated at an appropriate amount, with sufficient overage, to meet the label claim while taking into account manufacturing variability. This is dictated in an approved Master Manufacturing Record (MMR). Once executed, the Batch Production Record (BPR) must document that the correct amount of the dietary ingredient was actually dispensed into the product during manufacture. Established in-process examinations and tests are then used to verify that the batch is uniformly mixed and meets the unit dosage weight and weight variation requirements. Variations on weight cannot exceed the overage amount to ensure that even the smallest dosage unit still complies with the label. In-process chemical tests can also be employed to verify the amount of a dietary ingredient. This can be particularly beneficial if the reason a dietary ingredient is exempted from testing is because of matrix interferences or instrumental quantitation limits.

Other finished product testing can also be used to support that an exempted ingredient is present in the product at the correct, labeled amount. Test results from chemically similar ingredients that are determined to be as expected suggest that the exempted ingredient is also present at expected levels because these ingredients will tend to react the same way during manufacture, especially if both ingredients are introduced and processed in the same step. Results obtained from finished product testing of other ingredients whose concentrations are associated with the exempted ingredient may also support that the exempted ingredient is present as expected.

Finally, the number of other finished product ingredient tests that are performed is important. If all other test results are determined to be within specification, it indicates that the product was manufactured according to the MMR and there is no reason to expect anything different from an exempted dietary ingredient.

Dietary supplement companies that are compliant with all parts of 21 CFR 111 will already be performing these activities. A procedure that summarizes the overall process of verifying the addition of a dietary ingredient can then be created and used as the test method reference on the Finished Product Specification. A separate document that describes the details of test exemptions per product should also be generated. The actual result obtained should be acquired from the completed batch production record.

The “By Input” approach is no longer relevant.

This article originally appeared in EAS-e-News February 2015 issue.

FDA Commissioner Hamburg to Step Down

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Hamburg, one of the longest-serving FDA commissioners in the modern era, told Reuters in an interview that her decision was prompted by the heavy demands of the job and the sheer length of time she has held the position.

Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), who for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine, disease control and drug approvals, is stepping down, Reuters News Agency has reported.

Hamburg, 59, is one of the longest-serving FDA commissioners in the modern era. She was nominated by President Barack Obama and confirmed by the U.S. Senate in May 2009 and last year was named the world’s 51st most powerful woman by Forbes.

Hamburg, one of the longest-serving FDA commissioners in the modern era, told Reuters in an interview that her decision was prompted by the heavy demands of the job and the sheer length of time she has held the position. “This is a very challenging job full of opportunities to make a huge and enduring difference,” she said, “but it is 24/7 and there are really really difficult decisions to make.”

Late last month, the agency named Dr. Robert Califf, a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. Reuters adds that Califf may be a potential successor to Hamburg.

A long-time public health official with extensive experience fighting AIDS and tuberculosis, Hamburg, who graduated from Harvard Medical School, previously served at the National Institutes of Health before becoming New York City’s health commissioner.

Click here to read the Reuters article.

Funding Critical for FSMA, Says FDA’s Taylor

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In an FDA blog, the Deputy Commissioner for Foods describes that work must be done right now to ensure that FSMA rules are implemented smoothly and effectively in late 2016 and 2017, and lists several areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

President Obama’s FY 2016 budget request would provide an additional $109 million for FSMA implementation. In the current fiscal year, FDA received an additional $27.5 million. And at this juncture as Congress considers the funding that will help transform all the plans and preparations for FSMA into protections that will greatly reduce the number of illnesses caused by contaminated foods and greatly increase consumer confidence in the safety of our food supply, this additional investment would be critical for the success of FSMA and its implementation, writes Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.

In an FDA Voice blog, Taylor describes that work must be done right now to ensure that the FSMA rules are implemented smoothly and effectively in late 2016 and 2017, and lists the areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

  • Approach to food safety inspections and compliance will be fundamentally different. FDA will deploy inspectors who are specialized in specific food commodities, rather than covering a broad range of FDA-regulated products. Backed by technical experts, they will assess the soundness and performance of a facility’s overall food safety system. Achieving this will require a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers and other staff involved in food safety activities.
  • For vast majority of food producers want to comply and keep their products safe. FDA will be issuing guidance documents that will be essential to helping industry meet FSMA requirements. Funds are needed now for FDA to recruit additional experts who can ensure that guidance development is based on the best science and knowledge of industry practices.
  • Education and technical assistance to help farmers, processors and importers—especially small businesses—implement the new standards. FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance. FDA has also joined with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) in providing grants that will fund food safety training for small, sustainable and organic farm owners and food processors.
  • State partnerships. There are more than 3,000 state, local and tribal government agencies involved in food safety. To align state programs with FDA’s new facility inspection and compliance approach, the agency will provide states with funds for inspector training, information sharing capacity with FDA and other states, state laboratory coordination, and inspector certification programs, and these preparations must be accelerated in 2016.
  • Modernize how we ensure the safety of imported foods. The Foreign Supplier Verification Program will require a substantial regulatory development process, increased staffing and the training of more than 400 investigative and compliance personnel within FDA to enforce the regulation. It will also require extensive training and technical assistance for importers.

Those are just the highlights; there’s much more to be done. The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed. This would be bad for everyone, including those who must meet the new standards and those who must enforce them. Most importantly, it would be bad for consumers, who want to be sure that the foods they are eating and serving their families are safe.

Click here for the full blog. 

FDA Seeks Key Investments for Implementing FSMA

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The agency makes a case for immediate investments now, and sustained funding in future years, explaining that there is a risk of delayed, uneven, and potentially disruptive implementation of FSMA, to the detriment of public health and the food industry.

The FDA Food Safety Modernization Act (FSMA) was signed into law in January 2011. FSMA reflects the need for a modern, global food safety system that prevents problems rather than primarily reacting to them after they have occurred.

The law, which received bipartisan support, followed a series of severe outbreaks of foodborne illness. It responds to the significant burden of foodborne illness in the United States each year, which the Centers for Disease Control and Prevention estimate at 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths. The economic losses to industry, including farmers, are enormous, estimated at over $75 billion per year.

Since FSMA was enacted, FDA has carried out extensive work to implement the law by publishing key FSMA proposed rules that would provide needed food safety protections for the American public, while at the same time making the proposed rules as flexible as possible and workable.

These proposed rules were informed by current industry practices and by conducting extensive outreach and dialogue across the country and overseas with farmers, manufacturers, commercial food handlers, consumers, and government partners.

Currently, FDA is under court-ordered deadlines to issue all seven of these key final rules:

  • The final rules for preventive controls for human and animal foods are due on August 30, 2015;
  • The final rules on produce safety, Foreign Supplier Verification Programs, and accreditation of third party auditors are due on October 31, 2015; and
  • The final rules for sanitary transportation and intentional adulteration are due on March 31, 2016, and May 31, 2016, respectively.

Implementation

Developing reasonable, effective, and flexible rules is just the first step in FSMA implementation. Much more needs to be done to ensure smooth and effective implementation in late 2016 and 2017. And additional funding is needed to support the following areas:

  • Inspection modernization and training;
  • Furthering the National Integrated Food Safety System;
  • Education and technical assistance for industry;
  • Technical staffing and guidance development at FDA;
  • Building the new import safety system; and
  • Risk analytics and evaluation.

FDA is also committed to change within the agency itself to enhance industry compliance with the FSMA rules. First, FDA is overhauling its inspection model to fulfill FSMA’s prevention mandate. To carry out the new model, FDA will increase specialization of the inspection and compliance workforce, build a new compliance culture within FDA that uses a variety of tools and incentives to achieve compliance, and invest in training to ensure expert and consistent inspections and sound decision making.

Second, the agency will assume that most in industry want to comply with food safety standards and thus will educate before and while it regulates through guidance, education, and technical assistance.

Third, the frequency and manner of FDA’s inspections will be guided by a company’s food safety culture and performance.

The allocation of funds needed in FY 2016 to make these changes is outlined below.

FY 2016 plans for requested budget authority

With a total of $1.3 billion in budget authority, an increase of $109.5 million, requested in the President’s Budget, FDA will make improvements in the following areas, continuing improvements that began with FY 2015 funds.

1. Inspection Modernization and Training – $25 million

FSMA fundamentally changes FDA’s approach to food safety oversight, from primarily reacting to problems to preventing them in the first place. New inspection and compliance strategies will be a key component of this shift. FDA is not requesting more inspectors for domestic inspections, but rather will increase efficiency and effectiveness of current inspectors through the use of new inspectional models and approaches. Inspectors are currently trained to inspect food manufacturers using a compliance model focused on finding evidence of violations and bringing enforcement cases. The new food safety paradigm will be focused on whether firms are implementing systems that effectively prevent food contamination, requiring fundamentally different approaches to food safety inspection and compliance. For example, FDA will deploy more specialized inspectors, supported by technical experts, to assess the soundness and performance of a facility’s overall food safety system and will use data to guide risk-based inspection priority, frequency, depth, and approach. FDA will also focus on ensuring consistency among inspections conducted by FDA or the states on behalf of FDA.

This new paradigm involves a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers, and other staff involved in food safety activities. FDA has also committed to improving risk-based targeting, which will require better data about facilities, new IT systems to identify and track risk, and methods for assessing and tracking inspection efficiency and inspector competency.

2. National Integrated Food Safety System – $32 million

Congress recognized that the success of FSMA implementation depends on fundamentally new approaches to collaboration among the more than 3,000 state, local, and tribal government agencies involved in food safety. Building a National Integrated Food Safety System is a complex and long-term process. To be successful in aligning state programs with FDA’s new facility inspection and compliance approach, approximately 1,000 state inspectors will need training, and the states will need real-time information sharing capacity with FDA and other states, state laboratory accreditation, and inspector certification programs. Those processes, which will be carried out mostly via FDA grants and cooperative agreements to states, have been ongoing but must be ramped up significantly in 2016 to help ensure that states conduct sound, consistent inspections when industry must comply with the new preventive controls rules starting in late 2016. In addition, to successfully implement the produce safety rule, FDA must build state partnerships and capacity in 2016 to provide education and technical assistance to growers in anticipation of the rule starting to be implemented in 2017.

3. Education and Technical Assistance for Industry – $11.5 million

With FDA’s new approach to ensuring food safety, education and technical assistance are needed to help farmers, processors, and importers—especially small businesses—implement the new prevention-oriented standards. Approximately 300,000 entities could be subject to the final FSMA rules. FDA believes that it should expend substantial financial resources to provide such assistance and will make training materials widely available to protect public health. FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance.

4. Technical Staffing and Guidance Development at FDA – $4 million

Maintaining an adequate number of highly qualified technical staff at FDA is always a priority and challenge, but FSMA makes it essential to achieve this goal. In addition to regulatory standards for FSMA, FDA is issuing guidance documents that express the agency’s current thinking and are essential to helping industry to comply with the FSMA requirements. Funds are needed now to recruit additional experts at FDA who can ensure that guidance development, which is now underway, is based on the best science and knowledge of industry practices. More experts are also needed to conduct outreach to industry, academia, and state extension services to ensure that their concerns are heard, that their advice is solicited and utilized, and that the guidance documents reflect the most cost-effective solutions achievable. They will also play an essential role in supporting FDA’s inspection and compliance force in properly overseeing implementation of the new standards and achieving high rates of compliance.

5. New Import Safety Systems – $25.5 million

Improving oversight of imported food is crucial to protect public health and ensure consumer confidence in food safety, regardless of whether food is produced domestically or imported. The food consumed by Americans today comes from over 200,000 different food facilities, more than half of which are located outside the United States. For example, about 50% of fresh fruits, 20% of fresh vegetables, and 80% of seafood consumed by Americans is imported. The volume of imported food has increased enormously over the past 20 years, going from fewer than 200,000 line-entries in the early 1990s to an estimated 12 million in 2013. The Foreign Supplier Verification Program (FSVP) mandated by FSMA, will require importers to implement supplier verification plans to help ensure food produced overseas meets U.S. food safety standards. This shift presents an enormous challenge for both FDA and food importers, given that there were approximately 88,000 consignees receiving food shipments last year. To be successful, FSVP implementation will require a substantial regulatory development process, training of more than 400 current FDA investigative and compliance personnel, and the addition of new staff (including 50 in 2016) with the audit skills needed to assess importer safety plans. It will also require extensive training and technical assistance for importers.

6. Risk Analytics and Evaluation – $4.5 million

Focusing decisions and resources on areas of greatest risk to health is a key element of FSMA, so FDA is developing new tools that will provide the information needed to do so. This includes new tools for ranking risks, prioritizing program activities based on opportunities to reduce risk, and linking risk-based priorities more clearly with budget formulation and execution. For example, these tools will better inform FDA about which foods, including animal foods, are most vulnerable to which bacterial contaminants, and where it should invest its research efforts to most effectively identify how to reduce contamination of food. This will improve FDA’s productivity in all areas, including research and standard setting, inspections, and guidance to industry.

Note: The $109.5 million increase in the food safety budget for FDA includes $7 million for necessary infrastructure costs.

Conclusion

Developing reasonable, effective, and flexible rules to create a modern, prevention-based food safety system is a formidable job, but it is just the first step in FSMA implementation. Much more needs to be done to lay the groundwork for smooth and effective implementation of FSMA in late 2016 and 2017. Without an immediate investment now, and sustained funding in future years, there is a risk of delayed, uneven, and potentially disruptive implementation of FSMA, to the detriment of public health and the food industry. 

Source: This article has been adapted from a paper authored by FDA, which can be accessed here.