Tag Archives: FSMA

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.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

The Impact of FSMA on Private Label Food Retailers

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

When fully implemented, possibly by the spring of 2016, the new U.S. Food Safety Modernization Act (FSMA) will raise the bar on food safety regulatory compliance both in the United States and around the world. The key provisions of FSMA will shift emphasis from the current reactive approach to food safety and food security, towards a more proactive science-based risk mitigation and prevention strategy. The impact will be felt across the entire global food supply delivery system from farm to fork including private label foods manufacturers, processors, suppliers, importers and retailers.

It has been projected that the sales of private label groceries in the United States alone will grow by 36 percent from $98 billion in 2011 to $133 billion in 2016. This impressive growth may be as a result of the competitive pricing of private label foods and the comparable quality with major brand products, as well as the convenience and customer trust in these in-store retail brands by today’s savvy shoppers. The consumer-friendly collaboration of private label manufacturers and retailers, or retailers that own their own private label manufacturing facilities is known to reduce the unnecessary supply chain costs by improving supply chain efficiency, enhances processes and systems, and improves the overall customer experience. These great value-proposition attributes will continue to make in-store private label products popular among consumers and profitable for businesses.

An important question however is how the new FSMA regulatory climate will impact these private label food products amid this growing popularity and in the context of the core business benefits of active management control, competitive prices, considerable return-on-investment and consumer satisfaction. On top of this list is the FSMA requirement for risk-based foreign supplier verification. This is to ensure that imported foods manufactured by foreign third party vendors or by US companies running their own facilities overseas are in compliance with the new FDA requirements, and that the food products are not adulterated or misbranded. Retailers of private label foods will be required to provide documented evidence from an accredited certification entity that shows that their foreign-supplied food products are in compliance. Frequent inspections of these foreign-based facilities and foods imported into the United States will be mandated under the new rule.

FSMA also sets the bar higher for retailers of private label foods in the key areas of food safety record keeping and documentation, traceability/recall programs, upgrading from ordinary HACCP to the more advanced Hazard Analysis and Risk-based Preventive Controls (HARPC), and implementing a verifiable supply chain management program. These provisions have the potential of making it more profitable for companies to manufacture their private label foods here in the United States instead of overseas where they lack active managerial control to ensure full compliance. Although domestic US-based manufacturers and suppliers are already covered under FSMA, retailers of private label food products manufactured in the United States are still advised to consistently verify that their suppliers are compliant, since retailers will also be liable for any infringement or negative outcome from such products.

For private label retailers that have proactively pursued industry benchmarking standards by insisting on GFSI certified facilities and who have an effective verifiable food safety management system in place, the impact of FSMA will be minimal. They will only need to re-examine their processes and systems to identify any gaps within the provisions of the new rule and put corrective actions in place. For others hoping to play catch-up, implementing the new FSMA requirements may become so overwhelming that the obvious business benefits of in-store private label foods like competitive prices and comparable quality with major brands may become severely undermined. The relationship of private label food manufacturers and processors with their retail partners could be impacted, as retailers would need to collaborate to profitably deliver what their customers want, namely, safe quality competitively priced mix of private label and brand food products.

Although the production and sale of safe quality food is mandatory to all food companies, under FSMA, small companies with less than $500k in annual sales and who sell directly to consumers within 275 miles radius of their facility may be exempt from some of the rigorous requirements of the preventive control rule. However, when large companies patronize these small local businesses, they must ensure that they are in full compliance since liability extends to retailers. National food service chains that manufacture their own private label ingredients and condiments or obtain these supplies from third party vendors are also expected to comply with the new rules. Overall, companies will be better off taking proactive steps in evaluating their suppliers’ food safety management system in line with the preventative control provisions under FSMA.

In conclusion, FSMA brings with it, a complete paradigm shift that will impact the entire global food supply chain. Retailers of private label foods must continue to assure their customers that their favorite in-store brands were produced, processed, stored and handled in a safe manner every step of the way. Thus, FSMA readiness and preparedness must include a comprehensive gap analysis to identify provisions of the new rules that must be implemented to stay ahead of the curve by next year when these regulations will potentially come into effect.

 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Top 5 FSMA Challenges

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

The year 2015 is almost two months in, and the U.S. Food and Drug Administration has got its head down looking at the comments to the re-proposed rules under the Food Safety Modernization Act (FSMA), with the first of several deadlines – August 31, 2014 – looming ahead.

Against this backdrop, food safety experts Dr. David Acheson, and Melanie Neumann, at The Acheson Group, discussed the Top 5 Challenges for becoming FSMA Compliant with SafetyChain Software’s Barbara Levin.

The top 5 challenges were identified as:

  1. Determining exactly which rules apply to you and what compliance will involve;
  2. Building a food safety plan – migrating from HACCP to HARPC;
  3. If you are a registered firm – building a supply chain management program;
  4. Determining what testing you will need to do; and
  5. Determining recordkeeping requirements for FDA.

Why have the above been identified as the top 5?

FSMA has thrown out a number of different rules, and for food companies, figuring out where you should fit can be difficult. For instance, should you be looking at Preventive Controls, or Foreign Supplier Verification Program? The language in the Produce Rule is complicated, so if you are a mixed type facility, it can be challenging. While most companies are familiar with Hazard Analysis at Critical Control Points or HACCP, the concept of migrating into Hazard Analysis and Risk-based Preventive Controls or HARPC is not that easy.

Getting a handle around your supply chain and its various components is just difficult, and just understanding what this requirement will involve will be a huge challenge.

While testing of agricultural water was addressed in the initial Produce Rule, the re-proposed Preventive Controls rule included environmental monitoring and finished product testing as requirements for compliance. It will be a challenge for companies to determine what kind of testing they will need to do.

Keeping track of the variety and volume of records that FDA will need to for FSMA will be a huge challenge.

While we could have picked up many more than five, these were the top five that we think will be the most challenging.

To determine what rules will apply to you and what will compliance involve, what are the top things you should be doing now?

Firstly, if you are not starting already to see what applies to you, then you are already behind. Do a FSMA readiness assessment and look at all the rules to determine which ones apply to you. For instance, if you are a company that makes cereal and cookies, then you probably don’t need to worry about the produce rule.

Once you determine the rules that are applicable to you, then the heavy lifting begins. You need to do a gap analysis to see where you are now and where you need to get to. Drawing out this road map to compliance then becomes critical, and that’s what companies need to do be doing now.

Building a food safety plan and migrating from HACCP to HARPC, what are the top things that you should be doing?

The goal of the preventive controls rule is to encourage food companies to start thinking much more about prevention. While HACCP principles are a great start, in some areas, it could be limited in scope, and focused only on critical control points that we can measure. But HARPC expands our thinking to risks that we can control that are beyond classic HACCP thinking, and don’t fit nicely into the seven steps of HACCP. For instance, hand washing – we may not be able to measure this, but this would still be a critical step to control risk. So it will be a challenge for food companies to take their HACCP program and elevate it to HARPC thinking.

If you are a registered firm, building a supply chain management program has been identified as the third challenge. How do you know if you have to register? What can you do now to build a supply chain management program? And would you consider this the biggest challenge for FSMA compliance?

The requirement for food companies to register has nothing to do with FSMA; it was included as part of Bioterrorism Act. According to this, if you are packing, holding, processing or manufacturing food, you need to register with FDA. FSMA added the requirement that this registration would need to be updated every two years. This requirement is now important as several of the supply chain management program rules, which are part of the Preventive Controls rule, apply to companies that need to register.

The requirement to have a supply chain management program was in very early versions of FSMA and then got pulled out, and then now it’s back. And it’s not going away. What can you do to prepare for this rule? Look at all your suppliers, look at who they are, what they are shipping to you – do a hazard analysis of all their products, know their risks and understand what they are doing to control that risk.

For instance, your supplier Mr. Smith is supplying you ground black pepper, which you are using in a variety of products. We have determined that ground black pepper has a potential for Salmonella risk and has been historically linked to Salmonella. So you need to do a hazard analysis and determine if it is a risky food and who is controlling that risk. Is it you or Mr. Smith, and that depends on what you are using that ingredient for. If you use it as a garnish in based potato chips, then there is no cooking or kill-step involved, so the risk should be controlled by Mr. Smith. Thus, FDA will expect you to figure out that Mr. Smith is indeed controlling that risk, which you can do through site visits and data.

Another scenario is that you get that pepper from Mr. Smith, but you are using it in soup, and thus, have your own kill step to control that risk. So you don’t need to pay that visit, put have your own procedures to address risk with that ingredient.

While ground black pepper is a straightforward example, where it gets tricky is when you have to do this will ALL your ingredients. Companies typically have hundreds of suppliers and thousands of ingredients. So start NOW to understand how this little part of the preventive controls rule will affect you; you only have about 18 months to figure this out. And for that reason, I think this will be a huge challenge.

How can companies determine what testing they will need to do? What should companies starting doing now?

While the original produce rule included testing requirements for water, the other testing requirements mandated by FSMA are mostly new. The preventive controls rule now requires food companies to have an environmental monitoring program in place. FDA has also laid out a strategy in which finished product testing can be used as a risk control system. It’s not mandated per se, but it may be a way to exercise the preventive controls rule. Companies need to plan right now to determine what kind of testing they will need to do, how to document it etc. The environmental monitoring program and product testing requirements are new. So start looking at these programs, understand the rules to determine which of these rules apply to you, and do the gap analysis and FSMA readiness assessment now.

You have identified that record keeping requirements for FDA will a major challenge. How can companies prepare for this?

Record keeping will be an area where companies are most likely to struggle. There will be mounds and mounds of documents that will be generated because of the FSMA rules. The days of filing cabinets are over, and it will be really hard to do this in a manual environment. Companies need to look at technology and automation to manage all this data. If companies happen to be regulated by dual agencies, we are talking about even more information that they need to collect and keep track of. So automate NOW.

We often notice that companies are keeping track of the right data and documentation, but are unable to prove this, and retrieve the information when needed. With FSMA, the agency is going to say, ‘if you can’t prove it, it didn’t happen.’ So companies need to get smart about having effective document retrieval systems.

Are there any additional challenges that FDA isn’t talking about that companies need to look out for?

While the above challenges broadly capture the most significant challenges, we think the following may also be something that companies would need to prepare for:

  1. High-risk list: This year, we expect FDA to announce some rules regarding this.
  2. Traceability requirements: FDA may reveal more about this and how his will link to the high-risk list.
  3. Voluntary Qualified Importer Program or VQIP: The needs and requirements for this are still not clear. We expect some rules to be proposed this year.
  4. Additionally, while we don’t expect it to happen, if FDA makes any radical changes with the final rules, that could generate some new challenges.

For more on this discussion, click here.

Retail Food Safety Forum

All About Food Policy: Interview with Baylen Linnekin

By Chelsey Davis
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GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains’ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.

GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains‘ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.

Linnekin is a licensed attorney and is the founder and executive director of Keep Food Legal Foundation, a Washington, DC-based 501(c)(3) nonprofit that promotes food freedom of choice—the right of every American to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of their own choosing. He serves as an adjunct professor at George Mason University Law School and an adjunct faculty member at American University, where his teaching focuses largely on contemporary food-policy issues. Along with faculty from Harvard Law School and UCLA Law School, Linnekin is one of six founding board members of the new Academy of Food Law & Policy. He is currently writing his first book, which focuses on the ways that government policies often thwart sustainable food practices, for Island Press. He is also serving as an expert witness in an ongoing First Amendment food-labeling lawsuit.

What are your thoughts on the final rules for menu and vending labeling that are set to be enforced by December 2015 (2016 for vending)? Do you think it will help fight obesity?

Linnekin: From both a theoretical and practical standpoint, mandatory menu- and vending-labeling is a lousy idea. Looking forward—from a theoretical perspective—even the chief architect of the country’s first menu-labeling law, former New York City health department head Thomas Farley, admits menu labeling “won’t stop the obesity epidemic[.]” Practically, we know Farley is right, as study after study has found that mandatory menu labeling doesn’t lead consumers to choose lower-calorie options, and may even cause them to choose options with more calories.

What is your take on “natural” labeling and advertising claims? Do you think things like this should be regulated, or better yet, more specific in regulation?

Linnekin: This is properly a matter for the courts. If someone believes they’ve been harmed by an “all natural” label—e.g., they were tricked into buying something by what they believe is a misleading label—then they should sue. The FDA should stay out of it. Instead, the FDA should permit any food label so long as it contains the required information—including an accurate list of ingredients—and doesn’t contain statements that are demonstrably false (fraudulent).

You talk about GMO labeling in a few of your recently published articles. If Congress were to pass a mandatory GMO-labeling law, what do you think would be the immediate ramifications to food manufacturers?

Linnekin: Mandatory GMO-labeling laws are bad for food manufacturers and consumers. Costs would rise for both thanks to new regulatory requirements and, for the former, threats of lawsuits. Thankfully, there doesn’t seem to be any stomach in Congress for passing a mandatory GMO-labeling law.

Can you elaborate on what you mean when you say things like, our “food freedom is under attack”?

Linnekin: I define food freedom as an individual’s right to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of his or her own choosing. Federal, state, and local government officials—both elected and working in regulatory agencies—are threatening this individual right. Many cities restrict a person’s right to plant a garden in their own yard, or to share food with the homeless and less fortunate. States have banned foods and food ingredients—from foie gras to Four Loko to raw milk. The federal government subsidizes farmers who grow some crops (i.e., corn and soy) and bans farmers from growing others (e.g., hemp). And it’s cracking down on foods that contain salt, caffeine, trans fats, and other ingredients. The list goes on. If the government were to restrict our speech—what comes out of our mouths—in the same way it does what we put into our mouths, we wouldn’t hesitate to say that free speech is under attack. That’s why I say food freedom is under attack.

With so many food recalls that occurred during 2014 and in previous years, how would you suggest food manufacturers prevent these issues while also not requiring additional regulation?

Linnekin: The U.S. food supply is remarkably safe. That’s thanks in very large part to the nation’s farmers and food manufacturers. The threat of harming consumers and consumer confidence—not to mention the lawsuits and calls for increased regulations that arise when such harm occurs—should be incentive enough for food companies to seek to prevent these issues from arising. But not all food regulations—even newer ones—are bad. I support the FDA’s mandatory recall authority under FSMA for many reasons, including because I think it makes lots of sense given the FDA’s original mission to protect food safety.

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. 

Top 6 Best Practices for Your Allergen Control Program

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Undeclared allergens are the cause of a great number of recalls in the United States, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under FSMA, good manufacturing practices are undergoing revisions, and the one area that has gotten the most attention is allergen control.

Undeclared allergens were responsible for the greatest number of recalls in the United States in 2013, causing significant consumer health issues, scrap costs, and sourcing conundrums. Under the Food Safety Modernization Act (FSMA), good manufacturing practices (GMPs) are undergoing revisions — and the one area that has gotten the most attention is allergen control. Under the new GMPs, an emphasis has been put on facilities to have an allergen control program.

Further, 15 million Americans and 17 million Europeans have documented food allergies. According to a study released by the Centers for Disease Control and Prevention (CDC), food allergies have increased by 50 percent among children from 1997 to 2011; and hospital admissions for severe reactions have increased seven-fold in Europe over the past decade, according to the European Academy of Allergy and Clinical Immunology.

FSMA’s Proposed Rule for Preventive Controls for Human Food has two major features–provisions requiring hazard analysis and risk-based preventive controls, and revisions to the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110. Included within these revisions is the requirement that each covered facility prepare and implement a written food safety plan, which includes a hazard analysis, preventive controls (e.g., process controls, food allergen controls, sanitation controls, and recall plan), monitoring procedures, corrective actions, verification activities, and recordkeeping.

Allergen Control Programs are multifaceted with elements ranging from ingredient supplier verification, storage, scheduling, formula and rework control, sanitation and changeovers, and label verification.

In essence, there are two main goals of an allergen control program, which appear simple on paper, but are very difficult to execute.

  • Goal #1: If you make a product with an allergen in it, you need to make sure that the allergen is declared on the label.
  • Goal #2: If you make a product that is NOT supposed to have a specific allergen in it, you need to do everything possible to prevent cross-contact.

So how can you make the most of your Allergen Control Program? Use these 6 Best Practices in this e-book, co-produced by TraceGains Inc. and AIB International. Click here to download.

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. 

Lawmakers Introduce Bill for Single “Food Safety Administration”

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Food safety oversight is currently split up among 15 agencies in the Departments of Health and Human Services, Agriculture, and Commerce. The Safe Food Act of 2015 introduced in both houses of Congress on Wednesday, aims to consolidate all the authorities for food safety inspections, enforcement and labeling into the Food Safety Administration.

Senator Dick Durbin (D-IL) and Representative Rosa DeLauro (D-CT) introduced bills in Congress yesterday with a goal to establish a single, independent federal food safety agency. The aim is to improve food safety for consumers, while also cutting back on the costs of a dispersed system with overlapping responsibilities between agencies, according to Durbin.

 

“What the bill does is remedy the situation,” DeLauro said. “With a single agency, we believe our country will be able to have the ability to detect relatively minor problems before they become major outbreaks.”

The Act would provide the Food Safety Administration with mandatory recall authority for unsafe food, require risk assessments and preventive control plans to reduce adulteration, authorize enforcement actions to strengthen contaminant performance standards, improve foreign food import inspections, and require full food traceability to better identify sources of outbreaks.

DeLauro said the bill builds on the improvements made in FDA’s Food Safety Modernization Act (FSMA).

The federal agencies that would be incorporated into one include:

  • FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM); 
  • The resources and facilities of FDA’s Office of Regulatory Affairs that administer and conduct inspections of food and feed facilities and imports; 
  • The resources and facilities of the Office of the FDA Commissioner that support CFSAN, CVM and inspections;
  • USDA’s Food Safety and Inspection Service;
  • The part of USDA’s Agriculture Marketing Service that administers shell egg surveillance services;
  • The part of USDA’s Research, Education, and Economics mission area related to food and feed safety;
  • The part of USDA’s Animal and Plant Inspection Health Service related to the management of animals going into the food supply; and
  • The part of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce that administers the seafood inspection program. 

A single food safety agency is not a new concept, and the two lawmakers have sponsored Safe Food Acts five times before, though the most recent was in 2007. In addition, the Government Accountability Office has reported on the need for better coordination of food safety activities over the years.

DeLauro mentioned eggs as an example to show how complicated the current food safety landscape was: “One agency manages the health of hens, another oversees the feed that they eat, another sets egg quality standards but does not test them for Salmonella,” she said. “While still in its shell, the egg is the responsibility of the Food and Drug Administration, but once it’s processed into an egg product, it becomes the responsibility of Food Safety and Inspection Service.”

Durbin and DeLauro are hoping to build bipartisan support for the bills. Current cosponsors of the Senate Safe Food Act include Sens. Dianne Feinstein (D-CA), Richard Blumenthal (D-CT) and Kirsten Gillibrand (D-NY). Cosponsors in the House include Reps. Barbara Lee (D-CA), Louise Slaughter (D-NY), James Langevin (D-RI), Bobby Rush (D-IL), Charles Rangel (D-NY), Jim McDermott (D-WA) and Delegate Eleanor Holmes Norton (D-DC).

Gina Kramer
Food Safety Think Tank

An Introduction

By Gina R. Nicholson-Kramer
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Gina Kramer

This new column on Food Safety Tech is a B2B forum for food safety tech, food manufacturing, food distribution, food retailer service/sales, and chemical and tools manufacturing companies in our industry. One of the important efforts we all have in common in this industry is we must continually identify food safety risk (or gaps) in food manufacturing, distribution, and sales to develop improved systems, methods, chemicals, and tools to fill these gaps and reduce risk. In the near future, many of these efforts will be mandatory due to the new regulatory rules being developed through FSMA.

Food Safety Think TankMy goal for this column is to facilitate new thinking to stimulate innovative solutions in food safety for our industry. I have the experience of leading large chain food sales and food service food safety programs; working with business professionals within our respective food companies and with our vendors, to develop systems and tools to improve food safety.

How can this column be of value to our industry?

  • Follow the column. Subscribe to FST News, and receive notifications of the column in your inbox whenever we post something new.
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  • Contribute. We are actively looking for industry professionals who want to share their work in food safety. Whether it’s benchmarking existing solutions or sharing your research that defines gaps and new opportunities for innovation, we need your contributions. Let’s invoke a broad range of new ideas across a wide range of issues to speed up new or improved tools, reduce cost, improve efficiency, and even develop new business models for food safety solutions. Write to me at Gina@SavourFoodSafety.com. I look forward to hearing from you.