Tag Archives: FSMA

Deirdre Schlunegger, Stop Foodborne Illness
Food Safety Culture Club

How We Use the Word ‘Recall’ Matters

By Deirdre Schlunegger
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Deirdre Schlunegger, Stop Foodborne Illness

“Recalls”. This topic got me thinking, what is the literal meaning of recall? So, I looked it up:

Verb

  1. Bring (a fact, event or situation) back into one’s mind, especially so as to recount it to others, remember.
    “I can still vaguely recall being taken to the hospital”
  2. Officially order (someone) to return to a place
    “the Panamanian ambassador was recalled from Peru”

Noun

  1. An act or instance of officially recalling someone or something
    “the recall of the ambassador”
  2. The action or faculty of remembering something learned or experienced.
    “their recall of dreams”

Many people think of FDA when hearing the word “recall”, and many consumers believe that the FDA often or even always orders recalls. In fact, the FDA relies on responsible parties to voluntarily recall food products when a threat exists, but FSMA’s mandatory recall authority allows FDA to mandate a recall only when the criteria under section 423 of the FD&C Act are met.

For most, the word “recall” is all too familiar. We hear it so often that I wonder if we are becoming desensitized to it. Almost daily we hear this item or that item has been recalled due to XXX, allergy, Salmonella, Listeria, foreign matter, and the list goes on. I counted 45 human and three pet food-related recalls just since May 1, 2018—that’s in just 84 days as I write this. So, for consumers (and we are all consumers), how do we hear the word recall and what is our visceral reaction when we hear the word? What actions if any do we take? Does it become too overwhelming? Are we becoming immune from the word? We are required to eat for survival sake and we don’t know if there is a problem with the food we are eating until after it has been recalled. At Stop Foodborne Illness, we send out recall notices every time there is a recall announced, which is typically a few times a week. Recently, a friend asked, “So, do I just quit eating to avoid contamination?”

I wonder if we can start a conversation about the term, how we use it and how to use the word and related action effectively. What does it mean for consumers? Is it only meaningful after the fact? The word and action of the word “prevention” is so much more powerful. Just “food” for thought.

Melody Ge, Kestrel Management
FST Soapbox

8 Tips to Food Safety Program Development for Small and Entrepreneurial Businesses

By Melody Ge
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Melody Ge, Kestrel Management

The FSMA HARPC regulation has been in the implementation phase for approximately a year. Many small and entrepreneurial businesses are in the process of starting or finalizing the development of a food safety plan to comply with FSMA requirements. This includes program development, operational awareness and employee training. Often, small companies find this development more challenging compared to mature companies for several reasons, including a lack of resources or simply not knowing where to start.

The following eight tips can help small businesses that are developing a food safety plan to comply with FSMA.

1. Don’t be scared.

FSMA Preventive Controls is nothing scary. It is simply a series of food safety protocols and related documentation. It might seem overwhelming at the beginning with many documents and changes; however, it is actually a good method and tool to help strengthen operation lines and management.

FSMA helps businesses sustain and streamline processes. It is helpful to first map out the production process from the very beginning (when raw materials are received) through the end (when finished products leave the facility). The more details that are documented on the process, the easier and less time consuming it will be later to prevent potential risks.

2. Be familiar with the process and the FDA hazard types.

Once all processes are mapped, take time to study and get familiar with them. It will be helpful to have a team of individuals with different job functions review process maps together. The objectives are to identify the following:

  • Where is the weakness?
  • Where can weaknesses be controlled?
  • What should be monitored?
  • When is a good time to monitor each process step?

According to FDA, five hazard types need to be considered and prevented: Physical, chemical, biological, intentional adulteration and radiological. These five types should always be kept in mind when reviewing and analyzing the direct production and non-direct production processes.

3. Thoroughly understand the entire supply chain.

Supply chain management is one of the key preventive controls required by FSMA. Just like mapping out the process, FDA requires each business to have a thorough understanding and control of its supply chain to ensure the risks are minimized from raw materials to end consumers. Whether you have foreign suppliers, distribution centers or co-manufacturers, finished product safety must not be compromised by any party. If foreign suppliers are being used, FSVP (Foreign Supplier Verification Program) must be implemented and communicated to vendors.

4. Think in food safety mindset.

If your business has just been established, then congratulations! You have the opportunity to start everything right from the beginning. Take food safety into consideration throughout every step in the process and operation. Considering food safety aspects and preventing hazard types might help you make your next good business decision.

5. Get everyone involved!

Food safety is not only the food safety and quality departments’ responsibilities; it reflects the entire company’s operational structure—from building structure, security, production line, and supply chain to procurement, HR and finance. Get everyone involved, from top management to line workers. Their expertise, experiences and feedback will help the entire program’s implementation and execution. With the inputs from each department function, the food safety program will be more practical to the entire business operation and, therefore, will be more solid and sustained, especially when it comes to ongoing implementation.

6. Designate one project leader.

If FSMA program development is considered a project that the whole company engages in, a project leader is required to make the journey efficient and smooth. The leader needs to have both the company operational experience, as well as food safety knowledge. The leader plays an important role in leading the project, coordinating the timeline, prioritizing work across departments, and communicating with all levels of employees.

7. Keep everything documented and recorded.

Documentation and recordkeeping are core to the entire program. Say what you do by writing down all procedures, policies, programs and SOPs. Do what you say by demonstrating what is contained in all records kept onsite. This is not only for audit purposes, but also for your own business growth. Your own operation data is the best data to improve and modify your processes, if needed. Records can be used for trend study and analysis after years in business. Records can reveal whether methods or programs implemented are working effectively and helping the business. Records can also provide strong support/evidence when there is an unexpected event.

8. Utilize free third-party resources.

There are many technologies linking the entire world together—leverage them to learn from your peers. GFSI-recognized certification programs, such as SQF, FSSC22000 and IFS, are releasing a global market program to specifically help small business start their programs. Webinars and trainings are available on many program development and food safety hot topics to help address challenges, and there are many tools and templates available for download to assist with documentation and recordkeeping.

Although there are a lot of perspectives and aspects to be considered to comply with FSMA, compliance can be achieved one step at a time. Start by mapping out your own production process today.

Mike Robach

The Future of Food Safety: A Q&A with Cargill’s Mike Robach

By Mahni Ghorashi
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Mike Robach

Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill. Mike joined Cargill in January 2004 to lead the company’s corporate food safety and regulatory affairs programs. In this role, he helps partners innovate and manage risk so they can feel empowered to nourish the world

Mike Robach
Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill

Mike has also worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. He serves as chairman of the board of directors of the Global Food Safety Initiative (GFSI) and is a member of the Institute of Food Technologists and the International Association of Food Protection, among many other organizations dedicated to ensuring safe food and bringing innovative technology into the agricultural industry. He has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health and food safety standards.

Mahni Ghorashi: What are the biggest risks to our food safety infrastructure in 2018? What’s keeping you up at night?

Mike Robach: The biggest risks I see have to do with supply chain integrity and how companies implement their systems. Too often we do not have line-of-sight to the origin of the commodities and ingredients that make up our products. With global supply networks it’s important to understand where and from whom you are getting your inputs. There is also a need for food safety capacity building throughout the global food system. Many small and medium companies, along with some large companies, do not have the proper training for their employees to manage a food safety program. We also have an issue with constantly changing regulations that are not uniform from country to country, adding risk to our business.

Ghorashi: What are you most excited about? What’s changing in a good way in the food safety sector?

Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace. Blockchain technology gives us the chance to drive greater transparency throughout the supply chain.

Ghorashi: Let’s talk about regulation. How is the implementation of FSMA going? Do you foresee any challenges with the next phase of implementation?

Check out last month’s Q&A with Frank Yiannas of WalmartRobach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

Ghorashi: If you take a look at the homepage of Food Safety News, all you see is recall after recall. Are transparency and technological advancement bringing more risks to light and are things generally trending towards improvement?

Robach: I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Ghorashi: What is the number one challenge of securing global supply chains for 2018?

Robach: Knowing and understanding the integrated supply chain. Having knowledge and control of the process from origination to consumption would be ideal. We need the implementation of risk-based, harmonized food safety management systems based on the principles of Codex. Assuring the application of these systems along with properly trained employees to implement these programs would be the first step towards a secure, safe global food system.

Ghorashi: How do international trade deals and the stance of the current administration affect the future of food safety policy?

Robach: International trade deals such as the Trans Pacific Partnership and NAFTA can do a lot for the assurance of safe food around the world and within regions. Making sure that food safety provisions are included in these trade deals can drive the implementation of food safety management systems that will ensure safe food for consumers everywhere. These types of deals should allow us to remove technical barriers to trade by basing the requirements on Codex principles and adhering to the WTO SPS agreement.

Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?

Robach: Blockchain has a role to play in driving more transparency across the integrated supply chain. It can allow companies to show consumers where their food comes from. It can also be used to quickly trace back product in the event of a food safety problem. Still, it’s an enabling technology, not a solution.

Ghorashi: What about CRISPR? How is the food industry starting to respond to this technology from both a policy and GMO screening?

Robach: Gene editing holds great promise and many companies are looking at its potential benefits. However, there is always the policy question on whether or not the use of this type of technology should be labeled. I think the food industry has not done enough to promote the use of technology and how food production has improved over the years. We should let consumers know how we apply science to making food safer, more nutritious and more sustainable. At Cargill we have the vision of being the leader in nourishing the world in a safe, responsible and sustainable way.

Ghorashi: What trends are you seeing in food safety processes within food companies? Are they becoming more decentralized? Less? How are they balancing innovation with decades-old food safety practices?

Robach: Through the Global Food Safety Initiative, we have promoted harmonized, risk-based food safety management systems. The GFSI-benchmarked certification programs provide an opportunity for companies to implement consistent food safety programs regardless of where they are in the world. Through the GFSI Global Market Program there’s a tool kit that less sophisticated companies can use as a pathway towards full certification. We are constantly updating the benchmarking requirements to assure they are keeping up with changing science and technology.

2018 Food Safety Supply Chain Conference, Blockchain

Beyond Supply Chain Trends: Blockchain, FSMA, Food Fraud, Audits and More

By Maria Fontanazza
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2018 Food Safety Supply Chain Conference, Blockchain
Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA

How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.

“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.

Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL

Fabien Robert, Nestle 2018 Food Safety Supply Chain Conference
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America

It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America

“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International

Bryan Cohn, 2018 Food Safety Supply Chain Conference
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons

The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
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FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

Audit

First Audit Stakeholders Meeting to Take Place at Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Audit

The Association for Food Safety Auditing Professionals (AFSAP) announces the selection of the Food Safety Supply Chain Conference as the site for the first Audit Stakeholders meeting on June 13 in Rockville, MD. This historic event will bring together FDA, accreditation bodies (ABs), certification bodies (CBs) and other interested parties to outline the requirements for FDA’s Accredited Certification to better understand the AB/CB roles in FSMA’s use of audits to protect the U.S. food supply.

There are two objectives for this meeting: First, the gaps in the current program must be explained so that all understand the challenges ahead. Second, and even more critical, will be to explore solutions such as creating a Voluntary Scheme Owner that will address those gaps.

Patricia Wester, PA Wester Consulting
Patricia Wester, AFSAP founder, will lead the groundbreaking audit panel at the 2018 Food Safety Supply Chain conference.

AFSAP’s founder, Patricia Wester, spearheaded the meeting to address critical questions regarding implementation of FDA’s Third-Party Audit program and provide a platform to discuss potential solutions.

“FDA’s program involves certification of regulatory compliance, which is an entirely new approach for CB’s currently involved in the GFSI system,” says Wester. “As currently structured, the individual CB’s responsibilities will include activities such as audit checklist development and auditor training requirements that will negatively impact audit consistency and dramatically increase audit costs. Another key concern is maintaining the audit documents, because regulations do not change on a regular cycle like GFSI, further adding costs and variability to the program.”

Supported by AFSAP’s food safety partners, NEHA and ANSI, long-time supporters of AFSAP’s efforts to raise awareness of FSMA’s use of audits, the Food Safety Supply Chain event provided the ideal venue to hold the discussion.

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

About Food Safety Tech

Food Safety Tech is an industry-specific eMagazine and Conference series serving the global food industry. Built on the platform of the next generation model for B2B publishing, Food Safety Tech delivers top quality content in a proactive manner through a weekly eNewsletter while maintaining a website, the eMagazine that stores the content providing easy accessibility. This hybrid model provides a two way street of digital communication to the global food industry. Food Safety Tech is published by Innovative Publishing, LLC.

FDA

FDA’s Data Dashboard Helps Companies Meet FSMA Supply Chain Requirements

By Food Safety Tech Staff
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FDA

FDA has launched a new section of its Data Dashboard to help food importers, manufacturers and processors meet supply chain requirements put forth by FSMA (specifically FSVP, and the PC rules). The dashboard provides ease in finding compliance and enforcement information related to companies.

Do you trust your suppliers? What about your supplier’s suppliers? | Food Safety Supply Chain Conference | June 12–13, 2018 | Learn more“The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.” – FDA

The agency also made improvements to its supplier evaluation resources page and added it to the dashboard so that companies can simultaneously search several databases. Users can search for information about warning letters, import refusal and import alerts.

 

Compliance, food safety

Leveraging FSVP Compliance: Do Less, Get More

By Benjamin England, Nicole Trimmer
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Compliance, food safety

With an ever-expanding international food trade and new government demands for food safety and supply chain transparency, the U.S. regulatory landscape is becoming increasingly more complex. FSMA (especially the Foreign Supplier Verification Program) aims to shift responsibilities for imported food safety from FDA to importers in an effort to reduce the regulatory burden on FDA. New regulations bring new burdens to food trade stakeholders, requiring significant investment. However, many of the data obligations of the FSVP rule dovetail with other agencies’ requirements.

Investments in one dataset can be leveraged to improve a company’s overall compliance related to international trade. The key is to integrate FSVP requirements into a strong regulatory compliance program without breaking the bank. This requires identifying data overlap, utilizing compliance integration to work smarter, not harder, leveraging the window of opportunity to collect more (and necessary) data from your foreign suppliers, and calling in the right help when needed.

TRUST…..BUT VERIFY: 2018 FSMA Focuses on Supplier Verification Activities | Learn more at the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MDToday’s International Supply Web

No longer can we reasonably talk about establishing, monitoring and maintaining a supply “chain” when importing anything. International trade in food and its ingredients is rarely bilateral—except for perhaps fresh produce, meat and seafood. Instead, food moves throughout a complex supply web of international transactions. Most processed food now contains ingredients from multiple countries, leading to food safety verification challenges and country of origin questions for finished goods.

The international supply web includes farms (land and aquaculture), agriculture cooperatives, food grade chemicals manufacturers, color and flavoring formulators and manufacturers, raw materials processors and fabricators, finished food processors & packers, warehouses, transportation companies, cooking, canning and irradiating facilities, shippers, exporters, product and commodities brokers, importers, wholesalers, retailers and e-tailers. Any (or all) of these players may be small operations located in different countries or multi-national conglomerates operating on several continents. There is very little food consumed in the United States that is not affected, in some way or another, by international commerce and trade.

Shift to a Preventive System

In 2011, Congress passed FSMA with the goal of moving U.S. food safety from a reactive to a preventive system, and integrating HACCP-like principles into the production of all food. Over the ensuing years, FDA issued seven major regulations that address various facets of food safety.

The Foreign Supplier Verification Program (FSVP) rule was included as a way to ensure that foods imported into the United States are produced in a manner that meets U.S. safety standards. FSVP requires that “importers,” which can be the distributors or retailers of products, verify and document the steps taken to ensure safe production of animal and human food. While the exact FSVP requirements vary depending on the commodity, the FSVP process often includes developing, maintaining and documenting a food safety plan and, as its name suggests, verifying that foreign suppliers are controlling for appropriate hazards. Developing and implementing these plans requires a wide variety of skills, including hazard analysis and risk assessment, establishing preventive controls, developing recall plans, and careful documentation of the process. FSVP also requires that verification activities be carried out by parties who have specific preventive control training, or “PCQIs” (Preventive Control Qualified Individuals).

Most importantly, FSMA and the FSVP rule shift the burden of safety from FDA to the importer. With increased interconnectedness, flaws in food safety documentation can become magnified throughout the system. Note that FSVP covers food safety only—not necessarily food traceability or food security defense—although there are opportunities for crossover ROIs. To achieve FSVP compliance, you need to know who is handling your food before it is imported, what they know about food safety, and how they apply food safety principles.

Cross-agency Data Usage

Approaching FSVP as a stand-alone regulatory compliance initiative is expensive and inefficient. Many activities and data elements that must be kept for other government agencies and their compliance programs should be linked together. The data your foreign suppliers must provide to international carriers for advanced notice to U.S. Customs and Border Protection (“CBP” or “Customs”) by importing carriers (airlines, trucking companies and vessel operators) is relevant to both Customs entry and FDA food safety compliance and documentation. This overlap presents an ideal opportunity to relieve the burden of the new FSVP requirements and kill two birds with one stone. And the overlap and leveraging opportunities are actually quite substantial—if one knows where and how to look for them.

For example, the USDA’s National Organic Program (NOP) regulations specify requirements for the processing, handling and labeling of raw materials and processed goods to meet organic standards. Organic labeling and marketing claims are affirmative assertions that the labeled food has not been exposed to processing steps, processing chemicals or particular substances (e.g., sewage sludge, ionizing radiation) that would cause it to fall out of the regulatory bounds of an organic food product. Where organic processing and handling crosses over to food safety, leveraging organic compliance documentation buttresses the safety of the resulting food—and the importer’s FSVP program.

Additionally, much of the information that the importer must know to properly classify their product under the Harmonized Tariff Schedule (HTS) is the same information that the importer needs for their FSVP plan; the importer must know the products, what they are made from, how they are processed, and how they are intended to be used to both properly classify and verify the safety of their product. Because FDA requires the importer to verify that its foreign supplier has a system that meets the domestic food safety standards, the foreign supplier must also be able to identify its own ingredient and raw material suppliers and their systems for food safety, as applicable. Therefore, the food importer’s FSVP process promotes documentation compliance with CBP’s and other government agencies’ requirements governing the country of origin of materials for applicability of preferential duty rates (e.g., under a free trade agreement) and country of origin labeling.

Another example of data overlap is the FSVP requirement for supplier verification and the responsibility to show correct valuation of your product for Customs. FSVP requires that you verify your suppliers and ensure your product is genuine, and Customs requires that you declare an appropriate valuation and identity for your shipment. If Customs investigates your shipment and determines your valuation is incorrect, it may trigger the Department of Commerce to investigate whether there are anti-dumping and countervailing issues going on with the product.

Issues with anti-dumping and countervailing duties are extremely time-consuming and expensive. In both 2008 and 2016, federal authorities investigated rumors of companies circumventing anti-dumping duties by transshipping food products through third countries (to conceal actual origin of the material). When Customs investigated a honey processing plant, they found evidence that the purported processor of Vietnamese honey was receiving finished product from China and relabeling it as originating from Vietnam. When importers declared imported Vietnamese honey, Customs determined from trace mineral testing that the honey was, as they suspected, Chinese. Customs seized the product. The lesson to learn from this is to know your suppliers and the actual supply web. In the case of country of origin violations, not verifying the country of origin can be costly. Where CBP finds negligence is involved, the agency can look back five years to recoup lost duty plus interest, and can even reopen old liquidated entries and assess monetary penalties. In completing your FSVP plan, requesting documentation demonstrating origin is a small additional step that furthers the strength of CBP-required documentation to support the origin declaration at entry. That’s leveraging.

Document, Document, Document

Under the Customs Modernization Act of 1993, the compliance watch-words for all importers (and customshouse brokers) are “record keeping,” “shared responsibility,” “reporting,” and “due diligence.” Anything that is required for a proper importation is subject to CBP review and audit—whether the requirement arises as supply chain and source data under the Seafood Import Monitoring Program (SIMP) under the National Marine Fisheries Service (NMFS), or organic labeling and compliance under USDA’s NOP regulations, or speciation documentation under the Lacey Act enforced by U.S. Fish and Wildlife (USFW), or FSVP implemented by FDA. Therefore, the engagement between food importer and foreign food supplier forced by FSVP opens the opportunity for the importer to clarify and shore up its documentation obligations for many other coexisting regulatory regimes.

A clear demonstration of this fact is borne out by the regular process that ensues when CBP issues to an importer of record a Customs Form 28 (or “CF28”). The CF28 is a CBP request for additional information relating to an imported shipment. The importer is usually required to respond within 30 days of its issuance. But ordinarily the CF28 is issued months (and sometimes years) after the importation occurred. Therefore, the CF28 process represents a significant challenge to the importer’s record keeping and compliance documentation systems, and legal liability to the importer’s bottom line.
Documents needed to respond adequately to a CF28 include contracts, purchase orders, packing lists, shipping documents, declarations to government authorities throughout the import process, powers of attorney, country of origin certifications, emails and other communications discussing any of these documents. CBP requests these documents to confirm the proper electronic data was submitted with the importation. And, of course, CBP is checking to see if the importer is attempting to circumvent U.S. import or export laws that may deprive the government of revenue.

The identity and location of an importer’s trading partners (including the foreign supplier and its suppliers), contracts between and among them (e.g., related to description, processing methods, equipment used, quality and condition of goods), origin documentation, proofs of packing and shipping, etc., are all subject to production via the CF28 process. Penalties for errors in the documentation that result in a regulatory or administrative action are imposed upon the importer (for failing to document or exercise due diligence in performing its function as an importer under U.S. law).

The FSVP regulation presents an ideal opportunity for the importer to establish and populate a compliance program that integrates its FDA import regulatory obligations with those of CBP and other regulatory agencies, as applicable. Failing to take this rare opportunity—at a time when foreign suppliers are expecting probing questions from their U.S. trading partners—is a mistake.

Because the government is more connected, it is essential to change how you prepare for and respond to issues that arise. Just as the FDA’s FSVP rule aims to move food safety from a reactionary to preventive system, coordinated proactive compliance with all government agency requirements will be necessary for the future. Further, with new regulations, your customs broker may not be equipped to deal with certain areas or when administrative matters escalate. But how do you prepare for any eventuality when the enforcement possibilities seem endless?

When preparing your FSVP plans, reviewing your Customs documentation, and reviewing other government agency requirements, it is critical that you think through all the potential issues that may arise with your product or its supply chain, and address them proactively in your documentation. What might an inspector or compliance officer think about the information provided? Is it thorough, clear, and logical? Does it tell a consistent narrative? What if another agency sees this information? Will they have further questions? The ultimate goal is accurate and thorough data for submissions to FDA, Customs and any other partner government agencies.

Key Steps to Prepare for the Worst-case Scenario

Lastly, let’s not forget that part of being prepared is preparing for the worst-case scenario. What happens when you are confronted by an issue? We recommend taking four key steps. First, marshal your resources (documents, documents). Second, ask, “Who are the key players in the story (e.g., which agencies are involved or could possibly be involved, and what are they requesting)?” The third question, a bit less straightforward, is, “How must I respond? (e.g., is the agency within its regulatory authority and required time constraints; are there conflicts of interest; what is the potential legal exposure to risk for different actions)?” Finally, do a gut check: Are the examinations subjective in nature or qualitative (rather than quantitative)? Is any required testing appropriate for the product? If you feel you cannot confidently answer these questions using current staff, we recommend you prepare for import issues by selecting professionals who have experience with integrated agency regulations and legal compliance requirements. The keys to expediting the process when working with multiple government regulatory agencies are integrating your compliance to ensure you have a true green-means-go light before you ship and being able to present a clear and consistent regulatory narrative to all agencies. This requires a clear understanding of how the government regulatory requirements actually intersect.

Glen Ramsey, Orkin
Bug Bytes

Implementing Pest Management Changes for FSMA

By Glen Ramsey
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Glen Ramsey, Orkin

Preparation is the key to success for any ongoing endeavor. In an industry where your enemies are fighting for survival at the expense of your business, you must be ready for anything. Your opponents are crafty, adaptable and more prevalent than you think.

No, I’m not describing your competitors. I’m talking about pests—a major threat to the integrity of food products and a threat to any facility’s bottom line. Whether it’s stored product pests contaminating inventory or rodents spreading pathogens as they skitter across equipment, pests are a risk that should be minimized.

With FSMA in full effect, preparation is more important than ever. FSMA mandates a proactive approach to food safety, and by extension, pest management. It’s important that the pest management program is exhaustive and integrates seamlessly into the overarching food safety plan.

Most, if not all, food processing facilities currently use an integrated pest management (IPM) program to help minimize the chance of pest problems, but FSMA puts more emphasis on being proactive to keep pests far from products at all times. Naturally, this doesn’t mean that a pest sighting in a facility is the end of the world, but it means that it should be resolved quickly, investigated and documented to help prevent such an occurrence from happening again.

Specifically, FSMA has numerous stipulations that trickle down to pest management.

  1. Hazard analysis. First, a comprehensive inspection should be done to identify the high-risk areas in your facility where pests may take residence. Entry points, potential food and water sources and harborage areas should all be noted.
  2. Preventive controls. Include regular facility maintenance reviews and a strict sanitation regimen in your food safety plan to help minimize the use of chemical pest management treatments.
  3. Monitoring. Use devices and employees to keep tabs on pest activity and conducive conditions to ensure preventive controls are working and executed across the facility.
  4. Corrective actions. Implement and enforce pest management solutions such as exclusion strategies (e.g., weather-stripping, door sweeps, vinyl strip doors), traps (e.g. pheromone traps, insect light traps, bait boxes), air curtains and repellants to help manage pest activity.
  5. Verification. Schedule regular service visits with your pest management professional to verify corrective actions are working to reduce pest problems over time. These visits should include an annual facility assessment and pest trend analysis, both of which help determine potential areas of improvement over time.
    6. Record keeping and documentation. Document every action taken to prevent pests. That includes corrective actions and their results to prove that your written IPM and food safety plan has been implemented and is effective in helping to manage pests at the facility.

With these key components accounted for, it will be easier to be prepared for pests. But, even still, the real-world implementation of these tactics might not be abundantly clear. That being the case, let’s take a look at what food processing facility managers can start doing today to help protect their facilities and demonstrate a proactive approach to food safety.

So, what’s the best way to be more proactive in preventing pests?

Well, that question has a plethora of possible answers, but four of the most important are sanitation, exclusion, staff training and monitoring.

Sanitation

Perhaps the most important of all, sanitation helps to eliminate two key attractants—food and water—that draw pests inside a facility. Any spot where food particles or moisture is collecting, pests will be looking to find.

But sanitation shouldn’t seem daunting. Here are some actions you can start doing today to step up your sanitation program:

  • Wipe down equipment regularly to break down the buildup of organic materials.
  • Wipe off countertops and sweep floors in common areas where food is present, then sanitize with an organic cleaner afterwards to eliminate any remaining odors.
  • Take out the garbage at least daily, and keep dumpsters at least 50 feet away from the building to avoid giving pests a harborage location nearby with an easy path to get indoors. Make sure to cleanse garbage bins and dumpsters regularly, or they’ll become attractive to pests, too!

Exclusion

A big part of preventing pests from getting inside a facility is simply blocking them out using exclusion.

During an inspection, a pest management provider will walk around the interior and exterior of the facility and look for any potential entry points for pests. They should recommend you seal any cracks and crevices they notice, as many pests can fit through extremely tiny gaps. For example, mice can fit through a hole the size of a dime. Gaps should be sealed with a water-resistant sealant to keep pests and moisture out.

In addition, make sure to keep windows and doors closed as much as possible or use screens to block pests. Automatic doors can help in this way, especially when paired with an air curtain to blow flying pests away from entrances. Pests can often come in through the biggest gap of all: The front door!

Staff Training

It’s always better to have a team behind you. Training employees on the basics of an IPM program and what they can do to help will take some of the weight off your shoulders.

Many pest management providers offer free staff training sessions, which can help employees understand what to look for around their work areas and what to do in the case of a pest sighting. Consider creating your own pest sighting protocol to make it clear what employees should do if and when a pest is spotted. They’ll need to record when, where, how many and what kind of pest(s) were seen at the time to give your pest management provider the best chance to create a customized solution to resolve the issue. If you can catch one of the pests in a container for future identification, that’s even better.

Monitoring

While employees can help by keeping an eye out for pests, it’s important to have ongoing monitoring techniques to measure pest activity around the facility.

Monitoring devices are a great way to do this, and your pest management professional can help you place them strategically around the hot spots in your facility. Fly lights, bait stations, pheromone traps and more can capture pests and serve a dual purpose. First, they’ll reduce pest populations around the facility, and, second, they’ll allow you and your pest management provider to see how many pests are present in certain areas.

Over time, this will give you a feel for which pest issues have been resolved and which continue to be a problem. That can determine the corrective actions taken and the long-term food safety plan, which will demonstrate a commitment to constant improvement. That’s a great thing to have on your side, especially when an auditor happens to stop by.

Documentation

I know, I know—this wasn’t one of the four “answers” listed, but it’s still incredibly important! Documentation helps ensure you get credit for being so prepared.

It’s recommended that facility managers keep a few documents on hand to keep things simple. The food safety plan, annual assessments, sighting reports, a list of service changes over time, a list of monitoring devices and proof of your pest management professional’s certification are all important documents to keep updated and ready to go. That way, you can rest easy knowing you’re prepared at a moment’s notice.

It is never too early to start preparing. Pests aren’t going to stop searching for a food source anytime soon, so don’t stop your proactive efforts to keep them at bay. Your financial department will thank you.

Stephen Ostroff, 2016 Food Safety Consortium

Blockchain Transformational, Says Ostroff. FDA Updates on Pathogens, FSMA, WGS and More

By Maria Fontanazza
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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. deputy commissioner for foods and veterinary medicine, sounds excited about the promise of blockchain. He also continues to enthusiastically wave the flag for whole genome sequencing (WGS) in solving foodborne illness cases. At the recent GMA Science Forum, Ostroff shared his usual update on incidents involving pathogens, agency progress in inspections and FSMA, and what the future holds.

The 2018 Food Safety Supply Chain conference features a Blockchain panel discussion | June 12–13 | Learn morePathogens

“There’s been essentially zero change in incidents of pathogens, and in some [cases there have been] increases—despite the fact that we’ve been doing quite a bit to improve the profile of food safety in the United States,” said Ostroff. This isn’t the first time that Ostroff pointed to the fact that foodborne illness is resistant to change, but he still emphasized the disappointment that industry is “way off” from the Healthy People 2020 target rate for pathogens established by the government. “None of these are close to where we thought we would be,” he said, referring to the government’s established target rates for Campylobacter, E.coli O157, Listeria, Salmonella, Vibrio and Yersinia.

Ostroff has previously pointed to improved diagnostics and surveillance systems as being partially responsible for a lack of improvement in the number of foodborne illness cases (due to higher detection rates), but during this particular presentation he brought attention to culture independent diagnostic tests (CIDTs)—which he said are having a “major impact on data collected in FoodNet.” CIDT is relatively new and is more rapid than the culture method, but it doesn’t allow for subtyping or antimicrobial resistance testing.

According to Ostroff, CIDTs have major implications for folks who work in food safety. The overall incidence of infection with foodborne pathogens is not decreasing, and the use of CIDTs makes assessment of trends difficult. CIDTs appear to be finding infections previously undiagnosed or unrecognized. In addition, they could affect the agency’s ability to monitor FSMA impact measures.

Inspections

The agency continues to look at inspection data from both the perspective of the number of inspections and their outcomes. During FY 2017, there were 1253 domestic and 146 foreign inspections. For FY 2018, there have already been 1610 domestic inspections to date.

Enforcement Discretion

In January, FDA issued new enforcement discretion for certain provisions in four FSMA rules. This included resolving issues related to the “farm” definition, requirements for food contact substances under FSVP, and certain written assurances in place for the Preventive Controls (human and animal) rule until FDA comes up with a practical solution to issues raised by stakeholders, Ostroff said.

Oversight of Food Imports

FDA continues to take a risk-based approach to FSVP and overseas inspections. Part of these efforts includes the agency’s systems recognition program where it looks at other mature food safety systems around the world to recognize countries that have programs similar to the United States. Thus far FDA has recognized Australia, Canada and New Zealand food safety systems; It is currently in the process of evaluating European Union members.

Intentional Adulteration Rule

The International Adulteration rule continues to be a hot topic of discussion, especially as it relates to associated costs. FDA is actively working on putting out a draft guidance that will discuss how to conduct vulnerability assessments, along with its interpretation of the rule, according to Ostroff. Part one of the draft should be out “in the very near future”, he said. He added that the agency is trying to be flexible with the rule and although food defense is an important component of food safety, companies should never do anything in the context of food defense that could pose a food safety risk.

Whole Genome Sequencing

WGS provides more precise identification at a genetic level and helps expedite recognition and response time for nearly all current foodborne illness and outbreak investigations. “It’s the new normal—it’s here and it’s here big time,” said Ostroff, adding that the GenomeTrakr network has more than 167,000 isolates sequences in the database and is becoming more and more powerful. “It’s amazing what this tool can do,” he said, citing two recent cases involving strains of Salmonella in papayas and kratom.

Blockchain

“I think blockchain can be really transformational in the world of food safety,” said Ostroff, calling it “traceability on steroids without question”. He thinks the technology could also be useful in addressing food fraud and economically motivated adulteration, and provide more consumer transparency. Right now the FDA is looking very closely at blockchain in context of traceability and FSMA.