In May 2016, FDA issued its final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (IA). This rule requires covered facilities to prepare and implement food defense plans. The first compliance date—for businesses with sales of $10 million or more per year and more than 500 full-time equivalent employees—is July 26, 2019. (Note that small businesses have until 2020 and very small businesses have until 2021.)

Just as important, FDA has announced it will begin routine inspections to verify compliance with the IA rule in March 2020. Given those dates, compliance with this rule should be a top priority for the approximately 3,400 impacted firms that operate 9,800 food facilities.

Requirements: Food Defense Plan

Let’s start by defining food defense and why it is so important. According to FDA, “Food defense is the effort to protect food from acts of intentional adulteration.” Intentional adulteration is any act where there is an intent to cause wide-scale public health harm, including acts of terrorism. As such, the rule is designed to primarily cover larger facilities with products that reach many people.

At its most basic level, the IA rule requires every covered facility to prepare and implement a food defense plan. The food defense plan incorporates four major elements:

1. The vulnerability assessment identifies those areas in the process that pose the greatest IA risks. Each step in the facility’s process should be evaluated for the following:
   • Potential severity and scale of the impact on the public
   • Physical access to the product
   • Ability to successfully alter/contaminate the product
2. Facilities must develop and implement mitigation/preventive strategies at each step in the process to address vulnerabilities and minimize the risks of IA.
3. A system must be put in place to ensure implementation of mitigation strategies and to effectively manage the following:
   • Monitoring mitigation strategies, including frequency
   • Corrective action response
   • Verification activities
4. Appropriate recordkeeping must be maintained for food defense monitoring, corrective actions, and verification, and key personnel must receive appropriate training.

Mock Exercise

Kestrel’s previous article on the Four A’s of Food Defense outlines a proactive approach to food defense that will help meet a key requirement by ensuring the organization is working to avoid the risks associated with food adulteration and contamination.

In addition, when conducting an assessment of food defense, IA, and generally accepted industry vulnerability, threats, and controls, Kestrel suggests completing a mock exercise scenario. This allows companies to:

1. Assess their food defense and IA programs under FSMA;
2. Test to confirm their program’s integrity, as documented and implemented; and
3. Conduct vulnerability scenarios to verify, validate, and make improvements. 

The following areas should be addressed in the assessment, strategies, and plan information:

• Facility
• Materials
• Packaging
• Processing
• Key activities
• Storage
• Transportation and distribution
• Management and personnel

A key aspect is also review of and improvements to training programs for all employees based on responsibility, recordkeeping process, management objectives, and program monitoring.

This activity provides the information needed to develop and implement an effective and compliant food defense and IA program under FSMA. Additionally, it can provide verification of the site’s programs, corrective actions to be implemented, and the necessary records of compliance.

Piece of the Puzzle

Food defense is a big piece of the FSMA puzzle. According to Kestrel Food Safety Principal Bill Bremer, “We have included food defense in virtually all of our program development activities this year for GFSI (all schemes) and now FSMA.” Kestrel has worked with over 400 food sites in passing audits and inspections that have included general or focused food defense and IA management programs in food categories including baking, candy/confection, meat, flavor/ingredients, grain, flour, packaging/contact materials, beverages, beans, chemicals, dietary supplements, commissary/catering, and more.

Doing so directly aligns with FDA’s requirements for companies to assess risk and implement preventive controls on a broad basis. Thinking about risk-based strategies—whether in the supply chain or internal systems or whether you are a grower or an importer—is key for any food company planning for the future. Preventive strategies are the essence of FSMA and HACCP. Proactively creating or updating a food defense and safety plan is the first step to ensure compliance.

Join Kestrel at the PROCESS EXPO, as we discuss this topic and others during our special food safety training courses this October in Chicago.

Before food can be imported into the U.S., it is subject to FDA inspection. These inspections are intended to ensure food imports are safe, sanitary, and properly labeled. While important in maintaining food safety, this process can be long and onerous. The Voluntary Qualified Importer Program (VQIP) was created by FDA to expedite this process.

What Is VQIP?

In essence, VQIP acts as the “TSA line” for food into the U.S. The voluntary program allows foreign suppliers to get expedited entry for their food products into the U.S., provided importers meet all eligibility criteria, including offering food from a facility certified under FDA’s accredited third-party program (see below).

Why Is VQIP Important?

There are a number of reasons a U.S. importer might choose to participate in VQIP, including the following:

• Enables expedited entry into the U.S. for all foods included in an approved application.
• Limits examination and/or sampling to “for cause” situations in which there is a potential threat to public health; any sampling or examination is done at destination or another location chosen by the importer and laboratory analysis of any samples is expedited.
• Provides assurance that a foreign supplier complies to FSMA rules, avoiding the need to further assess the supplier.
• Incentivizes importers to adopt a robust system of supply chain management.
• Moves any perishable or short shelf-life product through the border quickly.

For foreign suppliers, there are also several benefits:

• Reduces the extra work of proving status as it relates to compliance to FSMA rules.
• Opens doors to new clients by making it easier for a U.S. importer to choose certified products versus a non-certified competitor.

Beyond that, VQIP further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

What Are the Eligibility Requirements?

A company must be a food importer to participate in VQIP (i.e., a person/entity that brings food or causes food to be brought from a foreign country into the U.S.). In addition, the following criteria must be met on the importer and the foreign supplier sides:

• Have 3+ years history of importing food to the U.S.
• Have a Dun & Bradstreet Data Universal Number System (DUNS) number (used as a unique identifier number)
• Use paperless filers/brokers who have received acceptable results during their last FDA Filer Evaluation
• Do not have any food you import subject to detention under an Import Alert or Class 1 recall
• Do not have any ongoing FDA administrative or judicial action, or other history of non-compliance with food safety regulations by the importer, other entities in the supply chain, or food
• Are in compliance with supplier verification and other importer responsibilities under the applicable FSVP or HACCP (i.e., juice, seafood) regulations
• Have not been the subject of any CBP penalties, forfeitures, or sanctions related to the safety or security of any FDA-regulated product imported or offered for import
• Have current facility certification, including farms, issued under FDA’s Accredited Third-Party Certification regulations for each foreign supplier of food in VQIP (see below)
• Develop and implement a Quality Assurance Program (QAP) (see below)

What Is Foreign Supplier Facility Certification?

VQIP is regulated by the FSMA rule on Accredited Third-Party Certification. This is a voluntary, fee-based program for the recognition of third-party auditors to conduct food safety audits and issue certifications of foreign sites and the foods they produce. An accredited third-party can perform audits against the Food, Drug and Cosmetics (FD&C) Act and other FDA applicable regulations, and issue a certificate attesting compliance.

Foreign suppliers must have a facility certification, which would be issued following a regulatory audit conducted by an accredited third-party certification body. This audit attests that the foreign supplier complies with applicable food safety requirements of the FD&C Act and FDA regulations. Note that certifications are not required for Foreign Supplier Verification Program (FSVP) and Preventive Controls rules.

What Is Included in the QAP?

According to the FDA, the VQIP QAP includes all the written policies and procedures the facility will use to ensure adequate control over the safety and security of foods being imported. The QAP should include the following information:

• Corporate quality policy statement relating to food safety and security throughout the supply chain
• Organizational structure, as well as functional responsibilities for those implementing the VQIP QAP
• Food safety policies and procedures to be implemented to ensure food safety from source to entry into the U.S.
• Food defense policies and procedures to ensure compliance with FDA’s intentional adulteration regulation
• Qualification requirements for employees responsible for implementing the VQIP QAP (e.g., knowledge of regulations, understanding of the QAP)
• Procedures for implementing your VQIP QAP
• Procedures for establishing and maintaining records regarding the structure, processes, procedures and implementation of the QAP
• Definitions
• References

How Do I Become Part of VQIP?

Importers must apply between January 1 and May 31 annually to be considered for VQIP. The VQIP fiscal year/benefit period is between October 1 and September 30, following application approval. Participants must submit an application every year; however, you may use data from the previous year’s application.

FDA will conduct a VQIP inspection to verify that you meet all eligibility criteria and have fully implemented food safety and food safety defense systems, as established in your QAP. FDA may also:

• Conduct an FSVP inspection
• Request a copy of food labels for those foods included in the application
• Ask you to submit supporting documentation (e.g., hazard analysis, lab results, food labels)

Additional information on VQIP and the application process can be found on the FDA website.

The ultimate responsibility for food safety lies with food service providers and their ability to develop and maintain effective food safety management systems. Currently, there is a shift in the emphasis of hazard analysis and preventive controls related to both Process Safety Management (PSM) and Hazard Analysis and Critical Control Points (HACCP). This is of particular concern for the food industry, where many regulations include both EHS and food safety requirements.

Many food operations fall under both PSM and HACCP requirements. In general, PSM is bulk chemical-centric for food operations, while HACCP is food safety risk-centric for maintaining food purity. (Common chemicals subject to both include anhydrous ammonia for cooling and chlorine for sanitation of product and processes. In addition, many large food processing types include process aids at levels under PSM.)

Changing regulations and the increased emphasis on hazard analysis require the food industry to develop well-documented and managed programs that address both PSM and HACCP using common approaches:

• Better use of organizational resources
• Standard programs
• Training efficiency and effectiveness
• Shared knowledge and approaches
• More effective and aligned hazard analysis management

About PSM

PSM is a key risk management practice that must be implemented for qualifying plants. PSM is covered in the recent Executive Order focused on modernization of high-risk sites and, as a result, is under greater scrutiny with regulator focus and recent events. While PSM is a highly visible requirement, it is currently not widely inspected and reviewed—though that may be changing. PSM generally entails a more event-driven inspection by interested parties other than the company. As a growing area of focus and concern, PSM will require plants to reassess and, potentially, update systems and operations to meet requirements.

About HACCP

HACCP, on the other hand, is widely implemented for food processing and is expanding with high visibility. HACCP is the historic requirement providing the accepted food safety plan for some food industries. HACCP is rapidly being advanced with FSMA and GFSI-level requirements, but requirements have not been fully established based on FSMA rulemaking. The complexity of programs is rapidly increasing, while the level of food industry sectors is expanding to include all food contact, packaging, GRAS, and distribution and transportation companies.

Hazard Analysis Methods

The hazard analysis methods under PSM and HACCP are similar but different:

• Process Hazard Analysis (PHA) is associated with high-risk chemicals or materials, and is required for compliance with PSM. A PHA is designed to protect people and the environment from specific hazards. PHA methods vary based on an organization’s determination of the best method for their situation. These methods are directed to the overall process and operating condition by the process step. PHA focuses largely on equipment, instrumentation, utilities, human actions, and external factors that might impact the process. It involves an organized, systematic analysis of potential hazards to improve safety and reduce the potential consequences of those hazards.
• Hazard Analysis and Preventive Control (HAPC) is associated with food safety risk under Hazard Analysis and Risk-based Preventive Controls (HARPC) and is an aspect of HACCP. HAPC is a growing regulatory compliance requirement related to food safety plans (FDA and USDA) that focuses on process, equipment, contamination, procedures, and control points. HAPC involves an organized and systematic analysis of potential risks to food and food materials to improve the purity of food during processing/handling by reducing contamination.

PHA and HAPC are required for facilities, as determined by the regulations, and include the following common requirements:

• Develop preventive control plan
• Perform hazard analysis for foreseeable hazards (written)
• Conduct “what-if” scenarios, rating, and ranking
• Identify and implement preventive controls, as well as intentional hazards and controls

Under both PSM and HACCP, all plans and records may be subject to inspections. Failures to act may be interpreted as willful non-conformance or probable cause for expanded inspection.

Additional Requirements

Companies subject to PSM and HACCP need to consider other related regulatory requirements, as well. This relationship in itself is key under GFSI.

• Records
  • Maintain evidence
  • Conduct development programs and hazard analysis adequately
  • Establish programs to ensure preventive controls
  • Conduct training
  • Validate and verify programs, completed forms
  • Record all key information relevant periods
• Inspections
  • PSM-level inspections can be part of incident follow-up or planned OSHA or NEP inspections; there is state registering of PSM inspections.
  • HACCP will be part of mandatory FDA inspections, by any qualified agency to FSMA, and required under GFSI; customers may also require HACCP as part of their supplier programs.
• Cleanup and Catch-up
  • Monitor effectiveness
  • Establish corrective actions
  • Verify programs and preventive controls
  • Monitor and support SOPs/GMPs
  • Diligently follow and record Management of Change (MOC)

In addition, hazardous materials and communication are key for both EHS and FDA, as well as areas like air quality, water quality, sanitation, and blood borne pathogen/bodily fluids.

The Right Resources

A higher level of compliance requires plans to be reassessed and, subsequently, the resources to reassess them. For many, once programs are developed, they are put into “maintain” mode. Historical knowledge isn’t captured or is lost to turnover.

Beyond that, PSM and HACCP both require that “qualified individuals” develop and manage these systems. Qualified individuals include a designated lead with certain experience and qualifications, as outlined in the requirements. Availability of resources is almost always an issue, as maintaining systems with just one person is very difficult, especially given organizational change.

Keeping qualified resources at the proper certification is difficult. New employees are now typically required to provide both oversight and operational capability. The mix of education, work experience, and certification are all important. The growing approach is to maintain teams with alternates to supplement the leads and to provide coverage for all situations, including daily/weekly schedules. This is an area that must be continually monitored and subjected to corrective action.

Alignment Strategy

The following tips will help to effectively align PSM and HACCP programs and strategies, and provide for efficient compliance with both regulatory programs:

• Establish plans to assess existing programs
• Apply continuous improvement (Plan-Do-Check-Act)
• Take inventory of qualified resources
• Align qualified personnel to PSM and HACCP teams
• Use a sub-team approach to ensure the necessary level of participation and backup
• Maintain multi-year strategy, planning, and training
• Establish a cleanup and catch-up approach for hazard analysis activities to move forward
• Use continuous improvement to maintain validated and verified programs

The Global Food Safety Initiative (GFSI) relies on a number of benchmarked schemes to establish food safety requirements; all are designed to ensure the quality and safety of a company’s products. In order to become certified to one of these GFSI-recognized schemes, a company must undergo a third-party audit by a certified auditor. Kestrel’s experience conducting these audits has revealed that companies who successfully achieve certification demonstrate a number of common attributes—regardless of their chosen scheme:

1. Corrective and preventive actions are up-to-date and current.
2. Continuous improvement/root cause analysis process is in place to make ongoing improvements and to ensure final resolutions to all out-of-control issues or non-conformances to the Food Safety Program.
3. Premises, facility, and building programs are established and operating, including controls, signage, direction, job training, and physical evidence of a fully implemented Food Safety Program.
4. Preventive maintenance system links scheduled maintenance to Hazard Analysis & Critical Control Points (HACCP) critical equipment monitoring requirements.
5. Approved materials and process specifications are managed and controlled.
6. Product identification and traceability processes are in place, including complete records detailing all activities for the production of food product.
7. Document management and control program is updated, validated, and maintained. Developing program management systems helps ensure compliance with document management and control.
8. Food safety program updates and management are completed through annual and multi-year planning for maintaining the Food Safety Program, including management of change, management review, approvals, and internal audit.
9. Records and verification management systems provide access to supporting data, as determined by FDA/FSMA and company programs.
10. Data management of food safety records outlines processes for assuring prompt or immediate access to critical records, as needed, for audit, compliance, or regulatory purposes.

A management system is the organizing framework that enables companies to achieve and sustain their operational and business objectives through a process of continuous improvement. A management system is designed to identify and manage risks—safety, environmental, quality, business continuity, food safety (and many others)—through an organized set of policies, procedures, practices, and resources that guide the enterprise and its activities to maximize business value.

The management system addresses:

• What is done and why
• How it is done and by whom
• How well it is being done
• How it is maintained and reviewed
• How it can be improved

Creating an Effective and Valuable Management System

Each company’s management system reflects its unique culture, vision, and values. To be effective and valuable, the management system must be tailored and focused on how it can enhance the business performance of the organization. It must also be:

• Useful to people in the operations
• Intuitive—organized the way operations people think
• Flexible—making use of methods and tools as they are developed and documented
• Valuable from the outset—addressing the most critical risks and processes
• Linked to the business of the business (not “pasted on”), with ownership at the operational level
• A means to better align operational quality, safety, and environment with the business

Attributes of an effective management system are senior management expectations and guidance coupled with employee engagement. Importantly, a management system involves a continual cycle of planning, implementing, reviewing, and improving the way in which safety, quality, and environmental obligations and objectives are met. In its simplest form, this involves implementing the Plan, Do, Check, Act/Adjust (P-D-C-A) cycle for continuous improvement.

Auditing for Ongoing Compliance

The connection between management systems and compliance is vital in avoiding recurring compliance issues and in reducing variation in compliance performance. In fact, reliable and effective regulatory compliance is commonly an outcome of consistent and reliable implementation of a management system.

Conducting periodic audits is a practical way to test a management system’s implementation maturity and effectiveness. One of the many advantages of audits is that they help identify gaps so that corrective/preventive actions can be put into place and then sustained and improved through the management system.

Audits also help companies with continuous improvement initiatives; properly developed audit programs help measure results over time. To achieve best value, audits should emphasize finding patterns that can yield opportunities for learning and continual improvement, rather than “gotchas” for exceptions that are discovered.

Management System Standards

Several options are available for structuring management systems, whether they are certified by third-party registrars and auditors, self-certified, or used as internal guidance and for potential certification readiness.

The International Organization for Standardization (ISO) standards are some of the most commonly applied. The ISO standards for quality (ISO 9001), environment (ISO 14001), health & safety (OHSAS 18001), business continuity (ISO 22301), and food safety (FSSC 22000) have consistent elements, allowing organizations to more easily align their various management systems. Aligned management systems help companies to achieve improved and more reliable quality, environmental, and health & safety performance, while adding measurable business value.

Certification

Companies can become certified to each of the standards discussed above. Certification has a number of benefits, including the following:

• Meet customer or supply chain requirements
• Use outside drivers to maintain management system process discipline (e.g., periodic risk assessment, document management, compliance evaluation, internal audits, management review)
• Take advantage of third-party assessment and recommendations
• Improve standing with regulatory agencies (e.g., USEPA, OSHA, FDA, and state programs)
• Demonstrate the application of industry best practice in the event of incidents/accidents requiring defense of practices

However, if there is no market or other business driver, certification can lead to unnecessary additional cost and effort regarding management system development. Certification in itself does not mean improved performance—management system structure, operation, and management commitment determine that.

Business Value

There are a number of reasons to implement a management system. A properly designed and implemented management system brings value to organizations in a number of ways:

• Risk management
  • Identify risks
  • Set priorities for improvement, measurement, and reporting
  • Provide great opportunity to identify, share, and learn best practices, while recognizing operational differences
• Protection of people
  • Send people home the way they arrived at work
  • Protect the public and the environment
• Compliance assurance
  • Improve and sustain regulatory compliance
• Business value
  • Continually improve quality, environmental, and safety performance across the organization (employee, public, equipment, infrastructure)
  • Reduce incident costs and accrued liabilities
  • Protect assets
• Reliability
  • Assure processes, methods, and practices are in place, documented, and consistently applied
  • Reduce variability in processes and performance
• Employee engagement
  • Help employees to find and use current versions of all procedures and documents
  • Provide a ready reference for field management to structure location-specific procedures
  • Enable the effective transfer of standards, methods, and know-how in employee training, new job assignments, and promotions

Join NACD and Kestrel on Thursday, April 4 at 12:00 p.m. (EDT) for a webinar on the U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA). During this webinar, Kestrel’s Roberto Bellavia, Principal in Food Safety Compliance, will provide an overview of FSMA rules applicable to the chemical ingredients industry, focusing on the receiving, storage, production, blending, and transportation of these products. Register here.

This webinar is a precursor to an upcoming in-person NACD regulatory workshop during which Kestrel will cover the FSMA regulations in-depth. This workshop will take place on June 12-13 in Oak Brook, Illinois, immediately following the Central Region Meeting. Registration for the workshop is forthcoming.

Designing and implementing a compliant Food Safety Management System (FSMS) can help organizations improve in many areas beyond the system’s defined tasks. It is critical for management to align the food safety objectives with the business needs for a successful and meaningful program implementation. Here are some of the top reasons why companies that work in the food industry may want to pursue developing and implementing an FSMS:

10. Identify and categorize the organization’s food safety risks.
Once this information is known, management can prioritize and decide how to eliminate or reduce business risks and liabilities to acceptable levels. These risks are often better controlled through strict management accounting. As a bonus, employees will become more attuned to thinking about risks and helping management improve overall operations.

9. Develop work instructions and/or procedures to guide employees’ actions and to ensure that each food safety task is completed in a disciplined manner and approved by management.
This will reduce the risk to an organization of an employee accidentally making a food safety mistake that causes the employee or others to be harmed (or worse). It also reduces the company’s risk of government inspections, fines, poor public perception, and loss of business due to a possible recall.

8. Assure management that they, in fact, know and understand the regulatory food safety requirements that must be met daily.
These requirements can be a driver of continual improvement by ensuring that the company has up-to-date procedures and work instructions for employees to follow every day.

7. Develop meaningful goals and objectives that drive food safety performance improvements and possibly reduce additional costs.
Each business will have different goals and these goals will likely change each year. Goals assure continuous improvement in food safety performance for the business over time.

6. Create a strong training and educational program that stems from well-written procedures and work instructions and that clearly defines the company’s requirements.
A well-trained workforce is a motivated and happy workforce. Turnover is reduced, accidents and incidents decrease, and production efficiencies increase. Employees are very aware when an organization takes time to ensure that each job requested is completed in the safest manner possible.

5. Develop appropriate monitoring and measurement practices.
Once all food safety requirements (e.g., FSMA, USDA, GFSI) are known and understood, the organization will be able to gauge food safety performance based on scientific data and regulations, and then guide the organization’s actions in a direction of continuous improvement and compliance.

4. Verify the FSMS is functioning as designed and implemented.
By continuously auditing each food safety program and function, the organization will discover issues of concern and non-conformances prior to an incident or agency/certifying body finding. Routine, non-biased audits allow the company to choose a timeframe that will help improve the situation without undue influence by outsiders.

3. Monitor and trend issues of concern and/or non-conformance and the actions used to rectify them through a fully functioning corrective/preventive action program.
As employees watch management fix problems, they will learn that management is concerned about continuous improvement. This will prompt employees to start making their own improvement suggestions. These suggestions will further drive improvement in areas outside the original FSMS.

2. Evaluate the business model and the FSMS in a holistic fashion.
By using this self-reflection and identifying improvement opportunities, management can direct responsibilities for improvement actions across many departments of the company. Each of these improvement opportunities has the potential to help the bottom line and reduce the possibility of a food safety liability now or in the future.

1. Know that the company has done everything to maintain the business in a manner that meets all food safety rules and regulations.
The last and most important benefit for an organization that goes through the process of designing and implementing a compliant FSMS is knowing that the organization has done everything possible to maintain its business in a manner that meets all food safety laws, regulations, and statutes every day the doors are open for business. To a business owner, that knowledge is priceless. This is how brands are built and how they maintain the promise of food safety to consumers.

On behalf of our team, Kestrel Management would like to invite you to attend the 6th Annual Food Safety Consortium Conference & Expo on Nov. 13-15 in Schaumburg, IL.

The Consortium is a premiere event for food safety education and networking—and we want to offer you the chance to visit us at the event (booth #119) for a discounted rate (see offer below).

You can accomplish more in two or three days at the Food Safety Consortium than you might otherwise achieve in weeks! Here are five ways the Food Safety Consortium will allow you to enhance your business:

• Get expert advice on specific challenges faced by your business.
• Listen to insights from thought leaders & innovators.
• Stay up-to-date with emerging or changing trends.
• Upgrade your skills, knowledge and on-the-job effectiveness.
• Gain new ideas and insights to grow your business.

Come see Kestrel at booth #119. When you register, use our discount code Cubs and receive a 20% discount off registration.

Our team is proud to be part of the Food Safety Consortium and hope to see you there!

When looking at FSMA, it’s important to look at what we should be doing in industry under FSMA’s prevention scheme. FDA seeks for companies to assess risk and implement preventive controls on a broad basis. Thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or an importer, is key for any food company when planning for the future.

From Reactive to Proactive

With the FSMA rules, FDA has moved from reactive to proactive. Preventive strategies are the essence of FSMA. Proactively creating or updating a food defense and safety plan is the first step to ensure compliance.

The four “A’s” of food defense, as outlined below, provide a methodology for building a proactive and comprehensive food defense program.

Step 1: Assess
Assess the risks throughout the supply chain, including to the origin of raw materials. Conduct a vulnerability assessment of weaknesses and critical control points to identify where someone could attempt product adulteration. The focus must be both inside and outside of company walls and extend to the source of materials and services within the supply chain for producers and distributors of food to the public.

Step 2: Access
Who has access to critical control points and food material risk areas? Pay close attention to the four key activity types that FDA has identified as particularly vulnerable to adulteration:

• Mixing and grinding activities that involve a high volume of food with a high potential for uniform mixing of a contaminant
• Ingredient handling with open access to the product stream
• Bulk liquid receiving and loading
• Liquid storage and handling, which is typically located in remote, isolated areas

Restrict access to these areas from suppliers, contractors, visitors, and most employees—limiting access to critical employees only. This provides a higher level of protection, and supports video and/or physical monitoring.

Step 3: Alerts
Alerts of intentional and unintentional food adulteration must be sent to the appropriate individuals, according to the documented food safety and defense program. Response time is critical. Every passing minute is a minute when more health risks could develop, leading to a greater chance of negative impacts on public safety and the related businesses.

Step 4: Audit
Auditing operational and regulatory compliance helps to ensure and maintain best food defense practices and provide documentation of compliance to regulators. FSMA promotes the safety of the U.S. food supply by focusing on prevention, rather than reactive response. Prevention is only as effective as the actual compliance processes put in place. Regular and random auditing, including remote video monitoring, provides evidence confirming that the appropriate preventive measures are taken and effective.

Taking a proactive approach to food defense that follows these four “A’s” will help meet a key requirement by ensuring that the organization is working to avoid the risks associated with food adulteration and contamination.

On Monday, September 17, 2018, the Office of the United States Trade Representative (USTR) released a list of approximately $200 billion worth of Chinese imports, including hundreds of chemicals, that will be subject to additional tariffs. The additional tariffs will be effective starting September 24, 2018, and initially will be in the amount of 10 percent. Starting January 1, 2019, the level of the additional tariffs will increase to 25 percent.

In the final list, the administration also removed nearly 300 items, but the Administration did not provide a specific list of products excluded. Included among the products removed from the proposed list are certain consumer electronics products, such as smart watches and Bluetooth devices; certain chemical inputs for manufactured goods, textiles and agriculture; certain health and safety products such as bicycle helmets, and child safety furniture such as car seats and playpens.

Individual companies may want to review the list to determine the status of Harmonized Tariff Schedule (HTS) codes of interest.

View the final tariff list here.

Read the USTR press release.