CDQAP Ruminations: Food Defense for Dairy Processors – Efficient, low-cost compliance with new FDA rules

Food Defense for Dairy Processors: Efficient, low-cost compliance with new FDA rules.

Starting in July 2019 the FDA is requiring food processors to develop plans and training to help prevent intentional adulteration of food. Below are some free on-line tools to help processors comply with the new regulations…

Highlights: What You Need to Know about FDA’s New “Food Defense” Regulations.  

  • As part of U.S. anti-terrorism efforts, starting in 2019, mid-to-large sized food processors will need to develop food defense plans and employee training to help prevent intentional adulteration of food.
  • Dairy farms are NOT included under these new regulations, unless they perform processing operations on the farm, like cheese-making or bottling. Dairies performing on-site processing are exempted from the rule if the facility’s sales of human food are less than $10 million per year.
  • For English speakers, the quickest, easiest, cheapest way to fulfill new employee training requirements is having them view a free, 30-45 minute on-line video
  • For mid to large size dairy processors developing a food defense plan, the free FDA Food Defense Plan Builder program is available on-line. Other resources are available.
  • For dairy producers interested in low-cost, effective methods of increasing their farm’s security see Preventing Rural Crime on Your Dairy and Dealing with Trespass and Drones on California Dairies

 BACKGROUND:

As part of the nation’s anti-terrorist efforts, in May of 2016 the FDA finalized the “Intentional Adulteration Rule”, part of its 2011 Food Safety Modernization Act (FSMA). The IA Rule requires that food processing facilities implement both “Food Defense” plans as well as training for employees working at sensitive processing steps.

Importantly, the FSMA – IA Rule does not apply to farms. This means that for dairy farms where there is no processing (like cheese-making or bottling) there are no additional security requirements. Dairies performing on-site processing are exempted from the rule if the facility’s sales of human food are less than $10 million per year. Some dairy producers, however, may consider enhancing security at the farm level to deter theft, vandalism and other rural crime.

About 9,800 food facilities throughout the nation are covered under the IA Rule, typically those marketing human food with valued at $10 million or more. Larger businesses (500 employees or more) have until July 2019 to comply. Small businesses, which employ fewer than 500 people, have until July, 2020 to comply. While very small businesses are exempt from most of the requirements. After July 2021 however, they may be requested to provide documentation of their exemption status.

Typically a food defense plan consists of 1) a vulnerability assessment of the facility, identifying points at greatest risk for intentional adulteration, 2) preventive strategies to address these vulnerabilities, 3) a system monitor the program and take corrective action, 4) record keeping and regular review. Relative to training, employees (and their supervisors) working at sensitive points in a facility are required to take food defense awareness.

The FDA has provide draft, non-binding guidance for industry on how to comply with the new Intentional Adulteration rule.

EMPLOYEE TRAINING FOR FOOD DEFENSE

The outline of courses below highlights differences in some of the prominent training sites. Importantly, none of the training resources are dairy specific. It is important to note that the training requirement in the IA rule is flexible, and companies may choose one of the trainings listed below or a similar food defense awareness training to satisfy this requirement. Companies may also develop their own training.

Online Food Defense Training Materials For Processor Employees

Food Defense Awareness for the IA Rule (FSPCA), Approx. 40 minutes completion. Certificates available. Not dairy-specific. Spanish not available. FREE.
For English speakers, this is the quickest, easiest, cheapest way to fulfill IA Rule training obligations. Other then three short module quizzes, no reading is required. The employee training is a fraction of the food defense information resources offered by this public-private collaboration whose mission is to assist food processors meet FSMA regulations. Use the Chrome browser rather than Internet Explorer to avoid problems.

Food Defense Awareness for Front-Line Employees (FDA), Approx. 40 minutes completion. Certificates available. Not dairy-specific. Spanish is available. FREE.
The course requires about 30 minutes of reading in English but the central information is contained in a 12 minute video available in both English and Spanish. Other resources for managers and food defense plan developers are also available. The separate “The Food Defense Awareness for Food Professionals” consists of 6 modules and is comprehensive, but is not designed for front-line employees.

Food Defense Awareness Online Training (FPDI), Approx. 6- minute completion. Certificates available. Not dairy-specific. Spanish not available. $50/per person*
*Once registered for this self-paced, on-line course you have 90 days to complete it. This course is by far the most comprehensive of any of the awareness courses, but it requires twice as long to complete and has test at the end. A more condensed video version of the course in English and Spanish is under development. The course is a fee-for-service, but different pricing schedules and in-person training are available. There are a number of other resources offered by this offered by this FDA Center of Excellence located at the University of Minnesota.

FSPCA’s FOOD DEFENSE AWARENESS FOR THE IA RULE

Based out of the Illinois Institute for Technology, the Food Safety Preventive Controls Alliance (FSPAC) is a public-private alliance created to provide educational programs to assist the food industry in complying with regulations promulgated as a result of FSMA. The program has developed an extensive catalog of both on-line an in-person courses related to food protection. Offerings include free quarterly webinars related to FSMA. Also included in this catalog is a 30 minute long voice-over slide set that could be used for employee training.

Specifically related to Food Defense, FSPAC has two online course offerings:

FSPCA Food Defense Awareness for the IA Rule: This online course is estimated to take 20-30 minutes and is presented completely with voice-over text slides, videos and animations so there is no focused reading or memorization required. For English speakers, this is the shortest, easiest way to fulfill IA Rule training obligations. Other than module quizzes, no reading is required. These videos however are available only in English. The course offers a certificate of completion and the cost is free. This training is designed for individuals assigned to work at “actionable process steps” and will meet the food defense awareness training requirement (21 CFR 121.4(b)(2)) within the Intentional Adulteration rule (IA rule). The course is divided into three modules: Intentional Adulteration and Food Defense Overview, Implementation of Food Defense at a Facility and Roles and Responsibilities. In addition to the course being free, there is no registration is required to launch the course. One hiccup in the program: if you are logged into the IFPTI host portal already, say for using other fee-based courses, the system will have trouble locating this free course.

FSPCA Overview of the Intentional Adulteration Rule (IA Rule): You cannot use Microsoft Explorer to access this training, you must use Chrome browser.  This training provides more in-depth information about FSMA’s IA Rule and is aimed toward owner and managers rather than employees.

A series of additional food defense modules are being developed and will focus on topics such as vulnerability assessments, mitigation strategies and food defense plan preparation.

FDA’s FOOD DEFENSE 101

Part of the FDA’s Food Defense 101 program, a free on-line course was developed to enable preparedness against an intentional attack against the nation’s food supply. The entire course consists of six modules focused on different industry needs: general awareness, training employees and developing a food defense plan. The most attractive aspects of the course are that it’s free, it doesn’t require registration and that it downloads easily on most computers. The most problematic aspect of the course is that it’s is extremely general with no specific templates on how to create a food defense plan. The module Food Defense Awareness for Front-Line Employees can be used for employee training, but requires about 30 minutes of reading time in English. The module’s most important information however is contained in a 12 minute video that is available in both English and Spanish. This same 12-minute video and accompanying posters is also available at the FDA’s Employees FIRST site in Chinese, French, Japanese, Korean and Vietnamese.  As with all the Food Defense resources listed here there is no specific reference to the dairy industry.

https://www.accessdata.fda.gov/scripts/FDTraining/index.cfm

Food Defense Awareness for Front-line Employees
The module provides awareness training for the front-line employee in food defense: differences between food safety and food defense, the importance of the front-line employee in food defense, identify threats the front-line employee may encounter and how to respond to these threats. The course requires considerable amount of reading, takes about 30 minutes to

“See Something, Say Something” Campaign™
This campaign was designed back in 2010 to improved awareness related to identifying and preventing in illicit or terrorist activities. The primary (in fact only) educational tools in this program are the See Something, Say Something posters in English, Spanish and Chinese. These posters are designed to help employees recognize and respond to suspicious activity.

Employees FIRST
Employees FIRST is an FDA initiative that food industry managers can include in their ongoing employee food defense training programs. It consists of the same 12 minute video used in the FDA’s  Food Defense Awareness for Front-line Employees teaching program and well as matching posters. Both the video and accompanying posters are available in English, Spanish, Chinese, French, Japanese, Korean and Vietnamese. The acronym “FIRST” stands for:

  • Follow company food defense plan and procedures.
  • Inspect your work area and surrounding areas.
  • Recognize anything out of the ordinary.
  • Secure all ingredients, supplies, and finished product.
  • Tell management if you notice anything unusual or suspicious

FPDI’s FOOD DEFENSE AWARENESS TRAINING

Located at the University of Minnesota the Food Protection and Defense Institute (FPDI) was launched as a Homeland Security Center of Excellence in 2004. The center has an extensive catalog of resources related to Food Defense. This particular course Food Defense Awareness Training was designed to help meet the FSMA requirement for Food Defense Awareness Training. The course is online and self-paced and takes approximately one hour to complete. The course consists of five modules, each starts with a video 5-10 minutes in length followed by a quiz with several questions. There is a final exam test at the end of the course. A passing grade is 80%. There are short notes, transcripts and references for each video. This is the most comprehensive of any of the awareness courses, but it does require twice as long to complete and is a fee-for-service course. To access the course you will need to create a temporary University of Minnesota account, a process which is fairly extensive. Once registered as an on-line student with the University of Minnesota you will purchase the course for $50 using a credit card. Once purchased, you have 90 days to complete the course. A certificate of completion is provided at the end of the training.

Food Defense Plan Resources
There are a number of organizations, both public and private, offering on-line information resources that may be useful for processors constructing food defense plans in order to comply with FSMA’s IA rule. The type of information resources available vary widely from software templates to databases of mitigation options.

FOOD AND DRUG ADMINISTRATION (FDA)

The federal Food and Drug Administration has an extensive menu of on-line resources related to Food Defense, some developed in-house and some in partnership with other public or private organizations to help food facilities prevent, prepare for, respond to, and recover from acts of intentional adulteration of the food supply.

Food Defense Plan Builder
A user-friendly software program designed to assist owners and operators develop customized food defense plans for their processing facilities. The template is downloaded to a secure company computer. Importantly however the FDA does not track or monitor the use of the program or have access to any content the tool generates. The tool leads the user through the process of creating a Food Defense Plan including developing a vulnerability assessment, selecting mitigation strategies, creating action plans and creating supporting documents and reports. There are two training videos describing the abilities and use of the software and should be viewed before attempting to use the tool.

 

 

 

 

 

Mitigation Strategies Database
The FDMSD provides a range of mitigation strategies to consider implementing at points, steps or procedures to minimize the vulnerability to an intentional attack. The database is integrated into the Food Defense Plan Builder so options can be selected and cut-and-pasted into the developing plan. To use the data without the accessing it through the Food Defense Plan Builder program, you can directly launch the program and then either browse by category or search by keyword.  The strategies of most use for dairy processors can be accessed by clicking on the “Farming/Agriculture” blue box button.

Food Related Emergency Exercise Bundle (FREE-B)
Developed in collaboration with CDC and USDA, the Food Related Emergency Exercise Bundle (FREE-B) is a compilation of eight scenarios based on both intentional and unintentional food contamination events. It is designed with the intention of assisting government regulatory and public health agencies in assessing existing food emergency response plans, protocols and procedures. The scenarios are designed to allow for companies to independently test their own plans or “play” with other stakeholders (medical community, private sector, law enforcement) in collaborative drills or exercises.

Guidance for Industry: Intentional Adulteration Rule – What Small Entities Need to Know
This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR 121 concerning Mitigation Strategies to Protect Food Against Intentional Adulteration. The rule is binding and has the full force and effect of law.

Intentional Adulteration Final Rule Video Presentation
This (somewhat dry) slide set provides background on the Intentional Adulteration final rule. It would likely be of little use for building food defense plans other than providing a 45,000 foot overview of the final rule.

 

Food Defense Vulnerability Assessments and Identification of Activity Types
The FDA has conducted vulnerability assessments on more than 50 products or processes, leading to the identification of processing steps of highest concern, and potential mitigation strategies to reduce vulnerabilities. The appendix in the report lists the four activity types where mitigation actions can most often be taken as 1) Coating/Mixing/Grinding/Rework 2) Ingredient Staging/Prep/Addition 3) Liquid Receiving/Loading 4) Liquid Storage/Hold/Surge Tanks. It’s possible that this report might hold some useful as background information for plan developers, but it is nearly a decade old and has been largely superseded by more recent tools such as the Food Defense Plan Builder. The report can only be accessed through an archived file.

FOOD PROTECTION & DEFENSE INSTITUTE (FPDI)

The Food Protection and Defense Institute (FPDI) was launched as a Homeland Security Center of Excellence Located at the University of Minnesota in 2004. The center has a catalog of training, research and collaboration tools available. These include:

FPDI Monthly Food Defense Webinars
Every month the FPDI delivers a webinar highlighting a single topic related to food defense. Each of these hour-long webinars is recorded and available for free downloading. The selected topics very widely in scope and include such titles as:

  • Cybersecurity and the Food Industry
  • Designing High Impact Risk Messages
  • Detecting Food Fraud Through DNA Analyses,
  • Ebola and the Food System
  • Lessons Learned from the 2014 Avian Influenza Outbreak.

Food Defense Readiness Assessment (FDRA)
The FDRA is a facility-based educational and self-assessment tool to assist food facilities in understanding, assessing level of readiness, and implementing mitigation strategies FSMA Intentional Adulteration Rule.  Readiness scores generated from the assessment are not intended to determine FSMA regulatory compliance. The tool is purchased at a cost of $99.95 per facility.

 

 

Intentional Adulteration Assessment Tool (IAAT)
The IAAT software tool is available as a downloadable platform designed to be installed on a computer at a food company (or corporate) location. A food company’s knowledgeable individual enters operational specifics of a food process into IAAT which calculates vulnerabilities based on objective criteria including threat agent characteristics and reports prioritized risk areas to the user. Contact FPDI to learn more about accessing the program for your organization.

 

   FoodSHIELD & CoreSHIELD
Operational for about 13 years CoreSHIELD is an information-sharing technology that provides a suite of web-based portals allowing public and private agriculture sectors a platform to coordinate their food defense efforts in a secure and efficient way. Government partners in CoreSHIELD include the Department of Homeland Security, FDA and USDA. CoreSHIELD portals connect a wide variety of organizations including laboratory networks charged with protecting food and feed such as Food Emergency Response Network (FERN), USDA’s National Animal Health Laboratory Network (NAHLN) and Animal Feed Network. A video describing the CoreSHIELD portal systems is available. FoodSHIELD is the largest and best known of the CoreSHIELD web-based portals and has some 15,000 active users. User-breakdown of FoodSHIELD includes about 30% Federal, 30% State, 10% academic and 10% industry. Members can create workgroups to engage existing groups with document centers, on-line meetings, surveys, news feeds, calendars, and discussion forums. The public side contains information on food protection issues, tools, events, jobs, and resources. Contact FPDI to learn more about accessing the program for your company.

Food Adulteration Incidents Registry (FAIR)
The FAIR is a compilation of historical and current events involving economically motivated and intentional adulteration of foods on a global scale. Data is routinely curated from publicly available sources and includes food adulteration incidents motivated by terrorism, sabotage, and fraudulent economic gain. The database contains over 730 unique incidents and continues to grow. Incidents occurring more than 5 years ago are available for free. Full access to the program requires subscription at $600 per subscriber per year.

 

World Factbook of Food
The WFF is designed to serve as a central reference repository of data related to food.  It is collected, curated, and routinely updated from numerous sources on a variety of topics including production, trade, common food and non-food uses, seasonality, processing steps and supply chain structure, food safety concerns, and past intentional adulteration events. Data is displayed in an easy to use website, including interactive graphs and detailed source information. Access to the program requires subscription at $600 per subscriber per year.

 

Criticality Spatial Analysis (CRISTAL)
Supply chains are often a complex network of suppliers, production and processing facilities, storage and distribution channels. CRISTAL is a geo-spatial web application that allows users to document, visualize, and compare supply chains in support of risk and criticality assessments, mitigation efforts, and event response. Contact FPDI to learn more about accessing the program for your organization.

 

Focused Integration of Data for Early Signals (FIDES)
In collaborations with both the FDA and the Department of Homeland Security FIDES performs “horizon scanning” for food system disruptions. The FIDES web application fuses multiple streams of data from disparate sources and displays information in the form of an online dashboard where users browse, search, and layer reference data sets related to food system disruption events. Examples of data currently included in FIDES are import refusals, global disasters, animal health alerts, food defense incidents, historical food safety incidents, import data, price alerts, and reference data on food production worldwide. Contact FPDI to learn more about accessing the program for your organization.