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From: Food Quality & Safety magazine, October/November 2006

Food Defense at the Federal Level

In mid 2005, Dr. Barbara Masters, administrator for the USDA’s Food Safety Inspection Service (FSIS), announced that the agency was changing its official heading regarding bio-terrorism from plant security to food defense.

by Stevbe Sayer

All this did to the plants that already had a plant security program in place was to have their regulatory essayist tap their delete button and type in “food defense” into their existing programs. For plants that didn’t have a food defense program in place, it should be a neon caveat for them to wake up and acknowledge that there exists, both domestically and internationally, a mushrooming insatiable 21st Century malediction that knows no boundaries: Terrorism.

The terms security and defense will pop up in any thesaurus as close synonyms. Food safety refers to guarding against the unintentional contamination of food, whereas food security and/or defense, involves safeguarding the food supply against premeditated acts of contamination.

America’s food supply continues to be highly susceptible to bioterrorism for a variety of reasons. A majority of the agricultural industries are highly concentrated to single-species, i.e. livestock feedlots, poultry houses, major food processing and distribution centers. This makes it rather easy for contamination and infection to spread quickly.

In addition, vertical integration of these industries also facilitates the geographical spread of contamination. Factor in the highly political and controversial issue concerning undocumented workers, many of whom are employed by food industries, susceptibility is exponentially amplified.

Threats to our food supply have potentially dire economic, health, societal, political and psychological implications. Calculated contamination of the food supply would connote significant public health consequences and widespread public panic. It would likely have a devastating impact to the economy compounded with the loss of hard-earned public confidence of the safety of our foods, including the efficacy of the government agencies assigned to protect it.

The nefarious events of 9/11, the ensuing anthrax incidents and the interminable zeitgeist tone of today’s current events continue to raise concerns of terrorists attacks to our food supply. These events have heightened international awareness that any country could become targets for biological, chemical, physical and radiological terrorism.

The World Health Organization addresses it this way: “Food is the most vulnerable to intentional contamination by debilitating or lethal agents. The diversity of sources of foods, including the global market, makes prevention difficult, if not impossible. In fact food offers the perfect vehicle for large-scale terrorist attacks.”

The year 2006 marks the FSIS Centennial. In that time, the FSIS has developed and put into place federal regulations for safe food and, most recently, food defense. The FSIS has more than 7,600 inspectors and veterinarians assigned to meat, poultry and egg plants, including ports-of-entry to obviate, detect and act in response to food safety/security emergencies.

Since 9/11, bio-security/food defense activities have dramatically increased at all levels of the federal government requiring tremendous logistics and coordination throughout. To fully appreciate FSIS food defense activities, an abridged synopsis of interrelated White House and departmental activities is needed.

On Oct. 8, 2002, President Bush established the Office of Homeland Security. The objective was to develop and coordinate the implementation of a comprehensive national strategy to secure our shores from terrorist coercion and attacks.

An internal USDA Homeland Security Council was structured to work in partnership with the Office of Homeland Security, the National Security Council and other departments to set a course for long-term success.

The council is responsible for establishing overall USDA Homeland Security policy, coordinating department-wide homeland security issues, tracking USDA progress on homeland security objectives and appointing a representative to interagency and other external groups. The council also ensures that information, research, and resources are shared and activities are coordinated with other federal agencies.

The Office of Food Defense & Emergency Response (OFDER) overlooks all homeland security activities within the FSIS. OFDER ensures that policy makers, scientists, and field staffs are prepared to prevent and respond to any food security threat.

OFDER was established in 2002 to develop and coordinate all FSIS activities in order to prevent, prepare, respond and recover from non-routine emergencies resulting from intentional and non-intentional contamination affecting meat, poultry and egg products. OFDER serves as the agency’s central office for homeland security issues and ensures coordination of its activities with the USDA Homeland Security Office, the Department of Homeland Security, FDA and other germane federal and state government agencies with food-related responsibilities.

OFDER draws its regulatory authority from the following Inspection Acts:

  • Federal Meat Inspection Act of 1906
  • Poultry Inspection Act of 1957
  • Egg Inspection Act of 1970

In May 2002, the FSIS issued the FSIS Security Guidelines for Food Processors to assist meat, poultry and egg plants with identifying ways to strengthen their food security protection. In August 2003, the FSIS Safety and Security Guidelines for the Transportation and Distribution of Meat, Poultry and Egg Products was issued, which focused on improving food safety and security in the transportation and distribution segments of the supply chain. From May through July 2005, a series of nationwide public workshops were jointly held by FSIS/FDA to discuss food security awareness and strategies. The curriculum had relative FSIS Food Security Directives/Notices including Model Food Safety Plans for meat, poultry, slaughter and egg establishments, including plants that import meat, poultry and egg products. Just prior to the workshops, in April of 2005, the FSIS issued a revised voluntary checklist: “Industry Self-Assessment Checklist for Food Security” for FSIS inspected establishments and importers to use with the objective of protecting commodities from becoming intentionally contaminated. The categories are:

  • Food Security Plan Management
  • Outside Security
  • Inside Security
  • Slaughter and Processing Security
  • Storage Security
  • Shipping and Receiving Security
  • Water and Ice Supply Security
  • Mail Handling Security
  • Personnel Security

The checklist, when pertinent to a company’s operation, provides clear methodologies to develop/append Food Defense Programs. Each category is generic to custom fit each plant’s unique needs.

Unveiled in September, FSIS Directive 5420.1, Revision 3, Amendment 1 addressed Homeland Security Threat Conditions Response- Food Defense Verification Procedures. The Homeland Security Advisory System based on color provides an effective means to circulate information regarding the risk of terrorist acts to Federal, State, and local authorities including the general public. This color code system is incorporated within the FSIS/USDA system.

Effective Sept. 15, the directive details the protocols that FSIS inspection program personnel at the establishment level are to follow when a threat condition of yellow, orange or red is declared by the Department of Homeland Security:

  • Elevation Yellow is when there is an elevated risk of terrorist attacks;
  • High Orange is when there is a high risk of terrorist attacks;
  • Severe Red is when there is a severe risk of terrorist attacks.

Every meat, poultry and egg establishment has an assigned FSIS inspector-in-charge (IIC). The IIC is responsible, among other things, to ensure and enforce all of the myriad federal regulations that govern a meat, poultry and egg establishment. Depending on the size and type of operation, there can be multiple inspectors assigned to a single establishment every working day.

There are a series of scenarios listed in Directive 5420.1, Revision 3, Amendment 1 involving a yellow, orange or red declaration by Homeland Security as well specific instructions when downgrading a color code notification.

Upon the notification by Homeland Security of a yellow, orange or red notice, OFDER will inform the FSIS Administrator and FSIS Management Council. OFDER will issue an e-mail letter to all employees notifying them of the heightened threat condition. The directive has specific instructions with regards to food defense verification procedures. Inspection personnel will continue to perform all normally scheduled food safety activities during such threats.

The areas of an establishment listed below, at minimum, are the sections of the establishment that are to be observed and documented by inspection personnel during a declared color elevated threat. Each of the headings contains sub-categories for plant inspectors to follow including instructions of communication and suggested activities:

  • O8S14 – Water System
  • O8S15 – Processing/Manufacturing
  • O8S16 – Storage Areas
  • O8S17 – Shipping & Receiving

In addition, the directive instructs the establishment IIC to notify the USDA district office in the event there is a direct attack on the establishment or surrounding areas. The district office then notifies appropriate local authorities which may include the FSIS Management Committee through the Office of Field Operations under OFDER.

Section IX of the directive spells out the purpose of an Emergency Food Defense Verification, noting that “procedures are to identify and mitigate to the maximum extent possible potential vulnerabilities in the security of an establishment that could lead to deliberate contamination. Examples of potential vulnerabilities include uncontrolled access to a restricted ingredient area: unrestricted access to a processing room; or unrestricted access to water systems.”

Section VIII indicates that “establishments should develop a functional food defense plan to set out control measures to prevent intentional adulteration of product. Although not required, FSIS encourages establishments to have a food defense plan.”

The directive also states that “an establishment is not obligated to provide a copy of its written plan to inspection personnel. If an establishment does provide a copy, inspection program personnel may use the plan when performing the food defense verification activities.”

“Do not make copies of the written plan. Inspection program personnel are not to show or share the plan with any outside source because it may contain sensitive security information.” the directive concludes.

Contrary to the FSIS present requirements concerning mandatory food defense programs, there is another regulatory appendage of the USDA that does require a written and verifiable program; the Livestock and Seed Program, (LS Program). The Commodity Procurement Branch of the LS Program purchases and supplies raw meat and cooked items including pork and fish for underprivileged children, disadvantaged families, charitable institutions, the elderly, the homeless and schools nationwide.

Pre-approved USDA inspected establishments that participate in the LS Program are audited once a month by another federal agency, the Audit, Review, and Compliance Branch (ARC) of the USDA’s Agricultural Marketing Service (AMS). These audits include not only ISO based food safety standards but also mandatory food defense requirements. The food defense audit also involves, if applicable, offsite storage of packaging materials that would be used in the program as well as independent freezers for the storage of commodities. Thus, the commodity supplier is responsible for not only the security at their processing plant(s) but also their dry packaging vendor, offsite temporary storage facilities, freezer storage and the security of the said products while in transit.

In June 2005, a Checklist/Report for Food Security Plans was issued by the AMS for their auditors to utilize during their monthly inspections. The categories below are similar to the FSIS/USDA April 2005 version reviewed earlier:

  • Food Security Plan Management
  • Outside & Inside Security
  • Slaughter & Processing Security
  • Shipping & Receiving Security
  • Storage Security
  • Water & Ice Supply Security
  • Mail Handling Security
  • Personnel Security
  • Controlled Access to Production and Storage Areas.

If any of the above areas are found to be seriously deficient by an auditor, it could result with the supplier being issued a critical non-compliance notice and suspended from continued participation in the LS Program until approved rectifications are made and approved by the AMS.

Dissimilar to the FSIS inspectors who have received only food defense training, AMS auditors have extensive criminal background checks and other security clearances by federal agencies, including food defense training prior to performing their food defense audits associated with the LS Program.

The LS Programs binding requirement of having in place a written and verifiable Food Defense Program could be a herald semaphore of change for the 6,000 FSIS/USDA inspected meat, poultry and egg establishments nationwide.

Although the FDA’s Bioterrorism Act of 2002 is not applicable to meat, poultry and egg plants, (because they are exclusively regulated by the USDA as per 21 CFR 1.2777 (b)), it would be sagacious for USDA establishments to register and abide in full to the regulatory requirements set by the FDA. Though statistics are not available on how many FSIS plants have a viable Plant Defense Program presently in place, it’s rather alarming that meat, poultry and egg plants are not required by FSIS, the FDA, or any other regulatory agency, to have in place a verifiable Food Defense Program.

Meat, poultry and eggs products exported into the U.S. from another country must be equivalent to all FSIS safety standards and regulations that are applied to foods produced in the United States. Imports must originate in eligible countries and from establishments certified by the country’s inspection service as being eligible to export to the U.S.

When an incoming shipment has met US Custom Service requirements. FSIS inspectors will check the documents to ensure the shipment is properly certified by the foreign country. Inspectors will examine each shipment for general conditions and labeling and then conduct inspection assignments.

Products that pass re-inspection are stamped with the USDA mark of inspection and are allowed to enter U.S. commerce for distribution. Products that do not meet U.S. requirements are stamped “U.S. Refused Entry” and are exported or destroyed within 45 days.

As a final point, the FSIS has in place a Technical Service Center, (TSC) with a well qualified staff available for both industry and the general public. The TSC serves as the agency’s hub for technical assistance and guidance regarding, among other things, the implementation of national policies, food safety and security directives.

An establishment’s Food Defense Program should be similarly structured on the guidelines of a HACCP System. There must also be total and unwavering commitment from top management. A Plant Defense committee should be developed with scheduled meetings held with a quorum developed and minutes recorded for future references.

Periodically, a documented risk reassessment of the defense program should be carried out to ensure all facets of the program are working as intended. Any deviations that occur should be corrected and noted on a correction action log, including preventive measures. Likewise, any amendments to the program should be documented with a description of the revisions.

Employers should view all of their employees as the “keystones” for their Plant Defense Programs. Employees continuously enter, meander and exit plant buildings every working day and night. They can be deterrent factors as well as a source of vigilant eyes.

The Food Defense Program should be proprietary in nature and be considered a company trade secret. In the last several years third-party customer audits, (Silliker Laboratories, AIB, Steritech. Food Safety Net Services, etc.,) have added Food Security Defense/ Bioterrorism evaluations to their audit checklists. This could create a risk of purloined documents being accessed including back-door exposures via the Freedom of Information Act.

To counter this, a company letterhead stating that a review of the plant’s written defense program is a company trade secret but a general overview can be offered. An epigrammatic synopsis highlighting the plants security program should be developed and presented to the auditor. Together with obvious visual safeguards in the semblance of hired security guards, ID cards, surveillance cameras, sign-in sheets, and posted security signs should collectively suffice in placating both the auditor and governmental inspectors.

The FSIS/USDA, acting as a modern day bivouac, has positively taken the initiative by informing and educating both private industry and the general public through nation-wide workshops, plant defense checklists, model security plans, FSIS Notices and Directives, and the availability/accessibility of the TSC. It’s now up to each establishment to become responsible and fully accountable and implement these and other available resources that would protect their unique operations from deliberate contamination that in turn would provide a security shield for the consuming public.

Steve Sayer is a 25-year veteran of the beef industry and food safety for S and R Consulting (Aliso Viejo, Calif.) Reach him at



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