Food defense at the federal level

"One of the things that I always say about bioterrorism, whether it's ourselves at the federal level, folks at the state level, or folks in the private industry, we've done many great things, especially since 9/11."

- Mike Johanns, Secretary of Agriculture from 2005 to 2007

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By Steve Sayer

INTRODUCTION

In mid 2005, Dr. Barbara Masters, Administrator for the United States Department of Agriculture (USDAs) Food Safety Inspection Service (FSIS) announced that the Agency was changing its official heading regarding Bio-Terrorism from "Plant Security" to "Food Defense."

All this did was 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 - wherever it was applicable.

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 distributing centers. This makes it rather easy for contamination and infection 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 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 event of 9/11, the ensuing anthrax incidents and the interminable zeitgeist tone of today's current events continue to raise concerns of terrorist 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 (WHO) addresses the threats of bio-terrorism 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."

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The year 2006 marked the Food Safety Inspection Service (FSIS) Centennial. In that time, the FSIS has developed and put into place federal regulations for safe foods, and most recently, food defense.

The FSIS/USDA has more than 7,600 inspectors and veterinarians assigned to meat, poultry and eggs plants (including - catfish), 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' many food defense activities, an abridged synopsis of interrelated White House and departmental activities is provided below that explains the complex genesis of food defense at FSIS/USDA.

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Onc Oct. 8, 2002, President Bush established the Office of Homeland Security.

The objective was to develop and coordinate the implementation of a comprehensive national security 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 Council and other germane departments to set a course for long-term success.

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

The Office of Food Defense & Emergency Response (OFDER) overlooks all homeland security activities in order to prevent, prepare, respond and recover from intentional and non-intentional contamination affecting meat, poultry, egg and catfish 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 Dept. of Homeland Security, FDA and other germane federal and state governmental agencies with food-related responsibilities.

OFDER draws its regulatory authority from the following Inspection Acts:

Federal Meat Inspection Act of 1906

Is a federal law that makes it illegal to adulterate or misbrand meat and meat products being sold as food, and ensures that meat and meat products are slaughtered?and processed?under strictly regulated sanitary conditions. These requirements also apply to imported meat products, which must be inspected under equivalent foreign standards.

Poultry Inspection Act of 1957

Requires FSIS/USDA to inspect all domesticated birds when slaughtered and processed into products for human consumption. By regulation, FSIS has defined domesticated birds as chickens, turkeys, ducks, geese, and?guinea fowl. Ratites were added in 2001. The primary goals of the law are to prevent?adulterated or misbranded?poultry and products from being sold as food, and to ensure that poultry and poultry products are slaughtered and processed under sanitary conditions. These requirements also apply to products produced and sold within states as well as to imports, which must be inspected under Equivalent Foreign Standards (21?U.S.C. 451 et seq.).

Egg Inspection Act of 1970

Congress passed the Egg Products Inspection Act (EPIA) in 1970. The EPIA provides for the mandatory continuous inspection of the processing of liquid, frozen, and dried egg products. For the next 25 years, the Poultry Division of USDA’s Agricultural Marketing Service (AMS) inspected egg products to ensure they were wholesome, otherwise not adulterated, and properly labeled and packaged to protect the health and welfare of consumers.

In 1995, the Food Safety and Inspection Service (FSIS) of the USDA became responsible for the inspection of egg products. FSIS inspects all egg products, with the exception of those products exempted under the Act, that are used by food manufacturers, foodservice, institutions, and retail markets. Officially inspected egg products will bear the USDA inspection mark.

The Department of Health and Human Services / FDA is responsible for the inspection of egg substitutes, imitation eggs, and similar products which are exempted from continuous inspection under the EPIA.

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On 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 Aug. 2003, 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 Jul. 2005, a series of nationwide public workshops were jointly held by FSIS/USDA/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, egg establishments, including plants that import meat, poultry, and egg products.

Just prior to the workshops, on Apr. of 2005, the FSIS issued a revised voluntary checklist: "Industry Self-Assessment Checklist for Food Security" 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 tailor 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 FSIS 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 Dept. 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 establishments 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 establishments. Depending on the size and type of operations, 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 colored code notification.

Upon the notification by Homeland Security of a yellow, orange or red notice, OFDER shall inform the FSIS Administrator and FSIS Management Council. OFDER shall issue an email letter to all employees notifying them of the heightened threat condition. The FSIS Directive has specific instructions with regards to food defense verification procedures. Inspection personnel will continue to perform all normally scheduled 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 - Potable Water System

O85S15 - Processing/Manufacturing

O85S16 - Storage Areas

O8S17 - Shipping & Receiving

In addition, the FSIS Directive instructs the establishment IIC to notify the FSIS/USDA District Office in the event here 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 the Field Operations under OFDR.

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 areas: unrestricted access to processing rooms; 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 products. Although not required, FSIS encourages establishments to have a Food Defense Plan.

The FSIS Directive also states that "an establishment is not obligated to provide a copy f 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 nay contain sensitive security information,"the FSIS Directive concludes.

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THE COMMODITY PROCUREMENT BRANCH OF THE LS PROGRAM

Contrary to the FSIS/USDA present requirement concerning mandatory food defense programs, there is another regulatory appendage of the USDA that DOES REQUIRE a written and verifiable food defense 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, disadvantages families, charitable institutions, the elderly, the homeless and schools nationwide.

Pre-approved FSIS/USDA inspected establishments that participate in the LS Program are audited once-a-month by (yet) another agency, the Audit, Review, and Compliance Branch (ARC) of the USDAs Agricultural Marketing Service (AMS).

These monthly AMS audits include not only ISO 9000 based food safety standards, but also mandatory food defense requirements. The food defense audit also includes, 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 as well as unloaded security protocols.

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

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

Controlled Access to Production and Storage Areas

If any of the above areas are found to be deficient by an AMS trained / accredited 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/USDA inspectors who have received only food defense trining, AMS auditors have extensive criminal background checks and other security clearances by federal agencies, including food defenses training prior to performing their food defense audits associated with the LS Program.

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

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Although the FDAs 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 prudent for FSIS/USDA establishments to register and abide in full to the regulatory requirements set by the FDAs Act of 2002.

Though statistics are not presently clear on how many FSIS plants have a viable Food Defense Program in place, it's rather alarming that meat, poultry and egg plants are not required by FSIS of the USDA, the FDA, or any other regulatory agency to have in place a verifiable Food Defense Program.

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IMPORTING SECURITY REQUIREMENTS

Meat, poultry and egg products exported into the U.S. from another country must be equivalent to all FSIS/USDA safety standards and regulations that are applied to foods produced in the U.S. Imports must originate in eligible countries and from establishment certified by the company's inspection service as being eligible to export to the U.S.

When an incoming shipment has met U.S. Custom Service requirements, FSIS/USDA shall check the documents to ensure the shipment is properly certified by the foreign country. Inspectors shall examine each shipment for general conditions and labeling and then conduct inspection assignment.

Products that pass re-inspections 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 "US Refused Entry" and are exported or destroyed within 45 days.

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As a nearing final point, the FSIS/USDA has in place a Technical Service Center (TSC) with a well qualified staff available for both the industry and 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 services Directives.

An establishment's Food Defense Program should be similar structured on the guidelines of a HACCP System. There must 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 any needed future references.

Periodically, documented Risk Assessment(s) of the defense program should be carried out to ensure all facets of the program are working as written and intended. Any deviations that occur should be corrected and noted on a corrective action log, including future preventive measures. Likewise, any amendments to the program must be documented with a description of the revisions with at least two (2) witnesses and signatures with the date(s) noted.

Employers must view all of their employees as the "keystones" for their Food Defense Programs. Employers continuously enter, meander and exit plant buildings every working day and night - they can be deterrent factors as well as 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 3rd-party customer requested audits, (Sillikier Laboratories, AIB, Steritech, Food Safety Net Services, etc.), have added Food Security Defense / Bioterrorism evaluations to their audit checklist. This could create a risk off purloined documents being accessed including back-door exposures via the Freedom of Information Act (FOIA).

IN CLOSING

FSIS/USDA, acting as modern day bivouac, positively took the initiative by informing and educating both private industry and the general public through nation-wide workshops, plant defense checklist, model security plans, germane 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.

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Currently, Steve Sayer is a workplace safety *consultant #accredited auditor to *OSHA, *EPA, *#GFSI, *USDA, *FDA, *Human Resources, *#and Humane Handling of feed birds and animals and is a technical writer for multiple industries, as well as a part-time maintenance worker for California State Beaches.

(The views and opinions expressed in this blog are strictly those of the author.)

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SIGNIFICANT UPDATES SINCE 2005

Although this article was originally published in November /December 2005, it shares how all of these different governmental agencies were developed and evolved to what is available now in 2022. I recall clearly when all of the new food security turn food defense programs were put into play as mentioned in this blog.

Being involved at the get-go with the National School Lunch Program (NSLP) in 2002 / 2003 - the company I was consulting had monthly AMS audits that began to include Food Defense Programs. The AMS had made food defense mandatory as mentioned.

GFSI

And of course around the late 1990s and early 2000s GFSI starting driving companies to attain accreditation that finally forced many meat, poultry and egg plants to have in place a viable food defense plan as per the specific requirements of GFSI, whether it be BRC, SQF or FSSC 22,000.

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Food Defense Plans & FSIS-Regulated Establishments

USDA Goal:?Adoption of functional food defense plans within 90 percent of FSIS-regulated establishments by 2015.

Annual Food Defense Plan Survey:?Adoption of functional food defense plans in FSIS-regulated establishments is measured via an annual food defense plan survey of FSIS inspection personnel.

There has been a continued positive trend in the adoption of functional food defense plans. As of 2014, 84 percent of FSIS-regulated establishments had a functional food defense plan.

*The percentage of functional food defense plans in FSIS establishments has continued to increase since 2006.

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Food Defense Frequently Asked Questions

Q: Do very small establishments benefit from having a food defense plan?

A:?Yes. All establishments, regardless of size, are susceptible to threats and therefore benefit from having a functional food defense plan.

Q: My establishment has a written food defense plan. Is that good enough?

A:?While having a written food defense plan is a step in the right direction, FSIS recommends the adoption of a functional plan, which is also implemented, tested regularly, and reviewed and maintained at least annually.

Q: Where can I find resources to help develop, implement, and exercise my functional food defense plan?

A:?Multiple tools have been developed to help an establishment adopt a functional food defense plan. Please see the “Food Defense Tools & Resources” section within this brochure for a list of available resources.

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