Food Security In Organic
Are We Ready?

By Robert B. Anderson


The security of our nation’s food manufacturing supply chain has come under close scrutiny since the terrorist acts of 2001. We have entered an era of bioterrorism that is marked by the heightened awareness of our vulnerabilities and an increasing commitment to homeland security. Government, businesses and consumers are concerned that the U.S. food industry might be a high-priority target for criminal and terrorist activity.

Responding to the events of Sept. 11, 2001, President Bush signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Several key provisions of the Bioterrorism Act took effect on Dec. 12, 2003, providing new and revamped legislation to protect the nation’s food supply. Four key sections of the Bioterrorism Act significantly impact the food industry. These include new regulations on facility registration, prior notice of food imports, administrative detention, and record keeping.

But, are American and international food firms ready to implement the Bioterrorism Act? Are organic producers and processors ready, and indeed, uniquely so? Unfortunately, results from a study by the Food Policy Institute (FPI) at Rutgers University indicate that many food companies are not prepared for the new U.S. Food and Drug Administration (FDA) rules under the Bioterrorism Act (www.foodpolicyinstitute.org). While food firms sympathized with the need for guidelines to protect the U.S. food system against possible bioterrorist or agroterrorist attacks, many felt that complying with the Bioterrorism Act would be a serious challenge and very expensive.

The fall 2003 online survey administered by the Woodbridge, NJ-based Food Institute and analyzed by FPI found many companies ill-prepared to meet the Bioterrorism Act’s Dec. 12 facility registration deadline, which requires domestic or foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. to register with the FDA. In the online survey, FPI polled 1,292 food industry professionals to determine the level of awareness among stakeholders as the Dec. 12 registration deadline approached (Figure 1). The survey showed that 50% of respondents were unaware of the registration deadline. Twenty-one percent of respondents indicated that they knew of the deadline, but as yet had made no preparations to comply. FPI Associate Director Brian Schilling summed up the study results, saying, “The majority of food firms [surveyed] believe that the Bioterrorism Act will lead to an overall increase in the security of the domestic food supply. It seems that the unanswered question for many is, ‘At what cost?’”

However, in this era of increased regulation and consumer concern, it is critical that the food industry as a whole respond to these threats with comprehensive food security and crisis management strategies. It is imperative that both organic and conventional food processors get up to speed about the requirements of the Bioterrorism Act, and do so quickly. There are many ways in which companies can effectively prepare and implement biosecurity measures not only to comply with the regulations, but also to achieve a greater assurance for their customers of their food products’ safety and security.

Securing Information
All food processors should visit the FDA website for more complete information and to download Bioterrorism Act related publications, compliance guidance documents and notices of interim final rules and public comment periods (www.cfsan.fda.gov). Essentially, FDA is actively working on the regulatory implementation of the following four provisions in Title III, Subtitle A of the Bioterrorism Act:

• Section 303: Administrative Detention
“Authorizes the Secretary of Health and Human Services, through FDA, to order the detention of food if an officer or qualified employee has credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals. The Act requires the Secretary, through FDA, to issue final regulations to expedite enforcement actions on perishable foods.”

A regulation regarding this provision, which will provide for the means and methods for the detaining of foods suspected of terrorist tampering, has been proposed by FDA and is expected to be implemented by June 2004.

• Section 305: Registration of Food and Animal Feed Facilities.
“Requires the owner, operator, or agent in charge of a domestic or foreign facility to register with FDA no later than Dec. 12, 2003. Facilities are defined as any factory, warehouse, or establishment, including importers, that manufacture, process, pack or hold food for human or animal consumption in the United States.”

In October 2003, the agency published an interim final rule mandating that every food facility, large and small, domestic and foreign, to register with the FDA by Dec. 12, 2003. Registration consists of providing information, such as the firm name, address, product brands and categories. Farms, restaurants, retail food establishments, nonprofit establishments that prepare or serve food, and fishing vessels not engaged in processing are exempt from this requirement. Also exempt are foreign facilities, if the food from the facility is to undergo further processing or packaging by another facility before it is exported to the U.S., or if the facility performs a minimal activity such as putting on a label. Other than these exemptions, states FDA, “the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.”

FDA, which anticipates approximately 420,000 food facilities to register under this mandate, expects that such a roster will enable the agency to quickly identify and locate affected food processors and other establishments in the event of deliberate or accidental contamination of food.

• Section 306: Establishment and Maintenance of Records.
“Requires the Secretary of Health and Human Services to establish requirements by Dec. 12, 2003 for the creation and maintenance of records needed to determine the immediate previous sources and the immediate subsequent recipients of food, (i.e., one up, one down). Such records are to allow FDA to address credible threats of serious adverse health consequences or death to humans or animals. Entities subject to these provisions are those that manufacture, process, pack, transport, distribute, receive, hold or import food. Farms and restaurants are exempt from these requirements.”

A regulation regarding the provision pertaining to record keeping has been proposed by FDA and is expected to be implemented by June 2004. The record keeping requirements will be phased in over an 18-month period from the promulgation of the regulation. This regulation will require the traceability of all foods, “one up, one down,” much as we have been doing in the organic industry for decades. However, the regulations require significantly more information and facilities will be required to respond with the records within four hours of requests made Monday through Friday, and within eight hours at all other times.

• Section 307: Prior Notice of Imported Food Shipments.
“Requires that prior notice of imported food shipments be given to FDA. The notice must include a description of the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. The Secretary of Health and Human Services, through FDA, must issue final regulations by Dec. 12, 2003.”

This regulation, which mandates that importers of food must give the FDA prior notice of every shipment of food before it can enter into the U.S, was published as an interim final rule in the Oct. 10, 2003 issue of the Federal Register. Issued jointly with the U.S. Bureau of Customs and Border Protection (CBP), the advance notification of what shipments contain and when they will arrive at our nation’s ports of entry is designed to help the agencies better target and conduct inspections of imported foods. The agency estimates that it may receive 25,000 such notifications per day.

Currently, FDA requires that companies must provide prior notice and receive FDA confirmation no more than five days before its arrival at a U.S. port of entry and no fewer than two hours before arrival by land via road; four hours before arrival by air or by land via rail; or eight hours before arrival by water. FDA indicates that this rule will have a phase-in compliance period through Aug. 12, 2004.

Beyond Compliance
The hard reality of today’s food security environment is that we have only just begun to see increased agency oversight and mandated government authority and control. The fact is that there are heightened expectations that the food industry will take responsibility for protecting our food supply, including imported ingredients and products. Since consumer confidence and brand loyalty are the most important assets of any food company, all of our customers expect effective high-risk management that will ensure the safety and security of the food products that we manufacture. Any interruption of a company’s ability to deliver products, for even a few days, can have a devastating long-term impact on sales and market share, as well as on relationships with customers, employees, shareholders and the public.

To put the types of crises a food company might face into perspective, consider these statistics:

• An astounding number, nearly half, of businesses never reopen their doors after experiencing a natural or man-made disaster. Nearly 10% of those that initially survive eventually fail because they can’t garner the resources necessary to recover in the first 18 months following the crisis.

• Only 5% of the crises that companies face are natural disasters. The other 95%, are man-made emergencies ranging from mislabeling, processing failures, employee rage and tampering.

• The courts have ruled that companies must exercise due diligence in anticipating and responding to serious threats. Inadequate preparedness gives tort lawyers enormous leverage and dramatically increases a company’s liability risk.

• Insurance typically covers only about 40% of a company’s total real losses and we will see more exclusions for damages resulting from acts of terrorism.

So here’s the bottom line: If your company experiences a disaster, the impact will absolutely negatively impact your bottom line. How well you are prepared to handle the crisis will largely determine how damaging that impact will be, very likely determining whether your company survives—or doesn’t.

In terms of handling a potential food security crisis, the organic segment of the food industry does have an edge in terms of record keeping. The organic industry has long recognized that tracking systems are effective tools in tracing sources of raw materials and ingredients used in the manufacture of foodstuffs that will make the label claim “organic,” as well as in the assurance of the integrity of processing aids, packaging, laboratory reagents and positive controls. A traceability system is an asset in assuring the integrity of organic foods, and once established, is a relatively easy discipline to maintain. With the scrutiny placed on the organic integrity of our ingredients and overall processing system, organic food companies are well placed to efficiently “add on” food security measures to their standard operating procedures. For example, as part of routine quality assurance in the certified organic food processor’s operation, the manufacturer must verify that all incoming ingredients are indeed organic. The food security “add on” component to this quality assurance step can be that management requires that the facility use only known, registered or permitted sources for ingredients as reviewed and verified by qualified staff.

However, we can’t be lulled into thinking we’ve got recording keeping for food security covered. The food security regulations have many additional requirements including mandates that companies provide the name, address and phone number of every vendor, as well as the name of the emergency contact person. They also require inbound and outbound transporter information, right down to the driver’s name. Most importantly, the potential of a terrorist threat and the Bioterrorism Act rules heighten everyone’s awareness of our responsibilities in the food supply chain, reinforcing our need to protect the integrity of our products and improves our ability to respond to a claim or crisis. So, how do we best accomplish this?

Key Components of Effective Food Security
Each of us who hold a position of responsibility in the food system needs to ask ourselves some very hard questions: How prepared are we? Have we proactively attempted to prevent acts of bioterrorism or tampering? How well would we manage a product recall in the face of a crisis in terms of informing and coordinating with FDA, the U.S. Department of Agriculture (USDA), the Office of Homeland Security, and state and local authorities? How will we manage and control our site and operations, as well as public and employee panic in the event of a bioterrorism event? Who will lead us through the crisis and how will we forthrightly manage information and the media while we continue to provide information to our business partners, victims, government agencies and the public?

There are several key components that food companies should employ when developing effective food security programs, including:

Crisis Prevention. Planning for the crisis that we hope will never happen is a powerful tool that fulfills a moral responsibility to protect all stakeholders and enhances the ability of a company to recover. By incorporating a proactive food security mindset into the corporate culture, food processors and handling operators will expand the company’s image and credibility, both internally and externally, and will enhance the company’s ability to recover while reducing the exposure to civil and criminal penalties.

Good crisis prevention requires a thorough review of the entire facility and its environs, standard operating procedures, quality assurance, purchasing, inventory and shipping controls, human resources protocol and record keeping systems, using the lens of food security to assess potential vulnerabilities to terrorism.

Food Security Planning. Develop a comprehensive food security plan that identifies the critical components necessary to protect your facility, employees, products, customers and the community from intentional contamination and harm. An initial assessment of the adequacy of food security procedures and operations is the first step, and should include the identification of food security control points on a facility diagram and/or flow charts. Next, the processor should develop a written security management strategy to prepare for and respond to tampering, bioterrorist or other malicious actions. The written plan should include information on how the company will identify, segregate and secure affected product in the event of a crisis situation. The food security plan should be reviewed annually, at minimum.

Food Security Audits. Conduct food security audits that evaluate and verify the effectiveness of your own food security program. Audits include assessments of the adequacy of the following program elements:

• Food security management activities, including staff training in food security awareness and how to report suspicious persons, as well as establishing a routine security check system of the areas in the facility where ingredients, processing aids, finished products and packaging are received, stored, processed and packaged.

• Personnel, including level of background checks, limits on access to specific areas of the facility and supervision of staff or visitors.

• Facility maintenance and monitoring, including the securing of doors, windows, storage areas, utility rooms and the perimeters of the facility grounds.

• Operations, including the inspection of incoming ingredients, processing aids and packaging for signs of tampering or contamination.

• Regulatory compliance, especially with the interim final rules and provisions of the Bioterrorism Act.

An experienced independent third party with an objective eye can help in seeing the proverbial trees in the food security forest and bring a fresh perspective and credibility to your food security program.

Crisis Management Planning. Even with the strictest security procedures in place, crises happen! Having a comprehensive crisis management plan at the ready—before an emergency occurs—is the most important tool you can develop. With emergency protocols clearly defined and a team of experts ready to spring into action in a crisis situation, you will be prepared to manage the incident in a way that protects lives, your brand and your business.

A Call to Action
Developing the food security plan is only half the battle: It is critical to take action to lower risks of terrorism.

• If you haven’t already done so, you must comply with the law and register your facilities immediately. Facilities can register online at www.fda.gov/ furls, or call (800) 216-7331 to obtain forms and assistance with registration.

• If you import foods, you must assure that your foreign processor is registered with FDA and give prior notice of the arrival of all foods entering the U.S. or they will be detained at the border and you’ll be responsible for demurage until it clears.

• It is important to begin the process of complying with proposed regulations for record keeping and administrative detention, which appear to be well on their way to being finalized.

• Stay informed. FDA intends to reopen the public comment period on the facility registration interim final rule for an additional 30 days in March 2004. Keep yourself updated on amendments at www.fda.gov/oc/ bioterrorism/bioact.html.

The organic food industry has an awesome responsibility to develop bold strategies for crisis prevention and food security that protect the integrity of our food supply and the viability of our economy. The proactive implementation of these measures will help to assure the survival of our businesses and our industry.

Robert B. Anderson is president and founder of Sustainable Strategies—Advisors in Food and Agriculture, based in Centre Hall, PA. Anderson is an authority on food security, with 35 years of hands-on experience in all facets of organic agriculture, food production, processing, marketing and retailing. He currently is an advisor to several organic agricultural initiatives and industry projects, as well as to the USDA Foreign Agriculture Service and U.S. Department of State. Until 2000, he held the position of president of Walnut Acres Organic Farms, one of the founding and most respected organic foods businesses in the U.S. He serves the U.S. Secretary of Agriculture as an advisor for sustainable agriculture and international trade. Anderson can be reached via e-mail at bobanderson1217@yahoo.com.