The new federal food safety law aims to prevent contamination rather than simply respond to it.
Americans spend more than $1 trillion on food each year, and usually we get what we pay for. Built into the cost in most instances are the safety and security of the various ingredients, from the time they're grown and prepared to the moment they enter our mouths. From that perspective, we enjoy one of the safest food supplies in the world. But the system's not perfect.
Every year, some 76 million Americans are affected by foodborne illnesses. That number is a best guess by the Centers for Disease Control and Prevention, which says it cannot be exact because many people just wait for their symptoms to go away and do not go to a doctor. Not everyone can wait, though, so what's more certain is that those illnesses annually result in an average of 325,000 hospitalizations and 5,000 deaths.
For the most part, those foodborne fatalities are caused by naturally occurring infections from bacteria and parasites and not from sabotage. But in recent decades, and especially since 9/11, deliberate contamination of the food supply by terrorists has been seen as a serious threat -- one with unique challenges requiring increased food inspection, disease surveillance, laboratory capacity, and awareness by health professionals and the public.
The Food Safety Modernization Act signed into law by President Obama on Jan. 4, 2011, is designed to meet some of those challenges. Among other measures, the law increases the number of inspections at all food facilities, requires annual inspections of high-risk facilities, and mandates that the food industry develop plans that identify hazards and implement the right preventive measures. What this latter part means is that all food manufacturers and suppliers now must have a safety plan in place to quickly identify and limit possible terrorist threats, notes ADT Security Services' Hank Monaco.
"If you think about it, this law really encompasses the whole food supply chain," said Monaco, vice president of commercial marketing for the Boca Raton, Fla.-based company, which is a division of Tyco International. "So if you're a company that manufactures, processes, distributes, or sells to the end user, you're going to be affected by this act. So you're going to really want to make sure you're paying attention to what the requirements are."
Where the food defense portions of the law are concerned, Monaco said ADT is helping companies integrate their security elements in three key areas. "One is ensuring they have access control, starting with perimeter protection and then controlling access to certain spots that are really critical points within the facility, using video surveillance and other necessary monitoring components. Two is alerts: having the proper equipment to alert the facility and those who need to know when something occurs. And then three is auditing, which is showing how you're ensuring that you are complying and doing what you say you're doing within FSMA. That third one is one of the big components of the act because it does give FDA the ability to come out and audit, which requires you to really validate what you're doing, as opposed to using merely internal auditing procedures."
In addition to expanding the Food and Drug Administration's access to a food company's records and testing results, the law enables FDA to more effectively counter a foodborne illness outbreak by giving the agency new authorities to order recalls and shut down tainted facilities. According to FDA, the main goal of the law is to ensure the U.S. food supply is safe by shifting federal regulators' focus toward preventing contamination rather than simply responding to it.
On the international level, the act requires importers to verify the safety of imported food and empowers FDA to deny entry of any goods that lack certification or adequate inspection by U.S. inspectors. Under the new regulatory framework, FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are in fact complying with U.S. food safety standards.
FDA for Thought
In all, FSMA is the latest in a series of federal actions taken since 9/11 to strengthen the safety and security of U.S. food. The Bioterrorism Act of 2002 contained a food safety requirement that prompted FDA to require companies in the food industry to register with the agency and give it prior notice of imported food shipments. It also authorized FDA to administratively detain suspect food and created a requirement for food companies to establish and maintain records for up to two years of information that could address credible threats.
In January 2004, the Bush administration issued a directive calling for a coordinated national approach to countering threats to the food supply, tasking the Department of Homeland Security with leading national food defense efforts while working with the Department of Agriculture, the Department of Health and Human Services (HHS), and EPA. Yet, despite increased responsibility and concern, FDA did not receive additional funding to support food-related anti-terrorism activities until FSMA came along, giving FDA more resources and power than it has had in its history.
When Sen. Richard Durbin, D-Ill., introduced FSMA in 2008, he said he could envision the legislation serving "as a starting point to bring our food safety laws into the 21st century." He added, "It is the first step toward a food safety system that is transparent, risk- and science-based, accountable to consumers, and dedicated to the public health goal of preventing foodborne illnesses."
Durbin was right to see FSMA as only a starting point. While it is the most comprehensive federal action for food defense to date, there are just too many links along the supply chain where the industry remains vulnerable. As HHS noted in guidance it issued in 2005, "Contaminating food does not require as much technical skill and organization as does weaponizing anthrax. Opportunities for access to the food supply stretch from farms and feedlots to restaurants and cafeterias. For example, terrorists could introduce an agent during the harvesting, packing, shipping, delivery, or preparation stage. Clearly, these acts are possible."
Prevention is the Intention
That intentional food and drug contamination can happen anywhere, any time, has been on the collective national consciousness since at least 1982. That was the year of the "Tylenol crisis," when seven people in the Chicago area died after taking what they thought was extra-strength Tylenol but was in fact potassium cyanide. Still unsolved, the case led to tough anti-tampering laws and widespread changes in how consumer goods are packaged. The ubiquity of tamper-resistant or tamper-evident seals on nearly all packaged food and drugs today is a direct result of the incident, but even those preventive measures are not enough to completely protect the public against anyone intent on tainting products. What is clear is that no amount of federal regulation can.
That said, there also is no question such measures have made the food supply safer, and FSMA is designed to increase the preventive-based controls. What exactly those controls will be is yet to be determined, but FDA now has a legislative mandate to figure it out for stakeholders across the food supply spectrum.
In a public meeting on April 20, Charlotte Christin, J.D., the senior policy advisor for FDA's Office of Policy, said the agency has been "crazy busy" preparing and issuing regulations and guidance documents related to the new law. Congress has established specific implementation dates in the legislation, but FDA, on its website, says a "long-term process will be needed to build a new food safety system based on prevention."
The agency adds that it is working on a proposed rule to establish the necessary science-based minimum standards for the safe production and harvesting of fruits and vegetables; the rule will address soil amendments, worker health and hygiene, packaging, temperature controls, water, and other issues. The agency says "it will be some time" before that regulation is implemented. In the meantime, the agency recommends that farmers begin assessing their operations in terms of food safety and review FDA's "Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," downloadable at www.fda.gov.
Some but not all FSMA provisions exclude restaurants and food retailers. Because they are not required to register with FDA, restaurants and retail food establishments are not subject to requirements for registered facilities, such as preventive controls; however, other FSMA provisions, such as the foreign supplier verification program, could apply to these establishments if they are food importers.
HHS and many state agencies offer guidance to establishments in the industry that are not affected by FSMA. A common theme in the guidance is that a food product can be contaminated at any point in the supply chain, from farm to fork. To reduce the risk of serving contaminated food, these agencies recommend that establishments purchase ingredients only from reputable vendors, schedule deliveries when staffers are present to inspect and secure the delivery, and examine foods before use -- eschewing those that have foreign objects or an unusual odor, texture, or appearance.
It should go without saying that any food or drug product with a damaged or missing safety seal or packaging that is cut, torn, punctured, or showing signs of leakage, spillage, or corrosion should simply be returned to the vendor.
Consider the Source
In the wake of the earthquake and tsunami that damaged Japan's Fukushima nuclear power plant in March 2011, Asian nations including China, Malaysia, the Philippines, Singapore, and Taiwan said they would test imported Japanese food for radiation. According to Orlando, Fla.-based food compliance company N2N Global, fresh food products such as dairy, meats, fruits, and vegetables within 90 miles of the disaster tested positive for higher-than-normal amounts of radiation, and Asian countries plan to ban any products found to be contaminated.
FDA estimates that foods imported from Japan make up less than 4 percent of foods imported into the United States, yet almost 60 percent of all products imported from Japan are foods. The most common food products imported include seafood, snack foods, and processed fruits and vegetables.
"Every expert says there is no immediate risk to the U.S. food supply, which is great news," said N2N Chairwoman Angela Paymard. "But consumers wanting to remain aware of any new developments can take some additional steps to ease their fears."
Paymard said whether the food is coming from Japan or other parts of the world, consumers should keep in mind that if food is processed and packaged, it should be safe as long as the seal is not broken. For fresh foods, the risk of contamination is higher. She recommended doing the following:
- Check the Country of Origin Labeling on fresh food. As part of the overall 2008 Farm Bill legislation, retailers must provide country of origin information at the point of sale for perishable agricultural commodities. This paved the way for companies to label their packages with the city and state from which the product came. If from outside the United States, the labeling includes the country from which it came, so consumers can decide whether they want to consume a product from any particular geographical region.
- Visit www.foodsafety.gov. FDA's job is to protect the public food supply. The agency monitors food domestically and has offices internationally. Consumers can log on to the FDA website and receive the latest information about radiation safety and the status of any contamination from Japan as seen by the people protecting and examining imports at U.S. borders.
Food tampering is a crime. The New York State Department of Health, like many other state agencies, offers guidance to those within its boundaries who work in restaurants and retail food establishments. One of those guidance documents recommends that workers "Remember 'INK'" if they suspect a tampering incident:
- Investigate suspicious activity immediately. Collect as much information as you can. Remove the suspect food from service.
- Notify local law enforcement if you suspect food tampering. Also call your local health department.
- Keep the food for evidence. Do not handle the food. Wrap it in plastic or place it in a plastic bag. Label the item clearly and separate it from your regular supplies.
This article originally appeared in the June 2011 issue of Occupational Health & Safety.
Ronnie Rittenberry is Managing Editor of Occupational Health & Safety.