FDA Adopts New Food Safety Regulations to Fight Terrorism

Federal Regulators are opening a new front in the War on Terror: food and beverage companies.

The Food and Drug Administration is taking its first steps toward crafting new food safety regulations that include a focus on the threat posed by terrorists and the “intentional adulteration” of food sources. Earlier this month it submitted a draft of those new regulations to the White House's Office of Information and Regulatory Affairs for review. That step restarts a long-delayed effort that begun when Congress passed the Food Safety Modernization Act in 2011.

The regulations will require food growers, beverage companies and bottlers, processors, restaurants, animal feed suppliers, and even cosmetic companies to better protect themselves against sabotage. “This is probably the most sweeping legislation in this industry in the last 50 years,” says Joe Kiefer, a partner with the law firm Snell & Wilmer who counts food safety among his specialties. Many in the food industry have compared the full law's massive effect to those the healthcare sector faced from the Affordable Care Act.

Under FSMA, the FDA is writing rules to require “comprehensive, science-based preventive controls across the food supply.”

Among the requirements for food and beverage companies:

Protect against the intentional adulteration of food, including mandating mitigation strategies to protect the food supply chain at a specific vulnerable point; 

Implement a written preventive controls plan, including evaluating potential hazards that could affect food safety, specifying what preventive controls will be put in place and how the facility will monitor these controls, and detailing actions to correct problems that arise; 

Adopt heightened recordkeeping requirements for what the FDA deems to be “high-risk foods” or ingredients;

The Act gives the FDA, in the agency's words, “unprecedented authority to better ensure that imported products … are safe for U.S. consumers.” For the first time, importers will have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. The FDA also gains the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the United States.

In addition, the FDA will have mandatory recall authority if a company refuses to voluntarily pull a product it suspects was tampered with.

Dairies, juice companies, and fish producers industries are already required to have a Hazard Analysis & Critical Control Points plan in place. The FDA's forthcoming rules would require those plans of all food facilities. Inspections will increase for a wide range of food industry activities, including toxin screens for the water that is used in growing and processing.

FSMA isn't the first time the FDA has tackled anti-terrorism efforts in conjunction with food safety. In 2002, the Bioterroism Act required all “food-manufacturing facilities” in the United States to register with the agency, a definition that included restaurants, farms, caterers, and grocery stores among others. It is unclear whether the pending rule will pick off where that legislation left off, for example, mandating criminal background checks for front-line food workers. 

The FDA has been slow to move on the regulatory package, advancing it piecemeal. It was supposed to act on anti-terrorism measures by July, but sought to extend that Congressional deadline into 2015. That didn't sit well with food activists, including the Center for Food Safety, which sued to expedite the rulemaking process. “Congress knew this was literally an issue of life or death, which is why it included mandatory deadlines in the law for its regulations,” George Kimbrell, lead attorney with the Center for Food Safety, said in a statement. “After the FDA utterly failed to meet even a single deadline, we sued them.”

Earlier this month, the Ninth Circuit Court of Appeals denied the FDA's Motion to Delay and ordered it to propose a draft version of new anti-terrorism regulations by Dec. 20. Under the judicial order, the rule must be proposed by Jan. 31, with a comment period that closes by May 31. The deadline for finalization is June 30, 2015.

In response to industry pressure, however, the FDA did extended the comment period on other proposed FSMA rules. The new deadline for feedback on foreign supplier verification programs is now Jan. 27, 2014; as is the deadline for comments on the accreditation of third-party auditors/certification bodies. Comments regarding preventive controls for animal food can be submitted until Feb. 26, 2014. Among the reasons for the extensions was that the Website used to submit comments was having technical glitches and was occasionally offline. In total, the rules already out for comment have received nearly 17,000 comments.

“Congress knew this was literally an issue of life or death, which is why it included mandatory deadlines in the law for its regulations. After the FDA utterly failed to meet even a single deadline, we sued them.”

—George Kimbrell,

Lead Attorney,

Center for Food Safety

Debra Dunne, a partner in the law firm Shook, Hardy & Bacon's Agribusiness & Food Safety Practice, says it is unfortunate the judicial decision will expedite the FDA's workload if it feels rules are not ready. “You have to balance the interests of public safety, but I do think the agency's argument for more time would have made for a better product,” Dunne says. She adds that the standards aren't clear and don't provide enough detail to tell food and beverage companies what is expected of them.

Getting Proactive

The shift sparked by the many FSMA requirements is, in simple terms, a move from traditional quality controls to preventative controls. “Under the old system, they were looking at critical control points in the process and hazards associated with them,” Kiefer says. “Now, the focus is really on having a preventative plan in place to address potential problems before they happen.”

Food industry concerns have increased as the regulations move closer to taking effect. One concern is that the expanded role of the FDA could conflict with the traditional role of the U.S. Department of Agriculture, leading to duplicative regulations and inspections. “Because the rulemaking isn't complete, nobody is exactly sure how extensive the overlap is going to be and how they are going to manage it,” Kiefer says. For example, meat has traditionally fallen under the USDA's purview. It is unclear whether there will be a carve-out that keeps meat producers and distributors under the exclusive oversight of the USDA, or if it will force meat packers to deal with both agencies.

DOCUMENTING HAZARDS

The following is an edited selection from the Food Safety Modernization Act's “Hazard Analysis and Risk Based Preventative Controls.”

The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated or misbranded, monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

The owner, operator, or agent in charge of a facility shall identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including: biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; hazards that occur naturally, or may be unintentionally introduced; identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and develop a written analysis of the hazards.

The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented; and the food manufactured, processed, packed, or held by such facility will not be adulterated.

The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented to provide assurances that the outcomes described shall be achieved.

The owner, operator, or agent in charge of a facility shall verify that the preventive controls implemented are adequate to control the hazards.

The owner, operator, or agent in charge of a facility shall maintain, for not less than two years, records documenting the monitoring of the preventive controls implemented, instances of non-conformance material to food safety, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.

Source: FDA.

Kiefer advises all food companies to undertake a comprehensive review of their hazard analysis process, or to develop one without delay if they don't already have one in place. “Sit down and review that plan,” he says. “Look at each stage of the process and where more can be done on preventative controls. That is what's going to be expected and mandated.”

Going forward, companies in the food sector will need to more carefully consider recordkeeping policies and document retention and destruction procedures. A Deloitte report, “Digesting the Food Safety Modernization Act,” details the recordkeeping challenges companies will face.

“The FSMA grants the FDA the authority to access and copy all records related to not just [an affected]  article of food, but also to those records related to any ‘other article of food which is likely to be affected in a similar manner,” it says. “These could include food produced on the same manufacturing line, or similar products manufactured in other facilities. Other records deemed related to a regulatory action by the FDA would also be subject to review and inspection.”

The proposal is raising questions about the ability to enforce the regulations when they reach the effective date, which has yet to be set. “There seems to be a lot of concern that the FDA is going to come up with all these requirements, rules, and standards, but will it really have the resources to go out and actually enforce them?” Kiefer asks. “Some of the rules have significant implications and go to the heart of the security of our food supply, but how aggressive will the agency be in the early stages of implementation?”

“One would hope there will be at least some time to get the house in order,” Dunne says. “What the timing will look like is a big question. Are we going to see this over a couple of years, or is it going to be a much shorter time period? It seems to me there will be pressure for a much shorter time period given the safety concerns.”