Food Safety Modernization Act

The new FDA Food Safety Modernization Act (FSMA) that recently was passed by Congress is one of the largest changes in food regulations since 1938. That’s more than 70 years, food safety pioneer Gale Prince said. Known as the “dean of recalls,” Prince has an in-depth perspective on how to make the food supply safer globally.

Previously, as featured in the Jan-March issue of Cactus IFT Newsletter, Prince addressed Cactus IFT about food safety. Now for a second time, he spoke – this time via WebX conference – to Cactus IFT members attending a chapter dinner at Fiesta Resort conference center in Tempe, Ariz., about the new act.

As he introduced the subject, Prince explained the FDA is reported to have to write about 50 regulations, guidance documents, and reports to congress in the next two to three years. “You can imagine the burden that is facing FDA,” Prince said.

FDA has divided requirements among 10 different teams. It is a major project. “Every time they pass an act there is a requirement most of the time,” Prince said. There are really three key things in the subject matter: Improving capacity to prevent food safety issues; improving capacity to detect and respond to food safety problems; and improving the safety of imported foods. Prince detailed each one of these in his talk.

There are different effective dates for key sections including the inspection of records, registration of facilities, fees, port shopping, inspection frequency and identification of high risk facilities, mandatory recall authority, authority to require import certification for food, and whistleblower protections.

There was one section that Prince said he wouldn’t go into great detail about and that’s whistleblower protection. But he warned, “If you have an employee that has reported food safety problems within the company or to an agency, there are some restrictions in the law that you have to be aware of because you can’t necessarily fire that individual or you can’t take action against that individual.”

Company executives should evaluate what they are doing within their company, Prince said, to avoid such situations. He recommends providing their employees the opportunity to register complaints internally.

Section 101

Starting off with Section 101 Inspection of Records, Prince said that act allows FDA to use what is deemed as “reasonable belief” for inspection of a facility if there is sufficient evidence that exposure to an article or food will cause serious adverse health consequences or death. They also have access to those records and related products that may have been made on that line.

“You need to think about your procedures and how you handle a regulatory inspection from FDA or one that maybe the state is doing under an FDA contract,” Prince said. “Take a look at your current requirements and think about what’s listed here.”

It’s also a good time to look at your records and how you are keeping records, Prince added, giving some thought as how you may wish to organize and separate them in a way that is different from the way they are currently available to FDA.

Section 102

Moving to Section 102, the Registration of Food Facilities, Prince said that under the Bioterrorism Act it was a one-time event. Now it is subject to renewal on even-numbered years from October to December. One of the new things under this law is that FDA can also suspend registration, Prince said, if there is reasonable probability for causing serious health consequences to humans or animals they can suspend registration.

Under Section 102, they may also amend the definition of what is called “food establishment.” The requirement is a provision allowing for small operations (e.g. roadside stands) to be apart from the FDA model of retail food code. However, it will probably not affect facilities dedicated solely to food manufacturing.

Section 103

According to Prince, “Section 103 [the Hazard Analysis and Risk-Based Preventive Controls] will probably be the one that causes all of us the most heartache.”

It’s very detailed. Currently there are HACCP requirements of juice and seafood. This is going to require evaluation the hazards of regular products and how they could be affected. It will also require implementation of preventive controls that will significantly minimize or prevent the occurrence of such hazards providing assurances that the food is not adulterated in its final form.

“This is going to be very demanding and, on top of that, FDA is required to develop some regulations on analysis,” Prince said.

The definition of what hazard analysis is very lengthy. It will have to reasonably foresee hazards such as biological, chemical, physical, radiological, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, additives, and unintentionally introduced hazards.

The Section also includes a novel regulation, intentionally introduced hazards. “This is totally new,” Prince said. Companies will end up likely having to develop a written analysis of hazards that can be introduced intentionally.

“It is a concern and even the regulatory community,” Prince said. “You might end up writing some points that the bad guys might be looking for.”

There are also preventive controls that must be implemented including identifying critical control points and implement preventive controls. The monitoring of effectiveness of prevention and assurance controls need to be effective including corrective actions that will reduce occurrences.

These preventive controls must be verified for adequacy and a periodic analysis will need to ensue, Prince said. Record-keeping shall be maintained for no less than two years of monitoring and verification measures.

“You have to have a written plan and documentation,” Prince said.

Preventive controls may include written programs for sanitation, training, environmental monitoring, etc. They will need to be provided promptly if asked for by FDA. There’s also a requirement of reanalysis whenever significant changes are made to a procedure or formulation of a food if there’s a potential of a new hazard, not less than once every three years.

There are exemptions like seafood, juice—which both already have HACCP plans—and for low-acid foods. Small businesses (less than $500,000 in annual sales) also have an exemption, but Prince warns, “If there’s an illness, they end up losing that particular exemption.” This was the part that became very dicey just before Christmas.

In the next 18 months, FDA is to promulgate regulations based on science with minimum standards for conducting hazard analysis and documenting hazard analysis.

“So, that’s section three and may have the biggest impact on industry,” Prince said.

Section 104

Section 104 is on Performance Standards. Every two years FDA will re-evaluate compliance with the regulations. They will issue science-based guidance documents to prevent contamination.

Section 105

Section 105 is about Standards for Produce Safety and will propose rule making to establish flexible, science-based, minimum standards for safe production and harvest of fruits and vegetables, how animals are used in and around the growing areas, as well as water use and irrigation.

The proposed rule making is to establish minimum standards for fruits and vegetables on considering hazards that occur naturally and those that occur unintentionally, as well as intentionally introduced.

“Some crazy individual who intentionally contaminates produce; you’re supposed to anticipate that and how to prevent it,” Prince sad. “It will also provide for coordination of education and enforcements activities by state and local.”

Small businesses have an exemption if $500,000 or 275 miles from the place of harvest. The business must notify consumer with labeling, retailer posting of signs when not packaged.

“You can still have the old personal garden, folks, it’s not regulated yet,” Prince joked.

Section 106

Section 106 is Protection Against Intentional Adulteration. It requires conducting a vulnerability assessment of the food system including biological, chemical, radiological, or other terrorism risk assessments.

“Much of this stuff is classified,” Prince said, making it a tender subject in Congress. “There was a lot of groaning in the room as it was being discussed.”

The rule requires consideration of the best available understanding of uncertainties of risks against intentional adulteration of food at vulnerable points and determining the types of science-based mitigation strategies and measures.

“You need to be looking on to food-defense plans, how well are you defending the food supply, and what is your security in and around the plant,” Prince said. “That is just the beginning.”

It requires promulgation of regulations to protect against the intentional adulteration of food, applies only to high risk of intentional contamination, and shall include foods of short shelf life, bulk, or batch form.

Prince said, “This is going to be mind-boggling and challenging for everybody.”

It does not apply to farms except those that produce milk. “I think you can understand the flavor of that one,” Prince said, alluding to the recent melamine scandal.

Section 107

Section 107 gives Authority to Collect Fees. The section allows for collection of fees when facilities fail an inspection and re-inspection takes place, and following noncompliance.
Fees also apply to those who do not comply with voluntary recall request, which can become very costly given how many FDA personnel it takes to perform a nationwide recall.

“It certainly provides incentive to do a voluntary recall,” Prince said.

Fees may also apply to importers participating in voluntary importer program (such as in the seafood industry) and for export certification to ship food and animal feed.

Section 110

Section 110 is Building Domestic Capacity that includes traceback and surveillance reports.

Section 111

Section 111 is Sanitary Food Transportation of Food. The act was passed several years ago as a free standing act that charts the department of transportation to promulgate regulations on sanitary food transportation. “It was never funded and was sitting,” Prince said. Now it will be rolled out in 18 months by FDA.

“I recall going through this issue in about 1972 or 3 as we were dealing with issues where they were back-hauling trash one way and food another way,” Prince said. “That’s what triggered this. The quality of railcars led to food contamination.”

Section 112

Section 112 is Food Allergy and Anaphylaxis Management. The main focus is on day care, Head Start and schools. It includes establishment of voluntary food allergy and anaphylaxis management guidelines.

“The big focus will be on bakeries, candy is another idea, but all of you should dust off your food allergen program and make sure it’s in good shape,” Prince said.

Section 115

Section 115 requires FDA to notify Department of Homeland Security in all instances in which the FDA refuses to admit a food into the U.S. at a port so that Customs and Border Control may prevent food contamination by refusing admittance.

“There’s been a practice in recent years where if a product was stopped from coming in Seattle, they may move it to Los Angeles or San Francisco, or may take it to Philadelphia to bring it in,” Prince said. “Now they are trying to get a handle on that.”

Section 201

Section 201 is about targeting of inspection resources for Domestic and Foreign Facilities and Port of Entry.

The FDA must identify high-risk facilities and shall allocate resources to inspect facilities based upon known safety risks, compliance history, effectiveness of facilities, and hazard analysis. Inspections are to increase in frequency of all facilities. Domestic high-risk facilities once every five years, domestic non-high risk once every seven years, foreign not less than 600 facilities every year.

They must identify known safety risks of food imported by countries and regions of origin, compliance history of importer, effectiveness of activities, and evaluate plans for voluntary qualified importers.

Section 202

Section 202 requires Laboratory Accreditation for Analyses of Foods. It requires establishment of a program for the testing of food by accredited labs in two years and publish the publicly available registry of laboratories, recognition of lab accreditation bodies including independent private and government labs and foreign labs.

FDA shall also develop model lab standards for sampling, analytical procedures, and internal quality. They shall reevaluate once every five years and shall promptly revoke the recognition of any body found not to be in compliance.

The results of testing shall be sent to FDA. Nothing in the act limits FDA the ability to review and act upon information from food testing to determine sufficiency of information and testing.

“This has got the laboratory community a little concerned,” said Prince.

Section 204

Section 204 enhances tracking and tracing of food and record keeping. The FDA must establish pilot projects in coordination with food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food-borne outbreaks and to address credible threats of serious adverse events (SAEs) to humans or animals. It needs to be done in no later than 270 days.

FDA must place particular emphasis on tracking and tracing programs for at least three different types of food that have been subject of outbreaks during last five years preceding 2011. They must establish these programs within the next 18 months and report to Congress.
FDA needs to evaluate domestic and international product tracing practices in commercial use. The FDA shall establish a tracing system to receive info to track and trace foods. They will also publish a notice of proposed record-keeping requirements in the next two years.
Last time Prince talked to Cactus IFT he talked about Pulse Net, which made a major difference in responding to food-borne outbreaks. FDA is making more advances to make investigations even quicker with similar technology.

Section 206

Section 206 is Mandatory Recall Authority, which provides opportunity for voluntary recall when there is reasonable probability that a product is adulterated. But it will impose mandatory recall if firm is unwilling to voluntary recall.

“They no longer have to scare you into it,” Prince said. They can just make you do it after producing evidence that you have a contaminated product in the market place.

Section 207

Section 207 is the Administrative Detention of Food. It requires FDA to issue an interim final rule on detention based upon “reason to believe” that a product “is adulterated or misbranded.”
Prince said that the meaning of “reason to believe” is going to cause “a few gray hairs.”

Other Sections

Prince went through all the other sections rapidly, which proved to be too much information to be all published in this newsletter. Still, there were some cautionary notes worth including here.

Prince warned about the section for Improving the Reportable Food Registry. It will require the FDA to publish a list of conspicuous locations providing consumer-oriented information, grocery notification, consumer notification about recalls within 24 hours.

Another section where he gave a caution was on Section 309 about “Smuggled Food.” The FDA shall develop and implement a strategy to better identify smuggled food and prevent entry.

“Be careful what you have in your pocket when you go through customs these days,” Prince said.
What about funding?
When asked about the funding that will go to FSMA, Prince answered, “At this point it has not been funded. We’ve got to wait and see. What happens if it is not funded? The act is still in place.”

How to get around FSMA?

When asked if there was a way to avoid FSMA by an audience member, Prince answered, “You have to have both below $500,000 and sell within 275 miles [of harvest] to be exempt.”