CHICAGO — Bakers need to gear up for compliance with pending food safety regulations to be issued by the Food and Drug Administration, said David W.K. Acheson, managing director, food and import safety, Leavitt Partners, Salt Lake City.

Dr. Acheson discussed the Food Safety Modernization Act with bakers attending the annual meeting of The Long Co. Sept. 23 at the Peninsula hotel in Chicago. He spent several years as a high ranking official at the F.D.A. with food safety responsibilities.

Questions have arisen over prospective implementation of the Food Safety Modernization Act (F.S.M.A.) in the face of an increasingly tight federal budget. Specific regulations coming from the act remain to be written.

“I believe the regulations will get written, but enforcement will lag behind,” Dr. Acheson said. He said this lag will not diminish expectations that the law’s goals will be achieved.

Dr. Acheson described the F.S.M.A. as the largest change in food safety since the Federal Food, Drug and Cosmetic Act of 1938 was passed. He said the most impactful changes relate to prevention and imported food with little direct impact from the F.S.M.A. on retailers and food service establishments. Growers and manufacturers also will be significantly affected, he said.

“It’s heavy, heavy focus on prevention,” Dr. Acheson said. “The F.D.A. has built with Congress the intent of preventing problems instead of reacting to them.”

While a changing regulatory landscape in Washington has contributed to the creation of the F.S.M.A., creation of the new law was driven principally by developments outside of the nation’s capitol, Dr. Acheson said.

He described the outbreak of illness from product shipped by Peanut Corporation of America in 2008-09 as a “huge driver” of the F.S.M.A.

“Because you all know that Congress can be a knee-jerk operation,” he said, adding that Congress also was driven by the melamine scandal in China.

In the P.C.A. episode, nine people died and at least 691 people in 46 states became sick after eating products containing peanuts. The peanut products originated from a P.C.A. plant in Georgia.

In the melamine case, the chemical, which is used in fertilizers in Asia, was detected in 2007 in the wheat gluten used by Canada-based Menu Foods.

In 2008, several companies in China were implicated in a scandal involving milk and infant formula with melamine, leading to kidney stones and renal failure, especially among young children. Dr. Acheson said clever individuals figured out protein content is measured by measuring nitrogen, so they added to ingredients fertilizer that was high in nitrogen content.

“It’s entirely logical, but, unfortunately it killed a lot of animals in the U.S. and injured a lot of children in China,” he said.

Of the P.C.A. and melamine scandals, Dr. Acheson said, “Those two things generated a lot of the new anguish around (installing) preventive controls.”

Advancing science is playing a major role in the heightened scrutiny of food safety issues, Dr. Acheson said.

Global, state and federal regulators have much better ways to “link illness to food in a way we haven’t seen before,” he said. “The agencies and public health officials are getting much better at connecting the dots.”

Against this backdrop, food recalls increased dramatically in 2009 and 2010 compared with prior years, Dr. Acheson said.

For bakers, serious introspection and analysis will be required to comply with the new law, Dr. Acheson said. Specifically, bakers need to understand where problems or vulnerabilities exist. Thinking in terms of bioterrorism and food defense, bakers should consider where food poisoning could be “intentionally” introduced. Critical control points must be identified, Dr. Acheson said. He said a
full-blown hazard analysis and critical control point (HACCP) program is not always necessary.

“It can be HACCP-like, but it doesn’t have to be conventional HACCP,” he said, identifying two parts to the risk analysis.

“The first part is finding those critical control points in your operations, and then identifying a way to control them,” he said.

The second part of this plan involves prerequisite programs like good manufacturing practices, sanitation, training and hygiene, environmental programs, recall programs and supply chain programs.

All of these need to be a part of a baker’s food safety plan.

He continued, “What does this mean? Step one is to make sure you have a food safety plan — Under the law, the F.D.A. is to target inspections based on risk. The agency may cooperate with other federal agencies, private third-party certification bodies and agreements with foreign governments to perform inspections. Firms that refuse inspection may be denied the authority to import into the United States.”

When the law was passed, an expectation was created in Congress that inspections would double annually from around 600 currently to 19,000 in fiscal 2016.

“I’m convinced it’s unrealistic and that it’s not going to happen,” he said.

Given the dearth of government resources, Dr. Acheson said there may be a temptation in the industry to ignore the risk of stepped-up inspections.

“You can take that view if you like, but it’s not a view I recommend,” he said. “Many of you may remember “Dirty Harry” movies from way back. Remember that scene where Harry is there with a gun in his hand and saying, ‘Are you feeling lucky today?’ That may be the way to approach it. The F.D.A. is going to say, ‘Are you feeling lucky today?’“

Dr. Acheson said the F.D.A. will use criminal and civil penalties more than in the past. He said they will go after a company aggressively when food safety is wantonly ignored.

State involvement will be a major part of the unfurling of the F.S.M.A., with a great F.D.A. focus on partnerships, Dr. Acheson said.

“The F.D.A. is going to develop more partnerships with states, giving them more federal authority than they have had in the past,” Dr. Acheson said.

Dr. Acheson offered the bakers guidance on F.S.M.A. compliance, starting with the creation of a food safety plan before July 2012. Beginning then, F.D.A. inspectors will want to see such plans.

He explained, “Many people will say, ‘That’s not hard. We’ll just create a plan that sits on the shelf waiting for an F.D.A. inspector who won’t show up anyway so it’s just going to gather a lot of dust.’ Fine, that’s relatively likely.”

Dr. Acheson advocated the pooling of resources through cooperatives, and suggested The Long Co. could develop a standard document that may then be specifically tailored to individual facilities. Fairly robust documents may be generated by the co-op because of the commonalities between baking plants.

More challenging for bakers will be preparation to prepare to explain the implementation of food safety plans.

“This is where the rubber hits the road,” he said. “You will have to demonstrate you are implementing your plan, that you are monitoring your critical control points and that you are collecting data as you are going along. If you are saying you are using a kill step, or some process to control the risks, you have to have validation that that kill step is actually doing what you say it’s doing, and verifying that it’s working on an ongoing basis, and document all of that information.

“When the F.D.A. shows up, it won’t be just ‘show me your plan,’ but ‘show me your monitoring records, show me that you are doing this on an ongoing, a daily basis.’”

Dr. Acheson said inspectors will be skeptical if told that a facility has not had a problem in the past.

He said, “If you say ‘no,’ are they likely to believe that? No. They are going to want to hear, ‘Yeah we had a problem. Something went out of whack. Something we were tracking went out of control.’ They’re going to ask you, ‘What was your corrective action?’ Document it. ‘What was the root cause analysis as to why that happened and how did you fix it?’ This is what’s going to give the F.D.A. the sense that you have your systems under control, and that you know what you’re doing. What that will do for you is essentially have them less likely to come back since they are basing their inspections on risk. If the agency sees you have it under control, then they will be more likely to minimize inspections. If the agency sees a loose thread, then all hell breaks loose.

“So it’s not about building a plan, but implementing it, monitoring it and showing it’s working.”

While considerable discussion around the F.S.M.A. has centered on provisions giving the F.D.A. the authority, for the first time ever, to issue mandatory food recalls, Dr. Acheson said the power will not be exercised often.

The F.D.A. has authority to retain food if it reasonably believes it may cause a serious, adverse health effect (even an allergen).

“I think it will be used very rarely,” he said.

Perhaps more attention ought to be focused on the agency’s power to suspend a food plant’s registration.

Dr. Acheson described this power as “potentially scary because everybody who is shipping commerce interstate needs to register, and the F.D.A. now has the authority to suspend that registration.”

Under the new law, food from a suspended facility may not be imported into or exported from the United States and may not be introduced into “interstate commerce in the United States.”

Dr. Acheson said it was the first time the F.D.A. has been given that authority. Criteria for such suspensions have not yet been set, he said.

Dr. Acheson warned that user fees, which from the drug industry has been a mainstay of F.D.A. funding for years, requires attention from bakers. Three particular areas may generate user fee, beginning with reinspections. If initial inspections generate a 483 form in response to a problem identified a reinspection may be needed if corrective action is required.

“If the F.D.A. has to come back to ensure you have met that corrective action, they will bill you for that revisit,” Dr. Acheson said. He warned that hourly fees ($225 per hour for domestic issues and $335 for international) “are not trivial numbers if they come up repeatedly.”

Also potentially expensive are F.D.A. fees associated with mandatory recalls. Repeating his view that mandatory recalls will be rare, he said no mandatory recalls are allowed without offering the company the choice of a voluntary recall.

If a company declines the voluntary recall, the F.D.A. has other options beyond a mandatory recall.

“If they mandate a recall, the company or firm starts to pick up the bill, and that can be vast,” he said.