As progress continues on the development and finalization of the Food and Drug Administration’s Food Safety Modernization Act, food and beverage industry executives are considering what they may do now to prepare. Joe Levitt, a partner in the Washington law firm of Hogan and Lovells, and former director of the F.D.A.’s Center for Food Safety and Applied Nutrition, said companies should start with the basics.

“Even before the F.S.M.A. rules come on line, the F.D.A. has gotten much more assertive in its food inspections and you will see more 483 reports (inspectional observations) issued, more warning letters issued and more environmental testing,” he said. “These are based on the F.D.A.’s age old G.M.P. (good manufacturing practice) regulations. This is basic food safety 101. You need to be sure you have all of your food processing steps thoroughly under your control. You need to be looking at your basic sanitation practices. F.D.A. is looking to see if employees are following the right practices while an inspection is being conducted.

“Allergen control: Are you separating goods properly? You need to be looking at the layout of your facility. Are raw and finished products in different sections? These are all food safety basics. That is what F.D.A. is looking for. They are delving more deeply into these issues than they did five years ago.

“But this can also be good preparation for when the new F.S.M.A. regs come on line; having a good strong set of foundational programs in place are essential for putting into place preventative control programs.”

Mr. Levitt called the F.D.A.’s access to records under F.S.M.A. a “sea change” for most food and beverage companies that have not had experience with the department’s seafood HACCP or juice HACCP programs.

“(Record keeping), that I think will be the single biggest change most food companies face,” he said. “That is because under the old procedures F.D.A. could only see what you are doing on the day of inspection. But with access to records F.D.A. can see what you did last week, last month and last year. So they are going to get a much broader scope of your activities. And in particular they will be able see when something went wrong and how you took corrective actions.”

While the F.D.A. will have greater records access, Mr. Levitt said there are some records that are off limits to the agency.

“Some records that are off limits to F.D.A. would be things like product formulas and financial information — there are several categories like that,” he said. “Records that will become available are those that are essentially part of a food safety plan. They want to know what happened on the factory floor, particularly when corrective actions were needed and that those corrective actions were properly implemented. And if you have in those records any information that is confidential, F.D.A. can see that — but if the inspector does take copies of the records, then under F.O.I.A. confidential information should be redacted. But F.D.A. is the final arbiter. Basically, the company can propose redaction and F.D.A. decides.”

Imports and audits

The Food and Drug Administration introduced two proposed rules governing imported foods earlier this year. The proposals would make importers accountable for verifying their foreign suppliers are working under prevention-oriented food safety practices. The agency also proposed to strengthen the quality and transparency of foreign food safety audits that many food companies and importers currently rely to help manage the safety of their global food supply chains.

Under the proposed regulations for Foreign Supplier Verification Programs (F.S.V.P.), U.S. importers would, for the first time, have a clearly defined responsibility to verify their suppliers produce food to meet U.S. food safety requirements. In general, importers would be required to have a plan for imported food, including identifying hazards associated with each food that are reasonably likely to occur. Importers would be required to conduct activities that provide adequate assurances that these identified hazards are being adequately controlled.

Mr. Levitt was positive about the F.S.V.P. proposal, most notably the F.D.A.’s effort to recognize the food safety systems of some foreign governments.

“They (F.D.A.) have done a pilot with New Zealand and found them comparable,” he said. “What the F.D.A. said is if you are importing from New Zealand, you can rely on that government to do a good job in overseeing the quality of the supplier’s operations. You can get a certificate from the New Zealand government that the supplier you are considering is in good standing.

“That is a sea change. New Zealand is a relatively small market, but F.D.A. could expand the program to other countries with advanced food safety systems, and that would allow food companies to focus their efforts on suppliers from countries with less advanced food safety systems. Large companies don’t have infinite resources either, and this would allow companies to put their efforts on those areas of the world with less oversight and rely on more advanced food safety systems to do that job for them.”

Under the second proposed rule, the F.D.A. would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which may be foreign government agencies or private
companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food, under certain circumstances.

“The surprise in the third-party accreditation proposed rule is that it would require third-party auditors doing a consultative audit (meaning, an audit for internal purposes only) to report to F.D.A. if there is a serious risk to public health,” Mr. Levitt said.

The import and third-party auditor proposed rules are open for comment until Nov. 26.