Flour, records and food safety
November 15, 2011
by Jeff Gelski
Many questions still surround the Food Safety Modernization Act that went into effect this past January. Even though many of their products are baked, grain-based foods manufacturers may want to stay alert to any upcoming answers because the F.S.M.A. applies to them, too. The Food and Drug Administration, for example, in the future may view wheat and flour as a “high-risk” food. The F.S.M.A. also emphasizes documentation, especially for imported ingredients, and it gives government more access to company records.
“The F.S.M.A., in effect, gives the F.D.A. a mandate to ‘require comprehensive, prevention-based controls’ across the entire food supply chain, along with the authority to inspect food company records based simply upon ‘reasonable suspicion,’” said Dan Best, director of sales and technical service for Enreco, Inc., Newton, Wis. “In this environment, it is essential that food companies protect themselves up front by providing solid, documentable records to show that they have anticipated and addressed all potential food safety events — well before they happen. Before, a food safety outbreak was ‘too late.’ Now, simply an F.D.A. inspection may be ‘too late.’”
Bill Pursley, vice-president of food safety education for AIB International, Manhattan, Kas., said, “Yes, you have to have written records, and you’re going to have to show that you validated each one of those programs, each one of those preventive controls.”
Deann Akins, principal food safety specialist at ConAgra Mills, Omaha, said new governmental authorities under the F.S.M.A. include mandatory recalls, expanded administration detention, suspension of registration, enhanced product traceability and additional record-keeping for high-risk foods. She added new authorities for imported products include importer accountability, third-party certification, certification for high-risk foods, voluntary qualified importer program, and authority to deny entry into the United States from a foreign facility if the F.D.A. is denied access by the facility or the country in which the facility is located.
Cliff Pappas, senior adviser for quality and HACCP for AIB International, spoke about the F.S.M.A. in a webinar earlier this year. He said companies, if they buy products such as ingredients from importers, need to know what foreign suppliers the importers use.
“You need to know your importer and foreign supplier,” he said.
The F.S.M.A. mandates bakers know their vendors and assure they comply with agency policy, said Lee Sanders, senior vice-president, government relations and public affairs for the Washington-based American Bakers Association.
“Doing this with U.S.-based suppliers is not difficult,” she said. “Bakers require vendors to provide a letter of guarantee that they are complying with all federal and local regulations, as well as provide a copy of a completed third-party audit such as A.I.B. This helps bakers verify that they have the necessary programs in place to comply.
“With imported ingredients, this task is more difficult. Bakers ask for verification that foreign suppliers have good food safety programs, but then bakers must assess what the foreign suppliers send us and decide if they are compliant or not. The industry needs a comprehensive third-party food safety verification audit that encompasses the necessary programs, practices and performance assessment to assure compliance.”
Bakers should include their vendors in an annual food safety risk assessment, Ms. Sanders said. They should look at performance data such as consumer complaints and compliance with specifications.
“Some common and important to act on consumer complaints that are likely vendor-related include items such as wood or stems in raisins, stones in flaked or whole grains, shells in nuts, plastics or strings in bagged ingredients, hardened ingredients that don’t disperse in mixing and metal in ground materials,” she said. “When a baker finds a performance issue, they should contact the vendor and ask what has changed. It is critical to investigate and find the source of the issue, then follow up to assure that effective and complete, corrective actions were taken.”
More rules to come
The F.D.A. will roll out the F.S.M.A. over several years. More updates may come in January of 2012, Mr. Pursley said.
The F.D.A. has yet to publish a list of high-risk foods. Traceability requirements will change for high-risk foods more than they will for foods that are not as high-risk, Dr. Pappas said in the webinar. He said the F.D.A. may designate food used in large quantities, which potentially may include wheat and flour, as high-risk food.
“Wheat might be classified as a high-risk food simply because it’s in so many products and used in so many different ways,” he said. “We hope that doesn’t happen.”
Food safety problems have affected the grain-based foods industry and led to changes in recent years. Nestle USA, Solon, Ohio, in June of 2009 voluntarily recalled refrigerated cookie dough after the F.D.A. and the Atlanta-based Centers for Disease Control and Prevention notified the company that they were conducting an investigation into reported E. coli 0157:H7 illnesses that may have been related to consumption of raw cookie dough.
Nestle USA in January of 2010 said it would use heat-treated flour in the manufacture of its Nestle Toll House refrigerated cookie dough, a move designed to significantly reduce microorganism content in products.
Ms. Sanders of the A.B.A. said, “Heat-treated flour is not needed in products that are baked. Heat treatment is only needed in products where there is a chance that consumers will eat the product without baking it, such as raw cookie dough.”
Heat-treated flour originally was developed in Great Britain and designed to replace chlorination of wheat flour, said Rob Ferguson, customer account executive for Siemer Specialty Ingredients, Teutopolis, Ill. He said his company began selling heat-treated flour to manufacturers of cookie dough inclusions about eight years ago. Now, manufacturers of seasoning blends and gravy mixes use the heat-treated flour, too.
“Flour is a raw ingredient,” Mr. Ferguson said. “With heightened awareness in regards to food safety and efforts to protect the end-user, there is definitely a lot more (companies) purchasing the heat-treated flour.”
Siemer Specialty Ingredients achieves 5-log validated pathogen reduction in its heat-treated flour, he said.
ConAgra Mills has achieved 5-log validated pathogen reduction in its ready-to-eat flour under its SafeGuard treatment and delivery system launched earlier this year.
“Log reduction is a mathematical term used to show the relative number of microbes eliminated from a product,” Dr. Akins said. “The 5-log refers to the reduction in the number of microorganisms by 100,000-fold. For example, if a food product contained 100,000 pertinent microorganisms, a 5-log reduction would reduce the number of pertinent microorganisms to 1.”
The validation, or scientific study, determines the total pathogen reduction in the food manufacturing process, she said. The log reduction required for a process depends on the particular regulatory or customer expectations.
“In the case of our SafeGuard treatment and delivery system, we are able to control the log reduction depending upon end product requirements,” Dr. Akins said. “What’s more, our natural process allows us to do this without negatively affecting the performance or taste of the final flour or grain product, which is unique to our system.”
She also pointed out the food safety benefits of heat-treated flour.
“It’s important to remember that grains and flour are raw agricultural ingredients,” Dr. Akins said. “Manufacturers that use these ingredients should ensure that they have a baking or cooking process that has been validated as an effective process for significantly reducing or eliminating harmful pathogens. For those products that don’t undergo a validated baking or cooking process, such as raw doughs, some frozen food products, and cold-pressed bars, heat-treated flour such as SafeGuard helps to mitigate the overall risk.”
The SafeGuard system from ConAgra Mills carries over into the delivery system.
“After processing, the SafeGuard ready-to-eat flour is loaded out through piping and bins designed for cleaning and sanitizing, a validated process that exceeds common flour milling standards,” Dr. Akins said.
The facility uses dedicated filtered air handling for transporting the flour through the system. Flour is delivered directly to the customer’s facility to prevent contamination during transportation.
“New custom-designed flour tankers have interior ‘gun-barrrel’ finishes that contain no obstructions that could harbor micro-growth,” Dr. Akins said. “Trailers are designed to be as full as possible to reduce environmental conditions for micro growth. Tankers are washed and sanitized in a state-of-the-art sanitizing facility where the processed is validated and verified.”
Besides raw dough, whole grains may be more susceptible to food safety problems than refined grains, Mr. Best of Enreco said.
“Because, by definition, whole grains are only minimally processed when brought in from the field, the microbiological integrity of all whole grains should be of concern,” he said. “Refining of wheat and other grains typically reduced microbial population by one to two logs (i.e.,
10-100-fold), so there is some protection granted in refined flours. However, whole grains come with their surface microbe populations relatively intact.”
Enrico has pursued SQF Level-3 (food defense) certification of its whole grain flaxseed ingredients, he said.
Work at the Almond Board of California, Modesto, Calif., provided guidance for Enreco’s food safety efforts. The Almond Board of California collaborated with the U.S. Department of Agriculture to develop pasteurization standards for the almond industry. Enreco then contacted a microbiological laboratory that had worked with the almond board. Enreco worked with the laboratory to develop techniques and conditions that would permit the laboratory to certify Enreco’s flaxseed kill-step. Enreco achieved 5-log validated pathogen reduction.
While baking product in an oven might constitute a kill-step, it may not be enough to meet the requirements of the F.S.MA.
“Pathogens can survive in soft cookies, for example, and also post-process contamination,” Mr. Best said. “Bakeries typically have zones of high moisture where microbes can flourish out of sight, out of mind. Introduction of microbial aerosols into bakery environments though whole grain and nut ingredients represents a potential threat that must be anticipated under the F.S.M.A.”
Companies that already have a Hazard Analysis and Critical Control Points (HACCP) plan in place still need to make certain their food safety efforts meet the criteria of the F.S.M.A., said Mr. Pappas of AIB International.
A.B.A. members are not satisfied that certification by a Global Food Safety Initiative (G.F.S.I.) audit is proof of compliance, Ms. Sanders said.
“The A.I.B. audit approach that looks at programs, practices and assesses performance is a better and more complete picture,” she said. “The combination of a G.F.S.I. certification and a good A.I.B. audit score together are really the best assurances of compliance availability today.”
Sources of F.S.M.A. information and updates
The Food Safety Modernization Act should be phased in over a period of about 2.5 years. Sources exist to answer questions on the F.S.M.A. and to provide updates on rule-making.
A section on the F.S.M.A. will be available in the knowledge center part of AIB International’s web site on Nov. 16. One section will summarize the law while another section will give updates on the rule-making process. Information on costs and fees associated with the F.S.M.A. also will be available, according to AIB International, Manhattan, Kas.
American Bakers Association
The American Bakers Association’s Food Technical Regulatory Affairs Committee (FTRAC) discussed the F.S.M.A. during a meeting Nov. 8-9 at Tufts University in Boston. The meeting covered such F.S.M.A. issues as foreign facility re-inspections, recall and importer re-inspection user fee rates for fiscal year 2012; fee amounts on small business; guidance on specific sector preventative controls; and third-party audits.
Leavitt Partners has joined forces with Faegre & Benson and B&D Consulting to provide guidance for companies seeking to navigate food safety challenges such as the F.S.M.A. The group will integrate technical, regulatory, legal, federal affairs, management consulting and coalition-building services.
Michael O. Leavitt, formerly the secretary of Health and Human Services for the United States, founded Leavitt Partners and now chairs the technical, scientific and regulatory advisory group that operates in the health care and food safety sectors.
Faegre & Benson, an international law firm, advises clients on supply chain management issues; counseling on reporting, recall plans and potential F.D.A. enforcement actions; handling litigation regarding potential claims arising from food contamination, recall or labeling issues; advising on food labeling and recordkeeping requirements; and assisting with risk management.
B&D Consulting, a national advisory and advocacy firm, has advisers who have federal agency and congressional expertise and have served as lead drafters and negotiators for F.S.M.A. and other F.D.A. reform bills.
“The need to integrate food safety with food quality and new compliance requirements in an environment of budgetary constraint requires broad risk-based thinking and priority setting, and I believe this collaboration will provide that to the food sector,” Mr. Leavitt said.