Peanuts. Tree nuts. Milk. Eggs. Wheat. Soybeans. Of the “Big 8” foods identified by the U.S. Food and Drug Administration (FDA) as containing allergenic proteins that are estimated to cause 90% of the allergic reactions in the U.S., these six commonly are used as ingredients in formulated products such as bakery goods. With more than 400 dough and baked cookie formulas in its library of offerings, Jana’s Classics, Inc., the Tualatin, OR-based premium pre-portioned dough and baked cookie manufacturer, takes a strong line on allergen control for this very reason.

“Literally, everything we make has an identified allergen in it,” states Susan Deeming, Ph.D., R.D, vice president of technical services. “Although we do manufacture a few cookie doughs without egg, all of our cookies do contain wheat flour.”  

Jana’s Classics’ founder and president Jana Taylor notes, “When you live the reality every day that most of your products contain allergenic ingredients and that a bakery deals with every allergen on the list except fish and shellfish, the complexity of the allergen potential becomes huge. The commitment to an effective allergen control program has to be a company-wide priority.” She smiles, adding, “To date, we don’t make a crab cookie, but our R&D team is quite innovative.”

Founded in 1984 by Taylor, a food technologist and home economist, Jana’s Classics has grown from a modest kitchen-based operation supplying local grocery stores with cookie dough to a 75,000- square-foot commercial production facility with more than 150 employees and an estimated $18 million in sales in 2001 to the in-store bakery, food service and dairy frozen dessert industries. The complexity of which Taylor speaks can be illustrated by a simplified list of products the company manufactures and supplies to such customers as Safeway, Baskin-Robbins 34 Flavors, Haagen-Dazs, Harrah’s Hotels, Coco’s Restaurants, American Airlines and Dreyers Grand Ice Cream: dairy product ingredient inclusions such as frozen dough pieces and miniature baked items; thaw-and-serve cookies; frozen, ready-to-bake cookies; and baked, ready-to-eat cookies.

With its burgeoning and varied customer base, Jana’s Classics runs several product lines each day over several shifts, ranging from snickerdoodles and sugar cookies to old-fashioned favorites like peanut butter and chocolate chip-pecan. State-of-the-art equipment in the plant includes two automated frozen dough lines, two automated full-bake lines, an in-line band oven system with cooling and enrobing capabilities, and a high-speed packaging/wrapping line. That’s a lot to keep track of, especially when it comes to allergen monitoring and control activities.

“We’re not just running one kind of cookie 24/7,” says Taylor. “Because we’re making artisan-type cookie products to service our different customer segments, our allergen control program is very detailed to accommodate the necessary changeovers during production. These changeovers necessitate precise and well-planned scheduling in order to meet our customers’ delivery goals and, at the same time, to address the need for certain products to be manufactured in certain areas due to allergen issues. You must set up the process both for production efficiency and for effective allergen control.”

Providing “Peace of Mind”
The allergen control program is just one facet of Jana’s Classics’ dedication and commitment to food safety and quality aims. The company boasts an impressive list of safety and quality standard certifications, which underscores its promise to customers and consumers: “Created, Guaranteed and Delivered to You—Peace of Mind.” The company is American Institute of Baking (AIB)‘Superior’ rated, meets U.S. Department of Agriculture (USDA) Dairy
Standards for six specific microbial tests, and is Kosher certified. It has a fully implemented Hazard Analysis & Critical Control Points (HACCP) program, and operates with established Sanitation Standard Operating Procedures (SSOPs) and Good Manufacturing Practices (GMPs).

In addition to the rigorous AIB audit, the facility also is regularly audited by its customers; in some respects, entailing an even greater degree of rigor. Over the past few years, customer interest in the company’s allergen control policies and procedures has noticeably increased, says Brian Campbell, Jana’s Classics’ quality assurance manager. This has been particularly the case with dairy/frozen dessert industry customers to which the company supplies both raw and baked inclusions for products such as specialty ice creams. These ingredients may contain additional allergens that must be declared.

“Questions about our allergen control program have come up with more frequency during customer audits,” he adds. “In fact, our customers demanded an allergen control program long before FDA required it, and this has been a real driver in terms of ensuring that our program is effective and well managed.”

Both regulatory compliance and meeting customer specifications are the key drivers in terms of allergen control, adds chief operating officer Sid Harvey. “The allergen control program is more driven by these requirements than it is by the marketing program. Many of our products end up as ingredients in someone else’s products, and as such, we have to be able to support their allergen program.

“And, it is important that the product comply with the labeling, and that the labeling is accurate. In other words, it is important that we have alerted the informed consumer—the person who is reading that label because he is concerned about his own allergies—about allergens contained in the product.”

Scheduling, Sequencing and Sanitation
While Jana’s Classics integrated an allergen control program into the production process early on in its operation, the company decided to perfect its processes and procedures a few years ago with the assistance of the University of Nebraska’s Food Allergy Research and Resource Program and its director, Susan Hefle, Ph.D. The updated policy and procedural document primarily requires “paying attention to the details,” notes Deeming.

There are several parts to the Jana’s Classics allergen control program. As raw materials arrive at the receiving bay, ingredients that are allergens or contain allergens are identified. The vendor specification sheets and ingredient statements that describe any allergens in the raw materials are checked. The materials are then placed in dedicated ingredient storage areas, where allergens such as nuts and eggs are kept separately. Individual raw materials and ingredients are sealed in containers to ensure that the integrity of each is intact. Production scheduling takes into account a product sequencing approach, as well as specific sanitation procedures that must follow each sequence of production. Cleaning and sanitation procedures are routinely verified. Finished, packaged product is labeled with an appropriate ingredient list and processing statement.

Production scheduling is a key part to the successful implementation of the allergen control program, and production scheduler Jamie Owen is responsible for laying the groundwork in this regard. We don’t publish a schedule until we hold a production planning meeting attended by team members from sanitation, quality assurance and production. This meeting is held once a week, before the schedule for the next week is published. We go over the proposed schedule line by line, day by day, in order to effectively address potential allergen or other problems, ensure that allergen sequencing is in place so that you’re not running a nut dough before a non-nut dough, and that you have enough time allotted for the specific amount of cleaning time required for each line after an allergen-containing product is run.”

The production procedures spelled out in the company’s allergen policy show how sequential processing coupled with a strict sanitation program is essential to the prevention of allergen cross-contamination in the plant. For example, basic sequencing of production requires that eggless products are run at the beginning of a shift, before egg-containing products. Similarly, peanut butter dough is run at the end of a shift. All chocolate doughs are run together, as are all nut doughs.

This allergen-sequencing approach, explains Harvey, “can be viewed as a hierarchy built from the most benign allergen-containing product to the most significant allergen-containing product. At the end of the sanitation cycle, you start again with the most benign product.”

But, he says, there is a more fundamental aspect of sequential processing that should be emphasized if the approach is to be used successfully. “Allergen sequencing takes precedence over all other considerations for scheduling. At Jana’s, this is unquestioned, and is not available to be questioned, in terms of our allergen control program. It is not ever violated. We’ll pay extra, we’ll run overtime, we’ll do extra sanitation, but we will not violate the allergen control program. It is fundamental, because just as soon as you compromise and make it available to tweak, you certainly will run into problems.”

The second prong of the allergen control program—sanitation procedures and scheduling—is just as significant to its effective implementation as sequencing. Sanitation procedures are specifically outlined for each allergen protein containing product, and the sanitation schedule is developed to ensure that both adequate cleaning time and verification of cleaning are allotted after each sequential run.

Verifying and documenting that cleaning and sanitation procedures are effective at each step is essential, says Campbell, to ensure that cross-contamination of allergens does not occur between runs. For example, between non- nut/nut or non-chocolate/chocolate doughs, line personnel would scrape the mixer, pull the die and filler block and scrape, scrape the feed rollers, clean as appropriate, reassemble the portioner and run the next dough. “We validated our cleaning processes using test kits from Neogen Corp., specifically the kit developed for peanut allergens. We’ve used such kits for testing product, as well as to test contact surfaces in the plant, primarily to validate our SSOPs to make sure that they are effective.

“After we validated the effectiveness of our SSOPs,” he continues, “we conduct routine monitoring using Ecolab ATP bioluminescence swabs to check all the hidden nooks and crannies that can be really tough to clean in a food plant environment, such as the rollers and belts. We’ll make a thorough inspection of the equipment and swab those niches to make sure that they are indeed clean and that no allergen residues remain on food contact surfaces.”

In the event that the ATP test indicates the surface is not fully cleaned, the equipment is recleaned until results are negative. In general, this would include a wash down of all contact surfaces, meaning a complete wash and sanitation of the mixer, seals, portioner, filler block and die, all belts and the freeze tunnel. As is routine, all wash and sanitation procedures are documented.

Ultimately, the finished product from each run receives appropriate labeling on which every ingredient is listed and sub- listed, so that all ingredients are declared. Jana’s Classics also includes statements about allergens and related policies and procedures, since lines are not dedicated to the manufacture of a single type of product. For example, the statement included on retail film and bulk cookie case labels reads: “This cookie was produced on equipment also used to manufacture products containing peanuts, tree nuts, eggs and dairy ingredients.”

Practical Advice: Be Proactive
The management at Jana’s Classics knows that training and education to promote company-wide knowledge of the company’s products and ingredients, food allergens, and policies and procedures for allergen control are very important to the success of the program. Major training for all levels of personnel provided by the University of Nebraska’s Food Allergy Research and Resource Program has included in-depth coverage of the food allergens of concern, the worker’s role in preventing cross-contamination and the regulatory perspective on allergen control.

Says Campbell, “Education is certainly one of the keys to the success of the allergen control program. There’s very good knowledge throughout the company about what allergens are and how to deal with them, from Jana Taylor all the way to the people who are packaging cookies in the plant. While some may not know technically what happens in the immune system if an allergic person ingests peanut proteins, we all know we play an important role in preventing the occurrence of such a reaction.”

The company also is forward-thinking in its approach to keeping abreast of new developments in allergens and allergen control. When introducing new products, research is conducted up front about possible allergens prior to placement on the production schedule. Checking with regulatory agencies, reading trade publications and networking with allergen research centers are excellent ways in which a food company can build on its knowledge base. “We must keep on top of emerging allergens,” notes Deeming. “If the Big 8 expands to the Big 12 or more, it could require the development of new strategies in terms of allergen control measures.”

Harvey adds, “We would not maintain that we’ve taken our allergen control program as far as it could possibly be taken, but we feel it is pretty well advanced. I believe that the next big breakthrough in allergen control will come from technology in the form of improved monitoring and testing mechanisms and real-time feedback. The peanut test kit was the first true breakthrough that we’ve seen, and I think we’ll see more of these developed for all of the various nut items.”

“We’re a solutions-driven company,” agrees Taylor. “Whether we’re talking about allergens, or microorganisms, or any number of issues, food safety is a way of life around Jana’s. It definitely starts at the top. As science and technology advance, and we’re able to use these advances for food safety applications, Jana’s will take those opportunities to further enhance our food safety program for our customers.”

Julie Larson Bricher is editorial director of Food Safety Magazine. A degreed, professional journalist and editor for 15 years, Bricher has covered the food processing, foodservice, retail grocery and environmental industries for a variety of leading business-to-business, scientific and trade association publications. She also is an experienced industry conference session planner, most recently organizing Food Safety Magazine’s sponsored sessions and speakers for The Food Safety Summit, presented by Eaton Hall Expositions, and cosponsored by the National Food Processors Association and the National Restaurant Association.