Setting New Standards

by Lynn Petrak
A structural overhaul, new verification system and revamped standards process give new meaning to the historic 3-A symbol.
Talk about a symbolic gesture. Nearly two years ago, a team of dairy processors, equipment manufacturers, professional sanitarians and government regulators came together to update the nation’s 3-A program, which had for years set standards and practices for equipment and systems used to produce, process and package milk, milk products and perishable foods. Their goal was make the system behind the venerable symbol as credible, efficient and fair as possible for all involved with its use and meaning.
What emerged over the course of several brainstorming sessions, group meetings and conference calls is a 21st century evolution of a concept born during the boom time for the mass production and distribution of dairy products during the first half of the 20th century.
The new-and-improved 3-A was cooperatively designed to reflect modern needs for speed, efficiency and versatility in equipment design, while keeping sanitation and hygienic processes the top priority. In early 2003, the change became official with the opening of 3-A Sanitary Standards Inc. (3-A SSI), a new organization based in McLean, Va.
According to those involved in ushering in the new era of 3-A, the stakes and ultimate goal of 3-A remain the protection of public health and safety through the use of sanitary standards and accepted practices.
Lee Blakely, president of cheese manufacturer Cheese and Protein International, Tulare, Calif., and a current 3-A SSI board member, uses 3-A-certififed equipment in his facilities and believes it makes a statement about a company’s commitment to quality and safety. “Food safety is paramount to the whole thing,” he says. “There isn’t anyone, from the manufacturer to the sanitarian, who wants something out there that poses a risk.”
Dan Meyer, director of technical services for American Dairy Products International (ADPI), Elmhurst, Ill., says the 3-A symbol is so linked with safety assurance that it is an invaluable tool for manufacturers and processors alike. “It gives your equipment an advantage over others if you carry the 3-A symbol,” says Meyer. “People know it and recognize it as a good piece of equipment.”
Stephen M. Perry, Ph.D., senior vice president of the McLean, Va.-based International Association of Food Industry Suppliers (IAFIS) and a founding 3-A SSI board member, agrees the impetus behind 3-A has always been and always will be to ensure equipment and products that run on them are
guaranteed. “That was the big issue — to bring credibility and have some teeth behind the symbol,” says Perry, who represents various equipment manufacturers that supply 3-A-certified machines and supplies to dairy customers as end users. “When USDA (U.S. Department of Agri­culture) and FDA (U.S. Food and Drug Administration) see that symbol on a piece of equipment, it has the credibility without them having to stop and take that equipment down.”
In general, the new 3-A program is different from its previous form in various ways — some significant, others more subtle. “The vision for the new group was to bring into it the responsibility of the oversight for drafting and creation of standards, and to also get off the ground a new third-party verification program,” explains Tim Rugh, executive director of 3-A SSI.
Allen Sayler, senior director of regulatory affairs and international standards for the Washington, D.C.-based International Dairy Foods Association (IDFA) and a founding director of 3-A SSI, stresses the new entity hinged on some core concepts. “We now have an integrated organization, a third-party verification program and a method of procedures for expediting the development and updating of standards. Those are the critical differences,” he says, adding that the changes are important across the board. “There is a benefit, if we do this right, for all parties.”
Robert Dumke, director of manufacturing for fluid-handling equipment manufacturer Alfa Laval, Richmond, Va., echoes that sentiment. “I think there is always room for improvement in any organization,” he says. “As we go forward with this initiative, we are taking it up to another level — it’s good for the manufacturers, the customers and the sanitarians. We are in this together.”
Historical Perspective
From the very beginning, the 3-A system has been dedicated to serving public health through the development of standards for food sanitation and hygiene.
According to Rugh, the system was, in many ways, ahead of its time. “The mission and structure of the organization is no different than it was 50 or 60 years ago,” he says. “There are still end users on the board, along with sanitarians, manufacturers and regulators. Some people have linked to the balance of powers, and that is exactly the way it is still set up.”
The earliest 3-A sanitary standards were created in the late 1920s. They were developed by IAFIS, along with the Milk Industry Foundation (MIF) and the International Association for Food Protection (IAFP), another founding organization that still serves on the revised 3-A SSI board today.
During the initial years of the program, 3-A expanded to include additional members, including equipment manufacturers and sanitarians. By 1944, what was considered the “modern” 3-A program was born, through the support of the government’s Public Health Service and the formation of a new committee comprising mainly processor groups and suppliers. Existing members IAFIS and MIF were joined by new representatives from the American Butter Institute, the International Ice Cream Association, the National Cheese Institute and ADPI.
In 1956, the 3-A symbol — which stands for the three original founding associations — was created. The symbol, largely unchanged today, was placed on equipment to identify it as having met the 3-A standards for design and fabrication. For decades, the use of the symbol has been managed by the 3-A Symbol Administrative Council Inc.
For years, in fact, the 3-A program was overseen by two separate groups. “3-A had been split in two parts,” explains Sayler. “One was the Symbol Council, and the other was the standards development group managed by the 3-A Steering Committee.”
Sayler recalls that complaints about equipment compliance by regulators were handled by the Symbol Council, while any updating or development of standards was done, usually once a year, by the steering committee and various task groups at 3-A.
The process for receiving 3-A status for equipment also didn’t vary much from the mid-20th century. Equipment manufacturers and fabricators went through self-certification and applied to the Symbol Council to be granted the 3-A symbol, which they then placed on their equipment. 3-A status had to be renewed on a regular basis, and equipment was inspected for compliance by regulators through the FDA, which had its own set of requirements.
Change in the Air
The need for modifications to the program eventually became apparent. Shortcomings in the 3-A system were noted by a variety of involved parties, from regulators to end users to founding organizations. “It was a process that fulfilled its need at its time, and it needed to be updated,” remembers Larry Hanson, president of Madison, Wis.-based Sani-Matic, a supplier of cleaning systems for food and beverage equipment.
Several indicators led to the perception that perhaps the model that had worked for so long was no longer optimal. One warning came from government representatives. “We were starting to run into situations where someone bought 3-A equipment and it said it was 3-A, and they’d get it installed,” recalls Blakely. “Then a regulatory person would come in and say, ‘This doesn’t meet 3-A.’”
Sayler, too, remembers regulators’ complaints about supposedly certified 3-A equipment. “FDA’s Milk Safety Branch sent a letter to the 3-A Symbol Council representing some of their frustrations, saying the FDA field inspectors were finding equipment with 3-A symbols that didn’t meet the standards, in their opinion,” he says.
Reports of non-compliance also were filed with the 3-A Symbol Council, which usually handled such issues. “It appeared to the regulators that the council wasn’t adjudicating it in a way that FDA was satisfied with,” says Sayler. “FDA’s view appeared to be that if some changes were not made, the FDA would not recognize the symbol.”
Such a scenario would have been disastrous at worst and problematic at best for equipment manufacturers and end users. If 3-A were no longer recognized, inspectors’ criteria could be different on a state-by-state basis, causing equipment fabricators to redesign their products for myriad specifications. “Manufacturers and equipment users strongly supported making a change, because of the past and future value of having consistent national standards for dairy equipment. The alternative would be to, say, make one piece of equipment for New York and another for California,” says Sayler.
Beyond challenges about compliance, other factors were causing industry leaders to think about amending the program. Technology was expanding at a fast pace, for example, and some of the standards weren’t updated as quickly as they could have been. “Changes in product design were happening more rapidly, speed was becoming more efficient, and you had to be able to respond more quickly to that,” explains Dean Girton, president of Girton Manufacturing Co. Inc., Millville, Pa., whose father sat on the original 3-A board.
Sayler, through his work at IDFA, also had seen the influx of more sophisticated equipment systems and materials. “New technology means new equipment is being made, and standards must reflect that advancement in design and technology,” he says.
Likewise, Hanson agrees the previous procedure of evaluating standards once a year wasn’t enough to handle the flow of new designs hitting the marketplace. “The process that was being used to write standards was fairly lengthy, and the continuity among the various stakeholders wasn’t necessarily smooth,” he says.
Meanwhile, another overall marketplace trend was taking shape, one that would impact the structure and process of 3-A. “There has been a general trend in many different industries toward more and more third-party verification to ensure conformity with regulations,” says Rugh. “Many new, independent organizations have been formed that do very parallel things as 3-A, and there continues to be growth there in the number of organizations that oversee some type of credentialing program.”
Finally, as these and other trends began to have an impact on how 3-A was perceived, the structure of the old 3-A organization was also deemed in need of adjustment. “It became obvious that the old way we managed things wasn’t going to be efficient and each of the various parts did some things on their own,” says Girton. “There was no opportunity for the parties to get together and sit down on a regular basis and say, ‘This is what we need to do.’”
Blakely also saw a need for end users such as himself — as well as equipment makers, sanitarians and regulators — to arrive at some sort of consensus about the direction and meaning of 3-A. “I said, ‘We need something here such as a guidebook or a rule map that says, ‘This is right, this is wrong,’” he recalls. “That way, everyone could be on the same page and there would be uniformity across the industry.”
Building a New Structure
Around the turn of the century, a process was set in motion to address the various percolating issues. “Stakeholders had a number of task force meetings in 2001 and set up a committee to look at different pieces of the problem. FDA, USDA, state regulators and industry were all participants,” says Sayler.
A smaller task force of eight to 10 people was then charged with turning brainstorm ideas into what Sayler calls “a linear thought process.” A core group of leaders worked on finalizing the details of a new structure based on input from various involved parties. Legal advice was sought at this stage to ensure the structure and bylaws of the new body would meet all organizational and fiscal requirements.
One challenge in defining a new structure was what to do with the current system. “The big problem is, how do you combine the 3-A Symbol Council with the 3-A Steering Committee activities? We felt we had to integrate them into a viable organization and spent a lot of time working with the 3-A Symbol Council to educate them and help them understand,” says Sayler. “We tried to be sensitive to their concerns, because they had been watching over this organization for a long time.”
Eventually, the 3-A Symbol Council gave approval and funding for the new organization, which was to be called 3-A Sanitary Standards Inc. and based at the IAFIS offices in Virginia. In early 2003, Rugh was brought on board as executive director, followed shortly after by the official business opening of the entity.
The initial “bones” of the new group were to be as balanced as the original 3-A, with a diverse board encompassing all of the participating parties. “Now, there are five founding member groups that make up the board,” explains Rugh. “IAFIS represents the equipment manufacturer group. There are two end user organizations — IDFA and ADPI — and the sanitarian group is IAFP. The fifth founding member is the Symbol Council.”
In addition, the board includes three non-voting members, including representatives from FDA, USDA and a 3-A Steering Committee chairperson.
The new organization is more integrated in other ways as well. 3-A SSI combines all facets of the 3-A sanitary standards system, including the standards writing process, the maintenance of the 3-A symbol and a third-party verification program. One of the first things to come out of the initial agreements was the new mission and goals for the program, as outlined by the group’s leadership.
3-A’s stated mission was to develop, maintain and publish uniform standards and practices for the sanitary design, fabrication, installation and operation of equipment. The mission also called for the use of state-of-the-art science-based expertise for the development of sanitary standards and accepted practices, to be harmonized with global standards and guidelines.
Symbols were addressed as well, because 3-A SSI was to promote the use of 3-A sanitary standards, 3-A accepted practices and the 3-A symbol, as well as to authorize and maintain the integrity of the symbol. The last two objectives were to maintain a uniform system to regulate and enforce proper use of the 3-A symbol to best enhance consumer product safety and to provide education concerning sanitary standards, accepted practices and the use of the symbol.
Looking back, those involved with the development of 3-A SSI say a great deal was accomplished in the relatively short time span, from late 2001 to early 2003. “We sat down for what we thought would be two or three years’ worth of discussions, and within two days we had an outline,” recalls Girton of the initial meetings. “Every delegate that represented the groups really came together with a spirit of ‘We are doing this to fix things.’”
Blakely agrees the level of cooperation and efficiency was impressive. “Once we formed the new entity, the old entity went away and it forced the new entity to kick it into gear to get things happening in a hurry,” he says. “It was an awful lot of work by an awful lot of people to get it done quickly.”
For his part, Rugh said the objectives became the immediate focus of the new group, which accounted for the sense of urgency balanced by attention to detail. “Looking at specific objectives, from Day One it has been very goal-oriented,” he says. “I’ve seen a lot of organizations get off the ground, and this one did a good job in the planning stages.”
Third-Party Verification
One of the first goals the new 3-A SSI laid out was the creation of a third-party verification system (TPV) system to help bolster the credibility of the 3-A symbol and ensure equipment was up to defined standards. “When I came on, the top priority was to get the new TPV program started,” says Rugh.
The notion of independent inspections of equipment used for dairy production and packaging was supported across the board. “I think it was very important,” says Hanson. “Although the majority of the system did a good job of self certification, it doesn’t take a lot of apples to spoil the whole barrel.”
Moving from self certification to a TPV model wasn’t a simple process, but the board and TPV committee knew it had to happen as quickly as possible. “A lot of work was done to get the basic procedures in place,” says Rugh. “The third-party inspections were to be done by a group of credentialed inspectors. Wrapped up in the TPV program was a separate accreditation program for which we had to assemble tools.”
Sayler, serving as chairman of the 3-A TPV Subcommittee, helped oversee the development of the TPV system. A trained consultant was brought in to aid in the development of an accreditation program. With a testing and credentialing program finalized in early spring last year, 3-A SSI began advertising for certified conformance evaluator (CCE) candidates. After a series of conference calls with prospective verifiers, 3-A SSI offered its first tests in April and May. “The candidates for CCEs primarily were people in the manufacturing industry or consultants to the dairy industry. In a couple of cases, they were from USDA,” says Sayler.
By the end of the first round of tests, more than 20 CCEs were accredited and ready for training. “Once they demonstrated the skill and knowledge of 3-A standards, we had to train them on the administrative part of the program, like how you file reports, who gets what and all the details. We also wanted to have uniformity between the CCEs, because we have a disparate group of people,” says Sayler, adding that the organization sponsored a two-day orientation course in July. A month later, the TPV program was officially launched, and the names of 26 CCEs who were available for hiring were published on the 3-A Web site (www.3-A.org).
At the same time, 3-A SSI outlined how the TPV program would work — namely that, to receive 3-A certification and the 3-A symbol, a manufacturer had to have equipment evaluated by a CCE. To make the process more gradual and adaptable, specific groups of equipment were subject to third-party verification by the end of 2003, with other groups to follow on a yearly basis until 2006. “We looked at all the equipment and divided them into eight groups,” says Sayler. “Those groups were then assigned a timeline when they had to go to TPV.”
Several manufacturers have already hired CCEs to inspect their equipment and file the appropriate reports for certification or re-certification for 3-A. Dumke says Alfa Laval recently found a CCE from the 3-A SSI list and brought him in to evaluate existing equipment that was up for re-certification this year. “It was a good process, we felt, and it gave us a point to collect all our data in one file. It will also help ensure that things are the way they should be,” he says.
Jody Hamilton, sanitary/pharmaceutical manager at United Industries Inc., a Beloit, Wis.-based supplier of industrial tubing, also contracted with a CCE to evaluate and certify some of the company’s products it supplies to dairy producers. “Now, instead of being 3-A certified, we can also say we are TPV certified,” says Hamilton. “Also, we used to put a 3-A symbol on our box end bar code, but we didn’t incorporate it into the stencil that is on the tube. The CCE said, ‘If you are 3-A, why don’t you put it there?’ So we did.”
The only concern Hamilton has is compliance by foreign competitors, who must send in samples of their products to be evaluated by third-party verifiers. “If you allow foreign companies to bring in something, will that be representative of their day-to-day products? When they come here, they look at all of your stock — your production stock, your on-the-floor stock, your shipping stock,” she says. “With those companies, how do you know unless you send someone over there?”
As the TPV program expands, such concerns are likely to be addressed by 3-A SSI leadership. Currently, the roster for CCEs listed through 3-A SSI stands at 33, with inspectors available in geographic regions throughout the country.
Steering the Issues
Beyond the startup of the TPV program, another early objective of the revised 3-A system was to create a more efficient way of setting sanitary standards and accepted practices. To that end, the process and procedures for writing and revising standards were updated, with the creation of a new 3-A SSI steering committee responsible for establishing standards and setting priorities for their development, and the formation of 13 working groups, to replace the previous 50 specific task groups.
“The standards development pro­cess has worked in an informal way for many years,” says Rugh. “With the new system, the drafting and preparation of documents can proceed at the pace that interest supports it.”
ADPI’s Meyer says the new working-group arrangement allows for more flexibility and efficiency in writing standards and responding to any issues or challenges. “In the past, the task group would meet, come up with a standard, bounce it off the sanitarians and pass it through. Now, the working groups are represented by manufacturers, regulatory officials, sanitarians and end users,” he explains. “From the get-go, all representatives will be at the table.”
Sayler agrees the new makeup of the groups will work to the benefit of all parties. “The key to this new process is that everyone is in the working group from the beginning,” he says. “It should contain the group expertise, so when the standard gets to the final consensus body, which is the 3-A steering committee, it is in very good form. That is a critical difference from the old groups.”
For his part, Perry foresees a fair balance of group members that will ensure all aspects of the supply and user chain are represented. “You’ll see across the list a wide variety of types and equipment, and you’ll also see a wide variety of companies. Some may have several product lines; others may be just a single company,” he says. “It cuts across the spectrum.”
The standards and practices aspect of 3-A got its most recent boost with accreditation by the American National Standards Institute (ANSI). “That is basically our mark of approval from the standards development organization,” says Rugh. “It shows that we operate in accordance with certain due process requirements.”
Getting the Word Out
At the mid-May annual meeting of 3-A SSI in Milwaukee, the steering committee and working groups were busy evaluating standard practices. This year, participants at the annual meeting also could attend a new education seminar, a daylong session organized to help those in all the various industries tied to 3-A learn about the latest changes and priorities.
Beyond the annual meeting, 3-A SSI and its various founding members, board of directors and participating committee and group members are getting the message across about the new era of 3-A. Various founding organizations — including IDFA, ADPI and IAFP — feature 3-A updates for their members on their Web sites and in various newsletters. In addition, Rugh and other representatives from 3-A SSI have attended several industry trade shows over the last two years to help inform attendees about the changes in the program.
Although the new 3-A only SSI has been up and running for a year and a half, reception by manufacturers, sanitarians, regulators and end users seems to be positive. “Change is always a challenge for everyone, but those intimately involved in the process recognize the sluggishness and weaknesses of the older systems,” says Girton. “It’s been embraced there.”
From Perry’s perspective at IAFIS, manufacturers’ reactions seem to be strong as well. “The early anecdotal evidence is that they were very pleased,” he says. “They wanted to see it happen, because it is a competitive advantage for them to have 3-A on their equipment. They wanted to level the playing field.”
Lynn Petrak is a freelance journalist based in the Chicago area.