Got Food Safety? The U.S. dairy industry does. In 2005 alone, 179.9 billion pounds of milk were produced in the U.S., yet despite this massive production and the vulnerability of dairy products to spoilage, less than one percent of foodborne illness outbreaks in the U.S. involve dairy products. Visit a dairy plant and you’ll see why. With their gleaming stainless steel and lengthy list of regulations, most milk and dairy processing plants rival the best hospitals when it comes to sanitation and food safety protocols.

But even with a nearly spotless food safety record, the dairy industry isn’t resting on its laurels, says Allen R. Sayler, Senior Director of Regulatory Affairs and International Standards for the International Dairy Foods Association (IDFA) ( Continued work with regulators on modernization of Good Manufacturing Practices, progress in the development and rollout of the National Conference on Interstate Milk Shipments (NCIMS) voluntary Hazard Analysis and Critical Control Points (HACCP) program, and support of supply chain and consumer education on issues such as allergen labeling, raw milk legislation and temperature abuse are ensuring that the dairy industry’s food safety reputation doesn’t get spoiled. Food Safety Magazine talked with Sayler about these and other emerging issues, challenges, and developments in the dairy food safety.

FSM: Allen, IDFA is involved with dairy food safety initiatives on many levels. What are some of the current hot topics in dairy food safety, regulatory developments or challenges the industry faces today?

Sayler: Over the last two years, IDFA staff and members spent a considerable amount of time working with the FDA as they reviewed the GMPs, which have not been updated since the 1980s, under the agency’s modernization initiative. We provided comment on several issues, including requiring plants to have written plans for the management of problematic issues such as allergens, Listeria and food contact surface sanitation. There were also some suggestions to offer greater flexibility within the GMPs, such as allowing dairies to develop their own training criteria specific to their products versus having mandated programs.

We understand that those comments are continuing to be reviewed and that the FDA will let us know later this year what they feel these updates should be. While there is nothing decided right now, this will probably have a pretty large impact on the industry including some added requirements. The interesting thing is that a number of the FDA suggestions are things that the industry has already taken it upon themselves to do.

Another development that we are happy to report is that FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is in the final stages of completing its reorganization. Historically, CFSAN’s organizational scheme divided dairy and dairy products into two groups: one that administered policies for Grade A products and another for non-Grade A products such as cheese, ice cream, milk powder and butter. The agency has now combined these categories into one group, which seems to make great administrative sense, and IDFA believes that this will make it easier for the industry to work with the FDA simply because we have one place to go to get answers. We also feel that this will best utilize the very limited resources the FDA has to commit to the dairy industry.

FSM: IDFA has also been very involved in proposed changes to the PMO and other NCIMS guidelines. What are some of these updates?

Sayler: State regulatory agencies, the FDA and the dairy industry come together every two years for the National Conference on Interstate Milk Shipments (NCIMS) to review and update minimum requirements for dairy farms, plants and the transport of dairy products. At this year’s May meeting, 105 proposals were reviewed at the meeting, and NCIMS delegates adopted 56 of these to update the Pasteurized Milk Ordinance (PMO) and other NCIMS documents. These directly affect state inspection of Grade A dairy farms and plants. It was a very successful meeting, and ultimately, with assistance from more than 50 Milk Industry Foundation (MIF) members, IDFA successfully advocated more flexibility in the PMO for dairy processors and other NCIMS documents that directly affect state inspection of Grade A dairy farms and plants.

Importantly, an agreement was made to give the Grade A definition committee six more months to determine whether non-standardized dairy products, such as smoothies, should be included under the PMO. Defining what “Grade A” means exactly has been an issue before the conference for a few years. Essentially, there is a definition in the PMO that was intended to provide some flexibility in assigned Grade A status to dairy products, but the label has been clouded with the introduction of innovative multi-ingredient products like smoothies, fruit-inclusion dairy beverages and multicomponent sour cream dips, cottage cheeses and yogurts that incorporate vegetables, fruits, spices and flavorings, which didn’t exist 10 years ago. The committee’s final recommendations will be issued by a memo from FDA, then voted on by state dairy regulators.

Two MIF proposals were adopted, along with amendments for a number of other proposals. MIF proposed new technologies for treating ingredients added after pasteurization and separate ratings for plants that process both fluid and dry products. These meet the criteria of improving or maintaining food safety and also provide some operational flexibility to dairy processors. Currently, there are some major restrictions on how and when you can add ingredients after pasteurization, and the PMO doesn’t really allow for new technologies. The FDA has indicated that the agency recognizes that these technologies could actually be used as a substitute for pasteurization and have the same food safety outcome. This will be a significant advancement that should drive development and validation of these new technologies; i.e., high pressure, electric or light pulse, filtration, bactofugation, etc.

The delegates also adopted the Grade A aseptic pilot program, which will combine aseptic requirements from the PMO and FDA’s Low Acid Canned Food program to reduce duplication and conflicting standards. The pilot will run for two years under the oversight of a new NCIMS Aseptic Pilot Program Implementation Committee. This pilot will include 22 Grade A aseptic pilot plants, plus some international plants. Currently, all Grade A aseptic dairy plants receive complete inspections under both programs.

The NCIMS International Certification Committee had submitted a proposal to establish a pilot program for foreign dairy plants to utilize certified NCIMS inspectors and rating officers to fulfill NCIMS requirements currently being conducted domestically by state dairy regulators. At the May conference, NCIMS agreed to extend the Grade A International Certification pilot program to evaluate whether private certifiers can be used instead of state regulators to effectively inspect and rate dairy farms and plants against Grade A standards. The program will be extended for two years, run under the oversight of the NCIMS International Certification Committee, and will use three private certifying companies to inspect and rate six international dairy plants. This pilot will take a strong food safety program (NCIMS) and internationalize it, increasing the food safety of imported dairy products.

In addition, NCIMS adopted 15 proposals that would increase options for dairy processing, such as approving additional methods to clean mix-proof valves while running product, using the same receiving equipment for Grade A and non-Grade A milk, expanding the use of plant-reclaimed water and open-tower water systems for cooling milk and milk products, and updating electronic record systems meeting guidelines.

At least six other proposals that would have placed unnecessary restrictions on the dairy industry were defeated. The U.S. Food and Drug Administration (FDA) has until late August to accept the adopted proposals, and the changes will become official next year in October. IDFA is also preparing a comprehensive member hotline communication to explain the many changes approved by NCIMS.

FSM: You’ve mentioned the progress made in developing and rolling out the voluntary dairy HACCP program under NCIMS. Can you elaborate on this?

Sayler: We are very happy that Grade A dairy plants have the opportunity to choose to operate under the HACCP food safety system instead of the traditional PMO. As you know, the Interstate Milk Shippers Program relies upon the Grade A PMO and related technical documents for sanitary standards, requirements and procedures it follows to ensure the safety and wholesomeness of Grade A milk and milk products. In 1997, the NCIMS appointed a committee charged with defining a program that could regulate dairy plants under the HACCP model. The goal of the NCIMS HACCP Committee was to provide dairy operators an alternative regulatory system to the traditional system under the PMO that would be accepted as equivalent to the PMO system.

Since then, the voluntary dairy HACCP program has been piloted, proven equivalent and added to Appendix K of the PMO, where requirements for dairy plant participation are detailed. So far, there are 11 plants in seven states operating under this program with two additional plants pending in two other states. The committee continues to work with FDA and industry to provide guidance and direction for program implementation, including standardization and training of FDA and state milk rating and listing officers.

This summer, IDFA will update its dairy and juice HACCP manuals to provide even more detailed guidance to help build HACCP programs including information about prerequisites, hazard analysis, developing critical control points and verification strategies. In the new dairy manual, the 21 dairy models will be expanded to include dry milk products, in addition to fluid milk, flavored milk, creams, ice cream products, many individual cheeses and butter. The new juice manual has six similar models that address common juices, such as orange juice, apple, grape or some of the juice combinations and will also be updated.

Once or twice a year we also provide intensive dairy and juice HACCP workshops. These are developed from principles of HACCP that IDFA has distilled down from many other sources including some of the leading U.S. experts, the international Codex guidelines and the National Advisory Committee on Microbiological Criteria in Food, whose base document published in 1997 is the bible for HACCP.

Our newest training tools are IDFA HACCP webinars where participants can view slides on their computer and then dial into a conference call to have direct interaction with the instructor and other participants. Two recent sessions focused on how to start a HACCP program and develop prerequisite. With the second session covering how to perform a hazard analysis properly, identify critical control points and create a dairy HACCP plan. We also have an IDFA HACCP Task Force, headed by Kathy Gombas of Dean Foods, that offers the opportunity to conference call with members about once every two months to provide a forum to ask questions and share information.

About a quarter of the juice on the U.S. market is processed at dairy plants, and of course, if you make juice in a dairy plant you need to comply with the FDA mandatory juice HACCP regulation. IDFA was involved in the taskforce that established national training criteria for the FDA juice HACCP rule, and we were able to develop a manual that was consistent with what FDA wanted for training the industry. However, as we heard from members regarding the FDA inspections conducted in their facilities, it became clear that the FDA field investigators had misunderstandings about what the rule required. That improved and we were getting fewer calls. However, last summer, FDA brought in their field investigators for additional training, and unfortunately, we started getting calls again. So, we have renewed discussions with FDA and have offered to partner with them to develop training criteria for FDA field staff to improve their understanding and compliance requirements pertaining to this particular regulation.

FSM: Other issues in dairy food safety in the news right now include raw milk and allergens. What is IDFA’s perspective on these issues?

Sayler: Because milk is listed as one of the “Big Eight” food allergens by FDA, this is certainly a food safety issue. However, it’s primarily a food labeling issue. In other words, consumers who have food allergies, dairy or otherwise, need to have clear labeling so they can avoid products containing ingredients that will adversely affect their health. So, it is important for the whole food industry, not just the dairy industry, to make sure that food labeling and handling programs are such that allergens do not inadvertently appear in food products or are mislabeled.

In 2004, well before FDA’s issuance of the FALCPA legislation mandating clear labeling of allergenic or allergen-containing foods, the dairy industry introduced an intensive program to segregate allergens in plants that produce both dairy and juice products. It is important to make sure that milk residue doesn’t find its way into the juice because then it is considered an allergen. The industry uses several processing controls to prevent this. One is to run all of the juices early in the day and then run the milk after. In this way the allergen, milk, is run after the equipment has been cleaned so the non-allergenic product, juice, can’t possibly be contaminated by any remaining residues. If there is a reason that juice product must be processed after a milk production run, the industry requires complete equipment and plant surface cleanup and there is a protocol to check that there is no milk residue remaining prior to the juice being run.

More importantly, the dairy industry also manufactures products like ice cream that use a lot of different ingredients to make all the frozen flavors we have grown to love—from Rocky Road to cookies-and-cream—and some of those ingredients, such as peanuts and walnuts, are identified as “Big Eight allergens” in their own right. In these cases, we have extended the allergen segregation and handling systems to ensure that they are segregated from the other products in the warehouse are clearly labeled and properly handled.

We also have labeling programs to ensure that product is labeled correctly labels for allergens. There is extensive effort made by the dairy industry to ensure consumers are getting what the label says they are getting.

IDFA has been monitoring the raw milk issue very closely. Lately, we are seeing more interest by state legislatures to introduce laws that would in some way allow consumers to access and purchase raw milk for their families. However, there are a number of misunderstandings that legislatures and consumers have about the consumption of raw milk. We are quite concerned because if you look at the public health history in this country, and go back into the early 1900s, before pasteurization, one of the largest causes of infant mortality was the consumption of raw milk. We learned some lessons and those lessons were translated into requiring pasteurization. It has been proven that the nutritional value of milk is not diminished in any substantial way by pasteurization. Studies show that the nutritional value of milk is substantial and very similar, whether you pasteurize it or not. If you get the nutritional value and you don’t have any of the risks, why would you feed raw milk to children? Despite all this, there is a part of the public out there that believes there is something unique and special about consuming raw milk, particularly for children, and this concerns us quite a bit.

While there is regulation at the national level that prohibits the interstate transportation of raw milk for direct consumer consumption, this is really a state-by-state issue. Some states that allow raw milk to be sold have legislation that requires consumers to go directly to the farm and a few may even require substantial testing before it can be sold, but the fact is that they are allowing it in some manner. Currently, more than half of the 50 states allow the sale of raw milk. We think is this is irresponsible because the public assumes that if something is legal then it is safe, especially with food. But consumption of raw milk, particularly by children, is never a complete safe practice.

FSM: We’ve focused on domestic food safety issues here. What are some issues at the global level?

Sayler: The Codex Alimentarius Commission, which is supported by the United Nations’ Food Agricultural Organization and the World Health Organization, establishes food standards for international trade. Codex has developed guidelines for HACCP including risk assessments, risk management and risk communication. It has also adopted model export documents for trade that would include certain food safety requirements.

The Codex Committee on Food Hygiene is probably most directly involved in food safety aspects internationally. This group has developed a number of guidelines, some that are specifically related to milk products and many that are broad-based, including those aimed at minimizing or preventing Listeria in foods and improving food hygiene throughout the supply chain. These documents were developed with the idea that over 170 member countries would eventually incorporate them in their national legislation. So far, several countries that have limited resources to create their own guidelines, especially developing countries, have adopted Codex guidelines as law.

As far as challenges, IDFA has an ongoing taskforce, established in 1999, to monitor activities related to the control and elimination of Johne’s disease, which has been found in cattle throughout the world. The National Institutes of Health and the FDA state that there is insufficient scientific evidence to demonstrate that the organism that causes Johne’s disease in cattle is a causative agent for Crohn’s disease in humans. And in fact, we did research in cooperation with USDA in 2001 that shows that pasteurization kills this organism. Our study was backed up by studies in New Zealand, Australia and Ireland, and so we believe that pasteurization provides protection against this organism, as it has for many others that are sometimes found in raw milk.

In the U.S., the federal and some state governments are supporting Johnes disease eradication programs. IDFA and other dairy trade organizations are strong supporters of this effort, as is the world dairy industry.