Like cream rising to the top of the milk bottle, new progress in making the implementation of a Hazard Analysis and Critical Con-trol Points (HACCP)-based food safety model a reality for dairy processing plants is gaining the attention of milk safety regulators and industry in the U.S. With the posting of the recently completed “Dairy Foods HACCP Hazards Control Guide” and “NCIMS HACCP System Audit Reports” with pop-up references on the U.S. Food and Drug Administration (FDA) website coming soon, the National Conference on Interstate Milk Shipments’ (NCIMS) Dairy Grade A Voluntary HACCP Program guidance offers the most up-to-date resource to regulators and the dairy industry since the program’s inception in 1997.

The FDA website currently contains numerous HACCP forms and model documents for use in developing a complete HACCP System including developing a hazard analysis, prerequisite programs, monitoring, validation and verification records. The new guidance documents provide regulatory and industry personnel with responsibilites for milk and dairy product safety with updated information on participation in the NCIMS Dairy Grade A Voluntary HACCP Program, as well as next steps in the committee’s program implementation efforts.[1]

FDA, with responsibility for regulation of foods shipped in interstate commerce including milk and milk products, collaborates with NCIMS, a voluntary organization directed and controlled by the member states and open to all persons interested in its objective of “assuring the safest possible milk supply for all the people.” NCIMS is governed by an executive board comprised of representatives from state departments of health and agriculture, FDA, the U.S. Department of Agriculture (USDA), and the dairy industry. Together, FDA and the NCIMS have developed a cooperative, federal-state program (the Interstate Milk Shipper Program) to ensure the sanitary quality of milk and milk products shipped interstate. The program is operated primarily by the states, with FDA providing varying degrees of scientific, technical, training and inspection assistance.

The result has been the establishment of a viable and effective certification and enforcement program for processors of Grade “A” milk and milk products and their raw milk supplies. This program has been of significant benefit to consumers by ensuring a safe milk supply from the cow to the consumer’s table.

Got HACCP?
The Interstate Milk Shippers Program relies upon the Grade “A” Pasteurized Milk Ordinance (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. During its biennial conference in 1997, NCIMS approved proposals to appoint a committee charged with defining a program that could be regulated under the HACCP model for both dairy farms and processing plants. The overarching aim 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.

Between 1997 and 1999, the NCIMS HACCP Committee worked to develop a proposal to bring back to the conference delegates at the 1999 conference. Upon further review, the committee found that the estimated time and resources needed to develop both farm and plant HACCP models could not be realistically achieved. It was decided that the group would focus its efforts on the processing plant side, given the existing history of dairy plant experience in using HACCP and a lack of farm models. The result was the development of the Phase I pilot program designed to serve as a beta test for dairy processors interested in setting up and implementing a HACCP program in their facilities. The NCIMS HACCP Committee aimed to conduct a comparison study of plants operating under the traditional PMO inspection system and those operating under a HACCP regulatory scheme to provide further information on reaching equivalency between the two, as well as further define the elements needed for implementation of HACCP in dairy plants. In 2001, the committee was granted an extension of this pilot program by the NCIMS conference delegates to allow more in-depth study of the accumulated data.

In 2003, the committee presented to delegates completed documentation of the voluntary HACCP pilot program comparison study and the proposed program that met the goals stated at the outset of the effort: that an inspection system under the HACCP model would be workable in the plants and that it would maintain milk safety at the same level as the traditional system, the PMO. The proposal was adopted and is now published as Appendix K of the PMO, which details the requirements for participation in the voluntary dairy HACCP program.[2] With the acceptance of the proposal in 2003 and the inclusion of HACCP as an alternative regulatory system in NCIMS and PMO, the role of the NCIMS HACCP committee changed from the initial task of developing a program to assisting and overseeing the implementation of the program. Currently, the committee is charged 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.

Proactive Progress, Current Challenges
In 2005, the NCIMS HACCP Implementation Committee is fully in the process of implementing the program, working with industry, state inspectors and federal regulators to expand participation in the program, continue standardization, and address implementation challenges identified in the past few years. Currently, there are 13 dairy plants in nine states participating in the NCIMS Dairy Grade A Voluntary HACCP Program: Tropical Cheese and Farmland Dairy (New Jersey); Publix Dairy (Florida); Oakhurst and Garelick Farms (Maine); Safeway Inc. and Wilcox (Washington); Yo Farm (Connecticut); Gosner Foods (Utah); Clover Stornetta (California); Meadow Brook Dairy and Dutch Valley (Pennsylvania); and St. Albans Cooperative Creamery (Vermont). The participation of these plants and state regulatory personnel in the pilot program has provided a wealth of information and feedback to the NCIMS HACCP Committee as it develops a workable implementation plan.

As part of setting the foundation for the implementation process, NCIMS has set minimum training requirements for program participants, including mandatory participation in the program’s core curriculum (i.e., training specific to NCIMS dairy HACCP in the PMO). The core curriculum covers HACCP basics, prerequisite programs, general recordkeeping requirements, and the specific, unique requirements of the NCIMS program. The latter include the necessity of drug residue testing and laboratory testing of finished products, requirements that are not necessarily required under a conventional HACCP system in other food production categories.

All training is open and available to both industry and regulatory personnel to ensure that these stakeholders receive the same message at the same time. This approach has been very successful. However, to date, the most significant voluntary dairy HACCP implementation challenges involve the provision of audit training, particularly for state regulatory personnel for whom this training is mandatory. Under the program, state personnel responsible for auditing and listing dairy plants must take an NCIMS HACCP auditing course, which is put on by members of the committee from industry, academia and regulatory. NCIMS works with the FDA’s State Training Branch, the office that manages these programs, procuring training facilities and providing staff for course management and instruction. NCIMS HACCP auditing training courses were heldin 2005 in Sacramento, CA, in 2004 in Albany, NY, and in 2001 in Baltimore, MD. Although the courses have been well-received by regulators and industry alike, the infrequency of the offerings is problematic. Training courses offered once a year or less poses problems when trained personnel leave positions, creating a knowledge gap at the dairy plant or state agency until another course is offered.

The committee’s current challenge is to determine how to provide core curriculum and auditing training in less time-intensive segments with increased frequency to allow more flexibility for those who want to participate in the NCIMS Dairy HACCP Program. To address the problem posed by lengthy waits between courses, for example, NCIMS is proposing the development of a web-based or CD-based course in conjunction with classroom instruction by a two-member team of trainers to make training more accessible to a wider range of interested parties. The committee is also considering the potential benefits of creating a one-day “start up” course for industry and state regulatory personnel to communicate the basics of how to get into the program and the elements of NCIMS HACCP, prerequisites and recordkeeping, and to share information on the resources available to assist facilities and agencies in the implementation process.[3] In addition, the FDA State Training Branch is in process of getting the existing auditing training course accredited as continuing education credit hours, which will assist interested parties in justifying the expenditure. Ultimately, an increase in the number of participating dairies and state regulatory agencies will allow FDA and NCIMS to offer an expanded number of training courses.

Weighing the Benefits of Dairy HACCP
Although both regualtory inspection systems under the PMO are considered equivalent, from the dairy plant’s perspective, there are a number of inherent advantages to implementing a HACCP system over a traditional system. As reported to the NCIMS HACCP Committee by the pilot plant program dairies, these advantages include:

1. Controlling Product Loss. The pilot plants reported that product losses are greatly minimized because HACCP allows the operation to better control production processes. For example, plants found that the monitoring aspect of a HACCP program was extremely beneficial in making early determinations when a process was awry or out of specification and thus, limited the amount of product involved before a correction could take place. That “sooner rather than later” troubleshooting approach translated into money saved.

2. Gaining a Competitive Edge with Customers. Several plants have reported that they’ve attracted new customers as a result of having a HACCP system in place, specifically when competing for contracts with dairies that do not operate under a dairy HACCP system. The plants relayed that prospective buyers indicated that a HACCP program gave their operations an definite edge over the competition.

3. Better Trained Employees and Staff. HACCP training helps employees learn why they do what they do and empowers them to take immediate corrective action when a process is not in control. According to the pilot plants, this motivated employees to take more responsibility for getting the job done right, rather than performing only the basics of the job. Knowing how to monitor the limits on plant processes enabled employees to take corrective actions when they saw a problem, independent of the availability of a supervisor, saving time and money for the plant.

4. Ability to Capitalize on Extended Product Runs. Plants that apply to operate extended product runs must conduct studies and hazard analyses under the NCIMS program in order to receive approval from the approriate state regulatory agency and FDA (for an extended run beyond one day). With HACCP in place, the dairy applying for extended run approval has an advantage in that it already has experience conducting the necessary hazard analysis, has prerequisite programs in place and has a system in place to verify monitoring and effective implementation of process controls. Plants operating under a traditional system may not have this type of training and records in place and would have to implement these before it could implement an extended run proposal even if its proposal was accepted by regulators.

5. Sleeping More Soundly at Night. Plant management and QC personnel reported a higher level of confidence in terms of the assurance of both safety and quality systems and outcomes in their plants when using the HACCP system, as compared with their previous system. The plants stated that with the additional oversight and record systems required in a HACCP operation, they were better able to show what they were doing and how they were doing it right the first time.

Dairies must also factor in the challenges of and impact on plant operations posed by implementing a HACCP system when considering participation in the NCIMS program One consideration for plants, especially small-sized operations, is the additional upfront costs associated with hiring specialized, dedicated program staff, such as a HACCP coordinator and/or records maintenance manager, if these duties cannot be handled by the current employee. In addition, training can take time away from employees’ regular production activities and the need for continuous and ongoing training of staff and records development and management tasks may require additional resources.

Plants should also consider the impact on operations and staff from an audit-versus-inspection time standpoint. As compared with inspections, audits are more time-intensive, generally requiring three days on average to conduct and can tie up staff time as plant personnel collect the requested records and take them to the auditor for review or participate in plant audit review tours, and so on. Compared with an average inspection that takes around two days, plants must consider carefully the impact of committing additional resources and staff time required when using a HACCP audit approach.

A plant that is operating under the NCIMS HACCP alternative and meets certain strict requirements may be audited less frequently than under the traditional program. The plant and regulatory personnel would be involved in fewer audits with each audit requiring a greater commitment of time. This is seen as an advantage by some participants because it allows for better utilization of resources by both the plant and the regulatory staff.

Advantages to regulators who elect to participate in the voluntary NCIMS Dairy HACCP Program include:

1. Ability to Better Evaluate Plant Operations. Overall, audits offer a more in-depth way to assess a plant’s performance than inspections. Unlike an inspection in which the inspector marks what he or she sees during the on-site visit, audits allow the regulator to evaluate what goes on in the plant at all times, even when he or she is not on-site, through record and plant performance documentation review.

2. More Informed Independent Assessment. The record keeping and documentation components of a HACCP program results in a greater amount of information available to the regulator. In HACCP plants, additional plant information may be available to the regulator, whereas in a traditional system, many of those records are typically considered propietary and the regulator is not allowed to see them. With the additional information gained from HACCP documentation, auditors are able to better provide a fully informed independent evaluation of the effectiveness of implementation.

3. Better Trained and More Knowledgeable Personnel. Under the NCIMS HACCP program, auditors have to be more familiar with every aspect of dairy operations—not just from a public health and safety standpoint but from the processing perspective. In other words, auditors must understand the plant’s processes in order to assess the safety and management of those systems. With this additional knowledge base, regulatory personnel will be able to work in tandem with plant personnel to identify potential areas of food safety risk and correct problems before product is released to consumers.

State regulatory agencies that are interested in developing a regulatory HACCP program for dairies will also need to consider additional front-end training and implementation costs involved with administering the program, as well as increased staff time needed to conduct audits. Also, because state laws and regulations have not been amended, modified or adopted that specifcally allow HACCP/auditing as an alternative to the traditional inspection system, there will be some additional up--front work needed on the part of regulators to incorporate it into licensing or other systems.

Moo-ving Forward
An important advantage for both the state regulatory agency and the dairy processing plant is that HACCP implementation fosters a cooperative team approach. Both stakeholders make a commitment to the other to work toward the same goal—safe dairy products—under the NCIMS HACCP alternative regulatory inspection program.
The success of the NCIMS Voluntary Grade A Dairy HACCP Program will be driven by industry as individual dairy plants step forward, commit to HACCP implementation and participate in the program. The NCIMS HACCP committeecan be a good resource in this regard, as can the Internatiional Dairy Foods Association (IDFA), which offers a number of educational programs and networking resources to industry.[4]

John A. Beers is Program Supervisor, Office of Dairy and Foods at the Virginia Department of Agriculture and Consumer Services (VDACS), where he began his career in April 1977 as a dairy inspector. At VDACS, he held the positions of Dairy Services Regional Manager and Assistant Chief in the Office of Veterinary Services prior to being promoted to manage the Dairy Services Program in 1988. During his career, Beers has been an active participant in the Dairy Division of the National Association of State Departments of Agriculture and the National Conference on Interstate Milk Shipments (NCIMS)., for which he currently serves as an Executive Board Member and is chair of several committees, including the HACCP Implementation Committee.

References
1. U.S. FDA CFSAN. Dairy Grade A Voluntary HACCP. References and current program documents. www.cfsan.fda.gov/~comm/haccpdai.html.
2. U.S. FDA CFSAN. Grade “A” PMO 2003 Revision. Appendix K: HACCP Program. www.cfsan.fda.gov/~ear/pmo03j-k.html#appk.
3. U.S. FDA CFSAN. Milk Safety References. http://vm.cfsan.fda.gov/~ear/prime.html or www.cfsan.fda.gov/~ear/p-nci.html.
4. International Dairy Food Association. www.idfa.org.

NCIMS HACCP Implementation Committee Members
The HACCP Implementation committee welcomes and encourages outside input that will assist it in accomplishing its tasks. Observers are welcome at meetings and are welcome to provide relevant input during deliberations. NCIMS HACCP Implement-ation Committee Chair John Beers can provide a history of deliberations and other information for those wishing to ask questions or provide input.

John A. Beers (Chair), Virginia Department of Agriculture & Consumer Services, Email: john.beers@vdacs.virginia.gov

Claudia G. Coles (Past Chair), Washington State Dept. of Agriculture, Email: ccoles@agr.wa.gov

Paul M. Hoge, Pennsylvania Dept. of Agriculture, Email: phoge@state.pa.us

Dennis Moore, New York Dept. of Agriculture, Email: dennis.moore@agmkt.state.ny.us

Kathy Stodola, Wisconsin Dept. of Agriculture, Email: Kathy.Stodola@datcp.state.wi.us

Kathy L. Gombas, Chair, HACCP Audit Training Subcommittee, Dean Foods Northeast, Email: kathy_gombas@deanfoods.com

Rebecca L. Piston, H.P. Hood LLC, Email: Rebecca.Piston@hphood.com

Dave J. Robbins, Chair, Technical Review Subcommittee, Chair, Hazard Guide Subcommitte, Dean Foods Company, Email: dave_robbins@deanfoods.com

Allen Sayler, International Dairy Foods Association, Email: asayler@idfa.org

William H. Sveum, Ph.D., Kraft Foods, Inc., Email: wsveum@kraft.com

Chris Newcomer, New-Tech Consulting Inc., Email: cnewcomer@prodigy.net

John Rushing, Ph.D., North Carolina State University, Email: john_rushing@ncsu.edu

Richard F. Graham, Technical Advisor, Email: richard_439@msn.com

Jim Fear, FDA Division of Human Resource Dev., Email: jfear@ora.fda.gov

Monica Metz, FDA Division of Dairy and Egg Safety, Email: mmetz@cfsan.fda.gov

Ray Niles, FDA Division of Human Resource Dev., Email: RNiles@ora.fda.gov

Stephen E. Pierson, FDA Regional Milk Specialist, Email: spierson@ora.fda.gov

Steven T. Sims, FDA Milk Safety Branch, Email: Steven.Sims@cfsan.fda.gov