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October/November 2005
Reprinted from Food Safety Magazine, October/November 2005, with permission of the publishers.
(Also available in PDF.)
Like cream rising to the top of the milk bottle, new progress in making the implementation of a Hazard Analysis and Critical Control 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.
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.
Here are a few highlights from the official Frequently Asked Questions (FAQs) page posted on the FDA website. Questions and answers about the voluntary dairy HACCP program involve topics ranging from auditing and training, to regulatory and plant operation considerations.
Source: U.S. FDA CFSAN. FAQs on NCIMS Dairy HACCP
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 held in 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.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:
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:
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.
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 committee can 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. He can be reached at john.beers@vdacs.virginia.gov.
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 Implementation 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 Subcomm.
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 Subcommittee
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: james.fear@fda.hhs.gov
Monica Metz
FDA Division of Dairy and Egg Safety
Email: monica.metz@fda.hhs.gov
Ray Niles
FDA Division of Human Resource Dev.
Email: raymond.niles@fda.hhs.gov
Stephen E. Pierson
FDA Regional Milk Specialist
Email: stephen.pierson@fda.hhs.gov
Steven T. Sims
FDA Milk Safety Branch
Email: steven.sims@fda.hhs.gov
Reprinted from Food Safety Magazine, October/November 2005, with Permission of the Publishers.
2005 © by the Target Group