U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 2, 2001

NCIMS HACCP Pilot Program Update

EXECUTIVE SUMMARY

The NCIMS HACCP Committee has been overseeing the implementation of the NCIMS HACCP Pilot program for dairy plants since the 1999 Conference. To date, the volunteer pilot plants and state regulators have shown that product manufactured under this program was as safe as under the traditional NCIMS PMO program. In addition, there was a strong feeling by state regulators that they understood the operation of the plant in more detail under the HACCP pilot and the industry personnel were more knowledgeable and better trained regarding their public health responsibilities. The result is that reciprocity between states for plants under the HACCP pilot has been maintained. For details of the HACCP pilot program, please refer to (http://www.cfsan.fda.gov/~lrd/haccp.html).

BACKGROUND

The 1997 National Conference on Interstate Milk Shipments (NCIMS) appointed a committee to address how a Hazard Analysis Critical Control Point (HACCP) system could be implemented, evaluated, monitored, and enforced under the NCIMS as a voluntary alternative to the traditional Inspection/Rating/ Check rating system.

The NCIMS HACCP Committee developed a pilot program for dairy processing plants and brought it to the 1999 NCIMS Conference where the voting delegates authorized the implementation of the voluntary program.

In July 1999, the HACCP Committee sent applications for participation to the pilot to all 50 states. Out of 16 applicants, six were chosen to represent a range of plant sizes, products, and FDA regions. The plants and states were selected with their signed commitment of resources devoted to the pilot program. The pilot plants and states which were selected are:

• Publix, Lakeland, FL
• Tropical Cheese, Perth Amboy, NJ
• Michigan Milk Producers Association, Ovid, MI
• Garelick Farms, Bangor, ME
• Safeway, Bellevue, WA
• Gossner Foods, Logan, UT

After FDA conducted a baseline sanitation rating of each facility, advisory visits with FDA and State regulators were performed, and then the pilot plants were audited and listed by the state agencies in early 2000. One plant was denied a HACCP listing at the time of its audit and, after making corrections, was subsequently listed by the state agency.

TRAINING

The NCIMS HACCP Committee and FDA’s State Training Branch conducted a HACCP training workshop in November 1999. All pilot plants, state regulatory agencies, and FDA Regional Milk Specialists involved in the pilot participated in this joint training session. The workshop focused on general HACCP principles, the pilot requirements, case studies, and auditing.

In addition, many state regulators, FDA Regional Milk Specialists, and industry representatives had the opportunity to attend the "HACCP: Applications in the Milk Industry" program held in May 2000 in St. Louis.

TECHNICAL RESOURCE TEAM

The HACCP Committee recognized that as the pilot program was implemented, questions about the pilot would need to be answered on an ongoing basis. To meet this need, the Committee established the Technical Resource Team (TRT). The TRT is composed of FDA, state, and industry representatives. Questions are usually submitted to the TRT via e-mail. The team then answers the questions and posts the answer on the NCIMS HACCP website (http://www.cfsan.fda.gov/~lrd/haccp.html). To date, the TRT has answered over 50 questions.

EVALUATION TEAM

The NCIMS HACCP Evaluation Team is composed of members from state regulatory, industry, FDA, and academia. The team conducted on-site evaluations of all six pilot sites during the summer and fall of 2000. The Evaluation Team found that:

• The level of food safety under the HACCP system was at least equivalent to the traditional system.
• The states have the capability to uniformly implement HACCP and provide for reciprocity between states.
• Additional time was needed to train plant personnel as well as state regulators.
• Resources required for the development, implementation, and verification of the plant’s HACCP system were greater than originally anticipated.
• The time spent on the initial audit was longer than the traditional inspection time.
• There was confusion about the relative difference between prerequisite programs, sanitation standard operating procedures, and critical control points.
• A "Hazards and Controls Guide" as well as models of HACCP plans and prerequisite programs should be developed.
• Auditing procedures need to be clarified and a standardization program in HACCP auditing needs to be developed.

The NCIMS HACCP Committee met for one week in January 2001 to study the evaluation team’s findings and revise the pilot program document.

PROPOSED EXTENSION AND EXPANSION OF THE NCIMS HACCP PILOT PROGRAM

Based on what we have learned from one year of operating under the voluntary NCIMS HACCP system, the HACCP Committee is updating the pilot program document and plans to submit it to the 2001 NCIMS Conference for the consideration of the voting delegates. The Committee will propose that the pilot program be extended to 2003 at which time the delegates will again have the opportunity to vote on the voluntary HACCP program. In addition, the HACCP Committee will ask the delegates at the 2001 NCIMS to consider our proposal to expand the pilot program to include other states and plants who would like to participate.

Hypertext updated by cjm 2001-FEB-14