Dairy HACCP - Evaluation of NCIMS HACCP Pilot Program Phase II Expansion (Appendix II: Listening Session Summary and Response)
NCIMS Dairy HACCP Regulatory Agency Listening Session
Discussion of Issues Raised
Southeast Regional Seminar - October 7, 2002
The comments of the regulatory agencies ranged from specific suggestions to more general, occasionally harder to define, concerns.
Be sure that the proposal documents are complete and made available as early as possible. For sure with the conference proposal so that they are all distributed with the proposals.
The committee agreed. NCIMS Proposal 316 includes these documents.
"Hands on training" in a HACCP milk plant preferably in small groups is critical to the uniformity of State and FDA auditors.
The Committee agreed. A recommended certification document was included with the proposal that specifies small group training as a part of the standardization process.
Be sure regulators, listing officers and FDA auditors are well trained (the USDA Meat program was cited as an example of how not to do things).
The committee has not used the USDA program as a model. The NCIMS HACCP Training committee will provide periodic and ongoing training and training opportunities if the conference delegates accept the proposal.
Provide negative as well as positive findings and objective analysis of our findings (there was concern raised about the initial public reports from the Evaluation Team that listed mostly positive findings and then the lack of a more complete public Evaluation Team Report at the 2001 NCIMS).
The committee agreed and the final NCIMS HACCP Committee Evaluation Team Report is a comprehensive document that includes recommendations as well as raw unedited information from state regulators, FDA Regional Milk Specialists and industry participants so the reader can reach their own conclusions.
Our seminar materials (NCIMS HACCP Symposium) should include Phase II and, where it is reasonable to do so, Phase I data summaries and observations. It is in this seminar data that I believe that we can, and should, respond to concerns identified in this document that we do not address in the proposal.
The committee agreed. The Evaluation Team's report will be available for review at the 2003 NCIMS Conference and much of the raw data has been divided into participants that were included in the Phase I & II pilot and those included only in the Phase II pilot.
If some questions remain unanswered, be honest and say so.
The Committee agrees and has followed that guidance. The opportunity to pilot the NCIMS HACCP program for four years and the extensive data gathering conducted by the Committee and Evaluation Team has reduced the number of questions that are unanswered so there is significant certainty regarding the implementation and operation of a voluntary alternative HACCP program within the NCIMS program.
Be sure State Dairy Program Directors know what they are getting into.
The Committee agreed and has modified the documents to make very clear the need for upper level regulatory commitment before a State elects to participate in this process.
Concerns and Recommendations Specific to the Pilot
Six-month audit frequencies were of concern. The issue was that States were feeling pressure to move to the six month audits when the State preferred to make audits more frequently.
The Committee agreed and has modified the HACCP proposal documents to clearly have the transition from a four month audit frequency to a six month audit frequency remain a decision of the state regulatory agency based on performance criteria applicable to the plant. (see Proposal 316, PMO Appendix K document.).
We need specific guidelines for repeat violations observed at regulatory inspections.
The Committee agreed and has modified the documents to make it clear that repeat violations under this HACCP system will be handled in the same manner as under the PMO, using the same authority and regulatory actions as under the current system.
Do not lose the construction and general sanitation aspects. (Regulatory personnel in both seafood and poultry HACCP programs stress the importance of not forgetting the sanitation aspects).
The Committee agreed and has modified the HACCP proposal documents to insure that dairy plant facility maintenance and cleanliness is a necessary part of any NCIMS HACCP program.
The current document does not make it easy for regulators to keep up with a milk plant that changes a lot. The Florida milk plant made 60 changes in 4 months. It took the regulator several days just to determine what had changed.
The Committee agreed and has modified the documents to require a centralized document control log. The HACCP pilot and the current proposal (316) to the 2003 Conference both require that the plant keep its HACCP written program documents up-to-date with the date of any changes recorded.
Do something to minimize the "nightmare" of cross-referencing changes from one product, prerequisite program, hazard analysis or monitoring record to all the others.
The committee agreed and the proposal (316) was modified to require better organization of the HACCP document to facilitate review by regulators.
The paperwork is unbelievable. This is made worse because records are not being maintained like they should. Still need to do a physical plant inspection. Find more during the physical inspection than what is found in the audit.
It is true that HACCP requires some additional paperwork from participating plants that has to be review by regulators during audits. However, the proposal was strengthened by including additional document controls. Also, the HACCP pilot training required the auditor to conduct a physical examination of the plant facilities to determine the effectiveness of the plant's HACCP program See questions #5.
Maintain the "three tiered" system (the routine regulator is not the listing officer).
The HACCP Committee, after piloting both a two tiered system and a three tiers system has decided to support a three tiered regulatory system and the current proposal (316) to the NCIMS Conference reflects support for the three tier system.
Provide more guidance as to what a failure is (a scoring system or other objective criteria) for regulatory, listing and FDA Check Auditing. The line between success and failure in HACCP pilot operations needs to be clarified.
The final proposal has been modified to include critical listing elements (CLEs) that provide more substance to define a HACCP system failure in a dairy plant.
Regulators are unsure of what to write on audit report. The plant complains if they write a lot.
It is clear to the HACCP Committee that additional training, as well as standardization of state regulators will be necessary to effectively regulate under a voluntary NCIMS HACCP program.
More technical guidance is needed in order to achieve uniformity. (How do you evaluate a plant under HACCP to assure consistency between the states)? The proposed Hazard guide and similar informational materials as well as national standardization of HACCP Listing Officers were seen as needed additions.
The Committee agreed and has included with the proposal, standardization recommendations aimed at achieving uniformity between states that participate in a voluntary NCIMS HACCP program. The Committee also recommends that the HACCP Committee's Technical Resource team be continued if the proposal is accepted to provide national interpretive guidance for the NCIMS HACCP program.
Unsolicited Positive Comment
- "The good thing of the HACCP program is that plants may accept and justify specific PMO applicable references."
(No suggestions for correction were identified during the listening session)
There is seen to be a lack of respect for current system and what it accomplishes (training lecturers and informal comments by HACCP Committee members were cited. Probing for more detail resulted in replays of conversations where individual HACCP Committee members were strongly defending the pilot).
The NCIMS HACCP Committee has always recognized that any voluntary HACCP alternative program will have to be built around the PMO as an excellent source of guidance. A number of the parts of the HACCP proposal are taken directly from the PMO. The HACCP Committee recognized that in order to implement an effective NCIMS HACCP program, it would have to go beyond the PMO and change the emphasis toward a more flexible food safety system.
Several other comments were variations on this theme. They include:
What is wrong with the current system?
The current system has proven to be a very effective food safety system to insure consumers are receiving safe and high quality dairy products. The voluntary HACCP alternative program to the current system has been developed to incorporate a different approach to achieving the same goal. This different approach does not replace the current system but adds an option for those plants and states that are interested in operating and regulating dairy plants under HACCP, a system that is recognized both domestically and internationally for many food products. This is another tool the states and industry have available for assuring the safety of milk and milk products.
There is a perception that HACCP is considered better even though it is not yet fully implemented and has not yet been proven (unspoken but clear anyway, this is seen as arrogant and, if the system turns out to be not as good, possibly dangerous).
The committee's charge was to develop and evaluate an alternative HACCP System under the NCIMS program that is at least equivalent to the current PMO-based system. WE believe we have done so. Our charge from the NCIMS delegates was not to evaluate whether HACCP was better than the traditional NCIMS system.
It is the traditional regulatory system that makes an industry HACCP system failsafe.
The traditional NCIMS system based on the PMO certainly has a very admirable record of producing safe dairy products. The NCIMS HACCP Committee has developed, from the Phase I and Phase II pilots, a HACCP regulatory system that achieves the same level of dairy product safety as the traditional system. This standalone feature of a voluntary NCIMS HACCP program is mandatory for it to be effective in the long run. See the NCIMS HACCP proposal (316), to identify the details of how the HACCP alternative achieves this, specifically the changes from the Phase I and II documents.
State officials can't see that a HACCP plant is any better than a plant regulated under the traditional system.
The NCIMS HACCP Committee built a regulatory HACCP system designed to be an equally effective alternative to the traditional system. It was not the Committee's focus to evaluate if HACCP was better than the traditional system. State official s who have participated in the HACCP pilot have found the HACCP System to be equivalent alternative to the traditional system, providing them with more information and a better understanding of plant operations.
Before you adopt HACCP be sure that it works as well as the traditional system. Once it's in place you will never get rid of it.
The purpose of piloting an NCIMS regulatory HACCP program has been to provide enough time to evaluate whether it works as well as the traditional system. The Evaluation Team report contains large amount of data that allow the reader to determine whether the NCIMS HACCP Committee has achieved this goal. The NCIMS HACCP Committee believes that proposal 316 is equivalent to the traditional system.
HACCP gives States an uneasy feeling.
The NCIMS HACCP Committee recognizes that the addition of a voluntary HACCP alternative to the traditional program may be challenging. The NCIMS HACCP Committee has spent four years in an effort to be sure a voluntary alternative to the traditional NCIMS program can achieve the same high standards as established by the traditional PMO-based program. See the Evaluation Team report, particularly the summary of questionnaires from participating states for insight into their experiences under a regulatory HACCP program.
States fear pressure from industry if a plant in their State wants to go HACCP even though the States do not have the resources to support that effort. States believe that the HACCP alternative will cost more time and money to get people trained and to get plants up and going and may well use more time long term in a time of rapidly disappearing State budgets. If no additional resources are provided, the drain to the voluntary HACCP alternative could negatively affect other programs they are responsible for. Even if States see the HACCP alternative as equivalent, this is an issue that will need to be addressed to gain their support.
The decision to participate in the voluntary HACCP alternative is completely up to the State (proposal 316) and the industry. Both parties must agree, otherwise the traditional system will be utilized to regulate Grade A dairy plants. This is clearly stated in the proposal.
At least one State felt, and did not like feeling, pressure to accept a HACCP pilot plant in their State. (Probing resulted in references to members of HACCP committee encouraging State participation in the pilot).
See the previous answer.
Several States expressed views that HACCP is a great QC program but makes poor regulatory program. They cited the Seafood HACCP programs in their southern states that they say are struggling. The consensus of States was that if milk fell to the health levels they see provided under the seafood HACCP program, it could result in a serious loss of public health protection (probing revealed that these folks are either administering or closely observing the seafood HACCP regulatory programs in their own states. This perception is a serious concern among the southern states. I believe that if unaddressed, this lack of confidence in regulatory HACCP will result in at least some serious public health officials in areas of the country with shared milk and seafood programs, such as in the south, opposing the NCIMS dairy HACCP).
The NCIMS HACCP program was developed over a four year period to work out the bugs and problems. The Committee began its efforts to develop an NCIMS HACCP program by researching a number of other regulatory HACCP programs including seafood, meat, and the Canadian dairy HACCP program. It was clear to the Committee that each of these programs had weaknesses that the current NCIMS HACCP proposal has avoided. The current NCIMS HACCP proposal (316) is not directly comparable to the Seafood HACCP system.
There has been a change for the worse in the relationship between the Milk plant and the regulatory since the pilot began. In the south, the relationship between regulators and milk plants has always been considered by the regulators to be a close one. The milk plant normally contacts the regulatory agency a lot as they consider changes. These contacts with regulatory were characterized as being as common as contacts from the plant to their own management. This was generally agreed to by all of the State regulators in the region. The regulatory agencies value and enjoy being in that type of consultative role. In Florida, under the pilot, this relationship abruptly stopped and the relationship between the plant and regulatory has not been what it was (probing for more detail resulted in information that the plant personnel had changed as HACCP was being initiated. The person selected to lead the new plant HACCP program was from a part of the industry where they did not seek out regulatory guidance and where the relationship with regulatory, while cordial was closer to adversarial).
Further probing of the above concern indicated another, possibly separate concern, that under the pilot the State regulator does not know the milk plant as well as they used to.
The Evaluation Team questionnaire data that was collected from state participants actually showed that relationships between plant and industry personnel generally improved during the pilot. The transition from the traditional NCIMS program to the HACCP pilot system results in a modification in the relationship between the state and plant personnel, demanding a more cooperative approach by both parties to make implementation of the NCIMS HACCP program successful.
There is apprehension that the traditional system is being set aside because of some "personal agendas". (Probing for more detail raised no current issues of substance but more of a harkening back to R#5 and some wording in a very old IDFA newsletter that was taken by them to mean that the purpose of HACCP was to better insulate industry from regulatory). Some on the HACCP Committee are perceived to be interested in getting HACCP accepted in order to gain some future consulting business or further some personal end .
The NCIMS HACCP Committee makeup is broad-based to gain input from a wide variety of viewpoints, including state regulators, FDA advisors and industry personnel. The piloting of a HACCP alternative over the last four years has resulted in a very solid foundation without excessive influence by any single group. The NCIMS HACCP Committee meetings were also open to all parties, including nonmembers as diverse opinions were considered and welcomed.
IDFA stopped providing hot lines and news letters to States after they began raising questions, see item above.
The Committee has received the following response from IDFA. "IDFA moved from a "Hot Line" system of distributing information to members and other interested parties to a weekly electronic newsletter and "Alert" system. In order to serve its members and reduce costs, the electronic newsletter and Alerts are distributed only to members. If there is enough interest from state and federal regulators, IDFA would revisit this decision to see whether the distribution of this material could be expanded.
There is no score in the IMS List. There should be no way to differentiate (on the IMS List) traditional from HACCP facilities since they are required to be equivalent.
Note, that with the adoption of proposals from the 2001 NCIMS Conference, plant rating scores are no longer published in the IMS List for the traditional system. An enforcement rating score is published for traditional plants, while under the voluntary HACCP alternative, there is no enforcement rating score. However, procedures to obtain correction of poor enforcement practices are including in proposal 316.
Some felt that the efforts of the NCIMS HACCP committee, and some of the Committee members, are perceived as being intended to promote HACCP rather that to determine objectively if it is effective.
The committee makeup was broad-based to gain input from diverse viewpoints. Diverse opinions were considered and welcomed. Committee members also had a wide variety of experiences with HACCP. The Evaluation Team was appointed to evaluate all data objectively to determine if the HACCP system was equivalent to the traditional system. See the answer to question #7.
How will HACCP equivalency be determined with other countries?
The NCIMS program, whether referring to the traditional PMO-based system or the proposed voluntary HACCP alternative, utilizes established methods to determine equivalency with foreign countries for imported Grade A products. The NCIMS HACCP proposal does not affect or change this equivalency process.
- Industry requirements for HACCP are promotional.
- They see HACCP as a requirement for global trade.
- They do not understand the benefits of the traditional system.
While the motivation for industry support of an NCIMS HACCP voluntary alternative is multi-faceted and not universal, it is very clear that the industry understands the traditional NCIMS system. The most prominent industry motivation for an NCIMS HACCP program is to reduce duplication since most dairy product buyers already require plants to have a HACCP system in place.
Some plants have expressed the desire to keep things the way they are. They have a plant HACCP program in place and want to continue to run on their terms.
The NCIMS HACCP Committee respected the reluctance of some states and dairy plants to participate in an NCIMS HACCP program so they designed a program that is a full voluntary alternative (proposal 316) to the traditional NCIMS program.
Is HACCP going to be required in the future to keep industry competitive?
Yes, the Evaluation Team found that HACCP is currently an industry requirement to do business with many customers.