SPEAKERS CONTENTS INSERTS
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IMPLEMENTATION OF THE HAZARD ANALYSIS CRITICAL CONTROL POINT SYSTEM
LIVESTOCK, DAIRY, AND POULTRY
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTH CONGRESS
MAY 20, 1998
Serial No. 10562
Printed for the use of the Committee on Agriculture
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COMMITTEE ON AGRICULTURE
ROBERT F. (BOB) SMITH, Oregon, Chairman
LARRY COMBEST, Texas,
BILL BARRETT, Nebraska
JOHN A. BOEHNER, Ohio
THOMAS W. EWING, Illinois
JOHN T. DOOLITTLE, California
BOB GOODLATTE, Virginia
RICHARD W. POMBO, California
CHARLES T. CANADY, Florida
NICK SMITH, Michigan
TERRY EVERETT, Alabama
FRANK D. LUCAS, Oklahoma
RON LEWIS, Kentucky
HELEN CHENOWETH, Idaho
JOHN N. HOSTETTLER, Indiana
ED BRYANT, Tennessee
MARK FOLEY, Florida
SAXBY CHAMBLISS, Georgia
RAY LaHOOD, Illinois
JO ANN EMERSON, Missouri
JERRY MORAN, Kansas
ROY BLOUNT, Missouri
Page 3 PREV PAGE TOP OF DOCCHARLES W. (CHIP) PICKERING, Mississippi
BOB SCHAFFER, Colorado
JOHN R. THUNE, South Dakota
WILLIAM L. JENKINS, Tennessee
JOHN COOKSEY, Louisiana
CHARLES W. STENHOLM, Texas,
Ranking Minority Member
GEORGE E. BROWN, Jr., California
GARY A. CONDIT, California
COLLIN C. PETERSON, Minnesota
CALVIN M. DOOLEY, California
EVA M. CLAYTON, North Carolina
DAVID MINGE, Minnesota
EARL F. HILLIARD, Alabama
EARL POMEROY, North Dakota
TIM HOLDEN, Pennsylvania
SCOTTY BAESLER, Kentucky
SANFORD D. BISHOP, Jr., Georgia
BENNIE G. THOMPSON, Mississippi
SAM FARR, California
JOHN ELIAS BALDACCI, Maine
MARION BERRY, Arkansas
VIRGIL H. GOODE, Jr., Virginia
MIKE McINTYRE, North Carolina
DEBBIE STABENOW, Michigan
Page 4 PREV PAGE TOP OF DOCBOB ETHERIDGE, North Carolina
CHRISTOPHER JOHN, Louisiana
JAY W. JOHNSON, Wisconsin
LEONARD L. BOSWELL, Iowa
PAUL UNGER, Majority Staff Director
DAVID G. DYE, Chief Counsel
STEPHEN HATERIUS, Minority Staff Director
Subcommittee on Livestock, Dairy, and Poultry
RICHARD W. POMBO, California, Chairman
JOHN A. BOEHNER, Ohio,
BOB GOODLATTE, Virginia
NICK SMITH, Michigan
FRANK D. LUCAS, Oklahoma
RON LEWIS, Kentucky
JOHN N. HOSTETTLER, Indiana
ROY BLOUNT, Missouri
CHARLES W. ''CHIP'' PICKERING, Mississippi
WILLIAM L. JENKINS, Tennessee
COLLIN C. PETERSON, Minnesota
EARL F. HILLIARD, Alabama
TIM HOLDEN, Pennsylvania
JAY W. JOHNSON, Wisconsin
Page 5 PREV PAGE TOP OF DOCCALVIN M. DOOLEY, California
SAM FARR, California
LEONARD L. BOSWELL, Iowa
C O N T E N T S
Barrett, Hon. Bill, a Representative in Congress from the State of Nebraska, opening statement
Peterson, Hon. Collin C., a Representative in Congress from the State of Minnesota, opening statement
Pombo, Hon. Richard W., a Representative in Congress from the State of California, opening statement
Smith, Hon. Robert F. (Bob), a Representative in Congress from the State of Oregon, prepared statement
Stenholm, Hon. Charles W., a Representative in Congress from the State of Texas, opening statement
Billy, Thomas J., Administrator, Food Safety and Inspection Service, U.S. Department of Agriculture
Harnage, Bobby L., national president, American Federation of Government Employees, AFL-CIO, statement
Page 6 PREV PAGE TOP OF DOC Lucas, Hon. Frank D., a Representative in Congress from the State of Oklahoma, submitted material
IMPLEMENTATION OF THE HAZARD ANALYSIS CRITICAL CONTROL POINT SYSTEM
WEDNESDAY, MAY 20, 1998
House of Representatives,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
The subcommittee met, pursuant to notice, at 1:10 p.m., in room 1300, Longworth House Office Building, Hon. Richard Pombo, (chairman of the subcommittee) presiding.
Present: Representatives Goodlatte, Smith of Michigan, Lucas, Lewis, Pickering, Peterson, Holden, Johnson, Condit, Dooley, Farr, Boswell, and Stenholm [ex officio].
Also present: Representative Barrett
Staff present: Pete Thomson, legislative director; Christopher D'Arcy, subcommittee staff director; John Goldberg, professional staff; Callista Bisek, assistant clerk; Mason Wiggins, and Danelle Farmer.
OPENING STATEMENT OF HON. RICHARD W. POMBO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA
Mr. POMBO. The meeting of the Subcommittee on Livestock, Dairy, and Poultry, to receive testimony on the implementation of the HACCP Inspection System by the U.S. Department of Agriculture.
Page 7 PREV PAGE TOP OF DOC Today's hearing will be the first of a number of hearings where this subcommittee will exercise its jurisdiction and oversight responsibilities with regard to the implementation of the HACCP Pathogen Reduction Rule for meat and poultry inspection.
Americans are truly blessed by having a food supply that leads the world in its abundance, variety, quality, affordability and safety. It is for that reason that American agriculture products are sought after worldwide and why our meat and poultry are recognized as the standard for quality and safety. Our continuing challenge is to make the best even better. Despite our high standards in food quality and safety, we can't be complacent.
We need to continue to find room for improvement, to be competitive in the global marketplace. It is in that spirit of continued improvement that the American meat industry, the Department of Agriculture, consumer groups, and scientific experts work together to produce the Pathogen Reduction Rule.
The purpose of this new rule was to create a better, safer, and more flexible and efficient meat inspection system. The hope was that the 90-year inspection system would be modernized for the health needs of the 21st century. Today hopes remain high, but there are some concerns as well. We are here this afternoon to address both.
Everyone who understands these issues wants to see HACCP succeed. I am looking to our witnesses for a progress report, to see how far we've come and how far we have yet to go. One area of concern focuses from the transition of the old system to the new one. What can be done about the layering of new regulations on top of old ones, especially when and where they conflict with each other.
There is also disappointment with the speed with which FSIS is moving on the regulatory review that Secretary Glickman promised Congress in July 1995. Nearly 3 years have passed and there appears to be little movement toward abolishing many fundamental pre-HACCP and some would say anti-HACCP regulations.
Page 8 PREV PAGE TOP OF DOC We need also to continue to focus on science as this rule becomes fully effective. HACCP is after a scientific approach to food safety. It is important that everyone involved in HACCP-based inspection or production systems understand the underlying scientific principles. There are concerns that few inspectors who were trained in the HACCP regulation were trained only at the last minute and without an in-depth instruction in the seven HACCP principles laid out by the Food Microbiology Advisory Committee.
And finally, we need to be concerned about the speedy resolution of conflict and disputes that naturally arrives from such major change in approach. We need to be able to resolve conflicts quickly and fairly and continue the business of safe, sound, quality food production.
I wish to welcome our panel here today and to thank them for their ongoing work with this subcommittee, industry, and all interested parties to make this rule work. Their willingness to roll up their sleeves and tackle many of these issues has produced results, and I hope these efforts will continue.
I'd like at this time to recognize the ranking member, Mr. Peterson.
OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MINNESOTA
Mr. PETERSON. Thank you, Mr. Chairman. First of all, I'd like to express my appreciation to you for holding this important oversight hearing. As you know, we are currently engaged in some of the most sweeping changes ever made in our meat and poultry inspection process, and I think this venture certainly deserves our full attention. We must continually watch the progress and the process of HACCP implementation while ensuring that our common goal is always an even safer food supply.
The implementation of such an enormous change in the meat and poultry inspection system is obviously a daunting task, and I am generally pleased with the progress to this point. Congress, consumers, the meat industry have all watched carefully, and I believe that almost everyone is cautiously optimistic.
Page 9 PREV PAGE TOP OF DOC In fact, there have been several bright spots, particularly I think in the area of communications. I have been pleased that the FSIS has continued to work intermittently with all the concerned interests.
In particular, I have been pleased with the agency's weekly meeting, where they've answered questions quickly and developed, I think, good communications. The agency's development of a toll-free technical center that provides 24-hour information has also ensured that plants have the information they need when they need it.
There are other, I think, positive aspects of the HACCP implementation. Most of these I think highlight the cooperation between the agency, the plant, inspectors, consumers, and the people involved, and I applaud these efforts.
But I must tell you that, as with any systematic change as large as this one there are certainly those areas that raise concern. From the start I have been concerned about the layering of regulation and the burden that this may place on improving the system.
Although I see some progress in regulatory reform, I think the progress has been slow and sporadic. In July 1995, Secretary Glickman wrote, ''I fully understand the importance of preventing bureaucratic layering,'' unquote. We were all encouraged by this approach, but continue to look for the results.
It is my hope that the agency will accelerate the elimination of unnecessary duplicating or unfounded regulations in time for the next very large wave of plants that are going to come on board with HACCP next January. It very much concerns me that we have a process with this volume of plants that we don't end up continuing to layer all these regulations.
I am also concerned about the agency's ability to adopt new technology and techniques that fit in with the HACCP model that would enhance food safety. I think, from what I have been able to tell, sometimes the bureaucracy is stopping us from getting to these new technologiessuch as steam vacuum use in beef or trisodium phosphate use in poultryare two examples of technology that took over a year to be adopted, to get through this process. And I just think that that is really not acceptable.
Page 10 PREV PAGE TOP OF DOC The result of the adoption of both of these examples has been dramatic reduction in pathogen numbers, and I would urge the agency to work harder to adopt a more effective and timely manner that we can get through this process to get these new technologies and techniques in place sooner rather than later so that we can further improve food safety.
And although, as I have mentioned, I have some concerns, I recognize the enormous task that we have before us, and I want to commend Mr. Billy and his staff for their efforts to date and encourage his continued cooperation as we move forward. And again, I want to thank him and staff to be here and the other witnesses for being with us today, and I look forward to the testimony and again, thank you, Mr. Chairman, for your leadership on this issue.
Mr. POMBO. Thank you.
Mr. Stenholm, did you have an opening statement that you wanted to make?
OPENING STATEMENT OF HON. CHARLES W. STENHOLM, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Mr. STENHOLM. Thank you, Mr. Chairman. I would like to make an opening statement today. I want to commend you for holding this hearing today on the implementation of the HACCP System. The implementation of HACCP will move our meat and poultry inspection system toward a more scientifically-sound system and offers the best vehicle for ensuring a safer food supply that gives consumers confidence of any other idea out there today.
This is a significant and vitally important change that will take the support of all interested parties to make it a success. I repeat it will take the support of all interested parties to make it a success. The USDA rule has several important elements that will help us to promote consumer confidence in our food supply. It targets critical control points in the production process that need to be controlled while continuing government oversight and inspection.
Because the public health goal of HACCP is to ensure that our food supply is as safe as possible, implementation decisions regarding HACCP must first and foremost be grounded through the use of the best science and public health policies available. Secretary Glickman and Administrator Billy are to be commended for the excellent leadership they are showing as we move our meat and poultry inspection system toward such a scientific foundation.
Page 11 PREV PAGE TOP OF DOC Much work, however, remains to be done. Regulation of this magnitude will cause some bumps in the road. What is important is how these issues are addressed when they arrive. I believe the weekly meetings the Food Safety and Inspection Service has held with industry folks has been instrumental in addressing several important issues which have arisen during implementation.
Several issues remain outstanding, and I am hopeful the following issues will soon be resolved: enhanced training and education for our inspectors, de-layering of unnecessary regulations and improved dispute resolution. Most importantly, we must ensure that HACCP is allowed to work as it is intended; and again, it must be a science-based inspection system.
HACCP is not a silver bullet for ensuring a 100 percent risk-free food supply. This is a goal which we will never be able to be achieve. Ensuring that science and technology play a leading in our meat and poultry inspection systems, however, will move us as close to that goal as humanly possible.
Again, Mr. Chairman, I thank you for holding this hearing today and look forward to hearing from the witnesses and working with you on this committee on a satisfactory resolution of the remaining obstacles.
Mr. POMBO. Thank you. I'd like to ask unanimous consent that Mr. Bill Barrett be allow to sit on the dais to participate in this hearing today. Hearing no objection, welcome.
OPENING STATEMENT OF HON. BILL BARRETT, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEBRASKA
Mr. BARRETT. Just to thank you, Mr. Chairman, for holding the hearing. I am delighted to see Mr. Billy as the lead and main witness today. Mr. Billy and I have had some interesting conversations in the recent past several month, inasmuch there were two very notable, serious food scares out in my State of Nebraska the past year.
Page 12 PREV PAGE TOP OF DOC One of the most difficult aspects I think in dealing with those situations was the public's lack of understanding, lack of knowledge about how meat and poultry inspections really work, and that became a very glaring thing to me as we went through that process.
I must say publicly that you and your staff were most helpful to me as we worked through the problem and tried to understand the intricacies of the recalls and the inspection procedures and how they work, and I thank you for that again.
But again, playing off the public's knowledge or lack of knowledge of the procedures, I think it's exacerbated by the emotional reporting that we had at that particular point in time, and you will recall that very well, and also a perception perhaps that the USDA doesn't really believe in its meat and poultry inspection system.
Sometimes I think it appears, as we came through that time at least, that the USDA inflates reports that Americans don't believe their food is safe in order to push perhaps a regulatory agenda. Now, I realize that the USDA supports food safety, but I also certainly hope that the USDA also supports producers and an industry which is so important, not only to my area, but other parts of the country, and that the USDA continues to be committed to fair regulations and open dialogue, and I think that's exactly what we are experiencing today.
So I welcome you and thank you, Mr. Chairman, for allowing me to be a part of it.
Mr. POMBO. Thank you for joining us today. All other members' statements will appear in the record.
[The prepared statement of Chairman Smith and Mr. Barrett follow:]
"The Official Committee record contains additional material here."
PREPARED STATEMENT OF HON. BILL BARRETT
Nebraska has been in the news over the past year because of several outbreaks of E. coli 0157:H7. It's been alleged the Food Safety and Inspection Service's HACCP regulation contributed to the outbreaks. While I don't believe that is the case, I want to thank Chairman Pombo for arranging this hearing so we can discuss FSIS's implementation of HACCP.
Page 13 PREV PAGE TOP OF DOC When Nebraska processing plants were involved in controlling E. coli contamination of ground meat, one of the biggest obstacles to me was the public's lack of understanding on FSIS procedures to ensure safe food and how HACCP works. This lack of knowledge was exacerbated by emotional reporting and the perception that USDA doesn't really believe in its meat and poultry inspection system. I intend to use this hearing to seek answers to how FSIS is educating the public about HACCP and to encourage USDA to be deliberate in its response to sensational news reports.
Unfortunately, it sometimes appears USDA inflates reports that Americans don't believe their food is safe in order to push a regulatory agenda. I realize USDA supports food safety. However, I certainly hope USDA also supports producers and the industry and is committed to fair regulation and open dialogue.
I challenge USDA to make clear its commitment to HACCP and our food safety systems. This doesn't mean I want USDA to hide the truth when something is wrong, but I want USDA to stop the doublespeak. Don't hide behind ''the public'' or ''public safety'' if USDA's actual goal is to impose a new regulatory system or influence public opinion.
As we all seek to meet the challenges of producing food in the 21st century, I believe that USDA, and especially FSIS, must take a leadership role in this debate. Politicizing food safety will do nothing in the long run to prevent illnesses or to improve our excellent food production system. I challenge USDA to rise above short-term political gains and to be a leader in food safety
Mr. POMBO.At this point I would like to welcome our panel: Mr. Billy has already been recognized; Dr. Mark Mina, Dr. Kaye Wachsmuth, and Ms. Pat Stolfa.
I wanted to get on the record, Mr. Billy, that in preparation for this hearing I met with industry groups, consumer groups, food safety groups, large and small alike; and every single one of them pointed you out for praise in the job that you are doing in trying to put this system together, and I think that that is a real feather in your cap, that people from all ends of the spectrum pointed you out specifically as doing a good job. Even if they did have complaints about procedures and process of how this is all being put together, they did point you out as doing what they felt was a good job in this. So you should be commended in that.
Page 14 PREV PAGE TOP OF DOC We have the first panel here so, Mr. Billy, if you're prepared, you may begin.
STATEMENT OF THOMAS J. BILLY, ADMINISTRATOR, FOOD SAFETY AND INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE; ACCOMPANIED BY MARK MINA, DEPUTY ADMINISTRATOR FOR FIELD OPERATIONS; KAYE WACHSMUTH, DEPUTY ADMINISTRATOR FOR PUBLIC HEALTH AND SCIENCE, AND PAT STOLFA, ASSISTANT DEPUTY ADMINISTRATOR FOR POLICY, PROGRAM DEVELOPMENT AND EVALUATION
Mr. BILLY. Thank you, Mr. Chairman. I very much appreciate your kind remarks. I also appreciate the opportunity to appear before you today to discuss the implementation of HACCP. My first thought in preparing my remarks for today's hearing was to jump right into the details of HACCP implementation.
However, I first would like to reflect on our excellent progress over the last 3 or 4 years and how important these changes are to industry, government and to the public as well. As you know, FSIS worked for quite some time to develop the modernized, science-based inspection system based on HACCP. Industry maintains very close working relationships with all interested parties: industry representatives, consumer groups, employee representatives and the scientific community.
The agency worked very hard to develop and maintain these relationships as we developed the final HACCP rules. As a matter of fact we held over 50 public meetings nationwide from publication to the proposed rule to the final rule, and our main goal was to afford everyone the opportunity to provide comments on how the meat and poultry inspection system should be modernized.
We know that the implementation of HACCP would require a significant change in the roles and the attitudes of both inspectors and industry. In the past some plants relied on inspectors to identify deficiencies before the company would take action to correct themthe so-called find-and-fix strategy or approach.
Page 15 PREV PAGE TOP OF DOC Implementation of HACCP clarifies the respective roles of industry and FSIS. Businesses that produce food are accountable for its safety. They need to look at all the likely hazards, ensure their systems address those problems, and take immediate action when the controls fail.
Today HACCP is in place in the largest meat and poultry plants, those with 500 or more employees. These large plants produce 75 percent of the raw meat and poultry and 45 percent of the processed products.
We have begun preparing for the second stage of HACCP implementation which will take effect in more than 3,000 small plants in January 1999. We'll will be working hard to provide assistance to make sure that these plants are prepared for HACCP implementation.
Based on the comments from our stakeholders, we are also refining our HACCP implementation strategy in six specific areas, and some of these areas were referred to in the opening comments from the committee. First, we've established a team of on-call experts managed from our Technical Services to help us make prompt decisions on complex scientific and technical issues regarding a plant's HACCP System.
For providing additional training for supervisory inspectors in systems concepts related to HACCP, we are expanding the cadre of FSIS HACCP experts to provide advice particularly targeted to small, very small plants.
We are improving notification to plants of findings that the plant's HACCP System is failing. We are specifying the steps in the appeal process that plants need to follow so that appeals can work effectively and resolve any disputes. And we are increasing the involvement of the National Advisory Committee on Microbiological Criteria for Foods in the development of additional guidelines to help us do a better job of making decisions in the scientific area.
As part of the HACCP rule we established performance standards for salmonella. Since HACCP implementation we have begun collecting compliance samples in the large plants that slaughter and or grind meat and poultry products.
Page 16 PREV PAGE TOP OF DOC I brought some charts with me to demonstrate what the data show. I thought this was important because as we get into thiseven though we have some very preliminary date, it's important to say, ''Well, what are you achieving? What are you seeing already?''
And so what I would like to do is submit these charts as part of my oral statement, Mr. Chairman, and explain them very briefly.
Now even though, as I said, the number of samples collected to date are very low, what's important is that we are seeing significant improvement already in the plants that are under HACCP, the large plants.
If you'll look at the two charts, the chart on the right is based on salmonella testing before HACCP was implemented. For 6 or more months we were out in the large plants collecting samples and analyzing the data. On the left, the salmonella prevalent from the baseline studies are, in effect, the performance standard that we expect to be met. If you look to the far right on that chart, the percent positive, you'll see that, for the different product classes, plants were right at or near the expected performance standards even prior to HACCP implementation.
More important, if you look at the chart on the right and look at the same numbers, you will see that in fact in most instances we've seen significant improvement. And I would call your attention in particular to the chicken carcasses, where we've seen the level go down more than half already in 3 months' time. And I think this is clear, early evidence of the hard work that industry is doing, using new technology to meet these performance standards.
Some of the data is very preliminary. It's based on limited resources. So we'll have more data to share with you as time passes, but I thought it was important to let you know that already we are seeing some real benefit in terms of food safety from the implementation of HACCP.
Page 17 PREV PAGE TOP OF DOC I also want to take this opportunity to say how pleased with the steps industry has taken to meet the food safety goals this administration has set. We have instituted a number of very complex changes, as you referred to, and HACCP is the most complex part of all those changes.
Right now we are learning a great deal from implementation of HACCP in the large plant, which will help us in implementing HACCP in the small and very small plants. Industry has stepped forward and accepted the challenge by developing new technologies in hazard control strategies for their HACCP plan.
Industry has risen to the occasion every time, and I commend them for that. I know they take pride in the fact that they are contributing positively to make meat and poultry safer.
I want to emphasize that, from our perspective, HACCP implementation is going well. I understand that there is continuing uneasiness about whether FSIS will return to the command and control approach, so I want to assure you that will not occur. There may be isolated instances where an inspector or a plant has not made the necessary cultural change, but we are dealing with each of those instances immediately and directly.
In closing, HACCP remains a work-in-progress that will need further fine-tuning in the weeks and months ahead. This is to be expected with such a complex revision in our inspection system. We are committed to working out any problems as they arise and to using a common sense approach to problem-solving. I am convinced that we can and we will do this successfully. Thank you very much.
[The prepared statement of Mr. Billy appears at the conclusion of the hearing.]
Mr. POMBO. Thank you very much. I'd like to start off by focusing, first of all, on the effort that is being made with the old system in place and the new system coming in. And one of the issues that this committee in the past has discussed with you was the concern about layering the new system underneath the old system and how difficult that is in just in the real world to actually put it in place.
Page 18 PREV PAGE TOP OF DOC And I'd like to know what efforts the Department is making at this time to stop that from continuing.
Mr. BILLY. Mr. Chairman, we are addressing that on several fronts. First, because of the comment we received on the rule in the proposal stage, we decided to phase-in HACCP over a 2- to 2 1/2- year period, and what that meant in terms of its impact on the program was: We would be operating two systems simultaneously during that phase-in period.
So the fact is, we have both the new system working in the large plants today, and the old system working in 6,000 plants throughout the country. As we continue to phase-in HACCP, the old system will gradually disappear, and we're approaching that in a way where that will be completely gone in early 2000.
To further address this, when we designed the inspection protocols that our inspectors would use, we did not take the old system which was built around the inspector carrying out certain tasksif they found a problem, asking the plant to fix it. And in our computer system for controlling the work of our inspectors we had over 500 such tasks.
Under HACCP we have changed those to procedures that are designed to evaluate the system. So it's just a total departure from how we have traditionally done inspection. In the large plants today our inspectors were trained and are carrying out procedures to evaluate the effectiveness of the HACCP System in place.
There are 49 such procedures, and with that strategy we believe that it creates a very clear delineation between the old system and the new system, and the evidence available to us for monitoring the role that our inspectors are carrying out under HACCP as well as the old system, and it seems to be working pretty well.
The third part of our strategy is to, in fact, modify our existing regulations, and several of the members have raised the issue of layering and concerns about conflicts between the old regs and the new regs. I need to say as clearly as I can that we are absolutely committed to reg reform. We are going to complete that process, but because of what I have already described where we have 6,000 plants under the old system, 300 under the new system, we need the existing regs to continue to work and apply as long as we have plants working under the old inspection approach.
Page 19 PREV PAGE TOP OF DOC So what we are trying to do is phase-in the regulatory changes in a manner and with the timing that is consistent with the phase-in of HACCP, and so that is the third part of our strategy.
Mr. POMBO. Let me follow up on this, Mr. Billy. Is it the Department policy, then, that plants that are operating under the new system are not regulated by the old regulations?
Mr. BILLY. They are required to meet the various performance standards that are in the regulations. We are completing the final rule on the complete revision of sanitation that takes what is there in terms ofI'll characterize command-and-control requirementsand turns them into performance standards.
So, we found a way in that example, the sanitation area, to complete the process of conversion from the old system to the new, but at this time for plants under HACCP and all other plants, they have to meet the regulatory requirements that are in the HACCP rule, the SSOP.
There are other regulatory requirements that are going to be phased-out, and we're in the process of doing that to that rule-making. So it's not as clean cut as, ''You don't do these. You do these.'' There are regulatory requirements in the old system that are being converted into performance standards or being eliminated, and we will complete that rulemaking later this summer.
Mr. POMBO. Mr. Peterson.
Mr. PETERSON. Thank you, Mr. Chairman.
Following up on that, you say you are going to complete that rulemaking later this summer. I guess what I would like to get a handle on is, can you give us a definite timeline or date certain as to when you would complete the regulatory review and when all these pre-HACCP rules that conflict with HACCP regulation will be removed? Can you give us a date certain, and if you can't give a timeline or a time certain, can you explain why you can't? You maybe already have done that a little bit.
Page 20 PREV PAGE TOP OF DOC Mr. BILLY. We have established a timeline for ourselves that is consistent with the phase-in of HACCP and expect to have completed the modification or elimination of all of the regulations that would conflict with HACCP or need to be changed in terms of making them more flexible in the science-based HACCP approach by January 2000, when HACCP is phased in, in the final set of plans.
I am not saying that every single regulation will have been finished by then, but all of them that have been identified as critical in terms of effectively implementing HACCP will have been completed by that deadline.
Mr. PETERSON. So in January 2000? So the small plants that are going to come online, the 3,500 plants coming online January of 1999 are going to have the same kind of problems that we experienced with the larger plants that have gone in place, but they are going to have to petition to try to get around these problems that are caused by the existing rules and all that.
I guess I have a real concern when these small plants come online that they don't have the kind of resources that the larger plants have, and there isn't anyway that you can get this done by the timeby January 1999?
Mr. BILLY. We've encouraged the industry in two regards to address this. One is we've asked the industry to look at our timeline and our priorities in terms of the sequence of making the rule changes, and they agreed to do that and will shortly be providing us that, their suggestions in terms of any changes to what we've identified.
Second, I've encouraged the industry to, in fact, petition us with proposed changes to the regulations. In other words, don't wait for us to figure out how we are going to change these. Instead, using the data and the information available to you, submit a petition that includes the proposed regulatory change and, through that process, we can accelerate the timing and the timeframe that we have.
Page 21 PREV PAGE TOP OF DOC And it looks to me like I think we're going to get a very positive response from the industry, and that will help us in terms of moving forward with that regulatory process.
Mr. PETERSON. So the way you envision them getting around to solving this is through the petition process?
Mr. BILLY. Yes, sir.
Mr. PETERSON. So I'd like to then extend this conversation to that, because I've been told that when plants have petitioned, that it gets in line with everything else and that this is not a swift process, that you end up kind of getting in the line with whatever else is being petitioned, which I am not sure exactly what that is.
But I guess my question is if that in fact is the solution, are you going to set up a separate place where these petitions can be sent where they will be a priority and where they will get out of this other line? And they'll get dealt with in a quick way because, as I am told, some of these petitions have taken a year to be processed; and that does not seem like a good way to resolve this. So are you going to do something there to speed this up?
Mr. BILLY. We've already taken one step, which is the senior managers in the agency meet every 3 months and reevaluate the priorities assigned to petitions, but we also are going to take advantage of the priorities identified by the response that the industry is going to provide us on their sense of what the priorities are, and we are prepared to shift emphasis in terms of responding to petitions that are consistent with those priorities to assure the smooth implementation of HACCP. So we will make adjustments and change priorities consistent with the input from the industry that we expect to receive shortly.
Mr. PETERSON. And that will then, I assume, significantly compress this timeframe?
Mr. BILLY. Yes, it will have a real impact because it controls what we are working on. So it will have a very direct impact.
Page 22 PREV PAGE TOP OF DOC Mr. PETERSON. If I might just one last thoughtin responding to our letter of May 1, you provided a list of regulatory review initiatives that are underway, but I think we'd still be interested in seeing what the status of these regulatory review activities are at the present time. I don't believe we've gotten a status report. Can you get us that, and how soon could we get it?
Mr. BILLY. In fact, I have it with me and I'll provide it to the committee and for the record.
[The information appears at the conclusion of the hearing.]
Mr. PETERSON. Thank you, Mr. Chairman.
Mr. POMBO. Mr. Goodlatte.
Mr. GOODLATTE. Thank you, Mr. Chairman. I thank you also for holding these hearings on this important subject.
Mr. Billy, welcome. We met first, I think, last year at the Egg and Poultry Convention in Atlanta, and we are glad to have you with us today.
You say in your response to the May 1 letter that you issued a new appeals policy notice on April 20. Part of that notice established an inspection appeal tracking system. Now that this system is in place, can you tell the committee how many appeals currently are in the system and the average length of time it has taken to resolve appeals submitted in the last month?
Mr. BILLY. I am sorry, I don't have that information with me, but I would be happy to provide it for the record.
Mr. GOODLATTE. Would you be able to get it to us today by any chance?
Mr. BILLY. I don't know the answer to that.
Mr. MINA. We might be able to get it for you tomorrow. Today would be a little bit difficult.
Page 23 PREV PAGE TOP OF DOC Mr. GOODLATTE. If you could provide it to my office and to the committee as soon as possible, I would very much appreciate it. But you do think you can provide it within a day, is that what you're
Mr. MINA. Yes.
Mr. GOODLATTE. I think you are to be commended for forming the Technical Advisory Group; however, it appears that only FSIS will be able to access this group to resolve disputes over half the planned and other food safety issues. Is this accurate? Is this to be a resource to the agency only?
Mr. MINA. Yes.
Mr. BILLY. Our plan in establishing that expert advisory group was to draw on the expertise and some of the time of our experts in various parts of the agency to help our inspectors and our field managers carry out their responsibilities in a HACCP environment, and we don't have the capacity, to be honest, to offer that to the industry as well.
Mr. GOODLATTE. Why is that? Wouldn't it be useful for the industry to be able to utilize that resource?
Mr. BILLY. I think it would if we had the capacity, but with the limitations in terms of number of people and the time available, our best judgment is we need that capacity to handle our direct needs to operate our responsibilities.
Mr. GOODLATTE. What would need to be done to work toward making that also available directly to industry?
Mr. BILLY. We would need to be able to probably go outside the agency and have the resources to enter into some arrangement with other experts that are available to draw on that expertise to help if you were to expand it.
Those same experts, incidentally, are available to industry now in the form of consultants, extension people at the land grant universities, State inspection personnel. So there's resources available to the industry directly at the present time.
Page 24 PREV PAGE TOP OF DOC Mr. GOODLATTE. Let me ask you in that regard, because as you know you can consult outside experts: If the industry were to form its own advisory group comprised of academically-credentialed, third-party experts for its own use, would the Technical Advisory Group be able to use these experts as an outside resource?
Mr. BILLY. I'd want to take a look at that and see how that was set up and how it would function. I wouldn't reject that idea out of hand. I'd be willing to look at it for sure.
Mr. GOODLATTE. Would you work with the committee and let us know how your thought process evolves on that because I would like to see that pursued?
Mr. BILLY. Yes, we do have in effect that kind of capacity now. It's represented by the National Micro Committee. So there is already established a framework there for getting that kind of advice.
To be frank, the problem we have is with the overall limitations on the amount of money that the Department can spend on advisory groups. We're limited in how often we can use that expertise. That's another concern in terms of the type of advisory committee you are talking about. We would have to take a very close look at how just such a committee as you suggested is set up in the context of the Advisory Committee Act and restrictions there.
So I don't want to make it sound too negative. I just want to make it clear that this isn't a simple matter. It would have to be looked at very closely.
Mr. GOODLATTE. Sure. Well, we would welcome your looking at it very closely, and if additional resources are needed to accomplish it, we're interested in that, but we also think that access to this kind of information would be useful and actually may be a very cost effective way of getting good information.
Thank you, Mr. Chairman.
Mr. POMBO. Mr. Stenholm.
Page 25 PREV PAGE TOP OF DOC Mr. STENHOLM. Thank you, Mr. Chairman.
Mr. Billy, I assume that you've had an opportunity to review the testimony submitted by the American Federation of Government Employees.
Mr. BILLY. Yes, I have.
Mr. STENHOLM. How would you respond to this testimony?
Mr. BILLY. I am disappointed in the testimony submitted by the American Federation of Government Employees on behalf of the leadership of the National Joint Council who represent meat and poultry inspectors. In my view, this statement seriously misstates both the intent and the actions taken by the Food Safety and Inspection Service in implementing the Pathogen Reduction Hazard Analysis Critical Control Point Rule.
Stating that HACCP is a ''honor system'' is an insult to the many fine rank-and-file inspectors who are on the front lines daily, ensuring meat and poultry plants are producing safe food for consumers. I do not believe that any of our inspectors would abrogate that responsibility to permit contaminated meat to ''find its way to your dinner table'' as the AFGE charges.
HACCP does represent a huge cultural change. HACCP requires industry to share in a new way the responsibility for producing safe meat and poultry, by meeting scientific performance standards established by FSIS. The role of the inspector is to ensure industry meet that responsibility. An inspector cannot be everywhere in a plant all at once, which is why HACCP requires extensive record keeping by industry.
The proposed HACCP pilots will permit FSIS to explore improved methods for inspectors to ensure that plants are meeting their food safety responsibilities. It will provide us with quantitative and qualitative scientific data on the effectiveness of these change procedures or methods.
Our goal is to protect consumers, and we will never approve any inspection method that does not meet that goal.
Page 26 PREV PAGE TOP OF DOC Mr. STENHOLM. Mr. Billy, in your response in the letter that was sent to you on May 1I commend you and thank you for your very thorough method in which you answered the questions. You state in that that FSIS needed to structure the final rule regarding HACCP plans to ensure that the industry would understand clearly what is required, and I certainly agree with that response.
However, I would like to know what you did to ensure that the inspectors would have the same clear level of understanding which apparently they do not, as a result of the testimony that they have submitted today.
Mr. BILLY. I think that the training program that we designed and provided to our inspectors, particularly the inspectors now carrying out HACCP procedures as we speak in the large plants, is very effective in terms of explaining to the inspectors the role that they're required or expected to play.
There is a difference between that role, making sure through observations, through sample collection, through records review, that HACCP is working effectively on a day-to-day basis, and the concerns raised by the union in terms of how we carry out our responsibilities online, on a slaughter line, in a slaughter plant; and that is the subject of the pilots that we have announced and we will be pursuing.
I think what you have here is a difference of view in terms of the ability of taking advantage of new technology and new procedures to accomplish the same consumer protection, but in a way that's more effective in terms of the utilization of our resources.
There are many food safety tasks that we presently aren't addressing beyond the slaughter in the processing plants, in distribution, at retail; and I believe that we could do a better job of our overall goal of improving the safety of meat and poultry products if we could redeploy some of our resources from the slaughter line to these other areas; and the pilots are designed to develop the scientific basis to show that in fact that's possible and convince all of the stakeholders that it's the right thing to do.
Page 27 PREV PAGE TOP OF DOC Change is hard, and some people like to resist or feel they should resist that kind of change. I think it's the right thing to do for the American public.
Mr. STENHOLM. Mr. Chairman, if I could be permitted 1 additional minute to observeI had the privilege of chairing this subcommittee in the early 1980s. The first time I saw a chart like this was in 1985. That was when we first started talking about the HACCP system and we first saw what good science could do to improving the safety of our meat and poultry supply.
I am very pleased to say that most, if not all, consumer groups today understand what this system can do if it's allowed to proceed as you are attempting to lead it, Mr. Billy, and I hope that somehow some way your statement today and your last answer to the question, that we will be able to get all parties to begin to roll up their sleeves and to recognize if we truly want a safer meat supply, we can do it through the HACCP system.
It will work. Good science will provide a safer food supply, guaranteed to consumers; nothing else will. But we've got a little ways to go, and, Mr. Chairman, I appreciate your direction on this and look forward to working with you.
Mr. POMBO. Thank you.
Mr. LUCAS. Thank you, Mr. Chairman.
Mr. Billy, not to belabor the point, but, nonetheless, to raise the point of concern brought to my attention by the folks back home, the Secretary's letter to my colleaguesour colleagues, I should sayfrom 3 years ago, pointing out that the FSIS would soon publish the comprehensive set of rulemaking notices to review FSIS regs and directives and policy notices and policy memorandums, that letter, that line is a bone of real contention back home with what I would define as medium-and small-sized plants because they look at how long and the process you've gone through to put these rules and regs together. And there's some real concern out there about how they will be impacted as they come on the line, and not just the plants, but the producers who produced the product that is processed through those plants.
Page 28 PREV PAGE TOP OF DOC So I listened with great intensity to your responses to my colleague's earlier questions and comments about the timeline. From your perspective, I guess my first question is: How concerned should my medium-sized people out there be, and what kind of an environment are they going to find themselves in and how you see this unfolding?
Mr. BILLY. One thing that might help clarify the change that's underway and provide some comfort to the people you are referring to, we have the established regulations. We have the longstanding regulations, the new regulations for HACCP and pathogen reduction. Once the regulations are in place, be they old or new, we then implement those regulations with directives, and the directives provide specific instruction to the inspectors on how they're to carry out their requirements or their procedures in a plant.
For plants under HACCP, most of the longstanding directives no longer apply. Though while there may be a regulation sitting there on the books, what is in fact done by the inspector is based on new regulations that are designed to implement HACCP, though it's not just a simple matter of old regulations sitting there and new.
At the same time, for the 6,000 plants still under the old system, the old directives apply, and they are being followed. So, it's more than just the regulations sitting there. It's how we have managed to differentiate between what inspectors will do under a HACCP approach and the traditional approach. And we've been very concerned about that difference, and Mark, Mr. Mina, and his staff have been watching very closely to see that the training we've provided and the different procedures are working as they were intended to work. And they're working pretty well.
We've got a 92 percent positive compliance with the new regulations based on the directives that apply to them. So I think the people you are referring to should take some comfort in how that's working already, and it will get better and better as we gain more experience, and by January of next year I think we will have virtually all of the bugs worked out of it so that it should be a pretty smooth transition for those small plants.
Page 29 PREV PAGE TOP OF DOC Mr. LUCAS. But you do appreciate the concern
Mr. BILLY. I sure do.
Mr. LUCAS [continuing]. Some might even say ''torment'' in some situations that these folks are going through, until this comprehensive process is done? I mean, they are caught in a never-never land, and they're an important part of the processing industry out there that has a huge impact on my day-to-day producers.
If I could change vein for just a moment, Mr. Chairman, and I ask by unanimous consent, I would like to submit a report for the record and follow with a question to the gentleman in that regard.
Mr. POMBO. Certainly.
[The information appears at the conclusion of the hearing.]
Mr. LUCAS. Thank you, Mr. Chairman.
In a report soon to be released by a nonprofit group, Resources for Future, there's some serious questions raised regarding of course both the cost and the benefits of mega-reg. If we assume that the order of magnitude of difference as concluded by this group proves accurate, and that's why I am submitting the report to the record, what percentageor maybe this is a good general question, Mr. Billywhat percentage of the smaller and very small plants do you think potentially will survive the implementation?
Mr. BILLY. To be fair, I, too, just received that report in the last 24 hours. I tried to read it last night. It's a fairly complicated economic model that has been applied, and I decided I'm not qualified to make any judgments about the model and the results. So I am going to forward it to our Economic Research Service and have them look at it and give me feedback in terms of what that report concludes.
I would be concerned if there were huge, significantly higher costs than what we anticipated in terms of HACCP implementation. We're doing a lot now in terms of our small plant project to mitigate the costs that were reflected in our original cost benefit analyses. We're providing technology to small and very small plants; we're assisting them in terms of HACCP orientation, software; we've developed new guidelines that help them step by step develop their HACCP planall of which were reflected as costs that they would bear to accomplish those things, and we're actively involved in that process. But we are going to look at that report and do an analysis.
Page 30 PREV PAGE TOP OF DOC I'd like to also call your attention to other reports, both done by the Economic Research Service. One was done last July. It's entitled, ''An Economic Assessment of Food Safety Regulations: The New Approach to Meat and Poultry Inspection,'' which did a review of the other side of the equation, the benefits side, in terms of illness and death, and reflects significant upward adjustment of the benefit that will be derived from improving the safety of meat and poultry products; and a second report that also was done by the Economic Research Service that looks at the secondary effects of food-borne illnesses as it relates to meat and poultry. I'd like to request that both of these reports as well be put into the record.
[The information appears at the conclusion of the hearing.]
Mr. LUCAS. If the chairman will indulge me, do those reports reflect the concept of a layered or an unlayered inspection system, Mr. Billy?
Mr. BILLY. Both of these reports are based on anticipating the benefits of a HACCP-based inspection system.
Mr. LUCAS. Thank you, Mr. Billy. Thank you, Mr. Chairman.
Mr. POMBO. Mr. Dooley.
Mr. DOOLEY. Thank you, Mr. Chairman.
And, Mr. Billy, I want to compliment you and the entire team for the efforts you've made to implement this, and I think really, if anything should be a validation of moving to the HACCP system, it certainly is the information that you have provided there which shows a significant reduction in the post implementation with the HACCP that certainly deals with salmonella.
Just to reiterate some of the concerns is that some of us felt pretty strongly that the adoption of the HACCP approach was one which we are going to be focusing really on the outcomes, because it is the outcome that is important in terms of the relative safety and wholesomeness of the product to the consumer. And your data there certainly shows that this is achieving that results.
Page 31 PREV PAGE TOP OF DOC I guess what I am still having difficulty understanding is that in the construction of a HACCP plan for a plant, that a plant might be presenting, is that there is still, then, the two layers, that they still have to comply with the pre-HACCP protocols or it will be out of compliance, regardless if they can demonstrate scientifically that it will have a reduction in maybe salmonella-positive plate counts?
Mr. BILLY. I think what you're getting at, as an example, would be requirements in the current regulation that establish a specific temperature, for example, that a cooked product would need to be cooked to or that a raw product would have to be chilled to, within a certain timeframe.
We do have those kinds of regulations. You'll see in the material that we submitted that we have specifically targeted those regulations for either elimination or modification. What we've said to industry in either of those instances is, if they have data, either from the literature or from their experience in that plant, that would show that an alternative procedure could be used and provide equal safety in terms of the outcome and approach us to either use that in a pilot setting, show that it will work, or petition us to formally change that and give us the raw material we need to accomplish such a regulatory change.
We encourage that. We want to see those kinds of changes, but there are instances, and in the areas that I've mentioned where at the present time a plant is required to meet the longstanding temperature chilling requirement or the cooking requirement until we complete this regulatory reform process.
Mr. DOOLEY. I guess, then, that what we're saying is, the only way that you can come up and implement maybe a new technology or a new process, which you can demonstrate on by a scientific basis that it is going to enhance the quality of that product to the consumerthe only way that an industry can implement that is by petitioning the Department through the regulatory, rulemaking processing to change a pre-HACCP rule?
Page 32 PREV PAGE TOP OF DOC Mr. BILLY. Or to propose that they be allowed to carry out a pilot where they would actually demonstrate that that alternative approach was working, and we have under the current regulation the authority to waive established regulatory requirements for purposes of carrying out a pilot that allows for a different type of strategy. And we have a number of pilots underway now, and the pilot, once approved, a pilot can continue until the regulation is ultimately changed.
Mr. DOOLEY. So, just to elaborate a little more on this, it's like on a chill bath for poultry where you are supposed to lower the carcass 8 hours of 40 degrees. Now when that was adopted back in 1960 or whenever, was that something that was adopted based on a science basis?
Mr. BILLY. Yes.
Mr. DOOLEY. And so, if you can come up with an alternative to that which demonstrates that you can provide another means of getting even at a better wholesome product and you provide the science, the only way you can do that now is you could put a HACCP program together that had this alternative and then make a request that USDA accepts this as a pilot program?
Mr. BILLY. Yes.
Mr. DOOLEY. And what would be then the process that the Department would utilize to determine whether or not they would accept this waiver?
Mr. BILLY. We have a staff that is dedicated to looking at those kinds of requests. They would review it. If it's acceptable, we would inform the company, and the pilot would start.
Mr. DOOLEY. Should I waive
Mr. PETERSON. Mr. Chairman, if I might
Mr. POMBO. Unanimous consent to be given an additional minute.
Page 33 PREV PAGE TOP OF DOC Mr. PETERSON. Well, just following up on that, I mean, I've got information on this situation. Maybe I don't understand it, but, as I was told, the FSIS Technical Service Center on January 22 indicated that a variance of this regulation on this very 40 degree deal would be acceptable. And so the poultry companies went out and got the literature, and whatever, and came up with an alternative method of getting to the same point because they're doing the process different and splitting the birds up, and whatever; and that then the FSIS rejected the alternative time temperature standard, citing pre-HACCP regulations still on the books requiring the 40 degrees specified amount of time.
So you canceledI mean they went through this process and you said that you can't do this because the regulation is on the books. So I guess I don't understand what this process is.
Mr. BILLY. The Technical Center, unfortunately, was not clear in terms of making those that they were talking to understand that when there's an existing regulatory requirement, the mechanism that's available to achieve what the Technical Center talked about needs to be this process that I've just described.
Mr. PETERSON. They didn't understand that at that time?
Mr. BILLY. Well, they didn't make it clear. I don't know if
Mr. PETERSON. So the industry was not told that you've got to petition or you've got to ask for a pilot program, or what happened?
Mr. BILLY. I don't know the answer to that. I am sorry. The industry people or the Tech CenterI could find out, but I don't know the answer.
In a follow-up meeting we did make it very clear that there is a mechanism that allows for this to occur and what that mechanism is and what information would be required. It's my impression that the concerned industry is in the process of putting forward such a approach that we are prepared to deal with in a very expeditious manner.
Page 34 PREV PAGE TOP OF DOC Mr. DOOLEY. So has USDA at this point issued any waivers of this type for a pilot program with a HACCP plan submission?
Mr. BILLY. One is the experiments, the pilots that are underway involving trisodium phosphate use online in the slaughter operation, and there's quite a number of plants that are able to use that, and that's in your words sort a waiver to accomplish that kind of thing.
Mr. DOOLEY. So if someone wanted
Mr. BILLY. And there are many others in the past where weoften the change that's come about is through that kind of a mechanism, and I think it works pretty well and can form the basis then for the regulatory change as well because you have then the scientific data and justification to change, formally change, the regulation so it pieces together in a very nice way to accomplish the change.
Mr. PETERSON. But it took a year to get this trisodium waiver, or whatever happened, and I don't think that's the same issue as this 40-degree issue. So I still don't think that we're getting the answer here, but I guess if this industry has been told of this, and you told me earlier you're going to have some new, fast-track petition process, how long is it going to take them to get something like this resolved? Is it going to be another year? Is it going to be like 2 weeks?
Mr. BILLY. No, I think it can happen quite quickly if
Mr. PETERSON. What does that mean? A month or two?
Mr. BILLY. I think it can certainly happen in a month or two. What has to happen is that we have to receive a proposal that addresses a number of areas that we've laid out in terms of guidelines that are available how to do this, and the company or companies need to spell out the protocol they're going to follow, the data they're going to collect, and do that in a way where we can then review it both scientifically as well as if necessary consult with the union, which we are obligated to do if it affects their job. If it in any way changes their job that is defined, then there is a review period where we consult with them that takes up to 20 days. So that is part of the process that we have.
Page 35 PREV PAGE TOP OF DOC Mr. POMBO. Mr. Pickering.
Mr. PICKERING. Thank you, Mr. Chairman. I know we have a vote and so I'll be very quick.
As you may know, in Mississippi, especially my district, poultry processing is extremely important. In my district it's the largest single segment of our economy, and so the quick implementation of HACCP and the effective training is critical to what we are trying to do and accomplish.
So let me just ask a couple of questions to that end. Do you allow the National Joint Council to review food safety rules for up to 20 days, and does that rule specificallyif that rule does not specifically impact inspector's jobs?
Mr. BILLY. We, consistent with the executive order that established the partnership strategy in the administration, we have worked hard to provide an opportunity for the National Joint Council to be part of the process of developing new strategies for HACCP and other changes. However, when it comes time to publish a specific regulatory proposal, then the union becomes an interested party, just like everyone else, and is treated as such.
When you said rules or regulations, once we trigger the regulatory proposal process they have an opportunity to comment like anyone else. If we're proposing to change their job, what they're expected to do, then we do, under the existing labor-management agreement, provide them up to 20 days to review what we're proposing to do and provide any input.
That's an obligation consistent with the Civil Service Reform Act requirements in terms of how management will work with the union with things that affect their job.
Mr. PICKERING. In light of the inspectors' lawsuit, do you believe the NJC's still support HACCP?
Page 36 PREV PAGE TOP OF DOC Mr. BILLY. I think you'd best ask the NJC what they support. I do know that we have posted 2,000 inspectors involved in HACCP implementation, as we speak, that seem to understand it. They seem to be following the procedures, and I am getting an awful lot of feedback that they like the new approach and it's making a difference in terms of food safety. So the NJC is a union, an entity, and I think you best ask that union what they think about it.
Mr. PICKERING. One final question is: If their lawsuit is successful, will Congress have to amend the inspection laws before HACCP can move forward?
Mr. BILLY. Given the fact that we're currently developing our response to their suit, I'd like to be provided some time to complete that process, and we will share with the committee the Department's response as soon as it's available.
Mr. PICKERING. Thank you, Mr. Chairman. I have some additional questions. I'd like to ask unanimous consent to submit those for your review and answer as quickly as possible.
Mr. POMBO. The record will be held open for additional questions by members. We have a series of four votes on the floor.
Mr. POMBO. Mr. Farr.
Mr. FARR. Well, first of all, I want to thank you very much. Thank you, Mr. Chairman. I'm really on the mega-issue rather than the micros they've been talking about. I think you are going to move into the forefront of everything that's going on in America because food safety is the issue. I mean, in Europe right now the Secretary's there and it's all regarded to food, health issues. The French aren't going to sign stuff, and I'm in an area where we met with farmers last Friday where they're all concerned because it's a row crop area and knowing that this is moving.
And the question really gets, is that we get into this risk issue we're alsohow are we doing to balance between the need for America to always be at the cutting edge? In California in the central coast we used to take things out of the field and go to a shed and process them in the shed. Now we are picking them in the field, putting them in the bag, and sending them right to the market. And people assume that everything that's in a bag is clean.
Page 37 PREV PAGE TOP OF DOC How is your industry going to goin the future how are we going to do this with a shifting workplace? You are not going to be able to have the kind of traditional inspections, and yet if you insist that you have those inspections you are going to kill the very adventure or new technology that America is on.
So I was at this meeting last week and the banks were there, and the insurance companies were there, and the financial market is going to start investing where you are, or depending on where you are. They are not going to give the loans unless there's the assurance that it's going to move more into a process that takes care of itself, where government isn't going to be the final arbitrator. It's going to be, franklyand so I am really interested in that. And how do you do that?
And also what's missing from this debate is the local participation. Some of our States are becoming more sophisticated than the Federal Government, particularly California, where all the pressure is on pesticide management and farm labor practices and health and risk scare, and they have local inspectors; they have State inspectors, and it seems they're not at the table with the Federal folks.
And so, could you justI probably don't have the time to get your response, and we'll go and vote, and I'd like to come back and get the response. What I'd like to hear is, where do we go from here in moving this technology because I think the HACCP approachyou're right, the science is good. You have a great background. You've done it in the seafood industry. Nobody ever thought we could do it there, and we're going to move into other areas, and how do we make sure as we move we don't scare the hell out of everybody and disrupt markets?
Mr. BILLY. I wait anxiously to respond. [Laughter.]
Mr.POMBO. I am going to give you some time to think about it. The committee will temporarily recess.
Page 38 PREV PAGE TOP OF DOC [Recess.]
Mr. POMBO. I'm going to call the hearing back to order, and I am sure that if you have a short version of your question that you could re-ask so that they could answer, it would be appreciated. Mr. Farr is recognized.
Mr. FARR. The question essentially goes to: What assurances are we going to have as we move into new technology and new fresh-to-market and the fresh-to-market is the closest to the spot. I think you are covering meat and poultry, but you are going to be moving in with this whole food safety issues into other kinds of crops. How are we going to alleviate the fear, promote the best technologies available, because that is an American skill, and also assure that the lending institution, because if there's uncertainty here we are going to find that farmers aren't going to get loans or processors aren't going to get insurance, and so I think we need to make sure that what we are doing here is solid, sound, and, frankly, user-friendly in a different sense and not just caving into what the users want, but in teaching and getting people together and assuring them. And the other part of the question is assuring that State and local officials will be at the table as well. Can you respond to those concerns?
Mr. BILLY. I sure will. I'll use the meat and poultry area as an example. I think it has broader application. The foundation for dealing with food safety problems from the farm to the table is science and technologyscience to understand the problem, why they are occurring, and then the appropriate technology to deal with them, and it doesn't matter at what level. That's the foundation.
So it seems to me one of the very important ingredients, then, is the research to develop that kind of understanding and develop the appropriate technology.
Next, I believe that in the meat and poultry area we have been very well served by the quality assurance programs that the producer community has put in place. Probably the best example and the most successful example is what the producer community was able to achieve in terms of dealing with pesticide residue and other residue. It is a huge success.
Page 39 PREV PAGE TOP OF DOC If you looked at the picture 10 or 15 years ago and where we are today, it is very clear to anyone that what happened there was that the producer community, using science and technology, developed a strategy to produce animals that did not have those kinds of problems, and it's been very successful. And I think that strategy of looking to the producer community itself and working with the producer community will pay big dividends in terms of dealing with the problem areas you are talking about.
Then I think the final thing is it's about cooperation and communication. The only way you are going to really achieve progress is by everybody working together. This has to happen. You need to find a mechanism for that to happen. We've worked real hard at that. As an agency, we are taking a totally different approach than we did 5 or 10 years agoin a very public, open process to get people talking to each other and really then find an ultimate solution to the problem we are trying to address.
Mr. FARR. Is the authorization mainly for meat and poultry, eggs and seafood, or do you have authorization to go into every other aspect of agriculture?
Mr. BILLY. We are very limited to meat and poultry and egg products by statute. That's where we focus. So FSIS as an agency does not address fruits and vegetables or other.
Mr. FARR. But you do fisheries?
Mr. BILLY. No, FDA does seafood. I spent 4 years there, almost 4 years a while back. I was instrumental in helping that agency to develop its HACCP strategy and procedures. It was the same strategy I just laid out.
Mr. FARR. In light of that, my concern and I think members of this committee is we usually get the crisis when somebody bumps up against the regulation and has had an impact on them, and then we turn and find out that we have all these different Federal agencies that we've got to deal with.
Page 40 PREV PAGE TOP OF DOC It seems to me that we ought to be much moreand I've been saying this to everybody that comes before this committeethat we in the Federal Government ought to be much better at having collaborative efforts among various departments because you've got the Commerce Department and the Agriculture Department and the Health Department all involved in these issues, and each one of them has their own jurisdictional authority, but when there's a problem they've got to all be there.
And we don't do a very good job of pulling together kind of the FEMA disaster, quick response, as we do in other areas, and I think we've got to do that, and you are taking the lead in inspection area, and I think your knowledge and experience ought to be shared with, how do we approach these protocols in a better way?
Mr. POMBO. Mr. Billy, in terms of the science, one of the questions that I have is that we've spent a lot of time in the past several years talking about peer review and having outside scientific panels review the science that's being done and give a third-party recommendation. Are you currently doing that with the HACCP system?
Mr. BILLY. We have, and we're in fact expanding that approach. Probably the best example is convening the Meat and Poultry Subcommittee of the National Advisory Committee on Microbiological Criteria for Food, where we have posed a series of questions to that subcommittee that has some of the best experts that are around from the public and private sector to help us refine our strategy in terms of making a decision about when a HACCP plan is adequate in terms of dealing with a pathogen, where there is no silver bullet, where the controls that are not an elimination kind of technology or approach is possible.
Mr. POMBO. Are you currently doing that or is that what you are moving into?
Mr. BILLY. We are doing that. Meetings have been held. Dr. Wachsmuth can give you a lot more detail about the discussions and the approach that's been taken.
Page 41 PREV PAGE TOP OF DOC Mr. POMBO. Doctor?
Mr. WACHSMUTH. Yes, the Meat and Poultry Subcommittee that Dr. Billy referred to met last weekI think it was last weekand we viewed the HACCP regulation in the light of the 1992, and then the 1997 HACCP document from the full Micro Advisory Committee, and concluded that generally the concepts and things in the regulationalthough there are some things specific to the regulationwere in concurrence and made some recommendations for helping the agency make that even more so in terms of fusing the 1997 document and some of the training that we'll do for the field at Texas A&M.
So the relationship is very active, interactive, and that subcommittee is responding well to the questions from the agency. They meet routinely, even when the full committee doesn't meet. Because of funding and other constraints the full committee meets threeat a maximum fourtimes a year, but the subcommittee has been meeting on a fairly regular basis.
Mr. POMBO. Funding is a problem when them having meetings?
Mr. WACHSMUTH. Yes. We have a limit to the amount of money that we can use to fund the Advisory Committees.
Mr. POMBO. Have you requested additional funding for that?
Mr. BILLY. Let me jump in here. The overall limit is set on the Department in terms of how much money can be spent on an Advisory Committee overall, and then what's available is prorated out, and we get an allocation that's available to us.
Mr. POMBO. Has the Department requested additional funding for this?
Mr. BILLY. My understanding is that they have.
Mr. POMBO. Would it be possible, if I ran a processing plant and developed a new technological advancement that would provide what I determined, what the test determined, was a safer end product, a cleaner end productwould it be possible under the current rules to get that approved and put into use within the next year?
Page 42 PREV PAGE TOP OF DOC Mr. BILLY. Yes.
Mr. POMBO. And would the so-called Advisory Committee that you speak of review the science and determine yes this does work?
Mr. BILLY. If that were necessary, we would absolutely take advantage of it, but we have a lot of expertise in the agency itself and would avoid that step, if we could, but if there were some broader questions or where it wasn't clear-cut, we would absolutely consult with the Advisory Committee.
Mr. POMBO. I haven't thought this all the way through, but it would appear to me that in a normal peer review process, that you would have a third party and that it would not be done in-house, even though I grant you that you do have a lot of expertise within the Department. It would seem to me to make sense that, if you are going to claim a peer review process that would be done by a third party, not done by somebody in the Department
Mr. BILLY. I am unaware ofusually with new technology or new procedures it's a fairly straightforward process: Look at the data and supporting information and make a determination about the effectiveness of the suitability of a different approach.
There are instances where science is such that additional input would be appropriate. On the other hand, I am not aware, other than using the Advisory Committee as we have described, which we want to take advantage ofI am not aware of any instance in the food regulatory area, here in the U.S. or anywhere else in the world that I am familiar with, that would have a third party making decisions about whether the process is adequate or not. In the end, I think it falls to the regulatory agency to make that decision.
Mr. POMBO. What about when there is a dispute?
Mr. BILLY. Then I think in those instances you get appropriate input, publish as we have many times, put your proposal in the Federal Register, and solicit the input of scientific experts from all phases. We have done that many times.
Page 43 PREV PAGE TOP OF DOC Mr. POMBO. Is the process there now if there is a dispute?
Mr. BILLY. Yes.
Mr. POMBO. How about when it comes to critical control points within HACCP?
Mr. BILLY. It's the same. If there was a dispute that in the end we felt we couldn't resolve, I'd be absolutely prepared to publish a notice, invite comment, hold a public meeting. We, in fact, did that in the rulemaking process for the HACCP rule. There was a lot of controversy about which pathogens or indicator organisms we should use, and so we called a public meeting. It lasted 2 or 3 days, as I recall, and we got excellent expert advice that had a significant impact on what the final rule contained.
It was open to everyone. Everyone could provide the input. So it wasn't limited to any particular, and as long asit seems to me, if the agency is open to accepting that kind of input and carefully considering it with a clear goal in mind in terms of food safety improvement, I think what we have available as far as mechanisms can work well.
Mr. POMBO. If the person making the application has been turned down or not accepted, is unsatisfied with the answer, can he call for third-party review? Or is that only within the authority of the Department?
Mr. BILLY. They can certainly ask for, as you're referring, a third party, someone to review it and provide additional input and advice to the agency, and we would absolutely consider that.
Mr. POMBO. Could they request that this Advisory Committee independently or do they have to have you make the request?
Mr. BILLY. Normally, it would be our doing it, manage the overall process in terms of using the time of the Advisory Committee, but we'd be open to a request like that and figure out the best strategy for getting additional input. I hope you are not hearing resistance. It's about managing a process and making decisions that will stand up to public review and doing it in a way where you are, in fact, availing yourselves of the best scientists.
Page 44 PREV PAGE TOP OF DOC Mr. POMBO. I realize, Mr. Billy, that it's your responsibility to manage the process and make sure that it stands up to public scrutiny. At the same time, I think that as an oversight committee we have the responsibility to ensure that process is fair and the science that your decisions are based on are the best possible science and the best possible conclusion, and that's where the questions come from.
Mr. PETERSON. I'd like to flip this around on the other end but talk maybe about the same kind of issues, about what happens if somebody thinks that the plant has broken the rules or an inspector thinks that they have done something where they give them one of these non-compliance reports apparently.
A couple of things. First of all, how long does it take to resolve one of these NR disputes?
Mr. BILLY. It varies a little bit, depending on what the issues are. Most can be resolved fairly quickly because they turn on the facts, the facts of the situation; but there are some that take some time because there's inconsistencies in terms of the apparent facts that are available.
Mr. PETERSON. Well, I'd like to know what ''relatively quickly'' and ''some time'' is. Is it relatively quickly, 2 days?
Mr. BILLY. A few hours to a few days. There are some where it takes a month or two to get it resolved.
Mr. PETERSON. And the way this process works, once we get into HACCP, if there's a dispute, the inspectors are the ones that have the hammer on this. Is that the deal?
Mr. BILLY. If there's a dispute, then the appeal would go through a process that would start with the circuit supervisor and then the district manager and then
Page 45 PREV PAGE TOP OF DOC Mr. PETERSON. Are these all part of your inspection service?
Mr. BILLY. Yes.
Mr. PETERSON. Do they belong to this union?
Mr. BILLY. No.
Mr. PETERSON. They don't?
Mr. BILLY. No.
Mr. PETERSON. So the people that belong to the union aren't in this process of making the decision?
Mr. BILLY. That's correct.
Mr. PETERSON. OK. So I was concerned about that, given their testimony; they could really muck up the system probably, but they're not in the
Mr. BILLY. No.
Mr. PETERSON. Well, we are hearing from some people that this process is takingwe've got the same kind of problems here we got on the other end. Maybe if you are a bigger plant, you can deal with this stuff.
I am again concerned if we get into a situation with the smaller plants that if you string them out very long, you are going to put them out of business. So is there this mechanism such that we don't have to worry aboutI had some indication here that there was a situation on one of these NRs that took three months. They appealed this and through the process took 3 months. Well, if we get into a situation, I could tell you these plants in my district aren't going to survive 3 months.
Mr. BILLY. An NR deals with an observed deficiency in terms of in a HACCP plant following the HACCP plan that the plant's put in place. Normally, they can be resolved pretty quickly, but if it gets very technical or very complex, then it can take longer. I am not satisfied with 3 months.
Page 46 PREV PAGE TOP OF DOC We've published a notice in April that formalized the appeal process. The agency had never done that before, and it has in it some control measures and some checks and balances that I think are going to serve us well. I'd like to see how that works and be able to provide the committee additional information after a month or less isn't a long time to come to judgment about a process.
So I think it shows a very clear commitment on our part. We want this appeal process to work, and we are going to do what we can to make it work.
Mr. PETERSON. But the process is such that you could kick it up three or four different levels. I mean, you go through it, so that's going to take a lot of time just in and of itself. Right?
Mr. BILLY. Well, I don't think, again, it needs to take a lot of time.
Mr. PETERSON. Well, but if some of these things can shut a plant down, and if you shut a plant down, and you go through four or five steps they are going to be out of business.
Mr. BILLY. Yes, and unless there's adulterated product that is being shipped from the plant, an NR that it calls, for example, records, problems, that kind of thingunless there's repeat NRs that indicate that the HACCP plan isn't working effectively, and then at the formalized weekly meetings that we are holding with the plant to inform them, repeat, what they've been provided on an individual NR basis in terms of indicating that there's a pattern that's occurring, that we are concerned about it, there's openness to discussing that.
If there's any individuals NRs in appeals that is taken into account, but it's not the inspector and the plant that makes the decision to withhold the marks of inspection. It's a process that involves the district manager and the circuit supervisor as well in terms of these kinds of problems with records.
Page 47 PREV PAGE TOP OF DOC Not if it's adulterated products, then the inspector in charge is authorized to make that decision, but usually that's pretty straightforward in terms of the product's adulteration.
We've tried to build into this checks and balances so the inspector in charge can make certain decisions. If it works to a system failure and it involves an adulterated product, they can ask immediately. If not, then the process I have described, which is new, is at play, and I think it's going to straighten out some of the past problems and work effectively. And we will know that soon.
I mean, in the next 2 or 3 months it will be clear whether what we have put in place is working well or not.
Mr. PETERSON. Yes, and we'll be watching that closely, but in my experience with these kinds of issues that we've run into where in other areas where you have difference of opinion, the issue comes up of maybe the way to resolve this is to take the appeals process outside of your own agency because you tend to support whatever your people are doing. That may or may not happen.
Did you consider that, because we've run into this with other situations where when you set the appeal process, FMHA we had this problem. In the appeals they didn't think they were getting the rightthat the agency was just an internal deal where they were all taking care of each other. How are you going to eliminate that perception or that problem if it might exist?
Mr. BILLY. In part our reorganization and the approach we have taken to HACCP implementation is designed to address that. We have set up a separate National Technical Center that doesn't report you through the lines to any of the district officesthey're independent of the district officesbut are available to deal with technical issues or scientific questions that can be part of a dispute about an NR.
Page 48 PREV PAGE TOP OF DOC Then to further aid the Technical Center, we've set up this Technical Advisory Group of other experts in the agency where it gets very complex in terms of an issue that could be associated with an NR. Those people are there to provide that kind of input in a way that I think will strengthen our ability to make the right decision and act consistently with what we are trying to achieve overall in terms of HACCP implementation.
They are not on the line. They're not down in the plant. They're sitting there, looking at these issues and not only making clear recommendations, but consistent recommendations. If the same issue comes up somewhere else, we'll be consistent in terms of how we are responding.
So, well, I hopethe Tech Centers are relatively new. There's written protocols that are new. We've got a lot going on here in terms of trying to address this. We obviously want it to work as well.
Mr. PETERSON. Well, I hope that it in fact does, but I can already envision a plant calling me and saying, ''I've got one of these NRs, and they are going to shut me down, and I've never heard about this before,'' and all of these things you've talked about. And, I mean, it seems like that always happens. So, I hope I don't get that call, but if I do, I'm going to be on the phone to you.
Mr. BILLY. Fair enough.
Mr. PETERSON. And we'll try to make it work. Thank you.
Mr. POMBO. Mr. Dooley.
Mr. DOOLEY. I just still would like to get to a better understanding. This HACCP process is something that I think is very, very exciting, but I guess what I am still looking to the future where you have the development of new technology that can again be very consistent with HACCP, and though it might result in a change in process and certainly is a deviation from pre-HACCP regulations.
Page 49 PREV PAGE TOP OF DOC Now, as I understand it, you said that there are two alternatives here, is that you can petition for change in the pre-HACCP regulation with the HACCP proposal or you can ask for a waiver with a pilot program that might be acceptable. When you go with a waiver with a pilot program, what happens when is it not a pilot program any longer?
Mr. BILLY. When the pilot is either terminated or we modify the regulations so that it's
Mr. DOOLEY. So in all instances you have to go throughwe are always going to have to go through a rule making process to modify the pre-HACCP reg?
Mr. BILLY. I need to make some distinctions I think will help. Historically, we've had prior approval requirements for new equipment, blueprints, and so forth. We've eliminated those. So in terms of equipment, if the technology that's captured in a certain of equipment, then there's a lot of flexibility for plants in terms of introducing new equipment.
Now if the equipment has an impact on the currently-defined job that an inspector is carrying out, where it would interfere with their ability to do that then we need to address that in some appropriate way, including consulting with the union, if in fact it results in changes in how they do their job.
Pilots, what you are talking about, normally are designed to address a deviation from the regulation. They require that poultry be chilled at 40 degrees within 8 hours. Someone wants to do that differently and not meet that specific regulatory requirement.
So that's not about equipment per se. It's about how do I have a means of doing that differently but achieve the same food safety effects, and it's through the pilot process that we've talked about that you can deviate from the regulatory requirements in the Code of Federal Regulations, and there's provisions in the law, in the regulations, for us to permit those kinds of deviations under the process that's tried. The value of having these pilots and moving that way it develops an information base we could then use to modify the regulations. And as we pointed out in our reg reform strategy, we want to modify these regulations, and this will actually facilitate that process.
Page 50 PREV PAGE TOP OF DOC Mr. DOOLEY. And I accept that. And I guess where I am looking at though is, are we ever going to get to the situation, though, we are going to see some of this technology, and I'd say even in the chill bath example that you use, which appears that it would be difficult to get a waiver with a pilot program where at least it wasn't agreed to earlier. I guess it was a HACCP plan that was submitted on that.
But even going back to a steam bath, back in 1995, when they were introduced in 1995, if we had HACCP in place then, and someone included that in their HACCP plan in 1995, what would have been the Department's reaction then to the utilization of that?
Mr. BILLY. At that time there was another regulation that required prior approval of that kind of new equipment. That prior approval requirement has been eliminated.
Mr. DOOLEY. Eliminated. So then I guess my interest is, is if we want to encourage this adoption technology which I think has a great promise in terms of even creating greater food safetyif a company has an interest in developing technology in a piece of equipment that has some proprietary value, that they want to implement then they can come in and they can ask for a waiver, but they cannot operate other than in a pilot program with a waiver until there is a rule making that changes the regulation? And in this case the unions would still havewhat is the union's involvement here?
Mr. BILLY. If the equipment that you're describing would in some manner affect the ability of the inspectors to carry out their currently-defined roles, then we would have to change what the inspector is doing to permit the pilot. Our obligation under the current labor-management agreement is to contact the union to inform them that we want to do this pilot and how we would intend to modify what the inspectors are doing to achieve what's required in terms of the inspectors' role, but permitting the pilot to go forward.
Normally, the union concurs with these. Often they'll have suggestions about some minor adjustments in the inspection protocol that we've suggested, but normally these move forward, but they are provided some time to consider it. They go through a process that they
Page 51 PREV PAGE TOP OF DOC Mr. DOOLEY. My concern here is that I think we're moving in the exactly right direction, and I am very, very pleased with the results that we have seen already, but I am a little concerned that it appears that there is some inconsistencies and impediments to what could even be a more rapid adoption of technology that could even further improve the product we're providing the consumers.
And that's where I am a little concerned about if we got somebody that could come in and demonstrate based on good science that we are going to deliver a good product, I am not so sure that even the union involvement at this point, if it's not science-based and it doesn't have any impact on outcome, I am not sure that that is consistent with this whole plan and the direction we are trying to move in terms of an outcome-based approach.
I am also not convinced that if you have a system that is trying to facilitate the adoption of new technology and you can give a waiver, and yet you have to go through a rule making process, if there's a proprietary interest and involvement in trying to keep this copyrightmake the copyright somewhat restricted, doesn't the rulemaking process blow that up and open it up?
Mr. BILLY. No, there is a way consistent with dealing with proprietary information where we can protect that through this process, the specific proprietary implementation. And we have done that in the past and are able to do that.
Let me give you a little bit more information, and I want to use another example. A while back we proposed a rule to modify our current regulatory requirements for cooked, ready-to-eat products. Now I'll use roast beef as an example. In the existing regulation there is a several-step process that a producer of this type of product has to go through and it actively engages the inspector in that process.
And we wanted to modify that regulatory requirement to what is more like a performance standard. So we proposed an alternative regulatory requirement that would describe a certain reduction in the number of pathogens, what's called the Law of Reduction. And I don't remember the specifics. Let's presume for the sake of discussion it was the Seventh Law of Reduction in any pathogens that would be present.
Page 52 PREV PAGE TOP OF DOC And that was actually underlying what the old regulatory requirement was. We put this proposal out for comment because if we just say, ''the requirement is the Seventh Law of Reduction'' without prior approval of equipment you can achieve that a lot of different ways. So it moves toward your flexibility in terms of new technology.
But the comments we got on that proposal suggested, you haven't gone far enough. There are instances where, based on, as an example, antimyfobial treatments that may have been used or other technologyit's not necessary to have a Seventh Law of Reduction. You need to be more flexible than that and allow for alternative processes that still accomplish the food safety objective but are more flexible than what we had originally proposed.
So that sent us back to the drawing board to consider how we in fact come out with a final rule that's more flexible than what we originally proposed. So, ultimately, that reg reform process will get you to where you are going, but what do we do in the interim? So what we're saying is take advantage of this alternative approach. It gives us the flexibility to introduce this new technology or equipment, and we'll get there and in fact the experience with a pilot will help us complete the rule making change.
Mr. DOOLEY. Thank you.
Mr. POMBO. Thank you. I want to take this opportunity to thank you for appearing before the subcommittee and answering our questions. The official record will remain open for 10 days to accept any further questions and answers from you as well as any other statements to be entered into the record.
In conclusion, I just want to reiterate that it is the subcommittee's opinionI believe it's everyone's opinionthat at this point things seem to be moving in a positive direction, and we are seeing positive results from the efforts that you have put forth at this point. Obviously, there are concerns. There are concerns that the subcommittee has. There are concerns that both consumer groups and industry share about I believe more doing with process than results. If we can continue on that path, work through those problems, when we get into the next phase of HACCP, I believe it will run much more smoothly.
Page 53 PREV PAGE TOP OF DOC But, again, thank you all very much and you're to be commended for the job you are doing. Thank you.
[Whereupon, at 3:43 p.m., the subcommittee adjourned subject to the call of the Chair.]
[Material submitted for inclusion in the record follows:]
Statement of Thomas J. Billy
Mr. Chairman and members of the subcommittee, I appreciate having this opportunity to appear before you today to discuss the implementation of Hazard Analysis and Critical Control Point system regulatory requirements. Today, I am accompanied by Dr. Mark Mina, Deputy Administrator of Field Operations, Dr. Kaye Wachsmuth, Deputy Administrator of Public Health and Science, and Patricia Stolfa, Assistant Deputy Administrator of Policy Development and Evaluation.
My first thought in preparing my remarks for today's hearing was to jump right into discussing the status of HACCP implementation. However, I'd like to first reflect on our excellent progress over the past 3 to 4 years, and how important these changes are to industry, to government, and to the public. It's easy to get caught up in deadlines and the future hurdles to overcome. I know some in industry and in government must feel overwhelmed with the various changes that have taken place over the past several years. But, I believe it is helpful to sit back every once in awhile, take a look at the big picture and evaluate how well we have done, and how far we have come, in the food safety arena.
The changes we have seen in food safety over the past 5 years are staggering. When the E. coli outbreak on the West Coast occurred in early 1993, HACCP was not required for any foods, other than those that were canned. The regulations covering meat and poultry were all command-and-control, and the Food Safety and Inspection Service (FSIS) was not organized in a manner that anticipated immediate and future public health demands. We've come a long way since then.
Page 54 PREV PAGE TOP OF DOC As you know, FSIS worked for quite some time to develop a science-based inspection system. FSIS maintained very close working relationships with all interested partiesindustry representatives, consumer groups, employee representatives, and the scientific communityin developing the HACCP final rule. As a matter of fact, we held over 50 public meetings nationwide from publication of the proposed rule through publication of the final rule on HACCP. Our main goal was to afford everyone the opportunity to provide comments on how the meat and poultry inspection system should be modernized.
I believe all parties involved learned from each other in discussions on how to accomplish this goal. For example, in the proposed rule the HACCP implementation date was based on the types of processes a plant had in place and the risks associated with the processes, not taking account of the differences between the size of plants. As you know, in the final rule plant size is the determining factor for when a plant will have to implement HACCP. We also modified testing requirements. In the proposed rule, plants would have had to conduct salmonella testing. In the final rule, FSIS assumed responsibility for the more costly salmonella testing.
At the public meetings, participants expressed the need for various HACCP guidance materials to help plants through the implementation process. We made a commitment to develop the materials, and I'm proud to say that they are accessible either online or from the Agency, free of charge. So far, we have distributed over 30,000 generic HACCP models. We don't have 30,000 plantsFederal and State combinedbut that tells me that these documents are finding a wide distribution, and that's good. The assistance is getting out to those who need it.
We've known that the implementation of HACCP would require a significant change in the roles and attitudes of both inspectors and industry. In the past, some plants relied on inspectors to identify deficiencies before the company would take action to correct them. Implementation of HACCP clarifies the respective roles of industry and FSIS. Businesses that produce food are accountable for its safety. They need to look at all the likely hazards, ensure their systems address those problems, and take immediate action if their controls fail.
Page 55 PREV PAGE TOP OF DOC The first timeline industry was required to meet was on January 27, 1997, when all plants were required to have in place a written plan to address sanitationcalled Sanitation Standard Operating Procedures (SSOPs). SSOPs instituted a process to ensure compliance with existing Federal sanitation requirements that focus on preventing direct product adulteration. This is a huge cultural changeboth for industry and our inspectors.
The implementation of SSOPs went extremely well. When you consider that ALL 6,000 plants were required to implement SSOPs and very few had problems doing so, we feel that's quite an accomplishment.
We also felt it was very important to answer any remaining questions on the new HACCP requirements prior to the January 1998 implementation date for the largest meat and poultry plants. From December 1997 through the end of January 1998, FSIS held four nationwide HACCP Implementation Meetings in Des Moines, IA; Denver, CO; Memphis, TN; and in Washington, DC. The meetings were well attended and provided participants with necessary information on HACCP in order to be ready for implementation on January 26.
Today, HACCP is in place in the largest meat and poultry plantsthose with 500 or more employees. ''Large'' plants produce 75 percent of the raw meat and poultry and 45 percent of processed products such as frozen dinners, frankfurters, or hams. All plants have implemented standard operating procedures for sanitation. Slaughter plants and plants that grind products are testing for generic E. coli and monitoring their results to verify the effectiveness of the process controls.
We have already begun preparing for the second stage of HACCP implementation, which will take effect in more than 3,000 ''small'' plantsthose with between 10 and 500 employeesin January 1999. Our field District Managers are in the process of sending letters to ask plant owners to confirm whether they fall into the ''small'' category. We plan to complete our list of all ''small'' plants by this June in order to provide assistance and make sure they are prepared for HACCP implementation.
Page 56 PREV PAGE TOP OF DOC Based on comments from our stakeholders, we are also refining our HACCP implementation strategy in six specific areas: (1) establishing a team of on-call experts managed from the FSIS Technical Services Center to help FSIS make prompt decisions on complex scientific and technical issues regarding a plant's HACCP system; (2) providing additional training for supervisory inspectors in systems concepts relating to HACCP; (3) expanding the cadre of FSIS HACCP experts providing ongoing advice and guidance on HACCP-related issues; (4) improving notification to plants of findings that a plant's HACCP system is failing; (5) specifying the steps in the appeals process; and (6) increasing involvement of the National Advisory Committee on Microbiological Criteria for Foods in the development of guidelines.
I want to emphasize that from our perspective, HACCP implementation is going well. I understand that there is continuing uneasiness about whether FSIS will return to a command-and-control approach, but I want to assure you that will not occur. There may be isolated instances where an inspector or a plant has not made the necessary cultural change, but we are dealing with each of those instances immediately. HACCP remains a work in progress that will need fine-tuning in the weeks and months to come. This is to be expected with such a complex revision of our inspection system. We are committed to working out any problems as they arise and to using a common-sense approach to problem solving. I am convinced that we can and will do this successfully.
I want to acknowledge the positive steps that industry has taken to meet the food safety goals this Administration has set. We have instituted a number of complex changeswith HACCP being the most complex change of all. Right now, we're learning a great deal from ''large'' plants, which will help us in implementing HACCP in ''small'' and ''very small'' plants. Industry has stepped forward and accepted the challenge by developing new technologies and programs for their HACCP plans. The industry has risen to the occasion every time, and I commend them for that. I know they take pride in the fact that they are contributing positively to making meat and poultry safer.
Page 57 PREV PAGE TOP OF DOC I'd like to commend my own Agency as well. We have many dedicated employees who have worked very hard to ensure the successful implementation of HACCP in January 1998 and who continue to work hard for the smooth transition to HACCP for ''small'' and ''very small'' plants in January 1999 and January 2000, respectively.
I think we did a good job training roughly 2,100 inspectors and other personnel to carry out their roles in a HACCP environment. Part of the training addressed how inspectors should interact with plant personnel in a professional manner. In addition to their special training, we also met with our supervisors to ensure they were ready to carry out their regulatory responsibilities under HACCP. And we held an array of successful meetings with industry that have kept essential lines of communication open and functioning. Additionally, we have prepared assistance materials to help plants comply with the new requirements.
In December and January, we held two sessions where we shared with industry the training materials used with our inspectors, so there would be a clear understanding and no surprises about how our employees are being instructed to carry out their regulatory responsibilities.
For the first 4 days of HACCP implementation, each inspection team sat down with plant management to discuss each plant's HACCP plan. This gave inspectors the opportunity to become familiar with the plan and both inspectors and plant management the chance to discuss their respective roles. Those meetings now take place on a weekly basis, providing for what we believe is improved communication between industry and the Agency.
All of this preparation by government and industry has helped to ensure that the implementation of HACCP was successful. Following the deadline for implementation, we did have to notify a small number of plants that their HACCP plans needed to include additional control measures to address specific areas where food safety hazards were likely to occur. All of these companies responded positively, and no regulatory enforcement was necessary.
Page 58 PREV PAGE TOP OF DOC I don't mean to imply that everything is perfect. It would be unrealistic to expect that with a change as complex as HACCP, no problems would be encountered. But the sky did not fall on January 26, 1998, as some predicted. As I said earlier, HACCP implementation is a work in progress. I can assure you that we will continue to work out any problems as the full implementation of HACCP in all plants continues.
RESOURCES FOR INDUSTRY
We are committed to assisting all plants in implementing HACCPnow and in the future. FSIS district managers are on call 24 hours a day, 7 days a week, to make rapid decisions and to respond promptly to emergencies. Plants are encouraged to call their district managers if they are having any problems.
In addition, the Technical Services Center is a valuable resource for those who have technical questions, and we have been getting positive feedback on the quality of the answers being provided by the Center. The Technical Services Center is operating a HACCP hotline (8002333935), with four phone lines open between the hours of 6 a.m. and 6 p.m. As of May 1, the hotline has received about 6,305 calls, with approximately half being from industry, and half from our inspectors. An average of 70 calls are being received each day. We are getting calls addressing a variety of areas, from FSIS verification and enforcement procedures to identifying critical control points.
To ensure open communication during the transition and adjustment to the HACCP system, FSIS has been holding weekly meetings with industry representatives to address implementation issues. I believe these meetings are very useful, for industry and for FSIS, to learn what steps need to be taken by each side to make HACCP work better. As a result of input received at these meetings and from other stakeholders, we are refining our HACCP implementation strategy in several areas.
For example, we have organized a Technical Advisory Group (TAG) to act as an added Agency resource in providing reliable and speedy assistance to Agency inspection personnel on public health and food safety issues. As part of the phasing in of HACCP, we are planning a continuous education program for supervisors at the in-plant, circuit and district levels that will further enhance their understanding of the systems approach, and the rationale for taking regulatory action on process deficiencies, when necessary. We are also planning a HACCP educational program for additional FSIS headquarters personnel that will focus on HACCP principles and implementation.
Page 59 PREV PAGE TOP OF DOC FSIS has issued an interim notice outlining the step-by-step process for FSIS inspection personnel to follow to notify establishments of intended enforcement actions. This notice will be replaced by new Rules of Practice, which were proposed in January and which we expect to finalize before the end of this year based upon our evaluation of the comments we have received and on our experience thus far with HACCP implementation.
We have issued a notice to inspectors and a letter to plants, explaining our policy on the appeals of inspection findings and decisions. We have also responded to a request by industry to create an appeals tracking system, which I will discuss a little later. FSIS is also utilizing the National Advisory Committee for Microbiological Criteria for Foods on the implementation of HACCP.
Based on a request received from industry, we've developed a list of the most commonly asked HACCP-related questions, from our inspectors and from industry, that have come into the Technical Services Center. We will be issuing the second set of questions and answers in the next few weeks.
In order to assist small and very small plants in meeting the requirements of the HACCP rule by the January 2000 implementation date, we are providing extensive technical assistance to small plants. We have targeted small plants because many are not familiar with HACCP. FSIS has made available to the industry a number of technical guidance materialsincluding the draft Guidebook for the Preparation of HACCP Plans, the Meat and Poultry Hazards and Control Guide, and draft generic HACCP models for 13 products and processes.
We have set up toll-free phone lines for assistance, facilitated demonstration projects around the country to help small and very small plants to better understand and apply the new requirements, and have held numerous meetings around the country to find out from plants what information they need to be successful with HACCP and how to strengthen the lines of communication between FSIS and industry. We've also created a HACCP Training Database that is available on the internet for plants that need information on HACCP-related services, equipment and software.
Page 60 PREV PAGE TOP OF DOC Just recently, on May 7, FSIS held a meeting on HACCP implementation for small plants. The meeting was very well attended by State inspection officials, the scientific community, consumer groups, and industry representatives. We covered a lot of information in one day. Dr. Catherine Woteki, Under Secretary for Food Safety, began the meeting by discussing how the Agency can work with all interested parties to maximize the opportunity for the success of small plants implementing HACCP. We discussed the status of FSIS and State assistance activities, and heard about the effective work being done by the HACCP Alliance and the private sector in HACCP training and assistance. The Under Secretary for Research, Education and Economics (REE) addressed the participants and discussed how REE can be more responsive to the needs of small plants implementing HACCP by conducting follow up training and applying successful HACCP training programs to other States and regions.
DATA FROM HACCP PLANTS
As part of the HACCP rule, we established performance standards for salmonella. Since February 1998, we have collected compliance samples on the largest plants that slaughter and/or grind meat and poultry products. Even though the number of samples collected to date in large slaughter plants is low, the percentage of plants positive for salmonella is equal to or below baseline prevalence data. The vast majority of plants are meeting the standards.
When comparing the large slaughter plant compliance data to the large slaughter plant pre-implementation data, decreases can be seen in the percent positive salmonella levels in the chicken carcasses. There appear to be no apparent differences in the salmonella levels in swine. Because there are only three large slaughter plants for steers/heifers and one large slaughter plant for cow/bulls, the number of samples is too few to evaluate.
Available data indicate that ''large'' plants have a 92 percent compliance rate with HACCP requirements to date, including the implementation and maintenance of SSOPs. As of last week, FSIS has taken enforcement actions to address HACCP systems failures in 13 HACCP plants. Follow up corrective and preventive actions in each of these plants have allowed operations to resume under FSIS monitoring.
Page 61 PREV PAGE TOP OF DOC To clarify notification procedures, we issued a notice to outline the step-by-step process for FSIS inspection personnel to follow in order to notify establishments of intended enforcement actions. The notice lays out the process to ensure that establishments are given appropriate advance notice of Agency regulatory actions. The notice directs FSIS in-plant supervisors to discuss developing trends at their weekly meetings with plant management, and explains how the Agency will inform management of industry's opportunity to respond to repetitive deficiencies that do not involve adulterated products leaving the plant. Inspectors will always act immediately to address adulterated products. This document adds interim procedures while the final Rules of Practice are being developed.
As we implement HACCP, I want to assure you that we recognize the importance of providing industry with due process, including notification and appeals. We are committed to providing plants with appropriate notice of violations and with well-defined avenues to appeal Agency actions. All actions that have been taken by FSIS to enforce SSOP regulations over the past year have been preceded by detailed notice of the basis for the action and of the procedures for appeal. The same procedures are being carried out for HACCP.
We believe that appeals of legitimate disagreements are both necessary and appropriate, and plants are encouraged to appeal inspector findings at the earliest point in the process. We also recognize the need for timely resolution of all appeals. In fact, based on a request received from industry at our weekly FSIS/industry meeting, we have begun work on establishing the Industry Appeals Tracking System (IATS) report, which will document and track information on appeals to help monitor and improve the appeals process.
We have created a team approach to enforcement, involving the inspector and compliance officer, that we believe will facilitate the accurate documentation of system failures, and the rapid resolution of disagreements. We expect that compliance officers should be on site within a few hours and have instructed them to complete their reports as soon as possible.
Page 62 PREV PAGE TOP OF DOC I want to stress that none of our enforcement actions are undertaken lightly. Each represents a great investment of agency resources. We recognize that they can have significant economic impact and cause market disruptions that affect not only the plant and workers but also its suppliers. We cannot and will not, on the other hand, allow more serious public health consequences. We are committed to ensuring that there is nationwide consistency and fairness to both plants and consumers.
FSIS has been carrying out a comprehensive review of its meat and poultry inspection regulations with the aim of improving their consistency with the Pathogen Reduction/HACCP regulations. We are planning to eliminate any regulations that are redundant or obsolete or raise concerns about a ''layering'' effect. We are committed to making our regulations less burdensome and easier to use.
We have published a number of documents already, including: a proposal to merge and simplify the meat and poultry sanitation regulations; a final rule to eliminate the prior approval requirement for facilities and equipment; a proposal on performance standards for the production of certain meat and poultry products with established standards of identity; and proposed Rules of Practice. We plan to complete these rulemakings before January 1999.
As we revise and consolidate our regulations, we are seeking ways to remedy any inequities that may exist. For instance, regarding the current poultry chilling standard, we expect that in the course of implementing the HACCP rule, we will develop the information necessary for reassessing its appropriateness. We have asked the industry to submit any data they have. Once the information is developed, we will review the poultry carcass time-temperature requirements with an eye to removing the command and control aspects while still ensuring that the food safety objectives will be met.
In closing, I am pleased with the progress both government and industry are making to improve food safety. I understand the significant challenges involved and commend industry for their commitment to making HACCP work. We will continue to work hard to resolve any problems that arise during HACCP implementationnow and in the future.
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"The Official Committee record contains additional material here."