Good Morning. 

I am not Rosemary Mucklow in disguise! And she is not suffering from cold feet! 

My name Jeremy Russell, I’m the Director of Communications and Legislative Issues at National Meat Association, and Rosemary asked me to be here in her place, because she had a last minute conflict. While I came here on a night flight, she flew to Washington on a night flight to attend a meeting requested by the Secretary of Agriculture on BSE. To the best of our knowledge, the reason for that meeting is not any new case of the disease, but rather the actions of both the United States Senate and a federal district court judge in Billings last week to prevent the U.S. Canadian border opening to the import into the U. S. of young cattle. 

Rosemary was going to tell you she felt honored, indeed overwhelmed, to be invited to speak with you this morning in the company of such august members of the scientific community. She said she felt that Salmonella, the subject matter of your conference, is kind of like a family member and she was glad to share with you some perspectives as a political scientist, rather than a real scientist which is the claim that most of you make. I share her qualifications, though not her longevity and institutional knowledge, so I hope you will understand that I come as the messenger, and if you ask tough questions, I’ll take them back to Oakland, California.

Salmonella is an undesirable attribute in any food, and meat and poultry is no exception. Meat provides this energetic microorganism an almost ideal environment in which to grow and prosper – a high water highly nutritional base. But we are able to arrest its otherwise luxuriant growth with refrigeration. Further, it arrives on our product and, despite stringent care in sanitary dressing procedures, it still manages to survive. 

Back in 1991 and 1992, USDA’s Food Safety Inspection Service, under the leadership of Dr. Russell Cross, determined that it was important that the agency gather information to develop baseline microbiological data on various meat and poultry products. Until that time, the agency had not collected any such information on the raw products it was regulating. It was testing for Salmonella on RTE products, and if found, they were considered adulterated. Rosemary remembers, during a very difficult inspectional review in Southern California in 1985, that one of our small members in that area that manufactured roast beef had great difficulty producing this popular product without Salmonella. Mr. Ralph Johnston, Chief Microbiologist at FSIS at the time, was sent by Dr. Houston to visit the plant and, despite their excellent modern cooking equipment, he was the one to find that it was not working as designed. The failure was that it was not delivering the wet bulb, the moist heat, by which our industry could still produce medium-rare roast beef but be sure that any traces of Salmonella were destroyed. The offending strain was Salmonella newport, and it was tracked by the epidemiologists to a dairy source and remedies were introduced to correct the problem out on the farm.

The baselines that were developed, again I would remind you that they were not intended to be used for regulatory rule-making purposes, eventually became the basis for consideration in rulemaking at FSIS in 1995 and 1996. In the February 1995 FSIS proposal for pathogen reduction and HACCP, it was noted that ongoing outbreaks of salmonellosis, attributed to consumption of contaminated meat and poultry and other food products, illustrated how serious a public health threat this can be, even when the incidence of contaminated carcasses is low. It was noted that FSIS was proposing to set interim targets for pathogen reduction, using as the starting point the baseline incidence of Salmonella contamination of finished carcasses in all raw meat and poultry slaughter operations and in raw ground meat or poultry products, and requiring reductions in Salmonella in relation to the baseline. 

In fact, in the Final Rule, published on July 25, 1996, performance standards were established. It has always puzzled us as to the huge variation set forth by FSIS. For instance, the performance standard for ground beef was a maximum of 5 positives out of 53 consecutive samples, by contrast with a maximum of 29 positives for ground turkey and 26 for ground chicken out of 53 consecutive samples. Now Rosemary admits that statistics was not her A subject, but no one has ever been able to explain, to the meat industry’s satisfaction, why USDA would tolerate a level almost 5 or 6 times as high in ground poultry as it set for ground beef. We think this was a political judgment, not a science-based judgment!

FSIS began collecting samples to confirm the regulatory performance standards in 1998, and questions arose, but it was difficult to get answers from FSIS. Under the 1996 final rule, a firm that failed to pass the first 53-sample test, and in the case of ground beef remember this was no more than 5 positives out of 53 samples, would be placed on notice that it had failed and to reassess itself for a second sample set. The first company that got to this step was Supreme Beef Processors in Dallas, Texas. It was the largest supplier of ground beef to the USDA’s commodity program. It prepared, and did everything that it could think of before the second sample set of 53 was started. Remember, that it will take about 11 or 12 weeks to collect one sample per day, for 53 consecutive days. It failed the second 53 sample test, and was again put on notice and prepared for a third round of testing. 

The third round of 53 samples ended in late November 1999, it had again exceeded the performance standard of no more than 5 positives, and on November 29, 1999, it received a letter towards the end of the afternoon from the Dallas Regional Office that FSIS was withdrawing inspection immediately, and thus they would not be able to operate the next morning, Tuesday, November 30, 1999. 

The action was taken, according to the FSIS letter, pursuant to 9 CFR 310.25(b) and specifically the regulation stated that it constituted failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan, and would therefore cause FSIS to suspend inspection services. 

Supreme Beef Processors filed a Complaint in the U. S. District Court for the Northern District of Texas the next morning that the requirements were arbitrary and capricious, that Salmonella was not an “adulterant” under the law. District Judge Joe Fish, that afternoon, issued a Temporary Restraining Order enjoining USDA from suspending or withdrawing inspection until further order. USDA inspectors returned to the plant the next morning, December 1, 1999. 

The next step in the legal process was a hearing on a Preliminary Injunction held on December 10 before Judge Fish. National Meat Association, joined by the American Association of Meat Processors, Southeastern Meat Association and Southwest Meat Association, and later joined by North American Meat Processors Association, sought to be amici, arguing that we had actively participated in the development and administration of food safety laws, regulations and policies and could be helpful. In direct testimony at the hearing, FSIS Administrator Tom Billy agreed with the premise that, if a plant fails to meet the standard on three consecutive series of tests, then the agency deems that to do so constitutes unsanitary conditions. He further elaborated that the standards allowed a basis for industry and the government to calibrate the level of effectiveness of a plant’s HACCP plan and he went on to say that the agency would conclude, when a plant failed the test three times, that the sanitary conditions were not adequate and that the HACCP plan was not adequate to achieve the performance standard that is their target. 

Administrator Billy later conceded in his testimony that there had not been significant problems with the sanitation practices at the plant, but that the agency deemed the plant to be unsanitary because of a Salmonella finding. And the case was won for Supreme with the question: So this plant could be spotless, most sanitary plant in the world, and if it fails the Salmonella performance standards, then it’s automatically deemed to be unsanitary, to which he replied: Yes.

The District Court decision, in favor of Supreme, was a severe shock to USDA. It came despite a deference given by the judicial system to regulatory authorities for their knowledge and resources. They ploughed on through the legal process until Judge Fish rendered a Permanent Injunction in May 2000 in favor of Supreme. Supreme meanwhile continued in business, but the publicity and public criticism, particularly by USDA’s allies in the consumer movement, took their toll. The USDA Commodity Program found a way to stop buying Supreme’s product and it had been its largest customer. On Christmas Day 1999, USDA reported an E. coli O157:H7 positive attributed to the company and that further exacerbated its problems. 

USDA was again shocked to be on the losing end of the Permanent Injunction which really knocked a hole in the 1996 regulations, but it went doggedly forward to an appeal before the 5th Circuit in Austin. It took over a year to get to the courtroom, and by that time the adverse publicity had caused Supreme to file bankruptcy and close its doors. The principle of the case was of great continuing interest to NMA and its fellow amici, and we were once again in Court in Austin, Texas in September 2001. Our ever-thoughtful lawyer, Philip Olsson, of Olsson, Frank & Weeda, had had the prescience to once again request that we be an intervenor. The U. S. attorney, arguing for USDA, told the three judge panel that, because the company was out of business, the case should be considered moot, referred to the district court and dismissed. Phil told the judges that, if they granted his client’s request to be an intervenor, then they could moot the mootness issue. 

The judges quit asking questions about mootness after he had spoken, and a few weeks later they ruled that NMA could stand as an intervenor. After a few more weeks, they ruled in Supreme’s favor and against the government. Wisely, the new Bush Administration chose not to appeal to the United States Supreme Court where it was fairly certain that they would lose again. 

The first political mistake was the utilization of data collected as a baseline to set a regulatory standard, with an end-point of what is effectively capital punishment for a meat or poultry establishment – suspension or withdrawal of inspection. The second mistake was to “deem” failure to meet the standard as an unsanitary plant condition. In fact, for a grinding operation, the Salmonella undoubtedly arrived with the meat and was more attributable to Supreme’s suppliers than to any condition in Supreme’s plant. 

The third mistake was to put on the stand to testify the Administrator of the program and not to have briefed him properly on the underlying statutory authority. He really blew it when he said that there was nothing wrong with the sanitary conditions in the plant, but that he was suspending inspection for sanitary conditions. You can’t have your cake and eat it too! 

The fourth mistake was the dogged determination, call it arrogance if you like, that the regulator has all the cards. It is true that the regulatory agency has lived longer than Supreme, but the decision had huge implications for the industry. 

We at NMA were greatly concerned when we analyzed the baseline data and made a very simple chart which showed both seasonality and geographic distribution of findings. Those wet, warm ambient conditions in the southern states support this pathogen much more than the dry colder conditions in the northern states. Would that all pathogens could fit this profile – you, better than I, know that some thrive in dry cold conditions, rather than wet warm conditions. 

Today, we hear very little about Salmonella performance testing. I can tell you, as other speakers from the meat industry will tell you, that the industry has invested millions and millions of dollars in technology to assure that sanitary dressing procedures in U. S. plants are of the highest standards in the world and include the most creative interventions designed to reduce invisible pathogens to non-detectable levels. 

These technologies include thermal processing such as carcass washes and steam pasteurization, chemical interventions, including rinses and spray treatments, and may someday be expanded into non-thermal processing technologies such as high pressure or ozone.

We believe that our procedures more than match our neighbors to the north in Canada, and that is one of the reasons why we should be able to slaughter Canadian cattle, rather than close our plants and let Canada build slaughter capacity at our expense and just send us the boxed meat. We want to keep those jobs here in the U. S. The efforts to stop the implementation of the Final Minimal Risk rule are seriously undermining our beef slaughter industry, and exporting our jobs north of the border.

To conclude, due to the previous experience of USDA when they put performance standards into practice based on data derived from baseline studies that were never designed for the purpose, any future regulatory action that USDA considers should be carefully thought out and based on sound scientific research conducted in such a manner that it would stand peer review. If sound scientific data is generated, and it shows a need for regulatory action that could improve public health and safety and is fair to meat and poultry products, discussion with the industry to gain their support would be appropriate. The industry has demonstrated support for government efforts to reduce foodborne illness from pathogens. The difficulties came more with how the government went about the changes, not that change was indeed necessary. 

Thanks again for inviting our perspective for your conference.


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