The amici who submit this brief are non-profit trade associations which represent meat packers and processors. The members range from very large slaughterhouses to small wholesale establishments which supply local hotels and restaurants. All of these packers and processors operate under federal meat inspection provided by the United States Department of Agriculture (USDA).

The issue presented in this case is whether the scientifically unsupportable Salmonella performance standard for raw ground beef can be used to suspend inspection at a grinding facility when: the USDA lacks statutory authority to suspend inspection; the standard was improperly promulgated; the incidence of salmonella does not constitute "adulteration;" and the incidence of salmonella likely originated in other USDA-inspected establishments.

This case arises because the USDA has attempted to withdraw its meat inspectors from the facilities of Supreme Beef Processors, Inc. (Supreme) and Supreme has filed this action seeking preliminary and permanent injuntive relief.

This case involves the pathogen reduction performance standard for Salmonella, 9 C.F.R. 310.25(b), which was promulgated by the USDA on July 25, 1996, 61 Fed. Reg. 38,806. Such performance levels set arbitrary levels of "acceptable" Salmonella incidence. The levels vary by species and products from a low of one percent for steer/heifer carcasses, to 2.7 percent for cow/bull carcasses, to 8.7 percent for swine, to 20-49.9 percent for various poultry products. The presence of Salmonella on raw ground beef does not render the product adulterated. Instead, the performance standard purports to be a measure of the establishment’s process.

The preamble to the final rule mandating the performance standard is replete with suggestions as to how a slaughterer can control its process. However, the USDA recognized that:

Establishments producing raw ground product from raw meat or poultry supplied by other establishments cannot use technologies for reducing pathogens that are designed for use on the surfaces of whole carcasses at the time of slaughter. Such establishments may require more control over incoming raw product, including contractual specifications to ensure that they begin their process with product that meets the standard, as well as careful adherence to their Sanitation SOP’s and HACCP plan.

61 Fed. Reg. at 38,846. In other words, the USDA could identify no controls a grinder can employ -- its sole advice is to be careful in what you buy.

Beyond the fact that a grinder is effectively dependent on its suppliers in complying with the standard, the standard is without support. For example, the standard for ground beef is derived from baseline sampling performed in 1993. However, that sampling was limited to 563 samples, 80 percent of which were taken in the three month period between August 31 and November 23, 1993. Further, the sampling focused predominantly on beef grinding facilities in the Northeast, with very limited sampling in the major livestock and meat production centers in the Middle West and Southwest.

Given the flawed nature of the standard and because it focuses on the segment of food production where the ability to apply meaningful pathogen controls is absent, the Amici strongly urge the Court to grant plaintiff’s application for preliminary and permanent injunction

ARGUMENT

Under the Administrative Procedure Act (APA), an agency action shall be held unlawful and set aside if it is "arbitrary, [or] capricious." 5 U.S.C. 706(2)(A). Moreover, agency action is also invalid if it is "in excess of statutory . . . authority [or] is without observance of procedure required by law." 5 U.S.C. 706(2)(C)&(D). Amici respectfully submit that the USDA, in adopting and enforcing its Salmonella performance standard, has violated each and every provision cited above. It has established a standard which is beyond a grinder’s ability to comply; it has established a standard based on inadequate and flawed data; it has failed to follow the procedural requirement of the APA that the public be given an opportunity to comment on what the agency ultimately adopts; and it has taken enforcement action in excess of its statutory authority.

In light of the above, Amici respectfully request that this Court issue a preliminary and permanent injunction against the USDA from enforcing the performance standard, at least until it adopts a standard which is not only reasonable and fair, but is in compliance with the law.

I.THE USDA PERFORMANCE STANDARD IS ARBITRARY AND CAPRICIOUS BECAUSE IT IS NOT POSSIBLE FOR GRINDERS TO PREVENT OR ELIMINATE SALMONELLA

Salmonella contamination occurs, in the first instance, during the slaughter process. Once the contamination occurs, there are simply no interventions available at the grinding stage to eliminate this organism.

The preamble to the final Salmonella performance standard supports this conclusion. In that document, the USDA itemizes a number of interventions a slaughterhouse can use to address Salmonella on the carcass, including: (1) hot water sprays; (2) lactic acid sprays; (3) other antimicrobial sprays; (4) spray-vacuum devices; and (5) basic trimming. 61 Fed. Reg. at 38,846. These measures are in addition to sanitary dressing practices which will minimize the contamination in the first instance.

In stark contrast to the variety of controls which are available at the slaughterhouse, the same preamble is remarkably silent on what a grinder can do to address Salmonella at its facility. Indeed, the sole suggestion proffered by the USDA is that grinders should obtain "more control over incoming raw product, including contractual specifications to ensure that they begin their process with product that meets the standard." 61 Fed. Reg. at 38,846. This is curious advice given that grinders must always obtain their raw materials from USDA inspected slaughterhouses which presumably are in compliance with the Salmonella performance standard.

The grinders have thus been placed in an awkward situation. Based on conversations with members of the Amici associations, a grinder cannot always be assured that the incoming raw materials will be free of Salmonella and a grinder’s end product cannot comply with the standard if its raw materials do not. There is no intervention technology approved which will eliminate Salmonella in raw ground beef -- irradiation technology has not yet been approved by the USDA -- and the only other intervention is cooking which totally changes the product.

Beyond the difficulties above, we respectfully note that the performance standard is based on an average. As a result, an establishment being sampled during months where Salmonella incidence on the raw materials is high will, by definition, more likely fail even if it is in compliance on average. Thus, in short order a plant may find itself out of compliance based solely on the season, not due to any culpability on its part.

Moreover, it is impractical for many grinders to follow the USDA’s one suggestion -- purchase raw materials that are free of Salmonella. Many members of the Amici associations are simply grinders and must purchase all their raw materials. If a grinder systematically rejects non-conforming suppliers, it will soon find itself without a source of supply and out of business.

The problem will be more pronounced in the coming months. To date, most of the reported USDA samples reflect conditions of carcasses in the winter months, a time when Salmonella is less prevalent. As the results begin for the summer months, we anticipate repetitive failure for many grinders. Moreover, we understand that most of the plants currently sampled are "large plants." The Amici represent a huge number of mid-to-small plants which are not represented by the results published to date.

Concerning the published findings, we find it interesting that the USDA has chosen to focus its sampling more on grinders, which lack effective controls, than on slaughterers. In its HACCP implementation report covering January 1998 to January 1999, the USDA notes that it completed sampling at ten ground beef facilities. Food Safety and Inspection Service, "HACCP Implementation: First Year Salmonella Test Results, January 26, 1998 to January 25, 1999," available at http://www.fsis.usda.gov/OPHS/salmdata.htm. Yet, in the same time period, the USDA only sampled three steer/heifer plants and one cow/bull plant. Moreover, in the next six months, the USDA apparently has not conducted any tests at slaughtering facilities where there are measures to reduce pathogen incidence. We question whether the USDA is actually undertaking a pathogen reduction program and whether its current approach is a fair allocation of resources.

Recognizing that standard setting is, by its very nature, arbitrary, we respectfully submit that when standard setting imposes a standard which is beyond the control of the regulated industry, it crosses over into a capricious act.

II.THE SALMONELLA PERFORMANCE STANDARD IS ARBITRARY AND CAPRICIOUS BECAUSE IT IS BASED ON INCOMPLETE, INSUFFICIENT DATA

The problems with the Salmonella performance standard identified above are the direct result of the USDA relying on sketchy, incomplete data in developing the standard. First, the data upon which the USDA based its standard were not developed over one year, but over only eight months, with approximately 80 percent of the samples collected in just a three month period. Thus, the data cannot fully take into account either seasonal variations or year to year variations (as noted above, Salmonella incidence is dependent, in part, on weather/temperature). Second, the USDA only used 563 samples in developing the baseline when there are over 1,590 plants producing ground beef. Moreover, the geographic distribution of the samples did not represent the entire United States. Most were taken in the Northeast (where the weather is cooler), with very limited sampling in the major livestock and meat production centers and in the Middle West and Southwest. Third, there was a bias in selection of the establishments sampled. There was a disproportionate number of samples taken from establishments grinding steers/heifers (which have a lower incidence of Salmonella). This translates into the fact that about half of the companies, mostly those smaller firms using trimmings from cows/bulls (which are higher in Salmonella incidence), will fail to meet the standard.

The statistical invalidity of the current standard is illustrated by the different levels of Salmonella allowed for different types of slaughterhouses. For those slaughtering steers and heifers, the performance standard is one percent. For those slaughtering cows and bulls, the performance standard is 2.7 percent. For ground beef establishments, the performance standard is 7.5 percent regardless of whether the meat being ground originates from the an establishment with a one percent performance standard or 2.7 percent performance standard. Thus, an establishment using cow and bull meat to make ground beef is immediately at a disadvantage on account of the nearly threefold higher incidence of Salmonella allowed for this source by the USDA performance standard.

We respectfully submit that the data relied upon by the USDA is not of a sufficient quality or quantity to support its performance standard for raw ground beef. Lacking factual and statistical justification, the standard is arbitrary and capricious.

III.BY ADOPTING A PERFORMANCE STANDARD AND ADDING ENFORCEMENT PROVISIONS IN THE FINAL RULE THAT WERE NOT PROPOSED, USDA FAILED TO PROVIDE A MEANINGFUL OPPORTUNITY TO COMMENT IN VIOLATION OF THE APA

The APA is designed to ensure that whenever an agency adopts a regulation, the public is given notice of the proposed regulation and a meaningful opportunity to comment. When such a procedure is followed, the exchange of ideas and information will help to assure a sound and fair rule. However, when, as here, the procedures are not followed, the rule is likely to be flawed, unfair, and impracticable.

On February 3, 1995, the USDA published its proposed Pathogen Reduction/HACCP regulation. 60 Fed. Reg. 6,774. This proposal contained three basic provisions. First, it would mandate the use of pathogen interventions and monitoring. Second, it would require establishments adopt and implement sanitation standard operating procedures. Third, it would mandate HACCP programs at all establishments.

As initially proposed, Salmonella testing was to be conducted by the establishment to monitor its process. In the event the establishment was deemed out of control, it would have to take appropriate actions to restore control. 60 Fed. Reg. 6839 (Proposed 9 C.F.R. 310.25(e)). Nowhere in this proposal did the USDA indicate that establishments failing the Salmonella test would summarily lose their inspection.

Inspected establishments and their representatives, including Amici, vigorously opposed this proposal. The primary basis for this opposition was that Salmonella is simply not a valid means of assessing process control. Apparently, the USDA concurred with these arguments because in the final rule it changed from Salmonella monitoring for process control verification to monitoring for generic e. coli for that purpose. And then, without any antecedent in the proposal, the USDA added a new provision dealing with Salmonella performance standard for the purpose of "pathogen reduction" and in connection with this new provision asserted authority to suspend inspection for failing the standard. 9 C.F.R. 310.25(b).

We respectfully submit this new provision denied Amici and their members the opportunity to comment on the Salmonella performance standard provisions. When an administrative agency adopts a provision that is substantially different from what was proposed, it is invalid. See Shell Oil v. E.P.A., 950 F.2d 741 (D.C. Cir. 1991); American Fed’n of Labor v. Donovan, 757 F.2d 330 (D.C. Cir. 1985). Here, the Salmonella performance standard is different than the proposed monitoring (which the USDA kept, albeit for a different organism) and the added enforcement provisions were entirely new. Amici respectfully submit that these regulatory requirements were improperly promulgated under the APA and therefore are invalid.

IV.USDA HAS NO STATUTORY AUTHORITY TO SUSPEND INSPECTION FOR FAILING TO MEET THE SALMONELLA PERFORMANCE STANDARD

It is basic administrative law that a government agency may only exercise the powers granted by Congress. See Bowen v. Georgetown University Hospital, 488 U.S. 204, 208 (1988); Federal Trade Commission v. National Lead Co., 352 U.S. 419, 428 (1957). "[T]he determinative question is not what [an agency] thinks it should do but what Congress has said it can do." Civil Aeronautics Board v. Delta Airlines, 367 U.S. 316, 322 (1961). The APA forbids an agency to act "in excess of statutory jurisdiction, authority, or limitations, or short of statutory right." 5 U.S.C. 706(2)(C).

The Defendant’s authority to withdraw or suspend inspection services is strictly limited under the Federal Meat Inspection Act (FMIA). 21 U.S.C. 601 et seq. First, the USDA may withdraw or suspend inspection services if the meat processor fails to destroy condemned carcasses or condemned meat products. 21 U.S.C. 604, 606. Second, the USDA can withdraw inspection if the establishment or a responsibly connected individual has been convicted of certain crimes (and then only after a formal administrative proceeding, during the pendency of which the establishment remains in operation). 21 U.S.C. 671. Since neither of these situations are present in the instant case, the FMIA does not support the action taken by the USDA here.

The USDA cannot justify the suspension on the basis of its authority found in 21 U.S.C. 608 dealing with sanitary conditions. That section provides, in relevant part: "where the sanitary conditions of any such establishment are such that the meat or meat food products are rendered adulterated, [USDA] shall refuse to allow said meat or meat food products to be labeled, marked, stamped, or tagged as ‘inspected and passed’." 21 U.S.C. 608.

Clearly this statutory authority does not support suspension of inspectors here. First, the presence of Salmonella on raw ground beef does not render the product adulterated. Second, the principal source of the Salmonella is the slaughtering environment, not the processing environment. Indeed, the only suggestion the USDA could make to the grinders to assist in compliance with the Salmonella standard is to pick their slaughtering suppliers carefully. Thus, not only is the product not adulterated, any contamination was unlikely caused by the sanitary conditions at the grinder. Third, and most importantly, this section does not authorize suspension. Indeed, it only permits the USDA to refuse to mark products inspected and passed if it affirmatively finds there is adulteration. The inspector must remain at the establishment.

The USDA’s suspension was without statutory support and is ultra vires. Accordingly, the illegal suspension should be preliminarily and permanently enjoined.

CONCLUSION

For the foregoing reasons, Amici respectfully request this court grant plaintiffs motion for a preliminary injunction.