The Honorable Dan Glickman March 5, 1998


U.S. Department of Agriculture

14th Street & Independence Avenue, S.W.

Room 200-A - Administration Building

Washington, D.C. 20250


Comments on Proposed Food Safety and Inspection Service

Rules of Practice

(Docket No. 95-025P)


Dear Mr. Secretary:

On January 5, 1998, National Meat Association wrote to you with other organizations to urge that the Food Safety and Inspection Service propose and promulgate its long delayed Rules of Practice for both Hazard Analysis Critical Control Point (HACCP) and Standard Sanitation Operating Procedure (SSOP) requirements. In that letter, we observed that such rules "must provide procedural due process protections for all inspected establishments."

Within a week after your receipt of the associations' letter, the Food Safety and Inspection Service (FSIS) published proposed Rules of Practice which FSIS had promised to complete "prior to the first implementation date for HACCP." 61 Fed. Reg. 38823 (July 25, 1996). Regrettably, the FSIS proposal represents a withdrawal and denial of due process rather than a recognition of this fundamental constitutional and statutory right. In fact, the Federal Meat Inspection Act actually provides more due process to a convicted felon than the proposed rules of practice would provide to a meat packer who experiences several defects which represent no imminent threat to health or safety. Just as you became involved to motivate the long delayed publication of a Rules of Practice proposal, we urge you to become involved to rectify this denial of basic constitutional rights.

Included in this comment is recommended language for Rules of Practice which would meet constitutional and statutory requirements. This language has been developed by National Meat Association in concert with several other associations. We are confident that when you review this language, as a lawyer, as a supporter of civil rights and civil liberties, and as Secretary of Agriculture, you will agree that it provides the minimum necessary guarantees of constitutional and statutory rights.


Under the proposed Rules of Practice, an inspector-in-charge could initiate enforcement action by withholding the mark of inspection without any prior notice or opportunity for response. The inspector's action would be referred to the FSIS district office, where the withholding of inspection would be affirmed by the issuance of a Notice of Suspension. That Notice, issued after the establishment is no longer operating, would specify the reasons for suspension and the place to take an appeal. The proposal provides neither notice and an opportunity for hearing prior to withdrawal of inspection, nor for any time limit on the agency's decision once inspection is

withdrawn. This is contrary to both the Constitution and the Administrative Procedure Act. In addition, because the establishment would be out of business and incurring huge losses, the Rules of Practice would have the coercive effect of forcing an establishment to settle and penalize an establishment which wished to honestly and forthrightly advocate its position that it was operating within acceptable parameters.

The requirement that the federal government provide due process is so fundamental that it is one of the rights set forth in the Bill of Rights to the Constitution. The Fifth Amendment provides that no person shall "be deprived of life, liberty, or property without due process of law." As Justice Frankfurter explained:

"It is now the settled doctrine of this Court that the Due Process Clause embodies a system of rights based on moral principles so deeply embedded in the traditions and feelings of our people as to be deemed fundamental to a civilized society as conceived by our whole history. Due Process is that which comports with the deepest notions of what is fair and right and just."

With respect to action taken by administrative agencies, the courts have held that the demands of due process require that a hearing be held before a final order becomes effective.

The standard of due process imposed by Congress, which is applicable to the FSIS rules of practice is set forth in the Administrative Procedure Act which provides that unless a person willfully violates the law or has endangered the public health, interest, or safety:

. . . the withdrawal, suspension, revocation, or annulment of a license is lawfulonly if, before the institution of agency proceedings therefor, the licensee has been given -- (1) notice by the agency in writing of the facts or conduct which may warrant the action, and (2) opportunity to demonstrate or achieve compliance with all lawful requirements. 5 U.S.C. 558(c). (emphasis added)


The proposed rules of practice set forth procedures which were tested by FSIS in 1996 and found wanting by a United States District Court. In Velasam Veal Connection v. USDA, No. C96-02338 (N.D.Cal., July 22, 1996), the United States District Court for the Northern District of California held that 558(c) of the APA applies to FSIS suspensions of inspection and that prior to suspending inspection, the agency must provide notice and an opportunity to demonstrate or achieve compliance with the agency's requirements. In Velasam, FSIS attempted to justify its preemptory withholding of inspection on the basis that there were willful violations and/or that public health was involved. The court rejected the agency's assertions noting that these exemptions "are directed to unusual emergency situations." Slip op. at 7. In regard to the public health exemption, the court pointed out that FSIS had not made any scientific showing of harm or imminent harm. The court found no willful violation and questioned whether the withholding had been directed at any violation at all. In finding that no emergency existed, the court noted that with continuous inspection, FSIS has the ability to closely and continuously monitor an establishment, and that an agency decision growing out of such monitoring is unlikely to involve an emergency.

Prior to the present proposal, FSIS has made provision for due process in its compliance procedures. For example, FSIS' previous quality control (QC) regulations included provisions for termination of QC program approvals. 9 C.F.R. 381.145. However, these regulations allowed summary termination only where FSIS determined that the establishment had prepared or distributed adulterated or misbranded product. Where an establishment was apparently failing to follow its QC program, the QC regulations required FSIS to notify the establishment and provide thirty (30) days to come into compliance. Likewise, when dealing with packaging materials, FSIS will only suspend use prior to an administrative hearing, where the use of the material poses an imminent threat to public health, 9 C.F.R. 381.144.


To remedy the gross deficiencies of due process in the proposed rules of practice, NMA is joining with other associations in suggesting language to be promulgated as 9 C.F.R. 500.1. In preparing this suggested language, we have tried to incorporate existing protections found in the current rules of practice, as supplemented by the requirements of the APA discussed above. We also used as the framework, the due process principles set forth in our letter to you, dated January 5, 1998. These procedures are expressly designed to apply to enforcement actions taken under the agency's Pathogen Reduction/HACCP rules (Mega-Reg). Our recommended language is:

(a)In any situation in which the Administrator believes that an establishment has not complied with Parts 416 or 417 of this chapter, or has failed to comply with the regulatory requirements provided in sections 310.25(a), 310.25(b)(3)(iii), 381.94(a), and 381.94(b)(3)(iii), the Administrator shall provide the establishment written notice that includes (1) a statement that the Administrator intends to withhold inspection services or institute a proceeding to suspend or withdraw inspection services; (2) a comprehensive description of the noncompliance, as alleged by the Administrator; and (3) a description of the actions the Administrator considers necessary to be taken by the recipient to comply with the applicable regulatory requirements that would eliminate the need to withhold the mark of inspection or commence such an administrative action. The Administrator shall also provide the establishment, in writing, an opportunity, within a reasonable time, either to demonstrate that it is in compliance with applicable regulatory requirements or an opportunity to achieve compliance.

(b)If, after providing written notice and an opportunity either to achieve or demonstrate compliance regarding the matters identified in the notice, the Administrator ultimately decides to proceed to suspend or withdraw inspection services, the establishment shall be permitted to continue to receive inspection services during the pendency of such proceeding: Provided, however, that if the Administrator determines that the establishment's alleged noncompliance was either willful or that the establishment's operations while the action is pending present an imminent hazard to health, the Administrator may then withhold the mark of inspection, and any such determination to withhold the mark of inspection shall be provided to the establishment in writing and shall include an explanation as to why preventive measures proposed by the establishment are not sufficient to achieve compliance. Any such determination by the Administrator shall constitute a final agency action.

(c)If, following a proceeding conducted in accordance with the Uniform Rules of Practice, an Administrative Law Judge finds, on the basis of clear and convincing evidence, that the recipient of inspection services has repeatedly failed to comply with the requirements of the Parts 416 and 417 or sections 310.25(a), 310.25(b)(3)(iii), 381.94(a), and 381.94(b)(3)(iii) of this chapter in a manner that is material to public health, then the Administrative Law Judge may issue an order withholding the mark of inspection or suspending, or withdrawing inspection at such establishment until such time that the recipient can demonstrate compliance with the applicable requirements.

Under subsection (a) of our recommended language, where the Administrator (or the in-plant program officials) believes that an establishment is in violation of the Mega-Reg requirements, the establishment would be given written notice of the basis for that concern and a reasonable opportunity to demonstrate or achieve compliance. This is the requirement set forth in 558(c) of the APA, which was applied to FSIS actions in the Velasam case cited above.

Pursuant to subsection (a), the establishment could either agree with the decision of the program official and submit a preventive action plan to allay the concerns, or appeal the matter. In either event, under subsection (b), withholding of the mark or suspension could not be imposed except as permitted by the APA: that is, where there was shown to be a willful violation or an imminent hazard to health. In this regard, the agency should take note of the Judge's statement in Velasam that these exceptions "are directed to unusual, emergency situations." Slip op. at 7.

If, after providing written notice and an opportunity to either achieve or demonstrate compliance, the administrator was still determined to withhold the mark of inspection or to institute an action to suspend or withdraw inspection services, the establishment would still be permitted to receive inspection services during the pendency of its appeal unless the administrator were to determine either that the establishment's alleged noncompliance was willful or that the establishment's operations presented an imminent hazard to health. The administrator's determination to withhold inspection services would constitute final agency action, appealable to a United States District Court. This provision is necessary because the Department's Judicial Officer has held that the Department's existing rules of practice do not permit interlocutory appeals. In re Velasam and Simon Samson, Order dismissing appeal, dated June 25, 1996.

Our recommended language for 9 C.F.R. 500.1 will meet the agency's and the public's interest in achieving compliance with both constitutional guarantees and effective meat and poultry inspection.


Separate and apart from the lack of due process in the proposed rules of practice, the agency is also proposing to remove 9 C.F.R. 335.40 which allows persons suspected of violating the Federal Meat Inspection Act "an opportunity to present their views regarding the alleged criminal violation to the Secretary of Agriculture before FSIS refers the violation to the Department of Justice for prosecution." The opportunity to present views is a statutory regulatory entitlement for poultry processors, but in a striking denial of equity to the red meat industry, the Department is eliminating these regulations while stating that "because the PYV process can be a useful administrative procedure, FSIS will continue to use the PYV process as a matter of administrative discretion, in appropriate situations." Since the specific statutory authorization for these procedures with red meat, the Processed Products Inspection Improvement Act of 1986 (Pub. L. 99-641, Title VI), was not re-authorized by Congress in 1992, "FSIS has determined that it is unnecessary to continue to include the provision in its regulations." 63 Fed. Reg. 1799. This backing away from equity between meat and poultry contradicts the policy pronouncements of Department officials favoring equity and runs counter to the petitions of both red meat and poultry organizations seeking equity (albeit not always in the same form). Where the agency presently provides the same procedure for both meat and poultry, removing the procedure for one but not the other, is bad policy and unwarranted.


For all of the reasons stated above, National Meat Association requests that you once again become personally involved in this due process issue to ensure that constitutional and statutory rights are accorded to companies implementing and operating HACCP-based inspection. The language which we have proposed is designed to achieve these important ends.

Respectfully submitted,

Rosemary Mucklow

Executive Director