NATIONAL MEAT ASSOCATION
1970 Broadway, Suite 825
Oakland, CA 94612
Ph. 510-763-1533 * Fax 510-763-6186
Email [email protected] * http://www.hooked.net/users/nma/
November 22, 1996
Thomas Billy, Administrator
Food Safety & Inspection Service
United States Department of Agriculture
Washington, DC 20250
Re: HACCP Compliance Comments
Dear Tom:
The preface to the Food Safety and Inspection Service's (FSIS) final Pathogen Control/ HACCP Regulation invites comments and suggestions on enforcement, alternative dispute resolution and due process issues regarding HACCP systems. See, Fed. Reg. 38823, July 25, 1996. The National Meat Association is a non-profit trade association representing meat packers and processors, as well as equipment manufacturers and suppliers who provide services to the meat industry. The association, with over 700 members throughout the United States, includes membership in Canada, Australia and Mexico. NMA respectfully responds to FSIS' invitation for comments.
A major problem with the proposed rules of practice in the agency's original proposal, was that they contained a serious lack of due process. (See proposed 326.7 and 335.33 at Fed.Reg. 6842-6843, Feb. 3, 1995.) Specifically, the rules of practice provided insufficient due process to support the sanction of withdrawal of inspection. This lack of due process was of great concern to inspected establishments and to Department officials.
The originally proposed regulations provided that if an establishment did not have a valid HACCP plan, the agency could first refuse inspection and then withdraw inspection. There were basically three reasons for which FSIS could find a plant's HACCP plan invalid and begin the process for withdrawal of inspection: (1) the HACCP plan did not comply with the regulations; (2) there was a recordkeeping deficiency; or (3) some processing problem led to adulteration of product. (See proposed 326.7(c)(2), 60 Fed. Reg. 6843.) If FSIS made any of these findings, an establishment would not be allowed to label product as inspected and passed until it took whatever corrective actions were specified by the Administrator. If the establishment failed to take the specified corrective actions, or if the alleged deficiency continued, then the Administrator would proceed to file a complaint seeking to withdraw inspection. (See proposed 335.33, 60 Fed. Reg. 6843.) Immediately upon the filing of the complaint, inspection would be withdrawn until the conclusion of the agency's hearing. (See proposed 335.33 supra.) This is a rather unusual compliance
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Thomas Billy, Administrator
Food Safety & Inspection Service
United States Department of Agriculture
Washington, DC 20250
Page 2
November 22, 1996
procedure: with the filing of the complaint, there would effectively be an immediate preliminary injunction and the establishment would be out of business.
If we compare this original proposal with the present withdrawal of inspection provisions of the Federal Meat Inspection Act, 21 U.S.C. Sec. 671, there is a major difference in the availability of due process. Under the present law, if an inspected company or an individual who is "responsibly connected" with an establishment is deemed to be "unfit to engage in any business requiring inspection," the agency may issue a complaint and obtain a hearing on that complaint before an administrative law judge (ALJ). During the course of that hearing, the establishment remains open and under inspection. If, after this hearing, the presiding ALJ determines that the establishment is unfit to process meat, then inspection is withdrawn. Contrast this with the originally proposed HACCP compliance procedures. If an establishment is alleged to be out of compliance, its HACCP program can be withdrawn immediately; thus, the company is effectively out of business.
FSIS' proposed compliance procedures are also at odds with the withdrawal provisions of other federal food statutes, such as the Food, Drug and Cosmetic Act's provisions regarding animal drugs. 21 U.S.C. Sec. 360b(e). The Food, Drug and Cosmetic Act provides that where the Secretary of Health and Human Services (HHS) decides that there is a problem with an approved animal drug, the Secretary can, after due notice and an opportunity for hearing, issue an order withdrawing approval of an application filed with respect to the new animal drug. In extreme situations where the Secretary finds that there is an imminent hazard to the health of man, or of the animals for which the drug is intended, she may immediately suspend the approval of such application. However, she must give the applicant prompt notice of this action and afford the applicant the opportunity for an expedited hearing. The authority conferred on the Secretary of HHS to suspend an animal drug approval cannot be delegated. Thus, if there is an imminent threat to health, the approval of the animal drug can be peremptorily withdrawn, but only by the individual and personal action of the Secretary of HHS.
The agency's Pathogen Reduction and HACCP regulations should contain the same due process protections which have always been available under federal food statutes when inspection or approvals have been withdrawn. Due process should include notice to the establishment of the specific allegations against it, an opportunity to correct the specific misconduct alleged, an expedited hearing opportunity at FSIS, and an expedited review by a United States District Court.
Absent these due process protections, an inspected company may be prevented from operating during the course of the hearing procedure. Although an ALJ may later find that the establishment committed no wrongdoing, summary withdrawal of inspection would put most
establishments out of business. It is simply unfair, and not supported by the underlying law, to
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Thomas Billy, Administrator
Food Safety & Inspection Service
United States Department of Agriculture
Washington, DC 20250
Page 3
November 22, 1996
shut down an establishment's operations for weeks or months during the resolution of a dispute over its HACCP plan.
The lack of due process also puts USDA personnel at great personal risk. The Supreme Court's Economou v. Butz decision provides precedent that persons who are denied due process in USDA enforcement proceedings may seek damages against the Secretary and his subordinates. Thus, lack of due process is not only a great risk to a processing plant, but also a risk to agency officials.
The lack of due process in the proposed rules of practice can be cured. Due process does exist with the present statutory provisions for withdrawal of inspection. Due process does exist in the animal drug provisions of the Food, Drug and Cosmetic Act. Thus, due process can be provided under the Pathogen Reduction/HACCP Regulation. Although summary withdrawal can be justified where there is an imminent hazard to health, it cannot be justified where there is an honest dispute over what constitutes compliance.
If final regulations fail to provide due process, due process will be provided by the courts. In a recent case in California, USDA summarily suspended inspection service from a small processor prior to providing a hearing. After failing to obtain pre-hearing relief from the USDA ALJ, the processor proceeded to District Court, alleging that the USDA lacked the statutory authority to suspend inspection prior to a hearing. The District Court held that before USDA could suspend inspection, it had to comply with the Administrative Procedure Act and that the Department could only suspend inspection prior to a hearing if there was either: (a) willful noncompliance with the law, or (b) a public emergency.
Compliance procedures represent the most significant element of the Pathogen Reduction/ HACCP Regulations not yet finalized. This is an important issue which has apparently been under active discussion within the Department. Department officials should substantially amend the compliance provisions which were originally proposed and develop compliance regulations which incorporate Constitutionally sufficient due process.
NMA appreciates the opportunity to submit the above comments in this matter. We would appreciate it if you would file our comments with the appropriate record on this matter.
Thank you very much.
Sincerely,
(signature: Rosemary Mucklow)
Rosemary Mucklow
Executive Director