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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
Presented by Carol Seymour, Assistant Deputy Administrator, District Enforcement Operations for Field Operations, Food Safety and Inspection Service, before the Food and Drug Law Institute's Food Regulatory Update '97, Washington, D.C., June 3, 1997.
Last year FSIS introduced new enforcement strategies that complement new regulations for HACCP and Pathogen Reduction. Today, I want to describe the underlying shift in FSIS culture that led us to adopt this new strategy and discuss the principles that will guide our future enforcement strategies.
The statutes that direct the U.S. Department of Agriculture and the Food and Drug Administration to regulate foods are very similar, but differ in two important respects. First, the statutes USDA administers impose Federal enforcement authorities directly on interstate commerce and indirectly on intrastate commerce through requirements that States operate comparable programs. Second, the statutes impose mandatory inspections by government employees of virtually all meat and poultry entering the commercial food supply.
This inspection mandate gives USDA its most powerful enforcement tool--the ability to intervene directly in the production process and retain, detain, or condemn any non-complying products before they can pose a risk to consumers. Historically, it is our most resource intensive enforcement activity, accounting for well over ninety percent of the FSIS budget and dictating to a large degree our enforcement priorities and organizational culture.
FSIS also uses an array of other enforcement authorities, including seeking criminal, civil, and administrative remedies. Historically, FSIS has most often sought criminal referrals for the most serious violations of the meat and poultry statutes. FSIS has used civil injunctions against non-Federally-inspected establishments, such as retail stores that violate regulatory limits on the amount of uninspected meat and poultry products they can sell to restaurants and institutions. In federally-inspected establishments, FSIS uses regulatory authorities to withhold the mark of inspection or brings administrative actions to withdraw the grant of inspection. The withdrawal of inspection is one of the strongest regulatory powers in our Federal Government. It literally takes away the firm's right to do business.
On July 25, 1996, FSIS published the Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems regulation. It requires meat and poultry establishments to prevent contamination through Sanitation Standard Operating Procedures, to meet national performance standards for Salmonella, and to adopt the science-based process control system called HACCP.
This regulation represents a major philosophical change for FSIS and demands a new enforcement strategy. Under traditional inspection, the finding that product is not adulterated is based on FSIS inspectors examining the product. Under the new regulatory framework, the finding that product is not adulterated is based on FSIS concluding that the establishment's food safety and sanitation control systems are preventing adulteration. It provides a clear distinction that industry is fully responsible for the compliance of the products it produces and markets.
The traditional system bases enforcement actions on the concept that FSIS inspectors document deficiencies and establishments correct them. The new system, however, focuses on prevention, rather than detection, of problems. As long as establishments maintain their control systems properly--including detecting, documenting, and correcting unavoidable deficiencies--FSIS will not need to take enforcement action.
Under the new prevention-oriented system, when a plant finds deficiencies, it means that its control systems are working. It is when problems are not detected, or not corrected, or the same problems keep occurring, that there is reason for concern. In these cases, FSIS inspectors, with assistance from enforcement officers, will not allow products to be marked "inspected and passed" and, thus, marketed, until the establishment addresses the product in question and provides reasonable assurances that corrections will lead to safe practices.
The new FSIS enforcement strategy meets three important criteria. First, it gives the public confidence that establishments are meeting their food safety responsibilities. Second, it promotes industry accountability. Third, it recognizes that FSIS is also accountable--accountable for fair and consistent enforcement actions and for providing procedural due process to businesses faced with enforcement actions.
The changes made in the enforcement area last year, although significant, are only a first step. FSIS will follow a series of design principles for enforcement as we move to enhance protection and prevent hazards from farm to table.
The primary objective of FSIS enforcement is to deter violations and assure that the thousands of businesses and individuals engaged in preparing, packing, shipping, storing, and delivering meat and poultry products are accountable for food safety. Our strict liability statutes place the responsibility on the regulated industries for preventing contamination and assuring proper labeling. Although industry accountability is not a new concept, we will emphasize it by targeting serious cases of negligence as well as intentional violations. While we intend to give regulated businesses every opportunity to comply, we also intend to vigorously pursue civil, criminal and administrative remedies when businesses put consumers at risk.
A second design principle involves reducing delays. Enforcement actions, by their very nature, are often time-consuming and fraught with procedural and other delays. While some delays are unavoidable and others are appropriate to assure due process, FSIS is committed to reducing or eliminating unnecessary delays that expose the public to unsafe or deceptively labeled foods. FSIS is implementing improvements that involve new technologies such as expanded use of computers and digital cameras to prepare and forward case files for action. Others changes are procedural, to efficiently review case documentation and make decisions to proceed. Still others involve speedier resolutions through such means as civil injunctions or administrative proceedings to suspend or withdraw inspection. These alternative resolutions might be considered in addition to or as alternatives to criminal prosecutions.
The third design principle requires us to make more efficient use of our resources. In the future, the FSIS workforce will be better trained and equipped to focus on its primary role of assuring compliance with the statutes and regulations. In the past we have focused primarily on inspecting products to sort out unsuitable meat and poultry. In the future, inspectors, aided by compliance officers, will concentrate on documenting breakdowns in required controls and other violations that could subject firms and individuals to enforcement actions.
FSIS regulates more than 7,000 businesses that slaughter animals and poultry and prepare meat and poultry products. Well over 90 percent of our current resources are used for this in-plant inspection. In addition, either directly or through state cooperative agreements, FSIS enforces the adulteration and misbranding provisions through distribution channels and retail, until the products reach the ultimate consumer. Less than four percent of our resources are devoted to these enforcement tasks. FSIS is developing an inspection model based on the prevention concepts of HACCP that will more effectively prevent violations. We will present this model for public dialogue, notice, and comment. We believe that more cost effective methods will actually improve compliance by inspected establishments and free up resources for monitoring distribution channels and retail for adulteration in products.
The fourth principle is to strengthen FSIS's partnerships with States. Since the E. coli O157:H7 outbreak in 1993, FSIS has redefined its parameters of enforcement to reach from the farm to the table. We have traditionally worked closely with state and local law enforcement agencies to refer information about possible violations and have often assisted them in documenting and prosecuting cases. These contacts have been both efficient, in making the best use of federal and state investigatory resources, and effective, in bringing cases in the most appropriate venue. On the horizon, we envision working with the Association of Food and Drug Officials (AFDO) and other organizations to coordinate monitoring of compliance in the food distribution chain and to identify the best ways for the new FSIS District Offices to work closely with states in developing and prosecuting cases.
Equity in sanctions is our fifth principle. FSIS has known for many years that equity in enforcement starts with regulations that apply uniformly across product lines and across the demographics of the regulated industries. We have also recognized the need to provide adequate notice of violations and an opportunity to comply. The next step is to ensure uniformity in decisions to document cases referred for prosecution. For example, absent other extenuating circumstances, it is unacceptable for a case involving mice in a warehouse to be treated as a minor violation in one area of the country and prosecuted as a felony in another area.
With the new FSIS organization, the 18 District Managers will manage their resources consistent with Agency priorities, including enforcement resources. To allow flexibility and still maintain uniformity among the districts, the Agency will:
Use more definitive language in regulations and preambles to better define what enforcement actions will be taken for regulatory violations;
Monitor and coordinate district case dispositions and actions on appeals to promote uniformity and equity; and
Develop national investigatory guidelines and protocols. This latter approach is particularly important since most significant cases documented by FSIS involve violations occurring in more than one district.
As a sixth design principle, FSIS will continue to identify ways to use our statutory authorities and regulatory enforcement as deterrents. For example, we are rethinking our current tendency to rely on criminal prosecutions as the primary remedy for violations. Given the competition for time in U.S. Attorneys' offices, and the overcrowded dockets of many courts, many cases are delayed and some worthwhile cases may never be brought. Also, courts may be reluctant to impose large fines or prison terms for non-violent cases, despite the potential for injury or death. Thus, while we are by no means abandoning criminal prosecutions, we are considering selective use of the following alternatives:
The Affirmative Civil Enforcement program which allows the government to seek and recover large fines as penalties when the violation involves harm to the government, such as sales under school lunch or military feeding programs.
Civil injunctions through which the government seeks the intervention of Federal courts to restrain or prevent future violations based on repetitive non-compliance.
Pre-trial abatement programs in which the government agrees to forego prosecution of the alleged violator based on an agreement that the violator will implement extraordinary measures to prevent future violations.
Broader publicity of agency requirements, including clear performance standards and available remedies for non-compliance, so there can be little doubt what firms must do to comply and what action they can expect if they violate the requirements.
Greater reliance on marketplace forces to encourage prevention of violations through, for example, contract provisions between private parties that include verification measures that go beyond the limits of government regulatory authority.
We already have authority to use these measures and we will use them selectively. We do not envision a future in which we would use these alternatives to the exclusion of criminal prosecution. Instead, we see them as effective alternatives or supplements to the primary approach in a number of cases.
In the final analysis, we expect that public outrage over violations of food safety and truthful labeling laws and the expectation of punishment will always serve as the most effective deterrents. We are mindful of the outrage that accompanied the E. coli outbreak involving fast food hamburgers. We will base future enforcement strategies on the idea that the public must have confidence that the government will protect it from negligence or wrongdoing anywhere in the marketing chain. Food adulteration, deceptive labeling, and other forms of fraud are crimes against consumers that must be prevented or subject to strong sanctions.
In a remarkable four years, FSIS has come a long way in revamping and improving its enforcement approach and procedures, particularly as they relate to federally inspected slaughter and processing plants. The work done to enforce the 1996 regulatory changes, coupled with changes anticipated by the design principles just outlined, will support a farm-to-table enforcement approach for the future.
For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Public Outreach and Communications
Phone: (202) 720-9352
Fax: (202) 720-9063
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