Food Safety and Inspection Service United States Department of Agriculture Washington, D.C. 20250-3700

Pathogen Reduction/HACCP &
HACCP Implementation

September 10, 1999

USDA Food Safety And Inspection Service
Quarterly Regulatory And Enforcement Report

April 1, 1999 to June 30, 1999

EXECUTIVE SUMMARY

This is the Food Safety and Inspection Service’s (FSIS) Quarterly Regulatory and Enforcement Report. Although this report focuses on regulatory and enforcement actions taken, it is important to recognize that this is only one aspect of the Agency's work. The Agency's main purpose is to protect public health by achieving compliance with laws and regulations. For example, the data indicate that plants operating under Hazard Analysis and Critical Control Point (HACCP) Systems have a 96 percent compliance rate for this reporting period.

The report provides a summary of the regulatory and enforcement actions, including those under the Pathogen Reduction/HACCP regulations, FSIS has taken to ensure that products that reach consumers are safe, wholesome, and properly labeled. FSIS inspects products produced in over 6,000 meat, poultry, and egg product plants. Since January 1998, approximately 300 large plants (those employing 500 or more employees) have been operating HACCP Systems with FSIS regulatory oversight. On January 25, 1999, approximately 2,300 small plants (those employing 10 or more, but fewer than 500 employees) began HACCP implementation. Very small plants (those employing fewer than 10 employees or with annual sales of less than $2.5 million) will phase in HACCP in January 2000.

Publication of this information is another step in the Agency's commitment to openness and transparency in its work to protect the public from adulterated or misbranded meat, poultry, and egg products.

The report is presented in sections that correspond with the category of action. Activities reported within the categories are either pending or experienced new activity during the reporting period. For example, during this quarter, FSIS detained nearly 8 million pounds of product and issued 822 warning letters for violations of law. FSIS also coordinated administrative actions, where regulatory or other authorities were applied in inspected plants, and managed USDA participation in criminal cases pending in Federal courts. These actions, along with the thousands of inspections made each day in plants throughout the country, form strong underpinnings for promoting compliance with food safety laws. Each section of this report is described and reported in more detail as follows:

FSIS ENFORCEMENT PROCESSES
NONCOMPLIANCE REPORTS AND APPEALS
PRODUCT CONTROL ACTIONS
LETTERS OF WARNING
ADMINISTRATIVE ACTIONS
CRIMINAL ACTIONS
CIVIL ACTIONS

FSIS ENFORCEMENT PROCESSES

USDA’s Food Safety and Inspection Service (FSIS) is charged with ensuring that meat, poultry, and egg products are safe, wholesome, and properly labeled. FSIS, in cooperation with state counterparts, inspects, monitors, and verifies the proper processing, handling, and labeling of meat and poultry products from the delivery of animals to the slaughterhouse to when the products reach consumers. FSIS, in cooperation with FDA and the states, provides similar coverage for egg products – the processed whole egg ingredients used in manufacturing other foods. (More information concerning egg products inspection and enforcement is provided in the FSIS publication "Focus on Egg Products" which can be accessed at: http://www.fsis.usda.gov/OA/pubs/eggprod.htm). This regulatory oversight generally reflects compliance by the large majority of businesses. However, if FSIS detects problems at any step along the way, it can use a number of product control and enforcement measures to protect consumers.

USDA has traditionally focused much of its effort on the plants that slaughter food animals and process products. USDA ensures that products at these establishments are produced in a sanitary environment in which inspectors or plant employees identify and eliminate potential food safety hazards. These establishments must apply for a grant of inspection from FSIS and demonstrate the ability to meet certain requirements for producing safe, wholesome, and accurately labeled food products. Requirements include meeting sanitation, facility, and operational standards and, through new requirements now being implemented, having preventive systems in place to ensure the production of safe and unadulterated food. Products from official establishments are labeled with the mark of inspection, indicating that they have been inspected and passed by USDA and can be sold in interstate commerce.

FSIS uses Compliance Officers throughout the chain of distribution to detect and detain potentially hazardous foods in commerce to prevent their consumption and to investigate violations of law. Even if products are produced under conditions that are safe and sanitary, abuse on the way to the consumer, for example, if transported in trucks that are too warm or if exposed to contamination, can result in product that can cause illness or injury. FSIS has recognized a need to spend increasing amounts of its energy on activities to promote safe transporting, warehousing, and retailing of meat, poultry, and egg products, and is moving forward on these efforts.

FSIS also works closely with USDA’s Office of Inspector General, which assists FSIS in pursuing complex criminal cases. In addition, many state and local jurisdictions have enforcement authorities that apply to USDA regulated products. FSIS cooperates with these other jurisdictions in investigations and case presentations. FSIS also participates with OIG and the U.S. Department of Justice in monitoring conditions of probation orders and pretrial diversion agreements developed to resolve cases.

In January 1997, FSIS began implementing new requirements in plants that produce meat and poultry. New regulations, entitled "Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems," require that federally inspected meat and poultry plants: (1) develop and implement a preventive HACCP plan; (2) develop and implement Sanitation Standard Operating Procedures (SSOP’s); (3) collect and analyze samples for the presence of generic E. coli, and record results; and (4) meet Salmonella performance standard requirements. These new requirements are designed to help target and reduce foodborne pathogens. All plants have already implemented SSOP’s and, as appropriate, are phasing in the other requirements. All large plants—accounting for most federally inspected meat and poultry sold—must now meet the requirements for HACCP Systems. Approximately 2,300 additional plants began implementing HACCP in January 1999. By the year 2000, HACCP implementation will be complete, even in the smallest plants.

This report provides a summary of the regulatory and enforcement actions, including actions that address the Pathogen Reduction/HACCP regulatory requirements, FSIS has taken to ensure that products that reach consumers are safe, wholesome, and properly labeled. The Agency recognizes that this report is a snapshot in time of a dynamic process. Some information will be out-of-date by the time this report is published (approximately one month after close of reporting period), and more current information will not be included. For example, many matters shown as under appeal will have been resolved by the time this report is published. Other actions could be appealed or closed after this reporting period. This information will be updated on a quarterly basis and made available to the public through future reports.

NONCOMPLIANCE REPORTS AND APPEALS

FSIS inspection program personnel perform thousands of inspection tasks and procedures each day to determine whether or not inspected plants are in compliance with regulatory requirements. Each time inspection program personnel make a non-compliance determination they complete a report explaining the nature of the regulatory action. They notify plant managers of problems by a written Noncompliance Report (NR) or, in plants that have not yet implemented HACCP, a Process Deficiency Record (PDR). NRs and PDRs document noncompliance determinations that occur in the plant’s sanitation and other controls and notify the plant that it must take action to remedy a problem and prevent its recurrence. If this is done, the plant will continue to operate without interruption. Problems reported on NRs and PDRs vary from minor labeling discrepancies to serious breakdowns in food safety controls. When deficiencies occur repeatedly or when the plant fails to prevent adulterated product from being shipped, FSIS takes action to control products and may take an action to withhold or suspend inspection.

As of June 30, 1999, approximately 300 large plants (plants with 500 or more employees) and approximately 2,300 small plants (plants employing 10 or more, but fewer than 500 employees) operated under HACCP-based inspection. Approximately 3,400 very small plants operated under traditional inspection. Because monitoring and documentation requirements in the two systems differ, the number and type of NRs and related appeals for HACCP plants cannot be accurately compared to the number and type of PDRs and related appeals for traditional plants. Plants can appeal NRs, PDRs, and other inspection decisions at various levels in the Office of Field Operations, within FSIS. FSIS has emphasized that appeals are both expected and appropriate to resolve legitimate disagreements. FSIS encourages plants to make their appeals in a timely manner. A tracking system for monitoring industry appeals became operational on May 11, 1998.

Table 1a provides numbers of NRs and PDRs issued by FSIS inspection personnel between April 1, 1999 and June 30, 1999. During this period, FSIS performed 1,115,001 inspection tasks at non-HACCP plants and 766,433 at HACCP plants. Table 1b shows the number of appeals and the dispositions of the appeals filed at traditional (non-HACCP) plants and at HACCP plants, from April 1 to June 30, 1999.

Table 1a. Process Deficiency Record and Noncompliance Report Totals

Table 1b. Appeals of PDRs and NRs (4/1/99--6/30/99)

(Total exceeds 80 because some plants filed multiple appeals.)

PRODUCT CONTROL ACTIONS

FSIS takes product control actions to gain physical control over products when there is reason to believe they are adulterated or misbranded. The actions ensure that those products do not enter commerce or, if they are already in commerce, that they do not reach consumers.

In official establishments, FSIS inspectors may retain products whenever there is evidence of unwholesomeness, or if products are adulterated or mislabeled. FSIS inspectors condemn animals for disease, contamination, or adulteration to prevent their use as human food. Figures for condemnations for livestock for the reporting period are as follows: FSIS inspected 18,507,427 livestock carcasses, of which 40,051 carcasses were condemned. FSIS inspected 1,130,211,157 poultry carcasses, of which 13,034,327 carcasses were condemned.

Detentions

After products are distributed from plants, FSIS Compliance Officers detain any that may be adulterated or misbranded. FSIS then has 20 days to request a Federal court to seize the product (see Civil Actions). Table 2 provides the number of detentions and the pounds of product involved in these actions for meat and poultry, reported in total and by FSIS District Office, for this quarterly reporting period. Most detentions result in voluntary disposal of the product and do not require court seizures.

Table 2. Detention Summary
(4/1/99 ¾ 6/30/99)

Recalls

A recall is a voluntary action by a firm to remove adulterated, misbranded, or suspect products from distribution. FSIS cannot require recalls but can recommend and monitor those that occur. Class I recalls involve a health hazard when there is a reasonable possibility that the use of the product will cause serious adverse health consequences or death. Class II recalls involve a health hazard when there is a remote probability of adverse health consequences from use of the product. Class III recalls involve a situation in which use of the product is not likely to cause adverse health consequences. For current information on recalls, go to the FSIS recalls web page at: http://www.fsis.usda.gov/OA/news/xrecalls.htm

Import Inspections

FSIS maintains a comprehensive system of import controls to carry out the requirements of the Federal meat, poultry, and egg products inspection laws to ensure the wholesomeness of imported products. The system of import controls involves two major components: oversight and reinspection. FSIS conducts a rigorous review of an exporting country’s controls to ensure they are equivalent to those of the United States, prior to the country’s eligibility to export to the United States. Reinspection of meat, poultry and egg products that enter the U.S. is based on statistical sampling and verifies the country’s inspection system is working. A product that fails to meet U.S. requirements is refused entry into this country. The product must be re-exported, destroyed or, in some cases, converted to animal food. Table 3 provides the total number of presented lots and pounds of imported meat and poultry products presented, reinspected, and refused entry during the period from April 1 to June 30, 1999.

Table 3. Imported Meat, Poultry and Egg Products
(4/1/99--6/30/99)

LETTERS OF WARNING

FSIS issues letters of warning (LOW) for minor violations of law that are not referred to United States Attorneys for prosecution. FSIS may also issue these warnings when a United States Attorney declines to prosecute a case or bring action against a specific business or person. These letters warn that FSIS may seek criminal action based on continued violations. Letters of warning may be issued to any individual or business, including Federal plants, wholesalers, distributors, restaurants, retail stores and other entities that process, store, or distribute meat and poultry products. Table 4 shows letters of warning issued by headquarters and by each of the eighteen FSIS District Offices during the reporting period.

Table 4. Letters of Warning for Criminal Actions
(4/1/99 ¾ 6/30/99)

ADMINISTRATIVE ACTIONS

FSIS inspects meat and poultry products and applies the marks of inspection when inspectors are able to determine that products are not adulterated. FSIS may temporarily withhold the marks of inspection from specific products, suspend inspection, or withdraw a grant of inspection if a plant is not meeting crucial requirements.

Withholding the Marks of Inspection

If a plant fails to prevent preparation and shipment of adulterated products or develops a pattern of noncompliance showing the plant’s sanitation or process control systems have failed, the Inspector-in-Charge notifies plant managers that the USDA mark of inspection is being withheld from some or all of the products in the plant. This action effectively shuts down affected operations, because it is illegal to sell products in interstate commerce that do not bear the USDA mark of inspection. Other non-affected parts of the plant, if any, may still operate.

Suspension of Inspection

FSIS may temporarily suspend inspection if a plant fails to present a corrective action plan to bring the plant sanitation or process control systems into compliance. As with withholding actions, a suspension shuts down all or part of the plant’s operations. USDA may hold in abeyance the suspension action if corrections are presented, put into effect, and effectively prevent additional problems. FSIS District Offices have established procedures to monitor and verify activities in plants where the suspension is being held in abeyance.

Notification to Establishments of Intended Enforcement Actions

In April 1998, FSIS established a procedure for notifying establishments of intended enforcement actions related to certain HACCP System inadequacies that have not resulted in actual shipment of adulterated products. Under this procedure, a notice will be issued to an establishment when the Inspector-in-Charge determines that a HACCP System inadequacy has occurred because the establishment has experienced multiple, recurring noncompliances and has failed to implement corrective and preventive measures to prevent a HACCP System inadequacy. The "Notice" informs the establishment that the nature and scope of the noncompliances indicate that their HACCP System is inadequate and, because of the trend of noncompliances, FSIS intends to withhold the marks of inspection and suspend inspection. The "Notice" explains the basis and references documentation for the intended enforcement action, and provides the establishment an opportunity to demonstrate why a HACCP System inadequacy determination should not be made or that the plant has achieved regulatory compliance.

Withdrawal of Inspection

In some situations, FSIS may decide that it is necessary to withdraw inspection from a plant. In these cases, FSIS withdraws inspection from a Federal plant by filing a complaint with the USDA Hearing Clerk. The plant may request a hearing before an Administrative Law Judge. If the action is based on insanitation, the plant will remain closed while proceedings go forward. In other cases that do not involve a threat to public health, operations may continue. These actions are often resolved by FSIS and the plant entering into a consent decision, which allows the plant to operate under certain specified conditions. Once inspection is withdrawn, a closed plant must reapply to receive Federal inspection.

USDA may initiate withholding, suspension, or withdrawal actions to limit a plant’s slaughtering or processing, or prevent the plant from operating altogether, based on any of the following reasons related to the PR/HACCP regulations:

• failure to collect and analyze samples for the presence of generic E. coli and record test results,
• failure to develop or implement Sanitation Standard Operating Procedures,
• failure to develop or implement a required HACCP plan, or
• failure to meet applicable Salmonella performance standard requirements.

In addition, USDA may initiate a withholding, suspension, or withdrawal action for any of these other reasons:

• insanitary conditions,
• inhumane slaughtering of livestock,
• failure to destroy condemned product, or
• interference with inspection personnel.

Tables 5, 6, and 7 list administrative actions (other than actions based on convictions) by establishment, initiated, pending, or closed, for the quarter, along with whether the action is based on an SSOP or HACCP Systems failure, or for some other reason, such as inhumane slaughter. In some plants, FSIS may find more than one basis for taking enforcement action or may take more than one action. For example, the plant has sanitation problems and is not conducting E. coli testing, or a sanitation problem occurs more than once. Tables 5 and 6 list these actions taken at large and small plants now operating under HACCP. Table 7 lists actions at plants still operating under traditional inspection. A plant is placed in a table dependent upon its size and whether HACCP is implemented. The enforcement action can be for any of the identified reasons. During this period, activity is reported concerning seventy-eight (78) plants. Thirty-four of the actions in these plants were initiated during this reporting period. Twenty-nine actions were also closed by letter of warning or other means during this period.

With regard to suspensions taken at small HACCP plants, Table 6 also identifies plants where suspension action was taken, but held in abeyance for a 90 day period. Certain small plants failed to fully meet basic regulatory requirements for HACCP implementation, in January, but had demonstrated positive efforts to do so. Given these efforts to comply with the regulations, FSIS allowed plants to complete their HACCP implementation and held the suspension action in abeyance.

Tables 5, 6, and 7 also identify those cases in which an appeal of the withholding or suspension action has been made, along with whether the appeal was granted or the administrative action was sustained (appeal denied). When decisions on appeals have not been made during the period of this report, the appeal is shown as pending and will be reported in the next quarterly report. During this period, a decision was reached concerning one appeal.

Table 5. Administrative Actions: Large HACCP Plants
(4/1/99 - 6/30/99)

Table 6. Administrative Actions: Small HACCP Plants
(4/1/99 - 6/30/99)

Table 7. Administrative Actions: Non-HACCP Plants
(4/1/99 - 6/30/99)

Withdrawal for Unfitness

Under the statutes it administers, FSIS also can move to withdraw inspection, after opportunity for a hearing, based on the unfitness of an applicant for, or a recipient of inspection, because of a felony conviction or more than one violation involving food. Table 8 identifies actions pending or taken (other than outstanding consent decisions) on this basis for this reporting period.

Table 8. Withdrawal for Unfitness
4/1/99-6/30/99

Removing Custom Exempt Privilege

The meat and poultry laws exempt certain operations from inspection. Custom exempt businesses slaughter animals or process meat for owners of the animals or products. When insanitary conditions create health hazards, FSIS may remove custom exempt privileges and require the plant to cease operations until sanitary conditions are restored. FSIS can also take action when custom facilities fail to properly label product as "Not for Sale." These businesses have the opportunity to correct violations prior to such actions. There were no new actions this reporting period.

CRIMINAL ACTIONS

If evidence is found that a person or business has engaged in violations of the Federal Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act, USDA may refer the case to the appropriate United States Attorney to pursue criminal prosecution. Conviction for a criminal offense can result in a fine, imprisonment, or both. Table 9 lists criminal actions and criminal cases in categories according to the status of the case, which may be indictment or information issued; pleas, convictions, or acquittals, and sentences rendered during this reporting period.

Table 9. Criminal Actions
(4/1/99 – 6/30/99)

Pre-Trial Diversion Agreements

In certain situations, United States Attorneys may enter into pre-trial diversion (PTD) agreements. Under these agreements, the government agrees not to proceed with criminal prosecution if the alleged violator meets certain terms and conditions. The terms and conditions of a PTD are tailored to fit each individual case. A PTD typically lasts twelve months. FSIS monitors these agreements so that we can assist the U. S. attorneys in determining whether prosecution should be re-instituted. If the divertee successfully completes the program, no criminal charges are filed. If, on the other hand, the divertee does not successfully complete the program, criminal charges are reinstated. This report discusses pre-trial diversion agreements in effect since the beginning of FY 1999. Future reports will show any new agreements and any change in the status of previous agreements. There were three pre-trial diversion agreements in effect for this quarter. Two involved the president and the manager of a cold storage facility who agreed to invest personal funds toward facility improvements and perform community service. Another involved the president of a food distributorship who was required to institute effective rodent control. These cases are still being monitored. There was one pre-trial diversion agreement initiated this quarter that involved a firm having approximately two thousand retail stores and fourteen distribution centers nationwide. The firm was responsible for having caused meat to be become adulterated, and for distributing the adulterated meat. This firm agreed to implement nationwide food safety and sanitation training programs at all its retail store and distribution center locations.

CIVIL ACTIONS

FSIS also has authority to seek a variety of civil actions in Federal Court.

Seizures

When FSIS has reason to believe distributed products are adulterated or misbranded, the Agency will, through the U.S. Attorney, institute a seizure action against the product. The product is held pending an adjudication of its status. If the court finds that the product is adulterated or misbranded, it will condemn the product. Condemned product is destroyed, sold, or, upon posting of an appropriate bond, returned to its owner to be brought into compliance with the law. Condemned product cannot be further processed to be used for human food. One seizure was initiated by FSIS during this reporting period.

Table 10. Seizure Actions
(4/1/99-6/30/99)

Injunctions

FSIS, through the U.S. Attorney, may request a U.S. District Court to enjoin repetitive violators of the FMIA, PPIA, or EPIA. The Agency seeks injunctions to stop uninspected retail stores from processing products without required inspection for wholesale business or to prevent or restrain other violations of law. There were no injunctions entered during the reporting period. Currently 29 firms are under injunctions.

False Claims Act Violations

The Department of Justice Affirmative Civil Enforcement (ACE) program is used by U.S. Attorneys to recover damages when a violation of law involves fraud against the Federal government. Under the False Claims Act, the government may recover three times its estimated losses. FSIS typically seeks action under this program for cases involving products, not in compliance, sold to the military, to public schools engaged in the school lunch program, or to other Federal institutions. ACE program actions are generally in lieu of criminal prosecution. There are no new actions to report this reporting period.

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