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

Pathogen Reduction/HACCP & HACCP Implementation

July 20, 2000

USDA Food Safety And Inspection Service
Quarterly Regulatory And Enforcement Report

January 1, 2000 through March 31, 2000

EXECUTIVE SUMMARY

This is the Food Safety and Inspection Service’s (FSIS) Quarterly Regulatory and Enforcement Report. 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. 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.

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. On January 25, 2000, approximately 3,400 very small plants (those employing fewer than 10 employees or with annual sales of less than $2.5 million) began HACCP implementation.

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 over 17 million pounds of product and issued 639 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.

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. 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, up until January 25, 2000, at very small plants that had yet not implemented HACCP, by a Process Deficiency Record (PDR). With the implementation of HACCP requirements at very small plants on January 25, 2000, the PDR system to document noncompliance was eliminated.

NRs 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 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 March 31, 2000, approximately 300 large plants (plants with 500 or more employees), approximately 2,300 small plants (plants employing 10 or more, but fewer than 500 employees), and approximately 3,400 very small plants (plants employing fewer than 10 employees or with annual sales of less than $2.5 million) operated under HACCP-based inspection. 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. FSIS maintains a tracking system for monitoring industry appeals.

Table 1a provides numbers of NRs issued by FSIS inspection personnel. The NR’s referenced in Table 1a were issued between January 1, 2000 to March 31, 2000. During this period, FSIS performed 1,367,930 inspection tasks at HACCP plants. There is no computer system data available for the number of inspection tasks or appeals performed at non-HACCP plants for the period January 1, 2000 through January 24, 2000 because the computer system for collecting this information was discontinued in preparation for HACCP implementation at very small plants. Table 1b shows the number of appeals and the dispositions of the appeals filed at HACCP plants, from January 1, 2000 to March 31, 2000.

Table 1a. Noncompliance Report Totals

Table 1b. Appeals of NRs (1/1/00 -- 3/31/00)

  (Total exceeds 102 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 21,371,678 livestock carcasses, of which 62,792 carcasses were condemned. FSIS inspected 1,705,925,208 poultry carcasses of which 18,771,387 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
(1/1/00 -- 3/31/00)

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 involves 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 January 1, 2000 to March 31, 2000.

Table 3. Imported Meat, Poultry and Egg Products
(1/1/00 -- 3/31/00)

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
(1/1/00 -- 3/31/00)

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.

Effective January 25, 2000, FSIS amended its Rules of Practice that apply to Agency enforcement actions. The Rules of Practice, which are located in 9 CFR Part 500, define each type of enforcement action FSIS can take, the conditions under which it is likely to take these actions, and the procedures FSIS will follow in doing so.

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 the assignment of inspectors 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

FSIS has an established procedure to notify establishments of intended enforcement actions related to certain types of noncompliance that have not resulted in actual shipment of adulterated products. Under this procedure, a notice is issued to an establishment when the Inspector-in-Charge determines that the establishment has experienced multiple, recurring noncompliances, or for other reasons, as specified in the Rule of Practice, and the establishment and has failed to implement corrective and preventive measures to prevent a system inadequacy. The "Notice" informs the establishment that the nature and scope of the noncompliance indicates that their HACCP system, or other system, is inadequate and, that FSIS intends to withhold the marks of inspection and suspend the assignment inspectors. The "Notice" explains the basis and references documentation for the intended enforcement action, and provides the establishment an opportunity to demonstrate why a 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.

As specified in the Rules of Practice, 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 reasons related to the PR/HACCP regulations such as:

• 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 other reasons such as:

• 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. These tables list actions taken at large, small, and very small plants. The enforcement action can be for any of the identified reasons. During this period, activity is reported concerning 138 plants. Seventy-eight of the actions in these plants were initiated during this reporting period. Thirty-nine actions were closed by letters of warning or other means during this period.

Tables 5, 6, and 7 also identify those cases in which an appeal of the withholding or suspension action may have 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, three appeals were filed or acted on.

With regards to suspensions taken at very small HACCP plants, some very small plants failed to fully meet basic regulatory requirements for HACCP implementation in January but had demonstrated positive efforts to do so. Given their effort to comply with the regulations, FSIS allowed certain plants to complete HACCP implementation, and held the suspension in abeyance. Generally the abeyance period provided to most of these very small plants that failed to meet basic HACCP requirements was for an 180 day period. Table 7 identifies suspensions initiated at very small plants for their failure to meet basic HACCP requirements. 

NOTE: Tables 5, 6, and 7 are contained in a separate document. The tables document is 186 KB in size. Estimated download time is 60 sec. over a 56.6 connection (118 sec. at 28.8).  You may return to this point after viewing the tables. [Click to view Tables 5, 6, 7]

Withdrawal for Unfitness

Removing Custom Exempt Privilege

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. FSIS frequently 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 may be reinstated. There were two pre-trail diversion agreements this quarter.

The first PTD involved a wholesale distributor which allegedly sold and transported approximately 2,380 pounds of fresh meat products that were gassy and malodorous and unfit for human consumption. The company, among other things, agreed to pay the United States a civil monetary penalty of $80,863.60, reimburse $25,000.00 to the USDA for the cost of the investigation, and make a charitable donation of $25,000.00 to a local food bank. The second PTD involved a Federal processing establishment which allegedly prepared various meat products, namely ground beef, ground beef patties, and pork sausage patties with soy, cereal, and water, without declaring it on the label. The company corporate officials, among other things, agreed not to commit further violations. Each of the corporate officials was also required to reimburse the government $2,000.00 for the cost of the investigation.

There were also two pre-trial diversions agreements which occurred late last quarter and were inadvertently omitted from the last report. The first involved a mineral and synthetic oil-based lubricant manufacturer, which produced products for processors and the pharmaceutical industries. The firm allegedly provided false chemical descriptions of their lubricants to FSIS’ compounds and packaging review branch in order to obtain approval for their use in the food manufacturing industry. The firm, among other things, agreed to pay $1.3 million dollars to

the United States, dedicate $250,000.00 to a supplemental environment project of their choice, and pay $750,000.00 to settle a pending civil enforcement action with the Environmental Protection Agency. The second involved a custom operator who allegedly assaulted a FSIS, Compliance Officer during the course of his official duties. As part of the agreement, prosecution is deferred for 12 months provided the custom operator does not violate any Federal, State and/or local law and cooperates with authorities regarding his farm and/or its contents.

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. There are no seizure actions reported for this period.

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. There are no ACE program actions reported for this period.