Quarterly Enforcement Report, Quarter 2, Fiscal Year 2008
The Food Safety and Inspection Service's (FSIS) Quarterly Enforcement Report provides a summary of the enforcement actions FSIS has taken to ensure that products that reach consumers are safe, wholesome, and properly labeled. Although this report focuses on enforcement actions taken, it is important to recognize that this is only one aspect of the Agency's mission to protect public health through food safety and food defense by achieving compliance with laws and regulations.
This report is a snapshot in time of a dynamic process. For example, matters shown as under appeal may be resolved by the time this report is published. Other actions could be appealed or closed after this reporting period. This information is updated on a quarterly basis and made available to the public in future reports.
The report is presented in sections that correspond with the category of enforcement action. Activities reported within the categories are either pending actions noted in earlier reports or new enforcement actions occurring during the reporting period. Each section of this report is described and reported in more detail as follows:
- NONCOMPLIANCE RECORDS AND APPEALS
- PORT-OF-ENTRY REINSPECTION
- PRODUCT CONTROL ACTIONS
- FSIS FOOD RECALLS
- NOTICES OF PROHIBITED ACTIVITY
- NOTICES OF WARNING
- ADMINISTRATIVE ACTIONS
- CRIMINAL ACTIONS
- CIVIL ACTIONS
NONCOMPLIANCE RECORDS AND APPEALS
FSIS inspection program personnel perform thousands of inspection procedures each day in federally inspected establishments 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 Noncompliance Record (NR). A NR is a written report that documents noncompliance with FSIS regulations. A NR notifies the establishment of the noncompliance and that it should take action to remedy the situation and prevent its recurrence. Noncompliance reported on NRs varies from non-food safety issues to serious breakdowns in food safety controls. When noncompliance occurs repeatedly, or when a plant fails to prevent adulterated product from being produced or shipped, FSIS takes action to control products and may take enforcement action under the FSIS Rules of Practice (9 CFR Part 500), such as to suspend inspection. Table 1 provides the number of verifications performed and non-compliances issued by inspection program personnel, and the national compliance rate by quarter for the current fiscal year. Table 2 provides the number of appeals filed by plants and the status of the appeals.
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FSIS conducts port-of-entry reinspections of imported meat, poultry, and egg products. This activity is a reinspection of products that have already been inspected and passed by an equivalent foreign inspection system. Thus, imported product reinspection is a monitoring activity for verifying on an on-going basis the equivalence of a foreign country's inspection system.
Port-of-entry reinspection is directed by the Automated Import Information System (AIIS), a centralized computer database that generates reinspection assignments and stores results. After clearing the Department of Homeland Security, Customs and Border Protection (DHS-CBP), and the Animal and Plant Health Inspection Service (APHIS), every imported meat, poultry, or egg product shipment must be presented to FSIS for routine inspection. When a meat or poultry shipment is presented for reinspection, the AIIS verifies that the product is from an eligible country and certified establishment. Shipments are refused entry if the foreign country, or the foreign establishment that produced the product, is not eligible to export to the United States.
All presented imported product shipments have a routine inspection conducted for general condition, labeling, proper certification, and accurate count. In addition, the AIIS assigns other types of reinspections (TOI) to a statistical portion of the presented products. These reinspections could include a physical examination of the product for visible defects, collection of samples for microbiological analysis, sampling for food chemistry analyses, and samples to be analyzed for drug and chemical residues. Shipments are randomly selected for reinspection using a statistical sampling plan that allocates samples by HACCP process categories. The level of sampling is based on the volume imported from the country within each category. Products that pass reinspection are considered accepted entry into the United States (US Inspected and Passed). Products that fail reinspection are rejected and must be re-exported, converted to non-human food, or destroyed. Product rejections cause the AIIS to automatically generate an increased rate of reinspection for future shipments of like product from the same establishment. Table 3a and Table 3b present meat and poultry inspection figures for the reporting period. Table 3c and Table 3d present egg product inspection figures.
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PRODUCT CONTROL ACTIONS
FSIS takes product control actions to gain physical control over products when there is reason to believe that they are adulterated, misbranded, or otherwise in violation of the FMIA, PPIA, or EPIA. These actions are designed to ensure that those products do not enter commerce or, if they are already in commerce, that they do not reach consumers.
Retentions and Condemnations
In official establishments, FSIS inspection program personnel may retain products that are adulterated or mislabeled when there are insanitary conditions, for inhumane slaughter or handling, when conditions preclude FSIS from determining that the product is not adulterated or misbranded, or for other reasons authorized by the statutes. FSIS inspection program personnel condemn animals for disease, contamination, or other reasons to prevent their use as human food. Table 4 provides figures for condemnations of livestock and poultry for the reporting period.
FSIS Investigators, Enforcement, Investigation and Analysis Officers (EIAOs), import officers, and other designated FSIS inspection program personnel will detain products that may be adulterated, misbranded, or otherwise in violation of the law when found in commerce. Most detentions result in voluntary action by the product owner or custodian, such as voluntary disposal of the product. If detained product cannot be disposed of within 20 days, then FSIS may request, through OGC and the U.S. Attorney, that a U.S. District Court enter an order to seize the product as provided for in the FMIA, PPIA, and EPIA. Tables 5a , 5b, and 5c provide the number of detentions and the pounds of product involved in these actions for meat, poultry, and egg products for this quarterly reporting period. Table 5a provides information on detentions made by the Compliance and Investigations Division (CID), Office of Program Evaluation, Enforcement and Review. Table 5b provides the detention information for the Office of International Affairs. Table 5c provides the detention information for the Office of Field Operations.
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FSIS Food Recalls
A food recall is a voluntary action by a manufacturer or distributor to protect the public from products that may cause health problems or possible death. A recall is intended to remove food products from commerce when there is reason to believe the products may be adulterated, misbranded, or otherwise in violation of the FMIA, PPIA, or EPIA. Recalls are initiated by the manufacturer or distributor of the meat, poultry, or egg products, sometimes at the request of FSIS. All recalls are voluntary. However, if a company refuses to recall its products, then FSIS has the legal authority to detain and seize those products in commerce.
FSIS classifies food recalls as follows:
- Class I - A Class I recall involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.
- Class II - A Class II recall involves a potential health hazard situation in which there is a remote probability of adverse health consequences from eating the food.
- Class III - A Class III recall involves a situation in which eating the food will not cause adverse health consequences.
Additional information on FSIS food recalls, the recall process, and current food recalls can be found on the FSIS recalls web page at: http://www.fsis.usda.gov/Fsis_Recalls/index.asp.
NOTICES OF PROHIBITED ACTIVITY
Firms that recall products are expected to provide notification to their consignees concerning the recalled product and request that customers review inventory records and segregate, hold, or destroy product. Firms that have already shipped or sold recalled product are to retrieve and control the product, prevent further distribution, and contact their consignees and have them retrieve and control product that is part of a recall. FSIS program personnel conduct "effectiveness checks" to ensure that the recalling firm and firms that received or distributed product subject to a recall take effective action to notify all consignees of the recalled product that there is a need to control and remove the recalled product from commerce.
In situations where FSIS determines that a federally inspected establishment or a firm operating in commerce has not taken responsibility to remove or control adulterated, misbranded, or other unsafe product in commerce or to advise its consignees of product that is subject to recall, it may issue prohibited activity warning notices to the firm. FSIS issues prohibited activity notices for the following:
- Failure of a recalling firm to notify its consignees of recalled product
- Failure of a consignee to notify its customers of recalled product
- Recalling firm or consignee found offering for sale recalled product
Table 6 contains information on prohibited activity notices FSIS issued during the reporting period.
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NOTICES OF WARNING
A Notice of Warning (NOW) provides notice of violations to firms and responsible individuals. FSIS issues a NOW to firms and individuals to notify them of prohibited acts or other conduct that violates FSIS statutes or regulations. Generally, FSIS issues a NOW for minor violations of law that are not referred to a United States Attorneys for prosecution or other action. FSIS may also issue a NOW when a U.S. Attorney declines to prosecute a case or bring action against a specific business or individual. A NOW identifies the violative conduct, condition, practice, or product, and the statutory or regulatory provisions violated. It advises the firm or individual that the Agency will not pursue further action for the violation and warns that FSIS may seek criminal prosecution or other action for continued or future violations. Notices 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, poultry, and egg products. Table 7 shows Notices of Warning issued by the Office of Program Evaluation, Enforcement and Review (OPEER) Evaluation and Enforcement Division (EED) and by each of the Compliance and Investigations Division (CID) Regions during the reporting period.
The FSIS Rules of Practice, which are set out in 9 CFR Part 500, define the type of administrative enforcement actions FSIS takes, the conditions under which these actions are appropriate, and the procedures FSIS will follow in taking these actions. These regulations provide notice to establishments of FSIS enforcement actions. These regulation provide notice to establishments of FSIS enforcement actions, criteria, and processes, and ensure that all establishments are afforded due process.
Administrative actions in the Rules of Practice include regulatory control action, withholding action, and suspension. These actions are defined in 9 CFR 500.1. FSIS takes these actions to prevent preparation and shipment of adulterated products, when products are produced under insanitary conditions, and for other reasons described in the Rules of Practice. When there is an imminent threat to public health or safety, such as the shipment of adulterated product, FSIS takes immediate enforcement action. In other situations, FSIS provides the establishment prior notification of intended enforcement action and the opportunity to demonstrate or achieve compliance. This is called a Notice of Intended Enforcement Action (NOIE). In appropriate situations, FSIS may defer an enforcement decision based on corrections submitted by the establishment. FSIS also may place a suspension action, if taken, in abeyance if an establishment presents and puts into effect corrective and preventive actions. FSIS Office of Field Operations, District Offices monitor and verify an establishment's implementation of corrective and preventive actions, and take follow-up action if needed to protect the public health. Table 8 summarizes suspensions and other administrative actions initiated and closed at federally inspected establishments during the reporting period.
Tables 9 , 10 , and 11 list these administrative actions (other than actions based on convictions) taken at large, small, and very small plants, by establishment, initiated, pending, or closed, for the period, along with the basis for the action. Tables 9 , 10 , and 11 also identify those cases in which an appeal of the 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.
Formal Adjudicatory Actions for Food Safety
In some situations, it is necessary to withdraw inspection from an establishment based on the failure of a recipient of inspection service to meet critical sanitation and food safety regulatory requirements (e.g., Sanitation Standard Operating Procedures (SSOP) or Hazard Analysis and Critical Control Point (HACCP) system regulations) necessary to protect the public health. In these cases, FSIS files an administrative complaint with the USDA Hearing Clerk. The plant may request a hearing before a USDA Administrative Law Judge. If the action is based on insanitation, or other imminent threats to public health or safety, the plant may remain closed while proceedings go forward. In other cases that do not involve a threat to public health, operations may continue. These actions may be resolved by FSIS and the plant entering into a consent decision, which allows the plant to operate under certain specified conditions. If inspection service is withdrawn, a closed plant must reapply to receive federal inspection. FSIS also may take enforcement action, by filing an administrative complaint, to deny federal inspection service to an applicant. These actions are taken in accordance with the FSIS Rules of Practice (9 CFR Part 500) and Department regulations governing formal adjudicatory proceedings (7 CFR Part 1, Subpart H). Table 12 identifies refusal and withdrawal actions pending or taken on this basis for the reporting period.
Withdrawal for Unfitness
FSIS can move to withdraw or deny inspection, after opportunity for a hearing, based on the unfitness of recipient or applicant for inspection because of a felony conviction, more than one violation involving food, or certain other violations set out in the statutes. Actions pending or taken (other than outstanding consent decisions) are reported. Table 13 identifies actions pending or taken on this basis for the reporting period.
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Removing Exempt Privilege
The meat and poultry laws exempt certain custom, retail, or other operations from inspection, such as facilities that slaughter animals or poultry, or process meat or poultry, for owners of the animals. When insanitary conditions create health hazards at these businesses, FSIS may remove custom or other exempt privileges through issuance of a Notice of Ineligibility, and require the business to cease operations until sanitary conditions are restored. FSIS can also take action when custom or other exempt facilities fail to properly label product as "Not for Sale." These exempt businesses have the opportunity to correct violations before or after such actions, contest the basis for such actions at hearings, and to enter settlement agreements to resolve actions. Table 14 lists actions pending or taken on this basis for the reporting period.
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, through the Office of the General Counsel (OGC) or the Inspector General (OIG), to the appropriate United States Attorney to pursue criminal prosecution. Conviction for a criminal offense can result in a fine, imprisonment, or both. Table 15 lists criminal case actions in categories according to the status of the case, which may be indictment or information issued, plea, and sentencing rendered during the reporting period.
PRE-TRIAL DIVERSION AGREEMENTS
In certain situations, United States Attorneys may enter into Pre-Trial Diversion (PTD) agreements with alleged violators in lieu of actual prosecution. 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 may be tailored to each individual case. 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. FSIS frequently monitors these agreements so that it can assist the United States Attorneys in determining whether the terms have been met or that prosecution should be re-instituted. Table 16 lists Pre-Trial Diversion agreements for the reporting period.
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FSIS also has authority to seek a variety of civil actions and case dispositions in Federal Court.
When FSIS has reason to believe distributed products are adulterated, misbranded, or otherwise in violation of law, the Agency will, through the USDA Office of the General Counsel and United States 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, misbranded, or otherwise in violation of FSIS laws, it will condemn the product. Condemned product cannot be further processed to be used for human food. Table 17 lists seizure actions for the reporting period.
FSIS, through the U.S. Attorney, may request a U.S. District Court to enjoin firms or individuals that engage in repetitive violations of the FMIA, PPIA or EPIA, or their actions pose a threat to public health and safety. An injunction requires an individual or firm to take certain action or to refrain from doing acts that violate the law. Injunctions may be resolved by a consent decree. Table 18 lists civil injunction actions.
False Claims Act and Other Actions
FSIS also works with OGC, OIG, and U.S. Attorneys to obtain other civil case outcomes. 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. Case examples where civil action may be appropriate include cases involving products, not in compliance, sold to the military, to public schools engaged in the school lunch program, or to other Federal institutions. Table 19 lists ACE actions and other cases involving civil enforcement or settlement.
FOR MORE INFORMATION:
|Media Inquiries:||(202) 720-9113|
|Congressional Inquiries:||(202) 720-3897|
|Constituent Inquiries:||(202) 720-9113|
|Freedom of Information Act Requests:||(202) 720-2109|
|FSIS Web site:||http://www.fsis.usda.gov|
Consumer Inquiries: Call USDA's Meat and Poultry Hotline at 1-888-674-6854 or 1-800-256-7072 for the hearing impaired, 10 a.m. to 4 p.m., Eastern Time.
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