Quarterly Enforcement Reports (Narrative, Archived v1)
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:
FSIS inspection program personnel perform thousands of inspection procedures each day in federally inspected establishments to determine whether or not inspected establishments are in compliance with regulatory requirements. Each time inspection program personnel make a noncompliance determination, they complete a Noncompliance Record (NR). An NR is a written record that documents noncompliance with FSIS regulations. An 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 an establishment 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 Code of Federal Regulations (CFR) Part 500), such as suspending inspection. Table 1 provides the number of verifications performed and noncompliances issued by inspection program personnel, and the national compliance rate for the current fiscal year through the quarterly reporting period.
Table 2 provides the number of appeals filed by establishments and the status of the appeals for the current fiscal year through the quarterly reporting period.
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 also a means of verifying the equivalence of a foreign country’s inspection system on an ongoing basis.
Port-of-entry reinspection uses the Public Health Information System (PHIS). PHIS is 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 reinspection. When a meat, poultry, or egg product shipment is presented for reinspection, the FSIS 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 imported product shipments presented for inspection receive a routine reinspection for general condition, labeling, proper certification, and accurate count. In addition, the PHIS assigns other types of (re)inspections (TOIs) to a statistical portion of the presented products. These reinspections could include a physical examination of the product for visible defects or a collection of samples for microbiological, food chemistry, drug, or chemical residue analysis. Shipments are randomly selected for reinspection using a statistical sampling plan that allocates samples by 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 for entry into the United States (U.S. Inspected and Passed). Products that fail a TOI are refused entry. Depending on the refused reason, the reason may be rectifiable (e.g., labeling issue). Regardless, products ultimately refused entry must be re-exported, converted to non-human food, or destroyed. Failed TOIs automatically generate an intensified rate of reinspection for future shipments of like product from the same establishment. Table 3a presents meat, (including Siluriformes fish), and poultry reinspection figures for the current fiscal year through the quarterly reporting period. Table 3b presents egg product reinspection figures for the current fiscal year through the quarterly reporting period.
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 Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA). These actions are designed to ensure that those products do not enter commerce or, if they are already in commerce, 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 current fiscal year through the quarterly reporting period.
FSIS program personnel detain products that may be adulterated, misbranded, or otherwise in violation of the law when found in commerce. Most detentions result in voluntary action, such as voluntary disposal of the product, by the product owner or custodian. If detained product cannot be disposed of within 20 days, then FSIS may request, through the Office of the General Counsel 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 and 5b provide the number of detentions and the pounds of product involved in these actions for meat, poultry, and egg products for the current fiscal year through the quarterly reporting period. Table 5a provides information on detentions made by the Office of Investigation, Enforcement and Audit (OIEA) (formerly Office of Program Evaluation, Enforcement and Review). Table 5b provides the detention information for the Office of Field Operations (OFO).
FSIS Food Recalls
A food recall is a voluntary action by a manufacturer or distributor to remove product from commerce to protect the public from consuming adulterated, misbranded, or other 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 recommendation 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 is found on the FSIS Recalls web page at www.fsis.usda.gov/recalls.
Establishments or firms that recall products are expected to provide notification to their consignees concerning the recalled product and to request that customers review inventory records and segregate, hold, or destroy product. When recalled product has already been shipped or sold, establishments 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 verify that the recalling firm has been diligent and successful in notifying and advising the consignees of the need to retrieve and control recalled product so that it is no longer available to consumers.
In situations in which FSIS determines that the establishment or 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 establishment or firm. FSIS issues prohibited activity notices for the following:
- Failure of a recalling establishment or firm to notify its consignees of recalled product
- Failure of a consignee to notify its customers of recalled product
- Recalling establishment, firm, or consignee found offering recalled product for sale
Table 6a and Table 6b contain information on prohibited activity notices that FSIS issued for the current fiscal year through the quarterly reporting period.
The FSIS Rules of Practice, which are set out in 9 CFR Part 500, define the type of administrative enforcement actions taken by FSIS, the conditions under which these actions are appropriate, and the procedures FSIS follows in taking these actions. FSIS takes these administrative actions to ensure sanitary conditions and the production of wholesome products, to prevent the preparation of adulterated products, and to ensure public health and safety.
FSIS administrative enforcement actions as defined in the Rules of Practice (9 CFR 500.1) include regulatory control actions, withholding actions, and suspensions. A regulatory control action is the retention of product, rejection of equipment, or refusal to allow the processing of a specified product. A withholding action is the refusal to allow the marks of inspection on products. A suspension action is the interruption of the assignment of FSIS employees in all, or part, of an establishment.
A suspension action may be taken by FSIS when products have been produced under insanitary conditions or when the establishment has shipped adulterated products. Other actions for which FSIS may take a suspension action include inhumane handling or slaughtering of livestock, intimidation of FSIS inspection officials, violations of a regulatory control action, or other reasons as 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 (NOIE).
FSIS also may place a suspension action, if taken, in abeyance, if an establishment presents and puts into effect corrective and preventive actions. In appropriate situations, FSIS also may defer an enforcement decision based on corrections submitted by the establishment. FSIS monitors and verifies an establishment’s implementation of corrective and preventive actions, and takes follow-up action if needed to protect the public health.
Table 7 lists administrative actions (i.e., NOIE, withholding action, and suspension in effect) initiated and closed for the current fiscal year through the quarterly reporting period.
Tables 8, 9, and 10 list the administrative actions (i.e. NOIE, withholding action, deferral, suspension in effect, suspension in abeyance, and closure) taken at large, small, and very small establishments, by establishment, initiated, pending, or closed, for the quarterly reporting period, along with the basis for the action. Tables 8, 9, and 10 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 or deny 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) required to protect public health. In these cases, FSIS files an administrative complaint with the USDA Hearing Clerk. The establishment 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 establishment 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 establishment entering into a consent decision, which allows the establishment to operate under certain specified conditions. If inspection service is withdrawn, an establishment 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 11 identifies actions to withdraw or deny inspection service taken or pending for the quarterly reporting period.
Withdrawal or Denial for Unfitness
FSIS can move to withdraw or deny inspection, after an opportunity for a hearing is given to the establishment, based on the unfitness of an applicant for, or recipient of, or anyone responsibly connected with the applicant or recipient of, inspection service because of a felony conviction, more than one violation involving food, or certain other violations defined in the statutes. Table 12 identifies actions taken or pending for past convictions for the quarterly reporting period.
Removing Exempt Privilege
The meat and poultry laws exempt certain custom, retail, or other operations from inspection, such as firms that slaughter animals or poultry, or process meat or poultry, for owners of the animals. When these firms do not meet statutory or regulatory requirements, including those to ensure sanitary conditions, FSIS may remove custom or other exemption privileges through the issuance of a Notice of Ineligibility and require the business to cease operations until sanitary conditions are restored or other noncompliance issues are corrected. Table 13 lists actions taken or pending on this basis for the quarterly reporting period.
Administrative Civil Penalties
FSIS may impose administrative civil penalties for violations of the requirement in the EPIA (21 U.S.C. 1037 (c)) and the regulations (9 CFR Part 590.50) that consumer-packed shell eggs be stored and transported at an ambient temperature at or below 45 degrees Fahrenheit. Specifically, the EPIA provides for a civil penalty of up to $7,500 for each violation. The amount of the civil penalty, which may be imposed pursuant to administrative proceedings, is based on the gravity of the offense, the culpability of the violator, and prior compliance history. Civil penalty actions may be resolved by stipulation agreement in lieu of an administrative complaint, by consent decision after filing of an administrative complaint, or through an order entered after an administrative hearing. Table 14 lists civil penalty enforcement actions and civil penalties taken or pending for the quarterly reporting period.
FSIS has authority to seek a variety of civil actions and case dispositions in Federal Court. Civil actions and dispositions include product seizures, injunctions, and other legal actions for cases involving fraud committed against the Federal government.
When FSIS has reason to believe distributed products are adulterated, misbranded, or otherwise in violation of law, the Agency will, through the 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 for use as human food. Table 15 lists seizure actions taken or pending for the quarterly 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 whose 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 16 lists civil injunction actions taken or pending for the quarterly reporting period.
False Claims Act and Other Actions
FSIS also works with Office of the General Counsel, Office of Inspector General, 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 in which 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 17 lists ACE actions and other cases involving civil enforcement or settlement taken or pending for the quarterly reporting period.
If evidence is found that an individual or firm has engaged in violations of the FMIA, PPIA, or EPIA, FSIS may refer the case, through the USDA Office of the General Counsel or the USDA Office of the Inspector General, to the appropriate U.S. Attorney to pursue criminal prosecution. Some violations may be addressed through a pre-trial diversion, which defers prosecution provided specified conditions, usually involving compliance with the law, are met. Other violations, generally those that do not rise to the level of prosecution, may be closed with a written Notice of Warning.
The outcome of a criminal prosecution may conclude in a final judgment on a verdict of guilty, a plea of guilty, or a plea of nolo contendere for the criminal offense charged. A conviction can result in a fine, imprisonment, or both. Table 18 lists criminal case actions taken or pending during the quarterly reporting period.
Pre-Trial Diversion and Other Agreements
In certain situations, U.S. Attorneys may enter into Pre-Trial Diversion or other 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 these agreements may be tailored to each individual case. If the violator successfully completes the program, no criminal charges are filed. If, on the other hand, the violator does not successfully complete the program, criminal charges may be reinstated. FSIS frequently monitors these agreements so that it can assist the U.S. Attorneys in determining whether the terms have been met or that prosecution should be reinstated. Table 19 lists Pre-Trial Diversion and other agreements for the quarterly reporting period.
Notice of Warning
Violation cases also may be closed with issuance of written warning letters, called a Notice of Warning (NOW). An NOW provides notice of violations to Federal establishments, firms, and responsible individuals. FSIS issues an NOW to establishments, firms, and individuals to notify them of prohibited acts or other conduct that violates FSIS statutes or regulations. Generally, FSIS issues an NOW for minor violations of law that are not referred to a U.S. Attorney for prosecution or other action. FSIS also may issue an NOW when a U.S. Attorney declines to prosecute a case or bring action against a specific establishment, firm, or individual.
An NOW identifies the violative conduct, condition, practice, or product, and the statutory or regulatory provisions violated. It advises the establishment, 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. An NOW may be issued to any individual, firm, Federal establishment, wholesaler, distributor, restaurant, retail store, or other in-commerce facility that processes, stores, or distributes meat, poultry, and egg products. Tables 20a and 20b show NOWs issued by OIEA (formerly Office of Program Evaluation, Enforcement and Review) for the current fiscal year through the quarterly reporting period.
1 Egg products are imported only from Canada.
2 Large establishments are defined as those having 500 or more employees; small establishments are those having 10 or more but fewer than 500 employees; very small establishments have fewer than 10 employees (61 Federal Register, No. 144, 38806-38989, 38819 (July 25, 1996)).