July 1, 2011 through September 30, 2011
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
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
- NOTICES OF PROHIBITED ACTIVITY
- ADMINISTRATIVE ACTIONS
- CIVIL ACTIONS
- CRIMINAL ACTIONS
I. 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 establishments are in compliance
with regulatory requirements. Each time inspection program personnel make a noncompliance determination, they
complete a Noncompliance Record (NR). A NR is a written record 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 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 CFR Part 500),
such as to suspend inspection. Table 1 provides the
number of verifications performed and noncompliances issued by inspection program personnel, and the national compliance
ate 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.
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II. PORT-OF-ENTRY REINSPECTION
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 an activity for
verifying, on an ongoing 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.1
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 receive a routine inspection for general condition, labeling, proper
certification, and accurate count. In addition, the AIIS assigns other types of reinspections 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
Hazard Analysis and Critical Control Point (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 for entry
into the United States (U.S. 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
and Table 3b present meat and poultry
reinspection figures for the current fiscal year through the quarterly reporting period.
and Table 3d present egg product
reinspection figures for the current fiscal year through the quarterly reporting period.
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III. 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 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, 5b,
and 5c 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 Program
Evaluation, Enforcement and Review (OPEER). Table 5b provides the detention information for
the Office of International Affairs (OIA). Table 5c provides the detention information for the
Office of Field Operations (OFO).
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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 can be
found on the FSIS Recalls Web page at http://www.fsis.usda.gov/Fsis_Recalls/index.asp.
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IV. NOTICES OF PROHIBITED ACTIVITY
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 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 for sale recalled product
Table 6a and Table 6b
contain information on prohibited activity notices that FSIS issued for the current fiscal year through the quarterly reporting period.
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V. ADMINISTRATIVE ACTIONS
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. Suspension actions are 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 for 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
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 the number of federally
inspected establishments with associated administrative actions (i.e. NOIE, withholding action, and suspension in effect)
initiated and closed for the current fiscal year through the quarterly reporting period.
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 establishments2, 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.
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VI. CIVIL ACTIONS
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 14
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 15
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 16
lists ACE actions and other cases involving civil
enforcement or settlement taken or pending for the quarterly reporting period.
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VIII. CRIMINAL ACTIONS
If evidence is found that an individual or firm has engaged in violations of the FMIA, PPIA, or EPIA, USDA may refer
the case, through the Office of the General Counsel or 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 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 17 lists criminal case actions
taken or pending during the quarterly reporting period.
Pre-Trial Diversion Agreements
In certain situations, U.S. Attorneys may enter into Pre-Trial Diversion (PTD) 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 18
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). A NOW
provides notice of violations to Federal establishments, firms, and responsible individuals. FSIS issues a NOW to
establishments, 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 U.S. Attorney for
prosecution or other action. FSIS also may issue a NOW when a U.S. Attorney declines to prosecute a case or bring action
against a specific establishment, firm, or individual. A 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. A 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 19a
and 19b show NOWs issued by OPEER for the
current fiscal year through the quarterly reporting period.
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FOR MORE INFORMATION
|Media, Congressional, and Constituent Inquiries:
|Freedom of Information Act Requests:
Consumer Inquiries: Call USDA's Meat and Poultry Hotline at 1-888-674-6854, 10 a.m. to 4 p.m., Eastern Time or e-mail: MPHotline.email@example.com
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