January 1, 2010 through March 31, 2010
INTRODUCTION
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
- 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 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 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
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.
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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 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.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 have a routine inspection conducted 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, 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 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. Table 3a
and Table 3b present meat and poultry
reinspection figures for the current fiscal year through the quarterly reporting period. Table 3c
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.
Detentions
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 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 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: https://webarchive.library.unt.edu/web/20120925145902/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 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 conduct "effectiveness checks" to ensure that the recalling,
receiving, and distributing firms are subject to a product recall, and 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 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. NOTICES OF WARNING
A Notice of Warning (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 may also 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. Table 7a
and 7b show NOWs issued by OPEER for the current
fiscal year through the quarterly reporting period.
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VI. 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, 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 Action (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 8 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.
Tables 9, 10,
and 11 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,2 by establishment, initiated, pending, or closed, for the quarterly reporting
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 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 the 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 12
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 13 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 or other noncompliance issues are restored or corrected. Table 14 lists actions taken or pending
on this basis for the quarterly reporting period.
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VII. CIVIL ACTIONS
FSIS also has authority to seek a variety of civil actions and case dispositions in Federal Court.
Seizures
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.
Injunctions
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 United States 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 17 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 United States Attorney
to pursue criminal prosecution. Conviction for a criminal offense 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 Agreements
In certain situations, U.S. 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 reinstated. Table 19
lists Pre-Trial Diversion agreements for the quarterly reporting period.
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FOR MORE INFORMATION
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Media Inquiries: |
(202) 720-9113 |
Congressional Inquiries: |
(202) 720-3897 |
Constituent Inquiries: |
(202) 720-9113 |
Freedom of Information Act Requests: |
(202) 720-2109 |
e-mail: fsis.foia@usda.gov |
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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.
e-mail: MPHotline.fsis@usda.gov
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