July l, 2010 through September 30,
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 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 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 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.
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, such as
voluntary disposal of the product, 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: 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 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 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. 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.
Tables 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 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 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 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 are restored or other noncompliance issues
are 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 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.
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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.
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) 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.
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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
FSIS Web site:
http://www.fsis.usda.gov
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