Meat and Poultry
Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce Risk of Foodborne Illnesses
Gao ID: GAO-02-902 August 30, 2002
Every year, some meat and poultry products are contaminated with microbial pathogens--such as Salmonella and E. coli--that cause foodborne illnesses and deaths. To improve the safety of meat and poultry products, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) introduced additional regulatory requirements for meat and poultry plants. These requirements are intended to ensure that plants operate food safety systems that are prevention-oriented and science-based. These systems, called Hazard Analysis and Critical Control Point (HACCP) systems, were phased in from January 1998 through January 2000 at all meat and poultry slaughter and processing plants. As the foundation of the HACCP system, plants are responsible for developing HACCP plans that, among other things, identify all of the contamination hazards that are reasonably likely to occur in a plant's particular production environment, establish all of the necessary steps to control these hazards, and have valid scientific evidence to support their decisions. GAO found that FSIS is not ensuring that all plants' HACCP plans meet regulatory requirements. As a result, consumers may be unnecessarily exposed to unsafe foods that can cause foodborne illnesses. In particular, FSIS's inspectors have not consistently identified and documented failures of plants' HACCP plans to comply with requirements. In addition, although sound science is the cornerstone of an effective HACCP plan, FSIS does not expect its inspectors to determine whether HACCP plans are based on sound science because inspectors lack the expertise to do so. FSIS is not consistently identifying repetitive violations, according to GAO's review of 1,180 noncompliance records for fiscal year 2001. This has occurred, in part, because FSIS has not established specific, uniform, and clearly defined criteria for its inspectors to use in determining when a violation is repetitive. Furthermore, at the district level, FSIS officials' understanding of the criteria to consider in determining if a violation is repetitive varied. Also, in several instances, inspectors have not fully documented the basis for their decisions about repetitive violations on noncompliance records. FSIS is not ensuring that plants take prompt and effective action to return to compliance after a HACCP violation has been identified. The longer that FSIS allows plants to remain out of compliance with regulatory requirements, the greater the risk that unsafe food will be produced and marketed.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
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GAO-02-902, Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce Risk of Foodborne Illnesses
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Report to the Committee on Agriculture, Nutrition, and Forestry U.S.
Senate:
United States General Accounting Office:
GAO:
August 2002:
Meat and Poultry:
Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce
Risk of Foodborne Illnesses:
GAO-02-902:
Contents:
Letter:
Results in Brief:
Background:
FSIS Is Not Ensuring that Plants‘ HACCP Plans Meet Regulatory
Requirements:
FSIS‘s Lack of Consistent Identification and Documentation of
Repetitive HACCP Violations Weakens Enforcement:
FSIS Is Not Ensuring That Plants Take Prompt and Effective Corrective
Action to Return to Compliance with HACCP Requirements after Violations
Have Been Identified:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Response:
Appendix I: Scope and Methodology:
Appendix II: Comments from the U.S. Department of Agriculture:
Appendix III: GAO Contacts and Staff Acknowledgments:
Tables:
Table 1: Percentage of Plants with No Documented HACCP Violations
during Fiscal Year 2001:
Table 2: Plant Size, Number of Noncompliance Records, and Number of
Repetitive Violations in 16 Plants during Fiscal Year 2001:
Table 3: Elapsed Time--From Failure of First Set to Passing Third Set-
-at Plants with Second-Set Failures of the Salmonella Performance
Standard and In-Depth Verification Reviews:
Table 4: Time Line of Events between In-Depth Verification Review and
Third Set of Salmonella Tests at One Plant:
Abbreviations:
FSIS: Food Safety and Inspection Service
GAO: General Accounting Office
HACCP: Hazard Analysis and Critical Control Point
USDA: U.S. Department of Agriculture:
Letter:
August 30, 2002:
The Honorable Tom Harkin
Chairman
The Honorable Richard G. Lugar
Ranking Minority Member
Committee on Agriculture, Nutrition, and Forestry
United States Senate:
Every year, some meat and poultry products are contaminated with
microbial pathogens, such as Salmonella and E. coli, that cause
foodborne illnesses and deaths. To improve the safety of meat and
poultry products, and in response to recommendations from GAO and the
National Academy of Sciences, the U.S. Department of Agriculture‘s
(USDA) Food Safety and Inspection Service (FSIS) implemented additional
regulatory requirements for meat and poultry plants. These requirements
are intended to ensure that plants operate food safety systems that are
prevention-oriented and science-based. These systems, called Hazard
Analysis and Critical Control Point (HACCP) systems, were phased in
from January 1998 through January 2000 at all meat and poultry
slaughter and processing plants. As the foundation of the HACCP system,
plants are responsible for developing HACCP plans that, among other
things, identify all of the contamination hazards that are reasonably
likely to occur in a plant‘s particular production environment,
establish all of the necessary steps to control these hazards, and have
valid scientific evidence to support their decisions. As a result of
implementing HACCP systems over the past 5 years, plants have accepted
significant new responsibilities for producing safe products, and FSIS
has made major changes to the roles and responsibilities of its
inspection workforce.
FSIS, through its 15 district offices across the country, oversees the
activities of about 7,500 federal inspectors who review the operations
of about 5,000 plants subject to the HACCP requirements
nationwide.[Footnote 1] About 3,400 inspectors are stationed in plants
along slaughter lines to provide traditional carcass-by-carcass
inspections using sight, touch, and smell. The remaining 4,100 FSIS
inspectors oversee HACCP systems in plants. As a part of their
oversight, inspectors determine if plants are complying with HACCP
requirements, including the requirement that their plans include the
following specific components:
* A hazard analysis that identifies all the food safety hazards--
biological, chemical, and physical--that are reasonably likely to occur
and measures to control them.
* Critical control points in plants‘ processes where controls can be
applied to prevent, eliminate, or reduce a food safety hazard to an
acceptable level.
* Critical limits (maximum or minimum values) at which the hazard
is controlled.
* Monitoring requirements to ensure that the measured values are within
critical limits.
* Corrective actions to be taken if critical limits are violated.
* Verification procedures to ensure that the plants‘ HACCP systems
result in safe products.
* Record keeping procedures for documenting HACCP requirements.
To help verify that plants‘ HACCP systems are effectively controlling
food safety hazards, FSIS inspectors test for the presence of the
pathogen Salmonella on raw meat and poultry in a series of samples--
referred to as a ’set.“ FSIS established limits for Salmonella, known
as ’performance standards,“ which vary depending on the type of
product. For example, no more than 1 percent of steer carcasses sampled
in a set of tests may contain Salmonella. In addition to limits on
Salmonella, FSIS has established a ’zero tolerance“ for visible feces
on carcasses at slaughter plants and considers the disease-causing
pathogen E. coli 0157:H7 an adulterant that is not allowed in ground
beef. FSIS also considers Salmonella, E. coli 0157:H7, and Listeria
monocytogenes adulterants in ready-to-eat products such as hot dogs and
luncheon meats.
When FSIS inspectors find a violation of the HACCP requirements, they
document the violation on a ’noncompliance record“ and advise the
plant. FSIS writes noncompliance records to document HACCP process
violations, such as a plant‘s failure to document its monitoring of
temperatures for a cooked product, as well as for violations of the
rules regarding pathogens. If the plant does not correct the violation,
FSIS may take an enforcement action, such as detaining the affected
meat or poultry product; slowing one or more production lines;
withholding the marks showing that a product has passed USDA
inspection; or suspending inspection services for one or more products
or the entire plant. While inspection services are suspended, a plant
cannot operate. However, FSIS may place a suspension on hold--referred
to as ’in abeyance“--to allow the plant to continue operating while it
corrects the violation.
In 1999, we reported that weaknesses in FSIS‘s training for its
inspectors affected its ability to ensure consistent and effective
oversight of HACCP.[Footnote 2] The following year, a USDA Inspector
General report identified shortcomings in plants‘ HACCP plans and
deficiencies in FSIS‘s oversight of HACCP‘s implementation.[Footnote 3]
To help address these problems, FSIS stepped up its inspector training
and initiated two new review mechanisms:
* Food safety systems correlation reviews, which examine a range of
inspector practices within FSIS districts to improve the effectiveness
of inspections.
* In-depth verification reviews of HACCP plans in plants with serious
safety problems to identify weaknesses in the scientific soundness of
the plans.
FSIS also introduced consumer safety officers into its workforce with
the scientific and technical expertise to, among other things, review
the scientific soundness of HACCP plans.
As you requested, this report (1) assesses whether FSIS is ensuring
that plants‘ HACCP plans meet regulatory requirements, (2) determines
whether FSIS is consistently identifying repetitive violations of HACCP
requirements, and (3) assesses whether FSIS is ensuring that plants
take prompt and effective action to return to compliance after the
agency has identified HACCP violations. As part of our review, we
analyzed 1,180 noncompliance records from 16 judgmentally selected meat
and poultry slaughter and processing plants where FSIS frequently found
HACCP-related violations in fiscal year 2001. Our sample included
different sizes of plants located in 10 different FSIS districts across
the country. We also analyzed files for the 68 HACCP enforcement cases
that were active in fiscal year 2001 in three FSIS districts, including
the two districts with the most plants in the country. In addition, we
analyzed data from the in-depth verification reviews that FSIS
conducted through the end of calendar year 2001 and the food safety
systems correlation reviews that it completed by May 2002. Appendix I
contains the details of our scope and methodology.
Results in Brief:
FSIS is not ensuring that all plants‘ HACCP plans meet regulatory
requirements and, as a result, consumers may be unnecessarily exposed
to unsafe foods that can cause foodborne illnesses. In particular,
FSIS‘s inspectors have not consistently identified and documented
failures of plants‘ HACCP plans to comply with requirements. For
example, FSIS‘s food safety systems correlation reviews in three FSIS
districts found that, in about 91 percent of the plants sampled,
inspectors had failed to document deficiencies in basic requirements
such as the requirement that plants have adequate documentation to
support the analysis of hazards in their HACCP plans. In addition,
although sound science is the cornerstone of an effective HACCP plan,
FSIS does not expect its inspectors to determine whether HACCP plans
are based on sound science because inspectors lack the expertise to do
so. FSIS has made limited progress in reviewing the scientific
soundness of plants‘ HACCP plans. While FSIS‘s in-depth verification
reviews have been useful in identifying numerous scientific weaknesses
in HACCP plans, only about 1 percent of plants have undergone these
time-and resource-intensive reviews. Similarly, consumer safety
officers will improve FSIS‘s ability to assess the scientific adequacy
of plants‘ HACCP plans. However, only about 6 percent of the officers
that FSIS needs are on board, and FSIS managers in two large districts
expressed concern that it may take years to assess the plans for all
plants in their districts. Finally, we found that inspectors had not
documented any HACCP violations in 55 percent of all plants during
2001; yet, when we showed these data to FSIS officials, they were
surprised at the large numbers and said the absence of violations was
unusual. For example, one field official said that if inspectors are
finding no HACCP violations for an entire year, they may not understand
their HACCP oversight responsibilities. In August 2002, FSIS told us it
has developed, and would soon release, a new directive to clarify
inspectors‘ responsibilities and new guidance for its supervisors to
use to verify that inspectors are, among other things, applying
appropriate inspection methods. FSIS also told us that it had
introduced an interactive computer tool for inspectors and others to
use to strengthen their knowledge of HACCP requirements.
FSIS is not consistently identifying repetitive violations, according
to our review of 1,180 noncompliance records for fiscal year 2001. This
has occurred in part because FSIS has not established specific,
uniform, and clearly defined criteria for its inspectors to use in
determining when a violation is repetitive. Furthermore, at the
district level, FSIS officials‘ understanding of the criteria to
consider in determining if a violation is repetitive varied. Also, in
several instances, inspectors have not fully documented the basis for
their decisions about repetitive violations on noncompliance records.
Identifying repetitive violations, and maintaining accurate
documentation on those decisions, is critical in deciding whether a
HACCP plan is flawed and/or an enforcement action is needed. Moreover,
we found that FSIS‘s inspection database did not provide summary
information on repetitive violations, which could help FSIS‘s managers
oversee inspectors‘ performance and plants‘ compliance with HACCP
requirements. Summary information should also help FSIS identify common
problems that may be better addressed by advising the industry to take
corrective actions instead of plant-by-plant enforcement. FSIS
officials agreed on the need for consistent criteria for identifying
repetitive violations and expect to issue a directive with those
criteria by the end of the calendar year. FSIS told us it has begun
testing software that will allow its managers to extract summary data
from the inspection database to help them better identify repetitive
violations.
Finally, FSIS is not ensuring that plants take prompt and effective
action to return to compliance after a HACCP violation has been
identified. For example, FSIS has not consistently ensured that the
actions that plants have taken were effective in eliminating repetitive
violations, particularly those relating to ’zero tolerance“ for visible
feces. Although plants are required to take corrective action each time
a violation is cited, the number of repetitive violations in various
plants--109 in one plant alone--shows that FSIS has not ensured that
recurring violations were eliminated. FSIS also has not ensured that
plants have taken immediate action, as required under HACCP rules, to
meet the Salmonella performance standard. At the plants that failed two
consecutive sets of tests for Salmonella, an average of 20 months
elapsed from the date of the failure of the first set until the plants
completed and passed a third set. Finally, when FSIS suspended
inspections at a plant, it generally placed those suspensions in
abeyance--often on the same day. This allowed the plants to operate
while they took corrective actions. According to FSIS guidance,
suspensions should not be held in abeyance for more than 90 days.
However, nearly all the plants that were suspended in the three FSIS
districts we examined had their suspensions placed in abeyance and were
allowed to remain in abeyance for an average of 10 months, during which
time they continued to operate. Moreover, we were generally unable to
verify the time frames in which plants were expected to complete
corrective actions or the actual time elapsed before the corrective
actions were completed because the enforcement case files did not
contain this information. The longer that FSIS allows plants to remain
out of compliance with regulatory requirements, the greater the risk
that unsafe food will be produced and marketed.
We are making several recommendations to the Secretary of Agriculture
to ensure that (1) FSIS inspectors better ensure that plants‘ HACCP
plans fully meet regulatory requirements, (2) FSIS inspectors and
district officials have consistent criteria for identifying repetitive
violations, and (3) plants act promptly and effectively to correct
violations. In commenting on a draft of this report, USDA agreed with
our recommendations but believes the report does not fully acknowledge
FSIS‘s progress and efforts to ensure that all plants meet regulatory
requirements. USDA described a number of actions that FSIS has recently
taken or is planning to take that are consistent with our
recommendations. We believe that our report reflects the status of
FSIS‘s ongoing and planned actions. If fully carried out and given
diligent management attention, these actions could go a long way toward
addressing the problems we found in FSIS‘s oversight and enforcement of
HACCP in U.S. meat and poultry plants and reducing consumers‘ risk of
foodborne illnesses.
Background:
According to the Centers for Disease Control and Prevention,
contaminated foods cause an estimated 76 million illnesses in the
United States each year, including 325,000 hospitalizations and
5,000 deaths. Illnesses stemming from contaminated meat and poultry
are responsible for an unknown portion of these illnesses and deaths.
The Federal Meat Inspection Act and the Poultry Products Inspection Act
give USDA responsibility for ensuring the safety and wholesomeness of
meat and poultry products that enter interstate commerce.[Footnote 4]
There are about 5,000 meat and poultry slaughter and processing plants
nationwide. According to the American Meat Institute, total meat and
poultry production in 2000 exceeded 80 billion pounds and sales were
estimated at more than $100 billion.
In January 1998, FSIS began phasing in HACCP regulatory requirements
for meat and poultry slaughter and processing plants. Large plants--
those with 500 or more employees--were required to have HACCP systems
in place by January 1998; small plants--those with 10 to 499 employees-
-by January 1999; and very small plants--those with fewer than 10
employees or annual sales of less than $2.5 million--by January 2000.
As part of its oversight efforts to verify that plants effectively
control food safety hazards, FSIS established standards for Salmonella
in raw meat and poultry products and for visible feces on carcasses in
slaughter plants.[Footnote 5] For Salmonella, FSIS established separate
standards for the carcasses of cows/bulls, steers/heifers, market hogs,
and broiler chickens, as well as for ground beef, ground chicken, and
ground turkey. When a Salmonella test is scheduled, the FSIS inspector
should take one sample each day the plant produces the product until a
set is complete, according to FSIS guidance. The number of samples in
the set depends on the product and ranges from a low of 51 samples for
broiler chickens to a high of 82 samples for steers and heifers. On
July 25, 2002, FSIS issued new, more-detailed guidance on actions the
agency and plants will take after Salmonella set failures. When a plant
fails a first set of Salmonella tests, FSIS will, among other things,
notify the plant in writing of the failure and assess the plant‘s HACCP
procedures. After a second consecutive Salmonella set failure, FSIS
will notify the plant that it must reassess its HACCP plan to determine
if changes are needed. After the plant completes its reassessment, FSIS
will conduct an in-depth verification review, among other things.
With regard to the zero tolerance standard for visible feces, the FSIS
inspector checks a prescribed number of carcasses on each production
shift to verify that the plant has successfully eliminated visible
fecal contamination.[Footnote 6] FSIS also requires plants to test meat
and poultry carcasses for generic E. coli--bacteria that occur
naturally in animals‘ intestinal tracts--to help ensure that the plants
are minimizing the risk that harmful bacteria may be on the carcasses.
In December 1999, we reported that FSIS inspectors were confused about
their authority to request changes to HACCP plans and recommended that
FSIS clarify and provide FSIS inspectors with additional training on
their roles, responsibilities, and authorities for reviewing and
verifying HACCP plans. We also recommended that FSIS review all plants‘
HACCP plans to verify that plants identify and control, through their
HACCP plans, all food safety hazards that are reasonably likely to
occur. In June 2000 USDA‘s Office of Inspector General reviewed 57
HACCP plans from 15 plants nationwide and reported that 14 of the
plants had at least one incomplete HACCP plan.[Footnote 7] The report
made recommendations to ensure that hazard analyses were complete and
all critical control points identified.
In response to these reports, FSIS implemented the following additional
oversight mechanisms:
* Food safety systems correlation reviews to improve the effectiveness
of FSIS inspection activities. The reviews examine a range of FSIS
plant inspection practices using a randomly selected sample of
10 percent or a minimum of 40 plants (whichever is greater) in an FSIS
district. From April 2001 to May 30, 2002, FSIS had completed reviews
in 7 of its 15 districts. Subsequent to each review, FSIS provides
targeted training to inspectors on the basis of the review‘s findings.
* In-depth verification reviews to examine plants‘ compliance with
HACCP plan design and implementation requirements. The reviews examine
elements of plants‘ HACCP plans, such as hazard analysis, critical
control points, and critical limits, and their implementation of these
plans. From February 2000 to June 30, 2002, FSIS had completed reviews
in 57 plants.
* Consumer safety officers have been trained by FSIS in microbiological
hazards, HACCP plan design, epidemiology, and statistics to, among
other things, review the scientific basis of HACCP plans. FSIS had 32
consumer safety officers in its district offices as of May 30, 2002.
FSIS plant inspectors have front-line responsibility for reviewing
HACCP plans to ensure that they meet basic regulatory requirements.
They use a ’noncompliance record“ to document violations of HACCP
requirements and actions taken by plants to correct the violations.
These records include the following information:
* A unique record number.
* The date of the violation.
* The oversight procedure that the inspector was performing (e.g.,
assessing the process for grinding meat) when the violation was
discovered.
* The element of the HACCP system--monitoring, corrective action,
record keeping, or plant verification--where the violation occurred.
* A written description of the violation.
* The plant management‘s written response stating both the immediate
action to correct the violation and any subsequent action to prevent
its recurrence.
If actions taken by a plant to correct a problem fail to prevent the
violation from recurring, the plant is said to have a ’repetitive
violation“--a recurring inability to maintain compliance with HACCP
requirements. According to HACCP regulations, repetitive violations
indicate that a plant‘s HACCP system is inadequate and that an
enforcement action may be warranted. An enforcement action can also be
taken for a single serious violation. FSIS may take the following types
of enforcement actions:
* A regulatory control action, which includes the retention of product,
rejection of equipment or facilities, slowing or stopping of production
lines, or refusal to allow the processing of specifically identified
product. This action is considered the least burdensome type of
enforcement action and can be initiated by an FSIS inspector to quickly
respond to violations that can be easily remedied.
* A withholding action is the inspector‘s or district officials‘
refusal to allow the USDA marks of inspection to be applied to the
product. This action is used for more serious HACCP violations, such as
repeated failure to maintain HACCP records adequate for inspectors to
determine whether or not a product was adulterated. This action may
affect all products in the plant or only those products produced by a
particular process. When only a particular process is involved, the
plant may continue with its other operations, but it may not distribute
the affected product.
* A suspension is an interruption in the assignment of FSIS inspectors
and, hence, production, in all or part of a plant. An FSIS district
manager may suspend inspections when the violation cannot be resolved
through a withholding action or there is an immediate threat to public
health. The district manager may put a suspension on hold--“in
abeyance“--to give the plant time to execute a plan to correct the
violation and prevent its future recurrence. FSIS guidance recommends
that suspension not be held in abeyance for more than 90 days.
* A withdrawal of the grant of inspection is the removal of FSIS from
the plant. Under this rarely used action, taken only by the FSIS
Administrator, a plant‘s products cannot enter interstate or foreign
commerce.
According to the June 2000 Inspector General‘s report, while some
plants had received numerous noncompliance records for the same
deficiency, FSIS‘s inspectors had no understanding of what number,
frequency, or nature of deficiencies would constitute a breakdown in
the system requiring an enforcement action. The report further found
that FSIS inspectors were unsure when to declare a plant‘s corrective
actions unworkable--a critical step in taking further enforcement
action.
FSIS Is Not Ensuring that Plants‘ HACCP Plans Meet Regulatory
Requirements:
According to FSIS‘s food safety systems correlation reviews, inspectors
are not consistently identifying and documenting failures of plants‘
HACCP plans to meet regulatory requirements. Furthermore, FSIS does not
expect its inspectors to determine whether HACCP plans are based on
sound science--the cornerstone of an effective plan. While in-depth
verification reviews examine the scientific aspects of HACCP plans,
they have been conducted in very few plants, and consumer safety
officers hired to review the scientific soundness of HACCP plans may
take several years to assess the plans at all plants. Moreover,
inspectors in 55 percent of the 5,000 plants nationwide did not
document any HACCP violations during fiscal year 2001. When we brought
this information to the attention of FSIS officials, they were
surprised that so many plants had no HACCP violations for an entire
year.
Food Safety Systems Correlation Reviews Show That FSIS Inspectors Did
Not Identify Violations in Plants‘ HACCP Plans:
FSIS‘s food safety systems correlation reviews show that plants have
deficiencies in their HACCP plans that FSIS‘s in-plant inspectors did
not identify and document in noncompliance records.[Footnote 8] Through
May 2002, FSIS conducted food safety systems correlation reviews for
seven districts and completed reports for six of those districts; it
plans to complete reviews in the remaining districts by the end of
fiscal year 2003. These reviews, which examine a random sample of
plants in a district, compare inspection practices within a district
to, among other things, better target inspector training.
While examining the findings of the six completed district review
reports, we found that a significant number of plants had deficiencies
in their HACCP plans that FSIS inspectors had not identified and
documented. For example, in about 91 percent of the plants sampled in
three districts, inspectors had failed to issue noncompliance records
for deficiencies in basic requirements such as the requirement that
plants have adequate documentation to support the analysis of hazards
in their HACCP plans.
* In 26 of 27 plants in one of the three districts, inspectors had not
issued noncompliance records for HACCP plans that failed to include
supporting documentation on the food safety hazards that were likely to
occur. Inspectors also had not issued noncompliance records for 15
plants with plans that failed to address the three categories of
hazards (biological, chemical, and physical) at each step of their
production processes.
* In 10 of 14 plants in another district, inspectors had not issued
noncompliance records for HACCP plans that had either not sufficiently
documented decisions, not included all likely hazards, or not addressed
specific pathogens.
* In the third district, inspectors had not issued noncompliance
records for any of the 15 plants with HACCP plans that did not
sufficiently document their hazard analyses.
The food safety system correlation reports did not elaborate on the
reasons for the lack of documented violations in noncompliance records.
However, all the reports included the general observation that ’a
number of inspection personnel“ were unclear about some of the basic
requirements of the HACCP program.
The Few In-Depth Verification Reviews Completed to Date Have Found
Potentially Serious Problems:
FSIS conducted in-depth verification reviews during calendar years 2000
and 2001 at 47 plants that it considered as having potentially serious
food safety risks.[Footnote 9] The 47 plants included 31 that had
failed to meet the Salmonella performance standard in two consecutive
sets of tests; 8 that tested positive for Listeria monocytogenes on
ready-to-eat meat or poultry products; 4 that tested positive for
E. coli 0157:H7 on ground beef; and 4 for other concerns.[Footnote 10]
We found that at 44 of these 47 plants, FSIS identified significant
violations of regulatory requirements in HACCP plans. In 42 of these 44
plants, the HACCP plans did not include a complete hazard analysis to
identify the biological, chemical, or physical food safety hazards that
were reasonably likely to occur.
* One plant did not have the required documentation to substantiate the
hazards that were identified in the hazard analysis. Instead, according
to the FSIS review team, the hazard analysis was based on the personal
experience and general knowledge of plant personnel.
* Another plant‘s hazard analysis addressed some but not all parts of
its production process where hazards could be introduced. Areas not
addressed included returned products, packaging materials, and nonmeat
ingredients.
* A third plant‘s hazard analysis failed to identify a biological
hazard as reasonably likely to occur for one product even though plant
personnel were checking the product for pathogenic bacteria. Because
the hazard was not identified in the plan and a critical control point
was not designated for the hazard, no HACCP documentation was generated
and no control measures were implemented to control the biological
hazard throughout the process.
In 35 of the 44 plants, the HACCP plans did not adequately identify
critical control points in their processes where controls could be
applied to prevent, eliminate, or reduce a food safety hazard to an
acceptable level.
* One plant‘s hazard analysis identified several biological and
chemical hazards as reasonably likely to occur at various steps in the
production process but did not establish critical control points to
address those hazards.
* Another plant‘s HACCP plan for its slaughter activities identified a
biological hazard at the animal-receiving step. The plant did not
establish a critical control point to address that risk. Instead, it
identified USDA inspection activities as the control measure. FSIS
regulations require the plant itself to have control measures for all
hazards that it identifies as reasonably likely to occur.
The in-depth verification reviews also showed that some plants may
have a fundamental misunderstanding of what constitutes a hazard that
is reasonably likely to occur. For example, when a plant fails a second
set of Salmonella tests or a single test for Listeria monocytogenes or
E. coli 0157:H7, it must reassess its HACCP plan to determine whether
any changes are needed to prevent the problem from reoccurring.
However, 15 of the 47 plants had not identified the pathogen that
prompted the in-depth verification review as a hazard that was
reasonably likely to occur. For example, the hazard analysis at one
plant that had failed two consecutive Salmonella sets did not identify
Salmonella as a hazard that was reasonably likely to occur--an
’egregious“ omission, according to FSIS‘s report on the review for that
plant.
The in-depth verification reviews are useful in identifying
deficiencies in the scientific aspects of plants‘ HACCP plans. However,
according to FSIS officials, they are too time-and resource-intensive
to be implemented on a broader scale. As of June 30, 2002, FSIS had
conducted reviews at 57 plants--or about 1 percent of the more than
5,000 plants nationwide.
Consumer Safety Officers Improve FSIS‘s Ability to Assess the
Scientific Adequacy of HACCP Plans, but Reviews of All Plans May Take
Years to Complete:
FSIS has recognized since HACCP‘s inception that its inspection
workforce did not collectively possess the skills needed to evaluate
the scientific validity of HACCP plans. As a result, FSIS does not
expect its inspectors to evaluate the scientific soundness of HACCP
plans. In October 2001, FSIS introduced consumer safety officers with
the scientific and technical skills to, among other things, assess the
scientific soundness of plants‘ HACCP plans. Initially, according to
district office officials, the consumer safety officers were reviewing
HACCP plans at plants where there was an indication of problems and
were finding significant violations of HACCP regulatory requirements.
In response to those findings, FSIS is taking enforcement actions to
address potential food safety risks. For example, in one district, as
of June 2002, consumer safety officers reviewed HACCP plans at 59
plants. As a result of these reviews, FSIS suspended 3 plants, sent
letters to 17 plants indicating its intention to take enforcement
action if changes were not made, and sent letters to 24 plants advising
them to reassess their HACCP plans within 30 days to correct
deficiencies.
FSIS plans to have 352 consumer safety officers by September 2005:
32 consumer safety officers on-board as of May 30, 2002; 50 more in
2002, plus 25 veterinary medical officers who will perform consumer
safety officer duties on a part-time basis; 105 new consumer safety
officers in fiscal year 2003; and 140 in fiscal year 2004. An FSIS
official estimated, however, that FSIS might need a total of 500
consumer safety officers, including cross-trained veterinary medical
officers, to carry out HACCP oversight responsibilities. Initially,
FSIS had planned to bring consumer safety officers on board more
quickly and in greater numbers. According to FSIS officials, Congress
did not approve FSIS‘s fiscal year 2000 budget request to hire consumer
safety officers and FSIS‘s efforts to retrain existing staff to fill
these positions have taken longer than FSIS anticipated.
Officials in the two largest district offices (Alameda, Calif. and
Albany, N.Y.) told us that it could take several years to ensure that
all HACCP plans at all of the nation‘s meat and poultry plants have a
sound scientific basis if FSIS cannot bring consumer safety officers on
board as quickly as expected. If this were to occur, an Alameda
District official told us it would take at least 4 years for the two
consumer safety officers it has now to review the more than 500 plants
in the district. Similarly, an Albany District official estimated that
its five consumer safety officers will need from 2 to 5 more years to
review HACCP plans at the district‘s more than 800 plants.
FSIS‘s Inspection Data Raise Further Concerns About Whether FSIS‘s
Inspectors Are Ensuring That All Plants Meet HACCP Regulatory
Requirements:
FSIS‘s headquarters and district officials told us that finding plants
with zero HACCP-related noncompliance records for an entire year would
be unusual. HACCP requirements are numerous, and FSIS inspects plants
on a daily basis, which creates many opportunities to identify and
document HACCP violations. And as one district official told us, there
are no perfect plants. That notwithstanding, our analysis of
information in FSIS‘s inspection database showed that 55 percent of all
plants had no documented HACCP-related violations during fiscal year
2001. (See table 1.) FSIS officials were surprised at the large
percentage without violations. FSIS had not analyzed these data for an
entire year. An FSIS field official told us that if inspectors are
finding no HACCP violations for an entire year at so many plants, they
may not understand their HACCP oversight responsibilities.
Table 1: Percentage of Plants with No Documented HACCP Violations
during Fiscal Year 2001:
FSIS district: Lawrence, Kans.; Number of HACCP plants: 218; Number of
plants with no violations: 144; Percentage of plants with no
violations: 66.
FSIS district: Philadelphia, Pa.; Number of HACCP plants: 390; Number
of plants with no violations: 249; Percentage of plants with no
violations: 64.
FSIS district: Beltsville, Md.; Number of HACCP plants: 166; Number of
plants with no violations: 105; Percentage of plants with no
violations: 63.
FSIS district: Pickerington, Ohio; Number of HACCP plants: 248; Number
of plants with no violations: 154; Percentage of plants with no
violations: 62.
FSIS district: Madison, Wis.; Number of HACCP plants: 277; Number of
plants with no violations: 168; Percentage of plants with no
violations: 61.
FSIS district: Des Moines, Iowa; Number of HACCP plants: 195; Number of
plants with no violations: 116; Percentage of plants with no
violations: 59.
FSIS district: Boulder, Colo.; Number of HACCP plants: 216; Number of
plants with no violations: 127; Percentage of plants with no
violations: 59.
FSIS district: Salem, Oreg.; Number of HACCP plants: 267; Number of
plants with no violations: 150; Percentage of plants with no
violations: 56.
FSIS district: Atlanta, Ga.; Number of HACCP plants: 379; Number of
plants with no violations: 211; Percentage of plants with no
violations: 56.
FSIS district: Dallas, Tex.; Number of HACCP plants: 243; Number of
plants with no violations: 132; Percentage of plants with no
violations: 54.
FSIS district: Jackson, Miss.; Number of HACCP plants: 221; Number of
plants with no violations: 115; Percentage of plants with no
violations: 52.
FSIS district: Chicago, Ill.; Number of HACCP plants: 330; Number of
plants with no violations: 170; Percentage of plants with no
violations: 52.
FSIS district: Raleigh, N.C.; Number of HACCP plants: 165; Number of
plants with no violations: 85; Percentage of plants with no violations:
52.
FSIS district: Albany, N.Y.; Number of HACCP plants: 838; Number of
plants with no violations: 425; Percentage of plants with no
violations: 51.
FSIS district: Alameda, Calif.; Number of HACCP plants: 530; Number of
plants with no violations: 268; Percentage of plants with no
violations: 51.
FSIS district: Springdale, Ark.; Number of HACCP plants: 183; Number of
plants with no violations: 84; Percentage of plants with no violations:
46.
FSIS district: Minneapolis, Minn.; Number of HACCP plants: 191; Number
of plants with no violations: 73; Percentage of plants with no
violations: 38.
FSIS district: Total; Number of HACCP plants: 5,057; Number of plants
with no violations: 2,776; Percentage of plants with no violations: 55.
Note: In May 2002, an organizational realignment consolidated FSIS‘s 17
district offices into 15. In the realignment, the Pickerington, Ohio,
office became a satellite office in the Chicago District, and the
Salem, Oregon, office became a satellite in the Boulder, Colorado,
District.
Source: GAO‘s analysis of FSIS‘s data.
[End of table]
As table 1 shows, the percentage of plants, by district, where no HACCP
violations were documented on noncompliance records ranged from 38 to
66 percent. Officials in several districts acknowledged that they had
reviewed reports that showed that some plants in their districts had no
documented HACCP violations. According to FSIS officials, they had not
analyzed the data for an entire year and were not aware of the extent
to which no violations had been documented. Two officials told us that
they had asked their circuit supervisors--who oversee FSIS‘s in-plant
inspectors--to investigate plants with no documented violations but
that they had not asked the supervisors to report back to them with the
results.
In fact, at 10 of the 43 plants in which FSIS‘s in-depth verification
reviews found serious HACCP implementation problems, FSIS inspectors
had not documented any HACCP violations on noncompliance records during
the 12 months preceding the review. For example, at one of those
plants, the in-depth verification review found that (1) corrective
actions taken by the plant were not documented, (2) monitoring records
did not show the time that product temperatures were checked, and (3)
the required annual reassessment of the HACCP plan had not been done.
Inspectors had not documented any of these violations.
Although FSIS has implemented a variety of inspector training
activities in response to our earlier report recommendations, it is
clear that some FSIS inspectors remain uncertain about their roles,
responsibilities, and authorities for reviewing and verifying plants‘
compliance with HACCP requirements. Following a meeting we had with
FSIS officials in June 2002 to alert them of our preliminary findings,
FSIS informed us, in a letter dated August 2, 2002, that it was taking
a number of actions aimed at addressing the problems we identified.
With regard to inspector activities, FSIS stated that it is developing
a directive explaining the responsibilities of inspectors under HACCP
and has introduced an interactive computer tool for inspectors and
others to use to strengthen HACCP problem solving using fictional
scenarios.
In its August 2, 2002 letter, FSIS also told us that the agency had
developed supervisory guidelines that will be a reference for managers
to use to verify that FSIS inspectors are carrying out their
responsibilities, including ’applying appropriate inspection methods;
using effective regulatory decision-making; documenting findings
appropriately; and when warranted, implementing enforcement actions
properly.“ The agency expects to train all field supervisors and
implement the new guidelines by October 1, 2002, and believes it will
then be better able to hold supervisors accountable for overseeing
inspectors‘ performance. The letter also stated that FSIS field offices
are evaluating the results of the food safety system correlation
reviews to determine how FSIS can improve the reviews and how it can
use the reviews to strengthen inspectors‘ effectiveness.
FSIS‘s Lack of Consistent Identification and Documentation of
Repetitive HACCP Violations Weakens Enforcement:
According to our review of 1,180 noncompliance records from 16 plants
for fiscal year 2001, plant inspectors have not consistently identified
and documented repetitive violations of HACCP requirements. The lack of
consistency occurs, in part, because FSIS has not established specific,
uniform criteria for identifying repetitive violations. Moreover, even
at the district level, officials‘ understanding of the factors that
should be considered in determining repetitive violations varied.
Furthermore, we found that FSIS‘s recently revised inspection data
system lacks important summary information that managers need to
oversee inspectors‘ identification of repetitive violations and
enforcement decisions. If FSIS does not consistently identify and
document repetitive violations, it cannot properly and equitably
enforce HACCP requirements.
The Factors That Inspectors Used to Identify Repetitive Violations
Differ:
FSIS has not established specific criteria for its inspectors to use
for determining when violations are repetitive. According to the
noncompliance records we analyzed, inspectors did not use the same
factors to identify repetitive violations of HACCP requirements. Table
2 shows the plant size and the number of noncompliance records and
repetitive violations for the 16 plants we examined.
Table 2: Plant Size, Number of Noncompliance Records, and Number of
Repetitive Violations in 16 Plants during Fiscal Year 2001:
Plant: Plant 1; Plant size: Very small; Number of noncompliance
records: 9; Number of repetitive
violations: 2.
Plant: Plant 2; Plant size: Very small; Number of noncompliance
records: 12; Number of repetitive
violations: 3.
Plant: Plant 3; Plant size: Very small; Number of noncompliance
records: 15; Number of repetitive
violations: 8.
Plant: Plant 4; Plant size: Small; Number of noncompliance records: 15;
Number of repetitive
violations: 4.
Plant: Plant 5; Plant size: Small; Number of noncompliance records: 23;
Number of repetitive
violations: 0.
Plant: Plant 6; Plant size: Small; Number of noncompliance records: 26;
Number of repetitive
violations: 16.
Plant: Plant 7; Plant size: Small; Number of noncompliance records: 60;
Number of repetitive
violations: 34.
Plant: Plant 8; Plant size: Small; Number of noncompliance records:
100; Number of repetitive
violations: 69.
Plant: Plant 9; Plant size: Small; Number of noncompliance records:
112; Number of repetitive
violations: 74.
Plant: Plant 10; Plant size: Small; Number of noncompliance records:
145; Number of repetitive
violations: 44.
Plant: Plant 11; Plant size: Large; Number of noncompliance records:
12; Number of repetitive
violations: 10.
Plant: Plant 12; Plant size: Large; Number of noncompliance records:
70; Number of repetitive
violations: 9.
Plant: Plant 13; Plant size: Large; Number of noncompliance records:
109; Number of repetitive
violations: 85.
Plant: Plant 14; Plant size: Large; Number of noncompliance records:
132; Number of repetitive
violations: 69.
Plant: Plant 15; Plant size: Large; Number of noncompliance records:
167; Number of repetitive
violations: 113.
Plant: Plant 16; Plant size: Large; Number of noncompliance records:
173; Number of repetitive
violations: 19.
Plant: Total; Plant size: [Empty]; Number of noncompliance records:
1,180; Number of repetitive
violations: 559.
Source: GAO‘s analysis of FSIS‘s documents.
[End of table]
We found the following variations:
* Inspectors differed in determining when a violation was repetitive,
which led to inconsistent action on similar violations. For example, in
one plant, two inspectors issued noncompliance records documenting
three violations over a 15-day period that had the same inspection
procedure (slaughter), element of the HACCP system (monitoring), and
violation (fecal contamination). One inspector issued the first and
second records 5 days apart; the other inspector issued the third
record 10 days later. The first inspector did not link the first and
second records and determine that the second record was repetitive.
However, the inspector who wrote the third record linked it to the two
earlier records, and determined that it was repetitive.
* Noncompliance records that contained the same information were not
always identified as repetitive, which led to inconsistent action on
the same violations and understating the potential seriousness of the
problem. For example, on 23 occasions, an inspector in one plant wrote
a noncompliance record followed within 2 days by another record
containing the same information. However, the inspector linked the
first record to the second and determined that the second was
repetitive on only one occasion.
* Inspectors used different time limits in which violations could be
linked as repetitive, which may misstate the seriousness of the
problem. For example, inspectors at one plant used a calendar month.
Violations occurring within the same month could be linked to one
another as repetitive, but violations in a subsequent month could not
be linked back to incidences in the previous months. Inspectors at
another plant used a period of 4 years. At this plant, noncompliance
records for some violations were linked as repetitive to as many as 225
other violations. FSIS has not given guidance on an appropriate length
of time for linking violations, but for training purposes, it uses a
rolling 90-day period as the time limit for linking violations as
repetitive, meaning that an inspector would look back 90 days from the
date of a violation.
We also found that when inspectors identified violations as repetitive,
they did not consistently document the basis for their decision--the
record identification numbers of the previous violations. For example,
at one plant, inspectors did not record the identification numbers for
75 percent of the previous repetitive violations, while at another
plant, 46 percent of repetitive violations did not have this
information. When documentation is lacking, FSIS cannot determine with
any confidence the number of times a violation has been repeated and
whether it warrants further enforcement action.
At the district level, we found that officials in the 10 districts
where we sampled noncompliance records used varying factors, such as
the type of violation (e.g., fecal contamination) or element (e.g.,
record keeping), that they said should be considered important in
determining whether violations were repetitive. District officials also
disagreed on the time period in which violations could be considered
repetitive; only one stated that they usually used the rolling 90-day
period.
FSIS‘s Inspection Database Provides FSIS Officials with Limited
Information on Repetitive Violations:
FSIS‘s Performance Based Inspection System, a database that captures
the results of inspection activities, generates reports on the total
number of HACCP inspections conducted and the percentage that resulted
in violations. This information is reported by the type of inspection
procedure (e.g., slaughter or processing) and the element of the HACCP
system where the violation occurred (e.g., monitoring or record
keeping). For example, the reports can identify the number and
percentage of various HACCP inspection procedures at a plant that
resulted in violations related to monitoring. FSIS‘s managers told us
they considered these reports adequate to identify the potential for a
repetitive problem and trigger the need to explore individual
noncompliance records to determine if a repetitive problem exists.
Consistently and accurately linking repetitive violations is important
because FSIS uses repetitive violations as a factor in assessing
whether a plant has an effective HACCP system, whether an enforcement
action is warranted, and whether the meat or poultry products from that
plant are safe for consumers.
However, the inspection database does not capture summary information
on the number of repetitive noncompliance records an inspector issues
to a plant, the nature of the repetitive deficiencies, or plant
managers‘ success or failure in taking effective preventive action.
This type of summary information could assist managers in both
overseeing inspectors‘ performance and plants‘ compliance with HACCP
requirements. In addition, it could serve as one indicator for
considering further enforcement action or for advising industry on the
need to address a common problem. For example, managers could oversee
inspectors‘ performance by comparing inspectors‘ rates of identifying
repeat violations. If an inspector identified high rates, then a
manager could investigate to determine if the inspector proposed or
took further enforcement action. If the inspector identified low rates
of repetitive violations, but the data showed high numbers of a
particular type of violation, then managers could investigate to
determine why these inspectors did not identify these as repetitive.
Managers have some information on repetitive violations, but not in
summary format. Inspectors enter information into the database on an
electronic version of the noncompliance record. Once entered, FSIS
inspectors, supervisors, and managers from almost any location
nationwide can review these individual noncompliance records. However,
to assess the extent of repetitive violations that a particular
inspector identified, a manager or supervisor would need to view every
noncompliance record--a cumbersome process. FSIS officials maintain
that the individual inspector is responsible for assessing the extent
of repetitive violations, making a professional judgment on the need
for further enforcement action, and bringing this matter to the
attention of managers. However, access by managers to summary
information on the repetitive violations that inspectors already
identified would facilitate management‘s oversight of HACCP
implementation.
Although FSIS headquarters and district officials told us throughout
our work that they had sufficient data on repetitive violations, in its
August 2, 2002 letter, FSIS stated that it now recognizes that it needs
to improve and strengthen its data systems to support management
decision making on repetitive violations. The letter stated that FSIS
has implemented several systems over the past 6 months in an effort to
address its need for better inspection information from its data
systems and is testing software that will enable district officials and
managers to extract information and summary reports to help identify
problem areas. The letter also stated that FSIS is pilot testing an
early warning system for district officials that draws on data from
various FSIS databases.
FSIS Is Not Ensuring That Plants Take Prompt and Effective Corrective
Action to Return to Compliance with HACCP Requirements after Violations
Have Been Identified:
FSIS is not ensuring that all plants take prompt and effective
corrective action to return to compliance with regulatory requirements
after violations have been identified in three areas. First, FSIS does
not consistently ensure that plants quickly take effective action to
eliminate repetitive violations, particularly those of the zero
tolerance standard for visible fecal contamination. Second, FSIS does
not ensure that plants take prompt action to meet the Salmonella
performance standard after a second consecutive failure. Finally, when
FSIS suspends inspection services at a plant because of serious
violations, it generally places those suspensions in abeyance, allowing
the plants to continue operating. However, it rarely identifies a time
frame for the plant to take corrective actions, and it does not track
the actual time the plant takes to make the correction. The longer that
FSIS allows plants to remain out of compliance with regulatory
requirements, the greater the risk that unsafe food will be produced
and enter the marketplace.
FSIS Does Not Consistently Ensure That Plants Quickly Take Effective
Action to Eliminate Repetitive Violations:
According to FSIS regulations, enforcement action is warranted when
plants fail to demonstrate that their HACCP systems adequately prevent
multiple or recurring violations. However, FSIS inspectors do not
consistently initiate enforcement actions in such cases. For example,
in the 1,180 noncompliance records we examined at 16 plants, the
violation of FSIS‘s zero tolerance standard for fecal contamination was
the most common type of repetitive violation. Each time an inspector
documents this violation, FSIS regulations require the plant to take
corrective action to remove the contamination. However, FSIS did not
take withholding or suspension enforcement actions at any of the 11
plants where repetitive fecal contamination was identified. For
example, FSIS issued 96 noncompliance records to one plant for these
violations and although 88 percent of these records were linked as
repetitive, FSIS did not initiate a withholding or suspension
enforcement action. District officials stated that FSIS did not
initiate an enforcement action because the plant had ’done a good job“
of addressing violations that were brought to its attention previously
and the number of noncompliance records issued to the plant for fecal
contamination was ’not out of line“ for a large plant. In addition, the
officials said that violations of the fecal standard are bound to occur
and most of the fecal contamination was minuscule--about one-eighth to
one-quarter of an inch in diameter.
In another case, inspectors issued 154 noncompliance records to a plant
for fecal contamination during the fiscal year, and they identified 109
of the deficiencies (71 percent) as repetitive, yet took no withholding
or suspension enforcement action. For this plant, an FSIS official told
us that the inspector did not recommend enforcement action because, in
the inspector‘s professional opinion, the findings did not warrant it.
However, because fecal matter can harbor serious contaminants,
including E. coli 0157: H7, any fecal matter is a potentially serious
health risk. FSIS‘s zero tolerance standard for visible feces
recognizes this risk.
At plants where FSIS conducted an in-depth verification review, the
noncompliance records also indicate that FSIS is not ensuring that
plants quickly take effective action to eliminate repetitive
violations. For example, at one slaughter plant, over 9-months, FSIS
inspectors documented 27 instances of animals presented for slaughter
that had levels of antibiotic drug residues that exceeded the amounts
allowed by FSIS. On the earliest noncompliance record we reviewed,
dated August 2000, the FSIS inspector wrote that the finding of
excessive drug residue indicates, ’that there may be an inadequacy in
[the plant‘s] HACCP plan to control food safety hazards identified in
[its] hazard analysis.“ However, it was not until April 2001, 8 months
later, that the plant implemented a program designed to prevent drug
residues from entering its products.
FSIS has not established consistent criteria for inspectors to consider
when assessing whether repetitive violations warrant a withholding or
suspension enforcement action. According to FSIS officials, the
decision to pursue an enforcement action is left to the professional
judgment of each plant inspector. However, some district officials and
inspectors we interviewed indicated that they would benefit from having
FSIS identify a uniform set of factors for them to assess when
considering whether an enforcement action is warranted. These officials
suggested, for example,
* the length of time between repetitive violations,
* the number of repetitive noncompliance records issued,
* the nature of the violations, and:
* the plant‘s efforts and/or success in implementing preventive
actions.
FSIS officials told us they recognize the need to establish criteria
for assessing whether repetitive violations warrant enforcement action
and are in the process of updating a policy directive to include such
criteria. FSIS expects to implement this directive in early 2003.
In addition, for repetitive violations, FSIS does not require
inspectors to document whether they had considered and recommended or
decided against an enforcement action. Such documentation would assist
other inspectors at the same plant in determining whether enforcement
actions are warranted when they issue additional noncompliance records
for similar violations. This documentation could also assist
supervisors and district office officials in overseeing plants‘
implementation of HACCP requirements.
FSIS Does Not Ensure That Plants Take Prompt Actions to Meet the
Salmonella Performance Standard after a Second Consecutive Failure:
FSIS does not ensure that plants take prompt corrective actions after
they fail to meet the Salmonella performance standard. The HACCP
regulations require that plants take immediate action to meet this
standard if they have failed a set, but they do not explain what is
meant by ’immediate action.“ However, our analysis of elapsed time
shows that plants are not taking prompt corrective actions in these
instances.
After a plant fails a second consecutive set of Salmonella tests, FSIS
requires the plant to reassess its HACCP plan to determine if it should
make any changes. In addition, FSIS has conducted in-depth verification
reviews to evaluate the design and implementation of HACCP plans at
plants that failed a second set of Salmonella tests. In 2000 and 2001,
FSIS conducted in-depth verification reviews at 31 of these plants. In
one case, FSIS conducted an in-depth verification review at one plant
that had failed three of the past four sets of tests. However, the
failure that triggered the review was the first set in a new series.
Following the in-depth verification review, 14 plants passed a third
set of tests and 5 failed. As of April 2002, for the remaining plants,
sampling was in process or FSIS was waiting to begin the third set of
tests.[Footnote 11]
As shown in table 3, our analysis of time frames for each step in the
process, from first-set failure to passing a third set of Salmonella
tests, shows that considerable time elapsed. These time frames are not
consistent with ensuring that plants immediately meet the performance
standard after a failure, as the regulations require.
Table 3: Elapsed Time--From Failure of First Set to Passing Third Set-
-at Plants with Second-Set Failures of the Salmonella Performance
Standard and In-Depth Verification Reviews:
Event: First-to second-set Salmonella failure; Average number of days
elapsed: 198; Range of days elapsed: 113 to 337; Number of plants:
30[A].
Event: Second-set failure to in-depth verification review; Average
number of days elapsed: 96; Range of days elapsed: 21 to 322; Number of
plants: 26[B].
Event: In-depth verification review to reassessment letter; Average
number of days elapsed: 76; Range of days elapsed: 11 to 284; Number of
plants: 28[C].
Event: FSIS‘s reassessment letter to plant‘s written response; Average
number of days elapsed: 37; Range of days elapsed: 12 to 82; Number of
plants: 26[D].
Event: In-depth verification review to third-set result; Average number
of days elapsed: 320; Range of days elapsed: 155 to 543; Number of
plants: 16[E].
Event: First-set Salmonella failure to third-set pass; Average number
of days elapsed: 608; Range of days elapsed: 340 to 929; Number of
plants: 14[F].
[A] Subsequent to the in-depth verification review, one of the 31
plants had its second-set Salmonella failure overturned on appeal.
Consequently, it was not included in this calculation.
[B] FSIS conducted an in-depth verification review at one plant that
had failed three of the past four sets of tests. However, the failure
that triggered the review was the first set in a new series. Therefore,
the time from second-set failure to the review could not be calculated.
Also, in three cases FSIS began the third set of tests prior to the in-
depth verification review. Therefore, these plants are not included in
this calculation.
[C] FSIS did not send reassessment letters to 2 of the 30 plants
because the in-depth verification reviews were conducted before the
agency required reassessment letters in these situations.
[D] Two plants did not receive reassessment letters and so did not send
a response to FSIS. One plant‘s response to the reassessment letter was
not dated, and FSIS did not provide us with the plant‘s response letter
in one case.
[E] As of April 4, 2002, FSIS had completed the third set of Salmonella
tests at 19 plants. However, in three cases the third set of tests was
begun prior to the in-depth verification review. Therefore, the time
from the review to third-set result could not be calculated for these
plants.
[F] Of the 19 plants for which a third set of Salmonella tests were
completed as of April 4, 2002, 14 passed and 5 failed.
Source: GAO‘s analysis of FSIS‘s data.
[End of table]
Our analysis showed that, on average, it took FSIS about 3 months from
the date of the second-set failure to begin an in-depth verification
review. Once the in-depth verification review was complete, an average
of 2½ months elapsed before FSIS sent its ’reassessment“ letter to the
plant listing all of the deficiencies in the design and implementation
of the HACCP plan found during the review. In one case, the period from
review to FSIS letter was 284 days--or more than 9 months. The
reassessment letter instructs the plant to respond to FSIS in writing
within 30 days stating the changes that will be made to meet the
Salmonella performance standard.
We found that plants came close to meeting this time frame--replying
within 37 days on average. On the other hand, FSIS does not
consistently require that plants quickly take steps to correct the
deficiencies identified by the in-depth verification reviews. As shown
in table 3, FSIS has allowed plants to take an average of 608 days--or
over 1½ years--from their first-set Salmonella failure until the
successful completion of a third set of tests. Over half that time, or
about 11 months, elapsed from the date of the in-depth verification
review until the successful completion of the third set of tests. For
example, at one plant in the Dallas district, 18 months elapsed from
the date of the in-depth verification review until the completion of
the third set of tests. (See table 4.):
Table 4: Time Line of Events between In-Depth Verification Review and
Third Set of Salmonella Tests at One Plant:
Date: Oct. 30 to Nov. 2, 2000; Action: FSIS team conducts the in-depth
verification review..
Date: Apr. 3, 2001; Action: FSIS sends the reassessment letter to the
plant..
Date: Apr. 25, 2001; Action: The plant responds to FSIS about what
changes it will make to its operations..
Date: May 21, 2001; Action: The plant asks for a delay in conducting
the third set of tests..
Date: Aug. 23, 2001; Action: FSIS writes the plant that the agency has
not yet received written notification of the completion dates for the
plant‘s improvement projects..
Date: Oct. 31, 2001; Action: The plant writes to FSIS that the
improvements would be completed by mid-November and asks that the third
set of tests not begin until after December 1, 2001..
Date: Dec. 3, 2001; Action: Sampling for the third set of tests
begins..
Date: Apr. 26, 2002; Action: The third set is completed and the plant
passes..
Source: GAO‘s analysis of FSIS‘s documents.
[End of table]
Officials in the Dallas District Office told us that 5 months elapsed
between the date of the in-depth verification review and FSIS‘s
reassessment letter largely because of the amount of time needed to
incorporate all of the in-depth verification review team‘s comments and
complete the report of the review‘s findings. About 8 months elapsed
from the date of the plant‘s response to the reassessment letter until
the third set of Salmonella tests began because, according to the
district officials, the district did not closely monitor the progress
of the changes the plant was making and because the plant requested and
received FSIS‘s permission to delay the third set until those changes
were made.
Because plants may continue to produce products that could pose a
Salmonella risk from the first-set failure until they pass, it is
important that the second-and third-set tests be scheduled and
completed as soon as possible. An FSIS headquarters official
acknowledged that, in some cases, the time between the second and third
set of Salmonella tests has been too long. However, the official stated
that plants sometimes make significant changes to their operations
after an in-depth verification review and the time needed to reassess,
modify and validate HACCP plans can be considerable. Nonetheless, in
the Dallas district case described above, at least a portion of the
delays were due to inattentive oversight by FSIS. In its August 2,
2002, letter to us, FSIS said it has designed and is ready to test a
tracking system for the in-depth verification reviews to assist the
agency in keeping those reviews timely and to allow for trend analysis
of review results over time.
FSIS further stated in that letter that USDA‘s Under Secretary for Food
Safety, in consultation with the Secretary of Agriculture, established
a new office--the Office of Program Evaluation, Enforcement and Review-
-to ensure that its programs and policies are implemented and monitored
correctly. The new office, which began operating on July 15, 2002, will
conduct in-depth examinations of FSIS policies to determine if the
policies are adequate or if additional actions are needed. The new
office began by looking at the Salmonella testing program to determine
whether it is accomplishing all it should to protect human health. It
expects to report its findings by mid-September 2002. In addition, FSIS
noted, ’using [the GAO preliminary findings] as a guide, [the new
office] has begun to assess the adequacy of the field staff‘s
implementation of HACCP.“ This preliminary report is also due in mid-
September.
FSIS Does Not Always Ensure That Plants Whose Suspensions Have Been
Placed on Hold Take Prompt Action to Return to Compliance:
FSIS is also not ensuring that plants take prompt corrective actions
when it places plants‘ suspensions in abeyance. When a suspension is
in abeyance, FSIS inspection services resume, and the plant continues
operating while it makes corrections. In analyzing 60 HACCP
administrative enforcement case files for 2001 for plants in the
Albany, Alameda, and Madison districts, at which FSIS had suspended
inspection services, we found that 57 of the 60 suspensions were placed
in abeyance. In half of the suspensions that were in abeyance (28 of
the 57 cases), FSIS placed the suspension in abeyance on the same day
the suspension was issued. Because there was either no or very limited
interruption in inspection services at the plant, the effect on the
plant, in terms of economic loss or disruption, was negligible.
On January 24, 2001, FSIS published policy guidance stating that no
plant‘s suspension should remain in abeyance for more than 90 days
without a specific ’operational reason,“ such as a violation that
involved a process that the plant operates intermittently. Limiting the
time that suspensions can remain in abeyance was also FSIS‘s practice
prior to the January 2001 policy notice establishing a specific time
frame. Our sample of the 57 enforcement cases included 30 plants that
had suspensions in abeyance that were closed after the 90-day policy
went into effect in January 2001. Of these 30 enforcement cases, only 1
was closed within 90 days. The average number of days from suspension
in abeyance to case closure was 316 days, or over 10 months. According
to FSIS officials in charge of enforcement in the three district
offices where we reviewed enforcement cases, the 90-day time frame for
holding suspensions in abeyance was not met because (1) the district
office did not require inspection personnel to report to them on
whether the plants had completed their corrective and preventive
actions within the 90-day period, (2) it often took longer than 90 days
for inspection personnel to inform the district office that plants had
completed their corrective and preventive actions and the cases could
be closed, and (3) closing these cases was a low priority for the
district office.
Further, none of FSIS‘s ’Notice of Suspension of Inspection“ documents
or other correspondence in the enforcement files for the 30 cases we
examined specified a date by which corrective actions were expected to
be implemented and their effectiveness verified. As long as FSIS does
not establish specific deadlines for plants with suspensions in
abeyance to correct their problems, plants have little incentive to
quickly implement and verify the effectiveness of their corrective
actions.
In addition, we were generally unable to verify that violations were
corrected before FSIS issued the letter ending the suspension in
abeyance and closing the case. The enforcement case files frequently
did not contain evidence showing how and when the district offices
determined that the plants had completed corrective and preventive
actions. However, in the Albany District Office, 6 of the 21 closed
enforcement files contained correspondence from inspection personnel to
the district office documenting how and when the plant had corrected
the violation and recommending closing the case. An FSIS headquarters
official responsible for enforcement activities told us that he would
expect to see documentation showing how decisions were reached in all
case files.
Moreover, in the Alameda district office, two of the four plants we
reviewed continued to have violations of the same requirements for
which the plant was suspended, according to the inspectors‘
documentation. Nevertheless, the suspension remained in abeyance, and
FSIS did not take any further enforcement action. For example, one
suspension that was placed in abeyance on the day it was issued in
October 2000 was the result of the plant‘s repeated failure to keep
adequate HACCP records to verify that critical control points were
being properly monitored to ensure food safety. In March 2001,
inspectors documented three more instances of the plant‘s failure to
keep the same type of HACCP records and two more instances in the
following months until the case was closed in September 2001.
FSIS also allows plants to have multiple suspensions in abeyance in
effect simultaneously, each for a separate production process, or to
have sequential suspensions in abeyance that last for extended periods
of time. As a result, a plant can continually struggle to meet
requirements and require special regulatory oversight for an extended
period of time and yet remain in business. For example, the plant in
the Alameda District mentioned above had sequential suspensions placed
in abeyance. In October 2001, just 1 month after the earlier suspension
was lifted, the district office sent the plant a letter indicating
FSIS‘s intention to take enforcement action because of the plant‘s
failure to collect product samples for E. coli testing, as required by
the HACCP regulations. On the basis of the plant‘s response to the
letter, the district office deferred any enforcement action for 90
days. Recognizing that this was a problem plant, in November 2001, the
district had a consumer safety officer conduct a comprehensive review
of the plant‘s HACCP system. Owing to the HACCP design and
implementation problems discovered by the consumer safety officer, such
as deficiencies in the hazard analysis and record keeping, inspection
was again suspended in early December 2001 and the suspension was
placed in abeyance 2 days later. In January 2002, because of the
plant‘s failure to adhere to its October 2001 plan to improve its
E. coli sampling procedures, inspection was again suspended and then
placed in abeyance 1 day later. Alameda district officials told us they
recommended to FSIS headquarters that FSIS withdraw this plant‘s grant
of inspection and were told that there was insufficient cause to take
this action.
In its August 2, 2002, letter to us, FSIS stated that an administrative
enforcement data system, which it implemented in January 2002, ’for
distributing copies, tracking status, and querying for information on
administrative actions“ provides, among other things, ’status reports
[that] show suspensions in abeyance to assist District Managers in
assuring proper follow up at these establishments.“ It further stated
that it sets ’very specific timelines for the plant to meet with
respect to corrective or preventive measures“ and that its ’in-plant
personnel conduct verification activities to ensure they are meeting
the conditions outlined in the timeline. If [plants] do not follow
through on the timeline/plan, the suspension is reinstated.“ FSIS‘s
letter went on to note that ’[t]he average time for the closure of
suspension actions placed in abeyance in [fiscal year] 2002 has been
105 days.“ However, unlike our analysis, this average time is based on
FSIS enforcement cases for violations of sanitation standards as well
as HACCP enforcement cases and, as the letter points out, does not
include an unspecified number of cases that remain open.
Conclusions:
Meat and poultry plants have many incentives to operate safely and
certainly many appear to be doing so under HACCP. Nevertheless, FSIS‘s
oversight and enforcement needs to be improved to ensure that it is
achieving its intended food safety objectives. FSIS inspectors are
currently not consistently identifying and documenting violations of
HACCP regulatory requirements, and FSIS has not assessed the scientific
soundness of all HACCP plans in a timely manner. Moreover, some FSIS
inspectors still do not have a clear understanding of their roles, and
FSIS managers have not been diligent in overseeing inspectors‘
activities. Finally, until consumer safety officers complete their
assessments, some plants may be operating with unsound HACCP plans.
These weaknesses limit the effectiveness of the HACCP system in
reducing the risks posed by pathogens and contaminants on meat and
poultry.
With regard to identifying repetitive violations--signs that a plant
may be struggling to fully meet HACCP requirements--FSIS‘s inspectors
and managers are confused about the factors that should be considered.
Until FSIS establishes clear, consistent criteria for determining and
documenting repetitive violations--and ensures that its inspectors and
managers understand these criteria--serious problems may go
unrecognized. The extraction of summary information on repetitive
violations from FSIS‘s inspection database would help determine, among
other things, when repetitive violations might indicate problems common
to an industry sector or an FSIS district.
Finally, the longer that FSIS allows plants to remain out of compliance
with HACCP requirements, the greater the risk that unsafe food will be
produced. When plants do not take actions that promptly and
successfully prevent repetitive violations--such as multiple recurring
violations of the zero tolerance standard for visible fecal
contamination--FSIS managers and officials must take enforcement
actions to compel plants to revise their HACCP plans to address these
problems. The system that FSIS has in place to address plants that fail
Salmonella performance standards--allowing plants to operate while
increased food safety risks persist for months and months--needs to be
reexamined. Similarly, FSIS‘s practice of placing a plant in suspension
but then immediately putting the suspension in abeyance for protracted
periods of time negates an important incentive for plants to quickly
correct problems. While some corrective actions could take a
significant period of time to implement--and placing a suspension in
abeyance might be warranted when FSIS is sure that interim actions will
provide for food safety--the circumstances should be clearly
established and progress closely monitored and documented to ensure
that plants are returning to compliance as soon as possible.
Recommendations for Executive Action:
To ensure that all HACCP plans fully meet regulatory requirements, we
recommend that the Secretary of Agriculture direct FSIS to:
* provide inspectors with additional training on their roles and
responsibilities under the HACCP system and use data, such as the
results from the food safety system correlation reviews, to help target
training to address specific weaknesses;
* develop procedures for its field supervisors and district managers to
use to monitor inspector activities, including, among other things,
ensuring that FSIS inspectors are consistently applying HACCP
requirements;
* develop a risk-based strategy and time frames for consumer safety
officers to complete their reviews of HACCP plans at all plants; and:
* develop a strategy for its supervisors, managers, and officials to
systematically use data, including annual data on noncompliance records
by districts, to help oversee plants‘ compliance with HACCP
requirements.
To ensure that FSIS inspectors and district officials use consistent
criteria for identifying repetitive violations of HACCP regulatory
requirements, we recommend that the Secretary of Agriculture direct
FSIS to:
* establish specific, uniform criteria for identifying repetitive
violations;
* ensure that inspectors consistently document repetitive violations;
* modify data management systems to capture the extent to which
inspectors are identifying repetitive violations at plants; and:
* develop a strategy for its supervisors, managers, and officials to
systemically use available data, including summary information, to help
identify repetitive violations.
To ensure that plants take prompt actions to correct violations, we
recommend that the Secretary of Agriculture direct FSIS to:
* establish clear, consistent criteria for inspectors to use when
considering whether to recommend suspension because of repetitive
violations;
* require its inspectors to document the basis for their decision on
whether or not to recommend further enforcement action based upon
documented repetitive violations;
* develop guidance with specific time frames for actions to be taken at
plants that fail a second set of Salmonella tests, including time
frames for FSIS to initiate an in-depth verification review, report the
results of the review, and initiate a third set of tests;
* establish, and document in enforcement case files, time frames for
plants with suspensions in abeyance to implement and verify the
necessary corrective actions; and:
* document in the enforcement case file how and when the district
office determined that the plant had completed its corrective actions
and, if the suspension is allowed to remain in abeyance for more than
90 days, the reason for the extension.
Agency Comments and Our Response:
We provided USDA with a draft of this report for review and comment.
USDA concurred with our recommendations but believes the report does
not fully acknowledge FSIS‘s progress and continuous efforts to ensure
that all plants meet regulatory requirements. Noting that FSIS has
placed significant resources into the processes and systems that
provided the data for our study, USDA states that FSIS has efforts
ongoing to evaluate the same data and has been open about addressing
these and other similar concerns and the need for associated program
improvements. USDA describes a number of actions that FSIS has recently
taken or is planning to take that are consistent with our
recommendations. We believe that our report accurately reflects the
status of FSIS‘s ongoing and planned actions. If fully carried out and
given diligent management attention, these actions could go a long way
toward addressing the problems we found in FSIS‘s oversight and
enforcement of HACCP in U.S. meat and poultry plants and helping to
reduce the risk of foodborne illness for American consumers. USDA‘s
comments are presented in appendix II. USDA also provided technical
suggestions, which we incorporated into the report as appropriate.
We conducted our review from August 2001 through August 2002 in
accordance with generally accepted government auditing standards.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the date of this letter. At that time, we will send copies of this
report to the congressional committees with jurisdiction over food
safety issues; the Secretary of Agriculture; the Administrator, Food
Safety and Inspection Service; the Director, Office of Management and
Budget; and other interested parties. We also will make copies
available to others upon request. In addition, the report will be
available at no charge on the GAO Web site at http://www.gao.gov:
If you have any questions about this report, please contact me or
Erin Lansburgh at (202) 512-3841. Key contributors to this report are
listed in appendix III.
Lawrence J. Dyckman
Director, Natural Resources
and Environment:
Signed by Lawrence J. Dyckman:
[End of section]
Appendix I: Scope and Methodology:
Our review of the Food Safety and Inspection Service‘s (FSIS)
enforcement of the Hazard Analysis and Critical Control Point (HACCP)
requirements focused exclusively on domestic meat and poultry slaughter
and processing plants subject to federal oversight. To assess whether
FSIS is ensuring that plants‘ HACCP plans meet regulatory requirements,
we analyzed data from several sources. These sources included the
following:
* The findings on the adequacy of HACCP plans from the food safety
systems correlation team review reports in six districts.
* The findings concerning HACCP plans from FSIS‘s reports for the 47
in-depth verification reviews of plants‘ HACCP systems completed in
calendar years 2000 and 2001.
* The approximately 700 HACCP-related noncompliance records written at
plants where FSIS conducted an in-depth verification review to
determine the type of deficiencies inspectors identified in the year
prior to the review.
* FSIS‘s Performance Based Inspection System database to identify the
number of plants in each district where no HACCP-related violations
were documented during fiscal year 2001.
We also visited 17 plants in California to view their HACCP systems in
operation and observe FSIS‘s oversight. We visited plants in each of
FSIS‘s three size categories--large (500 or more employees), small (10
to 499 employees), and very small (fewer than 10 employees or annual
sales of less than $2.5 million). The plants we visited were engaged in
the slaughter and/or processing of chickens, turkeys, hogs, and cattle.
We reviewed HACCP-related documents and discussed the plant‘s HACCP
system with FSIS officials at each of the plants we visited. In
addition, we obtained information from headquarters and district office
officials on the goals, training, and responsibilities of consumer
safety officers. We also reviewed the HACCP regulations, FSIS
directives and other policy documents, and interviewed FSIS officials
from headquarters and the Technical Service Center regarding the
agency‘s approach to reviewing HACCP plans.
To determine whether FSIS is consistently identifying repetitive
violations of HACCP requirements, we judgmentally selected 16 plants
located in 10 FSIS districts. We selected these plants from among those
where FSIS frequently found violations in fiscal year 2001.
Specifically, we selected our sample from among those plants where
8 percent or more of the time, when FSIS conducted a HACCP inspection,
it found a violation. Only about 4 percent of the total plants subject
to HACCP inspection met this criterion. We excluded from our sample any
plants that are participating in FSIS‘s HACCP-Based Inspection Models
Project or those that had been subject to an enforcement
action.[Footnote 12] Of the 16 plants we selected, FSIS considers 6 to
be large, 7 small, and 3 very small. Ten of the plants we selected were
poultry plants and 6 were beef plants. We analyzed all of the HACCP-
related noncompliance records provided by FSIS for fiscal year 2001 at
these 16 plants--in total 1,180 records--to determine the extent to
which inspectors had identified repetitive violations. We interviewed
district officials from the 10 district offices to determine the
factors they consider important in determining whether violations were
repetitive. The district officials we spoke to included district
managers; assistant district managers for enforcement; HACCP inspection
coordinators; managers of inspection staff at a group of plants in a
district, known as ’circuit supervisors;“ and veterinarians and an
inspector at plants. We also interviewed FSIS headquarters officials
and district officials to discuss issues raised from our review of the
noncompliance records. We reviewed FSIS‘s policy documents and training
materials related to determining repetitive violations.
To assess whether FSIS is ensuring that plants take prompt and
effective action to return to compliance after the agency has
identified HACCP violations, we analyzed data from three different
sources. First, we analyzed the type and rate of repetitive violations
identified by inspectors in our sample of 16 plants and spoke to FSIS
officials in district offices to discuss why no further action was
taken. Second, we analyzed FSIS‘s data on the 31 plants that failed a
second set of Salmonella tests and, at which FSIS conducted an in-depth
verification review, to identify the time that elapsed between the
first, second, and third sets of Salmonella tests. Third, we analyzed
the case files for 68 HACCP administrative enforcement cases that were
active in fiscal year 2001 from three FSIS districts (Albany, Alameda,
Madison). We selected these three districts because they represented
large, medium and small enforcement caseloads and were located in three
different regions of the country. Albany and Alameda are the districts
with the largest number of plants. We interviewed the assistant
district managers for enforcement in each of the three districts
regarding the actions taken on these cases. We also spoke to FSIS
headquarters officials about enforcement issues and reviewed FSIS‘s
policy documents related to HACCP enforcement.
We conducted our review from August 2001 through August 2002 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the U.S. Department of Agriculture:
Note: GAO‘s comments supplementing those in the report‘s text appear at
the end of this appendix.
United States Department of Agriculture:
Food Safety and Inspection Service:
Washington, D.C. 20250:
AUG 26 2002:
Lawrence J. Dyckman:
Director, Natural Resources and Environment Food and Agriculture
Issues:
U.S. General Accounting Office 441 G Street, N.W. Room 2T23 Washington,
DC 20548:
Dear Mr. Dyckman:
Thank you for the opportunity to review and provide comments on the
U.S. General Accounting Office (GAO) Draft Report, Meat and Poultry -
Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce
Risk of Foodborne Illnesses, No. GAO-02-902. Although we agree with the
GAO recommendations, we believe that the report does not fully
acknowledge our progress and continuous efforts to fully ensure that
all plants meet regulatory requirements. Further, it should be
recognized that FSIS has placed significant resources into the
processes and systems that generate the data and information used by
GAO to evaluate our program. FSIS has ongoing efforts to routinely
evaluate the same type of data. FSIS has been open about addressing
these and other similar concerns and the need for associated program
enhancements.
Our comments will highlight a number of actions that we have taken to
ensure that regulatory requirements are met. Many of these actions have
been implemented over the last few months and are reflected in Agency
Directives, Notices and other guidelines. FSIS has used much of the
same data as GAO in conducting its internal assessments that have led
to many actual and planned improvements of our internal policies,
procedures and guidance. Further, we believe that the GAO report
validates, through its recommendations, the course of action that the
Agency is taking to enhance the implementation of the Hazard Analysis
and Critical Control Point (HACCP) program and continue to ensure that
plants are meeting our regulatory requirements.
GENERAL COMMENTS:
1.We believe that the title of the report is a bit misleading. We
suggest a different title such as ’Continued USDA Oversight and
Enforcement of Safety Rules Needed to Reduce Risk of Foodborne
Illnesses“.
2. The GAO report noted what appears to be inconsistent implementation
of HACCP. Similar observations made earlier by FSIS officials resulted
in several directives and notices being prepared to provide
supplemental guidance and clarification of existing policies and
requirements.
a. In response to decision by the United States Court of Appeals for
the
Fifth Circuit, No. 00-11008, USDA v. Supreme Beef Processors, Inc., the
Agriculture Secretary Ann M. Veneman announced several initiatives that
FSIS would undertake to address issues related to implementation and
enforcement of the Salmonella performance standards. These initiatives
include the development of procedures to ensure that inspection
activities continue to adequately verify an establishment‘s total food
safety program and revisions in the Agency‘s response to Salmonella
sample set failures.
b. FSIS has developed FSIS Notice 28-02, Action To BE Taken In
Establishments Subject to Salmonella Testing, dated July 25, 2002. This
notice provides program personnel with verification activities that
they are to carry out in slaughter operations subject to the Salmonella
performance standards and grinding operations that are subject to
Salmonella
testing. Carrying out these activities is a way to ensure the proper
performance of verification activities with respect to an
establishment‘s
total food safety program. This notice also provides new steps the
Agency
will take should an establishment fail to meet the standards.
c. FSIS also issued FSIS Notice 36-01, Rules of Practice, dated
September 5, 2001. The directive was issued to ensure that all
inspection program personnel are knowledgeable about the enforcement
actions that the Agency may take (generally) in inspected
establishments, the circumstances under which the various types of
enforcement actions are appropriate and can be taken, and the
procedures that the Agency will follow in doing so. The rules of
practice provide a key link between inspection and enforcement
activities.
d. On August 9, 2002, we issued FSIS Notice 29-02, HACCP Verification
Procedures and the 30-day Reassessment Letter, which clarifies how
inspection program personnel should respond when they find evidence of
a deviation from a critical limit or a HACCP noncompliance while
performing an 01 and 02 HACCP verification procedure. This notice also
clarifies issues regarding when inspection program personnel should
issue 30-day reassessment letters.
e. The Under Secretary for Food Safety, Dr. Elsa A. Murano, in
consultation with Secretary Veneman, established within FSIS an office
that is designed to ensure our programs and policies are implemented
and monitored correctly. This new office, Office of Program Evaluation,
Enforcement and Review (PEER), will be headed by two veterans of FSIS -
one with vast Headquarters experience and the other with extensive
field experience. PEER, was established to provide focus to internal
review of FSIS programs, as well as an additional set of eyes for the
Administrator in assessing effectiveness of regulatory activities. PEER
began functioning as a unit on Monday, July 15, 2002, will conduct in-
depth examinations of policies established by FSIS to determine if
those policies are adequate or if additional steps are necessary. For
example, as its first review, the PEER staff began on Monday, July 15,
a review of the FSIS Salmonella testing program to determine if that
program is accomplishing all that it should in protecting public
health.
Recent reports by consumer activists are being studied to highlight
areas
of concern to be examined.
Review of the implementation of policies by Field staff is also a
function of the PEER office. The PEER staff has also begun to assess
the adequacy of the field staff‘s implementation of HACCP. This initial
review will include an assessment of Food Safety System Correlation
(FSSC) reports, conversations with District Managers and other
officials. This staff, which includes investigators located in the
field, will also be able to conduct quick investigations when problems
arise in the field, although compliance officers are also on site for
such investigations.
f. We are also updating FSIS Directive 5000.1, Enforcement of
Regulatory
Requirements in Establishments Subject to the HACCP System Regulations
(including regulations on Sanitation Standard Operating Procedures
(SSOP‘s), E. coli Testing and Criteria, and Salmonella Performance
Standards). This directive provides instructions to supervisory
personnel, consumer safety officers, circuit supervisors, and
inspection program personnel for reviewing an establishment‘s HACCP
plan and otherwise enforcing the HACCP system regulations (9 CFR part
417). It also updates previous instructions to inspection program
personnel regarding the regulations on sanitation performance standards
(SPS) and SSOP‘s (9 CFR part 416). This directive fully explains to our
inspectors their responsibilities under SPS, SSOP, and HACCP and
provides them questions to consider in performing their
responsibilities.
3. The GAO report recognized our FSSC reviews for identifying trends/
weaknesses in our verification and enforcement activities under HACCP.
The FSSC‘s also identify areas in which the industry needs to improve
in terms of the quality of industry HACCP plans. The FSIS is continuing
these reviews and the correlation/training sessions it holds for its
inspection force and for industry following completion of the reviews
in each District. Correlation in all the district offices will be
completed by the end of FY 2003. FSIS is evaluating the FSSC‘s on an
ongoing basis to determine what additional improvements can be made and
how the trends identified can be used to strengthen the knowledge and
effectiveness of the inspection force and industry.
4.FSIS is improving its systems for ensuring frontline accountability
by putting in place a formal process and tools that will be mandatory
for frontline supervisors to use to ensure that inspection program
personnel carry out their assigned job responsibilities as required
under the Pathogen Reduction/Hazard Analysis and Critical Control Point
(PR/HACCP) regulations.
FSIS Directive 4430.3, In-Plant Performance System (IPPS) Reviews,
dated June 17, 2002, and comprehensive Supervisory Guidelines have been
distributed through the Agency directives system. These documents
provide specific instructions and guidance on how to assess the
performance of non-supervisory inspection program personnel in PR/HACCP
system environment. The Supervisory Guidelines are a reference for
verifying that inspection program personnel are carrying out their
responsibilities. These include applying appropriate inspection
methods; using effective regulatory decision-making; documenting
findings
appropriately; and when warranted, implementing enforcement actions
properly.
The IPPS directive requires that each field supervisor conduct as many
as three formal, on-site reviews of each non-supervisory, in-plant
employee focusing on specific aspects of the individual‘s job
requirements. The supervisor will be required to document the results
of each review by indicating the specific job requirements that were
reviewed, and by documenting any deficiencies in knowledge or execution
identified. The supervisor must also document the follow-up activities
taken to address the deficiencies. This tool not only targets
accountability of non-supervisory personnel but also targets the
accountability of the field supervisors who are responsible for
monitoring the activities of inspection personnel and ensuring
consistent and effective verification of regulatory requirements by
those personnel.
All field supervisors will receive training in the IPPS system by
October l, 2002, when the system will be fully implemented. FSIS will
also audit the training and the implementation of the system, once in
place, to ensure that it is being carried out as intended.
5. In a continuing effort to enhance and improve the scientific basis
of
our inspection activities, FSIS has implemented a new service to
facilitate greater sharing of knowledge and information with and among
FSIS field personnel. This new service is identified as the
’Interactive Knowledge Exchange (IKE),“ and is described below.
The IKE is a new tool available to all field employees. It helps keep
employees current, and provides correlation, on regulatory
requirements, directives, notices, HACCP, S SOP, and/or agency sampling
programs. Through the use of scenarios IKE allows, an employee to
review FSIS requirements and hopefully to correlate with his or her
work-group and supervisor regarding the application of those
requirements:
A scenario pertaining to an inspection related subject is sent out
electronically on a bi-weekly basis to all field employees. Each
scenario includes a ’what would you do?“ or ’what is the correct action
to take?“ section, with suggested solutions to problems or issues
raised in the scenario.
Any employee may ask questions regarding these scenarios. It is
believed, however, that the greatest benefit may be gained from
discussions of the scenarios and questions within individual work
groups and with supervisors. The scenarios, and any subsequent
questions and answers, are intended to aid FSIS employees through
increased understanding and correlation of regulations, policies, and
standards for the inspection of meat, poultry, and egg products. If
questions pertaining to any of the scenarios or answers given on IKE
are not resolved through discussions within the work-group or with the
supervisor, they can be submitted via electronically for further review
and resolution to the Technical Service Center.
6. GAO‘s report recognizes that FSIS knew it needed a more
scientifically trained and capable workforce to ensure that it could
identify problems with the design of HACCP plans. GAO accurately relays
FSIS‘ plan to add several hundred Consumer Safety Officers (CSO) to its
workforce. However, budget constraints have meant that hiring and
training CSOs can happen only incrementally over a period of years.
FSIS plans to hire up to 50 CSO per year. In addition to hiring and
training CSOs for each district, FSIS has trained its District
Veterinary Medical Specialists and will be training additional members
of its workforce in the CSO methodology to increase the cadre of
employees capable of assessing the design and scientific aspects of
establishments‘ HACCP plans.
7. GAO also concludes that FSIS‘ inspection related data systems
provide
FSIS managers with limited information on repetitive noncompliance.
FSIS has implemented several systems over the past 6 months in an
effort to address this need which we have also recognized as an issue.
Following is a brief description of each system:
* PBIS 5.0 - GAO‘s report outlines the capabilities of PBIS 5.0 but
also
points out that trend analysis and summaries are not generated by an
automated system to help managers identify problem areas. FSIS is
testing software that will enable field managers to use PBIS 5.0 to
extract needed information and summary reports for this purpose.
* District Early Warning System - This system is being pilot tested.
This system will extract and compile data from various FSIS databases
relating to inspection, sampling, and enforcement and generates an
’early warning“ for District Managers when the combination of certain
events or findings reach pre-determined thresholds.
* Administrative Enforcement Data System - This electronic system for
distributing copies, tracking status, and querying for information on
administrative actions was implemented in January 2002. Among other
things, status reports show suspensions in abeyance to assist District
Managers in assuring proper follow up at these establishments.
* FSIS Directive 5000.1 - This directive will set out factors to
consider in deciding whether there has been repetitive noncompliances.
8. FSIS Notice 5-01, District Managers Responsibilities in assessing an
Establishment‘s Response to a Notice of Intended Enforcement (NOIE),
dated January 24, 2001, establishes deferral and abeyance processes
after a NOIE is issued. Under this notice, a District Manager (DM) can
defer action on a NOIE or hold a suspension action in abeyance if the
establishment, in response to the NOIE, submits corrective actions that
the District Manager has substantial reason to believe are adequate.
The District Manager is expected to make a decision on the adequacy of
the action as soon as sufficient information becomes available. The
notice indicates deferrals and abeyance should be for no more than 90
days without cause. This allows us to put plants on notice and then
allow
the plant to implement the plan and demonstrate the plan is effective.
FSIS does not believe that plants are given too much time to comply
with regulatory requirements. For example, when a suspension is put in
abeyance, the plant establishes specific timelines for corrective or
preventive measures, and our in-plant personnel conduct verification
activities to ensure they are meeting the conditions outlined in the
timeline. If they do not follow through on the timeline/plan, the
suspension is reinstated.As of July 10, there have been 13
reinstatements offisuspension in FY 2002 compared to 11 in FY 2001.
FSIS policy provides for a 90-day timeframe for monitoring and
verifying effective plant implementation of corrective and preventive
actions proposed in response to an enforcement action. Timeframes may
be shortened in appropriate cases.
The Agency implemented enhanced electronic and management systems for
tracking the status of administrative enforcement actions in order to
ensure effective oversight and follow-up actions by Districts to close
or initiate enforcement action. When FSIS verification shows plant
implementation has been effective and resulted in compliance with
regulatory requirements, the enforcement action is closed. If FSIS
verification shows continued noncompliance or failure of the plant to
implement its proposed corrective actions, the agency takes enforcement
action, such as the suspension of operations. When plants are unable to
restore sanitary conditions and assure future compliance with food
safety requirements, the agency proceeds with additional action, which
may include formal legal action to continue the suspension or withdraw
the grant of inspection.
9. An analysis of current enforcement data shows substantial
improvement in the enforcement arena. The average time for the closure
of suspension actions placed in abeyance in FY 2002 has been 105 days.
This average is based upon violations of HACCP and SSOPs. This data has
been provided to GAO auditors. Other cases remain open for reasons such
as
voluntary suspensions, ongoing criminal or other investigations,
voluntary
cessation of operations, or for other reasons.
The GAO report also sites a concern regarding multiple suspensions in a
single plant. Many federal establishments conduct both slaughter and
processing operations or may have processing operations under various
production categories. Enforcement actions may be initiated based on
problems in different segments of plant operations. Thus, multiple
actions may be appropriate in some cases.
10. The GAO concluded that the time between a Salmonella set failure
and an In-Depth Verification (IDV), time between the on-site IDV work,
the final report and 30-day reassessment letter are too long. We agree
that improvements in the timeliness of the IDV process are needed. The
timeliness between IDV and reporting of results has steadily improved.
However, we realize further improvement is needed. The FSIS Technical
Service Center (TSC) is revamping the IDV process, to require the
report of findings be issued immediately after the conclusion of the
review. An IDV tracking system is being developed to ensure timeliness
and to allow for trend analysis of IDV results over time. The system is
designed and ready for testing.
11. FSIS announced recently that it would notify all suppliers of
ground beef grinders of positive Exoli 0157:H7 results at the time a
positive sample result is obtained on ground beef. Notification will be
both orally and in writing, and will state that although FSIS is unsure
which supplier may have provided the product in question, FSIS
encourages all of these suppliers to conduct their own investigations
and testing until such time as the cause of the positive is determined.
This will serve to decrease response time on suspect positives.
12. Lastly, the Agency has moved to establish ’End Dates“ for the
completion of third Salmonella sets. It is clear that too much time
elapse not only between sample sets but in some cases, within a sample
set. PEER is specifically looking at this issue as part of its review
of the Salmonella testing program and will make recommendations
quickly. Additionally, a trend analysis data center is being
established at the FSIS TSC in Omaha, NE. The function of this office
will be to review test results and other data concerning the
effectiveness and safety of a plants operations and provide an early
warning system of problems.
Enclosed you will find additional technical and editorial comments. If
you have any questions, please contact Ronald F. Hicks, Assistant
Administrator for Program Evaluation, Enforcement and Review.
Sincerely,
William J. Hudnall Acting Administrator:
Signed by William J. Hudnall:
Enclosure:
[End of comments]
The following are GAO‘s comments on the August 26, 2002, letter from
the U.S. Department of Agriculture.
GAO‘s Comments:
1. USDA believes the report does not fully acknowledge FSIS‘s progress
and continuous efforts to ensure that all plants meet regulatory
requirements. It noted that FSIS has placed significant resources into
the processes and systems that provided the data for our study and that
FSIS has efforts ongoing to evaluate the same data. Our draft report
acknowledges that in response to reports from GAO and USDA‘s Office of
Inspector General, FSIS initiated the food safety systems correlation
reviews and in-depth verification reviews and recognizes that these
reviews have been useful in identifying problems with HACCP
implementation. USDA describes a number of actions that FSIS has
recently taken or is planning to take that are consistent with our
recommendations. Many of these actions, if fully carried out, may go a
long way toward addressing the problems we found in FSIS‘s oversight
and enforcement of HACCP. However, diligent management attention will
be needed to ensure this.
2. USDA believes that the title of the report is misleading. We
disagree. We believe the title accurately reflects the concerns
detailed throughout the body of the report.
3. The July 25, 2002, FSIS notice 28-02--Action to Be Taken in
Establishments Subject to Salmonella Testing--does not establish
specific time frames for actions to be taken at plants that fail a
second set of Salmonella tests as we recommend.
4. While the September 5, 2001, notice 36-01--Rules of Practice--
identifies FSIS‘s various enforcement tools and general circumstances
in which each type would be appropriate, it does not establish clear,
consistent criteria for inspectors to use when considering whether to
recommend a suspension as an enforcement action in response to
repetitive violations. We are recommending that FSIS do so.
5. FSIS‘s August 9, 2002, notice 29-02--HACCP Verification Procedures
and the 30-day Reassessment Letter--addresses our recommendation for
the need for additional training for inspectors on their roles and
responsibilities. However, FSIS‘s efforts to provide training for
inspectors on their roles and responsibilities, in response to our
previous report recommendation, were not fully effective. We are
keeping this recommendation because it is too early to tell whether
this effort will be effective.
6. Our draft report acknowledged that FSIS had established a new office
to ensure that its programs and policies are implemented and monitored
correctly. While the review of the Salmonella testing program does not
directly address any of our recommendations, it may help FSIS to
provide inspector training and procedures for field supervisors and
district managers to oversee inspector activities--which we do
recommend--with respect to Salmonella requirements.
7. FSIS directive 5000.1--Enforcement of Regulatory Requirements in
Establishments Subject to HACCP System Regulations (including
regulations on Sanitation Standard Operating Procedures, E. coli
Testing and Criteria, and Salmonella Performance Standards)--should
help FSIS address several of our recommendations, including those
related to ensuring that all HACCP plans fully meet regulatory
requirements and ensuring that plants take prompt actions to correct
violations.
8. FSIS directive 4430.3--In-Plant Performance System (IPPS) Reviews--
should respond to our recommendation regarding procedures to monitor
inspector activities. FSIS is planning to implement the new directive
and begin training supervisors in October 2002. We are keeping this
recommendation to ensure the directive is implemented as planned.
9. This new interactive computer tool that inspectors, supervisors, and
managers can use to strengthen HACCP problem solving using fictional
scenarios. It should help FSIS address our recommendations regarding
inspector training and supervisor oversight of inspector activities.
10. The draft report acknowledged the budget constraints regarding the
hiring of consumer safety officers.
11. FSIS is still testing the PBIS 5.0 and district early warning
systems, which should provide useful data for FSIS managers to carry
out their HACCP responsibilities.
12. FSIS does not believe that plants are given too much time to comply
with regulatory requirements. We disagree. Our review of enforcement
case files found that, on average, these cases were closed in 10 months
rather than the 3 months (90 days) recommended by FSIS. In addition,
while it may be FSIS‘s policy to establish specific time frames for
plants to make corrective actions, none of the 30 enforcement case
files we examined for plants with suspensions in abeyance that were
closed after the 90-day policy went into effect contained this
information.
13. We were not able to determine whether there has been improvement in
the average amount of time it takes FSIS to close HACCP-related
suspensions in abeyance because the data FSIS provided us with included
suspensions for both sanitation violations as well as those for HACCP
violations. In addition, when they are closed, it is not known how the
unspecified number of cases that currently remain open will affect the
average closure time.
14. We did not question the appropriateness of plants having multiple
suspensions. Rather, we questioned the appropriateness of placing
suspensions in abeyance at plants that have had repeated problems or
multiple problems. The examples cited in our report involved (1) a
plant suspension that remained in abeyance even though the plant
continued to violate the same requirements for which it had been
originally suspended and (2) a plant that had multiple sequential
suspensions placed in abeyance.
[End of section]
Appendix III: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Lawrence J. Dyckman (202) 512-3841
J. Erin Lansburgh (202) 512-3017:
Acknowledgments:
In addition to those named above, Leo G. Acosta, Judy K. Hoovler,
James L. Ohl, and Stephen D. Secrist made key contributions to this
report.
[End of section]
FOOTNOTES
[1] According to FSIS, the approximately 5,000 HACCP plants include
about 1,200 plants that slaughter and/or process meat, 300 that
slaughter and/or process poultry, and 3,500 plants that slaughter and/
or process both meat and poultry. FSIS also inspects sanitation at,
among others, plants that store or ship meat or poultry products. These
plants are not required to have HACCP plans because they do not produce
products.
[2] See U.S. General Accounting Office, Meat and Poultry: Improved
Oversight and Training Will Strengthen New Food Safety System, GAO/
RCED-00-16 (Washington, D.C.: Dec. 8, 1999).
[3] See U.S. Department of Agriculture, Office of Inspector General,
Food Safety and Inspection Service: Implementation of the Hazard
Analysis and Critical Control Point System, Report No. 24001-3
(Washington, D.C.: June 2000).
[4] See 21 U.S.C. 601 et seq. for meat and 21 U.S.C. 451 et seq. for
poultry.
[5] According to FSIS, the agency selected Salmonella for testing
because, among other reasons, it is the most common bacterial cause of
foodborne illness and intervention strategies to reduce the presence of
Salmonella on raw products should be effective against other pathogens.
[6] The zero tolerance standard also applies to contamination from the
contents of the animal‘s digestive system and its mammary glands
(milk).
[7] Plants that operate more than one production process, such as
animal slaughter and the preparation of a cooked product, must
establish a HACCP plan for each process. As a result, some plants have
multiple HACCP plans.
[8] We did not talk to inspectors to find out if they identified
violations but did not document them in noncompliance records. But
because they are required to do so, we assumed that they documented all
violations they found.
[9] From January 1, 2002 to June 30, 2002, FSIS conducted an additional
10 in-depth verification reviews. These reviews fell outside of the
time period we used for analysis.
[10] Following the in-depth verification review, one plant had the
second set Salmonella failure overturned on appeal. In another
instance, FSIS conducted an in-depth verification review at a plant
that failed three of its past four sets of Salmonella tests; the
failure that triggered the review was the first set of a new series of
tests.
[11] As of April 4, 2002, of the five plants that failed a third
consecutive set of tests, one had failed a fourth set, two had passed,
one had sampling in progress, and one had not yet begun further
sampling.
[12] At plants participating in this project, plant personnel, instead
of FSIS inspectors, examine each carcass to make an initial
determination whether it is unacceptable and should be removed from the
slaughter line. A reduced number of FSIS inspectors are still at each
plant to ensure that safety and quality standards are met.
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