[Federal Register: July 25, 1996 (Rules and Regulations)]
[Page 38856-38906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy96-20]
[[pp. 38856-38906]] Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
[[Continued from page 38855]]
[[Page 38856]]
Cooling and Chilling Requirements for Raw Meat and Poultry
FSIS proposed that establishments slaughtering livestock be
required to chill carcass surfaces and hot-boned meat to 50 deg.F
(10 deg.C) within 5 hours and then to 40 deg.F (4.4 deg.C) within 24
hours of slaughter or meat and bone separation. Chilling of meat
products such as liver and cheek meat would have been required to begin
within one hour of removal from a carcass. The proposed rule also would
have changed existing poultry chilling requirements (Sec. 381.66) to be
comparable with those proposed for meat. Chilling would have been
required unless the raw product was going directly from slaughter to
heat processing.
The proposal also would have required that establishments maintain
raw meat and poultry products at an internal temperature of 40 deg.F or
below while in the establishment and before release into commerce. Raw
products not chilled in accordance with the requirements would have
required further processing to kill pathogens or would be condemned.
Lastly, the proposal would have required each establishment
handling raw product to have a written plan for temperature controls
and monitoring and make monitoring records available to FSIS upon
request.
The proposed rule was based on good manufacturing practices
generally prevalent in the industry. FSIS's position was that
temperature controls, which are known to prevent bacterial growth, are
an accepted part of current industry practices, are already required by
regulation for poultry carcasses, and should be mandated for all raw
product to minimize the possibility that raw products leaving official
establishments bear significant levels of pathogenic microorganisms.
Commenters generally supported the concept that establishments
should be required to chill raw product as a means of minimizing the
growth of harmful bacteria. Some commenters supported the time and
temperature requirements as proposed. Others argued that the specific
time and temperature combinations in the proposed rule were unduly
restrictive and unworkable. A number of commenters advocated ``more
realistic'' cooling requirements that take into consideration
establishment and product variety, different processing operations, and
diverse shipping and receiving operations. These commenters supported
the use of independent ``process authorities'' to advise establishments
on cooling carcasses and other raw products. Some suggested that the
proposed chilling requirements should be recast as guidelines.
Many commenters questioned the need for any regulatory requirements
for chilling and asserted that it was conceptually at odds with the
proposed HACCP provisions. They recommended that FSIS defer any
regulation on chilling because establishments would have to address
chilling as part of their HACCP plans.
Some commenters raised concerns about the scientific basis of the
proposed time and temperature requirements. They asserted that the
cooling requirements would not result in any demonstrable improvement
in food safety because they were not based on scientifically valid
data. A number of commenters said that the proposed time and
temperature requirements were simply not achievable by the beef
industry due to the large size of beef carcasses. Also, they said that
these carcass cooling requirements might change meat quality attributes
such as product texture and palatability.
Many commenters asserted that FSIS's regulatory focus and the
economic burdens are placed entirely on establishments when, these
commenters argue, a large proportion of foodborne illnesses are caused
by temperature abuse and other mishandling of raw products after they
leave the establishment.
Many commenters expressed concern about risks to employees' health
that could result from employees working continuously in a colder
environment. They cited worker safety studies showing many human
physical ailments are created or aggravated by cold ambient
temperatures. Worker safety was also cited as an issue on the grounds
that the difficulty of handling and cutting meat at such cold
temperatures increases the potential for accidents and injuries.
Some commenters noted that FSIS did not specify how the equivalence
of alternative procedures could be established. In addition, some
suggested specific alternative methodologies they thought would provide
equivalent procedures, such as cooling with dry ice, CO<INF>2, or
nitrogen. Others either did not approve of using any alternative
chilling process or wanted them to be included in the final rule.
Some commenters questioned the rationale for proposing identical
requirements for meat and poultry. They said that using the same set of
requirements for all species fails to take into account the variation
in carcass size.
Commenters from small businesses said they did not have the cooling
capacity to comply with the proposed requirements, and that the cost of
expanding facilities, obtaining the necessary refrigeration equipment,
and retaining quantities of carcasses long enough to chill them to
40 deg.F before shipping was prohibitive.
Other commenters said the time and temperature requirements
conflicted with religious, cultural, and ethnic practices. For example,
there are ethnic markets for ``hot pork,'' whereby hogs are slaughtered
and delivered directly to customers for preparation and consumption
with little or no intervening chilling. A similar process is used with
lamb, goat, and beef for Moslem customers. Some commenters asserted
that the proposed requirements also conflict with and preclude the
Kosher process of ritual salting of poultry.
Commenters also were concerned that carcasses that are processed in
one establishment and shipped to another establishment for immediate
further processing or directly to an off-site cooling facility would
have to meet carcass cooling requirements.
Questions were raised about the disposition of products that did
not meet temperature requirements. Concern was expressed about the
possible condemnation of large quantities of product based on slight
deviations from temperature requirements that would not by themselves
jeopardize food safety.
A number of commenters addressed the proposed shipping temperature
requirements. Many asserted that temperature variation during shipping
is a significant problem. Several commenters asked about their
liability for product after it has left their custody and is found
later, e.g., at a warehouse or retail establishment, to have been
subjected to temperature abuse or other mishandling. Related comments
stated that time and temperature controls were important at all stages
of food production, especially at retail, and should be more of a focus
of FSIS's regulatory oversight.
A few commenters expressed concern about the burden of preparing a
written plan and the proposed recordkeeping requirements.
After reviewing the comments, FSIS agrees that the proposed
regulations on this issue should not be promulgated at this time. FSIS
is persuaded that the complexity and variety of acceptable chilling
practices now in use make the proposed prescriptive time and
temperature requirements unduly burdensome and impractical. FSIS
[[Page 38857]]
intends to seek an alternative that will not conflict with Kosher or
other religious, cultural, or ethnic practices that do not present food
safety hazards to consumers. FSIS has concluded that its food safety
objectives may be achieved more effectively by regulatory means other
than those proposed.
Nevertheless, FSIS continues to believe that prompt, thorough
chilling of carcasses and raw meat and poultry products by slaughtering
establishments is necessary to minimize consumers' exposure to
pathogenic microorganisms. Cooling of carcasses is generally
acknowledged to be an essential component of any establishment's
processing controls for safe food production.
FSIS agrees with those commenters who stated that keeping raw
products cooled after they leave the establishment, during
transportation, storage, distribution, and sale to consumers, is
essential if growth of pathogenic microorganisms on raw products is to
be prevented. This is consistent with FSIS's farm-to-table food safety
strategy.
Instead, FSIS believes that the best way to regulate in this area
would be by having as a performance standard a maximum temperature for
products being shipped into commerce, and at which raw products in
commerce must be maintained. This standard would be applicable to all
persons who handle such product before the product reaches the
consumer. FSIS believes that there are at least two possible
temperatures for this purpose.
A mandatory temperature of 41 deg.F would provide a large margin of
safety against the multiplication of pathogenic bacteria, which
generally will not multiply at temperatures below 50 deg.F. It is
similar to the maximum temperature of 40 deg.F originally proposed by
FSIS and recommended in Agriculture Handbook No. 412. It is also the
same temperature as that specified in the Food and Drug
Administration's current model Food Code which is offered for adoption
by States and other government entities with jurisdiction over food
service, retail food stores and food vending machine operations.
Alternatively, a temperature of 45 deg.F would still provide a
margin of safety and also is that required in FDA's current Good
Manufacturing Regulations for refrigerated foods generally. It also
would comport with the temperature established for raw product in
commerce by the European Union. That temperature is increasingly
accepted as a standard for raw product storage and transportation by
other countries and appears to be an emerging standard for
international trade.
FSIS could supplement the shipping/storage temperature regulations
with guidelines, including recommended criteria for microorganisms,
that would provide purchasers and vendors in commerce additional means
by which to determine whether products bear a level of bacteria
indicative of temperature abuse and, therefore, are likely to bear
levels of pathogenic microorganisms that could be associated with
foodborne illnesses.
FSIS has concluded that development of such a performance standard
requires that it obtain additional information and engage in further
rulemaking. Therefore, FSIS will extend and expand this rulemaking
proceeding on the issue of cooling raw meat and poultry products. FSIS
will consider alternatives to the specific time and temperature
requirements it proposed, including performance standards governing
cooling during transportation and storage of raw meat and poultry,
probably in the form of a maximum temperature for transporting and
holding such product.
As the next step in its proceedings on this topic, FSIS plans to
hold a public conference to gather further information on the many
technical and practical issues raised in the comments as well as on
possible alternatives to the proposal which will be outlined in the
Agency's announcement of the conference.
International Trade
The inspection statutes require that meat and poultry products
imported into the United States be produced under an inspection system
equivalent to the U.S. inspection system.
A large number of commenters requested that FSIS clarify how it
will determine the ``equivalence'' of foreign inspection systems
following HACCP implementation. Commenters questioned exactly how FSIS
will determine foreign system equivalency regarding HACCP systems.
Further, some commenters asserted that requiring foreign equivalency
with the U.S. HACCP system could create problems in foreign trade if
HACCP implementation in the United States causes some foreign
inspection programs previously designated ``equivalent'' to lose that
designation.
Foreign countries with establishments exporting to the United
States must establish inspection system requirements ``equivalent to''
U.S. requirements. This means that all foreign meat and poultry
establishments that export meat to the United States must operate HACCP
systems or process control systems ``equivalent to'' HACCP. They must
also adopt equivalent performance standards.
The components of FSIS's current import inspection system will not
change. As part of the evaluation of the laws, policies, and
administration of the inspection system of any foreign country eligible
to export meat or poultry products into the United States, FSIS will
assess the status of HACCP-- or equivalent process control system-
implementation in that country. This assessment will include on-site
reviews of individual establishments, laboratories, and other
facilities within the foreign system. The ``equivalency'' of foreign
inspection will be determined at this stage.
Further, when these regulations are implemented, the import
inspection system will continue to include port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. All countries exporting raw products to the United States must
develop and implement performance standards that are equivalent to the
pathogen reduction performance standards for Salmonella. They must also
be able to demonstrate that they have systems in place to assure
compliance with the standards.
As of January 1, 1995, 1,395 establishments in 36 countries were
certified to export meat or poultry products to the United States.
Canada, with 599 establishments; Denmark, with 125; Australia, with 111
establishments; and New Zealand, with 94 establishments, accounted for
two-thirds of those, which were collectively the source of 85 percent
of the 2.6 billion pounds of product imported into the United States
during 1994. Canada, Denmark, Australia, and New Zealand are currently
developing HACCP systems.
Most of the comments concerning the impact on exports dealt with
the proposed requirement for antimicrobial treatment of U.S. product
and the proposed exemption for exported product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses.
A number of commenters cited the fact that a proposed exemption
would be ineffective because establishments cannot segregate treated
product from untreated product. Commenters said this occurs because
antimicrobial treatments are performed on whole carcasses, while most
meat and poultry is exported in parts. This condition, the commenters
argued, would cause
[[Page 38858]]
significant operational difficulty to establishments that were required
to separate product that had and had not been treated, as well as
inventory management problems. This requirement might also result in an
artificial trade barrier with countries such as Canada, which restrict
use of certain antimicrobial treatments. Suggestions were made that
FSIS should obtain Codex support and acceptance for the proposed
antimicrobial interventions as a means to overcome international
objections to their use. The Agency's decision not to mandate
antimicrobial treatments largely negates these concerns. FSIS will
continue to work within Codex and in its bilateral relations with major
trading partners to ensure that the scientific basis for food safety
practices in the U.S. are understood and accepted.
The final rule will affect U.S. exports only if an establishment
has difficulty meeting the new microbial performance standards without
using an antimicrobial treatment. FSIS is aware that alternative
technologies now available can facilitate international trade. For
example, public comments indicated that trisodium phosphate is approved
for use in Canada and the United Kingdom, and is being considered by
the European Union, Australia, and New Zealand. Steam vacuum systems
constitute an improved technology for establishments exporting beef and
pork products.
Recordkeeping and Record Retention
FSIS notes that recordkeeping requirements and record retention
periods for sanitation SOP's, microbiological testing, and HACCP are
found in 416.12, 310.25(b)(4), and 381.94(b)(4), and 417.5,
respectively. The proposed amendments to sections 320.1, 320.3,
381.175, and 381.177 were intended to continue FSIS' practice of cross-
referencing recordkeeping requirements in Secs. 320.1, 320.3, 381.175,
and 381.177. FSIS has determined that it is unnecessary to amend these
sections at this time, especially in view of its ongoing efforts to
simplify, consolidate, and streamline the meat and poultry inspection
regulations.
Finished Product Standards for Poultry Carcasses
FSIS proposed to remove the feces nonconformance specification from
the poultry finished product standards regulations (Sec. 381.76, Table
1). That change in the poultry products inspection regulations is being
effected not in this final rule but in the forthcoming final rule,
``Enhanced Poultry Inspection; Revision of Finished Product Standards
with Respect to Fecal Contamination,'' Docket No. 94-016F.
VI. Economic Impact Analysis and Executive Orders
Executive Order 12866
This rule has been determined to be economically significant and
was reviewed by OMB under Executive Order 12866.
HACCP-based Regulatory Program Produces Net Benefit to Society
FSIS has prepared a Final Regulatory Impact Assessment (FRIA) that
evaluates the costs and benefits of a mandatory HACCP-based program for
all meat and poultry establishments under inspection. The FRIA
concludes that mandating HACCP systems will lead to potential benefits
that far exceed industry implementation and operating costs.
The 20-year industry costs of implementing the HACCP-based
regulatory program are estimated to be $968 to $1,156 million. The 20-
year costs to the government are estimated at $56.5 million. FSIS
estimated that the proposed rule would have 20-year costs of $2.2
billion dollars. The costs from the Preliminary Regulatory Impact
Analysis (PRIA) are not directly comparable to costs estimated for the
final rule. The proposed rule had a larger number of explicit
regulatory requirements. The PRIA focused on estimating the predictable
costs of meeting those requirements and included an implicit assumption
that compliance with the proposed requirements would assure compliance
with pathogen reduction objectives. In contrast, the final rule allows
for greater flexibility in meeting the pathogen reduction standards,
but also outlines a more rigorous enforcement strategy. Thus for the
FRIA, it was necessary to develop separate cost estimates for the
potential costs of meeting the new pathogen reduction performance
standards for Salmonella. Modifications incorporated into the final
rule have both reduced the total estimated costs and redistributed
costs in a way that reduces the relative burden on smaller
establishments.
Both the preliminary and final analysis identify a potential public
health benefit of $7.13 to $26.59 billion, tied to eliminating the
contamination by four pathogens that now occurs in meat and poultry
establishments. These four pathogens include the three most common
enteric pathogens of animal origin: Campylobacter jejuni/coli, E. coli
O157:H7, Salmonella and one environmental pathogen Listeria
monocytogenes. The potential benefit estimate is tied to the
minimization of risk from the 90 percent of these pathogens that are
estimated to contaminate meat and poultry during slaughter and dressing
procedures. The remaining 10 percent of contamination is estimated to
occur after the product leaves the manufacturing sector. The link
between regulatory effectiveness, where effectiveness refers to the
percentage of pathogens eliminated at the manufacturing stage, and
health benefits is the assumption that a reduction in pathogens leads
to a proportional reduction in foodborne illness. The high and low
range for potential benefits occurs because of the current uncertainty
in the estimates of the number of cases of foodborne illness and death
attributable to pathogens that enter the meat and poultry supply at the
manufacturing stage.
The benefits analysis in the FRIA concludes that there is
insufficient knowledge to predict with certainty the effectiveness of
the rule, where effectiveness refers to the percentage of pathogens
eliminated at the manufacturing stage. Without specific predictions of
effectiveness, FSIS has calculated projected health benefits for a
range of effectiveness levels. For example, if the HACCP-based program
can reduce the four pathogens by 50 percent and that reduction leads to
a proportionate reduction in foodborne illness, the projected benefits
range from $3.6 to $13.3 billion, which is half the potential benefit
estimate of $7.13 to $26.59 billion.
If the low potential benefit estimate is correct, the analysis
shows that the new HACCP-based program must reduce pathogens by 15 to
17 percent before benefits outweigh projected costs. If the high
estimate is the correct estimate, the new program needs to reduce
pathogens by only 4 to 5 percent to generate net societal benefits.
While there were a large number of comments relating to the
effectiveness estimates in the PRIA, there were no comments that
claimed or implied that HACCP would not reduce pathogens at levels
necessary to produce net societal benefits. The requirements of the
final rule are organized around the following three components:
<bullet> The requirement that all inspected establishments
develop and implement HACCP programs based on the seven recognized
principles of HACCP.
<bullet> The requirement that all inspected establishments
develop and implement Sanitation SOP's.
<bullet> The requirements that all establishments that slaughter
cattle, swine, chickens or turkeys implement a microbial sampling
[[Page 38859]]
program using E. coli (generic) as a measure of control of slaughter
and sanitary dressing procedures and that all establishments that
slaughter cattle, swine, chickens or turkeys or produce raw ground
product from these animals or birds meet new pathogen reduction
performance standards for Salmonella.
The proposal and final rule can be viewed as two scenarios for
implementing a mandatory HACCP-based regulatory program. While it's not
possible to compare the benefits of these two options, the FRIA does
present a comparison of the costs.
Table 5 summarizes the estimated costs for both the proposal and
final rule by individual regulatory component. As mentioned above, the
costs are not directly comparable because the regulatory components
have changed. Table 5 shows that all costs have been eliminated for the
components of time-and-temperature requirements and antimicrobial
treatments. However, the discussion of potential costs in the FRIA
recognizes that some establishments may use antimicrobial treatments to
help meet the pathogen reduction performance standards for Salmonella.
Other establishments may impose temperature limits to help control
Salmonella growth.
Table 5 includes the final cost estimate for generic E. coli
sampling in slaughter establishments under the regulatory component for
microbial testing. The costs for required microbial sampling have
decreased substantially from the proposal.
In the FRIA, FSIS increased or added a cost estimate for four
regulatory components. First, based on comments, FSIS added costs for
recurring training to account for the fact that employee turnover will
sometimes require establishments to train additional employees. Second,
FSIS also added a minimal cost for annual reassessment of HACCP plans,
although the Agency believes that reassessment will be negligible for
establishments successfully operating HACCP systems. Third, FSIS has
increased the estimated cost for HACCP plan development. The estimate
for this cost was increased after reviewing public comments and
assessing the overall impact on plan development costs of decisions to
eliminate time-and-temperature and antimicrobial treatment requirements
prior to HACCP implementation. Finally, the Agency recognizes that some
establishments will have difficulty meeting the new performance
standards for Salmonella and that implementing sanitation SOP's and
HACCP plans will not always assure sufficient pathogen reduction. The
FRIA has developed two scenarios that lead to low and high cost
estimates related to potential actions that establishments might
undertake. Such actions include both process modifications to reduce
pathogens and the implementation of Salmonella testing programs to
assure compliance with the new performance standards.
As shown in Table 5, the two scenarios developed in the FRIA lead
to a range in cost estimates of $55.5 to $243.5 million to comply with
the new pathogen reduction standards for Salmonella. The FRIA
recognizes that the performance criteria for generic E. coli also
create a set of potential costs for slaughter establishments. A line
for these costs is shown in Table 5 along with the entry that these
costs were not separately quantified.
As discussed in the FRIA, the anticipated actions to comply with
the generic E. coli criteria are the same as the anticipated actions to
comply with the standards for Salmonella. FSIS has concluded that if
the low cost scenario for Salmonella compliance proves to be more
accurate, than the Agency would expect to see some compliance costs for
the generic E. coli performance criteria. If the high cost scenario is
correct, then the compliance actions taken to assure compliance with
the Salmonella standards should also assure compliance with the generic
E. coli criteria.
Table 5.--Comparison of Costs--Proposal to Final
[$ Millions--Present value of 20-year costs]
----------------------------------------------------------------------------------------------------------------
Regulatory component Proposal Final
----------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's.............. 175.9<SUP>a................................ 171.9
II. Time/Temperature Requirements 45.5.................................. 0.0
III. Antimicrobial Treatments.... 51.7.................................. 0.0
IV. Micro Testing................ 1,396.3<SUP>b.............................. 174.1
V. Compliance With Salmonella Not Separately Estimated<SUP>c............. 55.5-243.5
Standards.
Compliance with generic E. Not Applicable........................ Not Separately Estimated
coli criteria.
VI. HACCP
Plan Development............. 35.7.................................. 54.8
Annual Plan Reassessment..... 0.0................................... 8.9
Recordkeeping (Recording, 456.4................................. 440.5<SUP>d
Reviewing and Storing Data).
Initial Training............. 24.2.................................. 22.7<SUP>d
Recurring Training........... 0.0................................... 22.1<SUP>e
VII. Additional Overtime......... 20.9.................................. 17.5<SUP>d
==============================================================================
Subtotal--Industry Costs... 2,206.6............................... 968.0-1,156.0
VIII. FSIS Costs................. 28.6<SUP>f................................. 56.5
------------------------------------------------------------------------------
Total...................... 2,235.2............................... 1,024.5-1,212.5
----------------------------------------------------------------------------------------------------------------
<SUP>a The preliminary analysis included a higher cost estimate for sanitation SOP's ($267.8 million) that resulted
because of a programming error. The cost estimate of $175.9 million is based on an effective date of 90 days
after publication.
<SUP>b The preliminary analysis was based on the premise that microbial testing would be expanded to cover all meat
and poultry processing after HACCP implementation. The proposed rule only required sampling for carcasses and
raw ground product. Thus, the cost estimate of $1,396.3 million was higher than the actual cost of the
proposed sampling requirements.
<SUP>c The preliminary analysis accounted for some of the cost of complying with the new standards under the
regulatory components of micro testing, antimicrobial treatments, and time and temperature requirements.
<SUP>d These costs are slightly different from the proposal because of changes in the implementation schedule.
<SUP>e FSIS added costs for recurring training based on the review of public comments.
<SUP>f Based on current estimates for the cost of training, inspector upgrades, and $0.5 million for annual HACCP
verification testing.
[[Page 38860]]
Market Failure Justifies Regulation of Pathogens
Since all raw meat and poultry products contain microorganisms that
may be pathogens, raw food unavoidably entails some risk to consumers
of pathogen-exposure and foodborne illness. The presence and level of
this risk cannot be determined by a consumer since pathogens are not
visible to the naked eye. The societal impact of this food safety
information deficit is a lack of accountability for foodborne illnesses
caused by pathogenic microorganisms. Consumers often cannot trace a
transitory illness to any particular food or even be certain it was
caused by food. Thus, food retailers and restaurateurs are generally
not held accountable by their customers for selling pathogen-
contaminated products and they, in turn, do not hold their wholesale
suppliers accountable either.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
business at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product.
The science and technology required to reduce meat and poultry
pathogens is well established, readily available, and commercially
practical. FSIS has concluded that the lack of consumer information
about meat and poultry product safety and the absence of adequate
incentives for industry to provide more than minimal levels of
processing safety represents a market failure requiring Federal
regulatory intervention. The present combination of market regulation
and industry self-policing has not resolved increasingly apparent
problems with meat and poultry pathogens. Documented cases of foodborne
illness each year, some of which have resulted in death, represent a
public health risk that FSIS has determined to be unacceptable. A
comprehensive Federal regulatory program is the only means available to
society for lowering foodborne pathogen risks to an acceptable level.
FSIS further concludes that a mandatory HACCP regulatory program is the
only means to attain this goal.
Regulatory Alternatives
After considering broader regulatory approaches including market
incentives and voluntary industry standards, FSIS has determined that
effective process control is needed throughout the meat and poultry
industry in order to minimize pathogen contamination of food products
and lower the risk of subsequent foodborne illness.
FSIS examined the following seven process control approaches before
determining that mandatory HACCP was the most effective means for
industry to eliminate pathogens in meat and poultry:
<bullet> Status quo
<bullet> Intensify present inspection
<bullet> Voluntary HACCP regulatory program
<bullet> Mandatory HACCP regulation with exemption for small
businesses
<bullet> Mandatory HACCP regulation only for ready-to-eat products
<bullet> Modified HACCP--negative records only
<bullet> Mandatory HACCP for all establishments
Each of these seven alternatives was assessed using the following
five effectiveness factors for process control:
<bullet> Controls production safety hazards
<bullet> Reduces foodborne illness
<bullet> Makes inspection more effective
<bullet> Increases consumer confidence
<bullet> Provides the opportunity for increased productivity
Only mandatory HACCP for all establishments was determined to meet
all five criteria; all of the others were found to be flawed in meeting
one or more of the target factors.
The full text of the Final Regulatory Impact Analysis is published
as a supplement to this document.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act (P.L. 104-4) requires (in Section
202) that agencies prepare an assessment of anticipated costs and
benefits before proposing any rule that may result in annual
expenditures by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000, (adjusted annually for
inflation). The preliminary and final RIA's fulfill this requirement of
the Unfunded Mandates Reform Act. FSIS has treated both the proposed
rule and this final rule as an economically significant regulatory
action, i.e., annual cost to the private sector of more than
$100,000,000, under Executive Order 12866 and has prepared a final
Regulatory Impact Analysis (RIA) in compliance with the provisions of
Executive Order 12866. The final RIA identifies annual recurring
private sector costs of from $99.6 to $119.8 million and potential
annual public health benefits of $.99 to $3.69 billion.
The Act also requires (in Section 205) that the Agency identify and
consider a reasonable number of regulatory alternatives and, from these
alternatives, select the least costly, most cost-effective, or least
burdensome alternative that achieves the objective of the rule. In the
final RIA, FSIS considered several broad regulatory alternatives and
selected the one that is both cost-effective and also the least
burdensome alternative that achieves the food safety objectives of the
rule. FSIS concluded that market incentives will not address the public
health risk resulting from microbial pathogens in meat and poultry,
primarily because there is rarely feedback to consumers that allows
more informed purchase decisions nor is there feedback which would
permit consumers who experience a foodborne illness to routinely, and
at low cost, seek compensation from responsible parties for losses
arising from their foodborne illness. Thus, market solutions would not
adequately address the food safety objectives on the rule. FSIS
concluded that an industry administered system of voluntary standards
is likely to be more expensive and less effective than a governmental
one. Finally, FSIS has recognized that public education is essential
for assuring food safety, but experience has shown that education alone
has limited effectiveness in reducing foodborne illness. Thus, while
consumer education may be cost-effective it would not meet the
objective of substantially reducing foodborne illness.
Based on a qualitative analysis of broad regulatory strategies, the
final RIA concluded that mandatory government standards were needed to
achieve a solution that is both cost-effective and meets the objective
of reducing the risk of foodborne illness from meat and poultry. Within
the framework of a mandatory regulatory program, the final RIA
discusses several alternatives to a mandatory HACCP-based program for
all inspected establishments including intensified inspection,
mandatory HACCP with a small business exemption and mandatory HACCP for
only ready-to-eat products. These alternatives were evaluated using
several criteria incorporating the goals of effectiveness, efficiency
and increased consumer confidence. Using these criteria FSIS concluded
that HACCP systems designed to meet microbial performance standards
will be both cost-effective and the least burdensome alternative for
meeting the foodborne illness reduction objectives of the rule. As the
final RIA points out, requiring mandatory process control without
microbial performance
[[Page 38861]]
standards could lead to processes that are well controlled at
unacceptable pathogen levels. FSIS believes that microbial performance
standards are necessary to achieve substantial pathogen reduction,
encourage industry innovation, and provide the impetus for continuing
improvement and increasing effectiveness.
Consistent with the requirements in Section 204 to provide
opportunity for input from State, local and tribal government
officials, FSIS held a ``Federal-State-Relations Conference,'' August
21-23, 1995, in Washington, D.C. This meeting, in which the National
Association of State Departments of Agriculture participated, provided
an opportunity for representatives from State government to engage in
an open exchange with senior USDA officials on the Pathogen Reduction/
HACCP proposal. In addition to Directors of State meat and poultry
inspection programs, the meeting included representatives from State
Departments of Agriculture, State Health Departments and local food
safety enforcement agencies.
Also related to the Section 204 requirements, on May 22, 1995 the
Agency held a public meeting for owners and representatives of small
meat and poultry establishments and other affected small businesses to
discuss the pathogen Reduction/HACCP proposal. Three Directors of State
meat and poultry inspection programs provided comments at the meeting.
Section 202 of the Act also requires a summary and evaluation of
comments received from State, local, or tribal governments. There were
a large number of comments from State and local governments, elected
members of State legislatures and associations representing State
programs or businesses within States. Collectively, these comments
covered most, if not all, of the issues addressed as part of this final
rule. This preamble and the final RIA represent a summary and
evaluation of these comments.
Most of the comments from State, local, or tribal governments
addressed the potential economic impact on small businesses. The Kansas
City meeting was intentionally focused on the small business issues.
Comments from the State program Directors included recommendations for
various forms of exemptions, voluntary programs or financial assistance
for small State inspected establishments. The Federal-State-Relations-
Conference included a more focused discussion on the cost to the State
programs. Attendees stated that FSIS failed to adequately consider the
cost of the changes to State programs and that FSIS was increasing the
resource demands for State programs without providing adequate funding.
There were also written comments stating that the proposed rule was
an unfunded Federal mandate because of the cost to small establishments
and the potential impact on State inspection programs. The preliminary
RIA did not address the impact on State programs. However, FSIS
recognizes that the 27 States operating their own meat and poultry
inspection programs will likely have to substantially modify their
programs after the HACCP/Pathogen Reduction regulation is finalized to
remain ``at least equal to'' Federal inspection programs as required by
the FMIA and PPIA. During the regulation's implementation period, FSIS
will be using the Agency's State-Federal Program resources to assist
the States in bringing the necessary changes to the State inspection
programs. Although FSIS has requested some additional funds to
implement this rule, FSIS has also acknowledged that implementation of
this rule will require eliminating some tasks, conducting other tasks
differently and streamlining the organization in order to free up
resources to fully address the new requirements. FSIS believes that the
same type of restructuring or reprogramming will take place within the
State programs. This does guarantee, however, that all States with
inspection programs will be able to implement the necessary program
changes without additional funds. FSIS believes, however, that with
FSIS assistance and with the flexibility provided under the ``equal
to'' provisions, most of the States should be able to modify their
programs with minimal additional costs. To the extent that there are
any additional costs, the State inspection programs are eligible to
receive up to 50 percent Federal matching funds.
Regulatory Flexibility Act
The Administrator, FSIS, has determined that this rule will have a
significant economic impact on a substantial number of small entities.
This final rule uses two size criteria for providing regulatory
flexibility for small entities. For livestock and poultry slaughter
facilities, the microbial sampling requirements vary depending on the
number of animals or birds slaughtered annually. This will
significantly reduce the microbial testing costs for smaller
establishments which, under the proposed rule, would have been required
to test each species they slaughter every day on which slaughter of
that species occurred. Under the final rule, establishments that
annually slaughter fewer than 6,000 cattle, 20,000 swine (or a
combination of such livestock not to exceed a total of 20,000, with a
maximum of 6,000 cattle), 60,000 turkeys or 440,000 chickens (or a
combination of chickens and turkeys not to exceed 60,000 turkeys or
440,000 birds total) will not be required to operate microbial sampling
programs on a continuous basis. Over 78 percent (2,098) of the total
2,682 slaughter establishments meet these criteria. These
establishments will be required to annually verify that their slaughter
and sanitary dressing processes are under control. However, after an
initial period of sampling in each year, these establishments will be
required to conduct further sampling in that year only if they make
major changes to facilities, equipment, and personnel whereby the
slaughter and dressing process is significantly changed.
These low-volume establishments will be required to analyze one
sample per week until they have demonstrated compliance with
established criteria. At a minimum, low-volume slaughter establishments
will be required to collect and analyze one sample per week until they
complete a sampling window (13 samples) annually in order to assess
whether the performance criteria continue to be met.
Small slaughter establishments that process only minor species
(e.g., goats, sheep, ducks, pheasants, etc.) will not be required to
conduct any sampling. Small slaughter establishments will also face
less burden because the final rule no longer requires that both cattle
and swine or chickens and turkeys be sampled in the same establishment,
i.e., if a low-volume establishment slaughters both cattle and swine or
turkeys and chickens, it will be required to analyze one sample per
week from the predominant species until it has demonstrated compliance
with established criteria. The costs of small slaughter establishments
are also reduced because the carcass cooling and antimicrobial near-
term requirements have been eliminated from the final rule. Sampling
frequencies for even the larger slaughter establishments will be based
on production-volume, thus spreading the cost per pound relatively
equally among establishments.
For the purpose of sequencing HACCP implementation FSIS has defined
a small entity using the Small Business Administration size standard
for a small meat or poultry manufacturing establishment. That is, all
establishments with fewer than 500 employees will have additional time
to implement HACCP. In addition, in
[[Page 38862]]
response to comments that there are hundreds of ``very small'' or
``micro'' establishments, the Agency will classify an establishment as
``very small'' if it has either fewer than 10 employees or annual sales
of less than $2.5 million. This sequencing of HACCP responds to a large
number of comments requesting that small businesses be given a longer
period of time to implement HACCP requirements. Many small businesses
stated they did not want to be exempt, but asked for more flexibility
in implementing HACCP.
The FRIA is based on 353 large firms implementing HACCP at 18
months, 2,941 small firms implementing HACCP at 30 months and 5,785
very small (2,892 Federal plus 2,893 State) firms implementing HACCP at
42 months.
Table 6 illustrates the costs for a small, single-shift, processing
establishment (no TQC or sanitation PQC program) with two distinct
production operations other than raw ground product (overall average
estimated at 2.29 operations per establishment).
Table 6.--Costs for Typical Single-Shift Processing Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 2,514 251
Recordkeeping.............................. 0 6,480
----------------------------
Total................................ 9,662 8,075
------------------------------------------------------------------------
If one of the two production operations produced a raw ground
product, the establishment would have to meet the pathogen reduction
performance standard for that product. The FRIA points out that raw
ground operations do not have the same opportunities to reduce
Salmonella levels as do slaughter establishments. They can control
growth by avoiding temperature abuse and can limit cross-contamination,
but basically they must depend on the Salmonella levels of their
incoming product in order to meet the performance standards. These
establishments may choose to test incoming product in order to
eliminate suppliers whose product is found to be positive. The FRIA has
assumed that the low volume producers would not test incoming
ingredients.
Table 7 illustrates the costs for a small, single-shift,
combination (slaughter and further processing) establishment that
slaughters cattle or swine, but not both, and has a single further
processing operation other than ground product. The establishment is
not under TQC inspection.
The cost of meeting the pathogen reduction performance standards
assumes that the establishment will use a hot water antimicrobial rinse
and have one sample per month analyzed at an outside laboratory ($33.35
per sample-$400 per year). The average number of head slaughtered in a
low volume establishment is approximately 5,000 annually. The annual
cost for the rinse is $400.
Table 7.--Costs for Typical Single-Shift Combination Establishment
[Dollars]
------------------------------------------------------------------------
Development
and Recurring
Requirement implementation annual
costs costs
------------------------------------------------------------------------
Sanitation SOP's........................... 190 1,242
Compliance with Salmonella Standards....... 0 800
E. coli Sampling........................... 1,043 653
HACCP Plan Development..................... 6,958 0
Annual Plan Reassessment................... 0 102
Training................................... 5,028 503
Recordkeeping.............................. 0 5,434
----------------------------
Total................................ 13,219 8,734
------------------------------------------------------------------------
The development costs for E. coli sampling in the small
establishment includes $640 for developing a sampling plan and $403 to
train an individual to conduct aseptic sampling. The recurring costs
are based on the assumption that an average low volume slaughter
establishment will have to complete two sampling windows (26 samples)
before they demonstrate compliance with established criteria.
The cost of HACCP training has doubled for the combination
establishment because the FRIA assumed that slaughter and processing
operations are significantly different, so that the establishment must
either train two employees or send one employee to two separate
training courses.
The HACCP recordkeeping costs (monitoring CCPs and recording
findings, reviewing records and storing records) in the above two
examples assume that the establishments are operating each process
continuously over a standard 52-week, 260-day, 2,080-hour work year.
Data collected during the preliminary analysis indicates that many low-
volume establishments frequently have only a single production line
operating at a given time. The final analysis estimates an average
annual cost for HACCP monitoring and recording of $4,030 for low-volume
establishments.
Executive Order 12778
This rule has been reviewed pursuant to Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under the FMIA and PPIA from imposing any requirements with respect to
federally inspected premises and facilities, and operations of such
establishments, that are in addition to, or different from, those
imposed under the FMIA and PPIA. States and local jurisdictions may,
however, exercise concurrent jurisdiction over meat and poultry
products that are outside official establishments for the purpose of
preventing the distribution of meat or poultry products that are
misbranded or adulterated under the FMIA or PPIA, or, in the case of
imported articles, which are not at such an establishment, after their
entry into the United States. Under the FMIA and PPIA, States that
maintain meat and poultry inspection programs must impose requirements
on State-inspected products and establishments that are at least equal
to those required under the FMIA and the PPIA. These States may,
however, impose more stringent requirements on such State-inspected
products and establishments.
Paperwork Requirements
The paperwork and recordkeeping for this rule are approved under
OMB number 0583-0103, ``Pathogen Reduction, Hazard Analysis and
Critical Control Points (HACCP) Systems.'' OMB approved 14,371,901
annual reporting hours. Overall, the burden hours associated with the
rule decreased. FSIS determined that the new burden is 8,053,319 hours,
a 6,318,582-hour reduction. This reduction resulted from the
elimination of proposed requirements and the adjustment of certain
burden hour estimations. The following discusses the finalized
paperwork and recordkeeping requirements and the changes in the burden
estimations.
Sanitation Standard Operating Procedures (Sanitation SOP's)
As part of establishments' sanitation requirements, each
establishment must develop and maintain Sanitation SOP's that must, at
a minimum, address core
[[Page 38863]]
sanitation procedures. As part of the Sanitation SOP's, establishment
employees(s) must record results of daily sanitation checks on a
checklist at the frequencies stated in the Sanitation SOP's. The
checklist must include both preoperational sanitation checks and
operational sanitation checks. This checklist must be made available to
FSIS upon request.
Agency subject matter experts and private consultants estimate that
it will take an average of 5, 10, and 25 hours to develop a sanitation
program for low, medium, and high volume establishments, respectively.
The burden of documenting the adherence to Sanitation SOP's is based on
three factors; recording, reviewing, and storage. Recording encompasses
conducting and inscribing the finding from an observation and filing of
the document produced. This action is assumed to take 15, 25, and 45
minutes per day in a low-, medium-, and high- volume establishment,
respectively. Review of the records generated is estimated to take 5,
10, and 20 minutes per day for a low-, medium-, and high-volume
establishment, respectively.
OMB approved 1,243,622 burden hours for Sanitation SOP's plan
development, recording and filing, and record review. FSIS determined
that the burden estimate for these activities was too high. Based on
more accurate data, FSIS reevaluated the burden estimate and calculated
the new burden hours to be 1,231,986 hours. This is a 11,636 burden
hour decrease.
Time and Temperature
As discussed earlier, the proposed time-and-temperature
requirements are eliminated. OMB approved 869,156 burden hours for
time-and-temperature requirements. Therefore, elimination of the time-
and-temperature requirements, results in a 869,156 burden hour
decrease.
Microbiological Testing
As part of microbiological testing, each slaughter establishment
must develop written procedures outlining specimen collection and
handling. The slaughter establishments will be responsible for entering
the results into a statistical process control chart or table. The data
and chart will be available for review by FSIS upon request.
Agency subject matter experts estimate that it will take 25 hours
for establishments to develop a microbial sampling and analysis plan.
It will take an estimated 17.5 minutes to collect samples and 5 minutes
per sample to enter data into the chart, review, and file the
information.
OMB has approved 1,177,924 burden hours for microbial testing plan
development, sample collection, and data entry by meat and poultry
establishments. As discussed earlier, the number of meat and poultry
establishments required by the Pathogen Reduction/HACCP proposal to
perform microbial testing and the number of tests required decreased.
FSIS reevaluated this burden estimate and concluded that the burden for
microbial testing by meat and poultry establishments is 468,061 burden
hours. Therefore, the burden hour decrease associated with microbial
testing is 709,863 hours.
HACCP
Establishments will develop written HACCP plans that include:
identification of the food safety hazards reasonably likely to occur;
identification and description of the critical control point for each
identified hazard; specification of the critical limit that may not be
exceeded at the CCP; description of the monitoring procedure or device
to be used; description of the corrective action to be taken if the
limit is exceeded; description of the records that will be generated
and maintained regarding this CCP; and description of the establishment
verification activities and the frequency at which they are to be
conducted. Performance standards or limits specified in related FSIS
regulations must be accounted for in the critical limits.
Establishments will keep records of measurements taken during
slaughter and processing, corrective actions, verification check
results, and related activities that contain the identity of the
product, the product code or slaughter production lot, and the date the
record was made. The record will be signed by the operator or observer.
The HACCP records will be reviewed by an establishment employee
other than the one who produced the record, if practicable, before the
product is distributed in commerce. If a HACCP-trained individual is
on-site, that person should be the second reviewer. The reviewer will
sign the records.
Although the amount of time to develop a plan for each process
varies based on its difficulty, Agency subject matter experts estimate
that low, medium, high volume and state establishments will need an
average of 136, 126, 113, and 78 hours to develop each plan. There are
an estimated 7.4 CCP's for each processing plan in Federal
establishments, 5 CCP's for each slaughter plan in Federal
establishments, and 5 CCP's for both types of plans in State slaughter
establishments. The recording and filing is assessed to take 5 minutes
per CCP and the review should take 2 minutes per CCP.
OMB approved 11,081,199 burden hours for the maintenance of the
HACCP-trained individual's resume, plan development, recording, and
record review. As discussed earlier, FSIS will not require personnel
resumes to be maintained, thus the burden reported for this activity is
eliminated. Also, FSIS determined that the burden estimate for plan
development, recording, and record review was too high. Based on more
accurate data, FSIS reevaluated the burden estimate and calculated the
new burden hours to be 6,353,272. This is a 4,727,927 burden hour
decrease.
To better illuminate the burden hour changes, the following table
is provided.
Table 8.--Changes in Burden Hours
----------------------------------------------------------------------------------------------------------------
Burden hours
Requirement approved by New burden Reduction in
OMB hours burden hours
----------------------------------------------------------------------------------------------------------------
SOP's for Sanitation............................................ 1,243,622 1,231,986 11,636
Time and Temperature............................................ 869,156 0.00 869,156
Microbiological Testing......................................... 1,177,924 468,061 709,863
HACCP........................................................... 11,081,199 6,353,272 4,727,927
-----------------------------------------------
Total (Hours)............................................. 14,371,901 8,053,319 6,318,582
----------------------------------------------------------------------------------------------------------------
[[Page 38864]]
The changes in the paperwork and recordkeeping requirements
contained in this rule have been submitted to the Office of Management
and Budget for approval under the Paperwork Reduction Act (44 U.S.C.
3501 et seq.).
VII. Final Rules
List of Subjects
9 CFR Part 304
Meat inspection.
9 CFR Part 308
Meat inspection.
9 CFR Part 310
Meat inspection, Microbial testing.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 327
Imports.
9 CFR Part 381
Poultry and Poultry products, Microbial testing.
9 CFR Part 416
Sanitation.
9 CFR Part 417
Hazard Analysis and Critical Control Point (HACCP) Systems.
For reasons set forth in the preamble, 9 CFR chapter III is amended
as follows:
PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF
INSPECTION
1. The authority citation for part 304 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. Section 304.3 is added to read as follows:
Sec. 304.3 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, as
required by part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, as required by Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
PART 308--SANITATION
3. The authority citation for part 308 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
4. Section 308.3 is amended by adding a sentence to the end of
paragraph (a) to read as follows:
Sec. 308.3 Establishments; sanitary condition; requirements.
(a) * * *. The provisions of part 416 of this chapter also apply.
* * * * *
PART 310--POST MORTEM INSPECTION
5. The authority citation for part 310 is revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. Part 310 is amended by adding a new Sec. 310.25 to read as
follows:
Sec. 310.25 Contamination with microorganisms; pathogen reduction
performance standards for Salmonella.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters cattle and/or hogs
shall test for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses in the cooler. Samples shall be collected by
sponging three sites on the selected carcass. On cattle carcasses,
establishments shall take samples from the flank, brisket, and rump; on
swine carcasses, establishments shall take samples from the ham, belly,
and jowl areas. <SUP>1
---------------------------------------------------------------------------
\1\ A copy of FSIS's ``Guidelines for E. coli Testing for
Process Control verification in Cattle and Swine Slaughter
Establishments'' is available for inspection in the FSIS Docket
Room.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples shall be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Bovines: 1 test per 300 carcasses
Swine: 1 test per 1,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 6,000
bovines, 20,000 swine, or a combination of bovines and swine not
exceeding 6,000 bovines and 20,000 animals total, shall collect one
sample per week starting the first full week of June and continuing
through August of each year. An establishment slaughtering both species
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or FSIS.
FSIS determinations that changes have been made requiring resumption of
weekly testing shall be provided to the establishment in writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for
[[Page 38865]]
analysis of E. coli that is approved by the Association of Official
Analytic Chemists International <SUP>2 or approved by a scientific body
in collaborative trials against the three tube Most Probable Number
(MPN) method and agreeing with the 95 percent upper and lower
confidence limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/cm\2\ of surface
area sponged. Results shall be recorded onto a process control chart or
table showing at least the most recent 13 test results, by class of
livestock slaughtered, permitting evaluation of the laboratory results
in accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
Maximum
Number of number
Slaughter class Lower limit of marginal Upper limit of marginal samples permitted
range range tested in marginal
range
(m)........................ (M)....................... (n) (c)
----------------------------------------------------------------------------------------------------------------
Steers/heifers............... Negative <SUP>a................. 100 cfu/cm\2\............. 13 3
Cows/bulls................... Negative <SUP>a................. 100 cfu/cm\2\............. 13 3
Market hogs.................. 10 cfu/cm\2\............... 10,000 cfu/cm\2\.......... 13 3
<SUP>a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of
at least 5 cfu/cm\2\ carcass surface area.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection shall be suspended in
accordance with rules of practice that will be adopted for such
proceedings upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standard; Salmonella.
(1) Raw meat product performance standards for Salmonella. An
establishment's raw meat products, when sampled and tested by FSIS for
Salmonella, as set forth in this section, may not test positive for
Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
------------------------------------------------------------------------
Maximum
Performance number of
Standard Number of positives
Class of product (percent samples to achieve
positive for tested (n) Standard
Salmonella)<SUP>a (c)
------------------------------------------------------------------------
Steers/heifers.................. 1.0% 82 1
Cows/bulls...................... 2.7% 58 2
Ground beef..................... 7.5% 53 5
Hogs............................ 8.7% 55 6
Fresh pork sausages............. <SUP>bN.A. N.A. N.A.
------------------------------------------------------------------------
<SUP>a Performance Standards are FSIS's calculation of the national
prevalence of Salmonella on the indicated raw product based on data
developed by FSIS in its nationwide microbiological data collection
programs and surveys. Copies of Reports on FSIS's Nationwide
Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of
Salmonella on raw products are available in the FSIS Docket Room.
<SUP>b Not available; values for fresh pork sausage will be added upon
completion data collection programs for those products.
(2) Enforcement. FSIS will sample and test raw meat products in an
individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.<SUP>3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Meat
and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an
[[Page 38866]]
establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product and take appropriate
corrective actions.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
7. The authority citation for part 320 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
8. Section 320.6 is amended by revising paragraph (a) to read as
follows:
Sec. 320.6 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection, as may be required by the
Administrator in special cases.
* * * * *
PART 327--IMPORTED PRODUCTS
9. The authority citation for Part 327 continues to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
10. Section 327.2 is amended by redesignating paragraphs (a)(2)(i)
(a)-(g) as (a)(2)(i) (A)-(G), redesignating paragraphs (a)(2)(ii) (a)-
(g) to (a)(2)(ii) (A)-(G), redesignating paragraph (a)(2)(ii)(h) as
(a)(2)(ii)(I), and by adding a new paragraph (a)(2)(ii)(H) to read as
set forth below, and by redesignating paragraphs (a)(2)(iv) (a)-(c) as
(a)(2)(iv) (A)-(C).
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
11. The authority citation for part 381 is revised to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
Subpart D--Application for Inspection; Grant or Refusal of
Inspection
12. A new Sec. 381.22 is added to subpart D to read as follows:
Sec. 381.22 Conditions for receiving inspection.
(a) Before being granted Federal inspection, an establishment shall
have developed written sanitation Standard Operating Procedures, in
accordance with Part 416 of this chapter.
(b) Before being granted Federal inspection, an establishment shall
have conducted a hazard analysis and developed and validated a HACCP
plan, in accordance with Secs. 417.2 and 417.4 of this chapter. A
conditional grant of inspection shall be issued for a period not to
exceed 90 days, during which period the establishment must validate its
HACCP plan.
(c) Before producing new product for distribution in commerce, an
establishment shall have conducted a hazard analysis and developed a
HACCP plan applicable to that product in accordance with Sec. 417.2 of
this chapter. During a period not to exceed 90 days after the date the
new product is produced for distribution in commerce, the establishment
shall validate its HACCP plan, in accordance with Sec. 417.4 of this
chapter.
Subpart H--Sanitation
13. Section 381.45 is amended to read as follows:
Sec. 381.45 Minimum standards for sanitation, facilities, and
operating procedures in official establishments.
The provisions of Secs. 381.46 and 381.61, inclusive, and part 416
of this chapter shall apply with respect to all official
establishments.
Subpart K--Post Mortem Inspection: Disposition of Carcasses and
Parts
14. Section 381.94 is added to subpart K to read as follows:
Sec. 381.94 Contamination with Microorganisms; process control
verification criteria and testing; pathogen reduction standards.
(a) Criteria for verifying process control; E. coli testing.
(1) Each official establishment that slaughters poultry shall test
for Escherichia coli Biotype I (E. coli) and shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements.
(i) Written procedures. Each establishment shall prepare written
specimen collection procedures which shall identify employees
designated to collect samples, and shall address location(s) of
sampling, how sampling randomness is achieved, and handling of the
sample to ensure sample integrity. The written procedure shall be made
available to FSIS upon request.
(ii) Sample collection. The establishment shall collect random
samples from carcasses. Carcasses to be sampled will be selected
randomly. Samples shall be collected by taking a whole bird from the
end of the chilling process, after the drip line, and rinsing it in an
amount of buffer appropriate for the type of bird being tested. <SUP>1
---------------------------------------------------------------------------
\1\ A copy of FSIS's guideline, ``Sampling Technique for E. coli
in Raw Meat and Poultry for Process Control Verification,'' is
available in the FSIS Docket Room for inspection.
---------------------------------------------------------------------------
(iii) Sampling frequency. Samples will be taken at a frequency
proportional to a slaughter establishment's volume of production, at
the following rates:
Chickens: 1 sample per 22,000 carcasses
Turkeys: 1 sample per 3,000 carcasses
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that
[[Page 38867]]
the alternative frequency is inadequate to verify the effectiveness of
the establishment's processing controls.
(v) Sampling in very low volume establishments.
(A) An establishment annually slaughtering no more than 440,000
chickens, 60,000 turkeys, or a combination of chickens and turkeys not
exceeding 60,000 turkeys and 440,000 birds total, shall collect one
sample per week starting the first full week of June through August of
each year. An establishment slaughtering both chickens and turkeys
shall collect samples from the species it slaughters in larger numbers.
Weekly samples shall be collected and tested until the establishment
has completed and recorded one series of 13 tests that meets the
criteria shown in Table 1 of paragraph (a)(5) of this section.
(B) Upon the establishment's meeting the requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or by
FSIS. FSIS determinations that changes have been made requiring
resumption of weekly testing shall be provided to the establishment in
writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for analysis of E. coli that is sensitive to 5 or fewer cfu/ml
of rinse fluid and is approved by the Association of Official Analytic
Chemists International <SUP>2 or approved by a scientific body in
collaborative trials against the three tube Most Probable Number (MPN)
method and agreeing with the 95 percent upper and lower confidence
limit of the appropriate MPN index.
---------------------------------------------------------------------------
\2\ A copy of the ``Official Methods of Analysis of the
Association of Official Analytical Chemists International,'' 16th
edition, 1995, is on file with the Director, Office of the Federal
Register, and may be purchased from the Association of Official
Analytical Chemists International, Inc., 481 North Frederick Ave.,
Suite 500, Gaithersburg, MD 20877-2417.
---------------------------------------------------------------------------
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of cfu/ml of rinse
fluid. Results shall be recorded onto a process control chart or table
showing at least the most recent 13 test results, by kind of poultry
slaughtered, permitting evaluation of the laboratory results in
accordance with the criteria set forth in paragraph (a)(5) of this
section. Records shall be retained at the establishment for a period of
12 months and shall be made available to FSIS upon request.
(5) Criteria for Evaluation of test results. An establishment is
operating within the criteria when the most recent E. coli test result
does not exceed the upper limit (M), and the number of samples, if any,
testing positive at levels above (m) is three or fewer out of the most
recent 13 samples (n) taken, as follows:
Table 1.--Evaluation of E. coli Test Results
----------------------------------------------------------------------------------------------------------------
Maximum number
Lower limit of Upper limit of Number of sample permitted in
Slaughter class marginal range marginal range tested (n) marginal range
(m) (M) (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................ 100 cfu/ml 1,000 cfu/ml 13 3
Turkeys............................. <SUP>a N.A. N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
<SUP>a Not available; values for turkeys will be added upon completion of data collection program for turkeys.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection will be suspended in
accordance with rules of practice that will be adopted for such
proceeding, upon a finding by FSIS that one or more provisions of
paragraphs (a) (1)-(4) of this section have not been complied with and
written notice of same has been provided to the establishment.
(b) Pathogen reduction performance standards; Salmonella.
(1) Raw poultry product performance standards for Salmonella. (i)
An establishment's raw poultry products, when sampled and tested by
FSIS for Salmonella as set forth in this section, may not test positive
for Salmonella at a rate exceeding the applicable national pathogen
reduction performance standard, as provided in Table 2:
Table 2.--Salmonella Performance Standards
----------------------------------------------------------------------------------------------------------------
Performance Maximum number of
Standard (percent Number of samples positives to
Class of product positive for tested (n) achieve Standard
Salmonella) <SUP>a (c)
----------------------------------------------------------------------------------------------------------------
Broilers............................................... <SUP>b 20.0% 51 12
Ground chicken......................................... 44.6 53 26
Ground turkey.......................................... 49.9 53 29
Turkeys................................................ <SUP>b N.A. N.A. N.A.
----------------------------------------------------------------------------------------------------------------
<SUP>a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw
products based on data developed by FSIS in its nationwide microbiological baseline data collection programs
and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide
Microbiological Surveys used in determining the prevalence of Salmonella on raw products are avialable in the
FSIS Docket Room.)
<SUP>b Standard is based on partial analysis of baseline survey data; subject to confirmation upon publication of
baseline survey report.
<SUP>d Not available; baseline targets for turkeys will be added upon completion of the data collection programs for
that product.
[[Page 38868]]
(2) Enforcement. FSIS will sample and test raw poultry products in
an individual establishment on an unannounced basis to determine
prevalence of Salmonella in such products to determine compliance with
the standard. The frequency and timing of such testing will be based on
the establishment's previous test results and other information
concerning the establishment's performance. In an establishment
producing more than one class of product subject to the pathogen
reduction standard, FSIS may sample any or all such classes of
products.<SUP>3
---------------------------------------------------------------------------
\3\ A copy of FSIS's ``Sample Collection Guidelines and
Procedure for Isolation and Identification of Salmonella from Raw
Meat and Poultry Products'' is available for inspection in the FSIS
Docket Room.
---------------------------------------------------------------------------
(3) Noncompliance and establishment response. When FSIS determines
that an establishment has not met the performance standard:
(i) The establishment shall take immediate action to meet the
standard.
(ii) If the establishment fails to meet the standard on the next
series of compliance tests for that product, the establishment shall
reassess its HACCP plan for that product.
(iii) Failure by the establishment to act in accordance with
paragraph (b)(3)(ii) of this section, or failure to meet the standard
on the third consecutive series of FSIS-conducted tests for that
product, constitutes failure to maintain sanitary conditions and
failure to maintain an adequate HACCP plan, in accordance with part 417
of this chapter, for that product, and will cause FSIS to suspend
inspection services. Such suspension will remain in effect until the
establishment submits to the FSIS Administrator or his/her designee
satisfactory written assurances detailing the action taken to correct
the HACCP system and, as appropriate, other measures taken by the
establishment to reduce the prevalence of pathogens.
Subpart Q--Records, Registration, and Reports
15. Section 381.180 is amended by revising paragraph (a) to read as
follows:
Sec. 381.180 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, mandatory
microbiological testing, and other aspects of the operations of the
establishment and the conduct of inspection thereat, as may be required
by the Administrator in special cases.
* * * * *
Subpart T--Imported Poultry Products
16. Section 381.196 is amended by redesignating paragraphs
(a)(2)(i) (a)-(g) as paragraphs (a)(2)(i) (A)-(G), redesignating
paragraphs (a)(2)(ii) (a)-(g) to (a)(2)(ii) (A)-(G), redesignating
paragraph (a)(2)(ii)(h) as (a)(2)(ii)(I), and by adding a new paragraph
(a)(2)(ii)(H) to read as set forth below, and redesignating paragraphs
(a)(2)(iv) (a)-(c) as (a)(2)(iv)(A)-(c).
Sec. 381.196 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(H) A Hazard Analysis and Critical Control Point (HACCP) system, as
set forth in part 417 of this chapter.
* * * * *
17. A new subchapter E, consisting of Parts 416 and 417 is added to
chapter III--Food Safety and Inspection Service, Meat and Poultry
Inspection, Department of Agriculture to read as follows:
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION
ACT AND THE POULTRY PRODUCTS INSPECTION ACT
Part
416 Sanitation
417 Hazard Analysis and Critical Control Point (HACCP) Systems
SUBCHAPTER E--REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT
INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT
PART 416--SANITATION
Sec.
416.11 General rules.
416.12 Development of sanitation SOP's.
416.13 Implementation of SOP's.
416.14 Maintenance of Sanitation SOP's.
416.15 Corrective Actions.
416.16 Recordkeeping Requirements.
416.17 Agency verification.
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 416.11 General rules.
Each official establishment shall develop, implement, and maintain
written standard operating procedures for sanitation (Sanitation SOP's)
in accordance with the requirements of this part.
Sec. 416.12 Development of Sanitation SOP's.
(a) The Sanitation SOP's shall describe all procedures an official
establishment will conduct daily, before and during operations,
sufficient to prevent direct contamination or adulteration of
product(s).
(b) The Sanitation SOP's shall be signed and dated by the
individual with overall authority on-site or a higher level official of
the establishment. This signature shall signify that the establishment
will implement the Sanitation SOP's as specified and will maintain the
Sanitation SOP's in accordance with the requirements of this part. The
Sanitation SOP's shall be signed and dated upon initially implementing
the Sanitation SOP's and upon any modification to the Sanitation SOP's.
(c) Procedures in the Sanitation SOP's that are to be conducted
prior to operations shall be identified as such, and shall address, at
a minimum, the cleaning of food contact surfaces of facilities,
equipment, and utensils.
(d) The Sanitation SOP's shall specify the frequency with which
each procedure in the Sanitation SOP's is to be conducted and identify
the establishment employee(s) responsible for the implementation and
maintenance of such procedure(s).
Sec. 416.13 Implementation of SOP's.
(a) Each official establishment shall conduct the pre-operational
procedures in the Sanitation SOP's before the start of operations.
(b) Each official establishment shall conduct all other procedures
in the Sanitation SOP's at the frequencies specified.
(c) Each official establishment shall monitor daily the
implementation of the procedures in the Sanitation SOP's.
Sec. 416.14 Maintenance of Sanitation SOP's.
Each official establishment shall routinely evaluate the
effectiveness of the Sanitation SOP's and the procedures therein in
preventing direct contamination or adulteration of product(s) and shall
revise both as necessary to keep them effective and current with
respect to changes in facilities, equipment, utensils, operations, or
personnel.
Sec. 416.15 Corrective Actions.
(a) Each official establishment shall take appropriate corrective
action(s) when either the establishment or FSIS determines that the
establishment's Sanitation SOP's or the procedures specified therein,
or the implementation or maintenance of the Sanitation SOP's, may have
failed to prevent direct
[[Page 38869]]
contamination or adulteration of product(s).
(b) Corrective actions include procedures to ensure appropriate
disposition of product(s) that may be contaminated, restore sanitary
conditions, and prevent the recurrence of direct contamination or
adulteration of product(s), including appropriate reevaluation and
modification of the Sanitation SOP's and the procedures specified
therein.
Sec. 416.16 Recordkeeping requirements.
(a) Each official establishment shall maintain daily records
sufficient to document the implementation and monitoring of the
Sanitation SOP's and any corrective actions taken. The establishment
employee(s) specified in the Sanitation SOP's as being responsible for
the implementation and monitoring of the procedure(s) specified in the
Sanitation SOP's shall authenticate these records with his or her
initials and the date.
(b) Records required by this part may be maintained on computers
provided the establishment implements appropriate controls to ensure
the integrity of the electronic data.
(c) Records required by this part shall be maintained for at least
6 months and made accesable available to FSIS. All such records shall
be maintained at the official establishment for 48 hours following
completion, after which they may be maintained off-site provided such
records can be made available to FSIS within 24 hours of request.
Sec. 416.17 Agency verification.
FSIS shall verify the adequacy and effectiveness of the Sanitation
SOP's and the procedures specified therein by determining that they
meet the requirements of this part. Such verification may include:
(a) Reviewing the Sanitation SOP's;
(b) Reviewing the daily records documenting the implementation of
the Sanitation SOP's and the procedures specified therein and any
corrective actions taken or required to be taken;
(c) Direct observation of the implementation of the Sanitation
SOP's and the procedures specified therein and any corrective actions
taken or required to be taken; and
(d) Direct observation or testing to assess the sanitary conditions
in the establishment.
PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
Sec.
417.1 Definitions.
417.2 Hazard analysis and HACCP plan.
417.3 Corrective actions.
417.4 Validation, verification, reassessment.
417.5 Records.
417.6 Inadequate HACCP Systems.
417.7 Training.
417.8 Agency verification.
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
Sec. 417.1 Definitions.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation
occurs.
Critical control point. A point, step, or procedure in a food
process at which control can be applied and, as a result, a food safety
hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit. The maximum or minimum value to which a physical,
biological, or chemical hazard must be controlled at a critical control
point to prevent, eliminate, or reduce to an acceptable level the
occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property
that may cause a food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP
plan itself.
Hazard. SEE Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be
used to control an identified food safety hazard.
Process-monitoring instrument. An instrument or device used to
indicate conditions during processing at a critical control point.
Responsible establishment official. The individual with overall
authority on-site or a higher level official of the establishment.
Sec. 417.2 Hazard Analysis and HACCP Plan.
(a) Hazard analysis. (1) Every official establishment shall
conduct, or have conducted for it, a hazard analysis to determine the
food safety hazards reasonably likely to occur in the production
process and identify the preventive measures the establishment can
apply to control those hazards. The hazard analysis shall include food
safety hazards that can occur before, during, and after entry into the
establishment. A food safety hazard that is reasonably likely to occur
is one for which a prudent establishment would establish controls
because it historically has occurred, or because there is a reasonable
possibility that it will occur in the particular type of product being
processed, in the absence of those controls.
(2) A flow chart describing the steps of each process and product
flow in the establishment shall be prepared, and the intended use or
consumers of the finished product shall be identified.
(3) Food safety hazards might be expected to arise from the
following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Zoonotic diseases;
(vii) Decomposition;
(viii) Parasites;
(ix) Unapproved use of direct or indirect food or color additives;
and
(x) Physical hazards.
(b) The HACCP plan. (1) Every establishment shall develop and
implement a written HACCP plan covering each product produced by that
establishment whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, based on the hazard
analysis conducted in accordance with paragraph (a) of this section,
including products in the following processing categories:
(i) Slaughter--all species.
(ii) Raw product--ground.
(iii) Raw product--not ground.
(iv) Thermally processed--commercially sterile.
(v) Not heat treated--shelf stable.
(vi) Heat treated--shelf stable.
(vii) Fully cooked--not shelf stable.
(viii) Heat treated but not fully cooked--not shelf stable.
(ix) Product with secondary inhibitors--not shelf stable.
(2) A single HACCP plan may encompass multiple products within a
single processing category identified in this paragraph, if the food
safety hazards, critical control points, critical limits, and
procedures required to be identified and performed in paragraph (c) of
this section are essentially the same, provided that any required
features of the plan that are unique to a specific product are clearly
delineated in the plan and are observed in practice.
(3) HACCP plans for thermally processed/commercially sterile
products do not have to address the food safety hazards associated with
microbiological contamination if the product is produced in accordance
with the requirements of part 318, subpart G, or part 381, subpart X,
of this chapter.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards identified in accordance with
paragraph (a) of this section, which must be controlled for each
process.
[[Page 38870]]
(2) List the critical control points for each of the identified
food safety hazards, including, as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the establishment, and
(ii) Critical control points designed to control food safety
hazards introduced outside the establishment, including food safety
hazards that occur before, during, and after entry into the
establishment;
(3) List the critical limits that must be met at each of the
critical control points. Critical limits shall, at a minimum, be
designed to ensure that applicable targets or performance standards
established by FSIS, and any other requirement set forth in this
chapter pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those
procedures will be performed, that will be used to monitor each of the
critical control points to ensure compliance with the critical limits;
(5) Include all corrective actions that have been developed in
accordance with Sec. 417.3(a) of this part, to be followed in response
to any deviation from a critical limit at a critical control point; and
(6) Provide for a recordkeeping system that documents the
monitoring of the critical control points. The records shall contain
the actual values and observations obtained during monitoring.
(7) List the verification procedures, and the frequency with which
those procedures will be performed, that the establishment will use in
accordance with Sec. 417.4 of this part.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated by the responsible establishment individual. This
signature shall signify that the establishment accepts and will
implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under
Sec. 417.4(a)(3) of this part.
(e) Pursuant to 21 U.S.C. 608 and 621, the failure of an
establishment to develop and implement a HACCP plan that complies with
this section, or to operate in accordance with the requirements of this
part, may render the products produced under those conditions
adulterated.
Sec. 417.3 Corrective actions.
(a) The written HACCP plan shall identify the corrective action to
be followed in response to a deviation from a critical limit. The HACCP
plan shall describe the corrective action to be taken, and assign
responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is
taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated
as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action
occurs, or if another unforeseen hazard arises, the establishment
shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
(2) Perform a review to determine the acceptability of the affected
product for distribution;
(3) Take action, when necessary, with respect to the affected
product to ensure that no product that is injurious to health or
otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an individual trained in
accordance with Sec. 417.7 of this part, to determine whether the newly
identified deviation or other unforeseen hazard should be incorporated
into the HACCP plan.
(c) All corrective actions taken in accordance with this section
shall be documented in records that are subject to verification in
accordance with Sec. 417.4(a)(2)(iii) and the recordkeeping
requirements of Sec. 417.5 of this part.
Sec. 417.4 Validation, Verification, Reassessment.
(a) Every establishment shall validate the HACCP plan's adequacy in
controlling the food safety hazards identified during the hazard
analysis, and shall verify that the plan is being effectively
implemented.
(1) Initial validation. Upon completion of the hazard analysis and
development of the HACCP plan, the establishment shall conduct
activities designed to determine that the HACCP plan is functioning as
intended. During this HACCP plan validation period, the establishment
shall repeatedly test the adequacy of the CCP's, critical limits,
monitoring and recordkeeping procedures, and corrective actions set
forth in the HACCP plan. Validation also encompasses reviews of the
records themselves, routinely generated by the HACCP system, in the
context of other validation activities.
(2) Ongoing verification activities. Ongoing verification
activities include, but are not limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective
actions; and
(iii) The review of records generated and maintained in accordance
with Sec. 417.5(a)(3) of this part.
(3) Reassessment of the HACCP plan. Every establishment shall
reassess the adequacy of the HACCP plan at least annually and whenever
any changes occur that could affect the hazard analysis or alter the
HACCP plan. Such changes may include, but are not limited to, changes
in: raw materials or source of raw materials; product formulation;
slaughter or processing methods or systems; production volume;
personnel; packaging; finished product distribution systems; or, the
intended use or consumers of the finished product. The reassessment
shall be performed by an individual trained in accordance with
Sec. 417.7 of this part. The HACCP plan shall be modified immediately
whenever a reassessment reveals that the plan no longer meets the
requirements of Sec. 417.2(c) of this part.
(b) Reassessment of the hazard analysis. Any establishment that
does not have a HACCP plan because a hazard analysis has revealed no
food safety hazards that are reasonably likely to occur shall reassess
the adequacy of the hazard analysis whenever a change occurs that could
reasonably affect whether a food safety hazard exists. Such changes may
include, but are not limited to, changes in: raw materials or source of
raw materials; product formulation; slaughter or processing methods or
systems; production volume; packaging; finished product distribution
systems; or, the intended use or consumers of the finished product.
Sec. 417.5 Records.
(a) The establishment shall maintain the following records
documenting the establishment's HACCP plan:
(1) The written hazard analysis prescribed in Sec. 417.2(a) of this
part, including all supporting documentation;
(2) The written HACCP plan, including decisionmaking documents
associated with the selection and development of CCP's and critical
limits, and documents supporting both the monitoring and verification
procedures selected and the frequency of those procedures.
(3) Records documenting the monitoring of CCP's and their critical
limits, including the recording of actual
[[Page 38871]]
times, temperatures, or other quantifiable values, as prescribed in the
establishment's HACCP plan; the calibration of process-monitoring
instruments; corrective actions, including all actions taken in
response to a deviation; verification procedures and results; product
code(s), product name or identity, or slaughter production lot. Each of
these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be
made at the time the specific event occurs and include the date and
time recorded, and shall be signed or initialed by the establishment
employee making the entry.
(c) Prior to shipping product, the establishment shall review the
records associated with the production of that product, documented in
accordance with this section, to ensure completeness, including the
determination that all critical limits were met and, if appropriate,
corrective actions were taken, including the proper disposition of
product. Where practicable, this review shall be conducted, dated, and
signed by an individual who did not produce the record(s), preferably
by someone trained in accordance with Sec. 417.7 of this part, or the
responsible establishment official.
(d) Records maintained on computers. The use of records maintained
on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
(e) Record retention. (1) Establishments shall retain all records
required by paragraph (a)(3) of this section as follows: for slaughter
activities for at least one year; for refrigerated product, for at
least one year; for frozen, preserved, or shelf-stable products, for at
least two years.
(2) Off-site storage of records required by paragraph (a)(3) of
this section is permitted after six months, if such records can be
retrieved and provided, on-site, within 24 hours of an FSIS employee's
request.
(f) Official review. All records required by this part and all
plans and procedures required by this part shall be available for
official review and copying.
Sec. 417.6 Inadequate HACCP Systems.
A HACCP system may be found to be inadequate if:
(a) The HACCP plan in operation does not meet the requirements set
forth in this part;
(b) Establishment personnel are not performing tasks specified in
the HACCP plan;
(c) The establishment fails to take corrective actions, as required
by Sec. 417.3 of this part;
(d) HACCP records are not being maintained as required in
Sec. 417.5 of this part; or
(e) Adulterated product is produced or shipped.
Sec. 417.7 Training.
(a) Only an individual who has met the requirements of paragraph
(b) of this section, but who need not be an employee of the
establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with Sec. 417.2(b)
of this part, which could include adapting a generic model that is
appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance
with Sec. 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed a course of
instruction in the application of the seven HACCP principles to meat or
poultry product processing, including a segment on the development of a
HACCP plan for a specific product and on record review.
Sec. 417.8 Agency verification.
FSIS will verify the adequacy of the HACCP plan(s) by determining
that each HACCP plan meets the requirements of this part and all other
applicable regulations. Such verification may include:
(a) Reviewing the HACCP plan;
(b) Reviewing the CCP records;
(c) Reviewing and determining the adequacy of corrective actions
taken when a deviation occurs;
(d) Reviewing the critical limits;
(e) Reviewing other records pertaining to the HACCP plan or system;
(f) Direct observation or measurement at a CCP;
(g) Sample collection and analysis to determine the product meets
all safety standards; and
(h) On-site observations and record review.
Done at Washington, DC, on: July 5, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
The following are appendices to the preamble of the Final Rule.
Note: The following appendices will not appear in the Code of
Federal Regulations.
Appendix A--Guidelines for Developing a Standard Operating Procedure
for Sanitation (Sanitation SOP's) in Federally Inspected Meat and
Poultry Establishments
I. Introduction
Foodborne illness is a significant public health problem in the
United States. While data on illness associated with meat and poultry
products are limited, data from various sources suggest that foodborne
microbial pathogens may cause up to 7 million cases of illness each
year, and 7,000 deaths. Of these, nearly 5 million cases of illness and
more than 4,000 deaths may be associated with meat and poultry
products.
FSIS is pursuing a broad and long-term science-based strategy to
improve the safety of meat and poultry products to better protect
public health. FSIS is undertaking steps to improve the safety of meat
and poultry throughout the food production, processing, distribution,
and marketing chain. The Agency's goal is to reduce the risk to public
health of consuming meat and poultry products by reducing pathogenic
microbial contamination. The FSIS strategy relies heavily on building
the principle of prevention into production processes.
Sections 308.7, 381.57 and 381.58 of the Meat and Poultry
Inspection Regulations require that rooms, compartments, equipment, and
utensils used for processing or handling meat or poultry in a federally
inspected establishment must be kept clean and in a sanitary condition.
Establishments are responsible for sanitation of facilities, equipment
and utensils.
Sanitation maintains or restores a state of cleanliness, and
promotes hygiene for the prevention of foodborne illness. Sanitation
encompasses many areas and functions of an establishment, even when not
in production. However, there are certain sanitary procedures that must
be addressed and maintained on a daily basis to prevent direct product
contamination or adulteration. Good sanitation is essential in these
areas to maintaining a safe food production process.
FSIS is requiring meat and poultry establishments to develop and
implement a written Standard Operating Procedure for sanitation
(Sanitation SOP's) which addresses these areas. An establishment's
adherence to its written Sanitation SOP will demonstrate knowledge of
and commitment to sanitation and production of safe meat and poultry
products.
New part 416 to the Meat and Poultry Inspection Regulations
requires that a written Sanitation SOP contain
[[Page 38872]]
established procedures to be followed routinely to maintain a sanitary
environment for producing safe and unadulterated food products. Plant
management must develop a Sanitation SOP that describes daily
sanitation procedures to be performed by the establishment. A
designated establishment employee(s) must monitor the Sanitation SOP
and document adherence to the SOP and any corrective actions taken to
prevent direct product contamination or adulteration. This written
documentation must be available to FSIS program employees.
These FSIS guidelines should help federally inspected meat or
poultry establishments develop, implement and monitor written
Sanitation SOPs.
The Sanitation SOP developed by the establishment must detail daily
sanitation procedures it will use before (pre-operational sanitation)
and during (operational sanitation) operation to prevent direct product
contamination or adulteration. FSIS program employees will verify an
establishment's adherence to its Sanitation SOP and will take
appropriate action when there is noncompliance.
These guidelines, where applicable, are for:
<bullet> Livestock Slaughter and/or Processing Establishments
<bullet> Poultry Slaughter and/or Processing Establishments
<bullet> Import Inspection Establishments
<bullet> Identification Warehouses
The establishment should update the Sanitation SOP to reflect
changes in equipment and facilities, processes, new technology, or
designated establishment employees.
II. Pre-operational Sanitation
Established procedures of pre-operational sanitation must result in
clean facilities, equipment and utensils prior to starting production.
Clean facilities, equipment, and utensils are free of any soil, tissue
debris, chemical or other injurious substance that could contaminate a
meat or poultry food product. Pre-operational sanitation established
procedures shall describe the daily, routine sanitary procedures to
prevent direct product contamination or adulteration. The sanitary
procedures must include the cleaning of product contact surfaces of
facilities, equipment and utensils to prevent direct product
contamination or adulteration. The following additional sanitary
procedures for pre-operational sanitation might include:
<bullet> Descriptions of equipment disassembly, reassembly after
cleaning, use of acceptable chemicals according to label directions,
and cleaning techniques.
<bullet> The application of sanitizers to product contact surfaces
after cleaning. Sanitizers are used to reduce or destroy bacteria that
may have survived the cleaning process.
III. Operational Sanitation
All federally inspected establishments must describe daily, routine
sanitary procedures that the establishment will conduct during
operations to prevent direct product contamination or adulteration.
Established procedures for operational sanitation must result in a
sanitary environment for preparing, storing, or handling any meat or
poultry food product in accordance with sections 308/381 of the Meat
and Poultry Inspection Regulations. Established procedures during
operations might include, where applicable:
<bullet> Equipment and utensil cleaning--sanitizing--disinfecting
during production, as appropriate, at breaks, between shifts, and at
midshift cleanup.
<bullet> Employee hygiene: includes personal hygiene, cleanliness
of outer garments and gloves, hair restraints, hand washing, health,
etc.
<bullet> Product handling in raw and in cooked product areas.
The established sanitary procedures for operational sanitation will
vary with the establishment. Establishments with complex processing
need additional sanitary procedures to ensure a sanitary environment
and to prevent cross contamination. Establishments that do not
slaughter or process (such as an Import Inspection facility) should
develop established sanitary procedures specific to that facility.
IV. Implementing and Monitoring of the Sanitation SOP
The Sanitation SOP shall identify establishment employee(s)
(positions rather than specific names of employees) responsible for the
implementation and maintenance of the Sanitation SOP. Employee(s) are
to be identified to monitor and evaluate the effectiveness of the
Sanitation SOP and make corrections when needed. The evaluation can be
performed by using one or more of the following methods: (1)
organoleptic (sensory--e.g., sight, feel, smell); (2) chemical (e.g.,
checking the chlorine level); (3) microbiological (e.g., microbial
swabbing and culturing of product contact surfaces of equipment or
utensils).
Establishments might specify the method, frequency, and
recordkeeping processes associated with monitoring. Pre-operational
sanitation monitoring should, at a minimum, evaluate and document the
effective cleaning of all direct product contact facilities, equipment,
and/or utensils that are to be used at the start of production.
Operational sanitation monitoring should, at a minimum, document
adherence to the SOP, including actions that identify and correct
instances or circumstances of direct product contamination which occur
from environmental sources (facilities, equipment, pests, etc.) or
employee practices (personal hygiene, product handling, etc.). All
establishment records of pre-operational and operational sanitation
monitoring, including corrective actions to prevent direct product
contamination or adulteration, must be maintained by the establishment
for at least six months, and be made available to FSIS program
employees. After 48 hours, they may be maintained off-site.
V. Corrective Actions
When deviations occur from the established sanitary procedures
within the Sanitation SOP, the establishment must take corrective
actions to prevent direct product contamination or adulteration.
Instructions should be provided to employees and management officials
for documenting corrective actions. The actions must be recorded.
Appendix B--Model of a Standard Operating Procedure for Sanitation
Hill-Top Meats has prepared a written Standard Operating Procedure
(SOP) for Sanitation. Let's look at the Sanitation SOP and discuss its
attributes (guidance and advice are inside the boxes).
Hill-Top Meats, Est. 38, Anytown, U.S.A. is a slaughter and medium
processing establishment. This plant receives live cattle for slaughter
and dressing and processes the carcasses into chubs of ground beef,
roast beef, and ready to eat beef products.
------------------------------------------------------------------------
-------------------------------------------------------------------------
This introductory information is not a regulatory requirement but
identifies the type of establishment and its production. The
information will help FSIS personnel, who are not familiar with the
establishment, review the Sanitation SOP.
------------------------------------------------------------------------
Management structure is as follows:
President--Joe Doe
Slaughter Manager--Ken Smith
Processing Manager--Susan Jones
Quality Control (QC) Manager--Gwen Summers
Sanitation Manager--Carl Anderson
The QC Manager is responsible for implementing and daily monitoring
of the Sanitation SOP and recording the findings and any corrective
actions. The
[[Page 38873]]
Slaughter, Processing and Sanitation Managers are responsible for
training and assigning specific duties to other employees and
monitoring their performance within the Sanitation SOP.
All records, data, checklists and other information pertaining to
the Sanitation SOP will be maintained on file and made available to
FSIS program employees.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The identification of establishment personnel (positions rather than
specific names of employees) responsible for implementing, maintaining,
monitoring and records associated with the Sanitation SOP is a
regulatory requirement. All records pertaining to the Sanitation SOP
must be kept on file and made available to FSIS personnel, but it is
not necessary to make that statement.
------------------------------------------------------------------------
Sanitation SOP for EST. 38
I. Preoperational Sanitation--Equipment and Facility Cleaning Objective
All equipment will be cleaned and sanitized prior to starting
production.
A. General Equipment Cleaning. (Simple equipment and hand tools are
cleaned and sanitized in the same manner but they do not require
disassembly and reassembly.)
1. Established Sanitary Procedures for Cleaning and Sanitizing
Equipment:
a. The equipment is disassembled. Parts are placed in the
designated tubs, racks, etc.
b. Product debris is removed.
c. Equipment parts are rinsed with water to remove remaining
debris.
d. An approved cleaner is applied to parts and they are cleaned
according to manufacturers' directions.
e. Equipment parts are rinsed with potable water.
f. Equipment is sanitized with an approved sanitizer, and rinsed
with potable water if required.
g. The equipment is reassembled.
h. The equipment is resanitized with an approved sanitizer, and
rinsed with potable water if required.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The established sanitary procedures are daily routine sanitary
procedures to prevent direct product contamination or adulteration.
Daily routine sanitary procedures to prevent direct product
contamination or adulteration are required in the Sanitation SOP; FSIS
personnel use them to verify compliance with the Sanitation SOP. The
procedures shall be specific for each establishment; however, they can
be as detailed as the establishment wants to make them.
------------------------------------------------------------------------
2. Implementing, Monitoring and Recordkeeping. The QC Manager
performs daily organoleptic sanitation inspection after preoperational
equipment cleaning and sanitizing. The results of the inspection are
recorded on Establishment Form E-1. If everything is acceptable, the
appropriate box is initialed. If corrective actions are needed, such
actions are to be documented (see below).
The QC Manager performs daily microbial monitoring for Total Plate
Counts (TPCs) after preoperational equipment cleaning and sanitizing.
The QC Manager swabs one square inch of a food contact surface on a
piece of equipment or hand tool within one hour prior to production.
The samples are plated and incubated at 35 deg. C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When the QC Manager determines that the equipment or hand tools
do not pass organoleptic examination, the cleaning procedure and
reinspection are repeated. The Sanitation Manager monitors the cleaning
of the equipment or hand tools and retrains sanitation crew employees,
if necessary. Corrective actions are recorded on Establishment Form E-
1.
b. If microbial counts exceed ____ CFUs/sq. in., the QC Manager
notifies the Sanitation Manager and attempts to determine the cause of
the high count (for example, cleaning procedures varied, new people
cleaned the equipment, sanitizer not applied). If microbial counts
remain high for several days, the QC Manager will confer with the
Sanitation Manager. The Sanitation Manager notifies sanitation crew
employees and reviews all cleaning and sanitizing procedures and
personal hygiene. Microbial counts are recorded on Establishment Form
M-1. Corrective actions to prevent direct product contamination or
adulteration are documented on Establishment Form E-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The establishment is required to monitor daily routine sanitation
activities as described in the Sanitation SOP, the establishment
determines the methods and frequency of monitoring. Microbiological
sampling is not required, but Hill-Top Meats wants to monitor the
effectiveness of the cleaning by daily microbial sampling, in addition
to organoleptic monitoring, and has set limits to enable them to take
appropriate action when those limits are exceeded. Establishment Forms
E-1 and M-1 are used only as examples; no specific forms or form
numbers are required. However, establishments must record the daily
completion or adherence to the established procedures in the Sanitation
SOP, any deviations from regulatory requirements, and corrective
actions.
------------------------------------------------------------------------
B. Cleaning of Facilities--including floors, walls and ceilings.
1. Cleaning Procedures.
a. Debris is swept up and discarded.
b. Facilities are rinsed with potable water.
c. Facilities are cleaned with an approved cleaner, according to
manufacturer's directions.
d. Facilities are rinsed with potable water.
2. Cleaning Frequency.
Floors and walls are cleaned at the end of each production day.
Ceilings are cleaned as needed, but at least once a week.
------------------------------------------------------------------------
-------------------------------------------------------------------------
There is no specific requirement to include facility cleaning in the
Sanitation SOP, unless part of the facility could directly contaminate
or adulterate product.
------------------------------------------------------------------------
3. Establishment Monitoring.
The QC Manager performs daily organoleptic inspection prior to the
start of operations. Results are recorded on Establishment Form E-1.
4. Corrective Actions.
When the QC Manager determines that the facilities do not pass
organoleptic inspection, the cleaning procedure and reinspection are
repeated. The Sanitation Manager monitors the cleaning of facilities
and retrains sanitation crew employees if necessary. Corrective actions
to prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
II. Operational Sanitation
Objective: Carcass dressing will be performed under sanitary
conditions and in a manner to prevent contamination of the carcass.
A. Slaughter Operations.
1. Established Methods for Carcass Dressing--
a. Employees will clean hands, arms, gloves, aprons, boots, etc.,
as often as
[[Page 38874]]
necessary during the dressing procedures.
b. Employees will clean and then sanitize with 180 deg. F. water,
knives and other hand tools, saws and other equipment, as often as
necessary during the dressing procedures to prevent contamination of
the skinned carcass.
c. The brisket saw is sanitized between carcasses using 180 deg. F.
water.
d. Eviscerating employees will maintain clean hands, arms, clothes,
aprons, boots and knives during the evisceration process. If
contamination occurs, the employee is required to step away from the
evisceration table onto a side platform to clean and sanitize apron,
boots and knives. It may be necessary to clean hands and arms with soap
and water. In cases of contamination from an abscess or other extensive
contamination, the employee may need to shower and change clothes
before resuming work.
e. The carcass splitting saw is sanitized with 180 deg. F. water
after each carcass.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The above methods for carcass dressing are specific for Hill-Top Meats.
The establishment considers them to be Good Manufacturing Practices for
their type of operation, to prevent direct contamination or
adulteration of carcasses. Each establishment determines the sanitary
procedures and any requirements they want to detail in their Sanitation
SOP.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Slaughter Manager is responsible for ensuring that employee
hygiene practices, sanitary conditions and cleaning procedures are
maintained during a production shift. The QC Manager monitors the
sanitation procedures twice during a production shift. Results are
recorded on Establishment Form E-1.
b. A Microbiological Control and Monitoring Program is used to
determine the level of bacteria on product contact surfaces of
equipment (e.g., knives, hand tools, evisceration table, etc.) and
outer garments (such as aprons and gloves) during production. The QC
Manager performs daily microbial monitoring for Total Plate Counts
(TPCs). The samples are plated and incubated at 35 deg.C. for 48 hours.
Colonies are counted and recorded as number of colony forming units
(CFU) per square inch of surface swabbed. Daily microbial counts are
documented on Establishment Form M-1.
3. Corrective Actions.
a. When equipment is visibly contaminated, contaminants are removed
by cleaning and sanitizing equipment prior to resuming production. The
Slaughter Manager attempts to determine the cause of the contamination
and takes corrective action. This may require adjusting equipment,
retraining employees, temporarily stopping or slowing the line speed,
etc. Corrective actions are recorded on Establishment Form E-1.
b. If microbial counts from equipment swabbing exceed the action
level set, the QC Manager notifies the Slaughter Manager. The Slaughter
Manager attempts to determine the cause (for example, new people not
adequately trained, equipment not adjusted properly) and takes
corrective action. If microbial counts remain above established limits
for several days, the QC Manager confers with the Slaughter Manager and
all slaughter operations are reviewed. The Slaughter Manager notifies
the slaughter employees and reviews personal hygiene, equipment
adjustment, and sanitary handling procedures. Corrective actions to
prevent direct product contamination or adulteration are recorded on
Establishment Form E-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The establishment is required to monitor the regulatory daily sanitation
activities as described in its Sanitation SOP, but each establishment
determines its own methods for monitoring, the frequency of monitoring,
and the corrective actions to include in the Sanitation SOP. Records
must be kept on daily completion of the established procedures,
deviations, and corrective actions.
------------------------------------------------------------------------
B. Processing Operations.
Objective: Processing is performed under sanitary conditions to
prevent direct and cross contamination of food products.
1. Established Sanitary Procedures for Processing--
a. Employees clean and sanitize hands, gloves, knives, wizard
knives, other hand tools, cutting boards, etc., as necessary during
processing to prevent contamination of food products.
b. All equipment, belt conveyors, tables, and other product contact
surfaces are cleaned and sanitized throughout the day as needed.
c. Employees take appropriate precautions when going from a raw
product area to a cooked product area, to prevent cross contamination
of cooked products. Employees change outer garments, wash hands and
sanitize hands with an approved hand sanitizer (sanitizer is equivalent
to 50 ppm chlorine), put on clean gloves for that room and step into a
boot sanitizing bath on leaving and entering the respective rooms.
d. Raw and cooked processing areas are separate. There is no cross
utilization of equipment between raw and cooked products.
e. Outer garments, such as aprons, smocks and gloves, are
identified and designated specifically for either the raw processing
rooms or the cooked processing rooms. Blue is designated for raw
processing rooms and orange for cooked processing rooms. The outer
garments are hung in designated locations when an employee leaves each
room. Outer garments are maintained in a clean and sanitary manner and
are changed at least daily and, if necessary, more often.
------------------------------------------------------------------------
-------------------------------------------------------------------------
Establishments with processing will determine their own established
sanitary procedures in the Sanitation SOP and any establishment
requirements. Hill-Top Meats considers its established procedures for
processing to be Good Manufacturing Practices.
------------------------------------------------------------------------
2. Monitoring and Recordkeeping.
a. The Processing Manager is responsible for ensuring that employee
hygiene practices, employee and product traffic patterns, sanitary
product handling procedures, and cleaning procedures are maintained
during a production shift. The QC Manager monitors the sanitation
procedures twice during a production shift. Results are recorded on
Establishment Form P-1.
b. A Microbiological Control and Monitoring Program is used to
determine and control the level of bacteria on both raw and cooked
product contact surfaces during production. Once a day, the QC Manager
performs Microbial Monitoring for Total Plate Counts (TPCs). The QC
Manager swabs one square inch on a product contact surface from each of
three randomly selected pieces of equipment in each raw product room
and cooked product room.
Note: The samples are taken from the cooked product rooms first
and then from the raw product rooms. The samples are plated and
incubated at 35 deg. C. for 48 hours. Colonies are counted and
recorded as number of colony forming units (CFU) per square inch of
surface swabbed. Microbial counts are documented on Establishment
Form M-1.
3. Corrective Actions.
a. When the QC Manager identifies sanitation problems, the QC
Manager notifies the Processing Manager. The Processing Manager stops
production, if necessary, and notifies processing employees to take
appropriate action to correct the sanitation problems. If necessary,
processing employees are retrained. Corrective actions are recorded on
Establishment Form P-1.
[[Page 38875]]
If microbial counts exceed the action level set for each piece of
equipment for the specific product in that production line, the QC
Manager notifies the Processing Manager. The Processing Manager
attempts to determine the cause (for example, new people going back and
forth between the raw and cooked rooms, gloves not being changed
regularly) and takes corrective action. Additional daily microbial
sampling is done on any equipment that showed high microbial counts,
until the counts fall below the action level. If microbial counts
remain high for several days, the QC Manager confers with the
Processing Manager and Sanitation Manager to review all operations that
impact that equipment. The Processing Manager notifies the processing
employees and reviews personal hygiene and sanitary product handling
procedures. Corrective actions are recorded on Establishment Form P-1.
------------------------------------------------------------------------
-------------------------------------------------------------------------
The monitoring and corrective actions are specific for Hill-Top Meats
only. Microbial sampling and monitoring are not required for product
contact surfaces. Each establishment determines its own procedures for
monitoring and the frequency of monitoring to include in its Sanitation
SOP.
------------------------------------------------------------------------
Appendix C--Guidebook for the Preparation of HACCP Plans
Preface
The Hazard Analysis Critical Control Points (HACCP) system is a
logical, scientific system that can control safety problems in food
production. HACCP is now being adopted worldwide. It works with any
type of food production system and with any food. It works by
controlling food safety hazards throughout the process. The hazards can
be biological, chemical, or physical.
This guidebook was developed to help meat and poultry
establishments prepare HACCP plans. The steps to developing a HACCP
plan can be used by all establishments, large or small, complex or
simple. The guidebook identifies additional sources of information, so
that small operators won't have to ``go it alone.''
The forms shown in this guidebook are examples only. Think of this
as a self-help guide or a do-it-yourself manual. There are many ways to
get to the final product--a good HACCP plan. So, choose the examples
that work best in your establishment.
The guidebook can be used to complement HACCP training. You may
also wish to use it in conjunction with a video about HACCP. The
guidebook will provide the basics. When you are ready to move on, there
are more specialized documents. FSIS is also publishing the Meat and
Poultry Products Hazards and Controls Guide. It explains in detail the
biological, chemical, and physical hazards that can occur at different
steps of meat and poultry slaughter and processing and provides some
examples of controls for those hazards. In addition, there will be a
series of Generic Models for different meat and poultry processes, to
be used as examples. You will probably want to look at the models for
processes that you use in your establishment. There will be model plans
for the following 13 processes:
Raw, Ground
Raw, Other
All Other Shelf-Stable, Heat Treated
Fully Cooked, Non-Shelf Stable
All Other Shelf-Stable, Not Heat Treated
All Non-Shelf Stable, Heat Treated, Not Fully Cooked
Non-Shelf Stable with Secondary Inhibitors
Thermally Processed/Commercially Sterile
Swine Slaughter
Poultry Slaughter
Beef Slaughter
Irradiation
Mechanically Separated Species
Developing a HACCP Plan
The Hazard Analysis and Critical Control Points (HACCP) System is a
logical, scientific approach to controlling safety problems in food
production. When a company adopts HACCP, it puts controls in place at
each point in the production system where safety problems could occur
from biological, chemical, or physical hazards. To start a HACCP
system, a company must first write a HACCP plan. This guidebook
explains how to write a HACCP plan in five preparatory steps and then
the seven HACCP principles.
The five ``pre-HACCP'' steps in this guidebook are:
1. Bring together your HACCP resources.
2. Describe the product and its method of distribution.
3. Develop a complete list of ingredients and raw materials used in
the product.
4. Develop a process flow diagram.
5. Meet the regulatory requirements for Sanitation Standard
Operating Procedures (SOPs).
Applying the seven HACCP principles makes up the major steps to
writing a HACCP plan. They are:
1. Conduct a hazard analysis.
2. Identify critical control points.
3. Establish critical limits for each critical control point.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish recordkeeping procedures.
7. Establish verification procedures.
As you read this guidebook and look at the examples, the process
for writing a HACCP plan should become clearer. This first section of
the guidebook explains the five ``pre-HACCP'' steps. The next seven
sections cover each of the HACCP principles that you will need to
follow to develop a HACCP plan.
Pre-HACCP Step 1--Bring Together Your HACCP Resources
The first step is to assemble your HACCP resources. When a company
develops a HACCP plan, it is important to bring as much knowledge to
the table as possible. Actually, you probably have access to more HACCP
resources than you think! With a small establishment, this might mean
bringing together one or two employees, one of whom has had HACCP
training. Your HACCP resources may include outside expertise. You can
get this expertise through your local Extension Office, a trade or
professional association, or a contractor of your choice. A larger
plant may wish to bring in employees from a number of departments, such
as production, sanitation, quality control, and engineering, as well as
employees directly involved in daily processing activities. There is no
magic number of employees needed to write a HACCP plan. It could be one
employee or, in a very large company, it could be seven or eight
people.
Your employee or employees writing the HACCP plan should understand
some basic things about your establishment: The technology and
equipment used in your processing lines; the practical aspects of food
operations; and the flow of the process in your plant. It will be a
bonus for your HACCP plan if those employees have some knowledge of the
applied aspects of food microbiology and of HACCP principles and
techniques, although this knowledge can be supplemented by outside
experts.
Pre-HACCP Step 2--Describe the Product and Its Method of Distribution
The second step is to describe completely each food product that
your plant makes. This will help identify hazards that may exist either
in the ingredients or in the packaging materials.
To describe your product, you might ask the following questions
about the product:
1. Common name?
[[Page 38876]]
For example, a cooked sausage could be called franks/hot dogs/
wieners.
2. How is it to be used?
Categories might include: Ready-to-eat, to be heated prior to
consumption, or for further processing.
3. The type of package?
For example, is it modified atmosphere packaging?
4. Length of shelf life?
In the cooked sausage example, the length of shelf life might be 30
to 50 days for modified atmospheric packaging.
5. Where will it be sold?
For example, will it be sold to wholesale, retail or institutions?
6. Labeling instructions?
``Keep Refrigerated'' would be a common labeling instruction for
meat and poultry products.
7. Is special distribution control needed?
For instance, should the product be kept refrigerated at or below
40 deg.F? Below is a blank Product Description Form. It is an example.
You may take it and tailor it to your own establishment.
Below is an example of a Product Description Form filled in for
cooked sausage. The HACCP Generic Models developed for 13 different
processes will give you more samples of product descriptions.
Pre-HACCP Step 3--Develop a Complete List of Ingredients and Raw
Materials
The third step is to develop a written list of ingredients and raw
materials for each process/product. You can write this on a very simple
form, as shown below. You may wish to divide the ingredients into just
two categories: Meat (meat such as boneless beef or chicken parts with
skin) and Other Ingredients (such as spices and preservatives). Below
is a sample Product and Ingredients Form for chunked and formed,
breaded chicken patties. Again, these forms are only examples to get
you started. You may wish to have more elaborate forms for your
establishment. The important thing is to list all ingredients that go
into each product!
Pre-HACCP Step 4--Develop a Process Flow Diagram
The next step is to construct a process flow diagram that
identifies all the steps used to prepare the product, from receiving
through final shipment. The diagram should not be so complex that it is
difficult to follow and understand, but must be complete from the
beginning of your process to the end.
You will want to verify the process flow diagram. You do this by
actually walking through the plant to make sure that the steps listed
on the diagram describe what really occurs in producing the product.
A blank process flow diagram is shown below. It is a very simple
form on which you may want to draw the flow freehand. If you have a
computer, you can make a fancier form, with arrows leading from step to
step.
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An example of a Process Flow Diagram for cooked sausage is shown
below. The employees in this case chose to construct a flow diagram for
the meat and poultry ingredients, another one for the non-meat
ingredients, and a third flow diagram for supplies such as packaging
materials. You will find more examples of process flow diagrams for
specific products in the HACCP Generic Models.
Remember, the purpose of this diagram is to find any places in your
specific establishment where hazards could occur. As with all HACCP
planning forms, the approving employee should sign and date the form,
for your records.
Pre-HACCP Step 5--Meet the Regulatory Requirements for Sanitation
Standard Operating Procedures
Good sanitation is one of the most basic ways to ensure that you
produce safe products. Maintaining good sanitation serves as an
excellent and necessary foundation for building your HACCP plan. It
also demonstrates that you have the commitment and resources to
successfully implement your HACCP plan. Because it is so important,
meeting the regulatory requirements for Sanitation Standard Operating
Procedures (SOPs) is a pre-HACCP requirement that must be carried out
in all establishments. A separate guide and a model Sanitation SOP have
been prepared and are available to help you with this activity.
Now you are ready to apply the seven principles that will produce a
HACCP plan suited to your plant and your products. Those principles and
how to carry them out will be discussed in detail in the next seven
sections of this guidebook.
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Principle 1--Conduct a Hazard Analysis
HACCP Principle No. 1 states:
``Conduct a hazard analysis. Prepare a list of steps in the process
where significant hazards occur and describe the preventive measures.''
The regulation defines a food safety hazard as ``Any biological,
chemical, or physical property that may cause a food to be unsafe for
human consumption.''
This section will define the hazards and discuss in general where
they may occur in meat and poultry production. It will then talk about
identifying hazards in your establishment.
Finally, this section will explain how you can apply preventive
measures to the hazards you have identified, to ensure that the
products are safe for consumers. A preventive measure is defined, in
the regulation, as ``Physical, chemical, or other means that can be
used to control an identified food safety hazard.''
You will find a far more detailed listing of and discussion of
hazards in the Meat and Poultry Products Hazards and Controls Guide.
The generic HACCP models discuss the hazards specific to various meat
and poultry processes, such as raw, ground product or swine slaughter.
In addition, the References section of this guidebook lists
publications which can help you identify hazards.
To identify biological, chemical, or physical hazards likely to
occur, you need to know about the chemical, physical, and
microbiological characteristics of meat, poultry, and other
ingredients, as well as how various processes affect those
characteristics. You also need to understand the interactions among
ingredients.
You need to evaluate each step in the process flow diagram to
determine whether a biological, chemical and/or physical hazard may be
introduced at that step and whether preventive measures are available.
Biological Hazards
Biological hazards are living organisms, including microorganisms,
that can put human health at risk. Biological hazards include bacteria,
parasites, protozoa, viruses, and the like.
Agricultural products and food animals carry a wide range of
bacteria. From a public health standpoint, most bacteria are harmless.
Others--the pathogenic microorganisms--can cause illness or even death
in humans. The numbers and types of bacteria vary from one food or
animal species to another, from one geographic region to another, and
with production and slaughter or harvesting methods. During production,
processing, packaging, transportation, preparation, storage and
service, any food may be exposed to bacterial contamination. The most
common biological hazards in meat and poultry are microbiological.
Some of the major pathogenic bacterial organisms that can cause
foodborne illness from eating meat or poultry are: Salmonella,
Clostridium perfringens, Listeria monocytogenes, Staphylococcus aureus,
Campylobacter jejuni, Yersinia enterocolitica, Bacillus cereus,
Clostridium botulinum, and Escherichia coli O157:H7.
In the Meat and Poultry Products Hazards and Controls Guide, you
will find a brief description of the major microorganisms of concern in
meat and poultry. Table 1 in that guide describes the temperature and
pH ranges and the minimum water activity needed for each organism to
grow. Table 4 lists some preventive measures for biological hazards. To
thoroughly identify significant biological hazards in your
establishment, you need to evaluate each specific ingredient and
processing step in your operation.
Chemical Hazards
Chemical hazards may also cause foodborne illnesses.
Chemical hazards fall into two categories:
1. Naturally occurring poisons or deleterious substances are those
that are natural constituents of foods and are not the result of
environmental, agricultural, industrial, or other contamination.
Examples include aflatoxins, mycotoxins, and shellfish toxins.
2. Added poisonous or deleterious substances are those which are
intentionally or unintentionally added to foods at some point in
growing, harvesting, storage, processing, packing, or distribution.
This group of chemicals can include pesticides, fungicides,
insecticides, fertilizers, and antibiotics, as well as direct and
indirect food additives. This group can also include chemicals such as
lubricants, cleaners, paints, and coatings.
To identify any chemical hazards, you first need to identify any
chemical residues that might be in the animal. To do this, think about
the following:
<bullet> The types of drugs and pesticides routinely used in
raising the animals which are the source of your meat and poultry
ingredients.
<bullet> Feeds and supplements fed to the animals.
<bullet> Environmental contaminants the animals may have come into
contact with. This includes both naturally occurring contaminants and
added contaminants.
<bullet> Pesticides used on plants that may end up as residues in
the animal.
<bullet> The source of the water the animals were allowed to drink.
You can use the following preventive measures to help ensure that
animals entering your establishment are free of harmful residues:
<bullet> Require that the animals have been raised in conjunction
with the January 1994 FDA Compliance Policy Guidelines.
<bullet> Require written assurances from suppliers for each lot of
animals, stating that the animals are free of illegal residues.
<bullet> Set your own maximum allowable residue limits for specific
drugs, pesticides, and environmental contaminants in animal urine or
tissues as targets to ensure that FDA and EPA tolerances are met.
<bullet> Ensure that trucks used to ship the animals do not have
chemical hazards that could contaminate the animals.
Most establishments use chemicals during processing and to keep
their operations sanitary. Yet you need to be aware that chemical
hazards can occur at any of the following points:
<bullet> Prior to receiving chemicals at your establishment.
<bullet> Upon receiving chemicals.
<bullet> At any point where a chemical is used during processing.
<bullet> During storage of chemicals.
<bullet> During the use of any cleaning agents, sanitizers,
lubricants, or other maintenance chemicals.
<bullet> Prior to shipment of the finished product.
<bullet> In trucks used to ship finished product.
Some of the measures you can use to prevent chemical hazards are:
<bullet> Use only approved chemicals.
<bullet> Have detailed product specifications for chemicals
entering your plant.
<bullet> Maintain letters of guarantee from suppliers.
<bullet> Inspect trucks used to ship finished product.
<bullet> Properly label and store all chemicals.
<bullet> Properly train employees who handle chemicals.
In the Meat and Poultry Products Hazards and Controls Guide, Table
5 lists some preventive measures for chemical hazards. For still more
information, see the publication HACCP--Establishing Hazard Analysis
Critical Control Point Program, Food Processors Institute, 1993.
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Physical Hazards
A physical hazard is any physical material not normally found in a
food which causes illness or injury to the individual using the
product. Physical hazards include a variety of foreign materials or
objects, such as glass, metal, and plastic. However, foreign objects
which cannot cause illness or injury are not hazards, even though they
may not be aesthetically pleasing to your customers.
A number of situations can result in physical hazards in finished
products. They include, but are not limited to:
<bullet> Contaminated raw materials.
<bullet> Poorly designed or poorly maintained facilities and
equipment. An example would be rust particles and paint chips falling
from overhead structures onto exposed product.
<bullet> Improper procedures or improper employee training and
practices. For example, by using the wrong cutting technique during the
cut-up/prefabrication process, employees could cut off and leave pieces
of their rubber gloves in the product.
Measures you can take to prevent physical hazards include, but are
not limited to:
<bullet> Make sure your plant specifications for building design
and operation are accurate and updated regularly.
<bullet> Make sure your letters of guarantee for ingredients and
product supplies are accurate and updated regularly.
<bullet> Perform random visual examinations of incoming product and
materials.
<bullet> Use magnets and metal detectors to help find metal
fragments that would be a physical hazard.
<bullet> Use stone traps and bone separators to remove these
potential physical hazards.
<bullet> Keep equipment well maintained.
<bullet> Train employees to identify potential problems.
To identify some preventive measures for physical hazards, see
Table 6 in the Meat and Poultry Products Hazards and Controls Guide.
Conducting a Hazard Analysis
Now that you have some understanding of the types of hazards that
can occur and how to identify and prevent them, you are ready to
conduct a hazard analysis for each process or product covered in your
HACCP plan.
A hazard analysis is the identification of any hazardous
biological, chemical, or physical properties in raw materials and
processing steps, and an assessment of their likely occurrence and
potential to cause food to be unsafe for consumption.
Your hazard analysis needs to be very specific to your
establishment and how you make your product, since hazards may vary
greatly from one establishment to another. This is due to differences
in: sources of ingredients, product formulations, processing equipment,
processing methods, duration of the processes and storage, and employee
experiences, knowledge, and attitudes.
You also need to review--and perhaps revise--your hazard analysis
whenever you make any changes in: raw materials suppliers, product
formulation, preparation procedures, processing steps, packaging
materials or procedures, distribution or intended use of the product.
Below is a blank Hazard Identification/Preventive Measures form
that you may wish to use for your hazard analysis. Below is an example
of that form filled in for hazards that might exist in a specific
establishment's ground beef process. The form contains space for the
process step in which the hazards could occur, the specific hazards,
and preventive measures to keep that hazard from occurring. Remember,
HACCP is a preventive system.
Steps in Conducting a Hazard Analysis
To conduct a hazard analysis, you need to do the following:
First--Evaluate Your Operation for Hazards
1. Review the product description developed in Pre-HACCP Step 2 and
determine how this information could influence your hazard analysis.
2. Look at all product ingredients and incoming materials for the
product. You developed this list in Pre-HACCP Step 3.
3. For each processing step identified in the process flow diagram,
determine if a biological, chemical or physical hazard(s) could exist
at that step.
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4. To help identify hazards, you can ask the following questions at
each processing step:
Could contaminants reach the product during this processing step?
Possibilities include: worker handling, contaminated equipment or
materials, cross-contamination from raw materials, leaking valves or
pipes, dead ends, splashing, etc.
Could any pathogens multiply during this process step to the point
where they became a hazard? Consider product temperature, hold time,
etc.
Could this step create a situation where an ingredient, work in
process, or finished product became contaminated with pathogens?
Could this step introduce a chemical hazard into the product?
Could this step introduce a physical hazard into the product?
5. Fully describe the hazards identified for each step.
6. For each incoming ingredient and material, indicate if a
biological, chemical and/or physical hazard exists.
7. To help identify hazards, you can ask the following questions
about each ingredient:
Could this ingredient contain any pathogenic microorganisms,
toxins, chemicals or physical objects?
If it became contaminated or were mishandled, could this ingredient
support the growth of pathogenic microorganisms?
Are any hazardous chemicals used in growing, harvesting, processing
or packaging the ingredient?
Is this ingredient hazardous if used in excessive amounts?
If this ingredient were left out or used in amounts lower than
recommended, could it result in microbial growth?
Are any chemical or physical hazards associated with this
ingredient?
8. You can ask the following questions about the product in
general:
Have any livestock entering the slaughter establishment been
subjected to hazardous chemicals?
Are any returned/reworked products used as ingredients?
If so, could they cause a hazard?
Are preservatives or additives used in the product formulation to
kill or inhibit the growth of microorganisms?
Do the amount and type of acid ingredients, and the resulting
product pH, affect the growth/survival of microorganisms?
Does the water activity of the finished product affect microbial
growth?
Should refrigeration be maintained for products during transit or
in storage?
Are any chemical or physical hazards associated with any packaging
materials?
9. Fully describe the hazards identified.
Second--Observe the Actual Operating Practices in Your Operation
After describing the hazards you've identified with each step, you
should:
1. Observe the actual operation in your establishment and be sure
that it is the usual process or practice.
2. Observe employee practices where raw or contaminated product
could cross-contaminate workers' hands, gloves or equipment used for
finished/post-process products.
3. Observe product handling past any kill step for potential cross-
contamination.
For additional information about potential biological, chemical,
and physical hazards, you may wish to consult tables 8 through 12 in
the Meat and Poultry Products Hazards and Controls Guide. They can
serve as a guide for identifying potential hazards in ingredients and
at various steps in slaughter and processing. However, they do not
address every ingredient and every processing step used in the meat and
poultry industry.
Preventive Measures
You have identified all significant biological, chemical and
physical hazards for each processing step and each ingredient. Now, it
is time to identify measures to prevent hazards from compromising the
safety of your finished product. Remember, you may not be able to
identify a preventive measure for every hazard that you identified. You
are ready to fill in the preventive measure(s) column of the Hazard
Identification/Preventive Measures Form.
Remember, HACCP defines a preventive measure as ``Physical,
chemical, or other means that can be used to control an identified food
safety hazard.''
Some examples of preventive measures are:
In beef slaughter, a chemical hazard could result from animals
having high levels of drug residues. As a preventive measure, you could
test the animals or require letters of guarantee from producers that
the animals are free of harmful residues.
In poultry slaughter, the venting, opening and evisceration process
could result in a biological hazard from cross contamination by
pathogenic microorganisms. Preventive measures for this hazard would
be: use Good Manufacturing Practices (GMP's) at all times; properly
maintain and operate equipment used to perform these tasks; and rinse
food contact surfaces on equipment with chlorinated water between each
carcass.
In the grinding step for cooked sausage, a physical hazard could be
metal fragments from the grinding equipment. There could be three
different preventive measures for this hazard. You could inspect the
grinding equipment daily to ensure that it is assembled and operated
correctly, is functioning properly, and is not worn or damaged. You
could have an employee visually examine the product at the packaging
step. Or you could use a metal detector at the packaging step.
In many operations, the packaging step could pose chemical hazards
from the packaging materials. A preventive measure could be a letter of
guarantee from the supplier that the packaging materials are all food
grade.
Once you have identified your preventive measures and written them
on your form, you are ready to go on to the next step in developing
your HACCP plan. See blank and filled-in forms for preventive measures
below.
Principle 2--Identify Critical Control Points
HACCP Principle No. 2 states:
``Identify the Critical Control Points (CCPs) in the process.''
A critical control point (CCP) is defined as ``A point, step, or
procedure in a food process at which control can be applied and, as a
result, a food safety hazard can be prevented, eliminated, or reduced
to acceptable levels.''
So far, in developing your HACCP plan, you have identified
biological, chemical, and physical hazards in the raw materials and
ingredients you use and in the steps of your process. You've also
identified preventive measures, if they exist, for each hazard that you
identified. With this information, your next step is to identify the
points in the process at which the preventive measures can be applied
to prevent, eliminate, or reduce the hazard. Then you can use the CCP
Decision Tree to assess each step in the process to determine whether
it is a critical control point. (Many control points may not be
critical; often, companies starting out in HACCP identify too many
control points.)
Fortunately, a great deal of work has already been done for you in
identifying CCPs. Many CCPs are already recognized in various food
processing and production systems. Some common CCPs are:
<bullet> Chilling.
<bullet> Cooking that must occur for a specific time and
temperature in order to destroy microbiological pathogens.
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<bullet> Product formulation controls, such as mixing ground beef
and spices to form a meatball.
<bullet> Certain processing procedures, such as filling and sealing
cans.
<bullet> Prevention of cross contamination between raw and cooked
product.
<bullet> Certain slaughter procedures, such as evisceration.
These are just a few examples of measures that may be CCPs.
There are many more possibilities. Different facilities, preparing
the same food, can differ in the number and location of hazards and the
points, steps or procedures which are critical control points. This is
due, in part, to differences in plant layouts, equipment used,
selection and sources of raw materials and ingredients, or the process
that is used.
Steps in Identifying Critical Control Points
A good tool for identifying Critical Control Points is the CCP
Decision Tree, shown below. The CCP Decision Tree was developed to help
companies separate CCPs from other controls. You will get the best
results if you use the Decision Tree very methodically and use simple,
descriptive, and familiar wording. You should apply the Decision Tree
at each step in the process where you have identified a hazard.
You can use the blank Critical Control Point Determination Form, to
record the results from your CCP Decision Tree work. Or, you may wish
to design your own form. An example of a filled-in Critical Control
Point Determination Form for poultry slaughter at one establishment is
shown below.
Determining whether a process step is a CCP is really a basic
exercise of answering four questions. To use the form and the Decision
Tree, follow the next six steps:
1. In Column 1 of the Critical Control Point Determination Form,
write in each step in the process where you have identified a hazard.
2. In Column 2, write in the identified hazard(s), indicating
whether it is biological, chemical or physical. Then take the
information you wrote on your Hazard Identification/Preventive Measures
form and answer the following questions for each hazard you identified.
3. Question #1--Do preventive measures exist for the identified
hazard?
Note: From a regulatory standpoint, no further action is
necessary if the hazard is not reasonably likely to occur.
If the answer is yes, write YES and proceed to the next question.
If the answer is no, ask the question ``Is control at this step
necessary for safety?''
If control is not necessary at this step in the process, this
process step is not a CCP. Write NO in Column 3 and write how and where
this hazard will be controlled. Proceed to the next process step and
identified hazard you have entered in Columns 1 and 2.
If control is necessary, in Column 3 explain how the step, process
or product will be modified to ensure safety.
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Once the step, process, or product has been modified, return to
Question #1.
4. Question #2--Does this step eliminate or reduce the likely
occurrence of the hazard(s) to an acceptable level?
If the answer is yes, write YES in Column 4 and identify the step
as a CCP in Column 7.
If the answer is no, write NO in Column 4 and proceed to the next
question.
5. Question #3--Could contamination with identified hazard(s) occur
in excess of acceptable levels or could these increase to unacceptable
levels?
If the answer is yes, write YES in Column 5 and proceed to the next
question.
If the answer is no, write NO in Column 5, indicating that the step
is not a CCP. Then proceed to the next process step and hazard.
6. Question #4--Will a subsequent step eliminate identified
hazard(s) or reduce the likely occurrence to an acceptable level?
If the answer is yes, write YES in Column 6, indicating that the
step is not a CCP. Then write down which processing step, which occurs
later, will reduce the hazard to acceptable levels. Then proceed to the
next process step and hazard.
If the answer is no, write NO in Column 6 and identify the step as
a CCP in Column 7.
Principle 3--Establish Critical Limits for Each Critical Control Point
HACCP Principle No. 3 states:
``Establish critical limits for preventive measures associated with
each identified CCP.''
The regulation defines critical limit as ``The maximum or minimum
value to which a physical, biological, or chemical hazard must be
controlled at a critical control point to prevent, eliminate, or reduce
to an acceptable level the occurrence of the identified food safety
hazard.''
<bullet> Critical limits are expressed as numbers, such as:
<bullet> Time/temperature
<bullet> Humidity
<bullet> Water activity
<bullet> pH
<bullet> Salt concentration
<bullet> Chlorine level
You will find that many critical limits for your identified CCPs
have already been established. You can find these limits in sources
such as regulatory requirements, scientific literature, experimental
studies, and through consultation with experts. Some examples of
regulatory critical limits for CCPs in meat and poultry production are
shown in Table 7 of the Meat and Poultry Products Hazards and Controls
Guide.
You may wish to establish critical limits that are stricter than
regulatory requirements. However, your critical limits must never be
less stringent than the requirements.
In some cases, you will need more than one critical limit to
control a particular hazard. For example, the critical limits for
cooked beef patties are time/temperature, pattie thickness, and
conveyor speed.
Below you will find an example of a Critical Limits, Monitoring and
Corrective Actions Form. You can use that form, or develop your own, to
use in this and the following two sections. You will find an example of
that form filled in for swine slaughter in one establishment below. You
can find examples of critical limits for specific processes in the
HACCP Generic Models.
Steps in Establishing Critical Limits
1. For each identified CCP, determine if there is a regulatory
critical limit. If so, write that critical limit--or a more stringent
one--into the critical limit column of your form.
For example, the regulatory critical limit for chilled poultry is
40 degrees F. So, for the chilling CCP in poultry slaughter, you would
write, in the Critical Limit column of your form: ``Deep breast muscle
temperature of <ls-thn-eq>40 degrees F. as the carcasses exit the
chiller.''
2. If there are no regulatory critical limits for a CCP, you need
to establish critical limits for the CCP that are adequate to maintain
control and prevent a food safety hazard. That is the responsibility of
each establishment. You may wish to obtain the assistance of outside
HACCP experts to help you determine critical limits for your CCPs. Once
you have identified critical limits, enter them into the critical limit
column of your form.
3. You should also file, for future reference, any documentation
such as letters from outside HACCP experts or scientific reports
supporting the critical limits you have identified. This documentation
will help validate that the limits have been properly established. In
addition, you should keep on file any test results that show your early
experience in implementing the HACCP plan, to demonstrate you can
implement what is written and make it work.
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Principle 4--Establish Monitoring Procedures
HACCP Principle No. 4 states:
``Establish CCP monitoring requirements. Establish procedures for
using the results of monitoring to adjust the process and maintain
control.''
Monitoring is a planned sequence of observations or measurements to
assess whether a CCP is under control and to produce an accurate record
for future use in verification.
Monitoring is essential to a HACCP system. Monitoring can warn you
if there is a trend towards loss of control, so that you can take
action to bring your process back into control before a critical limit
is exceeded. For example, say that an establishment tests the pH of a
batch of product at 6 a.m., 7 a.m., and 8 a.m. Each time, the pH is
within acceptable limits, but it is steadily climbing towards the high
end of the range. This information is showing a trend and the
establishment should take action to prevent the pH from exceeding the
critical limits.
The monitoring procedures you will establish at CCPs will generally
relate to on-line processes. Monitoring may be continuous or non-
continuous. Continuous monitoring at a CCP usually is done with
measuring equipment, such as automatic time-temperature equipment used
at a cooking step. Continuous monitoring is better because it results
in a permanent record that you can review and evaluate to ensure that
the CCP is under control. However, you should regularly check
continuous monitoring equipment for accuracy.
You should use non-continuous monitoring procedures when continuous
monitoring is not feasible. Non-continuous monitoring can include:
visual examinations; monitoring of ingredient specifications;
measurements of pH, water activity (Aw), and product temperatures;
attribute sampling; and the like. When you use non-continuous
monitoring, you need to ensure that the frequency of monitoring is
enough to ensure that the hazard is under control and that the
monitoring is performed at random times. For instance, each plant needs
to set its own times and frequency for checking the cooking time/
temperature of products. This may vary from one establishment to
another because of differences in plant size, plant layout, the type of
product, the length of time for processing, and the product flow.
Each establishment has the responsibility to establish a frequency
that ensures that the CCP is under control. In some cases, you may have
to perform tests at a CCP or use statistically based sampling.
Monitoring will go much more smoothly if you:
<bullet> Clearly identify the employee(s) responsible for
monitoring.
<bullet> Train the employee(s) monitoring the CCPs in the testing
procedures, the critical limits established, the methods of recording
test results, and actions to be taken when critical limits are
exceeded.
<bullet> Ensure that the employee(s) understand the purpose and
importance of monitoring.
You can use the Critical Limits, Monitoring and Corrective Actions
Form shown below, or you can develop your own form. Below is an example
of a form filled in for swine slaughter in one establishment.
Steps in Establishing Monitoring Procedures
You can identify monitoring procedures for your HACCP plan by doing
the following:
1. For each CCP, identify the best monitoring procedure.
2. Determine the frequency of monitoring for each CCP.
3. Determine if the monitoring activity needs to be done randomly
to get a good representation of the product throughout the day's
production. If it does, decide how the random monitoring will be done.
4. Determine what testing procedures need to be done for each
monitoring function. For example, will you need to do a chlorine check
or a temperature measurement?
5. Identify and train the employee(s) responsible for monitoring.
6. Make sure that the employee doing the monitoring signs all
records and documents associated with CCP monitoring. Also make sure
that the monitoring results are documented or recorded at the time the
monitoring takes place.
7. Enter the above information in the monitoring column of your
form.
Principle 5--Establish Corrective Actions
HACCP Principle No. 5 states:
``Establish corrective action to be taken when monitoring indicates
that there is a deviation from an established critical limit.''
The regulation defines corrective action as ``Procedures to be
followed when a deviation occurs.''
A deviation is a failure to meet a critical limit.
Since HACCP is a preventive system to correct problems before they
affect the safety of the food, you have to plan in advance to correct
potential deviations from established critical limits. Once your HACCP
plan is in place, any time a critical limit is not met, you will need
to take corrective actions. Those corrective actions should include:
1. Determining the disposition of non-complying product;
2. Correcting the cause of the non-compliance to prevent a
recurrence;
3. Demonstrating that the CCP is once again under control (this
means examining the process or product again at that CCP and getting
results that are within the critical limits);
4. Maintaining records of the corrective actions.
Under HACCP, you determine in advance what you will do when a
critical limit is not met at a CCP. The employee(s) monitoring CCPs
should understand this process and be trained to perform the
appropriate corrective actions. It is important that an establishment
record all corrective actions and that the employee responsible for
taking the corrective actions sign all the documentation.
In some cases, the product in question will be held for further
investigation of the deviation. This investigation may require a
thorough record review, product testing, or consultation with a
processing authority.
Some examples of corrective actions are:
<bullet> Immediately adjust the process and hold product for
further evaluation and disposition.
<bullet> Empower employees to stop the line when a deviation
occurs, hold all product not in compliance, and call in the plant's
quality control manager.
<bullet> Rely on an approved alternate process that can be
substituted for the one that is out of control at the specific critical
control point. For example, if the in-line eviscerators in a poultry
slaughter plant are malfunctioning, evisceration can be done by hand as
long as Good Manufacturing Practices (GMPs) are followed.
Regardless of the corrective actions you take, you need to keep
records that include:
<bullet> The deviation that was identified.
<bullet> The reason for holding the product; the time and date of
the hold; the amount of product involved; the disposition and/or
release of product; and the individual who made the disposition
decision.
<bullet> Actions to prevent the deviation from recurring.
You can use the Critical Limits, Monitoring and Corrective Actions
form below or you can develop your own
[[Page 38897]]
form. A sample form, filled in for swine slaughter, appears below.
Steps in Establishing Corrective Actions
1. For each CCP, determine the corrective action to take if the
critical limits are exceeded. Determine what should be done with the
product if a deviation occurs at this step. You may need more than one
corrective action for a CCP.
2. Develop the record form to capture all the necessary information
on the deviation, and identify the employee responsible for maintaining
and signing the record.
3. Ensure that employees conducting the monitoring at each CCP are
fully trained and know the corrective actions to take if a deviation
occurs.
4. Enter the appropriate corrective action(s) for each CCP in the
corrective action column of the Critical Limits, Monitoring and
Corrective Actions form and identify the record that will be
maintained.
Principle 6--Establish Recordkeeping Procedures
HACCP Principle No. 6 states:
``Establish effective recordkeeping procedures that document the
HACCP system.''
Maintaining proper HACCP records is an essential part of the HACCP
system. Good HACCP records--meaning that they are accurate and
complete--can be very helpful to you for the following reasons:
<bullet> Records serve as written documentation of your
establishment's compliance with its HACCP plan.
<bullet> Records allow you to trace the history of an ingredient,
in-process operations, or a finished product, should problems arise.
<bullet> Records help you identify trends in a particular operation
that could result in a deviation if not corrected.
<bullet> If you were ever faced with a product recall, HACCP
records could help you identify and narrow the scope of such a recall.
<bullet> Well-maintained records are good evidence in potential
legal actions against an establishment.
In accordance with the HACCP principles, your HACCP system should
include records for CCPs, establishment of critical limits, handling of
deviations, and your HACCP plan. Examples of these and other HACCP
forms that may be useful in assembling the HACCP plan are located in
the appropriate sections of this guidebook. For your review, these
forms are:
Product(s) Description Form
Product and Ingredients Form
Process Flow Diagram Form
Hazard Identification/Preventive Measures Form
CCP Determination Form
Critical Limits, Monitoring and Corrective Actions Form
Recordkeeping and Verification Form (Verification will be explained in
the next section of this guidebook)
HACCP Plan Form
In many cases, the records you currently maintain may be sufficient
to document your HACCP system. Records must contain at least the
following information: title and date of record; product
identification; critical criteria or limits; a line for the monitor's
signature; a place for the reviewer's signature; and, an orderly manner
for entering the required data.
An example of a blank Recordkeeping and Verification Form is found
below. Also below is an example of the form filled in for cooked
sausage in one establishment.
Steps in Establishing Recordkeeping Procedures
1. Review the records you currently maintain and determine which
ones adequately address the monitoring of the CCPs you have identified,
or develop forms for this information.
2. Develop any forms necessary to fully record corrective actions
taken when deviations occur.
3. Develop forms to document your HACCP system. (This will be
explained in the next section, on verification).
4. Identify the monitoring employees responsible for entering data
into the records and ensure that they understand their roles and
responsibilities.
5. Enter the record form name(s) on the Recordkeeping and
Verification Form under the records column adjacent to the appropriate
CCP. (Verification will be explained in the next section).
6. Enter the appropriate record form name(s) on the Recordkeeping
and Verification Form under the verification procedures column adjacent
to the appropriate CCP. (Verification will be explained in the next
section).
Principle 7--Establish Verification Procedures
HACCP Principle No. 7 states:
``Establish procedures to verify that the HACCP system is working
correctly.''
After a HACCP plan has been put into place, verification activities
occur on an ongoing basis. Verification entails the use of methods,
procedures, or tests in addition to those used in monitoring, to
determine whether the HACCP system is operating as intended.
Simply stated, you need to verify that your HACCP system is working
the way you expected it to work. There are several areas that warrant
checking. You will probably first want to review your HACCP plan to
determine whether the CCPs and critical limits that you established are
really the right ones and that you are controlling and monitoring them
adequately. You should also make sure that employees are following your
procedures for taking corrective actions when a critical limit is
exceeded. Finally, you should check to see that your employees are
keeping good HACCP records.
By doing these things, you will evaluate the day-to-day operation
of your HACCP system. Don't be surprised if you find that you need to
fine-tune your HACCP plan.
Some things you can do to verify your HACCP system are:
<bullet> Analytically test or audit your monitoring procedures;
<bullet> Calibrate your temperature equipment;
<bullet> Sample your product, including microbiological sampling;
<bullet> Review your monitoring records;
<bullet> Review your records of deviations and product
dispositions;
<bullet> Inspect and audit your establishment's operations;
<bullet> Sample for environmental and other concerns.
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You can use the Recordkeeping and Verification Form to record your
verification procedures. A sample blank form appears below. An example
filled in for cooked sausage in one establishment appears below.
Steps in Establishing Verification Procedures
1. Determine the appropriate verification procedure to ensure that
each CCP and critical limit is adequately controlled and monitored.
2. For each CCP, determine procedures to ensure that employees are
following your established procedures for handling product deviations
and for recordkeeping.
3. Identify the frequencies for conducting any verification checks
and the records where the results will be recorded.
4. Enter the appropriate details on the Recordkeeping and
Verification Form for future reference.
Validate Your HACCP Plan
It is very important to validate your HACCP plan. The regulation
defines validation as ``the scientific and technical process for
determining that the CCPs and associated critical limits are adequate
and sufficient to control likely hazards.''
Simply put, when you validate your HACCP plan, you demonstrate that
what you have written and put into place can actually prevent,
eliminate, or reduce the levels of hazards that you have identified.
To validate your HACCP plan, you need to assemble information to
show that your HACCP plan will work to control the process and to
prevent food safety hazards. There are two types of information that
you will probably collect. First, you will likely gather supporting
scientific information, such as studies that establish the time and
temperatures necessary to kill certain harmful bacteria. Second, you
may wish to gather practical information, such as test results from
products produced under your HACCP plan. An example of a test might be
microbiological analysis of your finished, ready-to-eat products. There
are many sources of information to validate your HACCP plan, including:
the scientific literature, product testing results, experimental
research results, scientifically-based regulatory requirements,
official FSIS guidelines, or information developed by process
authorities.
You have a great deal of flexibility in assembling the information
to validate your plan, in terms of both source and quantity of
information. For example, a slaughter plant should validate that its
plan ensures residue control, to prevent violative levels of chemicals,
animal drugs or pesticides in carcasses. A slaughter plant might choose
to purchase animals only from suppliers who provide veterinary
certifications that the animals have been raised under a program that
assures that all animal drugs, pesticides, and other chemicals are
properly used. In this situation, the establishment could validate this
critical control point with the following information: a copy of the
residue prevention program under which the producer is certified; a
report of an on-site visit to the feedlot; and results of analyses of
carcasses for compounds of concern.
Validation is simpler for HACCP plans for products such as cooked
beef, roast beef, or cooked corned beef. Current regulatory
requirements for these products include scientifically-based processing
times, temperatures, and handling requirements. Your HACCP plan would
need only to reflect these regulatory requirements; additional
information would be unnecessary. In this case, you could do a minimal
number of product analyses to demonstrate that hazards of concern, such
as Salmonella, were not found in the products produced under the HACCP
plan.
It is important that you reassess your HACCP plan at least once a
year and whenever any of the following occurs:
1. Potential new hazards are identified that may be introduced into
the process for the product.
2. You add new ingredients.
3. You change the process steps or procedures.
4. You introduce new or different processing equipment.
Finishing Your HACCP Plan
Now you are ready to assemble all your information into one HACCP
Plan. A sample HACCP Plan blank form is provided below. An example of a
form filled in for one establishment's canned beef stew process is
shown below. It is important for your records that you assemble all
your information into a final HACCP plan. To make sure that your HACCP
Plan is complete, you may want to check it against the checklist
provided in the next section of this guidebook.
Now you are ready to put your HACCP Plan into action and make HACCP
a reality in your establishment.
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HACCP Plan Checklist
You can use the HACCP Plan Checklist provided in this section to
ensure that your HACCP plan adequately addresses all seven HACCP
principles.
When completing the checklist, if you answer ``NO'' to any
question, you reevaluate that section of the HACCP plan and make
whatever modifications are necessary. Some modifications may require
the assistance of recognized HACCP experts.
Any time you make major changes to the HACCP plan based upon
product or process modifications, it would be advisable to review the
checklist to ensure that the revisions are acceptable.
You can keep the HACCP Plan Checklist as part of your HACCP plan
for future reference and to provide documented evidence that your HACCP
plan addresses all seven HACCP principles.
ESTABLISHMENT NO.------------------------------------------------------
PRODUCT/PROCESS--------------------------------------------------------
DATE-------------------------------------------------------------------
HACCP Plan Checklist
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
A. DESCRIBE THE PRODUCT YES NO
1. Does the HACCP plan include:
a. The producer/establishment and the product name?
b. The ingredients and raw materials used along with the product receipt or formulation?
c. The packaging used?
d. The temperature at which the product is intended to be held, distributed and sold?
e. The manner in which the product will be prepared for consumption?
2. Has a flow diagram for the production of the product been developed that is clear,
simple, and descriptive of the steps in the process?
3. Has the flow diagram been verified for accuracy and completeness against the actual
operating process?
B. CONDUCT A HAZARD ANALYSIS YES NO
1. Have all steps in the process been identified and listed where hazards of potential
significance occur?
2. Have all hazards associated with each identified step been listed?
3. Have safety concerns been differentiated from quality concerns?
4. Have preventive measures to control the identified hazard been identified, if they exist,
and listed?
C. IDENTIFY CRITICAL CONTROL POINTS YES NO
1. Has the CCP Decision Tree been used to help determine if a particular step is a CCP for a
previously identified hazard?
2. Have the CCPs been entered on the forms?
3. Have all significant hazards identified during the hazard analysis been addressed?
D. ESTABLISH CRITICAL LIMITS YES NO
1. Have critical limits been established for each preventive measure at each CCP?
2. Has the validity of the critical limits to control the identified hazard been
established?
3. Were critical limits obtained from the regulations, processing authority, etc?
4. Is documentation attesting to the adequacy of the critical limits maintained on file at
the establishment?
E. ESTABLISH MONITORING PROCEDURES YES NO
1. Have monitoring procedures been developed to assure that preventive measures necessary
for control at each CCP are maintained within the established critical limits?
2. Are the monitoring procedures continuous or, where continuous monitoring is not possible,
is the frequency of monitoring sufficiently reliable to indicate that the hazard is under
control?
3. Have procedures been developed for systematically recording the monitoring data?
4. Have employees responsible for monitoring been identified and trained?
5. Have employees responsible for reviewing monitoring records been identified and trained?
6. Have signatures of responsible individuals been required on the monitoring records?
7. Have procedures been developed for using the results of monitoring to adjust the process
and maintain control?
F. ESTABLISH CORRECTIVE ACTIONS YES NO
1. Have specific corrective actions been developed for each CCP?
2. Do the corrective actions address:
a. Reestablishment of process control?
b. Disposition of affected product?
c. Procedures to correct the cause of non-compliance and to prevent the deviation from
recurring?
3. Have procedures been established to record the corrective actions?
4. Have procedures been established for reviewing the corrective action records?
G. ESTABLISH RECORDKEEPING PROCEDURES YES NO
1. Have procedures been established to maintain the HACCP plan on file at the establishment?
2. Do the HACCP records include:
Description of the product and its intended use?
Flow diagram for the process, indicating CCPs?
Preventive measures?
Critical limits?
Monitoring system:
Corrective action plans for deviations from critical limits?
Recordkeeping procedures for monitoring?
Procedures for verification of the HACCP system?
H. ESTABLISH VERIFICATION PROCEDURES YES NO
1. Have procedures been included to verify that all significant hazards were identified in
the HACCP plan when it was developed?
2. Have procedures been included to verify that the critical limits are adequate to control
the identified hazards?
3. Are procedures in place to verify that the HACCP system is functioning properly?
[[Page 38904]]
4. Are procedures in place to reassess the HACCP plan and system on a regular basis or
whenever significant product, process or packaging changes occur?
----------------------------------------------------------------------------------------------------------------
References
Agriculture Canada. Food Safety Enhancement Program--
Implementation Manual. Camelot Drive, Nepean, Ontario, Canada.
American Meat Institute Foundation. HACCP: The Hazard Analysis and
Critical Control Point System in the Meat and Poultry Industry.
1994. Washington, D.C.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks in the United States, 1973-1987: Pathogens, vehicles, and
trends.'' J. Food Protect. 53: 804-817.
Bean, N. H. and Griffin, P. M. 1990. ``Foodborne disease
outbreaks, 5-year summary, 1983-1987.'' J. Food Protect. 53: 711.
Corlett, D.A., Jr. and R.F. Steir. 1991. ``Risk assessment
within the HACCP system.'' Food Control 2:71-72.
Council for Agricultural Science and Technology. Risks
Associated with Foodborne Pathogens. February 1993.
Environmental Protection Agency. 1992. Tolerances for Pesticides
in Foods. Title 40, Code of Federal Regulations, Part 185. U.S.
Government Printing Office, Washington, DC.
FDA. 1989. The Food Defect Action Levels. FDA/CFSAN. Washington,
DC.
FDA. 1994. Fish and Fishery Products Hazards and Control Guide--
Get Hooked on Seafood Safety. Office of Seafood. Washington, DC.
International Commission on Microbiological Specification for
Foods. 1989. Microorganisms in Foods 4. Application of hazard
analysis and critical control point (HACCP) system to ensure
microbiological safety and quality. Blackwell Scientific
Publications, Boston.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). March 20, 1992--Hazard Analysis and Critical Control
Point System. Int. J. Food Micr. 16: 1-23.
National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). June 1993--Report on Generic HACCP for Raw Beef.
Food Micr. 10: 449-488.
Oblinger, J. L., ed. 1988. ``Bacteria Associated with Foodborne
Illnesses, A Scientific Status Summary by the Institute of Food
Technologists Expert Panel on Food Safety and Nutrition.'' Food
Technol. 42(4).
Padhye, N. V.; Doyle, M. P. 1992. ``E. Coli 0157:H7
Epidemiology, pathogenesis, and methods for detection in food.'' J.
Food Prot. 55:55-565.
Pierson, M. D. and Corlett, D. A., Jr. ed. 1992. HACCP/
Principles and Applications. Van Nostrand Reinhold.
Schuchat, A., Swaminathan, B. And Broome, C.V. 1991.
``Epidemiology of human listeriosis.'' Clin. Microbiol. Rev. 4: 169-
183.
Stevenson, K. E. ed. 1993. HACCP-Establishing Hazard analysis
Critical Control Point Programs. A Workshop Manual. The Food
Processors Institute. Washington, D.C.
Tauxe, R.V., Hargett-Bean, N., Patton, C.M. and Wachsmuth. I.K.
1988. ``Campylobacter isolates in the United States, 1982-1986.''
In, CDC Surveillance Summaries, June 1988. MMWR 37 (No. SS- 2) : 1-
13.
Tauxe, R. V., Epidemiology of Camplyobacter jejuni infections in
the United States and other Industrialized Nations. In Nachamkin,
Blaser, Tompkins, ed. Camplyobacter jejuni: Current Status and
Future Trends, 1994, chapter 2, pages 9-19.
Todd, E. 1990. ``Epidemiology of Foodborne Illness: North
America.'' The Lancet 336:788.
Tompkin, R. B. 1990. ``The Use of HACCP in the Production of
Meat and Poultry Products. J. of Food Protect.'' 53(9): 795-803.
Tompkin, R. B. 1995. The Use of HACCP for Producing and
Distributing Processed Meat and Poultry Products. In Advances in
Meat Research. Volume 10. Hazard Analysis Critical Control Point
(HACCP) in Meat, Poultry and Seafoods. Chapman & Hall (In Press).
USDA, 1994. List of Propriety Substances and Nonfood Compounds
Authorized for Use under USDA Inspection and Grading Programs. USDA,
FSIS, Washington, DC.
Internet Home Pages
Agriculture Canada
http://aceis.agr.ca
Center for Disease Control
http://fftp.cdc.gov/pub/mmwr/MMWRweekly
Food Law Sites
http://www.fsci.umn.edu/FoodLaw/foodlaw.html
HACCP95
http://www.cvm.uiuc.edu/announcements/haccp95/haccp95.html
International Meat and Poultry HACCP Alliance
http://ifse.tamv.edu./haccpall.html
Material Safety Data Sheets
http://listeria.nwfsc.noaa.gov/msds.html
U.S. Department of Agriculture
http://www.usda.gov
U.S. Food and Drug Administration/Bad Bug Book
http://vm.cfsan.fda.gov/list.html
Appendix D--Hazards and Preventive Measures Guide
Preface
This Guide is designed to help a plant's HACCP team conduct a
hazard analysis (HACCP Principle 1) by providing both general and
detailed information on hazards associated with meat and poultry
products and by listing some of the controls that can be used to
prevent or manage those hazards. When using this Guide it is very
important to remember that it is not all-inclusive: There may be other
hazards associated with ingredients or processes; there may be other
control measures. The examples assembled here are to help plant HACCP
teams think through all the hazards that could affect their product and
know about various controls that can be used.
Section I describes some of the biological (including
microbiological), chemical, and physical hazards generally recognized
and associated with meat and poultry products. This section can serve
as a resource when the HACCP team begins the hazard analysis. It is
probably useful to read through this general information early in the
process of developing the HACCP plan. This will help the team form an
idea of what is meant by a given hazard.
Section II provides information on generally recognized preventive
measures used in the meat and poultry industry to control biological,
chemical, and physical hazards. This section also has examples of
regulatory critical limits associated with some preventive measures.
Sections III, IV, and V list processing steps, hazards, and
controls for beef, poultry, and swine slaughter. This section should be
used with the process flow diagram developed by the HACCP team.
Section VI presents hazards and controls organized according to
ingredients, including both meat and poultry ingredients and other
ingredients used in meat and poultry production. This section should be
used with the list of ingredients developed by the HACCP team.
Section VII contains a set of tables identifying potential hazards
at various processing steps used to produce meat and poultry products.
This section should be used with the process flow diagram developed by
the plant's HACCP team.
Section VIII contains a list of valuable references that will help
the plant's HACCP team further develop the HACCP plan.
Section I
Overview of Biological, Chemical, and Physical Hazards
In a HACCP system, a hazard is defined as a biological, chemical,
or physical property that may cause a food
[[Page 38905]]
to be unsafe for human consumption. This guide is a reference for plant
HACCP teams to use in their hazard identification and analysis. It is
not intended to be totally inclusive; the team may have other
information or may rely on additional references.
Biological Hazards
Biological hazards, which are mainly bacterial, can cause either
foodborne infections or intoxications. A foodborne infection is caused
by a person ingesting a number of pathogenic microorganisms sufficient
to cause infection as a result of their multiplication, e.g.,
salmonellosis. A foodborne intoxication is caused by the ingestion of
already formed toxins produced by some bacteria when they multiply in
food, e.g., staphylococcal enterotoxin.
When assessing bacterial hazards to human health in meat and
poultry products, nine pathogenic bacteria must be considered. The
following identifies and discusses the nine pathogenic microorganisms
of concern.
Bacillus cereus
B. cereus foodborne intoxication includes two recognized types of
illness--diarrheal and emetic (vomiting).
Foods associated with illness include: Boiled and fried rice,
custards, cecal products meats, vegetables, and fish; food mixtures
such as sauces, puddings, soups, casseroles, pastries, and salads.
Campylobacter jejuni
Campylobacteriosis is the illness caused by C. jejuni. It is also
often known as campylobacter enteritis or gastroenteritis.
Food associated with illness include: raw and undercooked chicken,
raw milk, non-chlorinated water.
Clostridium botulinum
Foodborne botulism (as distinct from wound botulism and infant
botulism) is a severe foodborne disease caused by the ingestion of
foods containing the potent neurotoxin formed during growth of the
organism. Botulism has a high mortality rate if not treated immediately
and properly.
Foods associated with disease include: sausages, meat products, and
seafood products, improperly canned foods, vegetable products.
Clostridium perfringens
Perfringens foodborne illness is the term used to describe the
common foodborne disease caused by the release of enterotoxin during
sporulation of C. perfringens in the gut.
Foods associated with illness include: meat and poultry products
and gravy.
Escherichia coli O157:H7
Hemorrhagic colitis is the name of the acute disease caused by E.
coli O157:H7.
Foods associated with illness: undercooked or raw hamburger (ground
beef) has been implicated in many documented outbreaks and in other
sporadic cases; other meat products, raw milk, untreated water.
Listeria monocytogenes
Listeriosis is the name of the general group of disorders caused by
L. monocytogenes.
Foods associated with illness: cole slaw, cooked poultry, cooked
meat, and raw milk, supposedly pasteurized fluid milk, cheeses
(particularly soft-ripened varieties). Its ability to grow at
temperatures as low as 3 deg.C permits multiplication in refrigerated
foods.
Salmonella spp
S. typhi and the paratyphoid bacteria are normally septicemic and
produce typhoid or typhoid-like fever in humans and are pathogenic only
for humans. Other forms of salmonellosis generally produce milder
symptoms. The organism is found in the intestinal tracts of warm
blooded animals.
Foods associated with illness: raw and cooked meats, poultry, eggs
(and exterior of egg shells), untreated water, raw milk and dairy
products, fish, shrimp, frog legs, yeast, sauces and salad dressing,
etc.
Staphylococcus aureus
Staphylococcal food poisoning (staphylococcal enterotoxicosis;
staphylococcal enterotoxemia) is the name of the condition caused by
the enterotoxins that some strains of S. aureus produce.
Foods associated with illness: meat and meat products; poultry and
egg products; egg, tuna, ham, chicken, potato, and macaroni salads;
sandwich fillings; milk and dairy products; etc.
Yersinia enterocolitica
Yersiniosis is the name of the disease caused by pathogenic species
in the genus Yersinia. The disease is a gastroenteritis with diarrhea
and/or vomiting, and fever and abdominal pain.
Foods associated with illness: meats, oysters, fish, milk, and
chitterlings.
Table 1.--Characteristics of Growth for Nine Pathogens Associated With Meat and Poultry Products
----------------------------------------------------------------------------------------------------------------
Temperature of
Pathogens growth pH Minimum A<INF>w
----------------------------------------------------------------------------------------------------------------
Bacillus cereus................................................. 10-48 deg.C 4.9-9.3 0.95
Campylobacter jejuni............................................ 30-47 deg.C 6.5-7.5 ..............
Clostridium botulinum........................................... 3.3-46 deg.C >4.6 0.94
(Types A,B,E)................................................... .............. .............. ..............
Clostridium perfringens......................................... 15-50 deg.C 5.5-8.0 0.95
Escherichia coli O157:H7........................................ 10-42 deg.C 4.5-9.0 ..............
Listeria monocytogenes.......................................... 2.5-44 deg.C 5.2-9.6 ..............
Salmonella...................................................... 5-46 deg.C .............. 4-9 0.94
Staphylococcus aureus........................................... 6.5-46 deg.C 5.2-9 0.86
Yersinis enterocolitica......................................... 2-45 deg.C 4.6-9.6 ..............
----------------------------------------------------------------------------------------------------------------
Zoonotic agents are biological hazards that cause disease in
animals and can be transmitted and cause disease in humans. The
following lists some zoonotic hazards:
Trichinella spiralis is a nematode parasite whose larval from
encysts primarily in the striated muscle of pigs, horses, rats, bears
and other mammals. Infection in humans results in ``flu-like symptoms''
(diarrhea, fever, stiffness, muscle pain, respiratory distress, etc.)
And heavy infection may lead to death.
Foods associated with illness include: raw and undercooked pork,
bear and equine meat.
Taenia saginata is a human tapeworm whose larval form (Cysticercus
bovis) encysts in the tissues of cattle.
Foods associated with illness include: raw or undercooked beef.
Taenia solium is a human tapeworm whose larval form (Cystricercus
cellulosae) encysts in the tissues of pigs,
[[Continued on page 38906]]