[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
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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.
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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.
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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.
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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.
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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.
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The established sanita