Docket No. FSIS-2009-0019

[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Proposed Rules]
[Pages 27135-27140]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2012-10895]

========================================================================
Proposed Rules
Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 /
Proposed Rules

[[Page 27135]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. FSIS-2009-0019]

HACCP Systems Validation

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Request for comment.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing this
document to propose to clarify its requirements for validation by an
official establishment of its Hazard Analysis Critical Control Point
(HACCP) system, that is, validation of both the critical control points
(CCPs) in the HACCP plan and any interventions or processes used to
support decisions in the hazard analysis. Validation of a HACCP system
involves two separate elements: The scientific or technical support for
the judgments made in designing the HACCP system, and evidence derived
from the execution of the HACCP plan to demonstrate that it is, in
fact, achieving the critical operational parameters documented in the
scientific or technical support.
The Agency is also announcing the availability of, and requesting
comments on, a revised draft guidance document prepared to assist
establishments in appropriately validating their HACCP systems. The
Agency received and analyzed comments on the initial draft of this
guidance, which the Agency posted on its Web site in March 2010. FSIS
is soliciting comments on this revised guidance and will hold a public
meeting to discuss the revised guidance before it issues final guidance
for HACCP systems validation.

DATES: Comments on this document and the revised guidance document,
``Compliance Guidance: HACCP Systems Validation,'' must be received by
July 9, 2012.

ADDRESSES: FSIS invites interested persons to submit comments on this
document and the related guidance. Comments may be submitted by either
of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, OPPD, RIMD, Docket Unit, Patriots Plaza 3,
1400 Independence Avenue SW., Mail Stop 3782, 8-163A, Washington, DC
20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2009-0019. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8:30 a.m.
and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: William K. Shaw, Jr., Ph.D., Office of
Policy and Program Development, FSIS, USDA, 1400 Independence Ave. SW.,
Patriots Plaza 3, Mailstop 3782, 8-142, Washington, DC 20250.
Telephone: (301) 504-0852 Fax: (202) 245-4792. Email:
william.shaw@fsis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

FSIS implements the Federal Meat Inspection Act (FMIA) (21 U.S.C.
601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C.
451 et seq.) to protect the health and welfare of consumers by
preventing the distribution in commerce of meat or poultry products
that are unwholesome, adulterated, or misbranded. To reduce the risk of
foodborne illness from meat or poultry products, FSIS issued
regulations on July 25, 1996, that require that federally inspected
establishments adopt HACCP systems (61 FR 38806). These regulations
require that federally inspected establishments adopt measures to
prevent or control the occurrence of food safety hazards at each stage
of the production process where such hazards are reasonably likely to
occur.
The HACCP regulations in 9 CFR part 417 require that each
establishment conduct a hazard analysis to determine the food safety
hazards reasonably likely to occur in its production process and to
identify the preventive measures the establishment can apply to control
those hazards in the production of particular products (9 CFR
417.2(a)). Whenever a hazard analysis reveals one or more food safety
hazards reasonably likely to occur in the production process, the HACCP
regulations require that the establishment develop and implement a
written HACCP plan, for each product, that includes specified measures
to prevent, eliminate, or reduce to an acceptable level the effects of
each hazard so identified (9 CFR 417.2(b)(1) and 9 CFR 417.2(c)). The
regulations in 9 CFR 417.2(c) require, among other things, that the
HACCP plan include CCPs at which such measures can be applied.
The HACCP regulations in 9 CFR part 417 also require that
establishments validate the HACCP plan's adequacy to control the food
safety hazards identified by the hazard analysis (9 CFR 417.4(a)). The
regulations in 9 CFR 417.4(a)(1) prescribe requirements for the initial
validation of an establishment's HACCP plan and require establishments
to ``conduct activities designed to determine that the HACCP plan is
functioning as intended.'' During this initial validation period,
establishments are to ``repeatedly test the adequacy of the CCPs,
critical limits, monitoring and recordkeeping procedures, and
corrective actions'' prescribed in their HACCP plans (9 CFR
417.4(a)(1)). The regulations state that ``[v]alidation also
encompasses reviews of the records themselves, routinely generated by
the HACCP system, in the context of other validation activities'' (9
CFR 417.4(a)(1)).
After an establishment has validated its HACCP plan, the
regulations require that it conduct ongoing verification activities and
reassess the HACCP plan at least annually or whenever a change occurs
that could affect its hazard analysis or HACCP plan (9 CFR 417.4(a)(2)
and 9 CFR 417(a)(3)).
The regulations in 9 CFR 417.5 require that establishments maintain

[[Page 27136]]

certain records that document their HACCP plans. In addition to records
associated with the HACCP plan itself, these records must include the
written hazard analysis prescribed in 9 CFR 417.2(a), including
supporting documentation (9 CFR 417.5(a)(1)).

HACCP System Validation

Initial validation period. Validation is the process of
demonstrating that a HACCP system, if operating as designed, can
adequately control identified hazards to produce a safe product. As
discussed above, the regulations in 9 CFR 417.4(a)(1) provide for an
initial validation period during which meat and poultry product
establishments are to conduct activities to validate their HACCP
systems. Official meat and poultry product establishments that were in
operation when FSIS issued its HACCP regulations in part 417 were
required to conduct this initial validation when they became subject to
part 417.
Since FSIS issued its HACCP regulations, meat and poultry product
establishments have been required to conduct a hazard analysis and
develop and validate a HACCP plan in accordance with 9 CFR 417.2 and 9
CFR 417.4 as a condition for receiving Federal inspection (9 CFR
304.3(b) and 9 CFR 381.22(b)). The regulations provide for the issuance
of a conditional grant of inspection for a period not to exceed 90 days
during which time the establishments are to complete their initial
HACCP plan validation.
In addition, if an establishment decides to produce a new product
for distribution in commerce, it is required to conduct a hazard
analysis and develop a HACCP plan applicable to that product before
introducing it into commerce (9 CFR 304.3(c) and 381.2(c)). The
establishment is required to complete the initial validation of the new
HACCP plan in accordance with 9 CFR 417.4 during a period not to exceed
90 days after the date the new product is produced for distribution in
commerce.
HACCP system records reviews. The regulations in 9 CFR 417.4(a)
identify certain activities that an establishment is required to
complete to validate its HACCP plans. These regulations state, among
other things, that validation is to encompass ``reviews of the records,
routinely generated by the HACCP system, in the context of the
validation.'' The ``HACCP system'' is defined as ``[t]he HACCP plan in
operation, including the HACCP plan itself'' (9 CFR 417.1). Thus, HACCP
plan validation under 9 CFR 417.4(a)(1) requires that an establishment
conduct reviews of both the records required in the HACCP plan, as well
as required records generated by the HACCP plan in operation.
The operation of a HACCP plan involves all activities performed by
the establishment to prevent or control food safety hazards identified
in the hazard analysis. An establishment may perform these activities
as part of its HACCP plan or as part of a program that contains
interventions or controls that could affect the hazard analysis but
that may or may not be referenced in the HACCP plan. For example, an
establishment may conduct activities to address an identified hazard as
part of a prerequisite program or as part of a program to comply with
specifications of a business customer. Because the results obtained
under these programs could affect decisions made in the hazard
analysis, an establishment is required to maintain records associated
with these programs as supporting documentation for its hazard analysis
(9 CFR 417.5(a)).
The written hazard analysis and supporting documentation are among
the records required under 9 CFR 417.5 to document the HACCP plan and,
as such, are also among the records ``routinely generated by the HACCP
system'' subject to review for validation under 9 CFR 417.4(a)(1).
Thus, if an establishment's supporting documentation for its hazard
analysis includes records associated with a prerequisite program that
provides for an intervention or process designed to prevent a hazard
from being likely to occur, the records required for validation under 9
CFR 417.4(a)(1) would need to cover all documents associated with the
prerequisite program. An establishment must assess whether these
records demonstrate that the intervention or control provided for in
the program can achieve results that support decisions in the hazard
analysis that a hazard is not reasonably likely to occur because of the
operation of the program.
Elements of validation. Validation under 9 CFR 417.4(a)(1) requires
that establishments assemble two types of data: (1) The scientific or
technical support for the judgments made in designing the HACCP system,
and (2) evidence derived from the HACCP plan in operation to
demonstrate that the establishment is able to implement the critical
operational parameters necessary to achieve the results documented in
the scientific or technical support.
Establishing and documenting the scientific or technical basis for
the HACCP system requires that the establishment gather scientific or
technical documentation demonstrating that the measures adopted in its
HACCP system are effective in controlling identified food safety
hazards. Scientific or technical support for a HACCP system may consist
of Agency guidance documents, documented expert advice from processing
authorities, an article from a peer-reviewed journal, a documented
scientific study, documented results from a pathogen modeling program,
or analogous information. To be effective, the scientific documentation
should identify: (1) The hazard that the measures are intended to
address; (2) the expected level of hazard reduction or prevention that
the measures will achieve; (3) the critical operational parameters,
such as time, temperature, humidity, and pH, that must be met for the
measures to be effective; (4) the processing steps necessary to achieve
the specified level of hazard reduction or prevention; and (5) how the
processing steps can be monitored.
For example, for scientific support of its HACCP system, an
establishment that processes beef carcasses may use a published journal
article that describes the use of a lactic acid spray system as an
antimicrobial intervention. To meet the first element of validation,
the journal article should identify E.coli O157:H7 and other pathogens
as the hazard that the lactic acid intervention is intended to address
and should specify the level of pathogen reduction that the
intervention is capable of achieving. The article should identify the
critical operational parameters needed for the intervention to be
effective, such as the design of the spray cabinet, the concentration
of the lactic acid, the pressure at which the spray is delivered, the
temperature of the acid at the point of delivery, and the temperature
of the carcass when the acid is applied.
Once an establishment has satisfactorily documented the scientific
or technical support for its HACCP system, the regulations require that
it ``repeatedly test the adequacy'' of the various components of its
HACCP plan in controlling identified hazards (9 CFR 417.4(a)(1)). This
element of the validation process requires that the establishment
demonstrate that the system will actually perform as expected. An
establishment must develop data to demonstrate that it has and can
routinely meet the scientifically documented parameters in its HACCP
systems under in-plant conditions, i.e., with its own employees and
equipment, and that its HACCP system, as implemented, is capable of
achieving

[[Page 27137]]

the expected results. Data used to support this in-plant demonstration
may include in-plant observations, measurements, microbiological test
results, documentation to demonstrate that employees have been properly
trained regarding the important aspects of their duties, or other
information to demonstrate that the establishment can implement the
preventive or control measures, as written into the HACCP system, in a
manner that achieves the intended food safety objective.
For example, an establishment that has incorporated the use of a
lactic acid spray intervention described in a peer-reviewed journal
article into its HACCP system will need to assemble documentation to
demonstrate that it is capable of following the procedures in the same
manner in which they are described in the study. To conduct the in-
plant demonstration, the establishment will need to measure and record
the results for all critical operational parameters identified in the
study, such as the concentration of the lactic acid spray, the pressure
of the spray, the temperature of the lactic acid, and the temperature
of the carcass at the point of delivery. The lactic acid intervention
will be validated if, at the end of 90 days, the establishment has
assembled data demonstrating that the establishment is consistently
meeting all critical operating parameters documented in the scientific
study under in-plant conditions.
As discussed above, an establishment must validate all measures
that it relies upon to prevent or control the hazards that it has
identified in its HACCP system, whether the measures are part of the
establishment's HACCP plan itself or part of a program that includes
interventions or controls that affect the hazard analysis. Under FSIS's
regulations, these measures are not considered to be validated until
the establishment has satisfied both elements described above.
For example, an establishment that receives, grinds, or otherwise
processes ground beef may determine that E. coli O157:H7 is not a
hazard reasonably likely to occur in its production process because it
has a prerequisite program incorporating purchase specifications that
require that the establishment's suppliers apply validated
interventions to address E. coli O157:H7 on the product that they send
the establishment. The establishment may reference the documentation
provided by the supplier as the support for the prerequisite program.
However, the prerequisite program is not validated until the receiving
establishment has documentation from each supplier, such as a letter of
guarantee, that assures that the supplier employs CCPs that address E.
coli O157:H7, describes those CCPs and the method of monitoring of them
and provides certificates of analysis that specify the sampling method
that the supplier uses and the results of that sampling. The receiving
establishment should also do its own testing or visit the supplier's
establishment to confirm that the supplier is executing the purchase
specifications in a consistent and effective manner to ensure that the
product the supplier sends does not contain detectable levels of E.
coli O157:H7. If the receiving establishment visits the supplier, the
receiving establishment should develop and maintain records that
document the findings of such visits.
As noted in the preamble to the HACCP final rule, adequate
validation needs to include both supporting scientific information as
well as in-plant operational data to ``* * * demonstrate not only that
[the establishment's] HACCP plan is theoretically sound, but also that
this establishment can implement it and make it work'' (61 FR 38806,
38826).

Initial Draft Guidance

FSIS developed an initial draft guidance document in 2010 to assist
the industry, particularly small and very small establishments, in
complying with the requirements for HACCP systems pursuant to 9 CFR
417.4. FSIS made this initial draft guidance available to the public in
March 2010 by posting it on the FSIS Web site and announcing its
availability in the Constituent Update. The Agency also mailed the
guidance document to all federally-inspected meat and poultry product
establishments.
The initial draft guidance described the types and sources of
scientific information that establishments can use to meet the first
element of the validation requirement, the scientific or technical
support. It also described the types of observational data and in-plant
measurements that establishments can use to meet the second element of
validation, the in-plant demonstration. The guidance also explained
that, in addition to gathering observational data, in-plant validation
requires demonstrating that the array of interventions and process
steps together in sequence are achieving the desired result. The
guidance included an Appendix titled ``Validation Examples for Raw
Products and Processed Products'' that provided examples on the kinds
of data that establishments could use to meet the validation
requirement.
With respect to the types of data that would be appropriate to
demonstrate that an establishment's HACCP system was achieving the
desired result, the initial draft guidance stated that:
``FSIS believes that microbiological testing that combines
enumeration of indicators with the presence/absence of an identified
pathogen in conjunction with monitoring critical parameters plays an
important role in the initial validation of many interventions for
biological food safety hazards. Microbiological testing data, where
appropriate, can provide establishments information about whether the
overall system of interventions can achieve the desired log reductions
documented in the scientific supporting documentation. Establishments
would need to provide support in instances where they believe
microbiological testing data is not needed to demonstrate the
effectiveness of the HACCP system in controlling biological food safety
hazards. Once the operational effectiveness of each individual
intervention is determined, the establishment can use microbiological
testing data in conjunction with the data on the individual
interventions to establish that the process as a whole results in the
production of safe, unadulterated product. In this final part of step 2
initial in-plant validation, the establishment should pull together the
data for each intervention and the data from microbiological testing at
various points throughout the HACCP system to ensure that the multiple
hurdle design of its entire HACCP system will result in the production
of safe, unadulterated products. Failure to take these steps will raise
questions whether the HACCP system has been adequately validated.''

Public Meeting

An array of issues were raised in comments submitted in response to
the initial draft guidance, particularly with respect to the guidance
on the use of microbiological testing to validate the effectiveness of
HACCP systems in controlling biological hazards. To address these
issues, the Agency developed, and made available on its Web site, a
supplemental fact sheet to assist small and very small meat and poultry
establishments obtain information to support the scientific design of
their HACCP systems (http://www.fsis.usda.gov/Science/HACCP_Validation/index.asp).
In addition, on June 14, 2010, FSIS held a public meeting to
discuss the draft HACCP validation guidance and received input from
stakeholders.

[[Page 27138]]

The transcripts of the July 2010 public meeting are available on
the FSIS Web site at: http://www.fsis.usda.gov/PDF/Transcripts_HACCP_Validation_061410.pdf.

Comments on the Initial Draft

FSIS received over 2000 comments on its March 2010 draft guidance
on HACCP validation from consumers of organic meat and poultry, small
livestock producers and family farmers, small and very small meat or
poultry processors, trade associations representing meat and poultry
processors, trade associations representing animal producers, State
Departments of Agriculture and other local or State government
officials, academics, insurance companies, and consumer advocacy
organizations.
FSIS has carefully considered the comments and re-evaluated its
draft guidance in light of these comments. Based on this re-evaluation,
FSIS has revised the draft guidance. Following is a brief summary and
discussion of the major issues raised by the comments.

1. Microbiological Testing vs. Critical Operating Parameters

Comment: FSIS received a significant number of comments on the use
of microbiological testing to validate a HACCP system. The majority of
these comments objected to the requirements for microbiological testing
as part of the in-plant demonstration component of validation. The
comments stated that the benefit of collecting microbial data is
unclear and is not justified by the significant financial burden that
such testing would impose.
A number of comments stated that instead of requiring
microbiological testing, the focus of in-plant validation should be on
critical operating parameters. The comments asserted that a scientific
study is the safest and most effective method to validate a process,
and that the in-plant validation should be focused on collecting data
to demonstrate that the establishment is properly implementing the
procedures described in the scientific support, allowing establishments
to focus on meeting the established parameters.
Response: FSIS agrees and has revised the draft guidance to remove
the references to the use of in-plant microbiological testing as a
necessary part of the in-plant demonstration component of the HACCP
validation process. FSIS has concluded that a key focus of validation
should be on the establishment's ability to achieve the scientifically
supported critical operating parameters under in-plant conditions. A
showing that the establishment can effectively achieve these parameters
will satisfy the in-plant demonstration requirements of validation and
fulfill the objectives of the HACCP regulations without imposing
significant costs on small businesses.
Accordingly, the in-plant demonstration of validation will be
considered effective when an establishment has demonstrated that it is
capable of effectively implementing the critical operational parameters
identified in the establishment's scientific or technical support.
Although references to microbiological testing in the initial in-
plant validation phase have been removed from the revised compliance
guidance, FSIS will continue to include establishments that are
conducting the initial validation in the Agency's regulatory
microbiological sampling programs. FSIS would question the adequacy of
an establishment's HACCP system if regulatory samples analyzed by the
Agency show non-compliance with microbiological standards.
Comment: Some comments pointed out that all parameters specified in
an establishment's supporting scientific and technical documentation
may not in fact be needed for the intervention or control measure to be
effective. The comments asserted that meeting only the critical
parameters necessary to successfully implement an intervention should
be required as part of the in-plant demonstration.
Response: As noted above, FSIS has revised the guidance to focus on
the critical operational parameters. The critical operating parameters
are those that have been shown to influence the effectiveness of an
intervention when variations occur. If some of the operational
parameters described in the scientific support have been found to have
no impact on the effectiveness of the intervention, there would be no
need to monitor those operational parameters during the initial
validation period.
Comment: Some comments suggested that FSIS create safe harbors for
establishments in which they can operate without concerns about the
validity of their process. The comments stated that the Agency should
only request in-plant information from an establishment when the
validity of the process is being questioned, or if the establishment is
implementing a new or unique process.
Several comments submitted by the industry stated that HACCP plans
are backed by scientific studies that have been conducted by a
university, trade association, or a regulatory body. The comments
stated that these scientific studies validate that an establishment's
HACCP plan is capable of producing a safe product.
Response: Establishments may use established processing guidelines,
such as Appendix A of the final rule ``Performance Standards for the
Production of Certain Meat and Poultry Products,'' for their scientific
support. The parameters established in these guidelines would be
considered ``safe harbors.'' However, the establishment would still
need to collect in-plant data to demonstrate that is capable of
achieving the critical operational parameters documented in these
processing guidelines to complete the validation.
The regulations that prescribe requirements for validation require
that establishments ``* * * repeatedly test the adequacy of the CCPs,
critical limits, monitoring and recordkeeping procedures, and
corrective actions'' described in their HACCP plans (9 CFR
417.4(a)(1)). While a scientific study may demonstrate that the HACCP
system is designed to effectively address the relevant hazards,
additional in-plant monitoring and observation is needed to demonstrate
that the system will function as designed. Thus, a scientific study on
its own is not sufficient to validate an establishment's HACCP system.
Comment: One trade association asked how the Agency will work to
ensure that small and very small plants have access to the scientific
support mentioned in the guidance document.
Response: FSIS has posted a list of relevant journal articles by
pathogen on its Web site (http://www.fsis.usda.gov/Science/HACCP_Validation_Articles/index.asp). The Agency is also developing a
tutorial on understanding scientific and technical journal articles and
identifying critical operational parameters. FSIS will post that
material on the Web site when it is complete.

2. Validation and Verification

Comment: Several comments expressed concern about requiring that
establishments implement regular, year-round microbiological testing,
regardless of whether problems have been identified. The comments also
expressed concern about the annual cost for ongoing in-plant testing.
Response: The concerns about ongoing or year-round testing
expressed by the comments are related to the on-going verification that
is required after the validation is complete. After an establishment
completes the initial validation, it is required to conduct
verification activities to demonstrate

[[Page 27139]]

that it continues to achieve the critical operating parameters on an
on-going basis. The draft guidance does note that these on-going
verification procedures may need to include microbiological testing,
although establishments may use a number of measures including ongoing
communication with suppliers and third party audits, to support the
HACCP system is functioning as intended on an ongoing basis.

3. Improve Agency Training and Management of Communication With Field
Personnel

Comment: Some comments submitted by trade associations representing
meat and poultry processors stated that FSIS needs to ensure that its
field personnel interpret the validation guidance in an accurate and
consistent manner. The comments suggested that FSIS conduct workshops
and training sessions on the validation guidance for industry and
inspection personnel.
Response: FSIS will provide instructions to the field when it
issues final guidance on HACCP validation. The Agency also will provide
additional materials and supplemental training to ensure that the
validation requirements are properly implemented.

4. Accommodating Small and Very Small Establishments

Comment: Several comments emphasized the importance of recognizing
that a ``one size fits all'' approach to regulatory requirements is not
the most effective approach. Some comments suggested that FSIS should
establish a separate set of requirements for small processors, or
perhaps exempt small processors from the HACCP validation requirements.
Response: FSIS agrees that it is important to provide small and
very small establishments the flexibility they need to comply with
regulatory requirements. At the same time, in order to ensure that meat
and poultry products are safe, wholesome, and accurately labeled, it is
essential for all establishments to effectively validate their HACCP
systems. The revised draft guidance provides small and very small
plants the flexibility to choose the most appropriate procedures for
them to achieve the requirements for HACCP validation. In addition,
FSIS will continue to assist small and very small plants in meeting the
regulatory requirements for HACCP through the Agency's ongoing small
and very small plant outreach activities.

5. Data Sharing

Comment: One industry commenter asked whether a company that owns
more than one establishment can use the validation data gathered from
one facility to validate the HACCP systems of other facilities owned by
the same company.
Response: Both the initial guidance document and our revised draft
guidance explain that if a company owns multiple establishments that
conduct the same operations, the establishments may use the same
scientific support for all establishments to satisfy the first element
of validation. However, each establishment would need to conduct its
own on-site study to demonstrate that it is capable of meeting the
critical operational parameters in the scientific study. It is
important that each establishment do so because variations exist from
establishment to establishment, such as differences in equipment
configurations or building structures, which could have an impact on
the implementation of a measure documented in the scientific support.

Revisions Made After Consideration of Comments

After careful consideration of the comments submitted on the March
2010 initial draft guidance, the Agency revised its draft guidance on
HACCP systems validation. Following is a summary of major areas that
FSIS addressed when it revised the draft guidance.
Scientific Support. As part of its HACCP verification activities,
in addition to the issues related to the in-plant demonstration
described above, FSIS has identified instances in which an
establishment's HACCP system design did not reflect the critical
operational parameters documented in the scientific or technical
support. Therefore, the revised draft guidance provides additional
recommendations on measures that an establishment can take to ensure
that its scientific or technical support is properly applied to its
production process and the hazards identified in the hazard analysis.
The guidance emphasizes that to be effective, the establishment's HACCP
system design must relate and adhere to the specifications in the
supporting documentation.
The revised draft guidance also discusses the five major types of
scientific support. These include: (1) Published processing guidelines,
e.g. Appendix A of the final rule ``Performance Standards for the
Production of Certain Meat and Poultry Products'' and Appendix B,
Compliance Guidelines for Cooling Heat-Treated Meat and Poultry
Products (Stabilization); (2) a scientific article from a peer-reviewed
journal; (3) a challenge or inoculated pack study that is designed to
determine the lethality or stabilization of a process; (4) data
gathered in-house; and (5) regulatory performance standards.
The revised draft guidance recommends that scientific support
contain microbiological data that specifies the level of pathogen
reduction that an intervention for a target pathogen identified in the
hazard analysis will achieve. If this information is not provided,
establishments will need to conduct or provide additional research to
show that either the target pathogen would behave similarly to the
microorganisms studied in the scientific support, or that the
intervention will function as intended.
In-plant support. The revised draft guidance explains that to
conduct an adequate in-plant demonstration, establishments need to
identify the critical operating parameters documented in the scientific
support. The draft guidance stresses that the critical operating
parameters often will be in addition to the critical limit associated
with the critical control points. The document provides that
establishments should implement all of the critical operating
parameters identified in the scientific support.
The draft document has also been revised to remove references the
use of in-plant microbiological testing as a necessary part of the in-
plant demonstration component of the HACCP validation process. Instead,
the revised guidance emphasizes the importance of achieving the
scientifically supported critical operating parameters under in-plant
conditions.
Identifying critical operating parameters. The revised draft
guidance contains a new Appendix, ``Guidance to Identify Critical
Operational Parameters from Supporting Documentation,'' that explains
how establishments can apply journal articles to their own processes
and how to identify in the journal article the essential or critical
operating parameters. FSIS will post information on its Web site on how
to identify critical operating parameters documented in a journal
article. This Web posting will include examples of journal articles
that have been broken down to identify the critical operating
parameters.
FSIS shared the revised draft HACCP validation guidance with the
National Advisory Committee on Meat and Poultry Inspection (NACMPI) at
the committee's public meeting held on September 22-23, 2011. The draft
compliance guidance that the Agency is making available through this
Federal

[[Page 27140]]

Register document reflects recommendations made by the NACMPI HACCP
Systems Validation Sub-Committee. Most of the revisions recommended by
NACMPI were to improve the clarity of the document. For example, in
response to a NACMPI recommendation, the draft compliance guidance now
clearly and concisely describes the distinction between validation and
verification and explains how the establishment's HACCP plan
reassessment fits into the process. The draft guidance reiterates that
the establishment is required to reassess its HACCP plan annually and
whenever changes occur that affect the hazard analysis or HACCP plan (9
CFR 417.2(a)). The draft guidance also makes clear that that to conduct
an effective reassessment, establishments should review the records
generated by the entire HACCP system and analyze these records to
determine how the HACCP system is performing as a whole. Pre-requisite
programs are a critical part of the environment in which HACCP plans
function and are therefore an important part of any HACCP plan
reassessment. FSIS also updated the guidance to include guidance for
validating cooking instructions for ground poultry patties.
The NACMPI report is available on the FSIS Web site at: http://www.fsis.usda.gov/PDF/Validation_Issue_Paper_Final.pdf.
In addition to comments on the draft guidance document, the NACMPI
also made recommendations on FSIS's implementation and verification
activities after the Agency issues final validation guidance. The
NACMPI recommended that FSIS ``phase in'' its activities to ensure that
establishments have appropriately validated HACCP systems by focusing
first on those product categories that present the greatest public
health risk. The NACMPI also recommended that at their next annual
reassessment, existing establishments should be expected to have
determined whether they need to collect additional in-plant data to
complete their validation or whether the data they have collected meet
the validation requirements. FSIS believes that both recommendations
have merit and requests comments on them.
The revised draft guidance document is available for public viewing
in the FSIS docket room and on the FSIS Web site at http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Assistance/index.asp. FSIS again invites comments on the revised guidance
document, as well as on the issues discussed in this Federal Register
document. The Agency will also hold a public meeting to discuss the
revised draft guidance and to solicit additional input on validation
requirements.

Next Steps

After considering the public input and comments it receives on the
revised draft guidance document, FSIS will issue a final guidance
document on HACCP system validation and publish a Federal Register
document to announce its availability. At that time, FSIS will also
announce when Agency personnel will begin to take enforcement actions
if it finds that an establishment has failed to conduct and document
in-plant validation.
Until then, FSIS inspection personnel will continue to issue a
noncompliance record (NR) if an establishment lacks the required
scientific or technical support for its HACCP system, or if the
scientific or technical support is inadequate. FSIS will also continue
to issue an NOIE if, taken together with other relevant findings, an
establishment's scientific or technical support is inadequate, and the
Agency can support a determination that the establishment's HACCP
system is inadequate for any of the reasons provided in 9 CFR 417.6.
FSIS will also continue to conduct Food Safety Assessments (FSAs).
If, when conducting an FSA, an EIAO finds that an establishment has not
completed the in-plant demonstration, the EIAO will note this finding
in the FSA and inform the establishment. Until the enforcement date,
FSIS will not issue NRs or take enforcement actions based solely on a
finding that an establishment lacks in-plant validation data.

Additional Public Notification

Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that
minorities, women, and persons with disabilities are aware of this
document, FSIS will announce it online through the FSIS Web page
located at http://www.fsis.usda.gov/regulations/2012_Notices_Index/.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS' policies, procedures, regulations, Federal
Register notices, public meetings, and other types of information that
could affect or would be of interest to constituents and stakeholders.
The Update is communicated via Listserv, a free electronic mail
subscription service for industry, trade groups, consumer interest
groups, health professionals, and other individuals who have asked to
be included. The Update is also available on the FSIS Web page. Through
the Listserv and Web page, FSIS is able to provide information to a
much broader and more diverse audience. In addition, FSIS offers an
email subscription service which provides automatic and customized
access to selected food safety news and information. This service is
available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Information is available about a variety of topics
including recalls, exports, regulations, directives, and notices.
Customers can add or delete subscriptions themselves, and they have the
option to password protect their accounts.

Done at Washington, DC, on May 1, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-10895 Filed 5-8-12; 8:45 am]
BILLING CODE 3410-DM-P