[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Proposed Rules]
[Pages 27135-27140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]]


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comments on, a revised draft guidance document prepared to assist 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 
    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: 



    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 
    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 
    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 

[[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, 

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 
    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 
    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 

[[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 
    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 

    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 
    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 
    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 

[[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 

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,
[FR Doc. 2012-10895 Filed 5-8-12; 8:45 am]