[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Proposed Rules]
[Pages 32184-32191]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2013-12763]



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: Notice of public meeting and request for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of updated guidance for Hazard Analysis Critical 
Control Point (HACCP) systems validation. In addition, FSIS is 
announcing that it will hold a public meeting on June 25, 2013, to 
review changes to the guidance announced in this notice and to take 
comments. The public meeting will also be available by teleconference.
    Following the public meeting, the Agency will accept written 
comments until July 25, 2013. Given the extensive opportunity for 
comment on the guidance, however, the Agency believes

[[Page 32185]]

that very few, if any, issues remain in this proceeding.

DATES: The public meeting will be held on June 25, 2013 from 8:30 a.m. 
to 12:30 p.m. On-site registration will begin at 8:00 a.m. Written 
comments may be submitted until July 25, 2013.

ADDRESSES: The public meeting will be held in the 1st Floor Auditorium 
of Patriots Plaza 3, 355 E Street SW., Washington, DC 20024.
    FSIS will finalize the agenda by June 18, 2013 and post it on the 
FSIS Web page at: http://www.fsis.usda.gov/News_&_Events/meetings_&_events/index.asp.
    Registration: Pre-registration is recommended. To pre-register, 
access the FSIS Web site at http://www.fsis.usda.gov/News_&_Events/meetings_&_events/index.asp. Call-in information will be provided via 
email to pre-registered participants. If you are interested in making a 
public comment during the teleconference, please indicate so on the 
registration form.
    In addition to the public meeting, interested persons may submit 
comments using 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 CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture (USDA), FSIS, OPPD, RIMS, Patriots Plaza 3, 
1400 Independence Avenue SW., Mail Stop 3782, Room 8-163A, Washington, 
DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20024.
    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 Avenue 
SW., Patriots Plaza 3, Mailstop 3782, Room 8-142, Washington, DC 20250. 
Telephone: (301) 504-0852 Fax: (202)245-4792. E-Mail: 


    FSIS administers 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, which 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 
    In the May 9, 2012 Federal Register (77 FR 27135), FSIS issued a 
notice to clarify its requirements for validation by an establishment 
of its HACCP system and to announce the availability of the draft 
guidance on validation, which is discussed in more detail below. The 
HACCP regulations in 9 CFR part 417 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)). These regulations 
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)). As FSIS explained in the May 9, 2012 Federal 
Register, 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.
    The regulations also provide that ``[v]alidation . . . 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)). As FSIS explained in the May 9, 2012 Federal Register, 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 establishment's validation records would need to 
include all documents associated with the prerequisite program. Thus, 
validation of the HACCP system involves validation of the critical 
control points in the HACCP plan, as well as of any interventions or 
processes used to support decisions in the hazard analysis.

Initial Draft Guidance

    In March 2010, FSIS posted on its Web site an initial draft 
guidance document to assist the industry, particularly small and very 
small establishments, in complying with the requirements for HACCP 
systems, pursuant to 9 CFR 417.4.
    On June 14, 2010, FSIS held a public meeting to discuss the initial 
draft HACCP validation guidance and received input from stakeholders. 
The transcript of the June 2010 public meeting is available on the FSIS 
Web site at: http://www.fsis.usda.gov/PDF/Transcripts_HACCP_Validation_061410.pdf.
    FSIS received over 2,000 comments on the initial draft guidance, 
particularly with respect to the use of microbiological testing to 
validate the effectiveness of HACCP systems in controlling biological 
hazards. The Agency considered the issues raised by the comments 
received in response to the May 2010 Federal Register notice and at the 
June 2010 public meeting and developed updated second draft compliance 
    On September 22-23, 2011, FSIS shared a second draft of the HACCP 
validation guidance with the National Advisory Committee on Meat and 
Poultry Inspection (NACMPI). The Committee reviewed the draft and 
provided comments and suggestions to FSIS on how to improve the 
guidance. The NACMPI report is available on the FSIS Web site at: 
http://www.fsis.usda.gov/PDF/Validation_Issue_Paper_Final.pdf. The 
Agency made additional revisions to the draft guidance in response to 
the input from NACMPI.
    In a May 9, 2012 Federal Register notice, FSIS announced the 
availability of, and requested comments on, the revised draft guidance 

[[Page 32186]]

(http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2009-0019.htm). In the May 
2012 Federal Register notice, the Agency also clarified its 
requirements for HACCP system validation and responded to the comments 
that it had received on the initial draft guidance. The May 2012 
Federal Register notice explained that the Agency was soliciting 
comments on the revised draft, and that it would hold another public 
meeting before issuing final guidance for HACCP systems validation (77 
FR 27135).

Comments on the Guidance

    FSIS received fifty-one (51) comments on its May 2012 revised draft 
guidance on HACCP validation from small and very small meat or poultry 
processors, trade associations representing animal producers, small 
business owners, corporations, State Departments of Agriculture, and 
consumer advocacy organizations. FSIS has carefully considered the 
comments and has revised its draft guidance in light of these comments. 
The following is a brief summary and discussion of the major issues 
raised in the comments to the draft guidance document.

1. Concerns About Validation, Its Applicability, and Cost

    Comment: Several commenters asked why the validation guidance or 
new FSIS enforcement of validation requirements is necessary, 
especially given the amount of time the HACCP regulations have been in 
place. These commenters stated that establishments should not have to 
``revalidate'' their systems.
    Response: The validation guidance is necessary because the Agency 
found that establishments have not adequately validated their systems. 
During the process of developing the draft guidance, FSIS added an 
appendix to the document that explains the need for validation and 
FSIS's experiences that led it to create the guidance document (e.g., 
FSIS's findings following a 2011 Lebanon bologna outbreak that the 
establishment's scientific support on file did not match the process 
the establishment was using to make the bologna; non-O157 positives in 
2012 that FSIS concluded likely occurred because of improperly designed 
interventions; and the chicken pot pie outbreaks in 2007 that FSIS 
concluded may have occurred because of improperly validated cooking 
    Based on findings from FSIS's data analyses and outbreak 
investigations, the Agency recommends that establishments use the 
guidance document to ensure that their HACCP systems are properly 
validated. On an annual basis, and whenever changes occur that affect 
the hazard analysis of the HACCP plan, the establishment should conduct 
a reassessment as required in 9 CFR 417.4(a)(3) (i.e., review records 
generated over the course of the previous year, or during the period 
the change occurred, that reflect how the HACCP system is performing as 
a whole and analyze them to determine whether food safety goals are 
being met).
    If the reassessment shows that the HACCP system is effective and 
functioning as intended, the establishment can consider continuing on 
with the same system and the same monitoring and verification 
procedures and frequencies. If reassessment shows that either their 
HACCP system was not set up correctly, is not being implemented 
consistently, or is no longer effective, the establishment would make 
changes to its HACCP system (e.g., add another intervention) and then 
would, in most cases, be required to validate any changes to its HACCP 
    While most establishments have assembled the scientific or 
technical documentation needed to support their HACCP systems, many 
establishments have not gathered the necessary in-plant validation data 
demonstrating that their HACCP systems are functioning as intended, 
which is why the guidance document is necessary. As is explained below, 
in approximately six months from the time that FSIS issues the final 
validation guidance, FSIS intends to begin verifying that 
establishments comply with all validation requirements.
    Comment: Several commenters expressed concern about the cost of 
validation, particularly for small establishments that have many 
different HACCP plans. One comment stated that if a very small 
establishment cannot afford to comply with validation requirements, it 
should have the option to return to ``conventional'' inspection instead 
of HACCP. Commenters were also concerned about the costs of obtaining 
in-plant microbial data and other costs associated with validation.
    Response: HACCP was implemented in 1996 and has resulted in great 
improvements in food safety. The Agency is not going back to a command 
and control inspection approach because it would not provide 
establishments with the flexibility to design innovative systems that 
ensure food safety.
    In the guidance, FSIS states that microbiological testing is needed 
for in-plant data in only limited circumstances and has provided low 
cost ways in which establishments can validate their systems in place 
of microbiological testing, such as ensuring that they are meeting the 
critical operating parameters of the interventions as defined in the 
scientific support. Therefore, FSIS estimates that costs associated 
with meeting validation requirements will be minimal.
    Comment: Several commenters stated that establishments should not 
have to validate their prerequisite programs because 9 CFR 417.4(a)(1) 
does not apply to prerequisite programs. One commenter recommended 
that, in the absence of a CCP, prerequisite programs referenced in the 
flow chart should be validated, but that otherwise, establishments 
should not be required to validate their prerequisite programs. The 
same commenter also requested that FSIS begin only reviewing validation 
for CCPs and then, at a later date, begin reviewing validation for 
prerequisite programs referenced in the flow chart. One commenter 
stated that only prerequisite programs that contain scientifically 
supported critical operating parameters (e.g., foreign material 
control, Good Manufacturing Practices, employee hygiene) should have to 
be validated. Several commenters stated that they needed guidance 
concerning how to validate pest control, employee hygiene, sanitation 
practices, and other processes.
    Response: Validation is the process of demonstrating that the HACCP 
system, as designed, can adequately control identified hazards to 
produce a safe, unadulterated product. Prerequisite programs designed 
to support a decision in the hazard analysis are part of the HACCP 
system. When an establishment determines that a hazard is not 
reasonably likely to occur because the prerequisite program prevents 
the hazard, that prerequisite program becomes part of the HACCP system. 
Therefore, prerequisite programs designed to support decisions in the 
hazard analysis (e.g. Sanitation Standard Operating Procedures 
(Sanitation SOPs), purchase specifications, antimicrobial 
interventions) need to be validated to ensure that the overall system 
can operate effectively. Even though 9 CFR 417.4(a)(1) does not refer 
to Sanitation SOPs or other prerequisite programs, establishments' 
initial validation activities need to include employee hygiene and 
other similar prerequisite programs if they are used to support 
decisions in the hazard analysis. As explained in the guidance, in 
order to validate such programs, establishments

[[Page 32187]]

need to provide scientific documentation that supports that they will 
work as intended and to collect in-plant data to support that the 
programs can be implemented as designed.
    Comment: Some commenters stated that establishments should not be 
required to validate cooking instructions because the cooking is 
performed by the consumer. One comment stated that discussion of 
validating the time and temperature combinations for cooking 
instructions should be removed from the guidance. Another commenter 
requested more guidance on how establishments should validate cooking 
instructions. Another commenter asked for confirmation that validated 
cooking instructions are not considered a CCP.
    Response: 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 HACCP plan 
itself or part of a program that includes measures that affect the 
hazard analysis. Thus, if an establishment's HACCP system includes 
cooking instructions as a measure to address a potential food safety 
hazard after entry into the establishment, the establishment must 
properly validate the instructions.
    As we saw in the 2007 salmonellosis outbreak associated with 
chicken pot pies, providing cooking instructions on a package that 
cannot be repeated by the consumer represents an increased risk to the 
consumer. Had the establishment validated the cooking instructions on 
the pot pies to ensure they would achieve the desired endpoint 
temperature under actual consumer cooking conditions, these illnesses 
may have been prevented (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5747a3.htm).
    If an establishment's HACCP system includes placing cooking 
instructions on the product's label, the instructions must be validated 
to ensure that consumers who follow the instructions will achieve the 
endpoint time/temperature needed to ensure that the product is cooked 
and safe to consume. While validated cooking instructions may be used 
as a control to address hazards that may occur after the product has 
left the establishment, the establishment is still required to address 
food safety hazards that are reasonably likely to occur in the 
production process and identify the measures the establishment can 
apply to control those hazards (9 CFR 417.2(a)(1). http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5747a3.htm).
    FSIS is in the process of developing a guidance document on 
validating cooking instructions for mechanically tenderized beef 
product. FSIS has previously recommended validated cooking instructions 
for product that appears to be ready-to-eat, but its meat or poultry 
components have not received a sufficient lethality step or some other 
component has not received a lethality step. http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10240.4/Resource_1.pdf Resource 1 for NRTE 
products that appear to be RTE (e.g., entrees, dinners, casseroles etc) 
(validated cooking instructions) http://www.fsis.usda.gov/PDF/Labeling_Policy_Guidance_Uncooked_Breaded_Boneless_Poultry_Products.pdf (this link includes the background information and Q&As)
    Comment: Several comments stated that establishments should not be 
required to collect in-plant data for more than one product in a HACCP 
process category. These commenters also requested guidance on how to 
select a product from within each HACCP category. Commenters noted that 
such in-plant data would include execution data for all CCPs, 
interventions, and prerequisite programs used to support decisions in 
the hazard analysis. One commenter questioned whether the establishment 
would need to validate the food safety system for each product if the 
only difference among products is a seasoning. Another commenter stated 
that it is possible to have in-plant data for product of one species 
within a HACCP category serve as in-plant data to validate the process 
for product from another species if there are no additional food safety 
concerns. Another commenter stated that FSIS's guidance should follow 
the NACMPI recommendations to group typical products into categories 
and select ``worst case products'' within the group.
    Response: In the revised guidance, FSIS has clarified that 
establishments are not required to collect in-plant data for more than 
one product within a HACCP process category. The guidance now provides 
information concerning how establishments should select a product from 
within a HACCP category. The guidance also provides information on how 
establishments can develop a decision-making document concerning 
product choices for collecting in-plant data. The guidance provides 
examples of how to collect in-plant data to aid industry, but 
establishments will have the flexibility to develop their own criteria.
    Comment: A few commenters requested confirmation that 
establishments would not have to conduct ``initial'' validation for all 
changes that result from reassessment. Several commenters asked whether 
the whole system would need to be validated or just a change following 
reassessment. One commenter stated that improved implementation of a 
HACCP system would not necessarily result in changes to the design of 
the system.
    Response: Establishments do not need to conduct validation of the 
whole system for all changes that result from reassessment. Depending 
on the change, the establishment will likely only need to validate that 
the change is functioning as intended. For example, an establishment 
may change the thickness of a raw patty product and determine that it 
only needs to validate that the cooking instructions still achieve the 
desired endpoint temperature at the new product thickness. In this 
example, the establishment would not need to validate the entire HACCP 
    Comment: Several commenters stated that very small establishments 
that produce products infrequently cannot obtain 13 production days 
worth of records within 90 calendar days. One commenter suggested 
extending the validation period beyond 90 calendar days in order to 
obtain 13 days worth of records. Another commenter requested that the 
guidance document clarify that large establishments have the 
flexibility to determine whether there are a sufficient number of 
production days within the 90 calendar-day period to gather appropriate 
    Response: The guidance explains that for large establishments, 90 
calendar days equates to approximately 60 production days. FSIS 
recognizes that many small and very small establishments do not operate 
daily. Therefore, the guidance also states that a minimum level of 
records from 13 production days within those initial 90 calendar days 
should be used to initially validate a small or very small 
establishment's HACCP system. The establishment should consider 
focusing validation activities on the product produced most frequently 
within each HACCP category.
    In the guidance, FSIS recognizes that there are some establishments 
that produce products so infrequently that they would not be able to 
gather records from 13 production days within those 90 initial calendar 
days. If the establishment infrequently produces several products that 
are each part of a separate HACCP category, there is

[[Page 32188]]

inherent risk with the processes if the establishment does not have 
experience in producing them. Therefore, to determine whether the 
system is properly designed and executed, even though the regulations 
provide 90 days for a conditional grant of inspection (9 CFR 304.3(b)), 
an establishment needing more than 90 days can ask the District Office, 
in writing, for additional time to collect at least 13 production days 
of records. The guidance explains that establishments may also consider 
evaluating data collected for products across multiple HACCP categories 
that share some common steps, ingredients, or equipment, to determine 
whether the data together can support its ability to meet critical 
operational parameters.
Scientific Support
    Comment: Appendix A of the final rule, ``Performance Standards for 
the Production of Certain Meat and Poultry Products'' (64 FR 746-748) 
is specific to Salmonella but is often used to support lethality of 
other pathogens, such as E. coli O157:H7 and Lm. Therefore, several 
commenters asked whether establishments could use Appendix A as 
scientific support for process controls for pathogens other than 
    Response: FSIS has revised the validation guidance to clarify that 
during slaughter, in order to be most effective, it is very important 
that interventions have been studied for the pathogen and product pair 
of interest. In addition, FSIS has clarified that for thermal 
processing treatments, Salmonella can be used as an indicator for other 
pathogens of concern. Therefore, Appendix A can be used as scientific 
justification for the process without further support that the results 
apply to other pathogens such as E. coli O157:H7 or Lm.
    Comment: Some commenters questioned whether their scientific 
support must be peer-reviewed. One commenter asked whether a processing 
authority could be an establishment owner with knowledge of the 
process. The commenter also asked if it could use documents that only 
provide a critical limit as scientific support (for example, a 
University publication or a textbook with growth limits of bacteria).
    Response: FSIS has revised the guidance to clarify that the Agency 
recommends peer-reviewed scientific data to support the process used, 
but does not require peer-reviewed data. An establishment may use peer-
reviewed scientific data or information in addition to a scientific 
article from a peer-reviewed journal as scientific support for its 
processes. Such information would include data from a textbook on the 
growth limits of certain pathogens, based on a food product's water 
activity and pH. This information could be used as scientific support 
because information in scientific textbooks has generally been peer-
reviewed. Peer-reviewed scientific data goes through a process of 
evaluation involving qualified individuals within the relevant field 
that ensures the integrity of the data.
    Scientific data that is not peer-reviewed is less reliable than 
peer-reviewed data, because there could be flaws in the science that a 
peer review would have revealed. If an establishment uses scientific 
data that is not peer-reviewed, the establishment may be subject to 
additional scrutiny by Agency personnel performing verification 
    An establishment may rely on a process authority to provide 
necessary scientific support for the establishment's process. As stated 
above, to meet validation requirements, the establishment is required 
to ensure that the scientific data and documentation provided by the 
processing authority supports that the process addresses the identified 
hazards, and meets the expectations for validation requirements.
    Comment: Several commenters stated that the guidance document is 
still too vague in terms of how close the scientific support needs to 
match an actual process. For example, commenters asked whether the 
manufacturer of a grinder would have to be the same as the grinder used 
in a supporting study. Commenters also asked how significant casing 
size differences among the process used and support studies would need 
to be before the support document would no longer apply. Commenters 
stated that parameters are often more controlled during research than 
in-plant, and that it is costly for establishments to measure 
temperature and pounds per square inch.
    Response: In the guidance, FSIS has clarified how scientific 
support should match an actual process. Generally, establishments 
should use the same critical operational parameters as those in the 
support documents. In some circumstances, establishments may be able to 
support using critical operational parameters that are different from 
those in the support documents (e.g., higher concentrations of 
antimicrobials or higher thermal processing temperatures). In these 
cases, establishments should provide justification supporting that the 
levels chosen are at least as effective as those in the support 
documents. This justification is needed because higher levels of a 
critical operational parameter may not always be equally effective. For 
example, antimicrobial agents may only be effective within a range of 
concentration after which point efficacy may decrease. Similarly, 
higher processing temperatures may result in the surface of the product 
drying out before adequate lethality is achieved. Establishments also 
need to ensure the levels are safe and suitable (http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/7120.1.pdf and 9 CFR 
    Comment: Several commenters stated that FSIS Notice 36-12 (http://www.fsis.usda.gov/oppde/rdad/FSISNotices/36-12.pdf) suggested that the 
challenge study establishments used in the case of the Lebanon bologna 
would not be adequate support because the critical operational 
parameters in the study did not match those used in the establishment.
    Response: The FSIS notice on Lebanon bologna explained that the 
actual process that the establishment used did not match the scientific 
support. As a result, the establishment's process did not achieve 
adequate lethality. Establishments producing Lebanon bologna can use 
the guidance as scientific support; however, they need to ensure that 
their process meets the critical operating parameters used in the 
    FSIS recognizes that scientific support performed in a laboratory 
may not always match an establishment's exact parameters. However, 
significant differences, such as the permeability of the casing used or 
the diameter of the product, are key factors that affect lethality and 
therefore cannot be overlooked. For instance, if an establishment wants 
to use a permeable casing, the establishment cannot assume that its 
process will achieve the same reduction in pathogens as achieved in a 
study using an impermeable casing.
    Comment: Some comments stated that discussion of critical 
operational parameters in the guidance will lead some to conclude that 
all parameters are critical. Several commenters requested that FSIS 
create a third party or consortium to help establishments identify 
scientific support and critical operational parameters. Another 
commenter requested that FSIS's guidance address validation and 
scientific support for additional hazards, such as viruses and 
    Several commenters stated that establishments do not have the 
expertise to scientifically support or identify critical operational 
parameters. One commenter stated that establishments

[[Page 32189]]

do not know how to test parameters of the different processes.
    Response: Critical operational parameters are the specific 
conditions that the intervention must operate under in order for it to 
be effective. The guidance document explains in detail how an 
establishment can identify the critical operational parameters in its 
scientific support. Specifically, Appendix 3, provides step-by-step 
guidance to establishments.
    FSIS will continue to post commonly cited journal articles on its 
Web site in which critical operational parameters have been identified 
and will offer support through askFSIS to establishments trying to 
identify critical operational parameters.
    Comment: One commenter requested that reference to Purac's modeling 
program be made within the guidance, and that the guidance address the 
use of pathogen modeling programs as scientific supporting 
documentation. The commenter also requested an additional example in 
the guidance to show how an establishment could validate the 
effectiveness of an antimicrobial agent through pathogen modeling.
    Response: FSIS has added a reference to pathogen modeling as a type 
of scientific support. In addition, FSIS has added an example in 
Appendix 3 to show how an establishment can validate its stabilization 
process through pathogen modeling. FSIS does not advocate certain 
programs and therefore did not cite Purac in the guidance.
    Comment: One commenter requested a listing of surrogate or 
indicator organisms that can be used for validation. Another commenter 
requested clarification on when establishments can use scientific 
support based on indicator organisms.
    Response: As explained in the guidance document, establishments 
should not rely on scientific support containing data from indicator or 
surrogate organisms unless available data establishes a relationship 
between the presence or level of a pathogen or toxin and the indicator 
organism. Such data can be collected from in-laboratory studies using 
indicator organisms that parallel the data in a challenge study 
performed with the inoculated pathogen. This data could be collected in 
the same way in which the pathogen is being tested or in another study 
performed under similar conditions. If similar and consistent reduction 
or control can be established, then control of the indicator organisms 
can be reliably used to indicate expected pathogen control in actual 
application in-plant.

2. Validation Worksheet Examples

    Comment: One commenter stated that FSIS should include an 
explanation of how the validation worksheet examples can be used. 
Another commenter recommended that the guidance state that 
establishments have flexibility to utilize approaches other than those 
in the worksheet examples. Two commenters recommended that FSIS 
recognize in the guidance that not all critical operational parameters 
identified in the Appendix will apply to all processes.
    Another commenter requested more detail be provided in the 
worksheet examples in terms of formatting and the types of data that 
establishments should collect.
    One comment stated that establishments' environmental monitoring 
verifies that the Sanitation SOPs are working as intended, but does not 
validate them.
    Response: In the guidance document, FSIS has added numerous 
validation worksheet examples to illustrate how an establishment may 
want to display its own in-plant validation data. As FSIS explains in 
the guidance, the validation worksheet examples are for illustration 
purposes only and are included to help establishments to understand the 
types of scientific support and in-plant documentation that are needed 
to comply with the validation requirements.
    With regard to the comment on the Sanitation SOP monitoring, FSIS 
included this data in the guidance as an example of data collected 
during the initial 90 days of the set-up of a new program. Scientific 
support is needed to support the frequency of testing (which would 
address the factors used to determine the frequency). In-plant 
validation data is needed to support that the testing is adequate.

3. Microbiological Testing

    Comment: One comment asked for clarification as to whether samples 
need to be collected for each and every process, product, or species, 
and whether establishments would need to collect 13 samples for every 
product produced, as in the regulations that require establishments to 
conduct testing for generic E. coli (9 CFR 310.25 and 381.94)
    Response: If an establishment's scientific support contains 
microbiological data showing the efficacy of the intervention against 
the identified food safety hazard, then the in-plant data does not need 
to include sampling. In that case, the in-plant data should support 
that the establishment follows the critical operational parameters from 
the study.
Agency Training and Implementation
    Comment: Commenters stated that FSIS should ensure that inspection 
program personnel consistently verify and enforce validation 
requirements. One commenter stated that FSIS should share training for 
FSIS personnel with industry.
    A commenter also recommended that FSIS hold regional sessions to 
communicate the policy to establishments, and that the Agency engage 
cooperative extension programs in its communication strategy. One 
commenter recommended that the Agency create a tutorial on 
understanding scientific articles and on identifying critical 
operational parameters. Commenters also requested that FSIS issue a 
notice or directive explaining how inspectors should use the validation 
    A few commenters requested that FSIS phase-in verification of 
validation requirements based on risk or product categories, rather 
than establishment size. One commenter requested an additional six 
months to gather validation documents before FSIS begins new 
verification activities related to validation.
    Response: The guidance is meant for establishments. FSIS will 
ensure inspection program personnel understand validation requirements 
and will issue necessary instructions to field personnel so that they 
are aware of the final guidance and share it with establishments. FSIS 
will also issue necessary instructions to field personnel for them to 
verify that establishments meet all validation requirements.
    FSIS will implement its new verification activities by phasing them 
in based on establishment size. For large establishments, the agency 
plans to wait approximately six months from the date that the final 
guidance is issued to start verifying and enforcing the second element 
of validation (initial in-plant validation). Thus, large establishments 
will have six months from the date that the final guidance is issued to 
gather all necessary in-plant demonstration documents.
    FSIS intends to begin verifying that small and very small 
establishments meet all validation requirements nine months from the 
date the final guidance is issued. Therefore, these establishments will 
have approximately nine months from the date the final guidance is 
issued to gather all necessary in-plant demonstration documents before 
FSIS will verify and

[[Page 32190]]

enforce the second element of validation.

Other Changes to Validation Guidance

    Examples: The guidance contains additional examples of food safety 
problems linked to inadequate validation and recommendations to aid 
establishments in meeting initial validation requirements. These 
examples demonstrate the need for validation and provide support for 
recommendations made within the guidance.
    Scientific Support Documents. FSIS has added a section to the 
guidance that explains to establishments how to determine whether 
scientific support documents are sufficiently related to the process, 
product, and hazard identified in the hazard analysis to constitute 
appropriate validation. The guidance explains that the supporting 
documentation should identify the hazard (biological, physical, and 
chemical), the expected level of hazard reduction or prevention to be 
achieved, all critical operational parameters or conditions necessary 
to address the hazard, the processing steps that will achieve the 
specified reduction or prevention, and how these processing steps can 
be monitored. FSIS has also included information on how establishments 
can identify supporting documentation that adequately addresses the 
expected level of hazard or reduction or prevention to be achieved. 
FSIS provided examples for biological, physical, and chemical hazards 
that should aid establishments in ensuring that the scientific support 
closely matches the hazard being controlled. FSIS has also clarified 
when establishments may use scientific support containing data from 
indicator or surrogate organisms.
    Critical Operational Parameters. The guidance continues to state 
that critical operational parameters are those necessary for 
interventions to be effective and explains how an establishment can 
identify the critical operational parameters in its scientific support. 
As discussed above in response to comments, establishments generally 
should use the same critical operational parameters as those in the 
support documents. However, in some circumstances, establishments may 
be able to support using critical operational parameters that are 
different from those in the support documents (e.g., higher 
concentrations of antimicrobials or higher thermal processing 
temperatures). In these cases, establishments should provide 
justification supporting that the levels chosen are at least as 
effective as those in the support documents.
    FSIS has added an additional Appendix (Appendix 2) to provide an 
example of a decision-making document an establishment could develop 
when it uses different levels of a critical operational parameter than 
the parameters in the support document. An establishment may use the 
decision-making document to explain the scientific rationale for why it 
is using critical operational parameters that are different from those 
in the support documents.
    In-plant data. The guidance recommends that establishments collect 
in-plant validation data for a wide variety of products and worst case 
scenarios. Appendix 4 of the guidance contains validation worksheet 
examples that establishments may reference to help them understand the 
types of scientific support and in-plant documentation that are needed 
to comply with the validation requirements.
    Initial validation vs. on-going verification. The guidance explains 
the differences between initial validation and on-going verification 
and the relationship between the activities performed to provide 
initial validation as opposed to on-going verification. The revised 
guidance also clarifies when changes that result from reassessment 
would not require validation. For example, an establishment may need to 
reassess its HACCP system following a change in supplier of a raw 
material, but the change would not require validation if the 
establishment determines that the composition of the raw material and 
microbiological profile are not significantly different from the 
material provided by the previous supplier. In other cases, changes 
that result from the reassessment would not require additional 
scientific support but would require additional in-plant demonstration 
data. For example, an establishment may find through reassessment that 
the design of an intervention was adequate, but that its employees are 
not implementing the intervention correctly. In that case, the 
establishment would only need to collect in-plant data to demonstrate 
that the intervention could be implemented appropriately. Depending on 
the change, the establishment would likely only need to validate that 
the change is functioning as intended and not the entire HACCP system. 
The current draft of the compliance guide is available for public 
viewing in the FSIS docket room and on the FSIS Web site at http://www.fsis.usda.gov/Significant_Guidance/index.asp.

Public Meeting

    On June 25, 2013, the Agency will hold a public meeting to review 
the information presented in this document and accept comments.

Next Steps

    Following the public meeting, the Agency will accept public comment 
for 30 days. Given the extensive opportunity for public comment on the 
compliance guide, it is likely that there are very few, if any, 
remaining issues. Therefore, FSIS does not foresee granting an 
extension to this final 30 day comment period. As soon as possible 
after the comment period ends, the Agency will issue a Federal Register 
notice announcing the final guidance and will post the final guidance 
to its Web page. FSIS will implement its new verification activities 
phased in by establishment size. As stated above, for large 
establishments, the Agency plans to delay verification of the second 
element of validation as part of its inspection activities for 
approximately six months from the date the final guidance is posted. 
For small and very small establishments, the Agency plans to delay 
implementation for approximately nine months from the date the final 
guidance is posted.
    Until FSIS begins enforcing all validation requirements, FSIS 
inspection personnel will continue to issue noncompliance records (NRs) 
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 continue to issue a Notice of Intended 
Enforcement 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.
    Moreover, if, in conducting a Food Safety Assessment (FSA), an 
Enforcement, Investigations, and Analysis Officer (EIAO) finds that an 
establishment has not collected in-plant data to demonstrate that its 
HACCP process works as intended, the EIAO will note this finding in the 
FSA and inform the establishment. Until FSIS begins enforcing the in-
plant data requirements, 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

    FSIS will announce this notice online through the FSIS Web page 
located at

[[Page 32191]]

    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, FSIS 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. In addition, FSIS offers an electronic mail 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_&_Events/Email_Subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

USDA Nondiscrimination Statement

    USDA prohibits discrimination in all its programs and activities on 
the basis of race, color, national origin, gender, religion, age, 
disability, political beliefs, sexual orientation, and marital or 
family status. (Not all prohibited bases apply to all programs.) 
Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, or 
audiotape.) should contact USDA's Target Center at (202) 720-2600 
(voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

    Done at Washington, DC on May 23, 2013.
Alfred V. Almanza,
[FR Doc. 2013-12763 Filed 5-24-13; 8:45 am]