[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Rules and Regulations]
[Pages 27557-27563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11581]



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Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Rules 
and Regulations

[[Page 27557]]



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: Notice of availability.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of the final revision of the Compliance Guideline for 
Hazard Analysis Critical Control Point (HACCP) systems validation and 
responding to comments received on the draft guide that FSIS published 
in May 2013 in the Federal Register. In addition, FSIS is announcing 
its plans to verify that establishments meet all validation 
requirements.

DATES: Establishments may start using the new guidance now. FSIS will 
begin verifying that large establishments meet all validation 
requirements on January 4, 2016. FSIS will begin verifying that small 
and very small establishments meet all verification requirements on 
April 4, 2016.

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. Email: 
william.shaw@fsis.usda.gov.

Background

    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, 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 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 that establishments ``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)). 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 
establishment is to maintain the initial validation records for the 
life of the HACCP system to meet the requirements of 9 CFR 417.5(a)(1) 
and 9 CFR 417.5(a)(2).
    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)). Because the results obtained under prerequisite 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)). 
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.

History of Validation 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/wps/wcm/connect/2708ef10-4996-4324-a2e2-3b6501ac81b1/Transcripts_HACCP_Validation_061410.pdf?MOD=AJPERES.
    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 an updated second draft of the 
compliance guidance.
    On September 22-23, 2011, FSIS shared the second draft of the HACCP 
validation guidance with the National Advisory Committee on Meat and 
Poultry Inspection (NACMPI). NACMPI 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/wps/wcm/connect/c87523dc-44d4-446e-be03-a3e60b2f8e8f/Validation_Issue_Paper_Final.pdf?MOD=AJPERES. The Agency made 
additional revisions to the draft guidance in response to the input 
from NACMPI.
    In a May 9, 2012, Federal Register notice (77 FR 27135), FSIS 
announced the availability of, and requested comments on, the revised 
draft guidance document (http://www.fsis.usda.gov/wps/wcm/connect/d000cb67-23bc-4303-8f7b-71dcba5e7cd7/2009-0019.pdf?MOD=AJPERES). In the 
May 2012 Federal Register notice, the Agency also clarified its 
requirements

[[Page 27558]]

for HACCP system validation and responded to the comments that it had 
received on the initial draft guidance. FSIS received fifty-one (51) 
comments on its May 2012 revised draft guidance.
    FSIS carefully considered the comments and, in a May 2013 Federal 
Register notice (78 FR 32186; May 29, 2013), announced a further 
revised draft guidance document. In addition to responding to comments 
and publishing the newly revised draft, FSIS also announced a final 
public meeting, which was held on June 25, 2013. The transcript of the 
June 2013 public meeting is available on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/d618094d-20f2-40a3-9103-a587b2fd8a01/Transcript-HACCP-Validation-062513.pdf?MOD=AJPERES.

Final Guidance

    The final guidance is posted at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. FSIS 
encourages establishments to use the guidance to assist them in 
complying with validation requirements. This guide represents FSIS's 
thinking and has been updated based on the most recent comments 
discussed below. FSIS will update it as necessary in the future.
    In response to the comments discussed below, the Agency made 
several improvements to the final guidance to clarify scientific 
support and in-plant data requirements. In addition to adding a 
description of expert advice from a processing authority as an example 
of an acceptable type of scientific support, the guidance now also 
provides information on how to design challenge studies and on types of 
microbiological data that should be included in the scientific support. 
FSIS has also included a new section in the guidance on the types of 
scientific support that could be used to validate prerequisite programs 
and a description of best practice guidelines that may be used as 
scientific or technical support. FSIS has provided additional 
information on how establishments should address situations where their 
scientific support does not include measurements of all critical 
operational parameters. The guidance also clarifies the type of in-
plant data that establishments should collect to validate that a new 
technology addresses hazards as intended. In addition, FSIS has added 
information on how establishments should validate that a prerequisite 
program works across multiple points or steps in the process. Finally, 
the guidance now contains an additional example of scientific support 
and in-plant data that can be used to validate storage temperature 
prerequisite programs.
    Response to Comments:
    FSIS received twenty-one (21) comments on its May 2013 revised 
draft guidance on HACCP validation from small and very small meat or 
poultry processors, trade associations, corporations, a consumer 
advocacy organization, a professional organization, and an individual. 
The following summarizes and responds to the major issues raised in the 
comments to the most recent draft guidance document.

1. Concerns about Validation, Its Applicability, and Cost

    Comment: A few commenters questioned the need for, and purpose of, 
the HACCP validation guidance, and several others sought additional 
information about what FSIS hopes to achieve by publishing the 
guidance. One commenter requested that, on an ongoing basis, FSIS 
provide examples of inadequate validation.
    Response: As addressed in response to comments in the May, 2013 
Federal Register notice (78 FR 32186), the validation guidance is 
necessary because the Agency has found that establishments have not 
adequately validated their systems. For example, following a 2011 
foodborne illness outbreak involving Lebanon bologna, FSIS found that 
the establishment's scientific support on file did not match the 
process the establishment was using to make the bologna. In 2012, FSIS 
concluded that E. coli (non-O157) positives likely occurred because of 
improperly designed interventions. Similarly, FSIS determined that an 
outbreak involving chicken pot pies in 2007 and a 2011 outbreak from 
turkey burgers may have occurred because of improperly validated 
cooking instructions.
    FSIS developed the guidelines particularly to help small and very 
small establishments comply with the regulatory requirements for 
validation. By periodically updating the guidance document, FSIS will 
continue to share, and explain how to address, examples of inadequate 
validation that are associated with food safety problems.
    Comment: Many commenters stated that cost of validation is high. 
One commenter said that the cost of validation may discourage meat 
establishments from implementing new food safety strategies or 
interventions.
    Response: Validation requirements are not new. FSIS estimates that 
costs associated with any new validation activities will be minimal. As 
addressed previously in response to comments and in previous versions 
of the guidance, microbiological testing is only necessary for in-plant 
data in limited circumstances, and FSIS has provided low cost ways that 
establishments can validate their systems in place of microbiological 
testing. FSIS expects that many establishments will be able to gather 
the necessary in-plant data from HACCP records already routinely being 
generated as part of the HACCP system.
    Comment: A few commenters stated that FSIS is altering the meaning 
of ``validation,'' especially when looking at accepted HACCP validation 
methods from 1996 to today. One commenter asked whether an 
establishment could choose ``conventional'' command and control 
inspection instead of meeting HACCP requirements, including validation 
requirements, if the establishment has a history of producing a safe 
product.
    Response: The final version of the guidance document is consistent 
with the principles of validation as outlined in the 1996 Pathogen 
Reduction; Hazard Analysis and Critical Control Point Systems Final 
Rule (HACCP Final Rule). The HACCP Final Rule stated that data 
assembled to validate a HACCP plan are usually of two types: (1) 
theoretical principles, expert advice from processing authorities, 
scientific data, or other information demonstrating that particular 
process control measures can adequately address specified hazards (such 
as studies establishing the temperatures necessary to kill organisms of 
concern); and (2) in-plant observations, measurements, test results, or 
other information demonstrating that the control measures, as written 
into a HACCP plan, can be implemented within a particular establishment 
to achieve the intended food safety objective. FSIS recognizes that 
there has been misunderstanding related to the principles of 
validation, which is why the Agency has developed this compliance 
guideline and will be issuing instructions to the field once 
establishments have been given the time to assemble the necessary 
documentation.
    As explained in the May 2013 Federal Register notice, the HACCP 
Final Rule has resulted in great improvements in food safety. The 
Agency is not going back to a command and control inspection approach 
because it does not provide establishments with the flexibility to 
design innovative systems and puts the responsibility for ensuring food 
safety on FSIS as opposed to the establishment.
    Comment: One commenter recommended that the guidance clarify

[[Page 27559]]

that establishments need to validate that prerequisite programs work as 
intended in the overall HACCP system to prevent hazards from occurring. 
The commenter said that the guidance should discuss validation of 
prerequisite programs as a complete system, where those controls are 
intended to support a conclusion that a hazard is not reasonably likely 
to occur.
    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, as the commenter recommended, establishments need to 
validate prerequisite programs designed to support decisions in the 
hazard analysis (e.g. Sanitation Standard Operating Procedures, 
purchase specifications, antimicrobial interventions) to ensure that 
the overall system can operate effectively. FSIS agrees that HACCP 
systems are generally designed to provide multiple hurdles of control. 
However, establishments should be able to support that each hurdle 
provides some level of prevention or control for the identified 
hazards.
    As explained in the guidance, in order to validate such programs, 
establishments need to provide scientific documentation that supports 
that the programs will work as intended and to collect in-plant data to 
support that the programs can be implemented as designed. FSIS has 
revised the guidance to provide more examples related to validation of 
prerequisite programs.
    Comment: Several commenters stated that some small establishments 
produce products so infrequently that they may not be able to obtain 13 
production days' worth of records within 90 calendar days. One 
commenter said that FSIS should ensure that establishments are afforded 
sufficient flexibility to tailor their HACCP systems to their specific 
circumstances and questioned the need for a mandatory, fixed validation 
period. One commenter asked for additional instruction on the 
information to include with a request to the District Office for 
additional time to collect in-plant data (e.g., longer than 90 days). 
Another commenter requested clarification regarding whether the request 
for an extension to obtain records necessary for validation applies 
only to establishments under a conditional grant, or if it applies to 
all establishments.
    Response: The regulations provide that the initial validation 
period is 90 calendar days (9 CFR 304.3(b) and (c) and 381.22(b) and 
(c)). Ninety days is the period whether a new establishment is 
operating under a conditional grant, or an existing establishment 
begins producing new product. Under either situation, for the first 90 
days, establishments validate that their system is working as intended 
to address hazards. For large establishments, 90 calendar days equates 
to approximately 60 production days. (See FSIS Directive 5220.1 and 78 
FR 32187.) 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. This number is 
consistent with FSIS Directive 5220.1 related to an establishment's 
initial validation. The Agency is recommending small and very small 
establishments review data from as few as 13 production days because it 
recognizes that collecting 60 production days' worth of records may be 
burdensome to small and very small plants.
    If the establishment infrequently produces several products that 
are each part of a separate HACCP category, there is 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 
initial validation, 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 when it first starts operating, 
when it begins producing new product, or for a modified HACCP plan if 
the results of a reassessment indicate additional support is needed. In 
the request, an establishment should state why more than 90 days are 
needed to collect the in-plant validation data, and how it plans to 
gather at least 13 production days worth of in-plant validation data 
within the next 30 calendar days. The request will then be evaluated on 
a case by case basis. The establishment should consider focusing 
validation activities on the product produced most frequently within 
each HACCP category. In addition, the establishment may consider 
evaluating data collected for products across multiple HACCP categories 
to determine whether the data together can support its ability to meet 
critical operational parameters.
    Small and very small establishments that do not currently have the 
necessary in-plant demonstration data will have until April 4, 2016 to 
collect the necessary documentation. Infrequent producers should be 
able to collect data from 13 production days over this time-frame.
    Comment: One commenter questioned whether small plants receiving 
boxed beef components will be required to validate how their multiple 
processes will address contamination introduced to the product before 
arriving at the establishment.
    Response: All establishments are required to validate that their 
food safety systems address hazards. There is no one, absolute way in 
which an establishment producing raw non-intact beef components is to 
control or prevent Shiga-toxin producing Escherichia coli (STEC) 
organisms in the product. An establishment may have Critical Control 
Points (CCPs) in its HACCP plan to control the hazard, may use its 
Sanitation Standard Operating Procedures or another prerequisite 
program to prevent the hazard, or may use a combination of these 
mechanisms. Establishments receiving product for grinding may have 
purchase specifications requiring that all their suppliers have one or 
more CCPs validated to eliminate or to reduce STEC organisms below 
detectable levels. Establishments, as part of their purchase 
specifications, may also receive certificates of analysis with each lot 
of raw beef components stating that the product has been tested and is 
negative for STEC organisms. In order to validate such pre-requisite 
programs, establishments need to provide scientific documentation that 
supports that the programs will work as intended and to collect in-
plant data to support that the programs can be implemented as designed. 
In the guidance, the validation worksheets include an example of the 
types of scientific support and in-plant data that can be used to 
validate a prerequisite supplier program that is designed to prevent 
the hazard from E. coli O157:H7 in raw ground beef or beef trim from 
being reasonably likely to occur.
In-Plant Data
    Comment: Two commenters stated that the Agency is trying to mandate 
testing through enforcing validation requirements.

[[Page 27560]]

    Response: As addressed in the May, 2013 Federal Register notice (78 
FR 32189) and previous drafts of the guidance, microbiological testing 
is needed for in-plant data in only limited circumstances where the 
scientific support is inadequate. FSIS will not require establishments 
to gather in-plant data before and after the application of an 
intervention if the establishment has adequate scientific supporting 
documentation, is following the parameters in the scientific support, 
and can demonstrate that it can meet the critical parameters during 
operation.
Scientific Support
    Comment: One commenter stated that an establishment lacking 
experience with a new technology should not have to collect additional 
scientific support for its process and should be able to rely on 
existing scientific support and in-plant data.
    Response: The current version of the guidance clarifies that an 
establishment introducing a new technology not established in the 
literature or applying a standard technology in an unusual way (e.g., 
modifying critical operational parameters from the literature) should 
gather scientific support and in-plant validation for its new or 
modified HACCP system under commercial operating conditions. It also 
clarifies that an establishment that lacks experience with a new 
technology should also gather scientific and in-plant validation data 
with the exception of when the effectiveness of the new technology has 
already been studied, but the establishment lacks experience 
implementing the technology. In this case, the effort to develop such 
information may focus more on the collection on in-plant validation 
data.
    Comment: Many commenters stated that there will always be 
differences between scientific studies and actual establishment 
processes, and that critical operational parameters implemented in 
actual processes may be missing from or different than those in the 
supporting scientific studies. Some commenters were also worried that 
it may be costly to conduct the necessary scientific research on the 
specific process used in the establishment. One commenter also said 
that the fact that the guidance states that ``equipment'' is a critical 
operational parameter may lead some establishment personnel, as well as 
FSIS inspection personnel, to assume that the equipment must be exactly 
the same (e.g., same manufacturer or model number) as that used in the 
scientific study. Another commenter asked whether establishments are 
required to validate each piece of equipment. One commenter also 
requested the Agency define ``process authority'' and state when 
information from a processing authority would be acceptable scientific 
support.
    Response: As explained in the current and previous versions of the 
guideline, critical operational parameters are the specific conditions 
that the intervention must operate under in order for it to be 
effective. Therefore, if the critical operational parameters 
implemented in the actual process are consistent with those in the 
supporting documentation, then establishments can expect to achieve 
similar results as those found in the scientific support. FSIS has 
identified a number of cases where differences in critical operational 
parameters between an establishment's scientific support and those 
implemented in the actual process led to food safety problems. For this 
reason, it is important that the establishment's actual process follow 
the critical operational parameters in its scientific support.
    FSIS recognizes that there may be cases where levels of a critical 
operational parameter in the scientific support may not match the level 
used in the actual process but is still effective. In those cases, as 
stated in the guidance, to document its scientific support the 
establishment should document its scientific rationale for determining 
that a different level would not affect the efficacy of the 
intervention or process. Such a justification can be provided by a 
process authority. However, as recommended in the guideline, the 
justification should include reference to peer-reviewed scientific data 
and should not rely on the processing authority's expert opinion alone 
to ensure that the decision is science based. If the establishment does 
not have a scientifically based rationale for why the different level 
would not affect the efficacy of the intervention or process, then the 
establishment would need to gather additional data.
    When an establishment uses critical operational parameters from 
multiple studies together in the same process, the establishment will 
need to support that the new combination of parameters would be as 
effective as those studied in the individual articles. An establishment 
will also need additional support if its documentation does not contain 
measurement of a critical operational parameter. For example, humidity 
is known to be a critical operational parameter during cooking. If an 
establishment's support for a heat treatment does not address humidity, 
the establishment will need to document why this parameter is not 
critical for that treatment. If no scientific justification can be 
provided, then the establishment will likely need additional data to 
support the undocumented process.
    The guidance continues to state that equipment is a critical 
operational parameter because the correct equipment is necessary to 
achieve other critical operational parameters within the process. Based 
on the comments, FSIS has clarified in the revised guidance that the 
equipment is a critical operational parameter in situations when using 
completely different equipment (e.g., a manual spray pump vs. a spray 
cabinet or a commercial smokehouse vs. a home-style dehydrator) would 
not achieve the critical parameters of the study (such as temperature, 
pressure, duration, volume, relative humidity). In most cases, the same 
equipment produced under a different model number or by a different 
manufacturer (e.g., a spray cabinet or smokehouse produced by a 
different manufacturer than that reported in the scientific support) 
should not affect the establishment's ability to meet other critical 
operational parameters such as temperature or pressure.
    Comment: One commenter asked whether Agency personnel would accept 
many commonly used supporting documents (e.g. Appendix A of the 
Compliance Guidelines For Meeting Lethality Performance Standards For 
Certain Meat And Poultry Products) as scientific support for validating 
the establishment's process.
    Response: Establishments may continue to use Appendix A as 
scientific support to validate that their food safety system 
effectively addresses hazards. FSIS included a Q&A in the previous and 
current versions of the guidance that addresses this concern. 
Specifically, the guidance reads, ``Question: If I use Appendix A as 
the scientific support documentation for a fully cooked RTE process, do 
I need additional scientific information? Answer: No, Appendix A has 
been validated to achieve the performance standards for the reduction 
of Salmonella contained in 9 CFR 318.17(a)(1) and 381.150(a)(1). 
Therefore, provided all critical operational parameters can be met, no 
additional support is needed.'' FSIS has and will continue to instruct 
inspection program personnel (IPP) and Enforcement, Investigation, and 
Analysis Officers (EIAOs) that FSIS guidance documents are a type of 
scientific support that may be used by

[[Page 27561]]

establishments to meet the first element of validation.
    Comment: One commenter questioned how an establishment could relate 
the effectiveness of a food safety strategy to a specific pathogen and 
adhere to the process that actually occurs in the plant, if pathogens 
cannot be introduced into the establishment. The commenter references a 
2002 guidance document titled ``Guidance for Minimizing the Risk of 
Escherichia coli O157H:7 and Salmonella in Beef Slaughter Operations'' 
(http://www.fsis.usda.gov/wps/wcm/connect/74de2bea-74d6-491b-b2cf-0047650bf0c6/BeefSlauterGuide.pdf?MOD=AJPERES) and a discussion in the 
guidance document regarding indicator testing. Another commenter stated 
that the following statement may prevent innovation when scientific 
support is not readily available: ``[i]n general, establishments should 
not rely on scientific support containing data only from indicator or 
surrogate organisms unless there is sufficient data to establish a 
relationship between the presence or level of a pathogen or toxin and 
the indicator organism.'' The commenter said that indicator or 
surrogate organisms can be used in-plant, provided there is data to 
establish a relationship between the two.
    Response: The previous and current versions of the validation 
guidance document address the use of indicator organisms during in-
plant validation studies (page 14). FSIS agrees that an establishment 
may use an indicator or surrogate organism to validate a process in-
plant, provided there is data to establish a relationship between the 
indicator or surrogate and pathogen. This fact is stated on page 14 and 
is consistent with the discussion on indicator organisms in the 
``Guidance for Minimizing the Risk of Escherichia coli O157H:7 and 
Salmonella in Beef Slaughter Operations.'' FSIS does not agree that the 
guidance will prevent innovation and is unclear why the commenter feels 
it will prevent innovation.
    Comment: Several commenters suggested that a consortium to identify 
critical operational parameters would be useful. Commenters also 
requested that FSIS provide a reference guide, pointing establishments 
to scientific documents and guidance on support for monitoring 
frequencies of CCPs be provided. One commenter asked where small and 
very small plant owners should get assistance with validating their 
HACCP plans and asked whether, and to what extent, the Agency's small 
plant office will give guidance to plant operators.
    Response: FSIS has several resources available to assist 
establishments with identifying critical operational parameters from 
scientific support documents including the askFSIS system and the small 
plant help desk. FSIS has also identified HACCP contacts and 
coordinators on its Web site that provide technical advice, assistance, 
and resources and that conduct activities to support HACCP 
implementation in small and very small plants.
    Comment: Two commenters stated that the guidance that 
establishments validate at least one product per HACCP category was not 
helpful. One of the commenters said that the Agency is instructing the 
meat industry to conduct its own individualized risk assessment of the 
products produced and to make the appropriate determination without any 
guidance from the Agency. The other commenter predicted that Agency 
personnel will not accept in-plant data for one product within each 
HACCP category as sufficient to validate the food safety system.
    Response: The guidance explains how to properly validate by 
identifying at least one product per HACCP category for which the 
establishment collects in-plant data. FSIS has provided food science 
principles that can be used to identify the products using a risk-based 
framework. By using such principles establishments can select a product 
most representative of a worst case scenario and therefore collect in-
plant data most protective of public health. FSIS recognized that 
collecting data for more than one product within each HACCP category 
could be burdensome. Therefore, the Agency requested input from NACMPI, 
and the committee agreed with this approach.
    Comment: A few commenters requested that the Agency include 
examples of processes that may use Appendix A and Appendix B as 
scientific support for validating their food safety system, since these 
Agency documents are commonly utilized as scientific support.
    Response: FSIS added examples of processes that can use Appendix A 
or B as scientific support in the May 2013 guidance. Examples are 
provided on pages 60 and 63 for processes using Appendix A and Appendix 
B as scientific support.
Examples
    Comment: One commenter asked why the roast beef example in the 
validation worksheet (that used Appendix A as the scientific support) 
did not identify dwell time.
    Response: The example using Appendix A on page 63 does include a 
dwell time of 112 minutes.
    Comment: One commenter recommended that the worksheet examples be 
more specific in terms of the type of data that should be collected.
    Response: The guidance provides additional examples of the types of 
scientific support and in-plant data that establishments could maintain 
for different products and processes in Appendix 4. As explained in the 
guidance, if an establishment has a specific question regarding the 
type of data that should be collected for its process and product, it 
can submit a question to the askFSIS system.
    Comment: One commenter said that the ongoing verification 
activities that are listed in the example on page 33 are unreasonable. 
Based on a particular example, the commenter also expressed concern 
that FSIS will require establishments to monitor all parameters on an 
ongoing basis. One commenter recommended that FSIS explain that the 
critical operational parameters are related to initial validation, and 
that not all critical operational parameters need to be monitored on an 
ongoing basis.
    Response: The current and previous versions of the guidance 
recognize that researchers may measure a number of parameters during a 
scientific study. However, not all of these are critical to the 
efficacy of the intervention studied. The establishment should document 
and explain any differences in its production process relative to any 
of the studies it used as supporting documentation. The current and 
previous versions of the guideline also state that establishments may 
only need to verify whether some of the critical operational parameters 
are working as intended during the initial validation period (e.g., 
spatial configuration). The Agency does agree that in the cited example 
in the guidance it was unclear (ongoing verification activities on page 
32), and FSIS has better delineated the activities that are conducted 
as part of monitoring vs. ongoing verification in the current guidance.
Agency Training and Implementation
    Comment: Several commenters asked the Agency to identify who is 
going to train all of the FSIS inspectors. The commenters also said 
FSIS needs to ensure consistency in enforcing verification 
requirements. One commenter requested that FSIS issue formal 
instructions to field personnel on verifying that establishments meet 
validation requirements. The

[[Page 27562]]

commenter also recommended that FSIS provide IPP with on-line training.
    Response: FSIS will provide instructions to IPP and EIAOs on how to 
verify validation requirements through FSIS Notices and Directives. The 
Agency also plans to provide necessary training to IPP and EIAOs.
    Comment: One commenter asked that Agency outreach staff conduct 
regional sessions around the country to explain validation requirements 
to industry.
    Response: FSIS will be holding webinars with the industry to 
communicate the recommendations in the final guidance document, clarify 
the regulations, and explain how FSIS will verify that establishments 
use both scientific support and in-plant data to validate that their 
systems, as designed and implemented, are working to address hazards.
    Comment: One commenter said that large establishments should be 
given more than six months to assemble the necessary in-plant 
validation documentation. The commenter stated that not all 
establishments may produce all products under all HACCP plans during 
the six-month period. Another commenter said that small and very small 
plants should be given more than 3 months longer than large plants to 
assemble the necessary documentation.
    Response: FSIS will implement its new verification activities by 
phasing them in based on establishment size. For large establishments, 
the Agency plans to wait until January 4, 2016, to start verifying that 
establishments meet all validation requirements, including maintaining 
in-plant validation data. Thus, large establishments will have 
approximately seven months to gather all necessary in-plant 
demonstration documents. FSIS believes this timeframe is adequate for 
large establishments to gather the necessary documentation because many 
of these establishments will be able to gather in-plant data from HACCP 
records that are already generated as part of the monitoring of 
critical limits or parameters of prerequisite programs. In addition, 
FSIS's implementation will correspond with establishments' annual 
reassessment. As part of the annual reassessment, establishments will 
review the data gathered during initial validation along with other 
documents gathered as part of the implementation of the HACCP system to 
evaluate the adequacy of the HACCP plan.
    FSIS intends to begin verifying that small and very small 
establishments meet all validation requirements beginning on April 4, 
2016. Therefore, these establishments will have approximately ten 
months to gather all necessary in-plant demonstration documents before 
FSIS will verify and enforce the second element of validation.
    Comment: Two commenters asked for information on who was going to 
verify establishments meet validation requirements. These commenters 
asked whether FSIS would ``approve'' establishments' validation 
documentation. One commenter also asked whether the Public Health 
Information System (PHIS) is programmed to have validation checks 
recorded.
    Response: FSIS does not approve an establishment's validation 
records. FSIS verifies compliance with regulatory requirements. IPP, 
including EIAOs, verify that establishments meet validation 
requirements, and FSIS will be providing instructions for performing 
verification for both types of personnel. Inspectors will verify that 
establishments meet validation requirements during performance of the 
Hazard Analysis Verification (HAV) tasks, and EIAOs will do a more in-
depth verification of establishment records to verify that 
establishments meet the validation requirement during food safety 
assessments. All Agency verification activities are documented in the 
PHIS system. Routine verification of validation occurs during 
performance of the HAV task, and findings related to validation are 
documented in PHIS as part of that task.
    Comment: One commenter expressed concern that the validation 
guidance will unnecessarily increase the number of non-compliance 
reports issued by FSIS inspection personnel.
    Response: As explained in the May 2013 Federal Register notice, the 
guidance is meant for establishments and does not set new requirements. 
FSIS will ensure that IPP understand validation requirements and, as 
stated above, 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 and 
training to field personnel for them to verify that establishments meet 
all validation requirements.
Next Steps
    FSIS will implement the new verification activities in a phased 
approach based on establishment size. For large establishments, 
verification of the second element of validation will be delayed until 
January 4, 2016. For small and very small establishments, the Agency 
will delay implementation until April 4, 2016. After establishments 
have had time to collect the necessary in-plant validation data, IPP 
will verify that establishments meet validation requirements during HAV 
tasks, and EIAOs will do a more in-depth verification of establishment 
records to verify that establishments meet validation requirements 
during food safety assessments.
    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, if the scientific or technical support is 
inadequate, or if the establishment's control measures (CCPs or 
prerequisite programs) do not incorporate the parameters described in 
the scientific support, and the establishment does not have data to 
support the technical adequacy of the control measures. 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 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.

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.
How To File a Complaint of Discrimination
    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.

[[Page 27563]]

    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, 
Fax: (202) 690-7442, Email: program.intake@usda.gov.

Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Additional Public Notification
    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this 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 our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, 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/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done at Washington, DC on: May 8, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-11581 Filed 5-13-15; 8:45 am]
BILLING CODE 3410-DM-P