[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]
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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 public meeting and request for comments.
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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:
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, 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
occur.
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
guidance.
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
document
[[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
instructions).
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
system.
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)
http://www.fsis.usda.gov/PDF/Info_on_Validation_of_Labeled_Cooking_Instructions_Raw_or_Partially_Cooked_Poultry.pdf
(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
system.
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
data.
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
Salmonella.
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
activities.
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
424.21(c)).
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
study.
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
protozoa.
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
guideline.
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
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http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
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,
Administrator.
[FR Doc. 2013-12763 Filed 5-24-13; 8:45 am]
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