scale public health harm. In the circumstance described by the comment
where a disgruntled employee is recruited by a terrorist organization,
the motivation of the employee has changed from harming the reputation
of the company to that of the terrorist organization intending to cause
wide-scale public health harm. The rule is designed to reduce the
likelihood that such an attack would be successful. Further, the
protections required by the rule would be effective in minimizing the
likelihood of success of a disgruntled employee, consumer, or
competitor who attempts an act of intentional adulteration at an
actionable process step--even if that act of intentional adulteration
is not intended to cause wide-scale public health harm. We continue to
believe that an approach that does not focus on preventing wide-scale
public health harm, but rather attempts to address intentional acts
regardless of their potential severity, would require restricting
access to nearly all points in the food system because these types of
attacks are typically conducted at areas of convenience and could occur
at any point in the food system.
b. Economically Motivated Adulteration
    In the proposed rule, we stated that the goal of the perpetrator of
economically motivated adulteration is for the adulteration to go
undetected so the perpetrator can continue to obtain the desired
economic benefit. Unlike with intentional adulteration, where the
intent is to cause wide scale public health harm through instances such
as acts of terrorism focused on the food supply, occurrences of
economically motivated adulteration are expected to be long term, and
would not be appropriately viewed as a rare occurrence, but rather as
reasonably likely to occur. Because of these reasons, we concluded that
the approaches in the PCHF and PCAF final rules are better suited to
address economically motivated adulteration. We sought comment on our
conclusions.
    We received numerous comments related to economically motivated
adulteration, including comments suggesting economically motivated
adulteration is best addressed in this rule, comments suggesting it is
best addressed in the PCHF and PCAF final rules, comments recommending
different hazard identification methodologies, comments related to
terminology and definitions, and comments requesting postponement of
any economically motivated adulteration-associated requirements.
    We continue to believe that the approaches in the PCHF and PCAF
final rules are better suited to address economically motivated
adulteration, and have finalized this rule with no requirements related
to economically motivated adulteration for facilities covered by those
rules. For further discussion see the PCHF final rule (80 FR 55908 at
56028-56029) and the PCAF final rule (80 FR 56170 at 56243-56246).
    In the proposed rule, we also tentatively decided not to require
produce farms subject to section 419 of the FD&C Act and farms that
produce milk (also referred to in this document as ``dairy farms'')
subject to section 420 of the FD&C Act to take measures to address
economically motivated adulteration. With regard to produce farms, we
tentatively concluded that there are not procedures, processes, or
practices that are reasonably necessary to be implemented by these
entities to prevent the introduction of known or reasonably foreseeable
biological, chemical, or physical hazards that can cause serious
adverse health consequences or death as a result of economically
motivated adulteration. With regard to farms that produce milk, we
tentatively concluded that there are not appropriate science-based
strategies or measures intended to protect against economically
motivated adulteration that can be applied at the farm. Those tentative
conclusions were based on our assessment that preventive controls are
suitable to address economically motivated adulteration when it is
perpetrated by the entity's supplier, but not when it is perpetrated by
the entity itself, and supplier controls are not warranted in this
context because of the lack of inputs into the growing, harvesting,
packing, or holding of produce or milk (i.e., activities within our
farm definition) that could be subject to economically motivated
adulteration that could cause serious adverse health consequences or
death under sections 419 and 420 of the FD&C Act.
    We received one comment suggesting we include requirements related
to economically motivated adulteration on produce farms and stating
that economically motivated adulteration (e.g., illegal use of dyes and
ripening agents) has occurred on foreign produce farms. We continue to
believe that preventive controls are suitable to address economically
motivated adulteration when it is perpetrated by an entity's supplier,
but not by the entity itself. Preventive controls for economically
motivated adulteration are not suitable to address the situation where
the same farm that would be economically adulterating the food (which
is already prohibited) would also be responsible for implementing
preventive controls to prevent the adulteration. After considering this
comment, we have finalized this rule with no requirements related to
economically motivated adulteration on produce and dairy farms.
3. Dairy Farms
    In the proposed rule, we stated that FDA-led vulnerability
assessments and associated data analyses identified certain categories
of points, steps, or

procedures in the food system which scored high on vulnerability scales
related to intentional adulteration of food, regardless of the food
being assessed. Two of these key activity types, liquid storage and
handling, and bulk liquid receiving and loading, are present on dairy
farms in areas such as the bulk liquid storage tank. We requested
comment on several questions, including whether and how access to the
bulk milk storage tank and milk house could be limited; the presence
and types of any mitigation strategies currently used on farms; and
whether and what mitigation strategies would be appropriate and
feasible given current dairy farming practices.
    Some comments acknowledge that limiting access to the bulk milk
tank and milk house is an important objective; however, these comments
describe significant challenges regarding limiting access to milk.
These comments state that some State laws require unannounced access to
the bulk tank and/or the milk house for food safety inspections.
Additionally, comments state that locking only the bulk tank would be
ineffective because this would still leave the milk accessible via the
milk house. These comments also state that it is common for many dairy
farms to leave the bulk tank and the milk house unlocked to facilitate
normal day-to-day operations and that any regulation requiring strictly
limiting access, such as locking the milk house, would be impractical
due to the multiple entry points and the number of personnel needed for
these measures to function effectively. Some comments suggest that FDA
engage in substantial dialogue with industry to gain a better
understanding of current practices and better ascertain the food
defense measures that would be effective and appropriate before issuing
regulations. Some comments state that FDA should utilize existing
programs to identify potential activities to reduce the vulnerability
to intentional adulteration on dairy farms because these programs have
demonstrated efficacy and have the structures in place to successfully
implement new food defense measures.
    Some comments state that FDA should not issue requirements for
dairy farms because they are not at high risk for intentional
adulteration. Some comments describe the willingness of stakeholders to
adopt voluntary food defense measures, with specific examples including
State-led education efforts and adoption of some elements of existing
FDA guidance relating to food defense measures on dairy farms. Some
comments state that any requirements should be limited to food defense
awareness training while other comments state that such training may be
beneficial and is provided on some farms, but more information is
needed to identify effective training programs.
    Additionally, several comments address procedural matters, with
many comments stating that FDA must either allow a full and separate
comment period for any potential requirements for dairy farms because
there were no requirements related to dairy farms in the proposed rule,
or issue a fully separate proposal for dairy farms which will cover the
requirements in their entirety independent of the intentional
adulteration regulations for facilities that are not farms. Some
comments also request that dairy processing facilities be exempt from
the requirements of this rule.
    Although we believe requiring mitigation strategies that restrict
access to milk on dairy farms is warranted based on risk, at this time
there are not strategies that limit access to milk that are appropriate
and practical to require for all farms. We believe it is important that
any mitigation strategies we consider imposing include restricting
access to milk while it is on farms. We agree with comments that state
that potential mitigation strategies, such as locking the milk tank and
milk house, are not currently workable given the realities of milking
schedules and the access to the bulk tank needed for food safety
inspections and milk collection. We need further dialogue with key
stakeholders and collaborative research to develop and identify
strategies that are protective and practical; we are aware of
technology-mediated advancements that are under development, and are
potentially promising for the future in this area. Given the current
lack of mitigation strategies that would practically limit access to
milk, we agree that working with the Federal-State collaborative
program for milk safety, the National Conference on Interstate Milk
Shipments (NCIMS), is the most appropriate way to address concerns
regarding intentional adulteration on dairy farms in the near term as
strategies that can limit access to milk while on farm are developed.
We believe NCIMS offers an effective platform for FDA to advance the
development and implementation of mitigation strategies for dairy farms
because the cooperative program includes key partners, such as the U.S.
Public Health Service/FDA, the States, and the dairy industry, and has
a central role in helping to ensure the safety of milk and milk
products.
    We are not exempting Pasteurized Milk Ordinance (PMO) facilities
that are not farms (e.g., dairy processing facilities) from complying
with this rule. Unlike farms, such facilities have identified effective
mitigation strategies available to them. In addition, PMO requirements
do not currently address intentional adulteration. Further, unlike
farms, these facilities are not exempt from the PCHF rule. We note that
the earliest compliance date for this rule (3 years) is the same as the
extended compliance date in the PCHF rule, which was chosen to give the
NCIMS time to modify the PMO to include the requirements of the PCHF
rule.

IV. Subpart A: Comments on Specific Provisions

A. Revisions to Definitions Also Used in Section 415 Registration
Regulations (21 CFR Part 1, Subpart H) and Section 414 Recordkeeping
Regulations (21 CFR Part 1, Subpart J)

    As discussed in the proposed rule (78 FR 78014 at 78030), several
terms we proposed have the same definitions as proposed in 21 CFR part
117 (the PCHF proposed rule) and therefore we did not include an
extensive discussion in the proposed rule of the following terms:
facility, farm, holding, manufacturing/processing, mixed-type facility,
and packing. We did not receive specific comments on any of our
proposed definitions for these terms, except that many comments state
that it is critical for FDA to cross-reference and be consistent with
the same terms as finalized in the PCHF final rule. We agree and we
have amended each of these terms to be consistent with the definitions
as finalized in the PCHF final rule. See section IV. of the PCHF final
rule for extensive discussion of the comments received and changes made
to these definitions.
1. Facility
    We proposed to define the term ``facility'' to mean a domestic
facility or a foreign facility that is required to register under
section 415 of the FD&C Act (21 U.S.C. 350d), in accordance with the
requirements of 21 CFR part 1, subpart H. We have finalized this term
as proposed, except that we have made editorial changes by removing the
U.S. Code citation and amended the Code of Federal Regulations
citation.
2. Farm
    We proposed to define the term ``farm'' by reference to the
definition of that term in Sec.  1.227 of this chapter. We have
finalized this term as proposed. For a detailed discussion of the
definition of ``farm,'' see sections IV.A and IV.B of the PCHF final
rule.

3. Holding
    We proposed to define the term ``holding'' to mean storage of food.
In addition, we proposed that holding facilities include warehouses,
cold storage facilities, storage silos, grain elevators, and liquid
storage tanks. Further, we proposed that for farms and farm mixed-type
facilities, holding also includes activities traditionally performed by
farms for the safe or effective storage of raw agricultural commodities
grown or raised on the same farm or another farm under the same
ownership, but does not include activities that transform a raw
agricultural commodity (RAC), as defined in section 201(r) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), into a processed
food as defined in section 201(gg). In this final rule, consistent with
the PCHF final rule, we have revised the definition for ``holding'' by
removing the distinction for farms and farm mixed-type facilities and
added that holding also includes activities performed incidental to
storage of a food, but does not include activities that transform a RAC
into a processed food and included additional examples of holding
activities. For a detailed discussion of the definition of ``holding,''
see section IV.D of the PCHF final rule.
4. Manufacturing/Processing
    We proposed to define manufacturing/processing to mean making food
from one or more ingredients, or synthesizing, preparing, treating,
modifying or manipulating food, including food crops or ingredients.
Further, the proposed definition provided that examples of
manufacturing/processing activities are cutting, peeling, trimming,
washing, waxing, eviscerating, rendering, cooking, baking, freezing,
cooling, pasteurizing, homogenizing, mixing, formulating, bottling,
milling, grinding, extracting juice, distilling, labeling, or
packaging. In addition, the proposed definition provided that for farms
and farm mixed-type facilities, manufacturing/processing does not
include activities that are part of harvesting, packing, or holding. In
this final rule, consistent with PCHF final rule, we have revised the
definition of ``manufacturing/processing'' by adding to the list of
examples and we have reorganized the listed examples to present them in
alphabetical order. For a detailed discussion of the definition of
``manufacturing/processing,'' see section IV.E of the PCHF final rule.
5. Mixed-Type Facility
    We proposed to define mixed-type facility to mean an establishment
that engages in both activities that are exempt from registration under
section 415 of the FD&C Act and activities that require the
establishment to be registered. The proposed definition also stated
that an example of such a facility is a ``farm mixed-type facility,''
which is an establishment that grows and harvests crops or raises
animals and may conduct other activities within the farm definition,
but also conducts activities that require the establishment to be
registered. In this final rule, consistent with PCHF final rule and as
a conforming change associated with the revisions to the ``farm''
definition, we have revised the example of a ``farm mixed-type
facility'' to specify that it is an establishment that is a farm, but
also conducts activities outside the farm definition that require the
establishment to be registered. For a detailed discussion of the
definition of ``mixed-type facility,'' see section IV.F of the PCHF
final rule.
6. Packing
    We proposed to define packing to mean placing food into a container
other than packaging the food. Further, the proposed rule provided that
for farms and farm mixed-type facilities, packing also includes
activities traditionally performed by farms to prepare RACs grown or
raised on the same farm or another farm under the same ownership for
storage and transport, but does not include activities that transform a
RAC, as defined in section 201(r) of the FD&C Act, into a processed
food as defined in section 201(gg). In this final rule, consistent with
the PCHF final rule, we have revised the definition for ``packing'' by
removing the distinction for farms and farm mixed-type facilities and
adding that packing includes activities performed incidental to packing
a food, but does not include activities that transform a RAC into a
processed food. We have also revised the definition to clarify that
packing includes ``re-packing.'' For a detailed discussion of the
definition of ``packing,'' see section IV.G of the PCHF final rule.

B. Other Definitions That We Proposed To Establish in Part 121

    To establish the scope of facilities, activities and food covered
by this regulation, we proposed to define key terms. We also proposed
to establish that the definitions in section 201 of the FD&C Act apply
when used in part 121. We received no comments regarding the use of
statutory definitions in section 201 of the FD&C Act, and we are
finalizing that provision without change. In this section, we discuss
each definition as proposed, related comments, and our responses.
1. Actionable Process Step
    We proposed to define the term ``actionable process step'' to mean
a point, step, or procedure in a food process at which food defense
measures can be applied and are essential to prevent or eliminate a
significant vulnerability or reduce such vulnerability to an acceptable
level. Although we did not receive comments on the proposed definition
for actionable process step, we have revised the definition to improve
understanding of the regulatory requirements in Sec.  121.130
(Vulnerability assessment to identify significant vulnerabilities and
actionable process steps) and to be consistent with the definition of
mitigation strategies. In this final rule, actionable process step is
defined to mean a point, step, or procedure in a food process where a
significant vulnerability exists and at which mitigation strategies can
be applied and are essential to significantly minimize or prevent the
significant vulnerability.
2. Contaminant
    We proposed to define the term ``contaminant'' to mean any
biological, chemical, physical or radiological agent that may be
intentionally added to food and that may cause illness, injury or
death.
    (Comment 39) Some comments assert the proposed language defining
``contaminant'' could be interpreted to include ingredients
intentionally added to food that resulted in harm, even if
unintentional, such as an unintended allergic or other adverse health
response. The comments urge FDA to clarify the meaning to be an
``intentional'' contaminant, for the purpose of this rule, by amending
the proposed definition as follows: ``Contaminant means any biological,
chemical, physical or radiological agent added to food to intentionally
cause illness, injury or death.''
    (Response 39) We agree with the possible confusion as pointed out
by the comments and have amended the proposed definition. The term
``contaminant'' is used in the context of intentional acts of
adulteration with intent to cause wide scale public health harm. We
agree that amending the proposed definition for contaminant to make
clear that the harm must be intended better reflects how the term is
used in this rule.

    (Comment 40) One comment asserts the term ``contaminant,'' is used
widely in the food and dietary supplement industries and that if FDA
were to include a definition for this term, it must employ a definition
that is consistent throughout all regulations pertaining to food and
dietary supplements. Further, one comment notes that this term is
defined differently in the proposed rule (i.e., a contaminant is any
agent that may be added to food) than it is in the Codex Alimentarius
guidelines (i.e., contaminants are substances that are ``not
intentionally added to food or feed''). The comment suggests that FDA
take note of this difference and consider revisions with the goal of
promoting consistency and common understanding of terminology.
    (Response 40) As discussed in the proposed rule (78 FR 78014 at
78031), we based the proposed definition, in part, on the definition of
``contaminant'' used in Codex Alimentarius guidelines, but made
modifications to reflect the narrower context that the term is used
within this rule. Further, as discussed in response to Comment 39, we
are amending the definition of ``contaminant'' to better reflect its
limited use in this rule.
3. Focused Mitigation Strategies
    We proposed to define the term ``focused mitigation strategies'' to
mean those risk-based, reasonably appropriate measures that a person
knowledgeable about food defense would employ to significantly minimize
or prevent significant vulnerabilities identified at actionable process
steps, and that are consistent with the current scientific
understanding of food defense at the time of the analysis.
    We explained in the proposed rule that a ``mitigation strategy'' is
a measure taken by a facility to reduce the potential for intentional
adulteration of food. We further explained that FDA divides mitigation
strategies into two types, ``broad mitigation strategies'' and
``focused mitigation strategies.'' We explained that broad mitigation
strategies are general facility-level measures that are intended to
minimize a facility's vulnerability, as a whole, to potential acts of
intentional adulteration. We provided some examples of broad mitigation
strategies, such as (1) physical security, such as perimeter security
fencing, locking exterior doors, penetration alarms; (2) personnel
security, such as pre-hire background and reference checks,
identification badges, and controlled visitor access; (3) securing
hazardous materials, such as cleaning products, laboratory materials,
and pesticides; (4) management practices, such as ingredient storage
inventory procedures; key security procedures, PINs or passwords;
procedures to restrict personal items from all food production areas;
procedures requiring IDs and uniforms to be returned when a person's
employment ends; and supplier verification or certification procedures;
and (5) crisis management planning, such as maintenance of updated
emergency contact information, procedures for responding to reported
threats, and establishment of a designated food defense leadership
team. We further explained that broad mitigation strategies, by nature,
are generally applicable to a facility, regardless of the type of food
being processed, and, as such, are not targeted to a specific
processing step in a food operation.
    In contrast, focused mitigation strategies are specific to an
actionable process step in a food operation where a significant
vulnerability is identified. They represent reasonably appropriate
measures that are necessary to reduce the likelihood of intentional
adulteration intended to cause wide scale public health harm. Focused
mitigation strategies are customized to the processing step at which
they are applied, tailored to existing facility practices and
procedures, and depend on an evaluation of the significant
vulnerability associated with the actionable process step at which they
are applied. In the proposal we tentatively concluded, based on our
vulnerability assessments, that the implementation of focused
mitigation strategies at actionable process steps in a food operation
is necessary to minimize or prevent the significant vulnerabilities
that are identified in a vulnerability assessment, regardless of the
existence of broad mitigation strategies.
    We further explained, in contrast to broad mitigation strategies,
focused mitigation strategies are targeted to actionable process steps
and, therefore, are more effective at countering an attacker who has
legitimate access to the facility. Our conclusion was based upon our
interactions with the intelligence community and the many vulnerability
assessments we conducted with industry, which showed that an act of
intentional adulteration by an insider presents significant risk for
that adulteration to result in wide scale public health harm and that
broad mitigation strategies are not specific enough, for example, to
counter the actions of an attacker who has legitimate access to the
facility (i.e., insider attack) or an attacker who circumvents
perimeter protections (e.g., scaling a fence), with the goal of
intentionally contaminating the food.
    Although the regulatory text now only refers to ``mitigation
strategies,'' we continue to believe that facilities must protect
vulnerable points in their operation from acts of intentional
adulteration intended to cause wide scale public health harm and that a
facility's vulnerability to acts of intentional adulteration by
attackers who have achieved access to the facility must be
significantly reduced or prevented to protect the food from intentional
adulteration intended to cause wide scale public health harm. General,
facility-level protections do not sufficiently address the significant
vulnerabilities within a facility because they do not address an inside
attacker who has obtained access to the facility.
    (Comment 41) Some comments state that the distinction between
``broad'' and ``focused'' mitigation strategies is confusing, and
request that the distinction be removed. One comment states the line
between broad and focused mitigation strategies is often blurry. The
comment asks how close ingredient handling needs to be to a gate for
the gate to be considered a focused mitigation strategy and not a broad
one. The comment further asserts that a mandate for focused mitigation
strategies will result in endless debates between facility management
and FDA investigators as to whether a particular mitigation strategy is
broad or focused and that this potential for difference of opinion
between facilities and FDA investigators is of significant concern for
industry stakeholders.
    (Response 41) The question asked by the comment highlights the
nuance and gradation that exists within mitigation strategies. After
considering the comments, we agree that many mitigation strategies may
not lend themselves to clear categorizations as either ``broad'' or
``focused,'' and we agree that the delineation between broad and
focused mitigation strategies, as described in the proposed rule, may
be confusing because of the wide diversity of potential mitigations as
well as variation as to how a facility chooses to implement a
particular strategy. As a result, we have modified the regulatory text
throughout the final rule to refer to ``mitigation strategy'' rather
than ``focused mitigation strategy.'' For example, Sec.  121.135 now
requires ``mitigation strategies for actionable process steps.'' Also,
the title of the rule has been modified to reflect this change.

4. Food
    We proposed to define the term ``food'' to mean food as defined in
section 201(f) of the FD&C Act and include raw materials and
ingredients.
    (Comment 42) Some comments urged us to clarify that the definition
of food does not include food contact substances as defined in section
409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)). One comment recommends
FDA amend the definition of food to exempt EPA registered
antimicrobials/pesticides and food contact substances which have no
ongoing intended technical effect in the final finished food.
    (Response 42) This rule only applies to facilities required to
register with FDA. The registration rule does not include food contact
substances and pesticides (21 CFR 1.227(a)(4)(i)). No change to the
definition of food in this rule is necessary.
5. Food Defense
    We proposed to define the term ``food defense'' to mean the effort
to protect food from intentional acts of adulteration where there is an
intent to cause public health harm and economic disruption.
    (Comment 43) One comment states that references to ``terrorism'' in
the preamble to the proposed rule were unnecessarily limiting and
confusing and recommends that instead of attempting to narrow the scope
of intentional adulteration to ``terrorism,'' FDA should use the
definition of ``food defense'' to explain and further clarify the focus
of activities covered by the rule.
    (Response 43) We agree with this comment and have modified the
definition of ``food defense'' in the final rule as follows: ``Food
defense means, for purposes of this part, the effort to protect food
from intentional acts of adulteration where there is intent to cause
wide scale public health harm.'' As discussed in the preamble to the
proposed rule, although we referred to the protection of the food
supply from ``acts of terrorism'' throughout the proposed rule, we
expect our approach would generally address acts intended to cause wide
scale public health harm, whether committed by terrorists, terrorist
organizations, individuals or groups of individuals. The purpose of
this rule is to protect the food supply against individuals or
organizations with the intent to cause wide scale public health harm.
Further, although economic disruption is likely to occur in any such
instance of wide scale public health harm, because the focus of the
rule is not the protection against economic disruption we have removed
that language from the definition of ``food defense'' for purposes of
this rule. In addition, as discussed in section III.G.2, economically
motivated adulteration is not addressed in this final rule.
    (Comment 44) One comment states that the proposed rule defines
``food defense'' within the scope of the rule and requests that FDA
establish a generalized definition of ``food defense'' that can be
adopted for the purposes of all FDA activities and subsequently the
scope of this rule can then be further elaborated. The comment proposes
the following definition of food defense: ``Actions and activities
related to prevention, protection, mitigation, response, and recovery
of the food system from intentional acts of adulteration. This includes
intentional adulteration from both terrorism and criminal activities.
Criminal activities include economically motivated adulteration, as
well as acts by disgruntled employees, consumers, or competitors
intending to cause public health harm or business disruption.''
    (Response 44) We decline this request. The purpose of Sec.  121.3
(Definitions) is to define terminology that is used within the
regulatory text of the rule. Therefore, the definitions of terms need
to be within the context and scope of the rule, rather than a
definition to be used by FDA or industry activities not related to the
rule in particular.
6. Monitor
    We proposed to define the term ``monitor'' to mean to conduct a
planned sequence of observations or measurements to assess whether
focused mitigation strategies are consistently applied and to produce
an accurate record for use in verification.
    (Comment 45) Some comments assert that food safety and food defense
require different terminology and suggest referring to the activities
as ``checking'' instead of ``monitoring.'' These comments go on to
suggest that the definition of checking should be ``to observe or
otherwise assess whether mitigation strategies or measures are in place
and fully implemented.'' The comments also state that ``a planned
sequence of observations and measurements'' may not be appropriate for
all or any mitigation strategies, and questions what kind of
measurements of a mitigation strategy a facility would take.
    (Response 45) We agree that using completely different terminology
is appropriate when components of a food safety and food defense HACCP-
type system differ in important, specific ways. As noted in the
Regulatory Approach discussion in section III.A, food safety uses the
term ``hazard analysis'' to identify hazards, while food defense uses
the term ``vulnerability assessment'' to identify significant
vulnerabilities. These terms are completely different because they
represent key disciplinary differences which require different
methodological considerations related to whether the adulteration is
intentional. A hazard analysis has very different considerations than a
vulnerability assessment.
    However, we disagree that completely different terminology is
appropriate for a term that describes the performance of similar
activities for both food safety and food defense. Monitoring is
conducted to perform a similar function and in similar ways in both a
food defense and a food safety framework. In both contexts monitoring
is conducted to assess whether control measures are operating as
intended, and in accordance with the food safety or food defense plan.
However, constant monitoring of some preventive controls is necessary
(e.g., time-temperature monitoring for pasteurization), while periodic
monitoring is likely to be more appropriate for many mitigation
strategies (e.g., checking the lock on an access hatch to a liquid
storage tank at the end of the tank cleaning cycle). Therefore, to
recognize that the management components for food safety and food
defense perform similar activities, but also include some differences,
we are changing the term to ``food defense monitoring'' to make clear
that the expectations for compliance are different. In additional
recognition that the management components for food safety and food
defense perform similar activities, we are finalizing the definition of
food defense monitoring to mean to conduct a planned sequence of
observations or measurements to assess whether mitigation strategies
are operating as intended. This definition is similar to the definition
of monitoring in the PCHF final rule.
    As we have concluded that, in some instances, similar terminology
is appropriate for activities that are conducted to perform similar
functions for food safety and food defense, incorporation of elements
from definitions of internationally recognized standards (e.g., Codex)
is appropriate for this rule. A ``planned sequence'' is included in the
definition because it is important to thoughtfully and systematically
assess whether mitigation

strategies are operating as intended, and the inclusion of ``a planned
sequence'' in the definition conveys this importance. For example, a
facility may establish and implement written monitoring procedures to
include a planned sequence of observations to monitor a lock on an
access hatch to occur at the end of every silo cleaning cycle, when
there is potential to add a contaminant because the access hatch can be
opened without the contents of the silo spilling out. Without planning
the sequence of observations of this mitigation strategy, monitoring
the strategy may occur in the middle of the cleaning cycle when the
access hatch must be open to complete the cleaning process, and would
therefore not be able to assess if the mitigation strategy was
functioning as intended (i.e., properly locking the access hatch at the
end of the cleaning cycle). Additionally, we include the term
``measurements'' not only to align more so with definitions from
international standards, but also to reflect a facility's flexibility
to choose the most appropriate mitigation strategy and how to monitor
that strategy. In many cases, a facility will observe that a mitigation
strategy is functioning as intended; however, there are some cases
where a facility may measure whether a strategy is functioning as
intended. For example, a facility may choose to implement a mitigation
strategy that is a thermal-kill step. It would then be necessary for
the facility to take measurements of the time and temperature to ensure
the thermal-kill step is functioning as intended. Additionally, we have
deleted ``consistently applied'' in the proposed definition and added
``operating as intended'' as this more closely aligns with the ISO
22000:2005 and with a similar change made in the PCHF final rule.
Finally, we have removed ``and to produce an accurate record for use in
verification'' from the proposed definition because the requirement for
documenting monitoring records is established by the requirement for
monitoring, and not by the definition of monitor. As discussed in
Response 89, we have made several revisions to the regulatory text,
with associated editorial changes, to clarify that monitoring records
may not always be necessary.
7. Significant Vulnerability
    We proposed to define the term ``significant vulnerability'' to
mean a vulnerability for which a prudent person knowledgeable about
food defense would employ food defense measures because of the
potential for serious adverse health consequences or death and the
degree of accessibility to that point in the food process.
    Although we did not receive comments on the proposed definition for
significant vulnerability, we have revised the definition to improve
understanding of the regulatory requirements in Sec.  121.130
(Vulnerability assessment to identify significant vulnerabilities and
actionable process steps). In this final rule, significant
vulnerability is defined to mean a vulnerability that, if exploited,
could reasonably be expected to cause wide scale public health harm. A
significant vulnerability is identified by a vulnerability assessment,
conducted by a qualified individual, that includes consideration of the
following: (1) Potential public health impact (e.g., severity and
scale) if a contaminant were added, (2) degree of physical access to
the product, and (3) ability of an attacker to successfully contaminate
the product. The assessment must consider the possibility of an inside
attacker. For further discussion of the related changes made to the
requirement in Sec.  121.130 for a vulnerability assessment to identify
significant vulnerabilities and actionable process steps, see section
V.B.
8. Significantly Minimize
    We proposed to define the term ``significantly minimize'' to mean
to reduce to an acceptable level, including to eliminate.
    We did not receive comments on the proposed definition for
significantly minimize and we are finalizing the definition as
proposed.
9. Small Business
    We proposed to define the term ``small business'' to mean a
business employing fewer than 500 persons. We proposed to establish the
same definition for small businesses as that which has been established
by the U.S. Small Business Administration under 13 CFR part 121 for
most food manufacturers. We did not receive any comments on this
definition. We are finalizing the definition as proposed, with several
changes for clarity. We are using the term ``500 full-time equivalent
employees'' rather than ``500 persons.'' In addition, we are adding a
definition of ``full-time equivalent employee'' to the definition
section (Sec.  121.3). We have made these changes because we will base
the calculation on ``full-time equivalent employees'' and use the same
approach to calculating full-time equivalent employees for the purpose
of this rule as we used to calculate full-time equivalent employees in
the section 414 recordkeeping regulations (see Sec.  1.328). Under this
approach, the number of full-time equivalent employees is determined by
dividing the total number of hours of salary or wages paid directly to
employees of the business entity claiming the exemption and of all of
its affiliates and subsidiaries by the number of hours of work in 1
year, 2,080 hours (i.e., 40 hours x 52 weeks).
    In addition, we are adding ``including any subsidiaries and
affiliates'' to the definition to provide clarity on how to calculate
``500 full-time equivalent employees'' for purposes of this rule.
10. Verification
    We proposed to define the term ``verification'' to mean those
activities, other than monitoring, that establish that the system is
operating according to the food defense plan.
    (Comment 46) One comment suggests ``verification'' be defined as
``the application of methods, procedures, tests and other evaluations,
in addition to monitoring, to determine whether a focused mitigation
strategy is or has been operating as intended.''
    (Response 46) We have revised the definition of food defense
verification to more closely align with the Codex definition of
verification. The term is now defined as the application of methods,
procedures, and other evaluations, in addition to food defense
monitoring, to determine whether a mitigation strategy or combination
of mitigation strategies is or has been operating as intended according
to the food defense plan. ``Methods, procedures, and other
evaluations'' better describes the scope of verification than
``activities'' used in the proposal. Although the Codex definition
includes ``test'' as a form of verification, we have not included it
because the rule does not require verification testing. We believe
changing ``that establish the system is operating'' to ``to determine
whether a mitigation strategy is or has been operating'' more
accurately describes the purpose of food defense verification. We have
added ``a combination of mitigation strategies'' to recognize that
facilities may use more than one mitigation strategy to significantly
minimize or prevent a significant vulnerability. The definition
proposed by the comment limits verification to mitigation strategies;
it does not require verification of the food defense plan. Verification
of the food defense plan reflects the fact that verification is broader
than just mitigation strategies; it includes, for example, verification
of food defense monitoring and corrective actions.

    (Comment 47) Some comments suggest using the term ``evaluation''
instead of verification. These comments suggest that evaluation be
defined as ``those activities, in addition to checking, that establish
that the facility is implementing a food defense plan.''
    (Response 47) We deny this request. As discussed in response to
Comment 46, we have revised the definition of food defense verification
to include ``evaluation'' because evaluation is an appropriate
verification activity. However, we disagree that completely different
terminology (in this case, ``evaluation'' rather than ``verification'')
is appropriate for a term that describes the performance of similar
activities for both food safety and food defense (see Responses 45 and
46). Verification is conducted to perform a similar function and in
similar ways in both a food defense and a food safety framework. In
both frameworks verification is conducted to determine whether control
measures are operating as intended according to the food safety or food
defense plan, and these verification activities are in addition to
monitoring. At the same time, by using the term ``food defense
verification,'' we make clear that verification as required by this
rule is not identical to verification required in the preventive
controls context.
11. Very Small Business
    We proposed to define the term ``very small business'' to mean a
business that has less than $10,000,000 in total annual sales for food,
adjusted for inflation. In the preamble of the proposed rule we
explained our rationale for defining ``very small businesses'' at the
$10,000,000 threshold because the purpose of this rule is to protect
the food supply against individuals or organizations with the intent to
cause wide scale public health harm. We tentatively conclude these
individuals or groups would likely target the product of relatively
large facilities, especially firms whose brand is nationally or
internationally recognizable. Some comments agree with our proposed
definition while others disagree. Among the comments that disagree with
the definition, some state that the $10,000,000 amount is too high or
too low, and several comments suggest alternatives to using dollar
amount as the threshold. We further discuss these comments and our
response to them in this document.
    Some comments submitted to the PCHF proposed rule request that we
specify that the monetary threshold for the definition be based on
average sales during a 3-year period on a rolling basis because
otherwise firms may be subject to significant changes in status from
year to year. Those comments also ask us to clarify that the sales are
to be evaluated retrospectively, not prospectively. Although we did not
receive similar comments to this rule, in an effort to be consistent
with the PCHF final rule, we have revised the definition of very small
business to specify that it is based on average sales during the 3-year
period preceding the applicable calendar year. The applicable calendar
year is the year after the 3 calendar years used to determine whether a
facility is a very small business.
    We also revised the definition to include the market value of human
food manufactured, processed, packed, or held without sale (e.g., held
for a fee). When there are no sales of human food, market value of the
human food manufactured, processed, packed, or held without sale is a
reasonable approach to calculating the dollar threshold for a very
small business.
    (Comment 48) One comment requests that FDA change the definition of
``very small business'' to only apply to $10,000,000 in annual sales of
food that is covered under the rule, and not to total annual food
sales. The comment asserts that basing the threshold on the sale of
food covered by the intentional adulteration rule, rather than all
food, would be necessary to be consistent with the fact that covered
produce is regulated under the produce rule. Specifically, the comment
requests that we exclude the sale of animal foods from the calculation
of annual food sales because this rule exempts the manufacturing,
processing, packing, or holding of animal foods. The comment further
argues that this approach is consistent with the statutory mandate that
FDA regulations be flexible in scale and supply chain appropriate and
provide special considerations for small and very small businesses.
    (Response 48) We have revised the definition of very small
businesses to include only the sale of human food plus the market value
of human food manufactured, processed, packed, or held without sale
(e.g., held for a fee). Under this revised definition, firms that
process both human and animal foods will not be required to include
sale of animal food in their calculation to determine whether they fall
under the $10,000,000 threshold.
    (Comment 49) Several comments expressed confusion with the varying
business size thresholds across the seven FSMA rules and stated that it
will be a significant challenge for the food industry to interpret and
decide which rules under FSMA they are required to comply with if the
definitions of the size of business are not consistent throughout all
FSMA rules. Some comments encourage us to establish a tiered system
that clearly outlines coverage under all FSMA rules by business size,
while others request that we provide clear guidance to assist firms,
especially small and very small businesses, to identify which of the
seven FSMA rules are applicable to them.
    (Response 49) We recognize that the varying business size
thresholds across the FSMA rules may be cause for confusion. However,
each of the rules differs in scope and intent, which compels us to
establish requirements and exemptions that are specific to and
appropriate for each rule. To help small and very small businesses
comply with each rule, we plan to issue Small Entity Compliance Guides.
    (Comment 50) One comment objected to exempting any facilities from
the rule, arguing that this would give terrorists a ``road map'' to
those facilities not covered and make them targets for intentional
adulteration. The comment recommends that FDA remove the exemptions for
very small businesses and qualified facilities completely.
    (Response 50) We disagree with this comment. Section 418(l)(2) of
the FD&C Act specifies that qualified facilities, which include very
small businesses, are not subject to the requirements in sections
418(a) through (i) and (n). We note that section 418(l)(2) requires
qualified facilities to submit one of two types of documentation to the
Secretary. The PCHF and PCAF rules have requirements reflecting this
provision but this rule does not. Section 418(l)(2)(B)(i)(I) requires
documentation that demonstrates that the facility has identified
potential hazards and is implementing and monitoring the preventive
controls. We have concluded that very small businesses are at reduced
risk and therefore do not have significant vulnerabilities that require
mitigation strategies. Therefore, there is nothing for very small
businesses to document under this option. In contrast, a human or
animal food facility is not at lesser risk of a food safety problem
solely because it is relatively small. Section 418(l)(i)(II) is
similarly inapplicable for several reasons. That section requires
documentation that a facility is in compliance with State, local,
county, or other applicable non-Federal food safety law. First, food
safety is traditionally viewed as separate from food defense. Second,
no States currently require food defense

measures, and States are unlikely to impose measures different from
those in this rule. Therefore, compliance with ``food safety law'' as
described in the provision would be irrelevant. In contrast, all States
have food safety laws. Further, regulations issued under section 420 of
the FD&C Act are to apply to food for which there is a high risk of
intentional contamination (section 420(c)). Individuals or groups
intending to cause wide scale public health harm are more likely to
target the product of relatively large facilities, especially for
facilities whose brands are nationally or internationally recognizable,
than to target very small businesses. Covering all facilities would be
inconsistent with the statutory requirement to limit coverage to foods
at high risk. The $10,000,000 threshold for very small businesses still
covers 97-98 percent of the market share of manufactured packaged foods
(Ref. 14). In addition, section 420(a)(1)(B) of the FD&C Act directs
FDA to consider the risks, costs, and benefits associated with
protecting food against intentional adulteration. Imposing the full
requirements of the rule on all facilities, regardless of size, would
almost triple the current cost of the rule while only covering an
additional 2-3 percent of the market share of manufactured foods.
    (Comment 51) One comment recommends we apply the lower dollar
amount used to define ``very small businesses'' in the PCHF proposed
rule. Another comment recommends that the threshold be lowered to
$3,000,000 because smaller companies are less likely to implement food
defense measures unless mandated.
    (Response 51) The higher threshold for very small businesses in
this rule as compared to the PCHF rule reflects the difference in the
nature of risk of intentional adulteration as compared to unintentional
adulteration (i.e., traditional food safety). This rule protects food
against intentional adulteration caused by individuals or organizations
whose goal is to maximize public health harm. An attacker would more
likely target the product of relatively large facilities, especially
firms whose brand is nationally or internationally recognizable. An
attack on such a target would potentially provide the desired wide
scale public health consequences and the significant public attention
that would accompany an attack on a recognizable brand. Such facilities
are likely to have larger batch sizes, potentially resulting in greater
human morbidity and mortality. Further, an attack on a well-recognized,
trusted brand is likely to result in greater loss of consumer
confidence in the food supply and in the government's ability to ensure
its safety and, consequently, cause greater economic disruption than a
relatively unknown brand that is distributed regionally.
    (Comment 52) Several comments argue that the $10,000,000 threshold
is too high, is arbitrary and not risk-based, and excludes many
suppliers and co-manufacturers to large food companies. The comments
state that suppliers who provide ingredients to larger firms would not
be covered under the rule and therefore would pose a significant
vulnerability to these large, nationally branded food manufacturers
that have large consumer exposure. They argue that this high threshold
creates a major hole in the industry that may be exploited, and they
point out that we identified ``ingredient handling'' as a key activity
type having significant vulnerabilities and therefore all ingredient
manufacturers need to be covered.
    (Response 52) The full name of the key activity type referenced is
``secondary ingredient handling.'' Secondary ingredient handling refers
to activity occurring in the production facility where the ingredient
is being added; it does not refer to a facility's ingredient supply
chain. The potential for incoming ingredients to be intentionally
adulterated is addressed by the rule's applicability to ingredient
suppliers. As with finished food, not all ingredient suppliers are
covered. The rule focuses on those foods at highest risk of intentional
adulteration; it does not eliminate all risk.
    (Comment 53) Several comments argue that the $10,000,000 threshold
is too low and recommend that we increase it to $50,000,000 or
$1,000,000,000 in annual sales. One comment states that for an
intentional adulteration event to happen, the brand or food must be one
that a terrorist or a similarly ill-intentioned person is likely to
target, which would encompass only the largest and most well-known food
brands. The comment goes on to argue that, ``the top roughly 250 food
brands in the Western world are owned by only a handful companies
having annual human food revenues from tens of billions of dollars to
over 100 billion dollars,'' and therefore, if we are focusing the rule
on those at ``high risk,'' as specified under section 420 of the FD&C
Act, then there is little benefit to be gained by imposing the
requirements of this rule on hundreds of thousands of companies whose
products are not likely to be targeted. The comment points out that
because we are ``unable to identify any previous act of intentional
adulteration intended to cause public health harm that was perpetrated
in a setting that would be covered by this rule (i.e., all such
previous attacks have involved restaurant or donated food), it would
appear that the risk of any such attack occurring is overall quite low,
and that only the most attractive targets can conceivably be considered
``high'' risk.''
    (Response 53) We decline this request. Although we agree that those
intending to cause wide scale public health harm would more likely
target the larger well known food brands, we disagree that there is
little benefit to be gained by imposing the requirements of this rule
on companies under a $50,000,000 or $1,000,000,000 threshold. To
identify which facilities to cover under this rule, we assessed risk
based on both the likelihood of being a target and the potential impact
to public health. If we were to increase the threshold for a very small
business to $50,000,000 or $1,000,000,000, a large number of facilities
producing large quantities of food, including some well-known brands,
would not be covered.
    (Comment 54) Several comments state that using annual sales is not
indicative of risk and offer alternative ways to define which
facilities are covered under the rule. The comments argue that annual
sales do not determine the potential consumer exposure as it relates to
preventing wide scale public health harm because more expensive
products could have higher annual sales but lower consumer exposure.
The comments point out that a manufacturer of a premium chocolate bar
would sell fewer chocolate bars than a commodity chocolate manufacturer
with sales of the same dollar amount. Some comments suggest
alternatives to using annual sales, including units of a product sold
(e.g., 100,000 retail units), number of servings, volume manufactured,
and distribution patterns of the product. Other comments recommend
using the shelf life of products or the shelf stableness of product as
alternatives.
    (Response 54) We use sales and the market value of food
manufactured, processed, packed, or held without sale as a proxy for
volume. We are aware that dollar amounts can be skewed by product
values and, thus, sales are an imperfect proxy for volume. However, we
are not aware of a more practical way to identify a threshold based on
volume or amount of product that could be applied across all product
sectors, and the comments provide no suggestions for how their
recommendations could be carried out.
    Shelf life and shelf stability are not necessarily good indicators
of the speed at which a particular product moves

through the distribution system because many products are sold and
consumed months, and even years, before their shelf life expires. The
risk of a product for intentional adulteration does not increase based
solely on a short shelf life. Similarly, a product that has a longer
shelf life is not necessarily at lower risk for intentional
adulteration; it could be an attractive target based on the potential
to cause wide scale public health harm.
    (Comment 55) One comment suggests that we base the very small
business definition on the number of full-time employees, similar to
how we define ``small business.'' The comment recommends that we define
``very small business'' at 50 full-time employees.
    (Response 55) We deny this request. The purpose of the definition
of ``very small business'' is to exempt the smallest businesses from
the requirements of the rule because they are less likely to be
targeted by individuals or organizations intending to cause wide scale
public health harm. The consideration of sales is consistent with the
other option for being a qualified facility under section 418 of the
FD&C Act, which also considers sales (section 418(l)(1)(C)). (As
discussed in IV.E.1 of this rule, we have removed the term ``qualified
facility'' from the exemption provided in Sec.  121.5(a) for simplicity
because any facility that would be a ``qualified facility'' as proposed
in Sec.  121.5(a) will also meet the definition for a ``very small
business.'')
    In contrast, section 418(l) of the FD&C Act does not specify any
particular criterion (whether sales or number of employees) for the
definition of ``small business,'' other than directing us to consider
the results of the Food Processing Sector Study. Basing the definition
of ``small business'' on the number of employees is consistent with our
approach to defining ``small business'' in many other regulations (see,
e.g., the PCHF final rule, Produce final rule, HACCP regulation for
juice (Sec.  120.1(b)(1)), the section 414 recordkeeping regulations
(69 FR 71562, December 9, 2004), and our CGMP regulation for
manufacturing, packaging, labeling, or holding operations for dietary
supplements (72 FR 34752, June 25, 2007)).
    (Comment 56) Some comments request that we change the definition of
``very small business'' to only include the total annual sales of food
in the United States, adjusted for inflation, for foreign facilities
that export food to the United States.
    (Response 56) A foreign business that sells more than the threshold
dollar amount of food has more resources than the businesses being
excluded, even if less than that threshold dollar amount reflects sales
to the United States. Likewise, a domestic business that sells more
than the threshold dollar amount of food has more resources than the
businesses being excluded, even if that domestic business exports some
of its food and, as a result, less than that threshold dollar amount
reflects sales within the United States. Further, this is consistent
with the PCHF final rule.
12. Vulnerability
    We proposed to define the term ``vulnerability'' to mean the
susceptibility of a point, step, or procedure in a facility's food
process to intentional adulteration.
    We did not receive comments on the proposed definition of
vulnerability and we are finalizing the definition as proposed.

C. Additional Definitions To Clarify Terms Not Defined in the Proposed
Rule

1. Adequate
    We have defined the term ``adequate'' to mean that which is needed
to accomplish the intended purpose in keeping with good public health
practices. See section V.E for a detailed discussion of the changes to
the requirement for food defense monitoring in Sec.  121.140, including
the requirement to monitor the mitigation strategies with ``adequate''
frequency to provide assurances that they are consistently performed.
2. Affiliate and Subsidiary
    We have defined the term ``affiliate'' to mean any facility that
controls, is controlled by, or is under common control with another
facility. We have defined the term ``subsidiary'' to mean any company
which is owned or controlled directly or indirectly by another company.
These definitions incorporate the definitions in sections 418(l)(4)(A)
and (D) of the FD&C Act and would make the meanings of these terms
clear when used in the definition of ``very small business.''
3. Full-Time Equivalent Employee
    We have established a definition for ``full-time equivalent
employee'' as a term used to represent the number of employees of a
business entity for the purpose of determining whether the business
qualifies as a small business. The number of full-time equivalent
employees is determined by dividing the total number of hours of salary
or wages paid directly to employees of the business entity and of all
of its affiliates by the number of hours of work in 1 year, 2,080 hours
(i.e., 40 hours x 52 weeks). If the result is not a whole number, round
down to the next lowest whole number. Because the calculation for the
number of employees affects the small business definition and extended
compliance dates, we are establishing the definition of ``full-time
equivalent employees'' in the definitions for this rule and modifying
the definition of ``small business'' to use the term ``500 full-time
equivalent employees'' rather than ``500 persons.''
4. Qualified Individual
    In this final rule, we have defined the term ``qualified
individual'' to mean a person who has the education, training, or
experience (or a combination thereof) necessary to perform an activity
required under subpart C, as appropriate to the individual's assigned
duties. A qualified individual may be, but is not required to be, an
employee of the establishment. See section V.H. for a detailed
discussion of the new requirements in Sec.  121.4--Qualifications of
Individuals Who Perform Activities Under Subpart C.
5. You
    In this final rule, we have defined the term ``you'' for purposes
of this part, to mean the owner, operator, or agent in charge of a
facility. We have made conforming changes throughout the regulatory
text to replace ``owner, operator, or agent in charge'' with ``you''
for simplicity and consistency with the PCHF and PCAF regulations.

D. Comments Asking FDA To Establish Additional Definitions or Otherwise
Clarify Terms Not Defined in the Rule

1. Correction
    (Comment 57) Some comments that request the addition of corrections
to the requirement related to corrective actions request we define
``correction'' to mean the action to eliminate a non-conformity.
    (Response 57) We decline this request. Because we are not providing
for corrections and the term ``corrections'' is not in the regulatory
text, there is no need to define the term.
2. Defensive Controls or Defensive Control Point
    (Comment 58) One comment requests that FDA consider adoption of
food defense terminology that is complementary to food safety
terminology used in the PCHF final rule, such as ``defensive controls''
or ``defense control point.''
    (Response 58) We decline the request to adopt the specific terms of
``defense controls'' or ``defense control point.''

Although the comment did not further explain what terms ``defense
controls'' or ``defense control point'' would replace, we believe
``actionable process steps'' and ``mitigation strategies''
appropriately differentiate these terms, related to intentional
adulteration, from analogous food safety terms used in the PCHF final
rule.
3. Reasonably Foreseeable
    (Comment 59) Some comments state FDA should clearly define what
constitutes a ``reasonably foreseeable'' threat as it relates to the
risk of intentional adulteration.
    (Response 59) We decline this request. The term ``reasonably
foreseeable'' is not used in the regulatory text of this rule.
4. Supply Chain
    (Comment 60) One comment requests that FDA define ``supply chain''
as it relates to food and provides a recommended definition to be
included in the rule.
    (Response 60) We decline this request. The term ``supply chain'' is
not used in the regulatory text of this rule.
5. Validation
    (Comment 61) One comment suggests we define ``validation'' as
obtaining evidence that a control measure or combination of control
measures, if properly implemented, is capable of controlling the hazard
to a specified outcome.
    (Response 61) We decline this request. The term ``validation'' is
not used in the regulatory text of this rule.
6. Miscellaneous
    (Comment 62) One comment requests that FDA define certain terms or
phrases that are used in some definitions and that the comment suggests
will have a wide range of interpretations. The comment cites
``acceptable level'' (used in the definitions of ``actionable process
step'' and ``significantly minimize''), ``reasonably appropriate
measures'' and ``person knowledgeable about food defense'' (both used
in the definition of ``focused mitigation strategies''), and ``prudent
person knowledgeable about food defense'' (used in the definition of
``significant vulnerability'').
    (Response 62) The terms ``acceptable level'' and ``reasonably
appropriate measures'' are meant to be flexible standards. We do not
need to define every term used in the definitions. By specifying that a
point, step, or procedure in a food process at which food defense
measures can be applied and are essential to prevent or eliminate a
significant vulnerability or reduce such vulnerability to an acceptable
level, the definition for actionable process step provides flexibility
for a facility to determine what that level would be in a particular
circumstance. We now use ``person knowledgeable about food defense''
without reference to ``prudent'' in the definitions of ``significant
vulnerability'' and ``mitigation strategies.'' A person knowledgeable
about food defense would meet the requirements of being a Qualified
Individual (Sec.  121.4).

E. Proposed Sec.  121.5--Exemptions

    We proposed to establish a series of exemptions from the
intentional adulteration requirements. We also sought comments on
whether we should exempt on-farm manufacturing, processing, packing, or
holding of the food identified as having low-risk production practices
identified in Appendix 4 to the Draft Risk Assessment (further
discussed in section I.C). We discuss these in the following sections.
1. Proposed Sec.  121.5(a)--Exemption Applicable to a Qualified
Facility
    We proposed to exempt a qualified facility, except that qualified
facilities must, upon request, provide for official review
documentation that was relied upon to demonstrate that the facility
meets this exemption. We also proposed that such documentation must be
retained for 2 years. We proposed to define qualified facility, in
part, as a facility that is (1) a very small business; or (2) a
facility to which certain circumstances must apply.
    We have removed the exemption applicable to a qualified facility
and replaced it with a very small business exemption. Revised Sec.
121.5(a) provides that this part does not apply to a very small
business, except that a very small business must, upon request, provide
for official review documentation sufficient to show that the facility
meets the exemption and that such documentation must be retained for 2
years. We have removed the term ``qualified facility'' from the
exemption provided in Sec.  121.5(a) to simplify the provision and
provide clarity as to the applicability of the exemption. For purposes
of this rule, any facility that would be a ``qualified facility'' as
proposed in Sec.  121.5(a) will also meet the definition for a ``very
small business.'' Further, section 418(l)(3) of the FD&C Act, which
provides for withdrawal of an exemption from a ``qualified facility,''
is not relevant because we are also issuing these requirements under
section 420 of the FD&C Act.
2. Proposed Sec.  121.5(b)--Exemption Applicable to Holding of Food
    We proposed to exempt holding of food, except the holding of food
in liquid storage tanks. We received one comment that disagrees with
the holding exemption, and have addressed the comment in Response 34.
After considering this comment, we are finalizing the exemption as
proposed.
3. Proposed Sec.  121.5(c)--Exemption Applicable To Packing, Re-
Packing, Labeling, or Re-Labeling of Food Where the Container That
Directly Contacts the Food Remains Intact
    We proposed to exempt packing, re-packing, labeling, or re-labeling
of food where the container that directly contacts the food remains
intact. We did not receive comments on the proposed exemption and we
are finalizing the exemption as proposed.
4. Proposed Sec.  121.5(d)--Exemption Applicable to Activities of a
Facility That Are Subject to Section 419 of the FD&C Act
    We proposed to exempt activities of a facility that are subject to
section 419 of the FD&C Act (Standards for Produce Safety). We did not
receive comments on the proposed exemption and we are finalizing the
exemption as proposed.
5. Proposed Sec.  121.5(e)--Exemption With Respect to Alcoholic
Beverages
    Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities)
provides a rule of construction for certain facilities engaged in the
manufacturing, processing, packing, or holding of alcoholic beverages
and other food. In the proposed rule, we discussed our interpretation
of section 116 of FSMA and requested comment on our interpretation.
Based on our interpretation, we proposed that part 121 would not apply
with respect to alcoholic beverages at facilities meeting two specified
conditions (78 FR 78014 at 78037). We also proposed that part 121 would
not apply with respect to food other than alcoholic beverages at
facilities described in the exemption, provided such food is in
prepackaged form that prevents direct human contact with the food and
constitutes not more than 5 percent of the overall sales of the
facility. No comments disagreed with the exemption of alcoholic
beverages, but some comments requested changes or clarifications to the
proposed activities covered in the exemption. After reviewing the
comments, we are finalizing this exemption as proposed.
    (Comment 63) Two comments supported the exemption for alcoholic
beverages and FDA's interpretation of

section 116 of FSMA, but one comment requests changing the language
from just ``alcoholic beverages'' to ``manufacturing, processing,
packing and holding of alcoholic beverages,'' stating that in reducing
the words FDA may unintentionally limit the scope of the exemption to
facilities holding finished beverage alcohol products.
    (Response 63) We agree with the comments that support the exemption
as written. We do not believe it is necessary to list the activities in
the codified as requested by one comment. Under section 415 of the FD&C
Act a facility is required to register as a facility because it is
engaged in manufacturing, processing, packing, or holding of one or
more alcoholic beverages. Therefore, the language stating ``alcoholic
beverages at a facility'' encompasses facilities engaged in the
activities listed previously and the regulatory text in Sec.  121.5(e)
clearly covers the intended exemption for the ``manufacturing,
processing, packing and holding of alcoholic beverages.''
    (Comment 64) One comment supports the exemption for alcoholic
beverages but requests that we further exempt craft breweries from
drying and packaging requirements for disposal of spent grains as
cattle feed to small farmers.
    (Response 64) The exemption established under the rule of
construction in section 116 of FSMA applies to alcoholic beverages, not
to any other food (see section 116(c) of FSMA (21 U.S.C. 2206(c)). The
by-products described in this comment appear to be products that would
be used in food for animals rather than in human food, and we exempt
these foods in section Sec.  121.5(f). Since this rule exempts both
alcoholic beverages at a facility, provided certain conditions are met,
and food for animals, we believe this comment misunderstands the
exemptions.
6. Proposed Sec.  121.5(f)--Exemption Applicable To Manufacturing,
Processing, Packing, or Holding of Food for Animals Other Than Man
    We proposed to exempt manufacturing, processing, packing, or
holding of food for animals other than man. Section 418(m) of the FD&C
Act authorizes FDA to exempt or modify the requirements for compliance
with section 418 with regard to facilities that engage solely in the
production of animal food. Further, section 420(c) of the FD&C Act
requires that regulations that FDA issues under that section apply only
to food for which there is a high risk of intentional contamination.
FDA tentatively concluded in the proposed rule that animal food is not
at a high risk for intentional contamination because our analysis shows
that adulteration of animal food has minimal potential for human
morbidity and mortality which would lead to wide scale public health
harm. In considering whether to provide an exemption related to animal
food, we evaluated three types of possible attack scenarios: (1)
Incorporation of a contaminant into feed to be used for muscle meat-
producing animals; (2) incorporation of a contaminant into feed to be
used for egg-producing or milk producing animals; and (3) incorporation
of a contaminant into pet food. With regard to the two former
scenarios, we did not identify any contaminants that could be
incorporated into feed at levels that would lead to human morbidity or
mortality among consumers that subsequently eat the meat, eggs or milk
without first showing noticeable clinical signs and/or mortality in the
animals. While some contaminants can increase the risk of chronic
disease, such as cancer, among consumers, such an outcome is not
consistent with our understanding of the goals of terrorist
organizations, which include a more immediate impact. Regarding the
third attack scenario, adulterants could be incorporated into feed or
pet food that result in significant animal morbidity and mortality as
well as lead to secondary infections of humans through cross
contamination, but this type of intentional adulteration of animal food
poses a lower risk because secondary human illness or death is not the
primary goal of an attacker with the intent to cause wide scale public
health harm. As such, the proposed rule would not apply to the
manufacturing, processing, packing, or holding of food for animals
other than man. We requested comment on our tentative conclusions. Some
comments agreed with our conclusions and support the exemption as
proposed. One comment supported the exemption but requested a
clarification of exempted activities. Some comments disagreed with our
conclusions and assert that animal food is at high risk for intentional
adulteration because it has been intentionally contaminated in the
past. Some comments state that FDA should protect against intentional
adulteration that leads to serious health consequences or death to
humans or animals. After reviewing the comments, we are finalizing the
exemption as proposed.
    (Comment 65) Some comments support our tentative conclusions and
agree that animal food would not be at high risk for intentional
contamination and lacks a significant potential for human morbidity and
mortality. One comment supports the exemption but requests
clarification that the exemption of animal feed includes the byproduct
of manufactured human food regardless of the small business exemption.
    (Response 65) We conclude that animal food, regardless of whether
it is produced at a facility solely engaged in the production of animal
food or at a facility engaged in the production of both animal and
human food, does not involve significant vulnerabilities that require
mitigation strategies under section 418 of the FD&C Act, and is not
high risk under section 420 of the FD&C Act. Therefore, we are not
requiring a vulnerability assessment to determine that there are no
actionable process steps present and no mitigation strategies needed.
Regarding the requested clarification, the exemption applies to animal
food regardless of whether a facility is part of a small business.
    (Comment 66) Some comments disagree with our conclusion that animal
feed would not be at high risk for intentional contamination for
several reasons. Some comments cite the 2007 incident of melamine in
animal food that sickened and killed many animals as an example of
previous intentional contamination suggesting that animal food is at
high risk for intentional contamination. Some comments state that in
section 420(c) of the FD&C Act the intent of Congress was for
regulations to be issued that addressed hazards that would cause
``serious health consequences or death to humans or animals.'' One
comment asserts that pet food and human food supply chains are
interconnected, and therefore should be covered by this rule. One
comment believes that animal food comes into our homes as pet food
therefore can harm families via cross-contamination. One comment
asserts that the risk of Foot and Mouth Disease has been the focus of
many exercises and discussions with respect to intentional adulteration
and asserts that terrorists have attacked livestock in the past.
    (Response 66) We disagree with these comments and continue to
believe that animal food is not at high risk for intentional
adulteration within the context of this rule. While we agree that some
animal feed could be intentionally contaminated, our analysis shows
only minimal potential for human morbidity and mortality as a result of
an attack during, or associated with, animal food production. We
analyzed both human and animal food using CARVER+Shock methodology. For
human food, our analyses show the potential for

significant human morbidity and mortality should intentional
adulteration occur at certain points in a food operation. In contrast,
for animal food, our analysis shows only minimal potential for human
morbidity or mortality as a result of attacks at points in an animal
food operation.
    Significantly, our CARVER+Shock vulnerability assessments of animal
food have had to focus entirely on economic consequences because of the
lack of potential for human morbidity and mortality. As stated in the
preamble to the proposed rule (78 FR 78014 at 78037), in considering
whether to provide an exemption related to animal food, we evaluated
three types of possible attack scenarios: (1) Incorporation of a
contaminant into feed to be used for muscle meat-producing animals; (2)
incorporation of a contaminant into feed to be used for egg-producing
or milk producing animals; and (3) incorporation of a contaminant into
pet food. With regard to the two former scenarios, we are not aware of
contaminants that could be incorporated into feed at levels that would
not produce noticeable clinical signs and/or mortality in animals but
would result in significant human morbidity or mortality among
consumers that subsequently eat the meat, eggs or milk. While such
contaminants can increase the long-term risk of chronic disease, such
as cancer, among consumers, such an outcome is not consistent with our
understanding of the more-immediate goals of individuals or groups
intending to cause wide scale public health harm.
    Regarding the third attack scenario, incorporation of a contaminant
into pet food, we are aware of contaminants that could be incorporated
into feed or pet food that could result in significant animal
(including pet) morbidity and mortality, including some which could
result in secondary infectious spread of disease (because some
infectious agents can be transmitted orally as well as through
aerosol). Such attacks could be significant from an economic and
societal standpoint. However, the risk that they pose with regard to
targeting by individuals or groups intending to cause wide scale public
health harm appears to be significantly lower than those involving
human morbidity and mortality.
    Foot and mouth disease, mentioned in one comment, can lead to
animal death and economic consequences, but does not affect human
morbidity or mortality. Because foot and mouth disease would not cause
wide scale public health harm, it does not change our conclusion that
animal food is a less attractive target than human food, when the
intent of the adulteration is to cause wide scale public health harm
for humans. The event in 2007 involving contamination of wheat flour
and wheat gluten with melamine that resulted in pet illnesses and
deaths did not affect human health and was motivated by economic gain.
That form of intentional adulteration (i.e., economically motivated
adulteration) is addressed by the PCHF and PCAF final rules.
7. Exemption for Low-Risk Activities at Farm Mixed-Type Facilities
    As discussed in section I.D, we issued for public comment an
``Appendix to Draft Qualitative Risk Assessment of Risk of Activity/
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm'' (the draft RA Appendix)
(78 FR 78064, December 24, 2013). The draft RA Appendix was conducted
to provide a science-based risk analysis to determine which foods'
production processes would be considered low risk with respect to the
risk of intentional adulteration. Based on the tentative conclusions of
the draft RA Appendix, we asked for comment in the proposed rule on
possible exemptions or modified requirements for this final rule. In
the draft RA Appendix we tentatively concluded that the production
processes for the following finished foods are low-risk: Eggs (in-
shell); fruits and vegetables other than pods, seeds for direct
consumption, and hesperidia (fresh, intact); game meats (whole or cut,
not ground or shredded, without secondary ingredients); peanuts and
tree nuts (raw, in-shell); and sugarcane and sugar beets (fresh,
intact). We sought comment on whether we should exempt on-farm
manufacturing, processing, packing, or holding of the foods identified
as having low-risk production practices when conducted by a small or
very small business if such activities are the only activities
conducted by the business that are subject to section 418 of the FD&C
Act.
    (Comment 67) Several comments agree with the conclusions of the
draft RA Appendix and state we should provide exemptions in the
regulatory text for those on-farm manufacturing, processing, packing,
or holding activities identified as having low-risk production
practices when conducted by a small or very small business if such
activities are the only activities conducted by the business subject to
section 418 of the FD&C Act.
    (Response 67) We agree with these comments. In addition, we have
conducted a reanalysis of the risk assessment and have identified some
foods included in the draft RA Appendix as being out of scope of the
final appendix because of the changes to the definition of ``farm''
made by the PCHF rule, including some foods determined to have low risk
production practices in the draft appendix. Finished foods that are
produced using only activities that fall within the farm definition
(e.g., RACs such as fruits and vegetables, grains, and unpasteurized
milk) are out of scope for the purposes of this final appendix because
this evaluation focuses on the production processes used to produce a
finished food and applies only to activities outside the farm
definition performed by facilities co-located on farms. Accordingly, we
have provided a new exemption in the regulatory text in Sec.  121.5(g)
that exempts on-farm manufacturing, processing, packing, or holding of
eggs (in-shell, other than RACs, e.g., pasteurized), and game meats
(whole or cut, not ground or shredded, without secondary ingredients)
when conducted by a small or very small business if such activities are
the only activities conducted by the business subject to section 418 of
the FD&C Act. This exemption is also appropriate under section 420 of
the FD&C Act because such activities are not high risk under that
provision.
    The draft RA, considered fruits and vegetables other than pods,
seeds for direct consumption, and hesperidia, and determined them to be
low risk. Because these foods are produced using only activities that
fall within the modified farm definition, these finished foods are now
out of scope of the RA. Additionally, peanuts, tree nuts (raw, in
shell), sugarcane, and sugar beets were also considered and determined
to be low risk in the draft RA. These foods similarly are out of scope
of the evaluation of risk because these foods are produced using only
activities that fall within the modified farm definition. The finished
foods mentioned in this paragraph, when produced on farms, are exempt
under Sec.  121.5(d).

V. Subpart C: Comments on Food Defense Measures

A. Proposed Sec.  121.126--Requirement for a Food Defense Plan

    We proposed that the owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food
defense plan which must include: (1) Written identification of
actionable process steps; (2) written focused mitigation strategies;
(3) written procedures for monitoring; (4) written corrective action

procedures; and (5) written verification procedures.
    Some comments agree with the requirements for a food defense plan
as proposed. In general, comments support the proposed requirement that
facilities develop and maintain food defense plans to protect food
against intentional adulteration. In the following paragraphs, we
discuss comments that disagree with, or suggest one or more changes to,
the proposed requirements. After considering these comments, we are
finalizing the provisions as proposed, with editorial and conforming
changes as discussed in the other applicable sections of this document.
    (Comment 68) Some comments state that facilities should be allowed
to develop food defense plans that are tailored to and best meet the
needs and unique characteristics of the establishment. Other comments
state that the requirements should be adequately broad and provide
flexibility so that companies can build on their plans over time based
on emerging threats and new mitigation strategies.
    (Response 68) We agree with these comments and recognize that there
needs to be flexibility within the requirements for a facility to
develop a food defense plan that meets its needs and unique
characteristics. In the final rule we have added flexibility for
management components (see Comment 88, Comment 92, Comment 93, and
Comment 95 for a detailed discussion). Additionally, we agree that food
defense plans should change over time based on emerging threats and
identification of new mitigation strategies. The rule (Sec.  121.157)
requires a reanalysis of the food defense plan as a whole or to the
applicable portion of the plan when any of the following circumstances
occur: a significant change made in the activities conducted at the
facility creates a reasonable potential for a new vulnerability or a
significant increase in a previously identified vulnerability; a
facility becomes aware of new information about potential
vulnerabilities; a mitigation strategy, a combination of mitigation
strategies, or the food defense plan as a whole is not properly
implemented; or whenever FDA requires reanalysis to respond to new
vulnerabilities, credible threats to the food supply, or developments
in scientific understanding. See section V.G.2 for more detailed
discussion of the reanalysis section.
    (Comment 69) Some comments state that many food facilities have
already voluntarily developed and implemented food defense plans. The
comments express concern that FDA would require companies to completely
overhaul their existing food defense plans that are already in place
and working properly. These comments argue that existing food defense
plans should be adequate to meet the requirements of this rule so long
as they were thoughtfully developed.
    (Response 69) We recognize that some facilities have already
voluntarily developed and implemented food defense plans. These
facilities likely have a head start on compliance with this rule. To
the extent a food defense plan satisfies elements of this rule, a
facility has less to do to meet these requirements. Further, in the
final rule we have specified that existing records do not need to be
duplicated if they contain all of the required information and satisfy
the requirements of part 121, subpart D (Sec.  121.330).
    (Comment 70) Some comments express concern that it is too premature
to require that all foreign facilities prepare and implement a food
defense plan.
    (Response 70) All foreign facilities do not have to prepare and
implement a food defense plan. For example, foreign facilities that are
not required to register are not subject to this rule. This includes a
foreign facility, if food from such a facility undergoes further
manufacturing/processing (including packaging) by another facility
outside the United States (21 CFR 1.226(a)). In addition, the rule
contains exemptions applicable to domestic and foreign facilities
(Sec.  121.5). For example, very small businesses are only required to
keep records documenting their status.

B. Proposed Sec.  121.130--Identification of Actionable Process Steps

    We proposed to require that the owner, operator, or agent in charge
of a facility identify any actionable process steps by either
conducting a facility-specific vulnerability assessment or by using the
four key activity types we identified. Recognizing that various
methodologies may exist to conduct a facility-specific vulnerability
assessment, and not wishing to preclude the benefits of future science
in this area, we did not propose to require a specific methodology for
the facility-specific vulnerability assessment. Further, we proposed
that regardless of the method chosen, the identification of actionable
process steps and the assessment leading to that identification must be
written.
    Some comments agree with the requirements as proposed. In the
following paragraphs, we discuss comments that suggest one or more
changes to, and/or disagree with the proposed requirements. After
considering the comments, we have revised this section as follows: (1)
Removing from the regulatory text the option to identify actionable
process steps by utilizing the four FDA-identified key activity types,
(2) adding to the regulatory text the factors that must be considered
when conducting a vulnerability assessment, (3) adding to the
regulatory text a requirement to explain why each process step was or
was not identified as an actionable process step, (4) adding to the
regulatory text a requirement that the vulnerability assessment must
consider the possibility of an inside attacker, and (5) changing the
title of this section to ``Vulnerability Assessment to Identify
Significant Vulnerabilities and Actionable Process Steps.''
    (Comment 71) Some comments recommend removing from the regulatory
text the option for facilities to use the key activity types as a
method for identifying actionable process steps, and instead, requiring
all facilities to conduct facility-specific vulnerability assessments.
Some comments recommend continuing to provide the option to use key
activity types but not specifically providing for it in the regulatory
text. Under this approach, key activity types would be considered an
``appropriate method'' for identifying actionable process steps with
the specific key activity types identified in guidance. These comments
express concern that identifying a particular methodology (i.e., key
activity types) in the codified indicates there is one ``right'' way to
conduct vulnerability assessments. Furthermore, some comments express
concern that the key activity types may become the de facto standard
for the regulatory inspection of actionable process steps, even if
facilities conduct facility-specific vulnerability assessments. Some
comments express concerns that including key activity types in the
codified would result in mitigation strategies being required at key
activity types regardless of the outcome of a facility-specific
vulnerability assessment.
    (Response 71) The key activity types are based upon the results of
over 50 vulnerability assessments which reflect the activities and
associated vulnerabilities present in a wide array of manufacturing
settings. The vulnerability assessments included consideration of the
three elements now required by Sec.  121.130 to be evaluated in any
vulnerability assessment: (1) The potential public health impact if a
contaminant were added (e.g., severity and scale); (2) the degree of
physical access to product; and (3) the ability of

an attacker to successfully contaminate the food. The four identified
key activity types are processes, steps, or procedures that
consistently ranked as the most vulnerable, regardless of the commodity
being assessed, and reflect significant vulnerabilities to intentional
adulteration caused by acts intended to cause wide scale public health
harm. Therefore, using the key activity types is an appropriate method
to conduct a vulnerability assessment. In addition, using key activity
types has the benefit of allowing facilities with less technical
expertise in conducting food defense vulnerability assessments to
leverage their expertise in food processing to identify actionable
process steps.
    However, in response to comments, we are no longer singling out key
activity types in the regulatory text. Importantly, using key activity
types remains as one appropriate vulnerability assessment method. We
intend to place the key activity types in guidance, which will provide
us with greater flexibility to update them in the future, if necessary.
The final rule provides firms the flexibility to choose a vulnerability
assessment methodology appropriate to their operations, provided that
methodology includes the three fundamental elements required by Sec.
121.130(a). We expect that some firms will use key activity types, and
some firms will use other methods.
    (Comment 72) Some comments recommend that vulnerability assessments
should consider the contribution of existing practices, procedures, and
programs that may already function to reduce vulnerability.
    (Response 72) When conducting facility-specific vulnerability
assessments, the role of existing measures (e.g., security practices,
procedures, or programs) should be determined on a case-by-case basis.
In general, existing measures that are applied to the process (e.g.,
locks, area access controls, peer or supervisory monitoring) and are
not inherent characteristics of a particular process step, should be
considered after the vulnerability assessment is completed and
actionable process steps have been identified, and should not be
considered during the identification of significant vulnerabilities.
For example, when evaluating the vulnerability of a mixing tank, a
facility would not conclude the tank does not represent a significant
vulnerability because the mixing tank lid and sampling ports are
routinely locked. Instead, the vulnerability of the mixing tank would
be evaluated as if the existing measure (in this case the locks) were
not in place. If, in the absence of properly implemented locks, the
mixing tank would be significantly vulnerable, then the facility would
identify the mixing tank as an actionable process step. The facility
may then decide that the existing locks could serve as a mitigation
strategy that reduces the significant vulnerability of the mixing tank
and evaluate if any other mitigation strategies are necessary. The food
defense plan would then capture the mixing tank step as an actionable
process step and the locks as the mitigation strategy. As a mitigation
strategy, the locks would be subject to mitigation strategy management
components (i.e., food defense monitoring, corrective actions, and
verification).
    There are some instances where it is appropriate to consider
existing food defense measures before the vulnerability assessment is
completed. For example, the owner of the same facility may assess a
second mixing tank that is part of an entirely closed system, with no
direct access points into the system, such that an individual
attempting to access this mixing tank likely would cause a major
disruption to the line, foiling any attempted intentional adulteration.
Because this second mixing tank has specific closed properties designed
into the system, that are inherent characteristics of the mixing tank,
it would be appropriate for the facility to consider these inherent
characteristics in the vulnerability assessment. Based on this
assessment, the facility may conclude that the inherent characteristics
of this mixing tank, in this case its enclosed nature, renders the
product inaccessible at this step and, therefore would not identify an
actionable process step associated with this mixing tank (in which
case, there would also be no requirement to implement a mitigation
strategy at this step).
    Permanent equipment changes may reduce a significant vulnerability
to such an extent that a processing step would no longer be considered
an actionable process step. For example, a facility might identify a
rotating air dryer as an actionable process step and in the supporting
rationale discuss the high degree of accessibility at the point where
product is fed from a pneumatic conveyor into the top of the dryer. The
facility later installs a permanent, clear plastic shield affixed to,
and extending from, the discharge of the pneumatic conveyor to the
opening of the dryer. The clear plastic shield enables workers to
supervise the product flow into the dryer while serving as an effective
barrier to an attacker wishing to introduce a contaminant into the
product at the dryer. This engineering improvement would significantly
minimize or eliminate access to product in the dryer and thereby
significantly minimize or prevent a significant vulnerability at this
process step. The implementation of this engineering improvement would
be detailed in the facility's food defense plan and, upon reanalysis,
the facility may determine that this processing step is no longer an
actionable process step.
    (Comment 73) Some comments recommend that vulnerability assessments
should consider downstream processing steps, the volume of product,
shelf life, marketplace turnover, and consumption patterns and that
additional details regarding vulnerability assessments should be in the
regulatory text. The comments did not provide specifics or
recommendations regarding what additional details about vulnerability
assessments should be included.
    (Response 73) As previously stated, we are not prescribing a
specific methodology that facilities must use to conduct vulnerability
assessments to identify actionable process steps. In the preamble to
the proposed rule, we listed a number of elements to consider when
conducting vulnerability assessments (78 FR 78014 at 78042) and did not
require particular elements in the regulatory text. However, in light
of comments requesting further vulnerability assessment details in the
regulatory text, and the removal of key activity types as a separately
identified option, we are specifying that three elements must be
considered in any vulnerability assessment. These three elements are
based on our extensive experience conducting vulnerability assessments
and collaborating with stakeholders to refine vulnerability assessment
methodology and are critical elements of an acceptable vulnerability
assessment methodology. Specifically, we have revised Sec.  121.130 to
require that for each processing step under evaluation, the facility
must consider, at a minimum: (1) The potential public health impact if
a contaminant were added (e.g., severity and scale); (2) the degree of
physical access to product; and (3) the ability of an attacker to
successfully contaminate the product.
    a. Element 1: The potential public health impact if a contaminant
were added (e.g., severity and scale). This factor includes, for each
processing step, consideration of the volume of product impacted, the
number of at risk servings generated, and the number of potential
exposures. As appropriate, and with sufficient scientific rigor, the
facility may also consider other factors such as food velocity (i.e.,
the speed at which a

particular product moves through the distribution system); potential
agents of concern; the infectious or lethal dose of agents of concern;
and the morbidity/mortality rate if the intentional adulteration were
successful. This element is required in the vulnerability assessment
because it enables facilities to focus resources on processing steps
with the highest degree of public health impact if the intentional
adulteration were successful.
    We recognize that some facilities may not have the scientific
knowledge to critically identify and evaluate individual agents of
concern across their production process. The potential public health
impact can also be determined through the consideration of the volume
of food at risk should an act of intentional adulteration be successful
at each process step. This approach would serve to extrapolate the
potential public health impact without the scientifically rigorous
examination of specific agents (e.g., consideration of infectious or
lethal dose). For example, using this approach, a facility considering
the potential public health impact of the intentional adulteration of
its primary ingredient storage tank would consider the volume of food
in the tank and the servings generated from this volume. If the
facility has a 50,000 gallon primary ingredient liquid storage tank
that would generate 800,000 one cup servings (50,000*16), the facility
would consider all of these 800,000 servings as being at risk. Note
that potential servings at risk is not limited to the amount of food
being processed at an actionable process step. This is illustrated by a
process step that applies a minor ingredient, such as a vitamin mixture
applied over toasted cereal as it passes underneath spray nozzles. The
facility's metering tank for application to the cereal is 10 gallons.
However, these 10 gallons will be sprayed over 100,000 servings of
cereal. The facility would conclude that 100,000 servings are at risk
if the intentional adulteration were successful at this point.
    A number of other factors may also go into the calculations a
facility uses to determine the potential public health impact. For
example, if a facility has conducted market research and concludes that
each distribution unit of 20 servings is typically consumed by four
persons, the potential public health impact of that distribution unit
could be considered four persons rather than 20.
    b. Element 2: The degree of physical access to product. This
element includes consideration of, at a minimum, the ability of an
attacker to conduct the attack at the particular processing step under
evaluation; and the openness of the processing step to intentional
adulteration, based on the presence of physical barriers such as gates,
railings, doors, lids, seals, shields, and other barriers. This element
is required in the vulnerability assessment because it enables
facilities to prioritize how easy or difficult it is to access product
at each processing step, based on the inherent characteristics of the
physical environment surrounding the step.
    c. Element 3: The ability of an attacker to successfully
contaminate the product. This element includes, for each processing
step, consideration of, at a minimum, the ease of introducing an agent
to the product; the ability for an agent to be uniformly mixed or
evenly applied; and the ability of an attacker to work unobserved and
have sufficient time to introduce the agent. As appropriate, and with
sufficient scientific rigor, the facility may also consider: The amount
of specific agent required; whether downstream dilution or
concentration steps would affect the volume of agent required; whether
downstream processing would or would not neutralize the agent(s) under
evaluation; and the ability of the attacker to successfully introduce a
sufficient volume of agent to the food without being detected or
interdicted. This element is required in the vulnerability assessment
because it enables facilities to understand whether the amount of agent
required at each processing step is feasible and if subsequent
processing steps would successfully remove an agent if present.
    Taken together, these three required vulnerability assessment
elements provide facilities appropriate tools to adequately identify
which vulnerabilities should be identified as significant
vulnerabilities (i.e., those vulnerabilities, if attacked, could
reasonably be expected to cause wide scale public health harm). If the
step under evaluation has significant vulnerabilities associated with
it and requires the application of mitigation strategies to prevent or
eliminate a significant vulnerability or reduce such vulnerability to
an acceptable level, the step would be categorized as an actionable
process step.
    By utilizing these three required elements when conducting a
vulnerability assessment, regardless of the vulnerability assessment
methodology utilized, facilities are provided with a systematic
approach that enables them to move in a logical, step-wise manner to
identify actionable process steps. First, a facility would develop a
list or flow diagram of each point, step, or procedure in the food
process under evaluation, recognizing that each processing step has
some associated vulnerability (i.e., the susceptibility of a point,
step, or procedure in a facility's food process to intentional
adulteration). Second, the facility would identify which
vulnerabilities are significant vulnerabilities (by using the three
required elements), and third, the facility would identify actionable
process steps where significant vulnerabilities are present. We intend
to provide further guidance on conducting vulnerability assessments to
satisfy these requirements.
    As noted previously, some comments suggested that vulnerability
assessments should consider downstream processing steps, the volume of
product, shelf life, marketplace turnover, and consumption patterns. We
have found that shelf life is not necessarily a good indicator of the
speed at which a particular product moves through the distribution
system (i.e., food velocity), because many products are sold and
consumed months, if not years, before their shelf life expires.
Marketplace turnover and consumption patterns are captured within the
concept of food velocity, which may be considered in a vulnerability
assessment as a component of Element 1, detailed previously in this
document. Likewise, the potential effect of downstream processing can
be considered as a component of Element 3, detailed previously in this
document.
    (Comment 74) One comment suggests adding laboratory professionals
to the list of possible vulnerability assessment team members.
    (Response 74) The list of potential members of the vulnerability
assessment team discussed in the preamble to the proposed rule is not
exhaustive (78 FR 78014 at 78042). The original list included
``personnel working in the areas of security, food safety/quality
assurance or control, human resources, operations, maintenance, and
other individuals deemed necessary to facilitate the formation of the
vulnerability assessment.'' We agree that laboratory professionals can
provide important contributions to the vulnerability assessment and can
be included as potential team members.
    (Comment 75) A few comments seek clarification on what type of
justification would be required in the instance where no significant
vulnerabilities are identified through a vulnerability assessment.
    (Response 75) It has been our experience that most facilities will
identify one or more significant vulnerabilities. For a facility to

conclude that it has no significant vulnerabilities and therefore no
actionable process steps, the facility would need to determine that
none of its production steps present a significant vulnerability for
wide scale public health harm from intentional adulteration. In
conducting its vulnerability assessment, the facility would need to
consider at each step of its process: (1) The potential public health
impact if a contaminant were added (e.g., severity and scale); (2) the
degree of physical access to the product; and (3) the ability of an
attacker to successfully contaminate the product. The written
vulnerability assessment, including the accompanying rationale
supporting the decision not to identify any significant vulnerabilities
would be important for determining if such a facility had complied with
Sec.  121.130.
    (Comment 76) One comment suggests the term ``vulnerability
assessment'' should be clearly defined in the rule.
    (Response 76) We deny this request. As discussed in Response 73,
Sec.  121.130 has been revised to provide required elements the
facility would need to consider at each step of its process when
conducting vulnerability assessments: (1) The potential public health
impact if a contaminant were added (e.g., severity and scale); (2) the
degree of physical access to the product; and (3) the ability of an
attacker to successfully contaminate the product. Additionally, the
definition for significant vulnerability has been revised to include
these three required elements, which underscores the importance of the
evaluation that leads to the identification of significant
vulnerabilities, which in turn leads to the identification of
actionable process steps.
    We believe the combination of required vulnerability assessment
elements in Sec.  121.130 and a revised definition for significant
vulnerability provides a high degree of specificity regarding what
constitutes a vulnerability assessment and will provide direction to
facilities as they select an appropriate vulnerability assessment
methodology.
    (Comment 77) One comment suggests that the term ``secondary
ingredient handling'' used in a key activity type is confusing because
it is not obvious whether ``secondary'' describes ``ingredient'' or
``handling,'' nor what is meant by ``secondary.''
    (Response 77) We are removing the key activity types from the
regulatory text, although the key activity types are one appropriate
method to conduct vulnerability assessments to identify actionable
process steps. Consequently, we will consider these comments when
developing guidance to support the use of key activity types as an
appropriate method to conduct a vulnerability assessment.
    (Comment 78) One comment suggests that the definition for
``holding'' used in two key activity types should be modified to
account for activities that involve the safe and effective storage of
raw agricultural commodities, other than fruits and vegetables,
intended for further distribution or processing, but does not include
activities that transform a raw agricultural commodity into a processed
food. The specific example of mineral oil applied to raw grains and
oilseeds for dust control was provided.
    (Response 78) In response to the comment, we have conducted an
analysis of this activity and believe that the storage of mineral oil
and its application onto raw, whole grains or oilseeds in accordance
with 21 CFR 172.878 is not a significant vulnerability and facilities
engaged in these specific practices are not required to evaluate these
processing steps when conducting vulnerability assessments (Ref. 15).
Facilities storing and using mineral oil on other food products, such
as baked goods, condiments, spices, or confectionery products, are
required to evaluate mineral oil storage and use when conducting
vulnerability assessments.
    Additionally, we are removing the key activity types from the
regulatory text, as discussed previously, although the key activity
types are one appropriate method to conduct vulnerability assessments
to identify actionable process steps. Further, we are revising the
definition of ``holding'' in this final rule, as discussed in section
IV.A.3, by removing the distinction for farms and farm mixed-type
facilities and adding that holding also includes activities performed
incidental to storage of a food, but does not include activities that
transform a RAC into a processed food and we include additional
examples of holding activities. However, the holding of food in liquid
storage tanks remains an activity subject to the rule under Sec.
121.5(b).
    (Comment 79) Some comments state that when conducting vulnerability
assessments, facilities should take different processing steps into
consideration, but facilities should not be expected to conduct
vulnerability assessments based on product type. Rather, they should be
able to conduct a tailored vulnerability assessment based on the best
methodology for each facility, either in its entirety or by any
appropriate, locally determined methodological approach, such as
grouping different production areas or processing steps.
    (Response 79) Facilities have the flexibility to choose a
vulnerability assessment methodology appropriate to their operations,
provided that methodology includes consideration of three fundamental
elements (i.e., the evaluation of the potential public health impact if
a contaminant were added (e.g., severity and scale), the degree of
physical access to the product, and the ability of an attacker to
successfully contaminate the product) and is performed by an individual
qualified by training and/or experience to conduct vulnerability
assessments. A facility must conduct written vulnerability assessments
for all of the foods that it manufactures/processes, packs, or holds.
We recognize there are instances where facilities are manufacturing
very similar products using either the same equipment and/or very
similar processes. In such instances, it is appropriate for the
facility to conduct vulnerability assessments of like products by
grouping these products into one or more processes and conducting
vulnerability assessments on these process groupings. However, any
product or process-specific differences must be carefully delineated
and noted in the vulnerability assessment, and the facility must
clearly identify the specific products included in each vulnerability
assessment. In some facilities with limited types of products, the
written vulnerability assessment may contain a single set of process
steps that addresses all of the products produced. For example, a
facility making fruit-flavored beverages may be able to conduct a
single vulnerability assessment for all of its beverages using a single
set of processing steps.
    In other facilities, there may not be a practical way to group all
products into a single set of process steps, and vulnerability
assessments may be needed for multiple groups of products. For example,
a facility that makes both ready-to-eat (RTE) entrees and entrees that
are not RTE may need to conduct a vulnerability assessment of the RTE
entrees and conduct a separate vulnerability assessment for the entrees
that are not RTE.
d. Qualified Individual
    (Comment 80) Several comments requested more information regarding
the requirement that vulnerability assessments must be conducted by
individual(s) qualified by experience and/or training using appropriate
methods. Specifically, additional clarification was requested regarding

training such individuals must receive (particularly in the absence of
FDA standardized curriculum); the process and criteria by which
relevant work experience may supplement or substitute for training; and
the criteria by which FDA will determine if the individual is
adequately qualified to conduct vulnerability assessments.
Additionally, several comments believe there is confusion with the use
of qualified individuals in this rule compared to other rules and
believe the term should be defined.
    (Response 80) We agree that further clarification is needed
regarding a definition for a qualified individual in the context of
this rule and in particular, how it relates to the qualifications
necessary to conduct vulnerability assessments. Consequently, in Sec.
121.3 we have defined a qualified individual to mean ``a person who has
the education, training, or experience (or a combination thereof)
necessary to perform an activity required under subpart C, as
appropriate to the individual's assigned duties. A qualified individual
may be, but is not required to be, an employee of the establishment.''
We have further clarified the qualifications necessary for the conduct
of a vulnerability assessment by creating a new section (Sec.  121.4,
Qualifications of Individuals Who Perform Activities Under Subpart C).
In Sec.  121.4 we state ``each individual responsible for . . .
conducting or overseeing a vulnerability assessment as required in
Sec.  121.130'' must (1) have the appropriate education, training, or
experience (or a combination thereof) necessary to properly perform the
activities; and (2) have successfully completed training for the
specific function at least equivalent to that received under a
standardized curriculum recognized as adequate by FDA or be otherwise
qualified through job experience to conduct the activities. Job
experience may qualify an individual to perform these functions if such
experience has provided an individual with knowledge at least
equivalent to that provided through the standardized curriculum. This
new definition and qualifications section has provided more information
on what would qualify an individual to perform a vulnerability
assessment. We believe that our definition of ``qualified individual''
as well as the qualifications required of those individuals have
addressed this need and fulfill the request of the comments. This new
approach is consistent with other FSMA rules, including the PCHF final
rule, which we believe allows for easier understanding and
implementation for the regulated industry.
    As stated in the preamble to the proposed rule, we recognize that
the task of performing a vulnerability assessment requires an
individual with a specific skill set to properly assess and prioritize
the various points, steps, or procedures in a food process to
characterize their susceptibility to intentional adulteration, to
identify significant vulnerabilities and to identify actionable process
steps where mitigation strategies are essential to significantly
minimize or eliminate the significant vulnerabilities. We also believe
that various activities required by this rule may require higher levels
of training based on the difficulty and intensity of the task. We
believe that a standardized curriculum will be required to ensure clear
and consistent training is provided for this activity. The training
developed for the purpose of conducting or overseeing a vulnerability
assessment will require an in-depth analysis of the functional and
thought processes required to properly characterize significant
vulnerabilities associated with a facility's points, steps or
procedures and the identification of actionable process steps. The
process of conducting a vulnerability assessment may be new to much of
the industry and the training must take this into consideration. The
standardized curriculum for conducting a vulnerability assessment will
need to be a comprehensive training that teaches an individual the
required components of a vulnerability assessment and provides enough
information for an individual to calibrate their decision making based
on the scientific analysis required by a vulnerability assessment. We
believe that the curriculum designed for this activity will require
multiple days and may best be offered in person.
    (Comment 81) A few comments believe the key activity type option
for identifying actionable process steps should include a requirement
that the evaluation be performed by an individual(s) qualified by
experience and/or training using appropriate methods.
    (Response 81) We agree with the comments and this is reflected in
the revised requirements. As explained in Response 71, key activity
types have been removed from the regulatory text, but are still
considered an appropriate method to conduct a vulnerability assessment.
The rule requires that a vulnerability assessment, no matter which
methodology is used, must be conducted or overseen by a qualified
individual. We note that the requirements to conduct or oversee a
vulnerability assessment will differ depending on the type of
vulnerability assessment conducted. Using key activity types requires
less technical expertise and experience than other methodologies and
this would be reflected in the necessary qualifications.

C. Proposed Sec.  121.135--Focused Mitigation Strategies for Actionable
Process Steps

    We proposed that the owner, operator, or agent in charge of a
facility must identify and implement focused mitigation strategies at
each actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by such facility
will not be adulterated under section 402 of the FD&C Act (21 U.S.C.
342). As discussed in section IV.B.3, in the final rule we use the term
``mitigation strategies'' and no longer reference focused and broad
mitigation strategies.
    In addition, we have modified this provision to provide that for
each mitigation strategy or combination of strategies implemented at
each actionable process step, the facility must include a written
explanation of how the mitigation strategy(ies) sufficiently minimizes
or prevents the significant vulnerability associated with the
actionable process step. In the preamble to the proposed rule, we
stated that a justification for how the strategy significantly reduces
or eliminates the risk of intentional adulteration at that actionable
process step(s) must be documented (see 78 FR 78014 at 78048); however,
this was not explicitly included in the regulatory text. We believe
that providing additional flexibility in the nature of the mitigation
strategies facilities may employ makes it critical that facilities
explain their rationale as to how the strategy(ies) are, in fact,
protective of the actionable process step. This explanation will
include a facility's rationale for selecting its mitigation strategies.
This explanation can provide additional benefits to the facility by
assisting them in the decision-making process for identifying
mitigation strategies as well as identifying the most appropriate
mitigation strategies management components for the mitigation
strategy(ies).
    Based on our vulnerability assessments, we believe that adequate
mitigation strategies are designed to minimize or eliminate the chances
an attacker would be successful if an act of intentional adulteration
were attempted at the actionable process step by either

(1) minimizing the accessibility of the product to an attacker (e.g.,
physically reducing access to the product by locking storage tanks) or
(2) reducing the opportunity for an attacker to successfully
contaminate the product (e.g., increasing observation of the area
through supervision or use of the buddy system), or a combination of
both. Mitigation strategies found within FDA's Mitigation Strategies
Database, generally, are designed to address one or both of these
concepts. The content of the Mitigation Strategies Database is derived
from our experience conducting vulnerability assessments with industry
and can serve as a resource for facilities to identify adequate and
appropriate mitigation strategies. The explanation of how the
mitigation strategy sufficiently minimizes or prevents the significant
vulnerability associated with the actionable process step would,
generally, address the mitigation strategy's impact on one or both of
these outcomes.
    For example, a facility seeking to protect its liquid storage
tank's access hatch with a lock may conclude that the lock
significantly reduces access to the liquid food stored in the tank by
rendering the hatch inaccessible and include this explanation in its