(Response 307) Consistent with Response 258, we have revised the
provision to specify that the equipment must be constructed so that it
can be kept ``clean and sanitary.''

E. Proposed Sec.  117.40(e)--Freezer and Cold Storage Compartments

    We proposed that each freezer and cold storage compartment used to
store and hold food capable of supporting growth of microorganisms must
be fitted with an indicating thermometer, temperature measuring device,
or temperature-recording device so installed as to show the temperature
accurately within the compartment. We also proposed to delete the
recommendation that each freezer and cold storage compartment used to
store and hold food capable of supporting growth of microorganisms be
fitted with an automatic control for regulating temperature or with an
automatic alarm system to indicate a significant temperature change in
a manual operation.
    (Comment 308) Some comments ask us to clarify that this requirement
is only for foods that require temperature control for food safety, and
does not apply to any intact fruits or vegetables that are only held at
specific temperatures for quality and shelf-life purposes. Some
comments ask us to change this requirement to a recommendation for the
same reason. Some comments assert that temperature control for intact
fruits and vegetables is likely not always necessary or even desirable
(e.g., to avoid chill damage).
    (Response 308) We decline this request. The requirement applies to
refrigerated storage when the establishment has placed food in a
refrigerated storage compartment, whether for food safety or for food
quality (e.g., to prevent the growth of spoilage microorganisms). The
provision, which is an existing requirement in Sec.  110.40, does not
specify which foods must be refrigerated or what the refrigeration
temperature must be. However, once the establishment has determined
that refrigerated storage is appropriate, either for food safety or
food quality, it is appropriate to require that the establishment have
evidence that it is refrigerating the food as it has decided to do.

F. Proposed Sec.  117.40(f)--Accurate and Precise Instruments and
Controls

    We proposed that instruments and controls used for measuring,
regulating, or recording temperatures, pH, acidity, water activity, or
other conditions that control or prevent the growth of undesirable
microorganisms in food must be accurate and precise and adequately
maintained, and adequate in number for their designated uses.
    (Comment 309) Some comments ask us to specify ``calibrated'' for
clarity, accuracy, and completeness. Some comments assert that proper
calibration of such equipment is essential to ensure food safety, and
does not entail so large a cost as to preclude even small companies
from compliance.
    (Response 309) We decline this request. The request of this comment
is already addressed by our proposal to revise this long-standing
provision to require that these types of instruments be accurate, as
well as precise. As discussed in Comment 519 and Response 519, some
types of instruments generally are subject to accuracy checks rather
than to calibration.

G. Proposed Sec.  117.40(g)--Compressed Air or Other Gases

    We proposed no revisions to the requirement that compressed air or
other gases mechanically introduced into food or used to clean food-
contact surfaces or equipment must be treated in such a way that food
is not contaminated with unlawful indirect food additives.
    (Comment 310) Some comments ask us to specify that compressed air
or other gases must be ``filtered or otherwise treated'' for clarity.
    (Response 310) We decline this request. We agree that filtration is
a common treatment to prevent contamination, but disagree that it is
necessary to modify this long-standing requirement to add this
particular example of a treatment to prevent contamination with
unlawful indirect food additives. As written, the provision provides
flexibility for an establishment to determine the appropriate treatment
for compressed air or other gases in a manner that works best for its
plant.
    (Comment 311) Some comments ask us to strike the phrase ``with
unlawful indirect food additives.'' These comments assert that the
wording would be equally effective without the phrase and that striking
it would result in a stronger and more absolute requirement.
    (Response 311) We decline this request. Although some persons might
realize that the provision requires them to protect against unlawful
indirect food additives, such an interpretation may not be universal.

XVIII. Subpart B: Comments on Proposed Sec.  117.80(a)--General
Processes and Controls

    We proposed to re-establish the provisions of Sec.  110.80 in new
Sec.  117.80(a) with some revisions to modernize them and with some

redesignations. Some comments support one or more of these proposed
provisions without change. Some comments that support the proposed
provisions suggest alternative or additional regulatory text (see,
e.g., Comment 316) or ask us to clarify how we will interpret the
provision (see, e.g., Comment 317). Other comments that support the
proposed provisions ask us to revise or clarify current provisions that
we proposed to re-establish in part 117 without change (see, e.g.,
Comment 312 and Comment 320).
    In the following sections, we discuss comments that ask us to
clarify the proposed provisions or that disagree with, or suggest one
or more changes to, the proposed provisions, including comments on
provisions that we did not propose to revise. After considering these
comments, we have revised the proposed provisions as shown in table 23,
with editorial and conforming changes as shown in table 52.

                             Table 23--Provisions for General Processes and Controls
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(a)(1 )--Adequate   No.......................  Yes......................  No.
 sanitation principles.
Sec.   117.80(a)(2)--Quality     No.......................  Yes......................  No.
 control operations.
Sec.   117.80(a)(3)--            No.......................  Yes......................  No.
 Supervising overall sanitation.
Sec.   117.80(a)(4)--Production  Yes......................  Yes......................  Yes.
 procedures.
Sec.   117.80(a)(5)--Chemical,   Yes......................  Yes......................  No.
 microbial, or extraneous-
 material testing procedures.
Sec.   117.80(a)(6)--            No.......................  Yes......................  No.
 Contaminated food.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(a)(1)--Adequate Sanitation Principles

    We proposed no revisions to the requirements of current Sec.
110.80 (proposed Sec.  117.80(a)(1)) that all operations in the
manufacturing, processing, packing, and holding of food (including
operations directed to receiving, inspecting, transporting, and
segregating) be conducted in accordance with adequate sanitation
principles.
    (Comment 312) Some comments ask us to clarity ``adequate sanitation
principles.'' Some of these comments express concern that facilities
receiving raw produce that will be further cleaned or processed will be
unable to meet this requirement and assert that this requirement will
not provide additional public health benefits.
    (Response 312) These comments fail to explain how we have
interpreted the provision in a way that has been problematic such that
clarification is necessary. The term ``adequate'' is a long-standing
term that we defined in its current form when we first established the
umbrella CGMPs in 1969 (34 FR 6977 at 6978). Furthermore, during a
previous rulemaking to revise the umbrella CGMPs and establish current
Sec.  110.80 we explained that the phrase ``adequate sanitation
principles'' must be broad so that industry can easily adapt sanitation
principles to its existing procedures (51 FR 22458 at 22461).
    (Comment 313) Some comments ask us to specify that operations be
conducted in accordance with adequate sanitation principles ``specific
to the operation'' to provide for extended time intervals between
sanitation procedures. These comments explain that in the case of low-
moisture almonds, sanitation intervals may be extended in order to
minimize addition of water into the facility.
    (Response 313) We decline this request. By specifying that
sanitation principles must be ``adequate,'' the provision already
provides flexibility such as that requested by these comments. In
addition, the rule does not specify any time intervals for conducting
sanitation operations and, thus, the provision needs no qualification
to provide flexibility for an establishment to adopt a frequency of
sanitation procedures consistent with its operations.

B. Proposed Sec.  117.80(a)(2)--Quality Control Operations

    We proposed no revisions to the requirements of current Sec.
110.80 (proposed Sec.  117.80(a)(2)) that appropriate quality control
operations be employed to ensure that food is suitable for human
consumption and that food-packaging materials are safe and suitable.
    (Comment 314) Some comments assert that specifying that food-
packaging materials must be ``safe and suitable'' is confusing because
the definition for ``safe and suitable'' at Sec.  130.3(d) defines the
phrase with respect to ingredients.
    (Response 314) The requirement is a long-standing provision that
has been used in this context for decades. When we first proposed this
provision during a previous rulemaking to revise the umbrella CGMPs, we
included this exact phrase and did not receive any comments regarding
its use (44 FR 33238 at 33246). Furthermore, as evidence that industry
commonly understands the use of the term ``suitable'' in the context of
CGMP requirements in addition to requirements applicable to ingredients
used in standardized foods, we note that we substituted the term
``suitable'' for ``fit'' in another provision (Sec.  110.80(a)(1)) in
response to comments from industry stating that ``suitable'' was a more
familiar term than ``fit'' (51 FR 22458 at 22470).

C. Proposed Sec.  117.80(a)(3)--Supervision of Overall Sanitation

    We proposed no revisions to the requirements of current Sec.
110.80 (proposed Sec.  117.80(a)(3)) that overall sanitation of the
plant be under the supervision of one or more competent individuals
assigned responsibility for this function.
    (Comment 315) Some comments ask us to revise this provision to
specify that it applies to overall cleaning of the plant, as well as
overall sanitation of the plant.
    (Response 315) We decline this request. Sanitation is a general
term that already encompasses cleaning (and, as appropriate,
sanitizing).

D. Proposed Sec.  117.80(a)(4)--Production Procedures

    We proposed that all reasonable precautions must be taken to ensure
that production procedures do not contribute to cross-contact and
contamination from any source.
    (Comment 316) Some comments assert that the phrase ``all reasonable
precautions'' is too extreme and prescriptive and suggest that
``adequate'' would be more appropriate than ``all'' to

describe the intended measures and precautions.
    (Response 316) We agree that ``adequate'' is more appropriate than
``all'' and have substituted the word ``adequate'' for ``all
reasonable'' in the final rule.

E. Proposed Sec.  117.80(a)(5)--Chemical, Microbial, or Extraneous-
Material Testing Procedures

    We proposed that chemical, microbial, or extraneous-material
testing procedures must be used where necessary to identify sanitation
failures or possible cross-contact and food contamination.
    (Comment 317) Some comments ask whether the word ``must'' in the
provision means that testing will always be required, including for
food allergens. Other comments assert that testing should only be used
when there is reason to suspect a specific problem has occurred and
when methods are available.
    (Response 317) Testing is not always required. The provision
provides flexibility for an establishment to test when appropriate,
such as when a facility determines that it is necessary to use rapid
ATP (adenosine triphosphate) swabs as an indicator of microbial or food
residue contamination to verify cleaning of a line prior to running a
different product (Ref. 56). Facilities commonly conduct tests on food
for microorganisms that indicate sanitation failures, such as testing
for total plate count, generic E. coli, total coliforms, etc. (Ref.
57). When the number of such organisms exceeds expectation, sanitation
or other failures are suspected and the facility can take actions to
determine the source of the problem.
    (Comment 318) Some comments oppose any implication that food
manufacturers are required to develop test methods or analytical
standards, or search out methods that are not readily available, for
this or any other purpose.
    (Response 318) The provision does not require food manufacturers to
develop test methods or analytical standards, or search out methods
that are not readily available.
    (Comment 319) Some comments suggest that testing as part of an
environmental monitoring program should be risk-based and include
allergens, but should not be required for finished product.
    (Response 319) The provision does not use the term ``environmental
monitoring,'' which is a term that has come to be associated with
monitoring for environmental pathogens rather than for other substances
that may contaminate the food processing environment. Likewise, the
provision does not establish requirements for environmental monitoring
for finished product. As discussed in Response 317, the provision
provides flexibility for an establishment to test when testing is
appropriate, such as when the facility determines testing would be
useful to verify adherence to CGMPs or when there is a problem such as
allergen cross-contact.

F. Proposed Sec.  117.80(a)(6)--Contaminated Food

    We proposed no revisions to the requirements of current Sec.
110.80 (proposed Sec.  117.80(a)(6)) that all food that has become
contaminated to the extent that it is adulterated be rejected, or if
permissible, treated or processed to eliminate the contamination.
    (Comment 320) Some comments assert that the use of the phrase ``if
permissible'' is vague and confusing and should be replaced by a
statement of precisely what is impermissible.
    (Response 320) We acknowledge that the phrase ``if permissible''
does not communicate the circumstances under which it is permissible to
treat or process a food to eliminate contamination. Rather than add
such circumstances to the rule, we have replaced the phrase ``if
permissible'' with ``if appropriate.'' In the following paragraphs, we
discuss examples of when treatment or processing to eliminate
contamination would or would not be appropriate.
    Some RACs, such as cocoa beans, can become adulterated with insects
or filth but may be fumigated or cleaned in accordance with an
application for reconditioning submitted to FDA to bring the product
into compliance. Acid or acidified canned goods with microbial
contamination due to a container defect may be reconditioned by sorting
out the defective containers to ensure that containers released into
commerce are intact and the product is not contaminated. Tree nuts with
signs of mold growth can be reconditioned using methods that separate
the moldy nuts from those that are not contaminated. Tree nuts found to
be contaminated with Salmonella may be treated by processes such as
steam or propylene oxide when such treatments have been validated to
provide an adequate reduction of Salmonella. A heat-treated food
contaminated from the environment, such as a heat-treated, dried
protein product, can sometimes be rehydrated, and a food establishment
could repeat the processing to reduce pathogens. Other products, such
as many types of produce, are not normally processed to reduce
pathogens, and product quality may be impacted by such treatments. Even
though processing techniques such as irradiation have the potential to
reduce pathogens, irradiation is a food additive that requires
approval. For example, as of January 15, 2015, irradiation had been
approved for control of foodborne pathogens and extension of shelf-life
in fresh iceberg lettuce and fresh spinach, but not in other fresh
leafy greens. Using irradiation for a purpose that has not been
approved (such as for the irradiation of fresh leafy greens other than
fresh iceberg lettuce and fresh spinach) would render the food
adulterated under section 402(a)(2)(C)(i) of the FD&C Act and, thus, it
would not be appropriate to treat or process fresh leafy greens other
than fresh iceberg lettuce and fresh spinach using irradiation.

XIX. Subpart B: Comments on Proposed Sec.  117.80(b)--Processes and
Controls for Raw Materials and Other Ingredients

    We proposed to re-establish the provisions of Sec.  110.80(a) in
new Sec.  117.80(b) with some revisions to modernize them. Some
comments support one or more of these proposed provisions without
change. For example, some comments support a new provision that would
require raw materials and ingredients that are food allergens, and
rework that contains food allergens, to be identified and held in a
manner that prevents allergen cross-contact. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text (see, e.g., Comment 324, Comment 325, Comment 328, and Comment
329) or ask us to clarify how we will interpret the provision (see,
e.g., Comment 323 and Comment 327).
    In the following sections, we discuss comments that ask us to
clarify the proposed provisions or that disagree with, or suggest one
or more changes to, the proposed provisions, including comments on
provisions that we did not propose to revise. After considering these
comments, we have revised the proposed provisions as shown in table 24,
with editorial and conforming changes as shown in table 52.

             Table 24--Provisions for Processes and Controls for Raw Materials and Other Ingredients
----------------------------------------------------------------------------------------------------------------
                                  Did we propose revisions   Did we get comments that
           Provision               or request comment on        disagreed with the         Did we modify the
                                   potential  revisions?       proposed provision?     proposed regulatory text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(b)(1)--            Yes......................  Yes......................  Yes.
 Inspection, storage, and
 handling of raw materials and
 other ingredients.
Sec.   117.80(b)(2)--Levels of   Yes......................  Yes......................  No.
 microorganisms in raw
 materials and other
 ingredients.
Sec.   117.80(b)(3)--Natural     Yes......................  Yes......................  No.
 toxins in raw materials and
 other ingredients.
Sec.   117.80(b)(4)--Pests,      Yes......................  Yes......................  No.
 undesirable microorganisms,
 and extraneous material in raw
 materials and other
 ingredients.
Sec.   117.80(b)(5)--Holding     Yes......................  Yes......................  No.
 raw materials, other
 ingredients, and rework in
 bulk.
Sec.   117.80(b)(6)--Frozen raw  No.......................  No.......................  No.
 materials and other
 ingredients.
Sec.   117.80(b)(7)--Liquid and  Yes......................  Yes......................  No.
 dry raw materials and other
 ingredients.
Sec.   117.80(b)(8)--Raw         Yes......................  Yes......................  No.
 materials and other
 ingredients that are food
 allergens.
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(b)(1)--Inspection, Segregation and Handling of
Raw Materials and Other Ingredients

    We proposed that raw materials and ingredients must be inspected
and segregated or otherwise handled as necessary to ascertain that they
are clean and suitable for processing into food and must be stored
under conditions that will protect against cross-contact and
contamination and minimize deterioration. Raw materials must be washed
or cleaned as necessary to remove soil or other contamination. Water
used for washing, rinsing, or conveying food must be safe and of
adequate sanitary quality. Water may be reused for washing, rinsing, or
conveying food if it does not increase the level of contamination of
the food or cause cross-contact.
    We also proposed to continue to recommend that containers and
carriers of raw materials be inspected on receipt to ensure that their
condition has not contributed to cross-contact, contamination, or
deterioration. However, we also requested comment on whether to
establish this recommendation as a requirement (78 FR 3646 at 3724).
    (Comment 321) Some comments express concern about revising current
Sec.  110.80(a)(1) to require, rather than recommend, that containers
and carriers of raw materials be inspected on receipt. Some comments
focus on practical problems associated with inspecting bins containing
RACs such as produce. These comments explain that produce bins received
by a packing establishment are too large to be handled directly and
instead are delivered by a fork lift followed by automated travel
through the establishment.
    (Response 321) We agree that circumstances such as those described
in these comments make it appropriate to continue to recommend, but not
require, that containers and carriers of raw materials be inspected on
receipt to ensure that their condition has not contributed to allergen
cross-contact, contamination, or deterioration. Therefore, we are not
re-establishing this nonbinding recommendation as a requirement.
Instead, as discussed in Response 67, we have deleted this non-binding
provision from the rule.

B. Proposed Sec.  117.80(b)(2)--Levels of Microorganisms in Raw
Materials and Other Ingredients

    We proposed that raw materials and ingredients must either not
contain levels of microorganisms that may render the food injurious to
health of humans, or they must be pasteurized or otherwise treated
during manufacturing operations so that they no longer contain levels
that would cause the product to be adulterated. We also proposed to
delete guidance regarding how to comply with this requirement.
    (Comment 322) Some comments ask us to supply the list of
microorganisms that may render the food injurious to the health of
humans. Some comments assert that we would have to establish acceptable
pathogen concentration limits in order for industry to comply with this
provision.
    (Response 322) We are not providing a list of microorganisms that
may render the food injurious to the health of humans. CGMPs establish
procedural requirements, not declarations of foods that are
adulterated. It is not necessary for us to establish acceptable
pathogen concentration limits in order for industry to comply with this
provision. Moreover, several Compliance Policy Guides (CPGs) provide
guidance to our investigators about agency policies that apply when
food is contaminated with microorganisms, and these CPGs are available
to industry (Ref. 58) (Ref. 59) (Ref. 60) (Ref. 61) (Ref. 62).
    (Comment 323) Some comments express concern about the requirement
for pasteurization, explaining that fresh produce cannot be
pasteurized.
    (Response 323) The proposed provision would not require
pasteurization of products such as produce. The proposed provision
clearly states that pasteurization or other treatment is only required
when raw materials and other ingredients contain levels of
microorganisms that may render the food injurious to health of humans.
However, when products such as produce contain levels of microorganisms
that may render the food injurious to health of humans, and the
products cannot be pasteurized or otherwise treated so that they no
longer contain levels that would cause the product to be adulterated,
other provisions require that the product be rejected and disposed of
in a manner that protects against the contamination of other food (see,
e.g., Sec. Sec.  117.80(a)(6) and 117.80(c)(9)).
    (Comment 324) Some comments assert that this requirement is overly
broad and should only apply to RTE food. These comments express the
view that we should not focus on the issue of microbiological
contamination in foods that are early in the supply chain (other than
produce that will be consumed without adequate processing or cooking).
Some comments suggest adding a statement to be provided in commercial
documentation accompanying the sale of produce not covered by the
proposed produce safety rule to alert potential purchasers to the
hazard that may exist and allow them to determine whether the food
offered for sale is suitable for their particular needs or whether the
food requires commercial formulation, processing, or both to adequately
reduce microorganisms.
    (Response 324) It is not necessary to narrow this requirement to
RTE food to

provide for use of raw materials and other ingredients that are early
in the supply chain. The requirement already clearly provides for
pasteurization or other treatment during manufacturing operations so
that the processed product would no longer contain levels that would
cause the product to be adulterated. See also our previous discussion
of the importance of this provision during a previous rulemaking to
revise the umbrella CGMPs (51 FR 22458 at 22470).
    We decline the request to require a statement in commercial
documentation when produce is not covered by the produce safety rule.
As discussed in section XXVII, we are providing for a narrow use of
commercial documentation, when a manufacturer/processor that has
identified a hazard requiring a preventive control does not establish a
preventive control because it: (1) Relies on its customer to ensure
that an identified hazard will be controlled and (2) discloses, in
documents accompanying the food, in accordance with the practice of the
trade, that the food is ``not processed to control [identified
hazard]'' (See Sec.  117.136(a)(2), (3), and (4)). That use of
commercial documentation reflects the outcome of a hazard analysis--in
particular, an outcome in which the manufacturer/processor determines
that a hazard requires a preventive control. The vast majority of the
produce that we proposed would not be subject to the requirements of
the forthcoming produce safety rule would either be produce that is
going to commercial processing that adequately reduces the presence of
microorganisms of public health significance or produce that is rarely
consumed raw. Thus, there would be no benefit to alert potential
purchasers to a hazard because such produce has been determined to be
low-risk, based on the findings of a qualitative assessment of risk
(e.g., for produce rarely consumed raw) or because it will not go
directly to the consumer but to commercial processing to adequately
reduce pathogens. We see no reason to also establish a broad CGMP
requirement that would apply regardless of the outcome of a hazard
analysis.

C. Proposed Sec.  117.80(b)(3)--Natural Toxins in Raw Materials and
Other Ingredients

    We proposed that raw materials and ingredients susceptible to
contamination with aflatoxin or other natural toxins comply with
current FDA regulations for poisonous or deleterious substances before
these materials or ingredients are incorporated into finished food. We
also proposed to delete guidance regarding how to comply with this
requirement and to delete a requirement for compliance with action
levels, which are not binding.
    (Comment 325) Some comments ask us to delete ``aflatoxin'' from the
provision because it is redundant with ``other natural toxin.''
    (Response 325) We decline this request. Aflatoxin is an important
natural toxin that is an example illustrating what we mean when we
refer to ``natural toxins.'' An illustrative example does not create a
redundancy.

D. Proposed Sec.  117.80(b)(4)--Pests, Undesirable Microorganisms and
Extraneous Materials in Raw Materials and Other Ingredients

    We proposed that raw materials, ingredients, and rework susceptible
to contamination with pests, undesirable microorganisms, or extraneous
material must comply with applicable FDA regulations for natural or
unavoidable defects if a manufacturer wishes to use the materials in
manufacturing food. We also proposed to delete guidance regarding how
to comply with this requirement and to delete the requirement for
compliance with action levels, which are not binding.
    (Comment 326) Some comments ask us to qualify that the requirement
does not apply if the manufacturing process includes steps that serve
to decontaminate the food.
    (Response 326) We decline this request. We have defined ``defect
action level'' to mean a level of a non-hazardous, naturally occurring,
unavoidable defect at which FDA may regard a food product
``adulterated'' and subject to enforcement action under section
402(a)(3) of the FD&C Act (see Sec.  117.3). It is not uncommon for an
establishment to receive raw materials (such as RACs) that contain
extraneous material that is removed before production. For example,
some methods of harvesting vegetable RACs (e.g., pulling up most of the
plant material in the field) result in inclusion of extraneous material
that is removed during initial cleaning steps at processing facilities.
It is not necessary to revise this long-standing requirement to provide
for such common procedures. Moreover, in general we use the term
``decontaminate'' to refer to an action taken when the substance is a
hazardous substance (such as a pathogen) rather than to a non-hazardous
substance.

E. Proposed Sec.  117.80(b)(5)--Holding Raw Materials, Other
Ingredients, and Rework in Bulk

    We proposed that raw materials, ingredients, and rework must be
held in bulk, or in containers designed and constructed so as to
protect against cross-contact and contamination and must be held at
such temperature and relative humidity and in such a manner as to
prevent the food from becoming adulterated. Material scheduled for
rework must be identified as such.
    (Comment 327) Some comments express concern that this requirement
would make the use of wooden bins in the produce industry problematic
and ask us to clarify whether it is our intent to prohibit use of
wooden bins. Some comments ask us to clarify whether the provision
would preclude using or storing containers (such as trailers and
gondolas used in the produce industry) outdoors because such containers
cannot be covered.
    (Response 327) We do not intend to interpret this provision in such
a way that would prohibit the use of wooden bins in the produce
industry or preclude using and storing containers such as trailers and
gondolas outside. Importantly, these CGMP requirements are long-
standing provisions that we have not interpreted as prohibiting wooden
containers in the produce industry. See also our ``Guide to Produce
Farm Investigations'' (Ref. 63), which applies during investigations
when an outbreak and traceback investigation implicates a farm and
related operations, or as a follow-up to a produce sample that tests
positive for contamination with a pathogen.
    (Comment 328) Some comments ask us to add ``in-process'' materials
to the provision.
    (Response 328) We decline this request, which is already covered by
Sec.  117.80(c)(7). We note that the requirements directed to raw
materials and other ingredients are established in Sec.  117.80(b),
whereas the requirements directed to in-process materials are
established in Sec.  117.80(c).

F. Proposed Sec.  117.80(b)(7)--Liquid or Dry Raw Materials and Other
Ingredients

    We proposed that liquid or dry raw materials and ingredients
received and stored in bulk form must be held in a manner that protects
against cross-contact and contamination.
    (Comment 329) Some comments ask us to revise the proposed provision
to clarify that liquid or dry raw materials and ingredients received
and stored in bulk form must be held in a manner that

protects against deterioration, as well as in a manner that protects
against allergen cross-contact and contamination.
    (Response 329) We decline this request. The rule already requires
that raw materials and ingredients be stored under conditions that will
minimize deterioration (see Sec.  117.80(b)(1)).

G. Proposed Sec.  117.80(b)(8)--Raw Materials and Other Ingredients
That Are Food Allergens

    We proposed to establish a new requirement that raw materials and
ingredients that are food allergens, and rework that contains food
allergens, be identified and held in a manner that prevents cross-
contact.
    (Comment 330) Some comments ask us to exempt finished, packaged
product that is later reworked from the proposed requirement.
    (Response 330) We decline this request. A product that is in
finished, packaged form, including label information that identifies
any food allergen, would be in compliance with the requirement and need
not be exempted. However, when a product is packaged, but not yet
labeled, it is necessary to identify the product in a way (other than a
product label) that would prevent allergen cross-contact while the
packaged product is being held. For example, shelves holding the
product before labeling operations could have a sign such as ``Contains
peanuts.''
    (Comment 331) Some comments ask us to modify the proposed
requirement to specify that it applies to raw materials and ingredients
that ``are or contain'' food allergens and that it applies to in-
process material, as well as to raw materials and ingredients and to
rework. These comments explain that such modifications would provide
clarity and completeness.
    (Response 331) We decline these requests. The rule defines ``food
allergen'' to mean a major food allergen as defined in section 201(qq)
of the FD&C Act, and section 201(qq) of the FD&C Act already specifies
that a major food allergen is a food that is one of several specified
foods and food groups, or contains protein derived from one of these
foods or food groups (78 FR 3646 at 3697). Thus, the request that the
provisions be directed to raw materials and other ingredients that
``are or contain'' food allergens is already addressed in the
definition of food allergen. Requirements applicable to in-process
material are addressed in Sec.  117.80(c)(5).

XX. Subpart B: Comments on Proposed Sec.  117.80(c)--Manufacturing
Operations

    We proposed that current Sec.  110.80(b) would become proposed
Sec.  117.80(c). We also proposed revisions to all provisions that
would be established in Sec.  117.80(c) except for the provisions that
would be established in Sec.  117.80(c)(1) and (c)(16).
    Some comments support one or more of these proposed provisions
without change. For example, some comments support provisions directed
to control of, or preventing contamination with, undesirable
microorganisms during manufacturing, storage, and handling. Other
comments that support the proposed provisions suggest alternative
regulatory text (see, e.g., Comment 334) or ask us to clarify how we
will interpret the provision (see, e.g., Comment 345 and Comment 346).
Other comments that support the proposed provisions ask us to revise or
clarify provisions that we proposed to re-establish in part 117 without
change (see, e.g., Comment 333).
    In the following sections, we discuss comments that ask us to
clarify the proposed provisions or that disagree with, or suggest one
or more changes to, the proposed provisions, including comments on
provisions that we did not propose to revise. After considering these
comments, we have revised the proposed provisions as shown in table 25,
with editorial and conforming changes as shown in table 52.

                  Table 25--Provisions for Processes and Controls for Manufacturing Operations
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
Sec.   117.80(c)(1)--Condition of      No.....................  Yes....................  Yes.
 equipment, utensils, and finished
 food containers.
Sec.   117.80(c)(2)--Conditions and    Yes....................  Yes....................  Yes.
 controls for food manufacturing,
 processing, packing, and holding.
Sec.   117.80(c)(3)--Food that can     Yes....................  Yes....................  No.
 support the rapid growth of
 undesirable microorganisms.
Sec.   117.80(c)(4)--Measures to       Yes....................  Yes....................  No.
 destroy or prevent the growth of
 undesirable microorganisms.
Sec.   117.80(c)(5)--Work-in-Process   Yes....................  Yes....................  No.
 and Rework.
Sec.   117.80(c)(6)--Finished food...  Yes....................  Yes....................  No.
Sec.   117.80(c)(7)--Equipment,        Yes....................  Yes....................  No.
 containers, and utensils.
Sec.   117.80(c)(8)--Metal and other   Yes....................  Yes....................  Yes.
 extraneous material.
Sec.   117.80(c)(9)--Disposal of       Yes....................  Yes....................  Yes.
 adulterated food, raw materials, and
 other ingredients.
Sec.   117.80(c)(10)--Manufacturing    Yes....................  No.....................  Yes.
 operations.
Sec.   117.80(c)(11)--Heat blanching,  Yes....................  Yes....................  Yes.
 and growth and contamination by
 thermophilic microorganisms, during
 manufacturing operations.
Sec.   117.80(c)(12)--Batters,         Yes....................  Yes....................  Yes.
 breading, sauces, gravies,
 dressings, and other similar
 preparations.
Sec.   117.80(c)(13)--Filling,         Yes....................  Yes....................  No.
 Assembling, Packaging and Other
 Operations.
Sec.   117.80(c)(14)--Food that        Yes....................  Yes....................  Yes.
 relies on the control of water
 activity for preventing the growth
 of undesirable microorganisms.
Sec.   117.80(c)(15)--Food that        Yes....................  Yes....................  Yes.
 relies on the control of pH for
 preventing the growth of undesirable
 microorganisms.
Sec.   117.80(c)(16)--Requirements     No.....................  Yes....................  Yes.
 for ice used in contact with food.

Sec.   117.80(c)(17)--Food-            Yes (proposed to         Yes....................  No (deleted as
 manufacturing areas and equipment.     delete).                                          proposed).
----------------------------------------------------------------------------------------------------------------

A. Proposed Sec.  117.80(c)(1)--Condition of Equipment, Utensils, and
Finished Food Containers

    We proposed no revisions to the requirements of current Sec.
110.80(b)(1) (proposed Sec.  117.80(c)(1)) that equipment and utensils
and finished food containers be maintained in an acceptable condition
through appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment must be taken apart for thorough cleaning.
    (Comment 332) Some comments assert that this provision precludes
the use of wooden bins, because wooden bins cannot be sanitized.
    (Response 332) This requirement is a long-standing provision that
provides flexibility for an establishment to sanitize when appropriate
by specifying that equipment, utensils, and food containers be
sanitized ``as necessary.'' For example, equipment food-contact
surfaces are usually sanitized after cleaning to minimize the potential
for contaminating food with undesirable microorganisms that accumulate
during processing and grow in food residues on the equipment. When
containers such as wooden bins cannot be sanitized, the establishment
is responsible for taking appropriate steps to adequately clean and
maintain the containers to minimize the potential for contaminating
food with undesirable microorganisms. To clarify that the standard
governing the condition of the equipment, utensils, and finished food
containers is the same public health standard that applies to other
provisions in Sec.  117.80, we have revised the provision to specify
that containers be kept in ``adequate'' condition rather than
``acceptable'' condition.
    (Comment 333) Some comments ask us to delete the term ``finished''
from ``finished food containers'' so that the requirements applicable
to the condition of equipment, utensils, and food containers will be
more complete.
    (Response 333) We agree that the requirements should apply to all
food containers used during manufacturing operations, not just to
``finished food containers.'' We note that we received comments about
the most appropriate adjective to describe the food containers subject
to this requirement during the rulemaking to establish this provision
in part 110. (See the discussion at 51 FR 22458 at 22471, in which we
responded to comments asking us to change ``finished product container
to ``bulk product container'' by explaining that finished product
containers includes bulk product containers.) Rather than perpetuate
questions as to how we are interpreting ``finished,'' we have deleted
this adjective.

B. Proposed Sec.  117.80(c)(2)--Conditions and Controls for Food
Manufacturing, Processing, Packing, and Holding

    We proposed that all food manufacturing, processing, packing, and
holding must be conducted under such conditions and controls as are
necessary to minimize the potential for the growth of microorganisms or
for the contamination of food. We also proposed to delete guidance
regarding how to comply with this requirement.
    (Comment 334) Some comments ask us to add ``in-process materials
and rework,'' ``cross-contact,'' and ``or deterioration'' for clarity
and completeness.
    (Response 334) We agree that adding ``allergen cross-contact'' is
necessary for completeness and have revised the proposed provision to
include it. We also agree that the provision needs to address
deterioration; doing so is consistent with the requirements applicable
to raw materials and other ingredients (see Sec.  117.80(b)(1)). We
decline the request to add ``in-process materials and rework'' to this
provision because in-process materials and rework are already covered
by the phrase ``all food.''

C. Proposed Sec.  117.80(c)(3)--Food That Can Support the Rapid Growth
of Undesirable Microorganisms

    We proposed that all food that can support the rapid growth of
undesirable microorganisms must be held at temperatures that will
prevent the food from becoming adulterated during manufacturing,
processing, packing, and holding. We also proposed to delete
recommendations for how to comply with this requirement.
    (Comment 335) Some comments ask us to keep requirements for
specific temperatures for holding hot food and cold food because there
is a direct correlation between temperature abuse and growth of
pathogenic bacteria.
    (Response 335) We agree that temperature abuse can lead to growth
of pathogenic bacteria. Importantly, the temperatures that have been in
current Sec.  110.80(b)(3) were recommendations rather than
requirements. As discussed in Response 67, we have deleted non-binding
provisions from the rule and intend to issue guidance that will include
much of the guidance that we have deleted from the umbrella CGMPs. As
noted in the 2013 proposed human preventive controls rule (see table 8,
78 FR 3646 at 3715), the temperatures needed for safe holding may vary
and the diversity of food to which the provision applies makes it
inappropriate to specify these temperatures in regulation. There is
information available currently on appropriate temperatures for a
variety of foods (e.g., in the Food Code (Ref. 51) and the PMO (Ref.
64)). Moreover, a continued approach to specific temperatures for
holding hot food and cold food through non-binding guidance is
particularly appropriate because we can reasonably expect ongoing
scientific advances that would alter our thinking on appropriate
temperatures to hold hot food and cold food.
    (Comment 336) Some comments ask us to require that food that can
support the rapid growth of undesirable microorganisms be held at
temperatures or ``in another manner'' that will prevent the food from
becoming adulterated. These comments assert that current or future
technology may provide other means of preventing microbial growth
besides temperature controls--e.g., through use of pressure or in
another as[hyphen]yet[hyphen]unforeseen manner.
    (Response 336) We agree that current or future technology may
provide other means of preventing microbial growth besides temperature
controls. However, we disagree that it is necessary to modify the
requirement to provide for preventing microbial growth by means other
than temperature control, because the provision does not identify
specific temperatures that must be used to prevent the food from
becoming adulterated. If, for example, a food that currently requires
refrigeration to

prevent adulteration becomes shelf-stable as a result of new
technology, the provision as written would allow the food to be held at
room temperature rather than under refrigeration.

D. Proposed Sec.  117.80(c)(4))--Measures To Destroy or Prevent the
Growth of Undesirable Microorganisms

    We proposed that measures such as sterilizing, irradiating,
pasteurizing, cooking, freezing, refrigerating, controlling pH, or
controlling water activity that are taken to destroy or prevent the
growth of undesirable microorganisms must be adequate under the
conditions of manufacture, handling, and distribution to prevent food
from being adulterated.
    (Comment 337) Some comments express concern that the measures
listed could be interpreted as an exhaustive list of processing methods
and, thus, hinder the development of new technologies. These comments
suggest adding ``or other measures'' at the end of the list.
    (Response 337) The phrase ``such as'' indicates that these are
examples of processing methods and that the list is not all inclusive.
We believe that the list of examples and wording of the provision
adequately express the intent behind this provision and allow the use
of other measures without the suggested addition.

E. Proposed Sec.  117.80(c)(5)--Work-in-Process and Rework

    We proposed that work-in-process and rework must be handled in a
manner that protects against cross-contact, contamination, and growth
of undesirable microorganisms.
    (Comment 338) Comments that address this proposed requirement ask
us to use the term ``in-process materials'' rather than ``work-in-
process.''
    (Response 338) As discussed in Response 71, we decline this
request.

F. Proposed Sec.  117.80(c)(6)--Finished Food

    We proposed that effective measures must be taken to protect
finished food from cross-contact and contamination by raw materials,
ingredients, or refuse. When raw materials, ingredients, or refuse are
unprotected, they must not be handled simultaneously in a receiving,
loading, or shipping area if that handling could result in cross-
contact or contaminated food. Food transported by conveyor must be
protected against cross-contact and contamination as necessary.
    (Comment 339) Some comments ask us to specify that raw materials,
ingredients, or refuse that are unprotected not be handled
simultaneously in ``the same area'' rather than in ``a receiving,
loading, or shipping area.'' The comments assert that this would be
clearer.
    (Response 339) We decline this request. We narrowly directed the
provision to address the potential for allergen cross-contact and for
contamination by unprotected raw materials, ingredients, and refuse
when finished food is in a receiving, loading, or shipping area.
Broadening the provision to prohibit handling raw materials,
ingredients, or refuse in the same area as finished food would imply
that raw materials, ingredients, or refuse will never be handled in the
production area where they may be needed or generated during
production.
    (Comment 340) Some comments ask us to revise the provision to add
``in-process'' food and ``cleaning and sanitizing agents, and other
chemicals'' for clarity and completeness.
    (Response 340) We decline this request. Work-in-process foods are
covered separately in Sec.  117.80(c)(5), and cleaning and sanitizing
agents are addressed in the requirements for sanitary operations (see
Sec.  117.35(b)(2)).

G. Proposed Sec.  117.80(c)(7)--Equipment, Containers, and Utensils

    We proposed that equipment, containers, and utensils used to
convey, hold, or store raw materials, work-in-process, rework, or food
must be constructed, handled, and maintained during manufacturing,
processing, packing, and holding in a manner that protects against
cross-contact and contamination.
    (Comment 341) Some comments ask us to specify that the equipment,
containers, and utensils also must be cleaned and sanitized during
manufacturing, processing, packing, and holding in a manner that
protects against cross[hyphen]contact and against contamination.
    (Response 341) We decline this request. Cleaning and sanitizing are
addressed in the requirements for sanitary operations (see Sec.
117.35(a)) and do not need to be addressed again in the requirements
for manufacturing operations.
    (Comment 342) Some comments ask us to add the phrase ``where
appropriate for food safety'' at the beginning of the provision because
food gases are manufactured, held, and distributed in a closed
pressurized system and are therefore not exposed to personnel or
environmental conditions where there is an impact on food safety.
    (Response 342) We decline this request. The closed pressurized
system described by the comment appears to satisfy the requirements of
the provision, as would other systems commonly used in the food
industry. The purpose of the provision is to set the standard; it is
not necessary to add that no specific actions are necessary for those
systems that inherently comply with the requirement.

H. Proposed Sec.  117.80(c)(8)--Metal or Other Extraneous Material

    We proposed that effective measures must be taken to protect
against the inclusion of metal or other extraneous material in food and
to delete guidance regarding how to comply with this requirement.
    (Comment 343) Some comments assert that it could be more effective
from the perspective of food safety to use a risk-based approach to
implementing protective measures against the inclusion of metal or
other extraneous material in food. These comments assert that the risk
of inclusion of metal is higher in cut fruits or vegetables than in
fresh whole fruits or vegetables and, thus, the measures used to
protect against the inclusion of metal should be different in cut
fruits or vegetables than in fresh whole fruits or vegetables.
    (Response 343) We agree that the measures used to protect against
the inclusion of metal likely will be different for cut fruits or
vegetables than for fresh whole fruits or vegetables and that a risk-
based approach can be helpful in determining how to comply with the
requirement. To emphasize the utility of a risk-based approach, we have
revised the provision to require ``adequate'' measures rather than
``effective'' measures; as defined in the rule (see Sec.  117.3), the
term ``adequate'' means that which is needed to accomplish the intended
purpose in keeping with good public health practice.

I. Proposed Sec.  117.80(c)(9)--Disposal of Adulterated Food, Raw
Materials, and Other Ingredients

    We proposed that food, raw materials, and ingredients that are
adulterated must be disposed of in a manner that protects against the
contamination of other food or, if the adulterated food is capable of
being reconditioned, it must be reconditioned using a method that has
been proven to be effective. We also proposed an editorial change to
make clear that reconditioning, rather than disposal, is an option and
to delete a provision that could be viewed as providing an option to
simply

reexamine adulterated food and subsequently find it not to be
adulterated.
    (Comment 344) Some comments ask us to retain the provision to
reexamine adulterated food and subsequently find it not to be
adulterated. These comments explain that there are processes that can
remove contaminants such as pesticides and heavy metals from foods such
as botanical extracts. Although laboratory studies or
small[hyphen]scale pilot batches may give an indication that the
reconditioning is likely to be effective, they cannot always guarantee
the treatment will be equally effective when scaled up to
commercial[hyphen]scale production batches. Because these methods have
not been ``proven to be effective,'' the appropriate approach to
determining whether the reconditioned food is no longer adulterated is
reexamination after the reconditioning is complete.
    (Response 344) We agree with these comments and have revised the
provision to make clearer that reexamination can only be used to
subsequently find that the food is not adulterated after the food has
been reconditioned. See the regulatory text of Sec.  117.80(c)(9).
    (Comment 345) Some comments ask us to clarify that the provision
only applies if the food has actually been found to be adulterated. The
comments assert that the provision should not apply where product has
been placed ``on hold'' due to an equipment failure (e.g., if product
is put on hold due to an inoperative metal detector until the
establishment can retest for potential metal contaminants).
    (Response 345) The provision only applies if the food is
adulterated. In the example described in these comments, if the food is
not adulterated, the establishment would not need to dispose of, or
recondition, the product.
    (Comment 346) Some comments ask us to clarify that the provision
does not apply to grains subject to the review inspection provisions
provided for by 7 CFR 800.125 and 800.135.
    (Response 346) In many cases, grains subject to the review
inspection provisions provided for by 7 CFR 800.125 and 800.135 are
RACs that are being held or transported by an establishment solely
engaged in holding or transporting RACs and subpart B (including Sec.
117.80(c)(8)) would not apply to the grains (see Sec.  117.5(k)). In
addition, as noted in Response 345, this provision only applies to food
that is adulterated.

J. Proposed Sec.  117.80(c)(10)--Performing Manufacturing Steps

    We proposed that steps such as washing, peeling, trimming, cutting,
sorting and inspecting, mashing, dewatering, cooling, shredding,
extruding, drying, whipping, defatting, and forming must be performed
so as to protect food against cross-contact and contamination. We
proposed that food should be protected from contaminants that may drip,
drain, or be drawn into food and requested comment on whether to
establish the recommendation regarding physical protection of food from
contaminants that may drip, drain, or be drawn into the food as a
requirement (78 FR 3646 at 3726). We also proposed to delete two
recommendations regarding adequate cleaning and sanitizing of food-
contact surfaces and regarding the use of time and temperature
controls.
    (Comment 347) Some comments agree that we should require, rather
than recommend, that food be protected from contaminants that may drip,
drain, or be drawn into food. Other comments express concern that
turning the current recommendation into a requirement could lead to a
de facto requirement for closed systems to be used in food production.
Some comments ask us to specify that the requirements only apply where
food is exposed.
    (Response 347) We agree that we should require, rather than
recommend, that food be protected from contaminants that may drip,
drain, or be drawn into food. We have not revised the regulatory text
to specify that the requirements only apply where food is exposed,
because such protections would only be needed if foods are exposed to
such conditions. Such a requirement would not lead to a de facto
requirement for a closed system, because this is not the only way to
protect food from such contaminants. For example, covers can be used on
kettles and tanks, and shields can be placed over conveyor lines.

K. Proposed Sec.  117.80(c)(11)--Heat Blanching and Growth and
Contamination by Thermophilic Microorganisms During Manufacturing
Operations

    We proposed that heat blanching, when required in the preparation
of food, should be effected by heating the food to the required
temperature, holding it at this temperature for the required time, and
then either rapidly cooling the food or passing it to subsequent
manufacturing without delay. We proposed that thermophilic growth and
contamination in blanchers should be minimized by the use of adequate
operating temperature and by periodic cleaning and requested comment on
whether to establish these two recommendations as requirements (78 FR
3646 at 3726).
    (Comment 348) Some comments support establishing the
recommendations in this provision as requirements. Other comments
oppose doing so and assert that these detailed steps may not be
important to protect the public health.
    (Response 348) We disagree that the use of adequate operating
temperature and periodic cleaning are not important to protect public
health. Improper cooling can lead to growth of pathogenic sporeforming
bacteria if product remains too long at temperatures that support their
multiplication. In addition, growth of thermophiles, while not a public
health issue, can lead to product spoilage, and, thus, adulteration. We
are establishing these two recommendations as requirements in the
regulatory text, along with associated editorial changes.

L. Proposed Sec.  117.80(c)(12)--Batters, Breading, Sauces, Gravies,
Dressings, and Other Similar Preparations

    We proposed that batters, breading, sauces, gravies, dressings, and
other similar preparations must be treated or maintained in such a
manner that they are protected against cross-contact and contamination.
We also proposed to clarify that these steps require protection against
cross-contact and to delete the recommendations for how to comply with
this requirement.
    (Comment 349) Some comments agree that we should delete the
provided examples of mechanisms to achieve compliance.
    (Response 349) We have deleted the examples as proposed.
    (Comment 350) Some comments ask us to modify the provision to
clarify that it applies to preparations that are held and used
repeatedly over time and to add ``dipping solutions'' as another
example of such a preparation.
    (Response 350) We agree that the provision applies to preparations
that are held and used repeatedly over time and that ``dipping
solutions'' is a useful example to add. We have revised the regulatory
text as requested by these comments.
    (Comment 351) Some comments ask us to add that another purpose of
the requirement is to minimize the potential for the growth of
undesirable microorganisms.
    (Response 351) This request would promote consistency in the
requirements throughout Sec.  117.80 and

we have revised the regulatory text accordingly.

M. Proposed Sec.  117.80(c)(13)--Filling, Assembling, Packaging and
Other Operations

    We proposed that filling, assembling, packaging, and other
operations must be performed in such a way that the food is protected
against cross-contact, contamination, and growth of undesirable
microorganisms. We also proposed to delete the recommendations for
achieving compliance with this requirement.
    (Comment 352) Some comments ask us to specify that the requirement
applies only to finished food to differentiate it from other provisions
in Sec.  117.80 and assert that without the modification the provision
would be redundant.
    (Response 352) The specific requirements of Sec.  117.80(c)(13) are
not redundant with other provisions in Sec.  117.80. The long-standing
provisions of Sec.  117.80 first address general requirements (Sec.
117.80(a)) and then address more specific requirements applicable to
raw materials and other ingredients (Sec.  117.80(b)) and manufacturing
operations (Sec.  117.80(c)). Although the comment does not define
``finished food,'' we consider that term to apply to a packaged and
labeled food product; filling, assembling, and packaging operations
would be conducted on in-process food to create a finished product.
Regardless of whether the appropriate term would be ``finished'' or
``in-process food,'' the comment provides no reason for why this long-
standing provision is not clear without specifying the production stage
of a food product that is subject to filling, assembling, and packaging
operations.

N. Proposed Sec.  117.80(c)(14)--Food That Relies on the Control of
Water Activity for Preventing the Growth of Undesirable Microorganisms

    We proposed that food, including dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of water
activity for preventing the growth of undesirable microorganisms must
be processed to, and maintained at, a safe moisture level. We also
proposed to delete the recommendations for achieving compliance with
this requirement.
    (Comment 353) Some comments assert that moisture level is not an
adequate food safety control measure. The comments ask us to revise the
requirement to reflect that it is the proper maintenance of water
activity, rather than moisture level, that will prevent growth of
undesirable microorganisms.
    (Response 353) The rule defines safe moisture level as a level of
moisture low enough to prevent the growth of undesirable microorganisms
in the finished product and notes that the safe moisture level is
related to water activity (Sec.  117.3). Although in most cases water
activity is the most suitable measurement to predict food safety,
moisture content is frequently used to assess the stability of grains
and nuts with respect to prevention of growth and mycotoxin production
by molds. We are retaining the term ``safe moisture level'' as a
broader term that takes into account the fact that measuring moisture
level and measuring water activity are both common industry practice
and, depending on the food, can be measures that are appropriate to
assess safety. The comments provide no basis for the assertion that
this long-standing provision is not an adequate food safety measure.
    (Comment 354) Some comments assert that water activity may not be
the only factor responsible for preventing the growth of undesirable
microorganisms in dry products and ask us to modify the regulatory text
to take into account other synergistic barriers for microbial growth
and toxin formation.
    (Response 354) We agree with these comments and have revised the
regulatory text to clarify that such products rely ``principally'' on
the control of water activity.
    (Comment 355) Some comments assert that nuts should be
``maintained'' at an appropriate moisture level rather than ``processed
to'' an appropriate moisture level.
    (Response 355) We acknowledge that some products need only be
``maintained'' at a safe moisture level and may not need to be
processed to achieve that level. However, we disagree that it is
necessary to modify this long-standing requirement to specify this
distinction. The comments do not provide examples of how we have been
interpreting this provision in a way that does not accommodate the
differences in products.
    (Comment 356) Some comments ask us to more closely adhere to the
current regulatory text (i.e., food, such as dry mixes . . .) rather
than the proposed regulatory text (i.e., food, including dry mixes . .
.).
    (Response 356) The final rule retains the long-standing language
``such as'' as requested by the comments. (See also the discussion in
Response 68.)

O. Proposed Sec.  117.80(c)(15)--Food That Relies on the Control of pH
for Preventing the Growth of Undesirable Microorganisms

    We proposed that food, including acid and acidified food, that
relies principally on the control of pH for preventing the growth of
undesirable microorganisms must be monitored and maintained at a pH of
4.6 or below. We also proposed to delete the recommendations for how to
comply with this requirement.
    (Comment 357) Some comments ask us to use the term ``equilibrated
pH'' or ``finished equilibrium pH'' for consistency with part 114. Some
comments ask us to add a definition for ``equilibrated pH'' in Sec.
117.3.
    (Response 357) We decline these requests. It is not necessary for
this long-standing provision in the umbrella food CGMPs to use
specialty terms used in the more specific CGMPs that apply to acidified
foods in order to make clear that the operative pH for the safety of
such foods is 4.6 or below.
    (Comment 358) Some comments ask us to more closely adhere to the
current language (i.e., food such as acid and acidified food . . .)
rather than the proposed language (i.e., food, including acid food and
acidified food . . .) to make it clear that the list is not intended to
be complete.
    (Response 358) The final rule retains the long-standing language
``such as'' as requested by the comments. (See also the discussion in
Response 68.)

P. Proposed Sec.  117.80(c)(16)--Requirements for Ice Used in Contact
With Food

    We proposed no revisions to the requirements of current Sec.
110.80(b)(16) (proposed Sec.  117.80(c)(16)) that when ice is used in
contact with food, it must be made from water that is safe and of
adequate sanitary quality, and must be used only if it has been
manufactured in accordance with current good manufacturing practice.
    (Comment 359) Some comments ask us to replace the requirement that
water must be safe and of adequate sanitary quality with a cross-
reference to the water quality requirements of Sec.  117.37(a).
    (Response 359) We acknowledge that cross-referencing the water
quality requirements established in Sec.  117.37(a), without describing
those requirements, would accurately convey the requirements for ice
used in contact with food. However, we believe there is value added by
continuing to emphasize the water quality standard within the
requirements for ice used in contact

with food. We have added a cross-reference to Sec.  117.37(a) but have
not deleted ``safe and of adequate sanitary quality.''

Q. Proposed Deletion of Current Sec.  110.80(b)(17)--Food-Manufacturing
Areas and Equipment

    We proposed to delete the current recommendation that food-
manufacturing areas and equipment used for manufacturing human food not
be used to manufacture nonhuman food-grade animal feed or inedible
products, unless there is no reasonable possibility for the
contamination of the human food. We tentatively concluded that this
recommendation would be more appropriate in guidance, which could
include examples of situations where there is no reasonable possibility
for the contamination of the human food.
    (Comment 360) Some comments ask us to retain this provision for
clarity and as a means to educate small, foreign, and new food
processors.
    (Response 360) We decline this request. The focus of the provision
is to emphasize the importance of manufacturing food in a way that
prevents contamination. Other provisions (such as Sec. Sec.  117.10(b),
117.20(a), 117.35(a), 117.40(a)(1), 117.80(a), and 117.93) already
require that an establishment prevent contamination from any source.
(See also the discussion in Response 67 about our decision to delete
those non-binding provisions of part 110 that we are not establishing
as requirements.)

XXI. Subpart B: Comments on Proposed Sec.  117.93--Warehousing and
Distribution

    Current Sec.  110.93 requires that storage and transportation of
finished food be under conditions that will protect food against
physical, chemical, and microbial contamination, as well as against
deterioration of the food and the container. We proposed a series of
revisions to these current requirements--i.e., to apply the
requirements to ``food'' rather than to ``finished food''; clarify that
storage and transportation of food must be under conditions that will
protect against allergen cross-contact in addition to protecting
against contamination of food; add radiological hazards as an
additional category of contaminants; and require protection against
``biological,'' rather than ``microbial'' contamination. With all of
these revisions, we proposed that storage and transportation of food
must be under conditions that will protect against cross-contact and
biological, chemical, physical, and radiological contamination of food,
as well as against deterioration of the food and the container.
    Some comments support one or more of these proposed revisions
without change. For example, some comments support adding radiological
hazards as an additional category of contaminants to the list of
contaminants which may be encountered in warehousing and distribution
because food may be subject to contamination with radiological hazards.
Other comments that support the proposed provisions suggest alternative
regulatory text (see, e.g., Comment 361) or ask us to clarify how we
will interpret the provision (see, e.g., Comment 363).
    In the following sections, we discuss comments that ask us to
clarify the proposed provision or that disagree with, or suggest one or
more changes to, the proposed provision. After considering these
comments, we are finalizing the provision as proposed (see table 26),
with editorial and conforming changes as shown in table 52.

                              Table 26--Provisions for Warehousing and Distribution
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
117.93--Warehousing and distribution.  Yes....................  Yes....................  No.
----------------------------------------------------------------------------------------------------------------

    (Comment 361) Some comments express concern that produce will spoil
and deteriorate even under the best conditions. These comments ask us
to modify the proposed requirements to address these concerns, such as
by specifying that the conditions will ``reasonably protect'' or by
revising ``will protect'' to ``will minimize to acceptable levels.''
    (Response 361) We decline this request. In some cases, this
provision will not apply to produce (i.e., when the produce is a RAC
subject to the exemption for an establishment solely engaged in the
holding or transportation of one or more RACs; see Sec.  117.5(k)).
When the produce is not subject to the RAC exemption (e.g., when the
produce is being handled in a fresh-cut processing facility), requiring
storage and transportation of produce under the conditions specified in
the provision is appropriate. The comments provide no basis that we
have been enforcing this long-standing provision in a manner that does
not acknowledge practical issues associated with the short shelf life
of produce in such facilities and, thus, that modifications such as
those suggested by the comments are necessary.
    (Comment 362) Some comments assert that regulations directed to
radiological hazards will act as a double regulation to hinder amicable
trade activities and will increase economic burden to manufacturers. As
discussed in Comment 410, these same comments ask us to provide that a
facility subject to the requirements for hazard analysis and risk-based
preventive controls may rely on existing systems in place to manage
radiological risks, such as steps taken by government officials to
inspect ingredients obtained from a geographic region that has been the
subject of a nuclear accident.
    (Response 362) See Response 410 for a discussion of how a facility
may consider existing systems in place to manage radiological risks,
but still has responsibilities to establish and implement preventive
controls to address a radiological hazard when circumstances warrant.
The comment provides no basis for its assertion that regulations
directed to radiological hazards will act as a double regulation to
hinder amicable trade activities and will increase economic burden to
manufacturers.
    (Comment 363) Some comments support our proposal to specify that
the requirements apply to ``food'' rather than to ``finished food,''
provided that doing so does not affect common and safe practices for
the transportation of RACs, such as transporting raw produce from the
field, or from packinghouses, in open top containers such as field
boxes, totes and gondola trucks.
    (Response 363) As discussed in the 2013 proposed human preventive
controls rule, we proposed to apply the CGMP requirements for storage
and transportation to ``food'' rather than ``finished food'' to ensure
food safety throughout the food chain, regardless of whether a food
product is a raw material or ingredient or in its finished state (78

FR 3646 at 3727). We intend this revision to clarify that the CGMP
provisions for warehousing and distribution apply to raw materials and
ingredients, including RACs. When a food establishment that stores and
transports RACs is subject to the CGMP provisions, common and safe
storage and transportation practices such as those described in our
1998 guidance entitled ``Guide to Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables (Ref. 13) would be appropriate.
    (Comment 364) As noted in Response 324, under the proposed produce
safety rule a farm that produces covered produce that is distributed
for commercial processing would be required to maintain documentation
of the identity of the recipient of the commercial processor. Some
comments appear to assume that a farm might distribute such products
with information disclosing that such produce was not grown in
compliance with part 112, should not be consumed raw, and/or requires
commercial processing. These comments ask us to add a provision that no
food whose labels, labeling, or commercial documentation accompanying
the sale contain any of the following notices may be sold or otherwise
distributed to any user except a commercial processor: Not grown in
compliance with part 112; Not for fresh or raw consumption; May require
commercial formulation, processing, or both to adequately reduce
microorganisms.
    (Response 364) We decline to add such a provision to the CGMP
requirements for distribution of food. As noted in Response 324, we do
not see a benefit to labeling produce as indicated because we believe
that the vast majority of such produce is low risk. However, as also
noted in Response 324, we are providing for a narrow use of commercial
documentation, which would include produce, when a manufacturer/
processor that has identified a hazard requiring a preventive control
does not establish a preventive control because it: (1) Relies on its
customer to ensure that an identified hazard will be controlled and (2)
discloses, in documents accompanying the food, in accordance with the
practice of the trade, that the food is ``not processed to control
[identified hazard]'' (See Sec.  117.136(a)(2), (3), and (4)).

XXII. Subpart B: Comments on Proposed Sec.  117.110 (Natural or
Unavoidable Defects in Food for Human Use That Present No Health
Hazards)

    We proposed to revise the current provisions directed to natural or
unavoidable defects in food for human use that present no health
hazard. Some comments support one or more of these proposed provisions
without change. Other comments that support the proposed provisions
suggest alternative or additional regulatory text (see, e.g., Comment
365, Comment 367, and Comment 368).
    In the following sections, we discuss comments that ask us to
clarify the proposed provisions or that disagree with, or suggest one
or more changes to, the proposed provisions, including comments on
provisions that we did not propose to revise. After considering these
comments, we have revised the proposed provisions as shown in table 27,
with editorial and conforming changes as shown in table 52.

                                  Table 27--Provisions for Defect Action Levels
----------------------------------------------------------------------------------------------------------------
                                            Did we propose
                                         revisions or request     Did we get comments       Did we modify the
              Provision                  comment on potential   that disagreed with the    proposed regulatory
                                              revisions?          proposed provision?             text?
----------------------------------------------------------------------------------------------------------------
117.110(a) and (b)--Description of     No.....................  Yes....................  Yes.
 defect action levels.
117.110(c)--Quality control            Yes....................  Yes....................  No.
 operations that reduce natural or
 unavoidable defects to the lowest
 level currently feasible.
117.110(d)--Mixing adulterated food    Yes....................  Yes....................  Yes.
 with food that is not adulterated.
117.110(e)--How to obtain the booklet  Yes (proposed to         Yes....................  Yes (provided Internet
 ``Defect Action Levels''.              delete).                                          address).
----------------------------------------------------------------------------------------------------------------

    We proposed that some foods, even when produced under current good
manufacturing practice, contain natural or unavoidable defects that at
low levels are not hazardous to health. The proposed provisions specify
that FDA establishes maximum levels for these defects in foods produced
under current good manufacturing practice and uses these levels in
deciding whether to recommend regulatory action. The proposed
provisions also specify that defect action levels are established for
foods when it is necessary and feasible to do so, and that these levels
are subject to change upon the development of new technology or the
availability of new information (proposed Sec.  117.110(a) and (b)).
    We also proposed that compliance with defect action levels does not
excuse violation of the requirement in section 402(a)(4) of the FD&C
Act that food not be prepared, packed, or held under unsanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health, or the
requirements in part 117 that food manufacturers, processers, packers,
and holders must observe current good manufacturing practice. Evidence
indicating that such a violation exists causes the food to be
adulterated, even though the amounts of natural or unavoidable defects
are lower than the currently established defect action levels. The
manufacturer, processor, packer and holder of food must at all times
utilize quality control operations that reduce natural or unavoidable
defects to the lowest level currently feasible (proposed Sec.
117.110(c)).
    We also proposed that the mixing of a food containing defects at
levels that render that food adulterated with another lot of food is
not permitted and renders the final food adulterated, regardless of the
defect level of the final food. (Proposed Sec.  117.110(d)).
    We proposed to delete current Sec.  110.110(e), which specifies
that a Defect Levels Handbook (a compilation of the current defect
action levels for natural or unavoidable defects in food for human use
that present no health hazard) may be obtained upon request from the
Center for Food Safety and Applied Nutrition.
    (Comment 365) Some comments assert that the word ``defects'' may
cause confusion in industry, because the term ``defects'' is commonly
used to describe quality or physical type attributes that do not pose a
risk to

public health. These comments ask us to consider using another term,
such as ``contaminant,'' in place of the term ``defect.''
    (Response 365) We decline this request. The specific term requested
by the comments (i.e., contaminant) often carries the connotation of
hazardous to health. However, we have added a definition of the term
``defect action level'' to the rule (see Response 165 and Sec.  117.3).
The defined term makes clear that the term does not refer to quality or
physical type attributes such as those described in the comments. We
also have deleted the first two full paragraphs of the proposed
provision (proposed Sec.  117.110(a) and (b)), which are no longer
necessary to provide context about the regulatory impact of the term
``defect action level,'' because the new definition of ``defect action
level'' explains that a defect action level is a level of a non-
hazardous, naturally occurring, unavoidable defect at which FDA may
regard a food product ``adulterated'' and subject to enforcement action
under section 402(a)(3) of the FD&C Act.
    (Comment 366) Some comments assert that a facility subject to this
provision will implement both CGMPs and a food safety plan as guiding
``quality control operations'' appropriate for this purpose. These
comments also assert that reducing natural or unavoidable defects to
``the lowest level currently feasible'' does not require a facility to
exceed CGMPs or go beyond preventive controls identified through a
hazard analysis. In the view of these comments, doing so would run
contrary to the risk-based principles that underlie FSMA and leading
food safety programs by requiring that all hazards be managed equally
without considering the outcomes of the hazard analysis. These comments
assert that successful, responsible food safety programs allocate
resources to hazards commensurate with their potential impact to the
public health.
    (Response 366) We agree that reducing natural or unavoidable
defects to ``the lowest level currently feasible'' does not require a
facility to exceed CGMPs or go beyond preventive controls identified
through a hazard analysis.
    (Comment 367) Some comments assert that the word ``reduce'' in
Sec.  117.110 (c) may not be appropriate for all facilities. As an
example, the comments explain that a brownskin almond facility that
solely sizes and sorts product before packaging may not have processes
to reduce microbial contaminants. Instead, that facility may rely upon
custom processors to reduce the level of microbial contamination. In
such a case, these comments note that it would be more accurate for the
provision to specify using quality control operations that ensure the
lowest level currently feasible for natural or unavoidable defects.
    (Response 367) We have not revised the provision to account for
circumstances such as those described in these comments. We acknowledge
that the production of some food products requires that food pass
through multiple facilities before the finished food is distributed
into commerce, and that a specific pathogen reduction step may occur at
only one of the applicable facilities. The comments do not provide any
examples of how we have interpreted this long-standing provision in the
past in a way that creates practical problems when applying the
provision to facilities such as those described in the comments.
    (Comment 368) Some comments ask us to retain the provision, in
Sec.  110.110(e), specifying that the Defect Levels Handbook may be
obtained upon request from the Center for Food Safety and Applied
Nutrition. These comments also ask us to add an FDA Web site where the
handbook may be obtained.
    (Response 368) We have added a reference to the Defect Levels
Handbook (Ref. 36) to the provisions as examples of defect action
levels that may render food adulterated, including an address on the
FDA Web site where this handbook may be obtained.

XXIII. Subpart C: Comments on Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls

    In the 2014 supplemental human preventive controls notice, we
proposed a series of changes to proposed subpart C and reopened the
comment period specifically with respect to these changes. The proposed
changes included: (1) Eliminating the term ``hazard reasonably likely
to occur'' throughout proposed subpart C (and, thus, deleting the
definition we had proposed for this term); (2) adding a new defined
term, ``significant hazard,'' and, in general, using this new term
instead of ``hazard reasonably likely to occur'' throughout the re-
proposed regulations; (3) defining ``known or reasonably foreseeable
hazard'' in place of ``reasonably foreseeable hazard'' and clarifying
that the new term means a hazard ``that has the potential to be
associated with the facility or the food'' rather than ``a potential .
. . hazard that may be associated with the facility or the food''; and
(4) providing additional flexibility to address concerns about re-
writing existing plans or programs to conform with the requirement of
the human preventive controls rule.
    We received many comments on the overall framework for hazard
analysis and risk-based preventive controls. We discuss each of these
comments in the discussion of the specific regulatory text applicable
to each comment. We show highlights of the changes we made after
considering these comments in table 28.

  Table 28--Revisions to the Overall Framework for Hazard Analysis and
                     Risk-Based Preventive Controls
------------------------------------------------------------------------
             Section                  Description          Revision
------------------------------------------------------------------------
117.3...........................  Definition of       Revise the
                                   ``significant       proposed term
                                   hazard''.           ``significant
                                                       hazard'' to
                                                       ``hazard
                                                       requiring a
                                                       preventive
                                                       control'' and
                                                       revise the
                                                       definition to
                                                       emphasize the
                                                       role of risk in
                                                       determining
                                                       whether a hazard
                                                       requires a
                                                       preventive
                                                       control.
117.3...........................  Definition of       Define the term
                                   ``corrections''.    ``correction'' to
                                                       distinguish
                                                       ``corrections''
                                                       from ``corrective
                                                       actions.''
117.135(c)(1), 117.140(a),        Flexibility in      Clarify that
 117.145, 117.155(a),              preventive          preventive
 117.160(a), 117.165(a),           controls and        control
 117.165(b).                       preventive          management
                                   control             components depend
                                   management          on the role of a
                                   components for      preventive
                                   monitoring,         control in the
                                   corrective          facility's food
                                   actions and         safety system, as
                                   corrections, and    well as the
                                   verification.       nature of the
                                                       preventive
                                                       control.
117.130(b)(1), 117.130(b)(2)....  Hazard              Emphasize that the
                                   identification.     hazard
                                                       identification
                                                       focuses on known
                                                       or reasonably
                                                       foreseeable
                                                       hazards (rather
                                                       than on all
                                                       hazards).

117.145(c)......................  Monitoring records  Provide for the
                                                       use of
                                                       ``exception
                                                       records'' for
                                                       monitoring
                                                       preventive
                                                       controls.
117.150(a)......................  Corrective action   Clarify that
                                   procedures.         corrective action
                                                       procedures depend
                                                       on the nature of
                                                       the hazard.
117.150(c)......................  Corrections.......  Provide for
                                                       additional
                                                       circumstances
                                                       when corrections,
                                                       rather than
                                                       corrective
                                                       actions, are
                                                       warranted.
117.160(c)......................  Preventive          Clarify that a
                                   controls that do    list of
                                   not require         preventive
                                   validation.         controls that do
                                                       not require
                                                       validation is not
                                                       an exhaustive
                                                       list.
117.165(a)(5)...................  Activities to       Clarify that there
                                   verify              could be
                                   implementation      alternative
                                   and effectiveness.  verification
                                                       activities of
                                                       implementation
                                                       and effectiveness
                                                       other than those
                                                       that we specify
                                                       in the rule.
117.165(b)......................  Written procedures  Clarify that
                                   for verification    written
                                   of implementation   procedures for
                                   and effectiveness.  verification of
                                                       implementation
                                                       and effectiveness
                                                       are established
                                                       and implemented
                                                       as appropriate to
                                                       the role of the
                                                       preventive
                                                       control in the
                                                       facility's food
                                                       safety system, as
                                                       well as
                                                       appropriate to
                                                       the facility, the
                                                       food, and the
                                                       nature of the
                                                       preventive
                                                       control.
117.170(b)......................  Reanalysis........  Provide for
                                                       reanalysis of an
                                                       applicable
                                                       portion of the
                                                       food safety plan
                                                       (rather than the
                                                       complete food
                                                       safety plan) in
                                                       specified
                                                       circumstances.
------------------------------------------------------------------------

XXIV. Subpart C: Comments on Proposed Sec.  117.126--Food Safety Plan

    We proposed requirements for a food safety plan. Some comments
support the proposed requirements without change. Some comments that
support the proposed provisions suggest alternative or additional
regulatory text (see, e.g., Comment 377 and Comment 381) or ask us to
clarify how we will interpret the provision (see, e.g., Comment 370).
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements or 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 shown in table 52.
    We proposed that the food safety plan be under the oversight of one
or more ``qualified individuals.'' As discussed in section IX.C.25, we
have changed the proposed term ``qualified individual'' to ``preventive
controls qualified individual'' because we are establishing a new
definition for ``qualified individual,'' with a meaning distinct from
``preventive controls qualified individual.'' To minimize the potential
for confusion for when the term ``qualified individual'' refers to the
proposed meaning of the term and when the term ``qualified individual''
refers to the meaning of that term as finalized in this rule, in the
remainder of this document we substitute the new term ``preventive
controls qualified individual'' for the proposed term ``qualified
individual,'' even though the proposed rule used the term ``qualified
individual.'' Likewise, we substitute the new term ``preventive
controls qualified individual'' for the proposed term ``qualified
individual'' when describing the comments to the proposed rule, even
though those comments use the term ``qualified individual.''
    We proposed that several other provisions of subpart C be under the
oversight of a ``qualified individual'' (now ``preventive controls
qualified individual''), and also proposed requirements that would
apply to the ``qualified individual'' (now ``preventive controls
qualified individual''). See, e.g., Sec. Sec.  117.160, 117.165,
117.170, 117.180, 117.190, and 117.206). As discussed in the preceding
paragraph, in the remainder of this document, we substitute the new
term ``preventive controls qualified individual'' for the proposed term
``qualified individual,'' when describing these proposed provisions and
the comments to these proposed provisions.

A. Proposed Sec.  117.126(a)(1)--Requirement for a Food Safety Plan

    We proposed that you must prepare, or have prepared, and implement
a written food safety plan.
    (Comment 369) Some comments ask us to emphasize that ``written''
means ``any type of recordable and reproducible format'' (e.g., as
paper or electronic documents). Some comments ask us to specify that
the components of the food safety plan need not be in a single document
or stored in one place.
    (Response 369) A ``written'' food safety plan can be either a paper
document or an electronic document, as provided by Sec.  117.305(a).
The final rule specifies that required information (which would include
the food safety plan) does not need to be kept in one set of records
(see Sec.  117.330 (b)), and a food safety plan may be prepared as a
set of documents kept in different locations within the facility (e.g.,
based on where they will be used), provided that each set of documents
is onsite. As provided in the recordkeeping provisions, electronic
records are considered to be onsite if they are accessible from an
onsite location.
    (Comment 370) Some comments agree with our previous statements that
facilities should be able to group food types or production method
types if hazards, control measures, parameters, and required
procedures, such as monitoring, are identical (78 FR 3646 at 3730).
These comments note that exceptions should be carefully delineated and
followed as appropriate. Some comments ask us to clarify that we will
allow food safety plans to share common provisions where there are
uniform systems in place. Some comments ask us to clarify whether one
plan is required for the facility or for each crop/food item
individually.
    (Response 370) We are requiring that a facility have a written food
safety plan that covers all the foods that it manufactures, processes,
packs, or holds. We recognize that, to the extent that the controls are
the same, there may be common controls that broadly apply to some or
all of a facility's food products. However, any product- or process-
specific differences must be carefully delineated and observed in
practice.
    In some facilities with limited types of products, the written food
safety plan may contain a single set of procedures that addresses all
of the products produced. For example, a facility

making fruit-flavored beverages may be able to address all of its
beverages in the same set of procedures. For other facilities, there
may not be a practical way to group the products and the written food
safety plan may need to contain more than one set of procedures to
address all of its products. For example, a facility that makes both
RTE entrees and entrees that are not RTE may choose to group the RTE
entrees in one set of procedures, but have a separate set of procedures
for the entrees that are not RTE. However, to the extent that some of
the written procedures in the food safety plan are the same for both
RTE entrees and entrees that are not RTE, the facility need not
duplicate those procedures in its written food safety plan. For
example, a facility that uses an electronic food safety plan could
store written procedures in multiple folders in the electronic system,
and the food safety plan for individual products (or groups of
products) could simply hyperlink to the written procedures applicable
to each product. Likewise, a facility that uses a paper-based food
safety plan could store written procedures in a binder or file cabinet,
with written cross-references to procedures that apply to more than one
product.
    (Comment 371) Some comments ask us to provide that the food safety
plan be handled at the corporate level rather than the facility level
if a corporation owns many facilities.
    (Response 371) A corporation may designate an individual at the
corporate level as the owner, operator, or agent in charge of a
particular facility. In addition, an employee of the corporation,
whether at headquarters or at another facility owned by the
corporation, may provide input into a particular facility's food safety
plan. As previously discussed, the food safety plan needs to be
facility specific (see the discussion of the facility-based nature of
the food safety plan in the 2013 proposed human preventive controls
rule, 78 FR 3646 at 3732). For example, even if a corporation makes
similar products at two separate facilities, it is unlikely that the
two facilities have exactly the same equipment and layout. Procedural
instructions must be tailored to the equipment being used, and the
layout of a facility may affect its approach to preventive controls
such as food allergen controls.
    (Comment 372) Some comments ask us to provide for facilities that
have HACCP plans to build off their existing HACCP programs. As an
example, these comments state that we could allow facilities to use
terms like ``critical limits'' for process controls rather than require
these foundational documents to be rewritten simply to change
terminology.
    (Response 372) A facility that has a HACCP plan (or other food
safety plan) in place before this rule becomes effective can build off
its existing program and can rely on existing records, supplemented as
necessary to include all of the required information and satisfy the
requirements of this rule (see Sec.  117.330). The rule does not
preclude the use of terms like ``critical limits'' that are associated
with HACCP systems.
    (Comment 373) Some comments ask us to provide templates that
facilities can use as models to develop their food safety plans. Some
comments ask us to accept Good Agricultural Practices (GAPs) food
safety plan formats and/or HACCP plans. Some comments provide specific
templates for us to consider.
    (Response 373) We decline the request to provide templates for
facilities to use to develop their food safety plans. The rule does not
specify the format of a food safety plan, and a facility has
flexibility to format its food safety plan in a way that works best for
the facility, provided that the plan includes all required information.
In general, internationally recognized food safety plan formats would
be acceptable, although modification and supplementation may be
necessary to comply with all requirements of the rule (see Sec.
117.330 on the use and adaptation of existing records). Training
materials being developed by the FSPCA may be useful in developing food
safety plans (see Response 2).
    We note that activities of farm mixed-type facilities that are
within the ``farm'' definition (e.g., packing and holding RACs) are not
subject to the human preventive controls rule. However, to the extent
that some components of GAPs-based food safety plans are relevant to a
facility (e.g., for an off-farm packinghouse), the facility has
flexibility to format its plan in a way that is consistent with GAPs-
based food safety plans.
    (Comment 374) Some comments ask us to clarify that a food safety
plan is not required when a facility is exempt as a qualified facility
(Sec.  117.5(a)) or as a facility solely engaged in the storage of
packaged food that is not exposed to the environment (Sec.  117.7).
    (Response 374) A qualified facility is exempt from the requirements
of subparts C and G, including the requirement to prepare and implement
a food safety plan, and is instead subject to the modified requirements
in Sec.  117.201. Likewise, a facility solely engaged in the storage of
packaged food that is not exposed to the environment is exempt from the
requirements of subparts C and G, including the requirement to prepare
and implement a food safety plan, and is instead subject to the
modified requirements in Sec.  117.206.
    (Comment 375) Some comments ask us to clarify that a food safety
plan is not required for facilities that store unexposed, refrigerated,
packaged TCS foods.
    (Response 375) We agree that a facility ``solely engaged'' in the
storage of unexposed, refrigerated, packaged TCS food is exempt from
the requirements of subparts C and G, including the requirement to
prepare and implement a food safety plan, and is instead is subject to
the modified requirements in Sec.  117.206 (see Sec.  117.7). However,
if a facility engages in other activities in addition to the storage of
unexposed, refrigerated, packaged TCS foods, the exemption does not
apply. In such a case, the facility must prepare and implement a food
safety plan. However, the modified requirements of Sec.  117.206 can be
informative with respect to what the food safety plan could include
regarding the storage of unexposed, refrigerated, packaged TCS food.
    (Comment 376) Some comments ask us to explain why a written food
safety plan is necessary, because adoption of a HACCP system is only
voluntary under the Codex General Principles of Food Hygiene.
    (Response 376) The requirement to prepare and implement a written
food safety plan is required by U.S. law (i.e., by section 418(h) of
the FD&C Act). In contrast, Codex standards are recommendations for
voluntary application by members and, thus, Codex provisions are only
mandatory if the standard is adopted by a country in its national
legislation.

B. Proposed Sec.  117.126(a)(2)--Preparation of the Food Safety Plan by
a Preventive Controls Qualified Individual

    We proposed that the food safety plan must be prepared, or its
preparation overseen, by one or more preventive controls qualified
individuals.
    (Comment 377) Some comments ask us to provide for a group of
preventive controls qualified individuals to prepare, or oversee the
preparation of, a food safety plan.
    (Response 377) The proposed regulatory text included in the 2014
supplemental human preventive controls notice provides for the food
safety plan to be prepared, or its

preparation overseen, by one or more preventive controls qualified
individuals, and we are finalizing that provision as proposed.
    (Comment 378) Some comments ask us to specify that oversight of the
food safety plan is voluntary rather than required.
    (Response 378) We decline this request. The food safety plan is the
foundation for a preventive approach to producing safe food. As
previously discussed, the food safety plan must be designed to
identify, and to significantly minimize or prevent, hazards for the
purpose of preventing illness or injury (78 FR 3646 at 3731). The
comments fail to explain how a facility could ensure the proper design
of an effective food safety plan without oversight by an individual who
satisfies the minimum requirements for a preventive controls qualified
individual (see the discussion of the requirements for a preventive
controls qualified individual in section XXXVI).
    (Comment 379) Some comments assert that oversight of the food
safety plan by a preventive controls qualified individual should not be
required for products subject to the PMO because the production of such
products is subject to the NCIMS process.
    (Response 379) As discussed in Response 214, we agree we should
make use of the existing system of oversight provided for by NCIMS,
which has been part of a cooperative program among the U.S. Public
Health Service/FDA, the States, and the dairy industry since 1950, and
we have provided an extended compliance date in order that the PMO be
revised for consistency with this rule. Under a revised PMO, Grade
``A'' facilities would need a preventive controls qualified individual
to make decisions about hazards and verification procedures such as
environmental monitoring specific to a facility and to review food
safety records.
    (Comment 380) Some comments express concern about the cost
associated with oversight of the food safety plan by a preventive
controls qualified individual, regardless of whether the preventive
controls qualified individual is employed by the facility or is a third
party. These comments focus on the burden that this oversight would
place on farms and small businesses, and note that the food industry is
a ``low margin'' industry. Some comments ask us to provide for an
officer or employee of a State agricultural agency to provide oversight
of the food safety plan, because such persons have the most specialized
knowledge concerning that State, it is more efficient for State
officials to travel to nearby farms, and farmers feel more comfortable
working with State employees.
    (Response 380) A farm is not subject to this rule for activities
within the ``farm'' definition. A farm mixed-type facility that is a
small or very small business and only conducts the low-risk activity/
food combinations specified in Sec.  117.5(g) and (h) is exempt from
the requirements of subparts C and G, including the requirement for
oversight of the food safety plan by a preventive controls qualified
individual. Furthermore, a farm mixed-type facility that is a very
small business, but does not satisfy the criteria for the exemptions
specified in Sec.  117.5(g) and (h), is a qualified facility that is
exempt from the requirements of subparts C and G, and is instead
subject to modified requirements that do not require oversight of a
food safety plan by a preventive controls qualified individual.
Moreover, we expect that some training materials and courses will be
available online, thereby helping to mitigate costs, both associated
with training of a preventive controls qualified individual and loss of
production manpower during training.
    We disagree that it would be appropriate for an officer or employee
of a State agricultural agency to provide oversight of the food safety
plan. The food safety plan and its oversight are the responsibility of
the facility, not State government officials. The role of an officer or
employee of a State agricultural agency would be in determining whether
the applicable facility is in compliance with the rule, such as during
inspection. State extension agents may be available to assist small
businesses, even if those agents are not the designated preventive
controls qualified individual for the facility, provided that such
agents do not also have any role in determining whether the applicable
facility is in compliance with the rule.
    We acknowledge that oversight of a food safety plan by a preventive
controls qualified individual is a cost associated with the rule, and
we have accounted for that cost in the FRIA for this rule (Ref. 38). To
minimize the burden on the smallest businesses, the definition of
``very small business'' establishes a $1,000,000 threshold, adjusted
for inflation, during the 3-year period preceding the applicable
calendar year. As already noted, a facility that satisfies the
definition of very small business is exempt from the requirements of
subparts C and G and instead is subject to modified requirements (see
Sec.  117.201), which do not require a food safety plan that is
prepared or overseen by a preventive controls qualified individual.

C. Proposed Sec.  117.126(b)--Contents of a Food Safety Plan

    We proposed that the written food safety plan must include the
written hazard analysis, preventive controls (including the supplier
program and the recall plan), procedures for monitoring the
implementation of the preventive controls, corrective action
procedures, and verification procedures. As discussed in more detail in
section XLII, we have revised the phrase ``supplier program'' to
``supply-chain program'' throughout the regulatory text. In the
remainder of this document, we use the phrase ``supply-chain program''
in section headings and when referring to the provisions of the final
rule. We continue to use the term ``supplier program'' when describing
the proposed provisions and the comments regarding the proposed
provisions.
    (Comment 381) Some comments ask us to specify that sanitation
controls must be in the food safety plan. Some comments ask us to
require equipment standards in the food safety plan, noting that it is
not possible to clean and sanitize equipment that is not designed and
constructed to be cleanable by meeting specific standards.
    (Response 381) Sanitation controls are one type of preventive
control. As appropriate to the facility and the food (e.g., to control
hazards such as environmental pathogens), sanitation controls for
cleanliness of food-contact surfaces and prevention of allergen cross-
contact and cross contamination would be required to be in the food
safety plan (Sec.  117.135(c)(3)).
    We are not adding a requirement to include equipment standards in
the food safety plan. The CGMPs established in subpart B already
require that all plant equipment and utensils be so designed and of
such material and workmanship so to be adequately cleanable (Sec.
117.40(a)(1)). It is not practical to specify equipment standards in
the CGMPs due to the wide range of equipment used by the food industry,
including equipment subject to ongoing development and improvement.
    (Comment 382) Some comments ask us to recognize that existing HACCP
plans, such as those developed in accordance with the EU 2004 Food
Hygiene law and GFSI-compliant food safety plans, can satisfy the
requirements for what must be in a food safety plan.
    (Response 382) To the extent that an existing HACCP plan or GFSI-
compliant food safety plan includes all required information, a
facility can use such

plans to meet the requirements of this rule. We expect that many
existing plans will need only minor supplementation to fully comply
with these requirements. Relying on existing records, with
supplementation as necessary to demonstrate compliance with the
requirements of the human preventive controls rule, is acceptable (see
Sec.  117.330).
    (Comment 383) Some comments ask us to explain the differences
between the food safety plan being established to implement FSMA and
HACCP plans established under current requirements or guidelines for
HACCP systems. These comments ask us to provide exporters with
background information and specific examples of differences, including
how firms are directed to set their critical control points and
critical limits.
    (Response 383) Table 29 compares the provisions of the food safety
plan required by this rule to the provisions of HACCP plans in some
current requirements or guidelines for HACCP systems. See also the
discussion in the 2013 proposed human preventive controls rule (78 FR
3646 at 3730-3732) and our memorandum comparing the provisions of this
rule to various existing domestic and international HACCP-based
standards (Ref. 65). This rule does not specify how a facility would
identify any applicable CCPs or critical limits. Importantly, this rule
explicitly provides that preventive controls include controls other
than those at CCPs that are also appropriate for food safety (Sec.
117.135(a)(2)(ii)). See also Response 2, in which we discuss both
future guidance and a preventive controls training curriculum being
developed by the FSPCA. We expect that both of these resources will
help facilities, including foreign facilities, understand the
requirements for a food safety plan.

                            Table 29--A Comparing the Food Safety Plan to HACCP Plans
----------------------------------------------------------------------------------------------------------------
                                                                                Federal HACCP  rules
                                                    NACMCF HACCP                            for juice,  seafood,
     Requirements              PC Rule               Guidelines        Codex HACCP  Annex       and meat  and
                                                                                poultry
----------------------------------------------------------------------------------------------------------------
Written plan..........  Yes..................  Yes..................  Yes.................  Yes.
Who is responsible for  The owner, operator    A HACCP team may need  Individual            The processor.
 preparing the plan?     or agent in charge     assistance from        businesses, with
                         of a facility must     outside experts        advice when
                         prepare, or have       knowledgeable in the   necessary from
                         prepared, and          hazards associated     other sources.
                         implement a written    with the product and
                         food safety plan.      process.
                         The food safety plan
                         must be prepared, or
                         its preparation
                         overseen, by one or
                         more preventive
                         controls qualified
                         individuals.
What does the plan       Written        Written        Written       Written
 contain?                hazard analysis.       hazard analysis.       hazard analysis.      hazard analysis.
                         Written        Must include   Must          Must list
                         preventive controls.   the hazard, the        include CCPs and      all food safety
                         Written        CCPs, and critical     critical limits.      hazards that are
                         supply-chain program.  limits.                Must          reasonably likely
                         Written        Must include   include monitoring    to occur, CCPs, and
                         recall plan.           monitoring             procedures.           critical limits.
                         Written        procedures.            Must          Must list
                         procedures for         Must include   include corrective    monitoring
                         monitoring the         corrective actions.    actions.              procedures.
                         implementation of      Must include   Must          Must
                         the preventive         verification           include               include corrective
                         controls.              procedures.            verification          action procedures.
                         Written        Must include   procedures.           Must
                         corrective action      recordkeeping          Must          include
                         procedures.            procedures.            include records.      verification
                         Written                                                     procedures;
                         verification                                                        Must
                         procedures.                                                         include
                                                                                recordkeeping
                                                                                procedures.
Is oversight required   Yes..................  Yes..................  Yes.................  Yes.
 by a person qualified
 by training and
 experience?
----------------------------------------------------------------------------------------------------------------

D. Proposed Sec.  117.126(c)--Records

    We proposed that the food safety plan is a record that is subject
to the recordkeeping requirements of subpart F. We received no comments
that disagreed with this proposed requirement and are finalizing it as
proposed.

E. Comments on Potential Requirements for Submission of a Facility
Profile to FDA

    We requested comment on whether to require submission to FDA of a
subset of the information that would be in a food safety plan (78 FR
3646 at 3768). This information, which could be referred to as a
``facility profile,'' could be submitted through an electronic form
using a menu selection approach at the same time as facility
registration, and could be updated biennially simultaneously with the
required biennial update of the food facility registration. We
described potential benefits to having a facility's food safety plan in
advance of an inspection, such as aiding in the efficient oversight of
preventive controls by allowing us to better target inspectional
activities to facilities that produce foods that have an increased
potential for contamination (particularly contamination with biological
hazards). We noted that facilities could benefit from our advance

preparation through interaction with better-informed investigators and
potentially reduced inspection time. We requested comment on the
utility and necessity of such an approach and on the specific types of
information that would be useful in developing a facility profile. We
also requested comment on any additional benefits that might be
obtained from using such an approach and any potential concerns with
this approach.
    We noted that we had previously announced an opportunity for public
comment on the proposed collection of additional food facility profile
information on a voluntary basis from firms that complete the FDA food
facility registration process (Federal Register of May 11, 2012, 77 FR
27779). In contrast to the voluntary submission of food facility
profile information described in that notice, in the 2013 proposed
human preventive controls rule we requested comment on whether the
submission of such information should be required.
    (Comment 384) Some comments state that submission of a facility
profile would be useful and support requiring such a submission.
However, most of the comments that addressed our request for comments
on such a submission express concern. Some comments assert that
requiring submission of a facility profile is outside of FDA's
statutory authority under FSMA. Other comments assert that submitting a
facility profile would not advance food safety goals or have a
commensurate benefit to food safety. Some comments express concern
about protection of confidential information. Other comments express
concern that we would misinterpret the submitted information in the
absence of discussion with the facility. Some comments assert that
receiving and evaluating the submitted information would be too time-
consuming for FDA, whereas other comments assert that submitting the
information would be too time-consuming for the facility. Some comments
state that a subset of the information that would be submitted could be
found in the Establishment Inspection Reports. Some comments assert
that we could use information already available through the Reportable
Food Registry to identify facilities that have needed to address a
serious food safety violation and target our inspectional resources to
those facilities. Some comments state that a facility profile is a not
a static document and would be very difficult to keep up-to-date.
    (Response 384) We have decided that we will not establish a
requirement for submission of a facility profile. We will explore other
mechanisms to achieve the goals we described in the 2013 proposed human
preventive controls rule.

XXV. Subpart C: Comments on Proposed Sec.  117.130--Hazard Analysis

    We proposed requirements for hazard analysis, including hazard
identification and hazard evaluation. Some comments support the
proposed requirements without change. For example, some comments
support our proposal for the hazard analysis to address ``known or
reasonably foreseeable hazards'' because this is consistent with Codex.
Other comments agree that the hazard analysis should address both the
severity of the potential hazard and the probability that the hazard
will be present in a food product. Other comments state that testing
for environmental pathogens may be impractical in certain situations
for facilities in chemical plants that also produce food additives and
that the proposed requirements for hazard evaluation make it clear that
in such facilities environmental monitoring would not be required. Some
comments that support the proposed provisions suggest alternative or
additional regulatory text (see, e.g., Comment 385, Comment 395,
Comment 406, and Comment 407) or ask us to clarify how we will
interpret the provision (see, e.g., Comment 418).
    In the following sections, we discuss comments that ask us to
clarify the proposed requirements or that disagree with, or suggest one