controls to address the hazards, and is monitoring the performance of
the preventive controls to ensure that such controls are effective
(Sec.  117.201(a)(2)(i)). The difference between the requirements of
the human preventive controls rule and the proposed produce safety rule
reflect differences in the distinct statutory provisions governing the
two rules.
    (Comment 576) Some comments emphasize that the modified
requirements need to ensure adequate protection of public health and
state that we should maintain and exercise oversight of qualified
facilities. Some comments ask that we provide enough specificity so
that qualified facilities know and understand their food safety
responsibilities towards consumers.
    (Response 576) A facility that satisfies criteria to be a qualified
facility continues to be responsible to produce food that will not be
adulterated under section 402 of the FD&C Act or misbranded under
section 403 of the FD&C Act. Such a facility is also subject to the
requirements of section 421 of the FD&C Act regarding frequency of
inspection of all facilities and to the new administrative tools
provided by FSMA, such as for suspension of registration (section 415
of the FD&C Act) and for mandatory recall (section 423 of the FD&C
Act). As discussed in Response 151, we expect that most qualified
facilities will be subject to the CGMP requirements of subpart B. As we
do now, we will continue to inspect these facilities for compliance
with those CGMP requirements.
    (Comment 577) Some comments ask which exemption a farm mixed-type
facility should follow if it satisfies criteria for a qualified
facility (Sec.  117.5(a)), as well as criteria for a very small
business that only conducts on-farm low-risk activity/food combinations
(specified in Sec.  117.5(g) and (h)).
    (Response 577) We describe these comments in more detail in Comment
202. As discussed in Response 202, a farm mixed-type facility that is a
very small business and that only conducts the low-risk activity/food
combinations listed in Sec.  117.5(g) and (h) may find it advantageous
to classify itself as a very small business eligible for the exemption
in Sec.  117.5(g) and (h) (which is not subject to the modified
requirements in Sec.  117.201) rather than as a qualified facility
(which is subject to the modified requirements in Sec.  117.201).
    (Comment 578) Some comments express concern about State access to
the records that a qualified facility maintains to support its
attestations, particularly when a State would conduct an inspection for
compliance with part 117 under contract to FDA. These comments express
concern about the time and resources necessary to verify the status of
a facility as a qualified facility and note that previous mechanisms
whereby we provide information to States in advance of inspection have
been slow. These comments also express concern that if the State must
verify the ``qualified facility'' status of all firms, including those
that are not FDA contracts, this could delay their ability to conduct
timely inspections and increase inspection time, reducing the number of
inspections conducted.
    (Response 578) We are sensitive to the time required for various
inspection activities and intend to communicate with States regarding
our expectations for how to verify whether a facility is a qualified
facility.
    (Comment 579) Some comments point out that the proposed procedures
for submission are silent on the process and timeframe for our review
and approval of the submitted documentation and ask us to clarify this
process and timeframe. Other comments ask us to clarify the
consequences to a facility if its submission is found to be
insufficient.
    (Response 579) We will not be approving the submitted attestations.
Instead, we intend to use the information to determine whether the
facility should be inspected for compliance with the requirements for
hazard analysis and risk-based preventive controls, or for compliance
with the modified requirements. During the inspection, we would ask to
see the records that the facility maintains to support any submitted
attestations.
    (Comment 580) Some comments ask us to clarify whether a foreign
facility would need to submit documentation of

its status as qualified facility. These comments note that a foreign
facility also would be required to provide information to an importer
and assert that submitting information to both FDA and an importer
would be a duplication of effort. These comments ask us to allow a
foreign facility that is a qualified facility to submit information to
either FDA or the importer, rather than to both FDA and the importer.
    (Response 580) We decline this request. Documentation submitted to
an importer would not reach FDA and, thus, could not satisfy the
requirements of this rule. As discussed in Response 572, we are
requiring submission of an attestation, on a form that can be submitted
either electronically or on paper, rather than submission of the
underlying information.

C. Proposed Sec.  117.201(a)--Documentation To Be Submitted

1. Proposed Sec.  117.201(a)(1)--Documentation That the Facility Is a
Qualified Facility
    We proposed that a qualified facility must submit documentation
that the facility is a qualified facility. We also proposed that for
the purpose of determining whether a facility satisfies the definition
of a qualified facility, the baseline year for calculating the
adjustment for inflation is 2011. As discussed in Response 572, we have
revised the provision to specify that the documentation that must be
submitted is an attestation.
    (Comment 581) Some comments ask us to clarify the documentation
required to certify that an operation is a qualified facility. Some
comments ask us to explicitly state that the documentation must include
financial and sales records of the business and its subsidiaries or
affiliates. Some comments ask us to clarify the types of records that
would be required to be submitted by foreign establishments to support
the classification of a foreign establishment as a ``qualified
facility.''
    (Response 581) The submission to FDA will be an attestation rather
than the records that the qualified facility relies on to support the
attestation; however, you must maintain those records relied upon to
support the ``attestations'' (see Sec.  117.201(f)). As previously
discussed, consistent with section 418(l)(2)(B)(ii) of the FD&C Act we
intend to issue guidance on the records that a facility could retain to
demonstrate that it is a qualified facility (78 FR 3646 at 3770). We
intend to focus on records demonstrating that a facility is a very
small business (i.e., financial records demonstrating that a business
averages less than the $1,000,000 threshold adjusted for inflation,
during the 3-year period preceding the applicable calendar year) rather
than records demonstrating that the average annual monetary value of
the food manufactured, processed, packed, or held at such facility that
is sold directly to qualified end-users during a three-year period
exceeded the average annual monetary value of the food sold by the
facility to all other purchasers. We expect that financial records
demonstrating that a business is a very small business will be less
burdensome for a qualified facility to maintain and require fewer
resources for FDA to review.
    (Comment 582) Some comments ask whether documentation demonstrating
that a facility is a qualified facility must be prepared by a
``preventive controls qualified individual'' as that term is defined in
Sec.  117.3.
    (Response 582) The rule does not require that documentation
demonstrating that a facility is a qualified facility be prepared by a
``preventive controls qualified individual.''
    (Comment 583) Some comments ask how the adjustment for inflation
will be calculated and how regulators such as the States will get this
information.
    (Response 583) We intend to use the Federal calculation for the
Gross Domestic Product price deflator, as provided by the Bureau of
Economic Analysis, to adjust for inflation. We will make the inflation-
adjusted dollar value to the baseline very small business sales cut-
offs (e.g., $1,000,000 in 2011) available on our Internet site. We will
update the values for the very small business exemptions and
qualifications annually using this calculation.
2. Proposed Sec.  117.201(a)(2)(i)--First Option for Documentation:
Food Safety Practices
    We proposed two options for satisfying the statutory documentation
requirement in section 418(l)(2)(B)(i) of the FD&C Act. Under the first
option (the food safety practices option), a qualified facility could
submit documentation demonstrating that it has identified the potential
hazards associated with the food being produced, is implementing
preventive controls to address the hazards, and is monitoring the
performance of the preventive controls to ensure that such controls are
effective. As discussed in Response 572, we have revised the provision
to specify that the submission is an attestation.
    (Comment 584) Some comments assert that the rule is vague about
what the applicable documentation should include and how exhaustive it
should be. Some comments ask whether documentation (such as a food
safety plan) must address all operations at the establishment or only
those that trigger the registration of the establishment as a facility.
Some comments ask us to clarify the difference between having
documentation to support food safety practices and attesting that the
facility has such documentation. Other comments ask whether a qualified
facility would need to have records documenting a risk analysis and
monitoring.
    (Response 584) If a qualified facility submits an attestation
regarding its food safety practices, the documentation that the
facility maintains for review during inspection must specify that the
facility has identified the potential hazards associated with the food
being produced, is implementing preventive controls to address the
hazards, and is monitoring the performance of the preventive controls
to ensure that such controls are effective (see Sec.
117.201(a)(2)(i)). For example, a qualified facility that produces one
or more nut butters might have documentation specifying that it has
determined that Salmonella is a hazard requiring a preventive control,
describing the roasting process that will control Salmonella,
describing sanitation controls to prevent contamination of the nut
butters with Salmonella, and describing an environmental monitoring
program to verify that its sanitation controls are effective. Likewise,
a qualified facility that prepares cooked soups that require
refrigeration for safety might have documentation specifying that it
has determined that Salmonella is a hazard requiring a preventive
control and supporting the temperature and time used in a thermal
process to kill Salmonella, with temperature controls for safety and
procedures for monitoring the temperature controls. A qualified
facility that makes pickles might have documentation specifying that
the hazard requiring a preventive control is C. botulinum, specifying
the final equilibrium pH (of the pickled cucumbers) that is controlling
the hazard, and demonstrating its monitoring of the pH during the
production process.
    As discussed in Response 572, a qualified facility that chooses the
food safety practices option for complying with the submission
requirements of this rule will attest to that by checking a statement
on a form. In contrast, a food safety plan (or other documentation)
that the qualified

facility relies on to support the attestation will be a record subject
to the recordkeeping requirements of subpart F.
    (Comment 585) Some comments ask us to clarify whether the
submission requirement addresses compliance with the CGMP requirements
of subpart B.
    (Response 585) The submission requirement does not address
compliance with the CGMP requirements of subpart B.
3. Proposed Sec.  117.201(a)(2)(ii)--Second Option for Documentation:
Compliance With Other Applicable Non-Federal Food Safety Law
    Under the second option for satisfying the statutory documentation
requirement, a qualified facility could submit documentation that it is
in compliance with State, local, county, or other applicable non-
Federal food safety law, including relevant laws and regulations of
foreign countries. As discussed in Response 572, we have revised the
provision to specify that the submission is an attestation. We also
have revised the provision to add ``tribal'' as an example of
applicable non-Federal food safety law to clarify for purposes of this
rule that a qualified facility could submit an attestation that it is
in compliance with tribal food safety law.
    (Comment 586) Some comments object to the proposed provision. These
comments point out that State and local requirements are inconsistent
and assert that such requirements are not sufficiently rigorous to
substitute for the FSMA requirement to conduct a hazard analysis and
establish and execute a documented food safety plan.
    (Response 586) The provision reflects the express statutory
direction of section 418(l)(2)(B)(i)(II) of the FD&C Act. See Response
576.
    (Comment 587) Some comments ask us to specify that a qualified
facility must document its compliance with the food safety laws of the
State where its products are sold.
    (Response 587) We decline this request. We interpret section
418(l)(2)(B)(i)(II) of the FD&C Act to apply to the State where a
qualified facility is located. This is consistent with how States
conduct inspections.
    (Comment 588) Some comments ask us to specify that a qualified
facility must document compliance with all applicable non-Federal food
safety laws.
    (Response 588) We decline this request. Section 418(l)(2)(B)(i)(II)
of the FD&C Act refers to compliance with ``State, local, county or
other applicable non-Federal food safety law'' (emphasis added).
    (Comment 589) Some comments ask us to revise the proposed provision
to make clear that a facility could submit an applicable attestation if
the facility is subject to a State or local ``cottage food'' law (laws
allowing sale of certain food from home kitchens). These comments
explain that some cottage food laws do not require State or local
authorities to inspect a facility or otherwise document that the
facility is in compliance with the cottage food law. In addition, under
some of these cottage food laws a facility would not have documentation
such as a license to support its compliance with food safety
requirements. Some of these comments ask us to revise the proposed
provision to specify that a facility could rely on a copy of the
relevant State law or regulation and a letter from the facility stating
that it complies with that law or regulation, or certification by an
appropriate agency (such as a State department of agriculture).
    (Response 589) As discussed in Response 572, we have revised the
regulatory text.to provide for qualified facilities to submit an
attestation that the facility is in compliance with State, local,
county, or other applicable non-Federal food safety law. During an
inspection, we expect the facility to be able to show us how the
facility is complying with the applicable food safety regulation
(including relevant licenses, inspection reports, certificates,
permits, credentials, or certifications), and producing safe food.
    (Comment 590) Some comments ask us to provide resources to the
States to implement the proposed provision. These comments also ask us
to develop and implement a strategic plan to provide resources (e.g.,
training, guidance) to State and local inspection agencies in advance
of the anticipated increased burden on State and local inspection
programs that will be created by the provision.
    (Response 590) We do not believe that specific training for State
or other government counterparts is necessary for the purposes of
inspecting a qualified facility that attested to having documentation
from a non-Federal regulatory authority. The State or other government
counterpart would merely examine applicable documentation (such as a
license, inspection report, certificate, permit, credentials, or
certification by an appropriate agency (such as a State department of
agriculture), which is specified in the provision. After inspecting
such documentation, the State or other government counterpart would
focus on inspection for compliance with CGMPs, as it has done in the
past.

D. Proposed Sec.  117.201(b)--Procedure for Submission

    We proposed that the documentation must be submitted to FDA either
electronically or by mail. As discussed in Response 572, we have
revised the regulatory text to update details regarding the electronic
and paper submission of a specific form. We are developing paper and
electronic versions of Form FDA 3942a, which is an information
collection provision that is subject to review by OMB under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We intend to
make the paper Form FDA 3942a available in the near future and invite
comments consistent with procedures for approval of the form by OMB.
    (Comment 591) Some comments recommend that any interface for
electronic submission of certification statements post adequate notice
of requirements the facility must meet and warnings detailing potential
penalties (e.g., for fraudulent submission).
    (Response 591) We intend that the electronic submission system will
operate in a manner similar to the existing electronic submission
system for registration of food facilities, including a certification
statement advising the person signing the form that, under 18 U.S.C.
1001, anyone who makes a materially false, fictitious, or fraudulent
statement to the U.S. Government is subject to criminal penalties. We
intend to include a similar certification statement on paper forms that
will be available for qualified facilities that choose to submit by
paper rather than through the electronic system. The electronic and
paper submission forms will focus on the attestation statements rather
than on other requirements that the facility is subject to. The Small
Entity Compliance Guide that we will issue in accordance with section
212 of the Small Business Regulatory Enforcement Fairness Act (Public
L. 104-121) will be better suited to helping qualified facilities
understand the requirements of the rule than information presented on a
submission form.

E. Proposed Sec.  117.201(c)--Frequency of Determination and Submission

    We proposed that the documentation must be: (1) Submitted to FDA
initially within 90 days of the applicable compliance date; and (2)
resubmitted at least every 2 years, or whenever there is a material
change to the information applicable to determining the status of a
facility.
    (Comment 592) Some comments assert that the proposed timeframe of
90

days to submit the required documentation would not provide sufficient
time to gather and submit the required documentation and ask us to
extend the timeframe--e.g., to 120 or 180 days.
    (Response 592) We are retaining the proposed timeframe for the
initial submission (within 90 days of the applicable compliance date).
The only documentation that the qualified facility will need to submit
is an attestation, which does not need to be gathered. Importantly,
however, documentation supporting the attestation must be available for
inspection by September 17, 2018. As discussed in Response 155 the
compliance date for a facility to retain records to support its status
as a qualified facility is January 1, 2016. As a companion change, we
are explicitly requiring that a facility determine and document its
status as a qualified facility on an annual basis by no later than July
1 of each calendar year (see Sec.  117.201(c)(1)).
    In addition, we have revised proposed Sec.  117.201(c)(1) (which we
are finalizing as Sec.  117.201(c)(2)(i)(A), (B), and (C)) to specify
the timeframe for the initial submission for three distinct
circumstances: (1) By December 17, 2018, for a facility that begins
manufacturing, processing, packing or holding food before September 17,
2018; (2) Before beginning operations, for a facility that begins
manufacturing, processing, packing or holding food after September 17,
2018; or (3) By July 31 of the applicable calendar year, when the
status of a facility changes from ``not a qualified facility'' to
``qualified facility'' based on the annual determination required by
paragraph (c)(1) of this section. See the discussion in Response 155
regarding the approach we intend to take in a number of circumstances
that could lead to a facility having records to support its status as a
qualified facility for fewer than 3 preceding calendar years.
    We have revised the provision to specify that the required biennial
submissions of the attestations must be made during a timeframe that
will coincide with the required biennial updates to facility
registration (See section 102 of FSMA)--i.e., during the period
beginning on October 1 and ending on December 31, beginning in 2020. In
determining that 2020 would be the first year for the required biennial
submissions of the attestations, we first considered that the first
submission of an attestation would be approximately December 2018 for
qualified facilities that are operating as of the date of this final
rule (i.e., approximately 90 days after the date of publication of this
rule). For qualified facilities that do not begin operations until
after December 2018, the first biennial submission will be required in
a timeframe less than two years, but once the qualified facility has
made its first submission the subsequent biennial submissions will all
be at two-year intervals. Coordinating the biennial submissions of the
required attestations with the biennial registration will reduce the
cumulative economic impact on the food industry of complying with two
separate requirements because qualified facilities that choose to
submit electronically will be able to submit electronically while
accessing the same electronic portal used for facility registration.
This approach is consistent with our approach to food labeling
requirements, where we establish a Uniform Compliance Date (see, e.g.,
79 FR 73201, December 10, 2014).
    (Comment 593) Some comments ask us to include an option within the
system to notify us when a facility's status as a ``qualified
facility'' changes--e.g., because its business expands or changes.
    (Response 593) Notifying us when there is a change in the
facility's status from ``qualified facility'' to ``not a qualified
facility'' is a requirement rather than an option. We included this
requirement in the proposed rule, and are establishing it in this final
rule. We made editorial changes to the provision to make this clearer.
    We also established a series of dates associated with the
facility's change in status from ``qualified facility'' to ``not a
qualified facility.'' First, we are specifying that when the status of
a facility changes from ``qualified facility'' to ``not a qualified
facility'' based on the required annual determination, the facility
must notify FDA of that change in status using Form 3942a by July 31 of
the applicable calendar year (see Sec.  117.201(c)(3)). We have
provided the facility with flexibility to wait until July 1 of a given
calendar year to determine whether its status changes (see Sec.
117.201(c)(1)); 30 days is an adequate timeframe to submit the form
notifying us of the change in status.
    Second, we are specifying that when the status of a facility
changes from ``qualified facility'' to ``not a qualified facility,''
the facility must comply with subparts C and G no later than December
31 of the applicable calendar year unless otherwise agreed to by FDA
and the facility (see Sec.  117.201(d)). In essence, this provision can
provide a facility with up to a full year to comply with the full
requirements for hazard analysis and risk-based preventive controls
when the facility determines its change in status early in the calendar
year. A facility that does not determine that change in status until
the required date of July 1 would still have 6 months to comply with
the full requirements for hazard analysis and risk-based preventive
controls. As we have done in the case of a qualified exemption being
withdrawn (see Sec.  117.257(d)(1)), we are providing flexibility for a
facility to comply in an alternative timeframe if agreed to by FDA and
the facility.
    (Comment 594) Some comments ask us to specify that the required
attestations be submitted annually rather than every 2 years. These
comments assert that annual submission would be consistent with the
statutory provisions that determine eligibility for status as a
qualified facility based on sales, which will vary each year. These
comments also assert that using the current mechanism for registration
of food facilities would not be burdensome and would provide us with
assurances that only facilities that satisfy criteria to be a qualified
facility will operate under the modified requirements, thereby
minimizing risk to public health.
    Other comments ask us to specify that the required attestations be
submitted every 5 years rather than every 2 years. These comments
assert that doing so would be consistent with the statutory direction
of section 201 of FSMA (Targeting of Inspection Resources) for non-high
risk food facilities. These comments also assert that we did not
provide specific reasons for the proposed 2 year timeframe and that re-
submitting the attestations every two years will increase cost in time
and labor.
    (Response 594) We decline both of these requests. The rule already
requires resubmission whenever there is a material change to the
information that changes the status of a facility as a qualified
facility. Therefore, if the facility's sales change its status, so that
it is no longer a qualified facility, the rule requires that facility
to notify us when its status changes. (Note that the definition of very
small business established in this rule is based on an average (of
sales plus market value of human food held without sale) during the 3-
year period preceding the applicable calendar year, rather than on
annual sales plus market value. See Response 155.) A biennial
submission is adequate to otherwise require a qualified facility to
affirmatively attest that it continues to satisfy the criteria for
being a qualified facility. A biennial submission is not overly
burdensome, because a facility can coordinate its biennial submission
with its biennial update to its facility registration. The suggested 5-
year submission based on

the targeted inspection frequency for non-high risk food facilities
implies that all qualified facilities produce such foods, which is not
the case.

F. Proposed Sec.  117.201(d)--Notification to Consumers (Final Sec.
117.201(e))

    We proposed that a qualified facility that does not submit
documentation of its food safety practices must provide notification to
consumers as to the name and complete business address of the facility
where the food was manufactured or processed (including the street
address or P.O. box, city, state, and zip code for domestic facilities,
and comparable full address information for foreign facilities).
    (Comment 595) Some comments assert that the proposed requirement
exceeds what is already present for food in packaged form (21 CFR
101.5), and that these differences will create confusion for regulators
and producers alike, with added costs but no food safety benefits. Some
comments assert that the proposed requirement will likely cause
consumer confusion at point of purchase and may discourage retail and
food service buyers from receiving products from qualified facilities.
Some comments ask us to specify that when a food packaging label is
required, the required information must appear prominently and
conspicuously on the label in compliance with Sec.  101.5.
    (Response 595) We decline these requests. The requirement for
notification to consumers is mandated by section 418(l)(7)(A) of the
FD&C Act. The labeling requirements applicable to packaged foods (Sec.
101.5) are established under a different statutory provision than the
labeling requirements applicable to qualified facilities (i.e., under
section 403(e) of the FD&C Act (21 U.S.C. 343(e)) rather than section
418(l)(7) of the FD&C Act). The comments provide no explanation of the
basis for their assertion that these differences will create confusion
for consumers at point of purchase or discourage retail and food
service buyers from receiving products from qualified facilities. As
previously discussed (78 FR 3646 at 3771), the use of the term
``business address'' in section 418(l)(7) of the FD&C Act contrasts
with Congress' use of a different term, ``place of business,'' in
section 403(e) of the FD&C Act. These comments do not address the
reasons we previously discussed for our tentative conclusion that the
use of the term ``business address'' in section 418(l)(7) demonstrates
Congress' intent to require the facility's full address, including the
street address or P.O. box, to appear on labels or other required
notifications when the facility has opted to not submit documentation
directed to food safety practices. In this document, we are affirming
that tentative conclusion. As discussed in section LVI.A, we are
establishing January 1, 2020, as the date when a qualified facility
that is subject to the notification requirements of Sec.  117.201(e)(1)
must notify consumers of the complete business address of the facility
where the food was manufactured or processed.

G. Proposed Sec.  117.201(e)--Records (Final Sec.  117.201(f))

    We proposed that a qualified facility must maintain those records
relied upon to support the required documentation. We also proposed
that the records that a qualified facility must maintain would be
subject to the requirements that would be established in subpart F of
this rule. As discussed in Response 572, after considering comments we
have revised the rule to specify that a qualified facility must
maintain those records relied upon to support the required attestations
(rather than the required documentation).
    (Comment 596) Some comments ask us to explicitly specify that we
have access to documents that establish a facility as a qualified
facility. Some comments assert that a facility may reasonably assume
that records such as financial records would not be available to us
because such records are excluded from the records that we have access
to under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act), as provided by Sec.
1.362.
    (Response 596) The rule explicitly specifies that we have access to
records that are required by the rule (see Sec.  117.320). If a
facility relies on financial records to demonstrate its status as a
qualified facility, we will have access to those financial records. The
exemption referred to by the comments for financial records (Sec.
1.362) is narrowly targeted to records required by the section 414
recordkeeping regulations and does not apply to records required by
this human preventive controls rule.
    (Comment 597) Some comments ask us to revise the rule to define
documentation as the actual records or true copies of the actual
records.
    (Response 597) The rule explicitly specifies that the records a
qualified facility relies on to support the required attestations must
be actual records, true copies, or electronic records. However, it does
so by requiring that the records that a qualified facility must
maintain are subject to the requirements in subpart F (see Sec.
117.305(a)), which specifies that these requirements apply to all
records required by this rule, rather than by specifying these
requirements within the provisions directed to modified requirements
for qualified facilities.
    (Comment 598) Some comments ask us to include a new section in
subpart F to cover additional requirements applying to the records that
a qualified facility must keep and make available to FDA upon request.
These comments assert that such a section is necessary to ensure that
qualified facilities understand their obligations. These comments also
assert that clarity is needed in light of the nature of the financial
records that would be required to support the facility's status as a
qualified facility.
    (Response 598) We decline this request. As discussed in Response
581, consistent with section 418(l)(2)(B)(ii) of the FD&C Act we intend
to issue guidance on the records that a facility could retain to
demonstrate that it is a qualified facility rather than specify these
records in the human preventive controls rule. Section 117.201(f)
already specifies that a qualified facility must maintain those records
relied upon to support the required attestations. There is no need to
repeat this requirement in subpart F, which establishes general
requirements for all records required by the rule but does not specify
those records required to demonstrate compliance with particular
requirements of the rule.

XXXIX. Subpart D: Comments on Proposed Sec.  117.206--Modified
Requirements That Apply to a Facility Solely Engaged in the Storage of
Unexposed Packaged Food

    We proposed that if your facility is solely engaged in the storage
of unexposed packaged food, you must conduct certain activities for any
such refrigerated packaged food that requires time/temperature control
to significantly minimize or prevent the growth of, or toxin production
by, microorganisms of public health significance. We requested comment
on the proposed list of modified requirements. Some comments that
support the proposed provisions suggest alternative or additional
regulatory text (see, e.g., Comment 599, Comment 600, Comment 604,
Comment 606, Comment 608, and Comment 610) or ask us to clarify how we
will interpret the provision (see, e.g., Comment 601 and Comment 602).
    In this section, 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 have
revised the proposed requirements as shown in table 41.

Table 41--Revisions to the Proposed Modified Requirements for Unexposed,
                       Refrigerated, Packaged Food
------------------------------------------------------------------------
            Section                Description            Revision
------------------------------------------------------------------------
117.206(a)....................  Circumstances      Clarify that the
                                 that make a        requirements apply
                                 facility subject   to a temperature
                                 to the modified    control area in a
                                 requirements for   facility that holds
                                 unexposed,         TCS food rather than
                                 refrigerated       to each product in
                                 packaged food.     the holding
                                                    facility.
117.206(a)(3).................  Modified           Clarify that
                                 requirements for   corrective actions
                                 corrective         need only be taken
                                 actions.           when a loss of
                                                    temperature control
                                                    may impact the
                                                    safety of the TCS
                                                    food.
117.206(a)(4)(i)..............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    accuracy checks, in
                                 temperature        addition to
                                 controls.          calibration, to
                                                    verify that
                                                    temperature controls
                                                    are consistently
                                                    implemented.
117.206(a)(4)(iii)............  Modified           Provide additional
                                 requirements for   flexibility for
                                 verification of    reviewing records of
                                 temperature        monitoring and
                                 controls.          corrective actions
                                                    either within a week
                                                    after the records
                                                    are made or within a
                                                    reasonable
                                                    timeframe.
117.206(a)(5)(i)..............  Records            Provide additional
                                 documenting the    flexibility for
                                 monitoring of      records documenting
                                 temperature        the monitoring of
                                 controls.          temperature controls
                                                    to be kept either as
                                                    affirmative records
                                                    demonstrating
                                                    temperature is
                                                    controlled or as
                                                    exception records
                                                    demonstrating loss
                                                    of temperature
                                                    control.
117.206(a)(5)(ii).............  Records            Conforming change
                                 documenting        associated with the
                                 corrective         modified
                                 actions.           requirements for
                                                    corrective actions
                                                    to clarify that
                                                    records of
                                                    corrective actions
                                                    are required when
                                                    there is a loss of
                                                    temperature control
                                                    that may impact the
                                                    safety of the TCS
                                                    food.
------------------------------------------------------------------------

A. Proposed Sec.  117.206(a)--Modified Requirements for Unexposed
Refrigerated Packaged Food That Requires Time/Temperature Controls

1. Proposed Sec.  117.206(a)(1)--Establish and Implement Temperature
Controls
    We proposed that if your facility is subject to the modified
requirements, you must establish and implement temperature controls
adequate to significantly minimize or prevent the growth of, or toxin
production by, microorganisms of public health significance.
    We also tentatively concluded that it would be rare for a facility
solely engaged in the storage of unexposed packaged food to not have
information regarding whether a refrigerated packaged food is a TCS
food and, if so, what specific temperature controls are necessary for
safe storage of the food. We requested comment on this tentative
conclusion.
    (Comment 599) Some comments ask us to clarify that the requirement
to establish and implement temperature controls applies to temperature
control areas in a facility rather than to each product in a facility.
    (Response 599) We agree that the requirement to establish and
implement temperature controls applies to temperature control areas in
a facility rather than to each product in a facility. To make this
clearer, we have revised the proposed requirement to clarify that the
facility must conduct activities as appropriate to ensure the
effectiveness of the temperature controls rather than conduct
activities ``for any such refrigerated packaged food.''
    (Comment 600) Some comments disagree with our tentative conclusion
that it would be rare for a facility solely engaged in the storage of
unexposed packaged food to not have information regarding whether a
refrigerated packaged food is a TCS food and, if so, what specific
temperature controls are necessary for safe storage of the food. These
comments ask us to specify that the responsibility for determining
whether a food is a TCS food falls to the manufacturer of the food
rather than the warehouse storing the food, because the warehouse
merely provides a service. Other comments note that the food product
owners determine the optimal conditions for storage of their products
based on their own hazard analysis and preventive controls, and that
the food product owners can simply communicate those requirements to
the warehouses that will store the products.
    (Response 600) In this type of circumstance, it is appropriate for
the manufacturer of the food to share the responsibility with the
warehouse for proper storage of the food. The various provisions of
section 418 of the FD&C act explicitly place the responsibility for
complying with the requirements for hazard analysis and risk-based
preventive controls, including modified requirements, on the owner,
operator, or agent in charge of a facility and, thus, a facility that
is a warehouse is responsible for its own food safety plan. Regardless,
the manufacturer also has responsibilities under section 418 of the
FD&C Act to determine the storage conditions necessary for food safety
and to take steps to ensure that the food is stored under conditions
that will ensure its safety.
    It is not necessary to specify this joint responsibility for
determining storage conditions in the rule, because the rule already
clearly specifies that its provisions apply to persons who manufacture/
process food, as well as to persons who hold food. Both the warehouse
and the manufacturer have flexibility in determining how to comply with
the rule, including the specific mechanism whereby the warehouse would
receive information about storage of a food product from the
manufacturer or owner of the product. Moreover, a citizen petition
submitted to FDA [Docket No. FDA-2011-P-0561], in requesting an
exemption or modified requirements for facilities solely engaged in the
storage of unexposed packaged foods, asserts that such facilities work
closely with food manufacturers to understand the conditions and
controls needed to ensure the quality of the foods they store and
distribute and that manufacturers appropriately instruct the warehouses
to ensure packaged products are being properly stored (78 FR 3646 at
3712).
    (Comment 601) Some comments ask us to clarify which facility--the
shipping facility or the receiving facility--will be responsible for
ensuring that temperature control is maintained during transportation
of TCS foods.

    (Response 601) See Response 423, which notes our intention to
address comments regarding the responsibilities of shippers and
receivers in the final sanitary transportation rule.
2. Proposed Sec.  117.206(a)(2)--Monitor the Temperature Controls
    We proposed that if your facility is subject to the modified
requirements, you must monitor the temperature controls with sufficient
frequency to provide assurance they are consistently performed. We
requested comment on whether there would be a benefit to requiring a
facility to develop written procedures for monitoring temperature.
    (Comment 602) Some comments ask us to explain in the preamble of
the final rule that we will accept monitoring systems that provide
exception reports to satisfy the modified requirements. The comments
describe exception reporting as a structure where automated systems are
designed to alert operators and management when the monitoring system
observes a deviation from an established limit. These comments assert
that monitoring of preventive controls by automated systems can be more
efficient than monitoring by personnel, and can eliminate human error.
    (Response 602) See also Response 468 and Response 610. We have
revised the recordkeeping provisions of these modified requirements to
provide that the temperature monitoring records for the modified
requirements may be kept either as affirmative records demonstrating
temperature is controlled or as exception records demonstrating loss of
temperature control. Although the comments explicitly ask us to provide
a clarification in the preamble of this rule, we decided the
clarification within the regulatory text would be clearer to facilities
that are subject to the requirements, as well as to investigators who
will be inspecting facilities for compliance with the rule.
    (Comment 603) Some comments state that written procedures for
monitoring temperature are not necessary. One reason provided by the
comments is that the required records (specified in proposed Sec.
117.206 (a)(5)) would provide sufficient information on the type and
frequency of monitoring. Another reason is that the specific activities
we proposed to ensure the effectiveness of the temperature controls
already address activities that a facility would include in a written
procedure.
    (Response 603) We agree with the comments that the rule does not
need to require that a facility develop written procedures for
monitoring temperature.
3. Proposed Sec.  117.206(a)(3)--Requirement to Take Corrective Actions
    We proposed that if your facility is subject to the modified
requirements, you must take appropriate corrective actions if there is
a problem with the temperature controls for a TCS food.
    (Comment 604) Some comments ask us to narrow the term ``temperature
controls'' to more specifically focus it on temperature controls that
are relevant to food safety because some problems with the controls may
not impact the product temperature (and, thus, would not impact food
safety).
    (Response 604) We have revised the proposed requirement (and the
applicable recordkeeping requirement) to specify that corrective
actions are necessary only when there is a loss of temperature control
that may impact the safety of a TCS food.
    (Comment 605) Some comments assert that the responsibility for
determining any corrective actions for a TCS food when there is a loss
of temperature control falls to the manufacturer of the food rather
than to the warehouse. These comments also assert that a warehouse is a
third party who is not legally empowered to make independent decisions
about when and where to ship the product, or not to ship it at all.
These comments ask us to clarify that the responsibility of a warehouse
for ``preventing'' affected food entering commerce ends when the
product is returned to the manufacturer or processor.
    (Response 605) Returning affected food to the manufacturer/
processor or owner of the food is one way to satisfy the requirement to
prevent food from entering commerce if the owner, operator, or agent in
charge of a warehouse cannot ensure the affected food is not
adulterated under section 402 of the FD&C Act, either on its own or
after consultation with the manufacturer or processor of the food. It
is not necessary to specify this specific action on the part of a
warehouse in the regulatory text.
4. Proposed Sec.  117.206(a)(4)--Requirement To Verify Consistent
Implementation of Temperature Controls
    We proposed that if your facility is subject to the modified
requirements, you must verify that temperature controls are
consistently implemented by: (1) Calibrating temperature monitoring and
recording devices; (2) reviewing records of calibration within a
reasonable time after the records are made; and (3) reviewing records
of monitoring and corrective actions taken to correct a problem with
the control of temperature within a week after the records are made.
    (Comment 606) Some comments assert that the proposed requirement to
``calibrate'' devices that monitor and record temperature is
inconsistent with the requirement to test such devices for accuracy in
the LACF regulations in part 113. These comments assert that ``accuracy
check'' is a more appropriate term to use in the modified requirements
because many instruments that monitor or record temperature have very
low drift values and may seldom require calibration.
    (Response 606) We have revised the proposed requirements to require
verification that temperature controls are consistently implemented by
calibrating temperature monitoring and recording devices or checking
them for accuracy. However, if the outcome of an accuracy check is that
a temperature monitoring or recording device is not accurate, the
facility must follow up by calibrating or replacing the device. See
also Comment 519 and Response 519.
    (Comment 607) Some comments assert that reviewing records of
calibration or accuracy checks is only needed if a designated tolerance
is exceeded.
    (Response 607) Although we recognize that in most instances an out-
of-calibration device will be identified and corrected at the time a
calibration or accuracy check is performed, this is not always the
case. The purpose of reviewing records of calibration or accuracy
checks is to identify a problem that may have been missed or may not
have been corrected rather than to react to a problem after the problem
is identified. The records review is also a verification that the
temperature controls were consistently implemented and that corrective
actions were taken if needed.
    (Comment 608) Some comments ask us to modify the frequency of
checking monitoring records to specify that it be done with a frequency
to demonstrate control rather than within a week after the records are
made.
    (Response 608) Consistent with Response 539, we have revised the
proposed requirement to require review of records of monitoring (as
well as records of corrective actions taken to correct a problem with
the control of temperature) within 7 working days after the records are
created or within a reasonable timeframe, provided that the preventive
controls qualified individual prepares (or oversees the preparation of)
a written justification for a timeframe that exceeds 7 working days.

    (Comment 609) Some comments assert that the proposed verification
and review activities are too prescriptive because they require reviews
that are not necessary. However, these comments also assert that the
proposed verification activities are too vague because they do not
specify the reasons for reviewing the records. These comments ask us to
focus the regulatory text on achieving the overall objective of the
review (i.e., ensuring the adequacy of the control) and to provide
examples of meaningful review activities in guidance.
    (Response 609) We disagree that the proposed verification
activities would require reviews that are not necessary. As noted in
Response 607, the purpose of the records review is both to identify a
problem with a temperature monitoring device that may not have been
detected or corrected, and to verify that the temperature controls were
consistently implemented and that corrective actions were taken if
needed. The requirement is consistent with requirement for records
review in subpart C (Sec.  117.165(a)(4)), which specifies records
review as a verification activity to ensure that the records are
complete, the activities reflected in the records occurred in
accordance with the food safety plan, the preventive controls are
effective, and appropriate decisions were made about corrective
actions.
5. Proposed Sec.  117.206(a)(5)--Establish and Maintain Records
    We proposed that if your facility is subject to the modified
requirements, you must establish and maintain records that document
monitoring, corrective actions, and verification activities.
    (Comment 610) Some comments state that temperature controls in
refrigerated warehouses are extremely reliable and therefore extensive
recordkeeping and record review are not value-added. These comments ask
us to revise the proposed provision to require a record only if a
deviation in the environmental temperature from the prescribed limits
was noted.
    (Response 610) See also Response 468 and Response 602. We have
revised the regulatory text to provide that temperature monitoring
records may be kept either as affirmative records demonstrating
temperature is controlled or as exception records demonstrating loss of
temperature control. The revised provision is consistent with the more
general requirement for monitoring records of refrigeration temperature
during storage of TCS food (see Sec.  117.145(c)(2)).

B. Proposed Sec.  117.206(b)--Records

    We proposed that the records that a facility must establish and
maintain for the proposed modified requirements are subject to the
requirements that would be established in proposed subpart F. We
received no comments that disagreed with our proposal, and are
finalizing proposed Sec.  117.206(b) without change.

XL. Subpart E: Comments on Proposed New Provisions for Withdrawal of a
Qualified Facility Exemption

    In the 2013 proposed human preventive controls rule, we proposed to
establish procedural requirements that would govern our withdrawal of
an exemption for a qualified facility (proposed subpart E; the
withdrawal provisions). In the 2014 supplemental human preventive
controls notice, we discussed several comments we received on these
withdrawal provisions, and proposed modifications and additions to
them. Some of the re-proposed provisions would modify the provisions
that we included in the 2013 proposed human preventive controls rule
(such as the timeframe for compliance with an order withdrawing an
exemption), whereas others would be new provisions (such as a procedure
to reinstate an exemption that had been withdrawn). In this section of
this document we discuss comments that we received on the withdrawal
provisions in the 2013 proposed human preventive controls rule, but did
not address in the 2014 supplemental human preventive controls notice.
We also discuss comments that we received on the re-proposed withdrawal
provisions in the 2014 supplemental human preventive controls notice.
    Most of the comments that support the proposed provisions suggest
alternative or additional regulatory text (see, e.g., Comment 612
through Comment 614, Comment 620 through Comment 626, Comment 628,
Comment 629, and Comment 631 through Comment 633) or ask us to clarify
how we will interpret the provision (see, e.g., Comment 617).
    For several provisions, we received no comments that disagreed with
our proposal, and are finalizing the provisions without change. These
provisions are Sec.  117.274 (Presiding officer for an appeal and for
an informal hearing); Sec.  117.277 (Timeframe for issuing a decision
on an appeal); Sec.  117.280 (Revocation of an order to withdraw a
qualified facility exemption); and Sec.  117.284 (Final agency action).
    In the following paragraphs, 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 have revised the proposed requirements as shown in table
42, with editorial and conforming changes as shown in table 52.

   Table 42--Revisions to the Proposed Provisions for Withdrawal of a
                      Qualified Facility Exemption
------------------------------------------------------------------------
           Section                 Description            Revision
------------------------------------------------------------------------
117.251(b)(2)...............  Timeframe for a       Allow 15 calendar
                               qualified facility    days, rather than
                               to respond to a       10 calendar days,
                               notification from     for the facility to
                               FDA about             respond.
                               circumstances that
                               may lead FDA to
                               withdraw the
                               facility's
                               exemption.
117.257(c)..................  Contents of an order  Editorial changes to
                               to withdraw a         clarify that the
                               qualified facility    order will specify
                               exemption.            which of two
                                                     circumstances that
                                                     may lead FDA to
                                                     withdraw a
                                                     qualified facility
                                                     exemption apply, or
                                                     whether both of
                                                     these two
                                                     circumstances
                                                     apply.
117.257(d)(1)...............  Contents of an order  Specify that the
                               to withdraw a         timeframe for the
                               qualified facility    qualified facility
                               exemption.            to comply with the
                                                     order is 120
                                                     calendar days after
                                                     the date of receipt
                                                     of the order, or
                                                     within a reasonable
                                                     timeframe, agreed
                                                     to by FDA, based on
                                                     a written
                                                     justification,
                                                     submitted to FDA,
                                                     for a timeframe
                                                     that exceeds 120
                                                     calendar days from
                                                     the date of receipt
                                                     of the order.
117.257(e)..................  Contents of an order  Include a statement
                               to withdraw a         informing the
                               qualified facility    facility that it
                               exemption.            may ask us to
                                                     reinstate an
                                                     exemption that was
                                                     withdrawn by
                                                     following the
                                                     procedures in Sec.
                                                      117.287.

117.257(d)(2)...............  Timeframe for a       Allow 15 calendar
                               qualified facility    days, rather than
                               to appeal an order    10 calendar days,
                               withdrawing the       for the facility to
                               facility's            appeal the order.
                               exemption.
117.260.....................  Compliance with, or   Specifies that a
                               appeal of, an order   qualified facility
                               to withdraw a         that loses its
                               qualified facility    exemption would no
                               exemption.            longer need to
                                                     comply with the
                                                     modified
                                                     requirements that
                                                     apply to qualified
                                                     facilities that
                                                     have an active
                                                     exemption.
117.260(a)(1) and (c)(1)....  Compliance with, or   Specify that the
                               appeal of, an order   timeframe for the
                               to withdraw a         qualified facility
                               qualified facility    to comply with the
                               exemption.            order is 120
                                                     calendar days after
                                                     the date of receipt
                                                     of the order, or
                                                     within a reasonable
                                                     timeframe, agreed
                                                     to by FDA, based on
                                                     a written
                                                     justification,
                                                     submitted to FDA,
                                                     for a timeframe
                                                     that exceeds 120
                                                     calendar days from
                                                     the date of receipt
                                                     of the order.
------------------------------------------------------------------------

A. Proposed Sec.  117.251--Circumstances That May Lead FDA To Withdraw
a Qualified Facility Exemption

    We proposed that we may withdraw the exemption that would apply to
a qualified facility in the event of an active investigation of a
foodborne illness outbreak that is directly linked to the qualified
facility, or if we determine that it is necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conditions or conduct associated with a qualified facility that are
material to the safety of the food manufactured, processed, packed, or
held at such facility. We also proposed that before we issue an order
to withdraw an exemption, we: (1) May consider one or more other
actions to protect the public health or mitigate a foodborne illness
outbreak; (2) must notify you, in writing, of circumstances that may
lead us to withdraw the exemption, and provide an opportunity for you
to respond in writing, within 10 calendar days of the date of receipt
of the notification, to our notification; and (3) must consider your
actions to address the circumstances that may lead us to withdraw the
exemption.
    (Comment 611) Some comments agree with the proposed provisions
regarding certain actions we may take, and other actions we must take,
before issuing an order to withdraw a qualified facility exemption. For
example, some comments agree that other regulatory actions should be
considered before withdrawing a qualified facility exemption, and some
comments agree that it is appropriate to assess corrective actions
taken by a qualified facility in response to a food safety problem when
considering whether to withdraw its exemption. Other comments agree
that these provisions are reasonable and will provide qualified
facilities due process and greater clarity on the withdrawal process,
but suggest that we could issue guidance rather than include these
provisions in the rule to allow us greater flexibility should we have
to act quickly to protect the public health.
    Other comments disagree with these proposed provisions and ask us
to delete them from the final rule. These comments assert that FSMA
does not require us to describe the actions that we may take prior to
withdrawing a qualified facility exemption and that it is not necessary
to do so because it is customary for us to work with a food facility to
address problems before taking enforcement actions. These comments also
express concern that listing possible regulatory actions before we
would issue an order to withdraw a qualified facility exemption could
create an expectation that we will always exercise such regulatory
actions before issuing the order. These comments also express concern
that being bound by these provisions could prevent us from acting
quickly to protect public health.
    (Response 611) We are retaining the provisions regarding certain
actions we may take, and other actions we must take, before issuing an
order to withdraw a qualified facility exemption. We agree that it is
customary for us to work with a food facility to address problems
before taking enforcement actions but disagree that specifying this
customary practice in the rule would prevent us from acting quickly to
protect public health. As previously discussed, we consider that
issuing an order to withdraw an exemption would be a rare event, in
part because alternative actions such as those described in these
provisions may provide a more expeditious approach to correcting a
problem than withdrawing an exemption (79 FR 58524 at 58553). We also
disagree that the rule binds us to take alternative regulatory action
before issuing an order to withdraw a qualified facility exemption,
other than to notify the facility in writing of circumstances that may
lead us to withdraw the exemption, provide an opportunity for the
facility to respond in writing, and consider the actions taken by the
facility to address the circumstances we describe. The rule clearly
specifies that regulatory actions such as a warning letter, recall,
administrative detention, suspension of registration, refusal of food
offered for import, seizure, and injunction are actions that we ``may''
(not ``must'') take before issuing an order to withdraw a qualified
facility exemption. Providing the facility with an opportunity to
correct the problems before we take steps to withdraw an exemption has
the potential to save agency resources associated with preparing an
order, responding to an appeal of the order and request for a hearing,
and administering a hearing. Directing resources to help a facility
correct problems, rather than to administer a withdrawal process that
could be resolved by the time of a hearing, is appropriate public
health policy.
    (Comment 612) Some comments ask us to specify that the notification
of circumstances that may lead FDA to withdraw the exemption must
include facts specific to the situation and information about how the
facility can remedy the situation.
    (Response 612) By specifying that we must notify the facility of
circumstances that may lead us to withdraw an exemption, we mean that
we would include facts specific to the situation. It is the
responsibility of the facility, not FDA, to remedy the situation.
    (Comment 613) Some comments ask us to state affirmatively that we
must not withdraw the exemption if the facility has satisfactorily
addressed the problematic conditions or conduct at the facility. These
comments assert that,

without this affirmative statement, the requirement that we ``consider
the actions taken by the facility'' remains unclear.
    (Response 613) We decline this request. If the facility has
satisfactorily addressed the problematic conditions or conduct, there
would be no problematic circumstances for us to describe in the order
withdrawing the qualified facility exemption.
    (Comment 614) Some comments ask us to provide additional time for a
qualified facility to respond, in writing, to a notification of
circumstances that may lead us to withdraw its exemption. Comments
suggest timeframes of 60, 90, and 120 days as a reasonable or
appropriate period of time for a qualified facility to compile
information and documentation of facts and to respond to a notification
of circumstances that may cause us to withdraw its exemption. Some of
these comments express concern that the proposed deadline is too short,
and that the short timeframe violates the intent of the exemption. Some
comments ask us to establish graduated response times, with less
response time allowed for more serious food safety concerns.
    (Response 614) We have revised the provision to provide for 15
calendar days, rather than 10 calendar days, for a facility to respond
in writing to our notification. The 15-day timeframe is the same as the
timeframe for responding to a warning letter. Circumstances that could
lead us to withdraw a qualified facility exemption require prompt
action on the part of a facility, just as circumstances that lead us to
issue a warning letter require prompt action.
    (Comment 615) Some comments ask us to clarify how an exemption can
be revoked (and restored) on diversified farms that produce both exempt
and non-exempt products.
    (Response 615) We assume that this comment is referring to a farm
mixed-type facility that produces some products (such as juice or
dietary supplements) that are exempt from the requirements for hazard
analysis and risk-based preventive controls, as well as some products
that are not exempt from these requirements. Neither withdrawing nor
reinstating a qualified facility exemption would have any impact on
products that are not subject to the requirements for hazard analysis
and risk-based preventive controls. In contrast, administrative
procedures such as injunction and suspension of registration likely
would apply to all food production by the facility.
    (Comment 616) Some comments ask us to consistently use either
``calendar days'' or ``working days'' throughout the provisions
directed to withdrawal of an exemption. Some comments ask us to use
``business days'' rather than ``calendar days'' or ``working days.''
    (Response 616) We have expressed the timeframes for all of the
withdrawal provisions in calendar days.
    (Comment 617) Some comments ask us to clarify that the decision to
withdraw a qualified exemption is an individualized determination and
will not be applied to a class of farmers by stating this clearly in
the preamble.
    (Response 617) The decision to withdraw a qualified exemption is an
individualized determination and will not be applied to a class of
facilities or farmers.
    (Comment 618) Some comments assert that the timeframes for
responding to a notification that an exemption may be withdrawn should
be the same regardless of whether the notification is sent to a
qualified facility subject to the human preventive controls rule or a
farm subject to the produce safety rule. These comments state that many
small farms do value-added processing and will be subject to both
rules.
    (Response 618) Although the produce safety rule is not yet final,
we intend to make the administrative procedures associated with
withdrawal of an exemption consistent to the extent practicable,
including the timeframe for responding to a notification.
    (Comment 619) Some comments ask us to expand the scope of the
withdrawal provisions to include facilities that would satisfy criteria
for an exemption from the requirements for hazard analysis and risk-
based preventive controls for low-risk activity/food combinations
(i.e., the exemptions in proposed Sec.  117.5(g) and (h)).
    (Response 619) We decline this request. Section 418 of the FD&C Act
does not provide for withdrawal of the exemptions established in Sec.
117.5(g) and (h). The withdrawal provision in section 418(l)(3) of the
FD&C Act is limited to qualified facilities.

B. Proposed Sec.  117.254--Issuance of an Order To Withdraw a Qualified
Facility Exemption

    We proposed procedures for the steps we would take to issue an
order to withdraw an exemption applicable to a qualified facility,
including procedures that would: (1) Emphasize that a senior FDA
official (such as an FDA District Director, the Director of the Office
of Compliance in the Center for Food Safety and Applied Nutrition, or a
more senior FDA official) must approve an order to withdraw the
exemption before the order is issued; (2) provide that any officer or
qualified employee of FDA may issue the order after it has been
approved; (3) specify that we would issue the order to the owner,
operator, or agent in charge of the facility; and (4) require that the
order be in writing and be signed and dated by the officer or qualified
employee of FDA who is issuing the order.
    (Comment 620) Some comments ask us to include in the procedures
timeframes for: (1) Submitting an order after an initial determination
that criteria for withdrawing an exemption are met; (2) approval or
denial by the FDA District Director; (3) issuing the withdrawal (with
automatic revocation of order if FDA does not issue the order within
the specified timeframe); and (4) delivery of the order to the owner,
operator, or agent in charge of the facility. Other comments recommend
that the procedures for issuing an order specify that we send the order
in a way that ensures its receipt, such as through certified mail with
confirmation of delivery to ensure the facility operator receives the
order.
    (Response 620) We are not establishing timeframes for the steps we
take before a facility receives an order for withdrawal of an
exemption. The timeframes surrounding our internal process for
developing an order have no bearing on the time that a facility will
need to respond to the order or on the information it will need to do
so. We agree that it is appropriate to specify timeframes for the
procedural steps that follow a facility's receipt of an order, and the
withdrawal procedures include such timeframes.
    We are not specifying that we send an order in a way that ensures
its receipt. Although certified mail with confirmation of delivery is
one way to ensure receipt, other methods are available, including
delivery through private carriers that provide mechanisms to document
receipt. In light of the provision (which we included in the 2014
supplemental human preventive controls notice) linking the timeframes
for a facility to comply with, or appeal, an order to the date of
receipt of the order (rather than to the date of the order), it will be
up to us to deliver the order in a way that provides us with evidence
of receipt.

C. Proposed Sec.  117.257--Contents of an Order To Withdraw a Qualified
Facility Exemption

    We proposed specific information that would be included in an order
to withdraw an exemption, including: (1) The date of the order and the
name, address, and location of the qualified

facility; (2) a brief, general statement of the reasons for the order,
including information relevant to the circumstances that led us to
issue the order; (3) a statement that the facility must either comply
with subpart C within 120 calendar days of receipt, or appeal the order
within 10 calendar days of receipt; (4) the text of section 418(l) of
the FD&C Act and of the withdrawal provisions in part 117, subpart E;
(5) information about an informal hearing on an appeal of the order;
and (6) contact information for appropriate senior FDA officials, as
well as the name and the title of the FDA representative who approved
the order.
    (Comment 621) Some comments recommend that the order specify which
of the two circumstances that could lead us to issue the order apply.
    (Response 621) We have made editorial changes to the regulatory
text to make it more clear that the provision requires us to specify
which circumstance applies (i.e., an active investigation of foodborne
illness, or conduct or conditions associated with the qualified
facility), or whether both of these two circumstances apply. See the
revised regulatory text for Sec.  117.257(c).
    (Comment 622) Some comments ask us to add more specific
requirements for the content of an order to withdraw an exemption,
including specific evidence about the circumstances leading to the
order. The comments maintain that doing so would help the facility
respond with particularity to the facts and issues contained in the
order if the facility appeals the order. The comments also recommend
that the order include the evidence on which the order is based
including, as applicable, evidence linking the active investigation of
a foodborne illness outbreak directly to the facility or measurable
evidence (collected using generally accepted scientific standards)
indicating the presence in the facility of pathogens that pose an
imminent threat to public health, or conduct or conditions that are
material to the safety of food. The comments also recommend that the
order include, when applicable, a statement explaining how altering the
conduct or conditions would prevent or mitigate a foodborne illness
outbreak.
    (Response 622) We agree that the order must provide sufficient
information to enable a facility to respond with particularity to
specific evidence about the circumstances leading to the order.
However, we disagree that the order must do so by including the
specific information recommended by the comments, and we have not
revised the proposed withdrawal provisions to incorporate the
suggestions of these comments. The comments appear to be more focused
on whether the circumstances that lead us to issue an order meet an
evidentiary standard than on explaining the problem so that a facility
can both understand the problem and respond with particularity to the
facts and issues contained in the order. The withdrawal provisions that
we are establishing in this provision require the order to include a
brief, general statement of the reasons for the order, including
information relevant to: (1) An active investigation of a foodborne
illness outbreak that is directly linked to the facility; or (2)
conditions or conduct associated with a qualified facility that are
material to the safety of the food manufactured, processed, packed, or
held at the facility. The requirements that we are establishing in this
provision would enable a qualified facility to both understand the
problem and respond to it. In addition, because other requirements in
these withdrawal provisions specify that we must notify a qualified
facility of circumstances that may lead us to withdraw its exemption
before we issue the actual order, the order withdrawing the exemption
would be the second time that the facility hears about the problems
(see Sec.  117.251(b)(2)). We intend that the process of responding to
the notification that we must send before issuing an order to withdraw
an exemption, including discussing the problems with FDA as warranted,
would provide additional information to the facility to enable the
facility to both understand the problem and respond to it.
    (Comment 623) Some comments ask us to provide 15 ``business days''
from date of receipt of the order, rather than the proposed 10 calendar
days from date of receipt of the order, for the facility to appeal the
order.
    (Response 623) We have revised the provision to provide for 15
calendar days, rather than 15 business days, for a facility to appeal
the order. We also have made conforming changes to establish the same
15 calendar timeframe in all provisions that specify the timeframe to
appeal the order (i.e., Sec. Sec.  117.260(a)(2), 117.264(a)(1), and
117.267(a)(2)). We also extended the timeframe for the hearing to be
held to be within 15 calendar days, rather than the proposed 10
calendar days, after the date the appeal is filed to provide more time
for the facility to prepare for the hearing (see Sec.  117.270(a)). The
timeframe for the hearing to be held continues to provide for an
alternative timeframe agreed upon in writing by both the facility and
FDA; a facility that would have preferred the proposed timeframe of 10
calendar days could request that the hearing be held more quickly than
15 calendar days.
    The 15-day timeframe is the same as the timeframe for responding to
a warning letter. As discussed in Response 614, circumstances that
could lead us to withdraw a qualified facility exemption require prompt
action on the part of a facility, just as circumstances that lead us to
issue a warning letter require prompt action.
    (Comment 624) Some comments support the proposed timeframe of 120
calendar days for a qualified facility whose exemption has been
withdrawn to comply with the human preventive controls rule, but ask us
to make the timeframe for complying with a FSMA rule the same
regardless of whether the exemption is withdrawn from a qualified
facility subject to the human preventive controls rule or from a farm
subject to the produce safety rule. Other comments ask us to extend the
timeframe to come into compliance--e.g., to 1 or 2 years. Some of these
comments suggest that qualified facilities should have 120 days to
develop a plan of action, but 2 years to fully comply. Some of the
comments argue that large farms and manufacturers are given a year to
come into compliance, and that requiring small and very small
businesses to comply in a shorter time period would effectively drive
them out of business. Other comments ask us to consider provisions that
would require compliance with only those portions of the rule that
formed the basis for the revocation.
    (Response 624) We continue to believe that the 120-day timeframe is
adequate, but we have added flexibility such that a facility may
request, with a justification in writing to FDA, a reasonable timeframe
for compliance that exceeds 120 calendar days from the receipt of the
order. FDA must grant the request for the facility to receive the
extended timeframe. We are not generally extending the timeframe
because circumstances that could lead us to withdraw a qualified
facility exemption require prompt action on the part of a facility. A
qualified facility that receives an order to withdraw its exemption
would have received advance notification of the circumstances leading
to the order and would have had an opportunity to correct the problems
rather than have us proceed to issue the order (see Sec.  117.251(b)).
If the facility requests a hearing, more than 40 days could elapse
between the date that the facility receives the order and the date that
the

presiding officer for the hearing confirms the order to withdraw the
exemption. Given that the circumstances that would lead us to issue the
order involve either: (1) An active investigation of a foodborne
illness outbreak that is directly linked to the qualified facility; or
(2) a determination that withdrawal of the exemption is necessary to
protect the public health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with the qualified
facility that are material to the safety of the food manufactured,
processed, packed, or held at the facility, a delay of 1 to 2 years to
comply with the rule is not warranted. We also do not believe that it
would be appropriate to require a facility to come into compliance with
only those provisions that formed the basis of the revocation. The
provisions of subparts C and G are interrelated and operate as a system
and therefore are not optimized through piecemeal implementation.
However, FDA may consider staggered implementation as an option in
granting a request for an extension of the timeframe to comply with an
order to withdraw the exemption for a qualified facility.
    As already discussed, the new requirements for hazard analysis and
risk-based preventive controls are not ``one-size-fits-all.'' Although
each facility subject to the rule must prepare and implement a food
safety plan, the preventive controls that the facility would establish
and implement would depend on the facility, the food, and the outcome
of the facility's hazard analysis. In addition, the preventive control
management components that a facility would establish and implement for
its preventive controls would be established as appropriate to ensure
the effectiveness of the preventive controls, taking into account the
nature of the preventive control and its role in the facility's food
safety system. (See Response 222.)
    Although the produce safety rule is not yet final, we intend to
make the administrative procedures associated with withdrawal of an
exemption consistent to the extent practicable, including the timeframe
to comply with the applicable rule if an exemption is withdrawn.
    (Comment 625) Some comments ask us include in the order a statement
that a facility may request that FDA reinstate an exemption that was
withdrawn by following the procedures in Sec.  117.287.
    (Response 625) We have revised the requirements for the contents of
an order as requested by these comments.

D. Proposed Sec.  117.260--Compliance With, or Appeal of, an Order To
Withdraw a Qualified Facility Exemption

    We proposed that: (1) You must either comply with applicable
requirements of part 117 within 120 calendar days of receipt, or appeal
the order within 10 calendar days of receipt; (2) submission of an
appeal, including submission of a request for an informal hearing, will
not operate to delay or stay any administrative action unless the
Commissioner of FDA, as a matter of discretion, determines that delay
or a stay is in the public interest; and (3) if you appeal the order,
and we confirm the order, you must comply with applicable requirements
of part 117 within 120 calendar days of confirmation of receipt of the
order.
    (Comment 626) Some comments ask us to specify that a qualified
facility that loses its exemption from the requirements for hazard
analysis and risk-based preventive controls would no longer need to
comply with the modified requirements that apply to qualified
facilities that have an active exemption.
    (Response 626) A qualified facility that loses its exemption from
the requirements for hazard analysis and risk-based preventive controls
would no longer need to comply with the modified requirements that
apply to qualified facilities that have an active exemption. To make
this clearer, the final withdrawal procedures now include this
information (see the regulatory text for Sec.  117.260(c)).

E. Proposed Sec.  117.264--Procedure for Submitting an Appeal

    We proposed that: (1) To appeal an order, you must submit a written
appeal to FDA within 10 calendar days of receipt and respond with
particularity to the facts and issues contained in the order, including
any supporting documentation upon which you rely; and (2) in your
written appeal, you may include a written request for an informal
hearing.
    (Comment 627) Some comments ask us to rely on records kept in the
normal course of business for documentation that will be sufficient to
respond to an order to withdraw a qualified facility's exemption,
rather than requiring a facility to ``respond with particularity to the
facts and issues contained in the order, including any supporting
documentation upon which the owner, operator or agent in charge of the
facility relies.'' These comments assert that we should not require a
facility that submits a written appeal to provide documents and records
that they are not required to keep.
    (Response 627) We decline this request. In a withdrawal action, FDA
is providing a qualified facility multiple opportunities to persuade
FDA that withdrawal is not appropriate. If the facility relies on
documentation as part of its response, it is reasonable to require that
this documentation be provided to FDA.

F. Proposed Sec.  117.267--Procedure for Requesting an Informal Hearing

    We proposed that if you appeal the order: (1) You may request an
informal hearing, and must do so together with your written appeal
(within 10 calendar days of the date of receipt of the order; and (2) a
request for an informal hearing may be denied, in whole or in part, if
the presiding officer determines that no genuine and substantial issue
of material fact has been raised by the material submitted; you would
receive written notice of the presiding officer's determination,
explaining the reason for the denial.
    (Comment 628) Some comments ask us to guarantee a hearing so that a
qualified facility can present its case in person before having its
exemption revoked.
    (Response 628) We decline this request. We agree that a qualified
facility has a right to appeal an order to withdraw an exemption, and
we have provided for a right to appeal.

G. Proposed Sec.  117.270--Requirements Applicable to an Informal
Hearing

    We proposed that if you request an informal hearing, and we grant
the request: (1) The hearing will be held within 10 calendar days after
the date the appeal is filed or, if applicable, within a timeframe
agreed upon in writing by you and by us; (2) the presiding officer may
require that the hearing be completed within 1 calendar day; and (3) we
must conduct the hearing in accordance with part 16 (21 CFR part 16),
with some specified modifications, including that no party shall have
the right, under Sec.  16.119, to petition FDA for reconsideration or a
stay of the presiding officer's final decision.
    (Comment 629) Some comments object to our proposal that no party
shall have the right, under Sec.  16.119, to petition FDA for
reconsideration or a stay of the presiding officer's final decision.
These comments assert that our justification (i.e., that the
circumstances that would lead to a withdrawal merit prompt action and
that a facility has the opportunity for judicial review in accordance
with 21

CFR 10.45) is not a sufficient argument for justifying the removal of
the option to file a motion for reconsideration or stay. These comments
ask us to revise proposed Sec.  117.270(c)(6) to specify that the
qualified facility shall have the right to file a motion for
reconsideration or stay.
    (Response 629) We decline this request. In the 2014 supplemental
human preventive controls notice, we proposed an additional mechanism
for a qualified facility to present its view that its exemption should
not be withdrawn--i.e., by providing advance written notification to a
qualified facility if we are considering withdrawing an exemption and
providing an opportunity for the facility to respond before we issue an
order to withdraw an exemption. We also proposed to provide an
opportunity for reinstatement of an exemption that had been withdrawn.
We believe the multiple opportunities now available to a facility
provide adequate opportunities for a facility's views to be considered,
and further mechanisms are not warranted.

H. Proposed Sec.  117.287--Reinstatement of a Qualified Facility
Exemption That Was Withdrawn

    We proposed four provisions for reinstating a withdrawn qualified
facility exemption. First, we proposed that if the FDA District
Director in whose district your facility is located (or, in the case of
a foreign facility, the Director of the Office of Compliance in the
Center for Food Safety and Applied Nutrition) determines that a
facility has adequately resolved problems with the conditions and
conduct that are material to the safety of the food manufactured,
processed, packed, or held at the facility and that continued
withdrawal of the exemption is not necessary to protect public health
and prevent or mitigate a foodborne illness outbreak, the FDA District
Director in whose district your facility is located (or in the case of
a foreign facility, the Director of the Office of Compliance in the
Center for Food Safety and Applied Nutrition) will, on his own
initiative or on the request of a facility, reinstate the exemption
(proposed Sec.  117.287(a)).
    Second, we proposed that you may ask FDA to reinstate an exemption
that has been withdrawn by following specific steps (Sec.
117.287(b)(1) and (2)). Third, we proposed that if your exemption was
withdrawn in the event of an active investigation of a foodborne
illness outbreak that is directly linked to your facility and FDA later
determines, after finishing the active investigation of a foodborne
illness outbreak, that the outbreak is not directly linked to your
facility, FDA will reinstate your qualified facility exemption and will
notify you in writing that your exempt status has been reinstated.
    We proposed that if your exemption was withdrawn both in the event
of an active investigation of a foodborne illness outbreak that is
directly linked to your facility and because FDA had determined that it
is necessary to protect the public health and prevent or mitigate a
foodborne illness outbreak based on conditions or conduct associated
with your facility that are material to the safety of the food
manufactured, processed, packed, or held at such facility, and FDA
later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will inform you of this finding, and you may ask FDA
to reinstate your qualified facility exemption.
    (Comment 630) Some comments agree with our tentative conclusion
that the absence of a specific provision in section 418 of the FD&C Act
for the reinstatement of an exemption that is withdrawn does not
preclude us from providing for such a process (79 FR 58524 at 58553).
Other comments disagree with that tentative conclusion and assert that
Congress crafted the withdrawal provision as a ``one strike, you're
out'' provision. These comments also assert that including the
withdrawal provision as a ``one strike, you're out'' provision was an
essential part of the legislative agreement that allowed for adoption
of the qualified facility exemption. These comments also assert that
reinstatement would undermine the intent of the withdrawal provision
because it would reduce the incentive for small food processors to
ensure that the products they sell are as safe as possible. These
comments also assert that a recognized principle of statutory
interpretation provides that exemptions to statutes should be strictly
construed, particularly when the statute addresses public health and
safety, and that we are giving the exemption an impermissibly broad
construction.
    Some comments ask why we believe that a business deserves a
``second bite of the apple'' in light of the understanding (under
proposed Sec.  117.251(b) and (c)) that we will first seek to correct
problems before considering withdrawal. These comments also question at
what point a facility would apply for reinstatement, and ask why we
would allow a facility that has already come into compliance with
FSMA's requirement to implement preventive controls to abandon those
controls in favor of reinstating its exempt status. These comments ask
us to eliminate the proposed provisions allowing for reinstatement.
    Some comments do not support the proposed reinstatement provisions
when a food facility has been directly linked to a foodborne illness
outbreak. Some comments support the proposed reinstatement provisions
only when we determine, after finishing an active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
the facility that had its exemption withdrawn.
    (Response 630) We disagree that the proposed reinstatement
provisions would give the exemption an impermissibly broad
construction. The express statutory language of section 418(l) of the
FD&C Act does not support the comments' assertion that the withdrawal
provision is a ``one strike, you're out'' provision. We also disagree
that reinstatement would undermine the intent of the withdrawal
provision because it would reduce the incentive for small food
processors to ensure that the products they sell are as safe as
possible. We expect that the withdrawal provision itself provides a big
incentive for small food processors to ensure that the products they
sell are as safe as possible because of the business disruption that
would occur if they are subject to withdrawal of the exemption. We
proposed that a facility would need to present data and information to
demonstrate that it has adequately resolved the problems with the
conditions or conduct that are material to the safety of the food
manufactured, processed, packed, or held at the facility, such that
continued withdrawal of the exemption is not necessary to protect
public health and prevent or mitigate a foodborne illness outbreak.
    We disagree that we should categorically refuse to consider
reinstating a qualified facility exemption if we had withdrawn the
exemption because a food facility had been directly linked to a
foodborne illness outbreak. First, if information later comes to light
to raise considerable doubt that a qualified facility had, indeed, been
directly linked to a foodborne illness outbreak, and conditions and
conduct at the facility do not otherwise warrant withdrawing the
facility's exemption, it would be appropriate for us to reinstate the
facility's exemption. Second, we would only reinstate the exemption if
we determined that a facility has adequately resolved any problems with
the conditions and conduct that are material to the safety of the food
manufactured, processed, packed, or

held at the facility and that continued withdrawal of the exemption is
not necessary to protect public health and prevent or mitigate a
foodborne illness outbreak.
    (Comment 631) Some comments that support the reinstatement of a
withdrawn exemption ask us to establish a timeframe within which FDA
will reinstate an exemption. Some comments ask us to specify in the
regulatory text that the reinstatement would occur in a reasonable
period of time, both in circumstances where FDA has decided on its own
initiative to reinstate the exemption and in circumstances where a
facility submits a request for reinstatement. Some comments suggest 10
days is a reasonable period of time within which FDA should reinstate
an exemption.
    (Response 631) We decline the requests to establish a timeframe for
reinstatement in the regulatory text. If we determine on our own
initiative to reinstate an exemption (e.g., because we later determine,
after finishing the active investigation of a foodborne illness
outbreak, that the outbreak is not directly linked to the facility),
our determination would be effective immediately. If we receive a
request to reinstate a withdrawn exemption, we intend to respond in a
reasonable timeframe consistent with available resources. In some
cases, we may respond that we need more information in order to
evaluate your request.
    (Comment 632) Some comments ask that the process for reinstatement
include at least one level of administrative appeal if we deny a
facility's request for reinstatement.
    (Response 632) We have not revised the regulatory text to provide
for an administrative appeal if we deny a facility's request for
reinstatement. Existing procedures allow a facility to ask for a
meeting with applicable FDA officials (see 21 CFR 10.65(c)) and appeal
our decision if we deny the request (see 21 CFR 10.75).
    (Comment 633) Some comments ask us to establish a 1-year
probationary period before the withdrawn qualified facility exemption
could be fully reinstated.
    (Response 633) We decline this request. We intend to act on a
request for reinstatement based on the merits of the data and
information presented in the request, not after a pre-determined
timeframe.

I. Conforming Amendment to 21 CFR Part 16

    We proposed to amend Sec.  16.1(b)(2) to include part 117, subpart
E, relating to the withdrawal of an exemption applicable to a qualified
facility, in the list of regulatory provisions under which regulatory
hearings are available. We received no comments that disagreed with
this proposed provision, and are finalizing it as proposed.

J. Other Comments on the Withdrawal Provisions

    (Comment 634) Several comments ask us to provide clarification
through guidance, issued for public comment, on a variety of topics
associated with the withdrawal provisions.
    (Response 634) We will consider the need for guidance in the
future. At this time, we consider that withdrawing an exemption would
be both rare and dependent upon the circumstances. We need to direct
our resources to developing guidance on issues that would apply more
broadly, and more generally, than the withdrawal provisions.
    (Comment 635) Some comments ask detailed questions about how we
would coordinate the withdrawal process with the States.
    (Response 635) In general, we work with our State partners and
other government counterparts in dealing with enforcement actions,
including coordinating actions or deferring to each other when one
department has authority to swiftly act to protect the consumer. In the
specific case of this rule, we are working through the PFP to develop
and implement a national Integrated Food Safety System consistent with
FSMA's emphasis on establishing partnerships for achieving compliance
(see Response 5 and section 209(b) of FSMA).
    (Comment 636) Some comments ask us to add provisions regarding
notification of the appropriate State regulatory agency when a
qualified facility exemption is withdrawn and reinstated.
    (Response 636) We decline this request. As previously noted, we are
sensitive to the time required for various inspection activities and
intend to communicate with States regarding our expectations for how to
verify whether a facility is a qualified facility. The status of a
facility as a qualified facility principally affects the requirements
that it is subject to, and will be most useful to FDA and our food
safety partners when preparing for inspection. At this time we do not
intend to establish a system notifying the applicable State authorities
at a point in time when the status of a facility as a qualified
facility changes, whether as a result of withdrawal or reinstatement of
a qualified facility exemption or because the facility's business has
grown to the point where it exceeds the financial threshold for very
small business. See also Response 635.

XLI. Subpart F: Comments on Proposed New Recordkeeping Requirements

    We proposed to establish in subpart F requirements that would apply
to all records that would be required by the various provisions of
proposed part 117, including general requirements related to the
content and form of records; additional requirements specific to the
food safety plan; requirements for record retention; requirements for
official review of records by FDA; and public disclosure.
    Some comments support the proposed requirements without change. For
example, some comments state that the proposed 2-year retention period
is consistent with the majority of food safety guidelines currently
being used in the fresh produce industry. Some comments that support
the proposed provisions suggest alternative or additional regulatory
text (see, e.g., Comment 639, Comment 642, and Comment 644 through
Comment 646) or ask us to clarify how we will interpret the provision
(see, e.g., Comment 643 and Comment 650).
    In the following paragraphs, 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 have revised the proposed requirements as shown in table
43, with editorial and conforming changes as shown in table 52.

     Table 43--Revisions to the Proposed Recordkeeping Requirements
------------------------------------------------------------------------
           Section                 Description            Revision
------------------------------------------------------------------------
117.305(c)..................  General requirements  Provide that the
                               applying to records.  time of an activity
                                                     being documented
                                                     only include the
                                                     time of the
                                                     activity when
                                                     appropriate.
117.305(g)..................  General requirements  Specify that
                               applying to records.  electronic records
                                                     are exempt from the
                                                     requirements of 21
                                                     CFR part 11.

117.315(a)(2)...............  Requirements for      Specify that records
                               record retention.     that a facility
                                                     relies on during
                                                     the 3-year period
                                                     preceding the
                                                     applicable calendar
                                                     year to support its
                                                     status as a
                                                     qualified facility
                                                     must be retained at
                                                     the facility for as
                                                     long as necessary
                                                     to support the
                                                     status of a
                                                     facility as a
                                                     qualified facility
                                                     during the
                                                     applicable calendar
                                                     year.
117.315(c)..................  Requirements for      Provide for offsite
                               record retention.     storage of all
                                                     records other than
                                                     the food safety
                                                     plan, provided that
                                                     the offsite records
                                                     can be retrieved
                                                     and provided onsite
                                                     within 24 hours of
                                                     request for
                                                     official review.
117.315(d)..................  Requirements for      Provide that the
                               record retention.     food safety plan
                                                     may be transferred
                                                     to some other
                                                     reasonably
                                                     accessible location
                                                     if the plant or
                                                     facility is closed
                                                     for a prolonged
                                                     period, provided
                                                     that it is returned
                                                     to the plant or
                                                     facility within 24
                                                     hours of request
                                                     for official
                                                     review.
117.320.....................  Requirements for      Clarify that FDA may
                               official review.      copy records upon
                                                     oral or written
                                                     request by a duly
                                                     authorized
                                                     representative of
                                                     the Secretary of
                                                     Health and Human
                                                     Services.
117.325.....................  Requirements for      Specify that the
                               public disclosure.    requirement applies
                                                     to records
                                                     ``obtained by
                                                     FDA''.
117.335.....................  Special requirements   Establish
                               applicable to a       requirements
                               written assurance.    applicable to all
                                                     written assurances
                                                     required by the
                                                     rule.
                                                     Establish
                                                     additional
                                                     requirements
                                                     applicable to
                                                     written assurances
                                                     that are required
                                                     when a food product
                                                     distributed by
                                                     manufacturer/
                                                     processor requires
                                                     further processing
                                                     for food safety by
                                                     a subsequent
                                                     manufacturer.
------------------------------------------------------------------------

A. Proposed Sec.  117.301--Records Subject to the Requirements of
Subpart F

    We proposed that all records required by part 117 would be subject
to all requirements of subpart F, except that certain specific
requirements (proposed Sec.  117.310) would apply only to the written
food safety plan. We also proposed that certain proposed requirements
(e.g., for records to contain the actual values and observations
obtained during monitoring and, as appropriate, during verification
activities) would not apply to the records that would be kept by
qualified facilities.
    (Comment 637) Some comments disagree with the proposal to exempt
the records that would be kept by qualified facilities from
requirements to keep accurate, detailed records. The comments note that
the proposed exemption would apply to qualified facilities regardless
of whether they operate under the first option for documentation (i.e.,
food safety practices) or under the second option for documentation
(i.e., compliance with non-Federal food safety laws). These comments
assert that the proposed detailed recordkeeping requirements should
apply to records relating to monitoring food safety practices and ask
us to revise the proposed requirements so that this exemption would
apply only to those qualified facilities that operate under non-Federal
food safety laws.
    (Response 637) We decline this request. We based the proposed
exemption on a statutory provision that a qualified facility is not
subject to certain requirements, including the statutory recordkeeping
requirements (see section 418(l)(2) of the FD&C Act). Although the
modified requirements that apply to a qualified facility require
submission of certain attestations to FDA (see Sec.  117.201(a) and
(b)), and these attestations must be supported by documentation (see
Sec.  117.201(f)), the rule does not require that records kept by a
qualified facility to support its attestations be the same type of
records that would be kept by a facility subject to subparts C and G.
For example, if the facility attests that it has identified the
potential hazards associated with the food being produced, implemented
preventive controls to address the hazards, and is monitoring the
performance of the preventive controls, the qualified facility might
support its attestation by having a standard operating procedure for
monitoring preventive controls rather than detailed records of actual
monitoring.

B. Proposed Sec.  117.305--General Requirements Applying to Records

    We proposed that the records must: (1) Be kept as original records,
true copies, or electronic records (and that electronic records must be
kept in accordance with part 11 (21 CFR part 11)); (2) contain the
actual values and observations obtained during monitoring and, as
appropriate, during verification activities; (3) be accurate,
indelible, and legible; (4) be created concurrently with performance of
the activity documented; (5) be as detailed as necessary to provide
history of work performed; and (6) include the name and location of the
plant or facility, the date and time of the activity documented, the
signature or initials of the person performing the activity, and, where
appropriate, the identity of the product and the production code, if
any.
    We have revised the provision to require information adequate to
identify the plant or facility (e.g., the name, and when necessary, the
location of the plant or facility) rather than to always require both
the name and location of the plant or facility (see Sec.
117.305(f)(1)). In some cases, the name of the plant or facility will
be adequate to identify it--e.g., when a plant or facility is not part
of a larger corporation that has facilities at more than one location.
In other cases, the name of the plant or facility may not, by itself,
be adequate to identify the plant or facility--e.g., when a plant or
facility is part of a larger corporation with more than one location
and the ``name'' of each plant or facility is the same.
    (Comment 638) Some comments assert that compliance with part 11 for
the secure operation of many systems

currently in use is unnecessary and would create the need to redesign
and recreate existing systems, thus leading to considerable cost and
complexity. These comments identify the requirement for hardware and
software to be validated as a key cost concern and assert that
validation activities would be difficult to maintain and would not
deliver added value. As an example, these comments explain that an
expectation for validation of electronic recordkeeping software and
hardware would be particularly problematic because software patches and
security updates are distributed on a nearly weekly basis, and express
the view that validation procedures are most appropriately applied
before use of a new system and after major software changes or updates.
These comments also assert that it would be costly, burdensome, and
require specialized resources to modify or replace existing electronic
systems to comply with part 11. These comments provide an example in
which a facility needed more than nine months to upgrade one system
alone to comply with part 11, and note that it would not be unusual for
companies to employ multiple systems, so the burden and cost would
exponentially increase. These comments ask us to instead require
facilities that use electronic records to use a secure system that
ensures records are trustworthy, reliable, and generally equivalent to
paper records and handwritten signatures executed on paper.
    Other comments express concern about the financial burden for small
facilities such as farm mixed-type facilities and ask us to either
modify requirements for farm mixed-type facilities, very small
businesses, and small businesses or provide that such facilities be
fully exempt from part 11 requirements for electronic records. Other
comments state that, as with the recordkeeping requirements under the
Bioterrorism Act, such requirements are disproportionate to the
regulatory need. Other comments state that many operators that use
electronic data records in the produce industry use open software and
would not meet part 11 requirements.
    Some comments state that major advances in software technology have
been made since part 11 published in 1997, and such advances must be
carefully considered in evaluating any potential expansion or new
applications of part 11. These comments also state that we already are
in the process of reevaluating part 11 for the regulations for which it
currently applies, citing industry guidance issued more than 10 years
ago in which we acknowledged that part 11 is unworkable in many
respects and decided to exercise enforcement discretion for part of the
regulations and announced plans to reexamine part 11 as a whole.
    Some comments recommend that we develop guidance, with input from
key stakeholders, to describe the kinds of systems and steps that can
be used to assure records meet the required standard. This guidance
should clearly establish that specific security needs will depend on
the circumstances, including the system at issue, its intended use, the
criticality of the preventive control or other food safety measure it
is used to manage, and other relevant factors. For example, these
comments explain that a quality system used to manage CCP documentation
would have greater security needs than a review of a Certificate of
Analysis for a non-sensitive ingredient.
    (Response 638) In light of the substantial burden that could be
created by the need to redesign large numbers of already existing
electronic records and recordkeeping, we are providing in new Sec.
117.305(g) that records that are established or maintained to satisfy
the requirements of part 117 and that meet the definition of electronic
records in Sec.  11.3(b)(6) are exempt from the requirements of part
11. As we did in the section 414 recordkeeping regulations, we also are
specifying that records that satisfy the requirements of part 117, but
that also are required under other applicable statutory provisions or
regulations, remain subject to part 11. The rule provides that a
facility may rely on existing records to satisfy the requirements of
this rule, and this rule does not change the status under part 11 of
any such records if those records are currently subject to part 11. As
we did in the rulemaking to establish the section 414 recordkeeping
regulations, we are establishing a conforming change in part 11 to
specify in new Sec.  11.1(i) that part 11 does not apply to records
required to be established or maintained under part 117, and that
records that satisfy the requirements of part 117, but that also are
required under other applicable statutory provisions or regulations,
remain subject to part 11.
    Although we are not specifying that part 11 applies, facilities
should take appropriate measures to ensure that records are
trustworthy, reliable, and generally equivalent to paper records and
handwritten signatures executed on paper.
    (Comment 639) Some comments assert that certain production and
associated activities are not time-sensitive and would not require
documentation of the time the activity is performed. These comments ask
us to modify the proposed requirements so that the records would only
require the time of the activity documented where appropriate for food
safety.
    (Response 639) We agree that certain activities (e.g., record
review and verification activities) are not time-sensitive and, thus,
would not need to include the time that the activity was performed. The
final rule provides flexibility for the facility to determine when to
document the time by specifying that the time be documented ``when
appropriate'' (see Sec.  117.305(f)(2)).
    (Comment 640) Some comments assert that concurrent record creation
will prove difficult in many food-processing environments. These
comments ask us to modify the proposed requirement that records be
created concurrently with the performance of the activity documented to
qualify that the requirement only applies where feasible, and that the
records could be created as soon as possible thereafter under
circumstances where concurrent record creation is not feasible.
    (Response 640) We decline this request. The comments did not
provide any examples of activities where concurrent record creation in
food manufacturing, processing, packing, or holding environments would
prove difficult, and we are not aware of any such example. For example,
we are not aware of any difficulty complying with long-standing similar
requirements associated with our HACCP regulations for seafood and
juice (see Sec. Sec.  123.9(a)(4) and 120.12(b)(4), respectively).
    (Comment 641) Some comments express concern about ``apparent
mandates'' that we will require records to be kept in the English
language and assert that the language of food factory documents should
not be dictated as a precondition for food exports. These comments ask
us to limit the documents that must written in English to reduce
translation and records duplication. These comments also ask us to
focus the requirements for English language on those documents that
must be submitted to FDA.
    (Response 641) We did not propose to require that any ``factory
records'' (such as the written food safety plan (Sec.  117.126) and the
implementation records listed in Sec.  117.190) be kept in the English
language. Consistent with other regulations for submissions to FDA
(such as for registration of a food facility), the form we will use for
a qualified facility to submit its required

attestations (Sec.  117.201(b) and (c)) will be in the English
language.

C. Proposed Sec.  117.310--Additional Requirements Applying to the Food
Safety Plan

    We proposed that the food safety plan must be signed and dated by
the owner, operator, or agent in charge of the facility upon initial
completion and upon any modification.
    (Comment 642) Some comments state that the provision would exclude
the preventive controls qualified individual from signing and dating
the food safety plan unless the preventive controls qualified
individual is the owner, operator, or agent in charge of the facility.
These comments ask us to revise the rule to allow the preventive
controls qualified individual to sign and date the food safety plan
(e.g., because it is the preventive controls qualified individual who
prepares (or oversees the preparation of) the food safety plan). Some
comments ask us to require that any preventive controls qualified
individuals who prepare (or oversee the preparation of) specific
sections of the food safety plan sign and date the applicable sections.
    (Response 642) We decline these requests. The statute expressly
directs the owner, operator, or agent in charge of a facility to
prepare the food safety plan (see section 418(h) of the FD&C Act). As
previously discussed, such a signature would provide direct evidence of
the owner, operator or agent's acceptance of the plan and commitment to
implementation of the plan (78 FR 3646 at 3782). A facility has
flexibility to require the signature of one or more preventive controls
qualified individuals who prepared, or oversaw the preparation of, its
food safety plan in addition to the minimum signature requirement
specified in the rule. Likewise, a facility also has flexibility to
require the signature of one or more members of its food safety team
who contributed to the preparation of the food safety plan, even if
those individuals are not serving as the preventive controls qualified
individual for the facility. (See also Response 377.)

D. Proposed Sec.  117.315--Requirements for Record Retention

    We proposed that: (1) All required records must be retained at the
plant or facility for at least 2 years after the date they were
prepared; (2) records relating to the general adequacy of equipment or
processes being used by a facility, including the results of scientific
studies and evaluations, must be retained at the facility for at least
2 years after their use is discontinued; (3) except for the food safety
plan, offsite storage of records is permitted after 6 months following
the date that the records were made if such records can be retrieved
and provided onsite within 24 hours of request for official review; and
(4) if the plant or facility is closed for a prolonged period, the
records may be transferred to some other reasonably accessible location
but must be returned to the plant or facility within 24 hours for
official review upon request.
    (Comment 643) Some comments ask us to clarify that the 2-year
record retention requirement only applies to records created after the
compliance date for the final rule.
    (Response 643) The retention requirements only apply to records
created after the applicable compliance date for the final rule. See
Response 155 and section LVI.A, which explain that the compliance date
for a facility to retain records to support its status as a qualified
facility is January 1, 2016. See also Response 646, which explains that
we have revised the record retention provisions to specify that records
that a facility relies on during the 3-year period preceding the
applicable calendar year to support its status as a qualified facility