onsite location (see Sec.  117.315(c)). We expect that the facility
would be able to access information and records relevant to the supply-
chain program within 24 hours (e.g., electronically) when the records
are maintained at corporate headquarters. As necessary and appropriate,
we intend to work with facilities on a case-by-case basis to determine
the best way to review records associated with the supply-chain program
when the supply-chain program is administered at the corporate level.
    (Comment 707) Some comments ask us to clarify in the regulatory
text that the required records are ``as appropriate to the supplier
program.''
    (Response 707) We have revised the regulatory text to specify that
the required records are ``as applicable to its supply-chain program''
(see Sec.  117.475(c)).

C. Documentation Demonstrating Use of the Written Procedures for
Receiving Raw Materials and Other Ingredients (Final Sec.
117.475(c)(5))

    We proposed to require documentation demonstrating that products
are received only from approved suppliers (proposed Sec.
117.136(g)(4)).
    (Comment 708) Some comments support the proposed requirement with
no changes. Other comments ask us to specify ``raw materials and
ingredients'' rather than ``products'' in the regulatory text.
    (Response 708) We have revised the regulatory text to specify ``raw
materials and other ingredients'' with associated conforming changes.

D. Documentation of the Conduct of an Onsite Audit (Final Sec.
117.475(c)(7))

    We proposed to require documentation of an onsite audit. This
documentation must include: (1) Documentation of audit procedures; (2)
the dates the audit was conducted; (3) the conclusions of the audit;
(4) corrective actions taken in response to significant deficiencies
identified during the audit; and (5) documentation that the audit was
conducted by a qualified auditor. For clarity, we have revised the
regulatory text to specify documentation of the ``conduct'' of an audit
and added a requirement for the documentation to include the name of
the supplier subject to the onsite audit.
    (Comment 709) Some comments ask us to maintain the confidentiality
of audit reports and exempt such audit reports from disclosure under
the FOIA.
    (Response 709) These comments are similar to comments we received
related to disclosure of other records required by this part (See
Comment 647 and Comment 650). We would establish the status of supply-
chain program records, such as audit reports, as available for, or
protected from, public disclosure on a case-by-case basis. As discussed
in Response 647, we primarily intend to copy such records when we
conduct an inspection for cause or if the preliminary assessment by our
investigator during a routine inspection is that regulatory follow-up
may be appropriate (e.g., if the report indicates that a significant
food safety problem was noted). See Response 650 for a discussion of
situations in which records would, or would not, be protected from
disclosure.
    (Comment 710) Some comments express concern about maintaining
documentation of the conclusions of an audit and documentation of
corrective actions taken in response to significant deficiencies
identified during the audit. These comments explain that FDA's access
to such documentation during inspection might discourage suppliers from
allowing unannounced audits. These comments ask us to delete these
proposed requirements. If the requirement regarding documentation of
corrective actions remains in the final rule, these comments ask us to
limit such documentation to situations in which the identified
deficiencies posed a risk to public health.
    (Response 710) We are retaining these documentation requirements as
proposed. These comments appear to be suggesting that documentation
requirements be established based on whether a business entity would
want us to see information during inspection rather than on the utility
and value of the documentation. We expect that receiving facilities, in
general, maintain documentation of the conclusions of audits that they
have conducted or arranged to have conducted. A receiving facility must
approve all of its suppliers, and documentation of corrective actions
taken in response to significant deficiencies identified during an
audit has value to a receiving facility in determining whether to
approve a supplier before first receiving any raw materials or other
ingredients and then on an ongoing basis.
    The rule does not require that onsite audits be unannounced,
although we acknowledge that some receiving facilities may see value in
unannounced audits. We decline the request to require a receiving
facility to maintain documentation of corrective actions only if the
identified deficiencies posed a risk to public health. If, for example,
a supplier's facility has filthy conditions or the raw materials and
other ingredients it supplies are contaminated with filth, a receiving
facility may find it inappropriate to approve that supplier. Even
though filth often does not pose a risk to public health, a food may be
deemed to be adulterated under section 402(a)(4) of the FD&C Act if it
has been prepared, packed, or held under insanitary conditions whereby
it may have become contaminated with filth.

E. Documentation of Sampling and Testing (Final Sec.  117.475(c)(8))

    We proposed to require records of sampling and testing. These
records must include: (1) Identification of the raw material or
ingredient tested (including lot number, as appropriate) and the number
of samples tested; (2) identification of the test(s) conducted,

including the analytical method(s) used; (3) the date(s) on which the
test(s) were conducted; (4) the results of the testing; (5) corrective
actions taken in response to detection of hazards; and (6) information
identifying the laboratory conducting the testing.
    (Comment 711) Some comments ask us to not apply the requirement to
maintain records related to sampling and testing to the receipt of RACs
because sampling and testing of RACs is neither common nor effective
for detecting biological or chemical hazards, especially in raw, intact
produce.
    (Response 711) We decline this request. These comments appear to
suggest that documentation requirements be established based on the
frequency and utility of sampling and testing a particular commodity
rather than on a determination by a receiving facility that sampling
and testing is an appropriate supplier verification activity for a
particular supplier. We disagree with such a suggestion. A receiving
facility that has determined that sampling and testing is an
appropriate supplier verification activity needs to maintain records of
those results as it would for any other supplier verification activity.
To the extent that these comments are concerned that the supply-chain
program requires sampling and testing of RACs, we emphasize that this
is not the case. See also Response 525 for a discussion of the
usefulness of sampling and testing as a verification measure for RACs.
    (Comment 712) Some comments ask us to allow documentation of
testing to include the date the test results were reported as an
alternative to the date(s) on which the test(s) were conducted.
    (Response 712) We have revised the provision to require ``The
date(s) on which the test(s) were conducted and the date of the
report.'' We agree that the date on which the test results are reported
can be important, but it should not be a replacement for the date of
the test.
    (Comment 713) Some comments ask us to add ``if necessary'' to the
end of the proposed requirement for documentation of corrective actions
taken in response to detection of hazards.
    (Response 713) We decline this request. The documentation is always
necessary if corrective actions are taken. The provision is about
maintaining documentation when corrective actions are taken, not about
the fact that corrective actions may not always be needed.

F. Documentation of Other Appropriate Supplier Verification Activity
(Final Sec.  117.475(c)(10))

    We proposed to require records of other appropriate verification
activities based on the risk associated with the ingredient. For
clarity and consistency, we have revised the proposed requirement to
specify ``documentation'' of the other appropriate supplier
verification activity rather than ``records'' of the activity. As a
conforming change associated with using the term ``supplier
performance,'' rather than ``risk of supplier,'' when discussing
factors associated with suppliers (see Response 673), the final
requirement specifies that the other appropriate supplier verification
activities are based on the supplier performance and the risk
associated with the raw material or other ingredient.
    (Comment 714) Some comments ask us to also specify that an
``other'' appropriate supplier verification activity be based on the
risk associated with raw materials and suppliers.
    (Response 714) We have revised the regulatory text to specify
``Documentation of other appropriate supplier verification activities
based on the supplier performance and the risk associated with the raw
material or other ingredient.'' The revised regulatory text of the
documentation tracks the regulatory text of this ``other'' appropriate
supplier verification activity (see Sec.  117.410(b)(4)). As discussed
in Response 673, ``supplier performance'' is more appropriate than
``risk associated with the supplier.''

G. Documentation of an Alternative Verification Activity for a Supplier
That Is a Farm That Is Not a ``Covered Farm'' for the Purposes of the
Future Produce Safety Rule (Final Sec.  117.475(c)(13))

    We proposed to require documentation of an alternative verification
activity for a supplier that is a farm that is not a ``covered farm''
for the purposes of the future produce safety rule, including: (1) The
documentation that the raw material or ingredient provided by the
supplier is not subject to the produce safety rule; and (2) the written
assurance that the supplier is producing the raw material or ingredient
in compliance with applicable FDA food safety regulations and that the
raw material or ingredient is not adulterated under section 402 of the
FD&C Act. We have revised the documentation to reflect the final
requirements of Sec.  117.430(d)--i.e., to require: (1) Written
assurance that the supplier is not a covered farm under part 112 in
accordance with Sec.  112.4(a), or in accordance with Sec. Sec.
112.4(b) and 112.5, before approving the supplier and on an annual
basis thereafter; and (2) the written assurance that the farm
acknowledges that its food is subject to section 402 of the FD&C Act
(or, when applicable, that its food is subject to relevant laws and
regulations of a country whose food safety system FDA has officially
recognized as comparable or has determined to be equivalent to that of
the United States).
    (Comment 715) Some comments ask us to delete this documentation
requirement because RACs except fruits and vegetables should be exempt
from supplier verification.
    (Response 715) See Response 693. This alternative supplier
verification activity is intended to minimize the burden on suppliers
that are small farms.
    (Comment 716) Some comments ask us to include a cross-reference to
the applicable requirement.
    (Response 716) We have not added this cross-reference. We agree
that adding the cross-reference has the potential to be helpful, but it
also has the potential to clutter the regulatory text. We considered it
would be more useful to specify what the documentation needs to be
rather than to specify the cross-reference to the applicable
alternative supplier verification activity.

L. Holding Human Food By-Products Intended for Use in Animal Food

    In the 2014 supplemental animal preventive controls notice, we
discussed proposed revisions to the human food CGMPs to address
comments about the practice of human food manufacturers sending by-
products to local farmers or animal food manufacturers for use as
animal food (79 FR 58524 at 58558). We explained that we were proposing
these revisions as part of the rulemaking for the animal preventive
controls rule. (See the discussion of these proposed revisions in the
animal preventive controls rule.) Because we proposed these revisions
as part of the rulemaking for the animal preventive controls rule, we
also are finalizing these provisions as part of that rulemaking. See
the final animal preventive controls rule, published elsewhere in this
issue of the Federal Register, for our response to comments on these
proposed revisions to the human food CGMPs. The final provisions, being
established in Sec.  117.95 (Holding and distribution of human food by-
products for use as animal food), require that:
    (1) Human food by-products held for distribution as animal food
without

additional manufacturing or processing by the human food processor, as
identified in Sec.  507.12, must be held under conditions that will
protect against contamination, including the following:
     Containers and equipment used to convey or hold human food
by-products for use as animal food before distribution must be
designed, constructed of appropriate material, cleaned as necessary,
and maintained to protect against the contamination of human food by-
products for use as animal food;
     Human food by-products for use as animal food held for
distribution must be held in a way to protect against contamination
from sources such as trash; and
     During holding, human food by-products for use as animal
food must be accurately identified.
    (2) Labeling that identifies the by-product by the common or usual
name must be affixed to or accompany human food by-products for use as
animal food when distributed.
    (3) Shipping containers (e.g., totes, drums, and tubs) and bulk
vehicles used to distribute human food by-products for use as animal
food must be examined prior to use to protect against contamination of
the human food by-products for use as animal food from the container or
vehicle when the facility is responsible for transporting the human
food by-products for use as animal food itself or arranges with a third
party to transport the human food by-products for use as animal food.

LI. Comments by Foreign Governments and Foreign Businesses

    We received several comments from foreign governments and foreign
businesses covering a wide range of issues. Many of those comments were
similar to comments made on certain topics by domestic stakeholders, so
we are addressing those comments in other sections throughout this
preamble. In this section, we are responding to comments that are
primarily focused on international issues, such as the obligations of
the United States under the World Trade Organization Agreement (WTO).
    (Comment 717) Some comments by foreign government representatives
ask us to provide ``special and differential treatment'' along with
technical assistance to help exporters from developing countries meet
the requirements of the rule. For special and differential treatment,
the comments propose extended periods of time for the implementation of
the rule by producers in developing countries, and flexibility in
implementation for small businesses in those countries. For technical
assistance, the comments request training and other forms of assistance
to help producers understand and implement the regulation.
    (Response 717) The concept of special and differential treatment is
incorporated in the WTO Agreements. Article 10.2 of the WTO SPS
Agreement states: ``Where the appropriate level of sanitary or
phytosanitary protection allows scope for the phased introduction . . .
longer time-frames for compliance should be accorded on products of
interest to developing country Members so as to maintain opportunities
for their exports.''
    In 2001, at the WTO Ministerial Conference in Doha, WTO Members
issued a Ministerial Decision that interpreted the special and
differential obligations of the SPS Agreement (Ref. 98). The
Ministerial Decision defined ``longer time-frame for compliance'' to
normally mean a period of not less than 6 months.
    We recognize that businesses of all sizes may need more time to
comply with the new requirements established under this rule. As
discussed in section LVI.A, the first compliance date for businesses
other than small and very small businesses will be one year after this
final rule is published in the Federal Register. Recognizing that
smaller businesses may need more time to comply with the requirements,
FDA is allowing two years for small businesses and three years for very
small businesses to comply. We anticipate that these extended
implementation periods for small businesses and very small businesses
will apply to a number of businesses in developing countries. Because
all of these time periods are longer than the 6 month minimum defined
in the WTO Ministerial Decision, we believe these implementation
periods are sufficient to address the needs of businesses in developing
countries, particularly for small and very small businesses in such
countries.
    In addition to the extended time periods for compliance for small
and very small businesses, we have also established modified
requirements for very small businesses, which we define as a business
(including any subsidiaries and affiliates) averaging less than
$1,000,000, adjusted for inflation, per year, during the 3-year period
preceding the applicable calendar year in sales of human food plus the
market value of human food manufactured, processed, packed, or held
without sale (e.g., held for a fee). These modified requirements for
very small businesses are less burdensome and are described in Sec.
117.201 of this regulation.
    In addition to the 1 to 3 year time periods for compliance for all
firms, and modified requirements for very small businesses, we intend
to work with the food industry, education organizations, USDA, the
United States Agency for International Development, and foreign
governments to develop tools and training programs to facilitate
implementation of this rule.
    (Comment 718) Some comments assert that the food safety systems of
the European Union and other countries afford a similar level of food
safety protection and must therefore be recognized by FDA as equivalent
under the WTO SPS Agreement. These comments urge FDA to accept the
HACCP plans and other steps taken to comply with European food safety
laws as being sufficient to comply with this rule.
    (Response 718) The concept of ``equivalence'' for food safety
regulatory measures is contained in Article 4 of the World Trade
Organization Agreement on the Application of Sanitary and Phytosanitary
Measures (the ``SPS Agreement'') (Ref. 99). That article provides that
WTO Member countries ``shall accept the sanitary or phytosanitary
measures of other Members as equivalent, even if these measures differ
from their own or from those used by other Members trading in the same
product, if the exporting Member objectively demonstrates to the
importing Member that its measures achieve the importing Member's
appropriate level of sanitary or phytosanitary protection.'' This
provision of the SPS Agreement envisions a process in which the
exporting country provides evidence to the food safety regulator in the
importing country in order to ``objectively demonstrate'' that the food
safety system in the exporting country meets the level of food safety
protection established by the importing country. To date, FDA has
considered equivalence as most appropriately applied to the assessment
of a foreign government's specific programs for specific types of
foods, such as shellfish and dairy products. In that context, the
equivalence assessment provides a very detailed comparison of each
measure that a country applies in controlling risks associated with the
particular commodity under review. FDA continues to have latitude to
engage in equivalence determinations for market access and as required
by our regulations for certain commodities. For example, FDA has active
equivalence

deliberations underway on Grade ``A'' dairy and will continue to engage
in equivalence activities as needed.
    In contrast to the assessment of equivalence for the regulation of
specific foods based upon a detailed review of an individual food
safety measure or group of measures applied to a specific food, FDA has
established a process of assessing foreign food safety systems to
identify systems that offer a comparable level of public health
protection as the U.S. food safety system for FDA regulated foods. We
refer to that process as ``systems recognition,'' which we discuss in
Response 719.
    (Comment 719) Some comments urge FDA to include a provision in this
rule that would reflect a determination made by FDA in the ``systems
recognition'' process so that FDA's compliance framework, including
audit and inspection activities, take into account the effectiveness of
the regulatory or administrative control of food safety systems. These
comments ask us to include a provision in this rule establishing that
an affirmative systems recognition determination by FDA for an
exporting country would be a sufficient basis to exempt exporting
producers from that country from their obligation to comply with the
requirements of this rule. Another comment urges FDA to utilize the
systems recognition process to recognize the effectiveness of the EU
system in order to avoid unnecessary or duplicative requirements and
controls on food imports from the European Union.
    (Response 719) We agree, in part, with this comment. Since 2010,
FDA has been developing a program of ``systems recognition'' to explore
ways to leverage the work of food safety authorities in countries that
have food safety systems that are comparable to that of FDA. Systems
recognition assessment provides a tool for identifying countries where
FDA can establish closer regulatory partnerships, including leveraging
the work conducted by FDA and foreign food safety authorities.
    We agree that the systems recognition program can allow FDA to take
into account the effectiveness of a foreign food safety regulatory
system as we develop a compliance framework for imported foods from a
country for which we have made an affirmative determination of
comparability via the systems recognition program. While we decline to
add an exemption for food imported from a country with affirmative
systems recognition determination by FDA, we note that the systems
recognition program is based upon the concept that foreign food
producers can meet U.S. food safety requirements by providing
assurances that these foods are produced according to the food safety
standards of a country that FDA has found to be comparable or
equivalent to that of the United States. Therefore, foreign producers
of foods that are subject to a systems recognition agreement can show
that their products are meeting FDA's requirements for imported foods
by virtue of the fact that they are meeting their domestic food safety
standards. Several provisions of the supply-chain program specifically
provide for consideration of relevant laws and regulations of a country
whose food safety system FDA has officially recognized as comparable or
has determined to be equivalent to that of the United States (see
Sec. Sec.  117.410(d)(1)(iii)(B); 117.430(c)(2), (d)(2), and (e)(2);
and 117.435(b) and (c)(1)(ii).
    We also note that we intend to publish a final FSVP rule in the
near future. There, we intend to establish modified requirements for
food imported from a foreign supplier in, and under the regulatory
oversight of, a country whose food safety system FDA has officially
recognized as ``comparable'' to that of the United States.
    Section 117.405(a)(2) of this rule provides the option for a
receiving facility that is an importer to comply with the supplier
verification requirements in this rule or with the foreign supplier
verification program requirements that we will establish in part 1,
subpart L for a raw material or other ingredient. We intend that the
final FSVP rule will contain a similar provision (derived from proposed
Sec.  1.502), so that only one supplier verification procedure needs to
be undertaken in order to comply with both rules when the specified
conditions are met.

LII. Editorial and Conforming Changes

    The revised regulatory text includes several changes that we have
made to make the requirements more clear and improve readability. The
revised regulatory text also includes several conforming changes that
we have made when a change to one provision affects other provisions.
We summarize the principal editorial and conforming changes in table
52.

          Table 52--Principal Editorial and Conforming Changes
------------------------------------------------------------------------
  Designation in the revised
   regulatory text (Sec.   )         Revision           Explanation
------------------------------------------------------------------------
 1.227................  Alphabetize the    Make it easier to
 1.328................   examples of        compare the examples
 117.3................   harvesting         of harvesting
                                 activities in      activities to the
                                 the definition     examples of
                                 of                 manufacturing/
                                 ``harvesting''.    processing
                                                    activities in the
                                                    definition of
                                                    ``manufacturing/
                                                    processing.''
 1.227................  Alphabetize the    Make it easier to
 1.328................   examples of        compare the examples
 117.3................   manufacturing/     of manufacturing/
                                 processing         processing
                                 activities in      activities to the
                                 the definition     examples of
                                 of                 harvesting
                                 ``manufacturing/   activities in the
                                 processing''.      definition of
                                                    ``harvesting.''
 11.1(i)..............  Specify that part  Conforming change
                                 11 does not        associated with the
                                 apply to records   recordkeeping
                                 required to be     requirements in Sec.
                                 established or       117.305, which
                                 maintained under   provide that part 11
                                 part 117, and      does not apply to
                                 that records       records required to
                                 that satisfy the   be established or
                                 requirements of    maintained under
                                 part 117, but      part 117.
                                 that also are
                                 required under
                                 other applicable
                                 statutory
                                 provisions or
                                 regulations,
                                 remain subject
                                 to part 11.
Throughout part 117...........             Conforming change
                                 Substitute the     associated with our
                                 term               proposal, in the
                                 ``adequate'' for   2014 supplemental
                                 the term           human preventive
                                 ``sufficient''.    controls notice, to
                                            make this
                                 Substitute the     substitution so that
                                 term               the rule
                                 ``inadequate''     consistently uses
                                 for the term       the term
                                 ``insufficient''.  ``adequate.''

Throughout part 117...........  Substitute the     Conforming change
                                 term               associated with the
                                 ``pathogen'' for   definition of
                                 the term           ``pathogen.''
                                 ``microorganism
                                 of public health
                                 significance''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``allergen    associated with the
                                 cross-contact''    definition of
                                 for the term       ``allergen cross-
                                 ``cross-           contact.''
                                 contact''.
Throughout part 117...........  Substitute the     Conforming change
                                 term               associated with
                                 ``preventive       adding the term
                                 controls           ``preventive
                                 qualified          controls qualified
                                 individual'' for   individual.''
                                 the term
                                 ``qualified
                                 individual''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``unexposed   associated with the
                                 packaged food''    definition of
                                 for the phrase     ``unexposed packaged
                                 ``packaged food    food.''
                                 that is not
                                 exposed to the
                                 environment''.
Throughout part 117...........  Substitute the     Conforming change
                                 phrase             associated with the
                                 ``chemical         definition of
                                 (including         ``hazard.''
                                 radiological)
                                 hazards'' for
                                 phrases such as
                                 ``chemical and
                                 radiological
                                 hazards''.
Throughout part 117...........  Substitute the     Conforming change
                                 term ``hazard      associated with the
                                 requiring a        proposed definition
                                 preventive         of ``significant
                                 control'' for      hazard'' (which we
                                 the term           now refer to as
                                 ``significant      ``hazard requiring a
                                 hazard''.          preventive
                                                    control.'')
Throughout part 117...........  Shorten ``raw      Conforming change
                                 agricultural       associated with the
                                 commodity as       new definition of
                                 defined in         ``raw agricultural
                                 section 201(r)     commodity.''
                                 of the Federal
                                 Food, Drug, and
                                 Cosmetic Act''
                                 to ``raw
                                 agricultural
                                 commodity''.
117.1(a)......................  Redesignate        Improve clarity.
                                 subparagraphs to
                                 distinguish
                                 between applying
                                 the provisions
                                 in determining
                                 whether food is
                                 adulterated and
                                 applying the
                                 provisions in
                                 determining
                                 whether there is
                                 a violation of
                                 the PHS Act.
117.3.........................  Substitute         Improve clarity.
                                 ``apply'' for
                                 ``are
                                 applicable'' in
                                 the introductory
                                 paragraph.
117.3.........................  Editorial changes  Improve clarity.
                                 to verb tense in
                                 the definition
                                 of ``ready-to-
                                 eat food''.
117.3.........................  Specify that the   Give prominence to
                                 definition of      this aspect of the
                                 ``very small       definition of ``very
                                 business''         small business.''
                                 includes any       The relevance of
                                 subsidiaries and   subsidiaries and
                                 affiliates of      affiliates to the
                                 the business.      definition of ``very
                                                    small business'' is
                                                    established in the
                                                    definition of
                                                    ``qualified
                                                    facility,'' but
                                                    including it again
                                                    in the definition of
                                                    ``very small
                                                    business'' will help
                                                    to ensure that it is
                                                    considered when
                                                    determining whether
                                                    the business is
                                                    within the dollar
                                                    threshold
                                                    established in the
                                                    definition of ``very
                                                    small business.''
117.3, 117.5, 117.7(a),         Substitute         Conforming change
 117.257(d)(1).                  ``subparts C and   associated with the
                                 G'' for            redesignation of the
                                 ``subpart C''.     requirements for a
                                                    supply-chain program
                                                    in new subpart G.
117.5(e)......................  Substitute         Correction to use the
                                 ``packaging''      same term as is used
                                 for ``packing''.   in part 111 for
                                                    CGMPs for dietary
                                                    supplements.
117.5(i)......................  Substitute         Improve clarity.
                                 ``Subparts C and
                                 G of this part
                                 do not apply
                                 with respect to
                                 food that is not
                                 an alcoholic
                                 beverage'' for
                                 ``Subparts C and
                                 G of this part
                                 do not apply
                                 with respect to
                                 food other than
                                 an alcoholic
                                 beverage''
                                 (emphasis added).
117.5(k)(2)...................  Specify that the   Clarification. The
                                 provision          provision only
                                 applies to those   applies to those
                                 RACs that are      produce RACs that
                                 produce as will    will have applicable
                                 be defined in      requirements in the
                                 the final          produce safety rule.
                                 produce safety
                                 rule.
 117.10(b), (b)(1),     Editorial changes  Improve clarity.
 and (b)(9).                     to clearly
 117.20(b)(2) and        distinguish
 (b)(6).                         requirements
 117.35(a), (d),         directed to
 (d)(2), (d)(3), (e), and (f).   allergen cross-
                                 contact from
                                 requirements
                                 directed to
                                 contamination.
 117.40(a)(6) and (b)
 117.80(a)(4) and
 (a)(6)
 117.80(b)(1), (b)(5),
 and (b)(7)
 117.80(c)(6), (c)(7),
 (c)(10), and (c)(12)

 117.93
 117.10...............  Conforming         The definition of
                                 changes            ``plant'' focuses on
                                 associated with    the building,
                                 the definition     structure, or parts
                                 of ``plant''.      thereof, used for or
                                                    in connection with
                                                    the manufacturing,
                                                    processing, packing,
                                                    or holding of human
                                                    food. The term
                                                    ``establishment''
                                                    focuses on a
                                                    business entity
                                                    rather than on
                                                    buildings or other
                                                    structures.
 117.20(a)
 117.37(d)
 117.305(f)
117.35(b).....................  Refer to ``letter  This long-standing
                                 of guarantee''     CGMP provision is
                                 rather than        not limited to
                                 ``supplier's       documents from a
                                 guarantee''.       ``supplier'' as that
                                                    term is defined in
                                                    this rule.
117.37(d).....................  Refer to           Editorial change.
                                 ``employees''
                                 rather than
                                 ``its
                                 employees''.
 117.80(b)(1) through   Changes to         Return to long-
 (8).                            consistently       standing terminology
 117.80(c)(7) and        refer to raw       in the CGMPs
 (c)(9).                         materials and      previously
                                 ``other            established in part
                                 ingredients''.     110.
117.80(c)(7)..................  Refer to ``other   Raw materials and
                                 food'' rather      other ingredients,
                                 than ``food'' in   work-in-process, and
                                 the phrase ``raw   rework are all types
                                 materials and      of food.
                                 other
                                 ingredients,
                                 work-in-process,
                                 rework, or
                                 food''.
117.126(b)(3), 117.135(c)(4),   Refer to ``supply- Conforming change
 117.140(b), 117.160(c)(4),      chain program''    associated with the
 117.190(a)(5).                  rather than        title of final
                                 ``supplier         subpart G (proposed
                                 program''.         Sec.   117.136).
 117.160(b)(2)........  Conforming         Improve clarity;
 117.170(b)(4)........   changes            consistency with the
                                 associated with    requirements for
                                 the definition     validation.
                                 of
                                 ``validation''.
117.165(a)(4)(ii).............  Refer to ``supply- Consequential change
                                 chain              as a result of the
                                 verification       requirement in Sec.
                                 activities,'' as    117.405(c) for
                                 well as            verification of an
                                 ``supplier         entity that is in
                                 verification       the supply-chain but
                                 activities''.      is not a supplier.
117.165(b)(1).................  Changes to         Conforming change
                                 require written    associated with the
                                 procedures for     requirements to
                                 method and         calibrate process
                                 frequency of       monitoring
                                 accuracy checks    instruments and
                                 for process        verification
                                 monitoring         instruments (or
                                 instruments and    check them for
                                 verification       accuracy).
                                 instruments.
117.170(c)(2).................  Conforming         Consistency with the
                                 changes            requirements for
                                 associated with    validating
                                 the timeframe      preventive controls.
                                 for validating
                                 preventive
                                 controls.
117.170(d)....................  Editorial changes  Improve clarity.
                                 to the
                                 requirement to
                                 revise the
                                 written food
                                 safety plan or
                                 document why
                                 revisions are
                                 not needed.
117.180(a)(3).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      validation of a
                                 determining an     preventive control.
                                 alternative
                                 timeframe for
                                 validation.
117.180(a)(4).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine that
                                 qualified          validation of a
                                 individual in      preventive control
                                 determining that   is not required.
                                 validation is
                                 not required.
117.180(a)(6).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for review
                                 individual in      of records of
                                 determining an     monitoring and
                                 alternative        corrective actions.
                                 timeframe for
                                 review of
                                 records of
                                 monitoring and
                                 corrective
                                 actions.
117.180(a)(8).................  Change to specify  Conforming change
                                 the role of the    associated with
                                 preventive         flexibility to
                                 controls           determine the
                                 qualified          timeframe for
                                 individual in      completing
                                 determining an     reanalysis.
                                 alternative
                                 timeframe for
                                 completing
                                 reanalysis.
117.80(b)(3)..................  Delete             ``Current'' is
                                 ``current'' from   unnecessary.
                                 ``current FDA
                                 regulations''.

117.201(a)(2)(ii).............  Editorial change   Improve clarity.
                                 to place the
                                 clause
                                 ``including
                                 through
                                 licenses,
                                 inspection
                                 reports,
                                 certificates,
                                 permits,
                                 credentials,
                                 certification by
                                 an appropriate
                                 agency (such as
                                 a State
                                 department of
                                 agriculture), or
                                 other evidence
                                 of oversight''
                                 at the end of
                                 the provision,
                                 rather than in a
                                 parenthetical at
                                 the beginning of
                                 the provision.
117.206(a)(2).................  Editorial change   Improve clarity.
                                 to specify
                                 ``provide
                                 assurance that
                                 the temperature
                                 controls are
                                 consistently
                                 performed''
                                 rather than
                                 ``provide
                                 assurance that
                                 they are
                                 consistently
                                 performed''.
 117.206(a)(4)(ii)....  Substitute the     Consistency with
 117.206(a)(4)(iii)...   phrase ``records   other recordkeeping
                                 are created''      requirements of the
                                 for the phrase     rule.
                                 ``records are
                                 made''.
117.206(a)(4)(iii)............  Change ``within a  Conforming change
                                 week'' to          associated with
                                 ``within 7         review of records of
                                 working days''.    monitoring and
                                                    corrective action
                                                    records.
Subpart E (title).............  Substitute the     Conforming change
 117.251..............   term ``qualified   associated with the
 117.254..............   facility           definition of
 117.257..............   exemption'' for    ``qualified facility
 117.260..............   the phrase         exemption.''
 117.264..............   ``exemption
 117.280..............   applicable to a
 117.251..............   qualified
                                 facility'' or
                                 the phrase
                                 ``exemption
                                 applicable to a
                                 qualified
                                 facility under
                                 Sec.
                                 117.5(a)''.
117.251(b)(1).................  Change ``import    Align with statutory
                                 alert'' to         language regarding
                                 ``refusal of       imports rather than
                                 food offered for   with specific
                                 import''.          procedures that FDA
                                                    uses for refusing
                                                    admission to foods
                                                    offered for import.
117.254(a)....................  Change ``FDA       The provision refers
                                 official senior    to two ``Directors''
                                 to such            and the clause
                                 Director'' to      applies to either
                                 ``FDA official     Director.
                                 senior to either
                                 such Director''.
117.257(c)(2).................  Refer to           Consistency with
                                 ``conditions or    regulatory text in
                                 conduct'' rather   Sec.
                                 than ``conduct     117.251(a)(2).
                                 or conditions''.
 117.260(a)(2)........  Change ``within    Conforming change to
 117.264(a)(1)........   10 calendar        reflect a timeframe
 117.267(a)(2)........   days'' to          of 15 calendar days,
 117.270(a)...........   ``within 15        rather than 10
                                 calendar days''.   calendar days, in
                                                    the order
                                                    withdrawing a
                                                    qualified facility
                                                    exemption.
 117.287(a)...........  Specify ``any      Clarify that
 117.287(b)(2)........   problems with      reinstatement of a
                                 the conditions     qualified exemption
                                 and conduct''      that was withdrawn
                                 rather than        requires resolution
                                 ``problems with    of any problems,
                                 the conditions     regardless of
                                 and conduct'' or   whether the problems
                                 ``problems with    related to
                                 the conditions     conditions, conduct,
                                 or conduct''.      or both conditions
                                                    and conduct.
117.305.......................  Refer to ``lot     Consistency with the
                                 code'' rather      definition of
                                 than               ``lot.''
                                 ``production
                                 code''.
117.310.......................  Editorial changes  Improve clarity.
                                 to present the
                                 requirement in
                                 active voice.
------------------------------------------------------------------------

LIII. Comments on FSMA's Rulemaking Provisions

A. Comments on Requirements in Section 418(n)(3) of the FD&C Act
Regarding Content

    FSMA specifies that this rule acknowledge differences in risk and
minimize, as appropriate, the number of separate standards that apply
to separate foods (section 418(n)(3)(C) of the FD&C Act). As previously
discussed, we consider that the proposed human preventive controls rule
strikes what we consider to be an appropriate balance between
acknowledging differences in risk and minimizing the number of separate
standards applied to separate foods (78 FR 3646 at 3785).
    (Comment 720) Some comments agree that the proposed human
preventive controls rule reflects a risk-based approach and our
recognition that a ``one -size-fits-all'' approach is not appropriate
in the application of hazard analysis and risk-based preventive
controls across the entire domestic and international food industry.
These comments ask us to retain this flexibility in the final rule by
describing the required and expected results of the program, but not
going as far as prescribing the process and methodology taken to get
there. Other comments emphasize that the final rule must provide
sufficient flexibility to allow facilities to adopt practices that are
practical and effective for their specific, individual operations.
    (Response 720) The final rule directs the owner, operator, or agent
in charge of a facility to establish and implement

a food safety plan that includes a written hazard analysis, preventive
controls that the facility identifies to control hazards requiring a
preventive control, and establish and implement appropriate preventive
control management components 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. As requested
by the comments, the rule does not prescribe the process and
methodology to ``get there.''
    (Comment 721) Some comments ask us to adopt a commodity-specific
approach to RACs when activities conducted on RACs are subject to the
human preventive controls rule. The requested commodity-specific
approach would exempt (or, at a minimum, defer regulation of) ``low-
risk commodities (such as table grapes)'' from the human preventive
controls rule. These comments note that we have acknowledged that just
five commodity groups (leafy greens, tomatoes, herbs, melons, and
sprouts) accounted for 77 percent of all produce-related outbreaks, 54
percent of produce-related illnesses, and 56 percent of produce-related
hospitalizations between 1996 and 2010 (78 FR 3504 at 3525). These
comments assert that the principal benefits of the FSMA rules will come
from regulating these crops and that we cannot claim to have
acknowledged differences in risk if we adopt a ``one-size-fits-all''
strategy. These comments ask us to apply the human preventive controls
rule only to RACs that fall within the five highest-risk commodity
groups and to any other specific commodities that we have determined
pose a comparable risk based on outbreak history and the commodity's
characteristics.
    Other comments asserting that the rule is ``one-size-fits-all''
likewise ask us to apply the human preventive controls rule only to the
highest risk commodities but do not narrowly direct their request to
RACs. Some of these comments state that regulations must be scale- and
supply-chain appropriate to be effective and assert that a ``one-size-
fits-all'' approach will put small and mid-sized farms and processors
out of business, undermining public health goals, such as increased
production of, availability of, and access to healthy foods, as well as
economic opportunity, equity, and job-creation goals.
    (Response 721) We decline these requests to apply the human
preventive controls rule only to foods determined to be of the highest
risk and disagree that the rule is ``one-size-fits-all.'' For example,
several provisions of the rule expressly qualify that the requirements
apply as appropriate to the facility, the food, the nature of the
preventive control and its role in the facility's food safety system,
the nature of the hazard, or a combination of these factors (see, e.g.,
Sec.  117.135(c), (c)(1), and (c)(3); Sec.  117.140(a) and (b); Sec.
117.150(a); Sec.  117.160(a); Sec.  117.165(a) and (b)); and Sec.
117.410(d)(1)). The exemptions we are establishing are provided by
section 103 of FSMA. As discussed in Response 222, facilities that are
subject to the rule would consider the risk presented by the products
as part of their hazard evaluation. A facility that appropriately
determines that there are no hazards requiring a preventive control
associated with its food products would document that determination in
its written hazard analysis but would not need to establish preventive
controls and associated preventive control management components for
its products. (See also Response 16.)
    (Comment 722) Some comments interpret the statutory direction in
section 418(n)(3)(C) of the FD&C Act to mean that Congress granted us
authority to provide flexibility for businesses of all sizes and types
(i.e., not just small businesses), as well as to acknowledge
differences in risk. These comments assert that section 418(n)(3)(C)
grants us authority to exempt distribution centers from the
requirements for hazard analysis and risk-based preventive controls
because: (1) Distribution centers are very low-risk facilities and (2)
requiring distribution centers to comply with those requirements would
not be practicable.
    (Response 722) We disagree with these comments. See Response 221
for our response to comments that ask us to establish exemptions based
on the risk presented by a food product and Response 226 for our
response to comments that request an exemption for facilities such as
supermarket distribution centers. The rule establishes an exemption for
facilities solely engaged in the storage of unexposed packaged food
(see Sec.  117.7(a)), except that there are modified requirements for
such establishments engaged in the storage of TCS foods (see Sec.
117.7(b) and 117.206).
    (Comment 723) Some comments state that Grade ``A'' dairy products
are already effectively regulated under the PMO, and assert that
subjecting these products to the human preventive controls rule would
apply two separate standards, doubling rather than minimizing the
number of separate standards that apply to separate foods. These
comments ask us to instead acknowledge the reduced risk profile of
foods produced in accordance with the PMO and allow dairy products to
continue to be regulated under one standard, the PMO. These comments
also assert that exempting PMO-regulated facilities from the rule would
allow us to better tailor our requirements to those foods not currently
manufactured under such regulatory programs, which would also minimize
the need to develop separate guidance and standards for this segment of
the dairy industry.
    (Response 723) See Response 214 for a discussion of our approach to
PMO-regulated facilities.
    (Comment 724) Some comments assert that the rule addresses
differences in risk based on the number of people affected in the event
of contaminated product being sold rather than on the types of hazards
identified for a particular food and the ability to address those
hazards via preventive practices, because the rule bases modified
requirements on company revenues, customer type (restaurant and retail
establishments), and customer location (275 mile radius). These
comments assert that the proposed modified requirements do not properly
address food safety risk through prevention and ask us to establish
risk-based standards that require preventive practices to address
identified hazards for a particular food and process for all companies
manufacturing, processing, packing, and holding food.
    Other comments assert that the statutory direction to require
hazard analysis and risk-based preventive controls for all facilities
that are required to register as a food facility under the section 415
registration regulations does not take into consideration the
significant differences in risk profiles of fresh produce facilities
and food processing and manufacturing facilities. These comments
further assert that the section 415 registration regulations are not
risk-based but simply served to keep a catalogue of facilities
supplying the U.S. food supply and that it is not logical or
appropriate that a fresh produce facility that packs RACs should be
subject to the same regulatory controls as food manufacturing
facilities such as those that produce canned foods or infant formula.
    (Response 724) We disagree with these comments. See Response 222,
in which we respond to comments asserting that a food safety plan
should only be required for high-risk processing facilities. The new
requirements for hazard analysis and risk-based preventive controls are
not ``one-size-fits-all,'' and facilities that are subject to the rule
would consider the risk

presented by the products as part of their hazard evaluation.

B. Comments on Requirements in Section 418(n)(5) of the FD&C Act
Regarding Review of Hazard Analysis and Preventive Controls Programs in
Existence on the Date of Enactment of FSMA

    FSMA directs us to review regulatory hazard analysis and preventive
control programs in existence on the date of its enactment, including
the PMO, to ensure that the regulations we establish are consistent, to
the extent practicable, with applicable domestic and internationally-
recognized standards in existence on that date. (See section 418(n)(5)
of the FD&C Act.) Consistent with that statutory direction, we
previously compared the key features of our proposed requirements to
implement section 418 of the FD&C Act to certain domestic and
international food safety standards (Ref. 100) (78 FR 3646 at 3785 to
3788).
    In the following paragraphs, we discuss comments specifically
directed to the statutory direction in section 418(n)(5) of the FD&C
Act. For examples of other comments related to the consistency of the
proposed human preventive controls rule with applicable domestic and
internationally-recognized standards, see Comment 8, Comment 215,
Comment 372, Comment 718, and Comment 719.
    (Comment 725) Some comments assert that a proper harmonization is
needed with international standards and ask us to harmonize the FSMA
requirements for the food safety plan with international and domestic
HACCP programs. These comments also ask us to explain any differences
between the FSMA food safety plan and the existing HACCP programs and
ask us to provide exporters with background information and specific
examples of differences, including how firms are directed to set their
CCPs and critical limits.
    (Response 725) As previously discussed (Ref. 102 and 78 FR 3646 at
3785 to 3788), we believe the human preventive controls rule is
consistent with existing food safety programs. We have updated our 2012
memorandum entitled ``Comparison of Proposed Subpart C (Hazard Analysis
and Risk-Based Preventive Controls) to Various Existing Domestic and
International HACCP-Based Standards'' (Ref. 102) to reflect the
provisions of the final human preventive controls rule (rather than the
proposed human preventive controls rule) (Ref. 65). The comparative
format of the updated memorandum provides the background information
and specific examples of differences requested by these comments.
    However, neither this rule nor our updated memorandum (Ref. 65)
provide firms with direction on how to set their CCPs and critical
limits. A facility has flexibility to establish and implement
appropriate preventive controls, including controls at CCPs and
including any critical limits that the facility determines are
necessary to provide assurances that hazards requiring a preventive
control will be significantly minimized or prevented and the food
manufactured, processed, packed, or held by the facility will not be
adulterated under section 402 of the FD&C Act or misbranded under
section 403(w) of the FD&C Act.
    (Comment 726) Some comments ask whether we concluded, in light of
the statutory direction in section 418(n)(5) of the FD&C Act, that the
CGMP requirements in combination with the standards of identity for
cheese in part 133 do not provide adequate public health controls
within the cheese manufacturing industry. According to these comments,
under regulations in part 133 many cheeses have an option to use
unpasteurized milk, provided the cheese manufactured from unpasteurized
milk is aged for at least 60 days at not less than 35 degrees F. These
comments ask whether the 60 day aging process will be recognized as a
preventive control.
    (Response 726) Section 418(n)(5) of the FD&C Act directs us to
review ``regulatory hazard analysis and preventive control programs''
in existence on the date of its enactment. We have not considered
provisions in the standards of identity (whether in part 133 or in
other standards of identity) in our analysis directed by section
418(n)(5) of the FD&C Act, because standards of identity are not hazard
analysis and preventive controls programs. We establish food standards,
such as the standards in part 133 (Cheeses and Related Cheese Products)
under section 401 of the FD&C Act (21 U.S.C. 341) to promote honesty
and fair dealing in the interest of consumers. In contrast to this role
of food standards, hazard analysis and preventive control programs
(e.g., HACCP) involve a systematic approach to the identification and
assessment of the risk (likelihood of occurrence and severity) of
hazards from a particular food or food production process or practice
and the control of those hazards (78 FR 3646 at 3659).
    We acknowledge that part 133 requires an aging period, such as at
least 60 days at not less than 35 degrees F, for cheese manufactured
from unpasteurized milk, and that this aging period was presumed to act
as a control measure to reduce the risk that pathogens would be present
when the cheese was consumed. We recently issued a request for comments
and for scientific data and information that would assist us in
identifying and evaluating intervention measures that might have an
effect on the presence of bacterial pathogens in cheeses manufactured
from unpasteurized milk (80 FR 46023, August 3, 2015). It is premature
to determine what role, if any, an aging process could play in a food
safety plan for the manufacture of cheese from unpasteurized milk.
    (Comment 727) Some comments assert that we did not make the
required comparison of the proposed human preventive controls rule to
the PMO available for review.
    (Response 727) The required comparison of the proposed human
preventive controls rule to the PMO is available in the docket for this
rulemaking (Docket FDA-2011-N-0920) (see Reference 193 to the proposed
human preventive controls rule). We stated that it was available during
the discussion of section 418(n)(5) of the FD&C Act (36 FR 3646 at
3786). For this final rule, we have both updated this comparison (Ref.
65) and prepared a separate comparison of the final provisions of this
rule to the PMO (Ref. 49).

LIV. Comments on Proposed Removal of 21 CFR Part 110--Current Good
Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

    We proposed to remove current part 110 after the compliance date
for all businesses to be in compliance with the requirements of new
part 117. We received no comments that disagreed with this proposal. As
discussed in section LVI.A, businesses will be required to comply with
new part 117 1, 2, or 3 years after September 17, 2015, depending on
the size of the business. Thus, part 110 will be removed on September
17, 2018.

LV. Comments on Proposed Conforming Amendments

    We proposed a series of conforming amendments to current
regulations (in Sec. Sec.  106.100(j) and (n), 114.5, 120.3, 120.5,
120.6(b), 123.3, 123.5(a), 123.11(b), 129.1, 179.25(a), and 211.1(c))
that refer to the requirements of part 110. With the proposed
conforming changes, these current regulations would refer to part 117,
as well as part 110. We also proposed that when part

110 is removed, all references to part 110 be removed from our
regulations.
    We received no comments that disagreed with the proposed conforming
changes. Therefore, at this time we are amending each of these current
regulations so that they refer to part 117, as well as part 110. When
part 110 is removed, we will issue conforming amendments to remove all
references to part 110 from our regulations.

LVI. Effective and Compliance Dates

A. Effective and Compliance Dates for Part 117

    We proposed that any final rule based on proposed part 117 become
effective 60 days after its date of publication in the Federal
Register, with staggered compliance dates (78 FR 3646 at 3673).
Businesses other than small and very small businesses would have 1 year
from the date of publication of the final rule to comply with the rule,
whereas small businesses would have 2 years and very small businesses
would have 3 years to comply with the rule. We proposed that these
staggered compliance dates would apply to the modernized CGMPs that
would be established in subpart B of part 117, as well as the new
requirements for hazard analysis and risk-based preventive controls (78
FR 3646 at 3674). The staggered compliance dates for compliance with
the modernized CGMPs would apply to all food establishments, including
those establishments that are subject to the CGMPs in subpart B, but
exempt from the new requirements for hazard analysis and risk-based
preventive controls in subparts C and G. For the purpose of determining
its compliance date, the definitions of ``small business'' and ``very
small business'' established in this rule apply, regardless of whether
a food establishment is subject to requirements of another rule (such
as our HACCP regulation for juice in part 120) that may have a
different definition for ``small business'' and ``very small
business.''
    Most of the comments support staggering the compliance dates. For
example, one comment states that the rule would substantially prevent
wide-ranging harm associated with contaminated processed foods, but at
a reasonable cost to the food industry, with ample exclusions and
extended compliance dates for small facilities. However, some of the
comments that support staggering the compliance dates suggest extending
the compliance dates for some sizes of business (see, e.g., Comment
728, Comment 730, and Comment 731).
    In the following sections, we discuss comments that suggest
extensions to the proposed compliance dates or ask us to clarify how
the compliance dates will apply. After considering these comments, we
are establishing the effective and compliance dates as proposed, except
for the following three changes. First, we are extending the compliance
date for PMO-regulated facilities to comply with the requirements of
subparts C and G to September 17, 2018 (See Response 214). Second, we
are establishing an earlier compliance date for the financial records
that a facility maintains to support its status as a very small
business that is eligible for the qualified facility exemption in Sec.
117.5(a). Specifically, the compliance date for a facility to retain
records to support its status as a qualified facility is January 1,
2016. (See Response 155.) Third, we are establishing separate
compliance dates for the supply-chain program provisions. As discussed
in Response 729, a receiving facility's compliance date with the
supply-chain program provisions of this rulemaking is the later of: (1)
March 17, 2017; (2) for a receiving facility that is a small business,
September 18, 2017; and (3) when the supplier of a raw material or
other ingredient will be subject to the human preventive controls rule
or the produce safety rule, 6 months after the receiving facility's
supplier of that raw material or other ingredient is required to comply
with the applicable rule. See table 53 and table 54 for a summary of
these compliance dates.

 Table 53--Compliance Dates for the Requirements of Part 117 Other Than
               the Requirements for a Supply-Chain Program
                               [Subpart G]
------------------------------------------------------------------------
            Size of business                     Compliance date
------------------------------------------------------------------------
Qualified facility (including very       September 17, 2018, except that
 small business) as defined in Sec.       the compliance date for a
 117.3.                                   facility to retain records to
                                          support its status as a
                                          qualified facility is January
                                          1, 2016.
Small business as defined in Sec.        September 18, 2017.
 117.3.
Businesses subject to the Pasteurized    September 17, 2018.
 Milk Ordinance.
All other businesses...................  September 19, 2016.
------------------------------------------------------------------------

   Table 54--Compliance Dates for the Requirements of the Supply-Chain
                                 Program
                               [Subpart G]
------------------------------------------------------------------------
               Situation                         Compliance date
------------------------------------------------------------------------
A receiving facility is a small          September 18, 2017.
 business and its supplier will not be
 subject to the human preventive
 controls rule or the produce safety
 rule.
A receiving facility is a small          The later of: September 18,
 business and its supplier is subject     2017 or 6 months after the
 to the human preventive controls rule    receiving facility's supplier
 or the produce safety rule.              of that raw material or other
                                          ingredient is required to
                                          comply with the applicable
                                          rule.
A receiving facility is not a small      March 17, 2017.
 business or a very small business and
 its supplier will not be subject to
 the human preventive controls rule or
 the produce safety rule.
A receiving facility is not a small      6 months after the receiving
 business or a very small business and    facility's supplier of that
 its supplier will be subject to the      raw material or other
 human preventive controls rule or the    ingredient is required to
 produce safety rule.                     comply with the applicable
                                          rule.
------------------------------------------------------------------------

    We also are establishing two additional compliance dates applicable
to qualified facilities. First, we are establishing December 17, 2018
as the compliance date for (1) the initial submission of the
attestation by a facility that it is a qualified facility (see Sec.
117.201(a)(1)) and (2) the attestation by a qualified facility about
its food safety practices (see Sec.  117.201(a)(2)(i)) or that it is in
compliance with non-Federal food safety law (see Sec.
117.201(a)(2)(ii)).
    Second, we are establishing January 1, 2020, as the compliance date
for the notification requirement of Sec.  117.201(e)(1). A qualified
facility that submits an attestation that it is in compliance with
applicable non-Federal food safety law must notify consumers as to the
name and complete business address of the facility where the food was
manufactured or processed (see Sec.  117.201(e)). If a food packaging
label is required, the required notification must appear prominently
and conspicuously on the label of the food (see Sec.  117.201(e)(1)).
This notification requirement may require some qualified facilities to
update the labels of their packaged food products.
    For many labeling requirements, the timeframe for a food
establishment to comply with new or revised labeling requirements is
governed by a uniform compliance date (see, e.g., 79 FR 73201, December
10, 2014 and 77 FR 70885, November 28, 2012). Use of a uniform
compliance date provides for an orderly and economical industry
adjustment to new labeling requirements by allowing sufficient lead
time to plan for the use of existing label inventories and the
development of new labeling materials. This policy serves consumers'
interests as well because the cost of multiple short-term label
revisions that would otherwise occur would likely be passed on to
consumers in the form of higher prices. We generally announce a uniform
compliance date during November or December of even-numbered calendar
years, and establish the uniform compliance date to be January 1 of an
upcoming even-numbered calendar year. For example, in December, 2014,
we issued a final rule establishing January 1, 2018, as the uniform
compliance date for food labeling regulations that are issued between
January 1, 2015, and December 31, 2016 (79 FR 73201). Likewise, in
November, 2012, we issued a final rule establishing January 1, 2016, as
the uniform compliance date for food labeling regulations that are
issued between January 1, 2013, and December 31, 2014 (77 FR 70885,
November 28, 2012). These uniform compliance dates provide a minimum of
1 year between the date when a food labeling regulation is issued and
the date when a food establishment must comply with that regulation.
Following this pattern, we intend that the next uniform compliance date
will be January 1, 2020 for food labeling regulations that are issued
between January 1, 2017 and December 31, 2018. A qualified facility
that submits an attestation that it is in compliance with non-Federal
food safety law would become subject to the notification requirement
during this timeframe--i.e., by December 31, 2018.
    The compliance date that we are establishing for the notification
requirement of Sec.  117.201(e) (i.e., January 1, 2020) is consistent
with the approach of a uniform compliance date and will provide a
qualified facility that chooses to submit an attestation about
compliance with non-Federal food safety law with more than 1 year from
the applicable general compliance date to comply with the notification
requirement. This compliance date also will provide such a qualified
facility with more than 4 years to comply with the notification
requirement relative to the date of publication of this rule.
    (Comment 728) Some comments assert that one year is not a
sufficient amount of time for any size firm to comply with the human
preventive controls rule based on experiences with the implementation
of our HACCP regulation for seafood. These comments assert that HACCP
required a ``cultural change'' for many seafood processors. The
comments acknowledge that the knowledge of HACCP and food safety
systems has advanced throughout the food industry in the nearly 20
years since we established our HACCP regulation for seafood but
nonetheless assert that firms will need to modify previously developed
food safety plans in order to comply with the rule. The comments also
assert that training cannot realistically begin until both the final
rule and associated guidance are published and that the experiences
with implementing our HACCP regulation for seafood should be magnified
for the human preventive controls rule because the universe of food
processors needing to comply will be much larger, both in the United
States and throughout the world. These comments ask us to establish a
2-year compliance period for the largest firms to allow time for the
training programs and guidance documents to be developed.
    (Response 728) We decline this request. As the comments
acknowledge, approximately 20 years have elapsed since we issued the
final rule establishing our HACCP regulation for seafood, and
requirements such as conducting a hazard analysis and implementing
appropriate preventive controls, with associated preventive control
management components, are no longer novel. We agree that the details
of the final requirements could not be known until publication of this
final rule, and that the guidance we are developing can help businesses
develop or modify their food safety plans and training programs.
However, the statutory direction in section 418 of the FD&C Act is
extensive and, thus, signaled the general nature of the requirements as
early as January 4, 2011, when FSMA was signed into law. In addition,
we conducted extensive stakeholder outreach during the 10-month comment
period for the 2013 proposed human preventive controls rule (79 FR
58524 at 58528). We also provided public notice about proposed changes
to the farm-related definitions that affect the determination of
whether a business is subject to the rule, the framework for hazard
analysis and risk-based preventive controls, and about specific
potential requirements for environmental monitoring, product testing,
and a supplier program, in the 2014 supplemental human preventive
controls notice, and conducted outreach activities to discuss the new
or revised proposed provisions in that supplemental notice (see section
I.A and Ref. 1 and Ref. 2). In light of the broad awareness of
preventive programs such as HACCP, the statutory direction in FSMA, and
extensive outreach associated with this rulemaking, we disagree that
the largest businesses will need more than one year to fully adapt
their programs to the specific requirements of the final rule. Although
a business may find it useful to revise certain aspects of its food
safety plan, or enhance its training materials, after we issue
implementation guidance such as that discussed in Response 2, such
revisions would serve to enhance the company's food safety plan rather
than be a necessary resource before a food safety plan could be
developed and implemented or before employees could be trained in their
specific duties associated with implementing the plan.
    Moreover, for our HACCP regulation for seafood we established a
single compliance date regardless of the size of the business, and
announced our intention to monitor the progress of the industry after
publication of the final rule. If we determined that the compliance
date for that regulation was placing a significant and unreasonable
burden on the industry, particularly on small businesses, we were
willing to

consider an extension for as much as one additional year or some form
of additional technical assistance (Federal Register of December 18,
1995, 60 FR 65096 at 65169). Approximately 5 years later, we issued the
final rule for our HACCP regulation for juice (January 19, 2001, 66 FR
6138), in which we staggered the compliance dates based on business
size and provided only one year for the largest businesses to comply.
The staggered compliance dates that we proposed for the human
preventive controls rule based on business size are consistent with the
approach we took for the HACCP regulation for juice, given increased
awareness of hazard analysis and the application of risk-based
preventive controls in the years after we issued the final rule for
seafood HACCP.
    (Comment 729) Some comments point out that there are staggered
compliance deadlines for small and very small businesses under both the
human preventive controls rule and the produce safety rule. These
comments express concern that to the extent a receiving facility
subject to the human preventive controls rule is required to comply
with the rule sooner than a current or prospective supplier, that
receiving facility is in effect creating pressure for that supplier to
come into compliance on a timetable inconsistent with that established
in the rules. The ``adequacy'' of the receiving facility's verification
activities becomes potentially even more problematic to demonstrate to
FDA inspectors.
    (Response 729) We are establishing separate compliance dates for
the supply-chain program provisions. While this adds complexity, we are
doing this for two main reasons. First, we are aligning, to the extent
feasible, the compliance dates of the supply-chain program provisions
of this rule with the compliance dates of the forthcoming FSVP rule,
which we intend to publish in the near future. This will provide
greater consistency across the programs, particularly with respect to
the verification of domestic and imported raw materials and
ingredients. For the FSVP rule, we proposed a minimum compliance period
of 18 months.
    Second, to address the concerns expressed in these comments we want
to minimize the likelihood that a receiving facility will be required
to comply with the supply-chain program provisions of this rulemaking
before its supplier is required to comply with applicable new food
safety regulations implementing FSMA. Our goal is to avoid a situation
in which a receiving facility would be required to develop a supply-
chain program for a food from a particular supplier and then be
required to revise this supply-chain program shortly thereafter once
the supplier is subject to an applicable new food safety regulation--
specifically, the human preventive controls rule or the forthcoming
produce safety rule.
    Therefore, a receiving facility's compliance date with the supply-
chain program provisions of this rulemaking is the later of: (1) March
17, 2017; (2) for a receiving facility that is a small business,
September 18, 2017; and (3) when the supplier of a raw material or
other ingredient will be subject to the human preventive controls rule
or the produce safety rule, six months after the receiving facility's
supplier of that raw material or other ingredient is required to comply
with the applicable rule.
    (Comment 730) One comment from a State department of agriculture
asserts that the farm-related definitions in the 2013 proposed human
preventive controls rule would cover a large sector of agricultural
operations that would not be able to comply due to cost and would need
a longer compliance schedule.
    (Response 730) We believe that the revised definitions that we
proposed in the 2014 supplemental human preventive controls notice for
``farm,'' and for on-farm manufacturing, processing, packing, and
holding activities that trigger a requirement for an establishment that
is also a farm to register as a food facility, largely address these
comments. Many activities that farms conduct on RACs, and that would
have triggered a requirement to register under the definitions
established in the section 415 registration regulations in 2003 (68 FR
58894), will not trigger a requirement to register under the
definitions we are establishing in this final rule.
    We are aware of the impact that food safety rulemakings may have on
small and very small businesses, and in the 2001 final rule to
establish our HACCP regulation for juice we began the practice of
reducing the burden on these businesses by staggering the compliance
dates and giving small and very small businesses additional time to
comply with food safety regulations. Since that time, we have continued
this practice of staggering compliance dates in rulemakings such as
establishing CGMPs for dietary supplements (June 25, 2007, 72 FR 34752)
and preventing Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation (July 9, 2009, 74 FR 33030 at 33034). We
believe that the staggered compliance dates in this final rule provide
adequate time for businesses of all sizes to comply with the rule, and
that the additional compliance time provided for small and very small
businesses sufficiently minimizes the burden on those businesses. (See
also Response 731.)
    (Comment 731) Some comments assert that differences between the
proposed compliance dates for different sizes of businesses subject to
the human preventive controls rule and the proposed compliance dates
for different sizes of businesses subject to the produce safety rule
will create confusion within industry and State and local regulators.
These comments also express concern that certain farms will be subject
to both rules at the same time, and that compliance with each rule will
require significant investment of both resources and time, both to
understand and to implement the various provisions. These comments ask
us to consider a process to permit very small and small farms (as
defined under the proposed produce safety rule) that are also mixed-
type facilities subject to the human preventive controls rule to apply
for a one-time compliance period extension of twelve months by
notifying FDA in writing. These comments assert that only a small
percentage of businesses will be eligible for such a one-time extension
and that the extension will enable a farmer to plan accordingly, first
implementing the produce safety rule and then implementing the human
preventive controls rule.
    (Response 731) We decline this request. See Response 730 regarding
the impact of the revised farm-related definitions on businesses that
conduct on-farm activities. A small or very small business that only
conducts the on-farm low-risk activity/food combinations we have
specified as exempt (see Sec.  117.5(g) and (h)) is exempt from all
requirements for hazard analysis and risk-based preventive controls. A
very small business that conducts on-farm activity/food combinations in
addition to those low-risk activity/food combinations would be subject
to an exemption as a qualified facility and is subject only to the
modified requirements we are establishing in Sec.  117.201.
    A small business that would not be exempt because it conducts other
activities in addition to those low-risk activity/food combinations
that would qualify the business for an exemption will have 2 years to
comply with the human preventive controls rule. We acknowledge that
complying with both the human preventive controls rule and the produce
safety rule involves significant new requirements, but we have provided
extended compliance periods and done substantial outreach.

    (Comment 732) Some comments ask us to clarify when a very small
business would need to comply with the rule if the business starts up
after the rule goes into effect. For example, if a very small business
starts up six months after the date of the final rule, would that
business have 2.5 years to comply, or would it need to comply
immediately?
    (Response 732) A very small business that is operating as of the
date of publication of the final rule, or begins operating any time
before the compliance date for very small businesses, must comply with
the rule by the compliance date for very small businesses. That date is
fixed in time and is not a moving date based on market entry. A very
small business that begins operation any time after the compliance date
for very small businesses must comply with the rule when it begins
operation, and should plan accordingly.

B. Effective and Compliance Dates for Revisions to Part 1

    This rule includes revisions to the ``farm definition,'' and to
activities related to the ``farm definition,'' in Sec. Sec.  1.227 and
1.328. This rule also includes technical amendments to Sec. Sec.
1.241, 1.276, and 1.361. We did not discuss effective and compliance
dates for these revisions to part 1 in either the 2013 proposed human
preventive controls rule or the 2014 supplemental human preventive
controls notice. See table 55 for the effective dates and compliance
dates that we are establishing in this final rule. As with the
requirements we are establishing in part 117, the revisions to part 1
become effective 60 days after the date of publication of this rule
(i.e., November 16, 2015). The compliance dates for the technical
amendments to Sec. Sec.  1.241, 1.276, and 1.361 are the same as the
effective dates. Two of these technical amendments change the citation
to the FD&C Act from ``the act'' to ``the Federal Food, Drug, and
Cosmetic Act''; the third technical amendment updates a cross-reference
to the definition of ``manufacturer'' in regulations for the prior
notice of imported food.
    The principal impact of the substantive revisions to the
definitions in the section 415 registration regulations and the section
414 recordkeeping regulations is whether the revised definitions affect
the classification of a business as an entity that is subject to these
regulations. We believe that some businesses that were subject to one
or both of these regulations will no longer be subject to either of
these regulations because the activities that these businesses conduct
are now within the ``farm'' definition and, thus, exempt from those
regulations. During the 60 day period between the publication of this
rule and its effective date, FDA does not intend to prioritize
enforcing the section 415 registration regulations and the section 414
recordkeeping regulations for businesses that will no longer be subject
to either or both of those regulations once the revisions are
effective.
    However, we cannot predetermine whether some businesses that
previously were not subject to the section 415 registration
regulations, the section 414 recordkeeping regulations, or both will
not become subject to one or both of those regulations. The approach we
are taking to the compliance date for the revisions to these
regulations is the same as the approach we took when we first
established these regulations. First, for the section 415 registration
regulations, the compliance date is the same date as the effective
date. Such establishments must register as a food facility by November
16, 2015. (See 68 FR 58894, which establishes an effective date for the
section 415 registration regulations but does not establish a different
date for compliance with those regulations.) An establishment that is
required to register as a food facility by November 16, 2015 will be
required to comply with the requirements in part 117 as described in
section LVI.A.
    For the section 414 recordkeeping regulations, we are requiring
that establishments that become subject to these requirements for the
first time as a result of the revisions that become effective November
16, 2015 comply with the requirements using the same criteria as we
applied when we first established this regulation as shown in table 55.
(See 69 FR 71562, December 9, 2004.)

Table 55--Compliance Dates for the Section 414 Recordkeeping Regulations
------------------------------------------------------------------------
             Size of business                      Compliance date
------------------------------------------------------------------------
10 or fewer full-time equivalent employees  September 18, 2017.
Businesses employing fewer than 500, but    March 17, 2017.
 more than 10 full-time equivalent
 employees
All other businesses                        September 19, 2016.
------------------------------------------------------------------------

C. Effective Dates for Conforming Amendments

    The conforming amendments to regulations in parts 106, 114, 120,
123, 129, 179, and 211 are technical amendments that add a cross-
reference to part 117 where the current regulation refers to part 110.
The conforming amendment to part 11 adds a reference to the scope of
part 11 that the records required under part 117 are not subject to
part 11. The conforming amendment to part 16 adds a reference to the
scope of part 16 for new procedures in part 117, subpart E that provide
a person with an opportunity for a hearing under part 16. These
conforming amendments are effective on November 16, 2015, the same date
as the effective date of part 117. We are not establishing compliance
dates for these conforming amendments. As a practical matter,
compliance dates will be determined by the dates for compliance with
part 117.

D. Delayed Effective Dates for Provisions That Refer to the Forthcoming
Rules for Produce Safety and Third-Party Certification

    The following provisions refer to provisions we intend to establish
in the near future in part 112 (Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption): Sec. Sec.
117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and
117.475(c)(13). In addition, paragraph (2) of the definition of
``qualified auditor'' in Sec.  117.3, and Sec.  117.435(d) refers to
provisions we intend to establish in the near future in part 1, subpart
M (Accredited Third-Party Food Safety Audits and Food or Facility
Certification). In addition, Sec. Sec.  117.405(a)(2) and 117.475(c)(2)
refer to provisions we intend to establish in the near future in part
1, subpart L (Foreign Supplier Verification Programs for Food
Importers). We will publish a document in the Federal Register
announcing the effective dates of paragraph (2) of the definition of
``qualified auditor'' in Sec.  117.3, and Sec. Sec.  117.5(k)(2),
117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.405(a)(2),
117.435(d), 117.475(c)(2) and 117.475(c)(13).

LVII. Compliance and Enforcement

    Gaining industry compliance with the provisions of this rule is as
important as establishing the provisions. A central element of our
strategy to gain industry compliance is to help make available to
facilities subject to this rule the education and technical assistance
they need to understand and implement the requirements (Ref. 6). Within
the Agency we are establishing a Food Safety Technical Assistance
Network and seeking funding to increase FDA staffing to provide a
central source of information to support industry

understanding and implementation of FSMA standards (Ref. 6). This will
allow us to respond in a timely and consistent way to industry
questions on preventive controls technical and compliance issues (Ref.
6).
    We also are working in collaboration with the FSPCA to develop
training materials and establish training and technical assistance
programs (Ref. 5) and (Ref. 7). The FSPCA includes members from FDA,
State food protection agencies, the food industry, and academia. It is
funded by a grant to the Illinois Institute of Technology's Institute
for Food Safety and Health, a nationally-recognized leader in food
safety. In addition to developing a standardized preventive controls
training curriculum, the FSPCA is developing selected sections of model
food safety plans for several food types that will provide needed
instructional examples. Although we have provided funding to the FSPCA
to develop a standardized preventive controls training curriculum, we
are unable to fund training for individual groups who might need
particular training materials.
    We also are partnering with the NIFA of USDA to administer the
FSMA-mandated National Food Safety Training, Education, Extension,
Outreach, and Technical Assistance Program, a grant program to provide
technical assistance for FSMA compliance to owners and operators of
small and medium-size farms and small food processors (Ref. 8). Such
efforts will help ensure widespread voluntary compliance by encouraging
greater understanding and adoption of established food safety
standards, guidance, and protocols.
    With regard to inspections, we will conduct regular inspections of
domestic facilities to ensure that facilities subject to this rule are
adequately implementing the required preventive controls and supply-
chain program, pursuant to our inspection authority under section 704
of the FD&C Act. Our inspections will verify that such facilities are
implementing systems that effectively prevent food contamination, and
in particular, that they comply with the rule by implementing
preventive controls, including supply-chain programs, to provide
assurances that any hazard requiring a preventive control or supply-
chain applied control has been significantly minimized or prevented.
    In order to effectively carry out this new paradigm of food safety
prevention, we will need to reorient and retrain our staff. To this
end, we are seeking additional funding, including for the training of
more than 2,000 FDA inspectors, compliance officers, and other staff
involved in food safety activities (Ref. 12).
    We also plan to leverage the resources of State, local, tribal, and
territorial governments to conduct domestic verification activities. We
are working with officials from these governments through the PFP to
develop and implement a national Integrated Food Safety System, which
will focus on establishing partnerships for achieving compliance (see
section 209(b) of FSMA), and which will allow us to utilize the
thousands of State, local, and tribal inspectors available to help with
the domestic verification process.
    Consistent with FSMA, we will use our current resources, new
resources that we obtain, and our partnerships to conduct regular
inspections of covered facilities, focusing on those facilities that
pose the highest risk to food safety. Section 201 of FSMA mandates that
FDA inspect domestic high-risk facilities no less than once every 3
years. We are currently meeting this mandate, and even exceeding it
with respect to certain domestic high-risk facilities. Once the FSMA
rulemakings come into effect, we intend to build on this track record
and to have an FDA or State inspection of domestic high-risk human food
facilities on an annual basis to ensure hazards have been significantly
minimized or prevented in compliance with this rule.

LVIII. Executive Order 13175

    In accordance with Executive Order 13175, FDA has consulted with
tribal government officials. A Tribal Summary Impact Statement has been
prepared that includes a summary of Tribal officials' concerns and how
FDA has addressed them (Ref. 101). Persons with access to the Internet
may obtain the Tribal Summary Impact Statement at http://www.fda.gov/pchfrule or at http://www.regulations.gov. Copies of the Tribal Summary
Impact Statement also may be obtained by contacting the person listed
under FOR FURTHER INFORMATION CONTACT.

LIX. Economic Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because facilities with less than 20 employees (both
qualified and non-qualified facilities) will bear a large portion of
the costs, the Agency concludes that the final rule will have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. FDA expects this final
rule to result in a 1-year expenditure that will exceed this amount.

LX. Analysis of Environmental Impact

    FDA has determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment (Ref. 102) (Ref. 103). Therefore,
neither an environmental assessment nor an environmental impact
statement is required.

LXI. Paperwork Reduction Act of 1995

    This rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act (PRA) of
1995 (44 U.S.C. 3501-3520). A description of these provisions is given
in the following paragraphs with an estimate of the annual
recordkeeping and reporting burdens. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
    Title: Current Good Manufacturing Practice, Hazard Analysis and
Risk-Based Preventive Controls for Human Food.
    Description: The Food and Drug Administration (FDA) is proposing to
amend its regulation for Current Good Manufacturing Practice in

Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it
and to add requirements for domestic and foreign facilities that are
required to register under section 415 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to establish and implement hazard analysis
and risk-based preventive controls for human food. FDA is taking this
action as part of its announced initiative to revisit the CGMPs since
they were last revised in 1986 and to implement new statutory
provisions in section 418 of the FD&C Act.
    Description of Respondents: Section 418 of the FD&C Act is
applicable to the owner, operator or agent in charge of a food facility
required to register under section 415 of the FD&C Act. Generally, a
facility is required to register if it manufactures, processes, packs,
or holds food for consumption in the United States. There are 83,819
such facilities; 37,134 of these facilities are considered
``qualified'' facilities and have reduced requirements in regards to
this rule-making.
    In the following paragraphs, we describe and respond to the
comments that we received for the PRA for both our 2013 proposed human
preventive controls rule and our 2014 supplemental human preventive
controls notice. We numbered each comment to help distinguish between
different comments. The number assigned to each comment is purely for
organizational purposes and does not signify the comment's value,
importance, or the order in which it was received.
    (Comment 733) Comments stated that we overestimated the
recordkeeping burden because we assume the burden is evenly distributed
across all facilities beginning in the first year. However, facilities
that are not small or very small have one year from the effective date
of the rule to come into compliance. For small facilities, compliance
is delayed for 2 years and very small facilities will have 3 years. The
agency's 7 year horizon for discounting burdens would need to be
staggered to account for the delayed compliance dates in order to
arrive at a consistent annualized burden of the records collection.
    (Response 733) We clarify that our estimate for the recordkeeping
burden for the first year is for the first full year that all
facilities are responsible for the requirements for the rule. We note
that the FRIA (Ref. 38) now uses a 10 year horizon for discounting
burdens.
    (Comment 734) Comments support our estimate that many facilities
already keep the records required by section 418 of the FD&C Act and
the proposed human preventive controls rule as good business practice.
Comments believe that preventive food safety systems are the norm for
the food industry. Comments believe this is demonstrated by what they
cite as 57 percent of the industry already operating under HACCP
programs. Not accounting for the effects of widespread adoption of
HACCP may result in an overestimate. The reason a majority of food
facilities have already implemented HACCP or a HACCP[hyphen]like
systems is that preventive systems are the best, most
cost[hyphen]effective means of insuring against recall costs and
potential criminal liability for releasing adulterated product into
commerce. If the industry standard is prevention, then the baseline for
calculating PRA burdens should be adjusted to account for that.
    (Response 734) We concur that we do not account for those
facilities that are in the process of adopting our requirements
independently. We do address the impact of a likely trend toward
adopting our requirements in the uncertainty analysis of our FRIA (Ref.
38).
    (Comment 735) Comments assert that knowledge transferred from
facilities already applying HACCP will be available to small and very
small facilities during the delayed implementation period. Delayed
implementation periods usually contemplate that smaller businesses will
benefit from increased availability of advanced technology and
knowledge that can lower the costs of compliance. Related comments
suggest that the PRA does not appear to have considered that during the
three[hyphen]year implementation period standardized templates and
software for hazard analyses and food safety plans may become available
for food facilities. The availability of templates and software would
reduce the time needed for small and very small facilities to prepare
mandatory documents.
    (Response 735) We concur that delayed implementation periods will
benefit smaller businesses from the increased availability of advanced
technology and knowledge that can lower the costs of compliance. We
allowed the staggered compliance period for this very reason. We
revised our estimate of the costs to learn about the requirements of
rule in the main analysis. In our revised analysis, we estimate that
facilities with fewer than 20 employees will devote 5 hours to learning
about their requirements, rather than 10 hours. For facilities with 20
to 99 employees, one individual at the level of an operations manager
will take about 10 hours to review and assess the requirements or to
learn about the requirements for their facility rather than 15 hours.
    (Comment 736) Comments suggest that the PRA review does not account
for reduced training costs for small and very small facilities derived
from the availability for hire of trained employees. The average
turnover rate in manufacturing in 2010 was 15 percent, suggesting some
small businesses will be able to hire qualified individuals rather than
training current employees.
    (Response 736) We agree that some new employees will already be
trained but we believe that we accounted for those that are already
trained by only including burden hours for employees at facilities that
disclosed to our survey that they did not conduct training. In
addition, we estimated a turnover rate of 10 percent, which indicates
that fewer new employees would require training than proposed by the
comments, indicating that we did not overestimate the burden hours.
    (Comment 737) Comments assert that we underestimated the
recordkeeping burden of the proposed information collection, that our
methodology and assumptions are wrong or that it is not possible to
adequately assess the accuracy of our recordkeeping burden estimates.
Comments further dispute our assessment that creation of a single food
safety plan will require 110 hours and that one plan will be required
per facility. In the experience of the comments' member organization,
it takes considerably longer, with a median of over 200 hours per
facility. Additionally, many plants currently have more than one HACCP
plan in place. Large plants have multiple products, raw materials,
processes, and equipment. Comments report that one large plant has 34
plans in place that took approximately 860 hours to develop and another
large plant has 25 plans in place that took approximately 1385 hours to
develop.
    (Response 737) We concur that establishments might have more than
one HACCP plan in place and we acknowledge that large establishments
might require considerably more than 110 hours to develop a food safety
plan. Our estimate is based on the average time to create a food safety
plan for establishments of all sizes, so our estimate includes very
small facilities that are likely to require considerably less than 110
hours, too.
    (Comment 738) Comments assert that it is not clear if our
assessment includes the considerable pre-work time that is required as
an input to development of a HACCP plan. Pre-work includes activities
such as employee training,

assembling the food safety plan team (which may require outside
experts, and specific company experts like microbiologists,
procurement, research and development, etc.), creating the processing
and product profile, and creating a flow diagram. Some estimated that
approximately 150-300 hours of pre-work are needed per facility before
the actual HACCP plan is prepared.
    (Response 738) Our analysis for the PRA includes pre-work time to
the extent that pre-work time includes preparing the documents that are
required in accordance with the rule. The preparation of records for
the validation of process controls might be considered pre-work and
would be considered in our estimate. We disagree that all of the pre-
work mentioned by the comments should be included in our estimate of
the burden hours.
    (Comment 739) Comments believe that a robust food safety plan
should be developed by a multidisciplinary group of professionals with
a broad skill set. These comments believe that it is unclear what wage
rate we used in our estimate of the operating and maintenance costs
associated with implementing and maintaining a food safety plan or if
those estimates consider the range of wages applicable to the broad
team involved in plan development.
    (Response 739) We concur that a multidisciplinary group of
professionals is likely to be involved in the plan development. Our
estimate is based on an average wage rate for the type of professional
that would be likely to develop the specific document. We included our
estimate for the average wage rate that we used for each type of
document in our description.
    (Comment 740) Comments suggest that our estimate that facilities
will keep records of 730 monitoring activities and that each record can
be made in about three minutes (36.5 hours total per year per
facility), severely underestimates both the number of activities and
the time required.
    (Response 740) Comments did not provide supporting evidence. In the
absence of a better substantiated estimate, we decline to revise our
estimate.
    (Comment 741) Comments assert that we severely underestimated the
number of monitoring records. Comments claim that several of their
members reported over 50,000 monitoring events in their facilities
annually. They provided as an example that if one production line has
two metal detectors and one barcode scanner, there would be three
records per shift, with three shifts per day. Assuming 300 days of
operation per year, this one line would have 2700 records per year.
Most plants have multiple lines and conduct monitoring beyond metal
detectors and bar code scanners. A large plant may have well over 730
monitoring events per day--not per year as FDA estimates.
    (Response 741) We concur that a large establishment might have
significantly more monitoring events. Our analysis is based on the
average of all establishments, including very small establishments that
are unlikely to so many events. In the absence of substantiated
evidence for the large average number of monitoring events, we decline
to revise our estimate.
    (Comment 742) Comments let us know that it is unclear what
activities are included in our time estimate. Comments claim that the
amount of time required to produce a record will vary depending on
whether the estimate only includes documenting time to create the
record or whether it also includes the underlying task of monitoring
and follow-up tasks like filing. Furthermore, the number of monitoring
events could be significantly higher than the estimate if all
preventive controls are subject to similar monitoring requirements as
critical control points. Thus, although some tasks may take only three
minutes to monitor, our members suggest that six minutes per monitoring
event may be a more accurate estimate of the information collection
burden.
    (Response 742) We concur with the comments that time will vary by
what's included in the task. The PRA requires that we include in our
burden estimate the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information. We believe our estimate
of 3 minutes, as an average over time, accurately reflects the entire
requirement for recordkeeping, including the initial time to create,
maintain and file the records. Many, if not most, records can be
created, maintained and filed in batch to reduce time, especially when
done electronically, so we decline to revise our estimate of 3 minutes,
in the absence of more evidence.
    (Comment 743) Comments claim that our estimated burden for
corrective action records assumes that 18,291 facilities subject to
preventive controls will have two corrective actions to document, which
will take one hour each to record. Our assessment does not explain the
basis for estimating that only 18,291 facilities will engage in
corrective actions. Because occasional deviations from expected values
are an unavoidable part of any manufacturing environment, it should be
expected that all facilities subject to preventive controls regulations
will have corrective actions to document annually. Comments claim that
our time estimate also appears to be low. Comments report that their
member's facilities typically engage in between 10 and 60 corrective
actions per year for critical control point deviations, which is
considerably higher than our proposed estimate of two actions per year.
Although it may take only one hour to manage the record involved with
the corrective action, additional time would be required to investigate
the underlying issue and implement the corrective action. We expect it
can take between two and four hours to investigate a single corrective
action and come up with a solution.
    (Response 743) We revised our estimate for the number of
establishments that would be subject to the requirements to 16,285
based on the most recent number of facilities registered with FDA and
that are subject to subparts C and G. We address elsewhere our reason
for not requiring all facilities to be subject to subparts C and G. We
recognize that some facilities will conduct more than our estimate of
two corrective actions per year. Our estimate is based on actions that
must be made to correct a problem that has occurred with the
implementation of a preventive control; or that might affect the safety
of the food. Many corrective actions might occur to address product
quality problems, unrelated to food safety. Further, our estimate for
the PRA is necessarily only related to the recordkeeping burden, and
should not include the additional time that would be required to
investigate the underlying issue and implement the corrective action.
    (Comment 744) Comments noted that our estimate for keeping
verification records assumes facilities will keep records of 244
verification events and that each record can be made in about three
minutes (12.2 hours total per year per facility). Comments claim that
our assessment does not explain whether this estimate considers the
broad scope of activities included in the definition of
``verification'' in the proposed rule (proposed Sec.  117.150),
although it should. The proposed regulatory definition of verification
not only includes verification of monitoring, corrective actions, and
implementation and effectiveness (e.g., calibration), but also includes
validation and reanalysis. Validation and reanalysis of a food safety
plan are extensive activities that take tens, if not hundreds, of hours
to conduct. The estimate does not appear

to account for these activities. The comments note that even when
considering just the traditional activities considered as verification
under HACCP, their members' experience shows that our current
verification estimate is too low. They received a wide range of
estimates of the number of verification events conducted annually--from
about 200 to over 14,000 events per year. Similarly, their members
report that it takes them between 8 minutes and 2 hours per
verification event. It is unclear whether our estimate includes only
the time to handle the record or also the time to conduct the
verification. The comments suggest this missing information in our
estimate may explain the range of responses in our survey. Comments
claim that the time to conduct the verification should be included.
    (Response 744) We concur that our estimates should assess the full
scope of activities associated with recordkeeping. Our analysis did
neglect to include the recordkeeping activities for the validation of
process controls, which are an essential part of verification. We added
our estimate for the burden of validation and we revised our
description about the recordkeeping burden for the food safety plan to
state that our estimate does include the burden of reanalysis of the
food safety plan. For the purposes of the PRA, our estimate of the
burden of recordkeeping is only for the time of recordkeeping, not the
full verification activity. We decline to revise our estimate based on
the comment because insufficient evidence was presented about just the
time for recordkeeping.
    (Comment 745) Comments noted that we estimate that 47,484 food
manufacturers will need to document the training of their preventive
controls qualified individual, which will take 15 minutes per facility.
(We note that the proposed rule defined and used the term ``qualified
individual, but the term in the final rule is ``preventive controls
qualified individual, and we use the term ``preventive controls
qualified individual'' in describing these comments on this topic.)
They are unclear why we estimate that only 47,484 food manufacturers
and not all registered facilities subject to preventive controls would
be required to have a preventive controls qualified individual and to
document that person's training. Comments state that their members
found that we are accurate in our assumption, although our estimate for
the documentation may take 30 minutes in some situations. Comments also
suggest that many facilities may need to document more than one
preventive controls qualified individual. Comments provide as an
example, that a thermal process authority outside of the plant may be a
qualified individual in terms of confirming the process has a validated
kill step, while the same facility will likely have a qualified
individual responsible for approving the food safety plan. This
situation would increase the time burden beyond estimate.
    (Response 745) Our estimate of 47,484 establishments that will need
to document the training of their preventive controls qualified
individual was based on our estimate of the number of facilities that
are subject to subparts C and G of the rule. We updated our estimate to
46,685 based on our most recent count of facilities registered with
FDA. Our estimate is based on the requirement that only one preventive
controls qualified individual is necessary to perform the requirements
of the provisions that require a preventive controls qualified
individual. Moreover, some preventive controls qualified individuals
may be qualified by experience and there would not be a need for
documentation of training.
    (Comment 746) Comments note that our estimate for submitting a new
domestic food facility profile will take 15 minutes. Comments believe
that we grossly underestimate the amount of time retailers will need to
respond to the form. Comments believe that the typical distribution
center carries 26 of the 27 product categories listed in the Draft
Form. Providing detail on the potential hazards and preventive controls
implemented for each product will take retailers a total of 20-30 or
more hours per facility. Most chain retailers have multiple facilities.
A national retailer will easily have a dozen or more distribution
centers. The largest food retailers will have several dozen. It is
conceivable that hundreds of hazard and preventive control entries will
be required to be made for each distribution center to respond to the
Draft Form if such facilities are required to input information on
hazards they do not control. The typical distribution center carries
more than 13,000 different SKUs of FDA-regulated foods. Completing the
form itself will require several hours due to all of the entries.
Compiling the information for each facility will take 20-30 hours.
Under the PRA, comments believe that we are required to consider not
only the time it takes to complete the form, but also the time it takes
to compile the information. Comments believe that we must revise our
estimate of the burden imposed by the information collection request
(ICR).
    (Response 746) We requested comment on whether to require
submission to FDA of a subset of the information that would be in a