requirements consistent with our perspective that quality assurance
must be nurtured (e.g., incorporation of the corrective action process
for both recognized accreditation bodies and LAAF-accredited
laboratories, submission by recognized accreditation bodies of their
internal audit reports, proficiency test requirements for each method
within the laboratories' scope of LAAF-accreditation at least every 12
months). Nevertheless, we decline the suggestion to define ``quality
assurance'' in this subpart because we conclude a definition is neither
necessary nor would it meaningfully add to the final rule. We prefer
instead to include in our standards provisions that will require the
quality assurance processes and actions we deem necessary for this
program.
    We note that the term, ``quality assurance'' appeared in Sec.
1.1148 of the proposed rule (``What quality assurance requirements must
accredited laboratories meet?''). In the final rule, we have omitted
the specific section regarding quality assurance requirements and
incorporated those requirements into Sec.  1.1138, which addresses the
eligibility requirements for LAAF-accredited laboratories.
    The term, ``raw data'' is not used so extensively in the final rule
as to warrant a definition. In fact, it only appears once in the
codified text, in Sec.  1.1152(d)(8), where we require as part of a
full analytical report, ``[a]ll original compilations of raw data
secured in the course of the analysis.'' We explain the term in two
ways. First, section 1.1152(d)(8) includes some examples of raw data,
and second, in our discussion of that provision at Response 119, below,
we have expounded on our thinking regarding this requirement. We
consider these forms of explanation to be sufficient in the context of
this subpart.
    (Comment 25) Some comments state that the term, ``specific major
food testing discipline'' is used throughout the proposed rule and
suggest that a definition for the term be added to the regulation for
additional clarity.
    (Response 25) We included the term, ``specific major food testing
discipline'' in proposed Sec.  1.1152(d) regarding permission to submit
abridged

analytical reports. To clarify the term, we have included detail in the
final rule at Sec.  1.1153(a) regarding the three major food testing
disciplines under this rule for purposes of submitting abridged
analytical reports. We identified these in the preamble to the proposed
rule regarding Sec.  1.1152(d) (see 84 FR 59484 (Nov. 4, 2019)) using
slightly different terms: ``microbiology, chemistry, and physical
(filth).'' In the final rule at 21 CFR 1.1153(a), we have codified the
specific major food testing disciplines that will be used to categorize
analytical reports for purposes of determining permission to submit
abridged analytical reports as ``biological, chemical, and physical.''
3. Who is subject to this subpart (Sec.  1.1103)?
    Proposed Sec.  1.1103 listed the entities subject to the subpart:
recognized accreditation bodies, entities seeking to become recognized
accreditation bodies, LAAF-accredited laboratories, entities seeking to
become LAAF-accredited laboratories, and owners and consignees who are
required to use LAAF-accredited laboratories for the food testing under
this program.
    We have made minor changes throughout this section to reflect
revised program terminology. Specifically, we have modified the term,
``accreditation'' to ``LAAF-accreditation'' in this section and
throughout the rule. Additionally, we have made minor editorial changes
on our own initiative to improve clarity. Comments regarding this
section are discussed below.
    (Comment 26) Some comments request clarification of which owners
and consignees will be covered by this final rule, stating that there
may be multiple owners and consignees in the context of imported food.
    (Response 26) FDA-regulated products imported into the United
States must comply with the same FDA laws and regulations that apply to
domestic products. Entries are submitted to U.S. Customs and Border
Protection which then refers entries of FDA-regulated products to FDA
for review. Imported items may not be distributed into commerce until
FDA has determined admissibility.
    If FDA detains a food product at the border under section 801(a) of
the FD&C Act because the food is or appears to be adulterated or
misbranded, but FDA has not yet refused admission, the owner or
consignee of the food may introduce testimonial evidence that the food
is admissible. Owners and consignees often engage laboratories to test
the food and submit to FDA the results of the testing, as testimony to
support admission. If FDA determines that the food testing results are
valid and that they demonstrate the detained product does not violate
the FD&C Act, FDA will release the food from detention and allow it to
proceed into the United States. The testing of detained product at the
direction of such owners and consignees is covered by this final rule
(see Sec.  1.1107(a)(4)).
    The DWPE procedure allows FDA to detain an imported product without
physically examining it at the time of entry. FDA employs the DWPE
procedure when there is a history of product that violates or appears
to violate the FD&C Act, or when other information indicates that
future entries may be violative. Import alerts inform FDA staff and the
public that we have enough evidence to allow for DWPE of particular
products. Testing to support removal from an import alert is also
covered by this final rule (see Sec.  1.1107(a)(5)). For more
information on FDA's import program generally see https://www.fda.gov/industry/import-program-food-and-drug-administration-fda; for more
information on DWPE, see https://www.fda.gov/media/71776/download.
    It is true that for a particular food shipment or entry being
offered for import into the United States, multiple parties may be
considered owners and/or consignees of the entry or of particular
products within that entry (i.e., line items or lines). However, there
is generally only one importer of record for each entry,\2\ and it is
the importer of record that is ultimately responsible for ensuring that
the product(s) complies with the FD&C Act and implementing regulations
at the time of entry. (See Sec.  1.83(a), where the term, ``owner or
consignee'' is defined for the purposes of articles offered for
import.) The importer of record may negotiate or contract with another
party such that the other party agrees to engage the laboratory to test
the product. Such arrangements are purely between the parties to the
shipment; at the end of the day the importer of record remains the
party ultimately responsible for the compliance of that entry and
therefore is ultimately responsible for amassing any testimonial
evidence (e.g., test results and associated analytical documentation)
in support of admission of the food.
---------------------------------------------------------------------------

    \2\ There may not be an importer of record for some informal
entries. (Informal entries, as defined by U.S. Customs and Border
Protection regulations, are usually valued at less than $2,500
(value subject to change) (19 CFR 143.21), and usually do not
require a bond. Some products are restricted from informal entry
(for example, high risk products), regardless of value.) For such
shipments that are not accompanied by an importer of record when
making entry, the owner or consignee of the line(s) will serve as
the responsible party when presenting evidence to FDA in support of
admission of the food.
---------------------------------------------------------------------------

D. Comments Regarding General Requirements

               Table 4--Revisions to General Requirements
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
Sec.   1.1107 When must food      Sec.   1.1107       Revised section
 testing be conducted under this   Under what          title to simplify
 subpart?                          circumstances       language and
                                   must food testing   incorporate
                                   be conducted        revised
                                   under this          terminology.
                                   subpart by an
                                   accredited
                                   laboratory?
Sec.   1.1108 When and how will   Sec.   1.1108 When  Revised section
 FDA issue a directed food         and how will FDA    title to reflect
 laboratory order?                 issue a food        revised
                                   testing order?      terminology.
Sec.   1.1109 How will FDA make   Sec.   1.1109 How   Revised section
 information about recognized      will FDA make       title to reflect
 accreditation bodies and LAAF-    information about   revised
 accredited laboratories           recognized          terminology.
 available to the public?          accreditation
                                   bodies and
                                   accredited
                                   laboratories
                                   available to the
                                   public?
Sec.   1.1110 What are the        N/A...............  New section which
 general requirements for                              consolidates
 submitting information to FDA                         requirements from
 under this subpart?                                   throughout the
                                                       proposed rule.
------------------------------------------------------------------------

1. When must food testing be conducted under this subpart (Sec.
1.1107)?
    Proposed Sec.  1.1107(a) stated that food testing must be conducted
under this subpart whenever food testing is conducted by or on behalf
of an owner or consignee in any of the following five circumstances:
(1) In response to explicit testing requirements that address an
identified or suspected food safety problem in existing FDA regulations
covering sprouts (21 CFR 112.146(a), (c) and (d)), shell eggs
(Sec. Sec.  118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii),
118.6(a)(2), 118.6(e)), and bottled drinking water (Sec.
129.35(a)(3)(i) (21 CFR 129.35(a)(3)(i))) (regarding the requirement to
test five samples from the same sampling site that originally tested
positive for Escherichia coli (E. coli)); (2) as required by FDA in a
directed food laboratory order (issued under Sec.  1.1108 of this
rule); (3) to address an identified or suspected food safety problem
and presented to FDA as part of evidence for a hearing under section
423(c) of the FD&C Act (21 U.S.C. 350l) prior to the issuance of a
mandatory food recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the FD&C Act (21 U.S.C. 350d) submitted after
an order suspending the registration of a food facility, or as part of
evidence submitted for an appeal of an administrative detention order
under section 304(h)(4)(A) of the FD&C Act (21 U.S.C. 334(h)(4)(A));
(4) in support of admission of an article of food under section 801(a)
of the FD&C Act; and (5) to support removal from an import alert
through successful consecutive testing.
    Section 1.1107(b) of the proposed rule stated that when food
testing is conducted under paragraph (a), analysis of samples must be
conducted by a laboratory that is LAAF-accredited for the appropriate
method(s). Proposed paragraph (c) stated the requirement for food
testing on articles of food offered for import into the United States
to be conducted after the articles have arrived in the United States
unless FDA has provided prior written authorization to the owner or
consignee that a sample(s) of the article(s) taken prior to arrival in
the United States is or would be representative of the article(s)
offered for import.
    We revised the proposed rule section title, ``Under what
circumstances must food testing be conducted under this subpart by an
accredited laboratory?'' to ``When must food testing be conducted under
this subpart?'' in the final rule. We have made changes throughout this
section to incorporate revised terminology. We also have made non-
substantive revisions to paragraph (a)(2) (to add the word,
``issued''), to paragraph (a)(3) to add an inadvertently omitted word
(``of''), and to paragraph (c) to improve clarity and readability.
Comments regarding this section are discussed below.
    (Comment 27) We received several comments regarding the proposed
policy to allow all testing under this subpart to be conducted ``by or
on behalf of an owner or consignee.'' Some comments contend that
laboratories operated by owners or consignees (``in-house''
laboratories) should be ineligible to conduct some or all tests
described in Sec.  1.1107. Other comments voice agreement with the
proposal.
    (Response 27) After considering the comments in light of the
statute, we are retaining the proposed policy such that in-house
laboratories may become LAAF-accredited to conduct any or all the
testing described in Sec.  1.1107 as long as those laboratories meet
all the laboratory requirements of this subpart. Please see the
discussion of this issue in Response 101 where we address the general
eligibility of these laboratories, as well as the impartiality and
conflict of interest requirements contained in Sec.  1.1147.
    (Comment 28) We received a few comments asking us to clarify the
foods to which the testing requirements in the final rule will apply.
Some of these comments ask whether any commodities would be exempt from
the final rule and state that seafood, juice, and low-acid canned foods
are exempt from certain requirements of the ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-based Preventive
Controls for Human Food'' (preventive controls for human food)
regulation (part 117 (21 CFR part 117)). Other comments inquire whether
the final rule would apply to any commodities other than sprouts, shell
eggs, and bottled drinking water.
    (Response 28) Proposed Sec.  1.1107(a) described the specific
circumstances under which food testing would need to be conducted under
this subpart by a LAAF-accredited laboratory. Sprouts, shell eggs, and
bottled drinking water are the only commodities for which specific
testing requirements contained in existing regulations are currently
covered by the final rule (see Sec.  1.1107(a)(1)(i) through (iii)).
The remaining circumstances in Sec.  1.1107(a) could require food
testing under this subpart for any food or environment within FDA's
jurisdiction. We note that hazards addressed by hazard analysis and
critical control point (HACCP) regulations for seafood (21 CFR part
123) and juice (21 CFR part 120), and those addressed by regulations
for low-acid canned food (21 CFR part 113), are exempt from certain
requirements of the preventive controls for human food regulation
because those commodities and hazards are covered by commodity-specific
HACCP or other regulations that predate the preventive controls for
human food regulation. Seafood, juice, and low-acid canned foods are
not exempt from this final rule. If seafood, juice, low-acid canned
foods, or any article of food or environment within FDA's jurisdiction
are covered by any of the circumstances described in Sec.  1.1107(a)(2)
through (5), then food testing must be conducted under this subpart by
a LAAF-accredited laboratory. For a discussion of program
implementation, see Response 14.
    (Comment 29) Some comments agree with our proposal regarding the
scope of testing that would be covered by the final rule. Some comments
express alignment with the general notion of FDA requiring the use of
LAAF-accredited laboratories in circumstances where heightened food
safety concerns exist. Other comments support the proposed requirement
that testing prescribed by certain explicit testing requirements in FDA
regulations to address an identified or suspected food safety problem
should be covered by this final rule. Specifically, some comments
support the inclusion of the bottled drinking water testing required in
Sec.  129.35(a)(3)(i) and agree that other bottled drinking water
testing required by FDA regulations does not constitute testing in
connection with an ``identified or suspected food safety problem'' and
therefore was properly excluded from coverage in the proposed rule.
    (Response 29) Section 422 of the FD&C Act prescribes several
circumstances in which testing must be conducted by a LAAF-accredited
laboratory. First, section 422(b)(1)(A)(i) of the FD&C Act requires
testing under this subpart to be conducted, ``in response to a specific
testing requirement under this Act or implementing regulations, when
applied to address an identified or suspected food safety problem.'' As
discussed in the proposed rule, we proposed to interpret section
422(b)(1)(A)(i) to apply to provisions of the FD&C Act or its
implementing regulations that explicitly require food testing. 84 FR
59452 at 59462. We identified nine explicit testing requirements in our
regulations that we tentatively concluded address an identified or
suspected food safety problem because each of those testing
requirements was a followup test after a

routine test indicated the presence of a pathogen or indicator organism
(i.e., an organism that indicates conditions in which an environmental
pathogen may be present). For example, Sec.  118.4(a)(2)(i) of our
shell egg safety regulation requires an environmental test for
Salmonella Enteritidis when the pullets are 14 to 16 weeks of age. If
the environmental test is positive, Sec.  118.4(a)(2)(iii) requires
shell egg testing to commence within 2 weeks of the start of egg laying
(unless the eggs are diverted to treatment, see Sec.  118.6(a)(2)). We
tentatively concluded that the followup shell egg testing would be
covered by the rule, but the initial environmental testing would not.
Section 422(b)(1)(A)(i) of the FD&C Act is implemented in Sec.
1.1107(a)(1) of this final rule. For a discussion of FDA's
interpretation of ``identified and suspected food safety problem,'' see
Response 35.
    Section 422(b)(1)(A)(ii) of the FD&C Act requires testing to be
conducted under this subpart, ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act is
implemented in Sec.  1.1108 of this final rule, which addresses the
directed food laboratory order. (For discussion of the directed food
laboratory order, see Comment 41 through Comment 56 and Responses,
below.) Section 422(b)(1)(A)(ii) of the FD&C Act also authorizes Sec.
1.1107(a)(3) of this final rule, which requires that food testing be
conducted under this program when it is conducted to address an
identified or suspected food safety problem and is presented to FDA in
three administrative procedural settings: As part of evidence for a
hearing under section 423(c) of the FD&C Act prior to the issuance of a
mandatory recall order, as part of a corrective action plan under
section 415(b)(3)(A) of the FD&C Act submitted after an order
suspending the registration of a food facility, or as part of evidence
submitted for an appeal of an administrative detention order under
section 304(h)(4)(A) of the FD&C Act.
    Section 422(b)(1)(B)(i) of the FD&C Act requires testing to be
conducted under this subpart, ``in support of admission of an article
of food under section 801(a).'' Section 422(b)(1)(B)(i) of the FD&C Act
is implemented in Sec.  1.1107(a)(4) of this final rule. Section
422(b)(1)(B)(ii) of the FD&C Act requires testing to be conducted under
this subpart when such testing is to support removal from an import
alert through successful consecutive testing, and is implemented in
Sec.  1.1107(a)(5) of this final rule.
    We appreciate those aspects of comments that express support for
the proposed testing provisions.
    (Comment 30) Some comments note that there have been foodborne
illnesses associated with shell eggs produced at farms with less than
3,000 laying hens. These comments also note that food safety recalls
associated with shell eggs, including from cage-free and free-range egg
farms that have less than 3,000 laying hens, affect all egg farms. In
the view of these comments, FDA's egg safety rule should therefore not
exclude shell egg producers with less than 3,000 laying hens, and all
egg farms regardless of size should be subject to this rule for the
testing described in Sec.  1.1107(a)(1)(ii).
    (Response 30) This final rule requires use of a LAAF-accredited
laboratory for certain followup tests that already are required by
other food safety regulations (Sec.  1.1107(a)(1)). Because shell egg
farms that have less than 3,000 laying hens are exempt from the egg
safety rule, such farms are not subject to this final rule for the egg
safety rule testing that falls within the scope of this subpart.
    (Comment 31) Some comments opine that our use of the term,
``corrective action testing'' with respect to followup testing in
response to an identified or suspected food safety problem appears to
mean something different than it does in the world of conformity
assessment. These comments assert that for conformity assessment
purposes, ``corrective action'' means that a laboratory takes an
``action to eliminate the cause of a nonconformity and to prevent
recurrence;'' these comments cite ISO/IEC 9001.
    (Response 31) In the proposed rule, we used the term, ``corrective
action'' to refer to actions taken by a conformity assessment entity in
response to a deficiency (see, e.g., 84 FR 59452 at 59491 (``the
probation notice would either inform the laboratory that the laboratory
has a specified time period to take corrective actions specified by
FDA[,] or request that the laboratory submit a corrective action plan
to FDA for FDA's approval that identifies the corrective actions it
will take to address deficiencies identified''). In the proposed rule,
we also used the term, ``corrective action'' to describe followup
activities undertaken by a food manufacturer or processor after product
or environmental testing indicates the presence of a pathogen or
indicator organism (84 FR 59452 at 59455).
    We understand why comments express the view that it may have been
confusing for the term, ``corrective action'' to mean two different
things in the proposed rule. In addition, in the proposed rule, we
could have been more precise in our use of the term, ``explicit
corrective action testing'' to describe testing covered by section
422(b)(1)(A)(i) of the FD&C Act. Section 422(b)(1)(A)(i) directs this
program to cover testing ``in response to a specific testing
requirement under [the FD&C Act] or implementing regulations, when
applied to address an identified or suspected food safety problem.''
Not all the testing described by this statutory language may be
properly categorized as corrective action testing, (e.g., the sprouts
environmental tests at 21 CFR 112.146(c) are considered verification
tests within the sprouts regulatory framework; see Sec.
1.1107(a)(1)(i)).\3\ To improve clarity and precision, we use the
phrase, ``explicit followup testing'' in the final rule to mean the
testing that we have determined will be subject to this subpart under
our section 422(b)(1)(A)(i) authority.
---------------------------------------------------------------------------

    \3\ For more information on sprouts environmental testing, see
the ``Compliance with and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations'' draft
guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-compliance-and-recommendations-implementation-standards-growing-harvesting.
---------------------------------------------------------------------------

    For the foregoing reasons, including to minimize risk of confusion
and to improve the final rule, we generally reserve use of the term,
``corrective action,'' to the conformity-assessment context, in this
document. Exceptions include discussion related to the preventive
controls regulations; see Comment and Response 37. For clarity we have
added the following definition of ``corrective action'' to Sec.
1.1102: ``Corrective action means an action taken by an accreditation
body or laboratory to investigate and eliminate the cause of a
deficiency so that it does not recur.'' Relatedly, in Sec. Sec.
1.1121, 1.1131, and 1.1161 of the final rule, we have added references
to the specific sections of the relevant ISO/IEC standard to clarify
the process a recognized accreditation body or LAAF-accredited
laboratory must take to address deficiencies through corrective action.
    (Comment 32) In the proposed rule, we described the circumstances
under which testing of imported food would be subject to the
requirements of this final rule. In brief, we proposed that an owner or
consignee whose entry has been detained because the food is or appears
to be adulterated or misbranded must use a LAAF-accredited laboratory
to conduct the food testing used as testimonial evidence supporting
admission to the United States. The

other import testing that we proposed to cover in this final rule is
testing to support the removal of food from import alert through
successful consecutive testing. Import alerts inform FDA's field staff
and the public that the Agency has enough evidence to allow for DWPE of
products that appear to be in violation of FDA's laws and regulations.
    Some comments express appreciation that the proposed rule included
information on when imported foods would need to be tested. Some
comments support our proposal to require the use of a LAAF-accredited
laboratory for testing conducted to support removal from import alert.
These comments endorse the portion of the proposed rule preamble that
discussed the importance of reliable testing of imports and indicate
that in the past, food commodities subject to import alert have caused
multiple foodborne illness outbreaks. These comments state that
although it will take many tools and approaches to ensure the safety of
imported foods, reliable testing is a critical component of a
successful strategy.
    (Response 32) With appreciation for these supportive comments, we
confirm that the import-related circumstances under which food testing
is required by this subpart in the proposed rule remain unchanged in
the final rule: Testing in support of admission of an article of food
under section 801(a) of the FD&C Act (Sec.  1.1107(a)(4)) and testing
to support removal from an import alert through successful consecutive
testing (Sec.  1.1107(a)(5)).
    (Comment 33) Some comments express confusion about when this final
rule would apply and asked when the requirements of the final rule
would apply to regulatory feed testing laboratories.
    (Response 33) A regulatory feed testing laboratory may choose to
seek LAAF-accreditation to conduct testing under this subpart. If
animal food were the subject of testing required to be conducted under
this program (i.e., the subject of food testing under Sec.
1.1107(a)(2) through (5)), then an owner or consignee would need to use
a LAAF-accredited laboratory to conduct the test. For a discussion of
program implementation, see Response 14.
    (Comment 34) Some comments express the erroneous understanding that
the laboratory accreditation final rule would apply only when food
testing is conducted in a food manufacturing or processing facility.
These comments express the concern that adulteration may occur after
the food leaves the production facility, in which case testing
conducted during production is outdated and inaccurate, and potentially
masks a food safety problem.
    (Response 34) We first clarify that the testing covered by this
rule is not limited to testing in a food manufacturing or processing
facility. Certain testing at farms is also covered; for example, Sec.
1.1107(a)(1)(ii) describes shell egg testing, and those eggs originate
on a poultry farm. In addition, this rule covers a significant number
of tests of imported food (Sec.  1.1107(a)(4) and (5)). Because FDA
agrees that adulteration may occur while food is in transit, the final
rule generally requires imported food products subject to this final
rule to be sampled and tested after the food has arrived in the United
States. (See Sec.  1.1107(c) and Response 40 for more on this topic.)
Thus, testing of imported food subject to this final rule generally
will occur at or near the U.S. border.
    FDA also has other tools to address adulteration that occurs
outside of production establishments, including another FSMA
regulation, the ``Sanitary Transportation of Human and Animal Food''
regulation (part 1, subpart O), which requires shippers, carriers by
motor vehicle or rail vehicle, receivers, and other persons engaged in
the transportation of food, to use sanitary transportation practices to
ensure that the food is not transported under conditions that may
render the food adulterated.
    (Comment 35) In the preamble to the proposed rule, we discussed
considerations in our interpretation of the phrase, ``identified or
suspected food safety problem,'' which appears in section
422(b)(1)(A)(i) and (ii) of the FD&C Act and is therefore important in
determining which testing will be covered by this subpart. Among other
things, we explored other uses of similar phrases elsewhere in FSMA. We
tentatively concluded that an ``identified food safety problem'' could
be present when a specific article of food violates a provision of the
FD&C Act that relates to food safety. We tentatively concluded that a
``suspected food safety problem'' typically would have a basis in fact
about a particular article of food (e.g., a lot or batch) or food
production environment (e.g., a specific facility). We reasoned that
the requisite suspicion would not be satisfied by the common or usual
characteristics of food (e.g., whether a food is considered ``high
risk'') or the manner in which the food is typically produced. We
tentatively concluded that the routine product testing and
environmental monitoring requirements required by the preventive
controls for human food regulation (see Sec.  117.165(a)(2) and (3),
respectively), are not conducted to address a suspected (or identified)
food safety problem, because this testing is conducted to verify the
implementation and effectiveness of preventive controls (``verification
testing'') and not because a food safety problem is suspected or
identified. 84 FR 59452 at 59462. This same tentative conclusion would
apply to the routine product testing and environmental monitoring
requirements required by the Current Good Manufacturing Practice,
Hazard Analysis, and Risk-based Preventive Controls for Food for
Animals (preventive controls for animal food) regulation (Sec.
507.49(a)(2) and (3) (21 CFR 507.49(a)(2)) and (3), respectively).
    In the proposed rule we explained that, in the preventive controls
for human food regulation, FDA indicated that an ``unanticipated food
safety problem'' could occur where a preventive control is not properly
implemented, including where a pathogen or indicator organism is
detected during routine product or environmental testing (verification
testing). In the proposed rule we tentatively concluded that, depending
on the circumstances, a routine test that indicated the presence of an
indicator organism would not necessarily constitute a suspected food
safety problem. 84 FR 59452 at 59462.
    Some comments dispute our interpretation of ``identified or
suspected food safety problem.'' From their perspective, there is no
need for the problem to be particularized to an article of food or a
facility. These comments state that the statute does not direct that
``an identified or suspected food safety problem,'' could only be
present in relation to a specific article of food or facility. The
comments argue that the appearance of the phrase, ``food safety
problems'' in two FSMA titles that cover multifaceted approaches to
food safety (Title I: ``Improving Capacity to Prevent Food Safety
Problems'' and Title II: ``Improving Capacity to Detect and Respond to
Food Safety Problems'') supports the position that Congress did not
intend for the same terms to be read narrowly in the context of section
422 of the FD&C Act. These comments indicate that the economic analysis
accompanying the proposed rule estimated that far fewer tests would be
subject to the LAAF program under section 422(b)(1)(A) than under
section 422(b)(1)(B) of the FD&C Act.
    (Response 35) The phrase, ``identified or suspected food safety
problem,'' appears twice in section 422(b)(1)(A) of

the FD&C Act and therefore helps demarcate which testing will be
covered by this subpart. The statute does not define either
``identified or suspected food safety problem,'' or ``food safety
problem,'' nor do those phrases appear elsewhere in the body of FSMA.
As referenced above, the phrase, ``food safety problem'' appears in the
FSMA titles: Title I, ``Improving Capacity to Prevent Food Safety
Problems,'' and Title II, ``Improving Capacity to Detect and Respond to
Food Safety Problems.'' Comments urge us to infer from the breadth of
the various provisions within each of those two titles, that when
Congress used the same phrase in section 422(b)(1)(A) of the FD&C Act,
it intended the phrase to be broadly interpreted. However, we cannot
impute such an intention to Congress without some indication of that
intent in section 422 of the FD&C Act or the legislative history.
Indeed, one could reasonably infer the opposite--that from the breadth
of the provisions within FSMA Titles I and II, Congress must have
intended for the phrase, ``food safety problems'' to have different
meanings in different contexts. In sum, ``food safety problem'' is not
defined in the statute, and thus it falls to FDA to elaborate on its
meaning.
    In the proposed rule, we looked at other FSMA standards and other
FSMA regulations, before making the tentative conclusions described
above in Comment 35. We finalize those conclusions without change.
    In this vein, we observe that the purpose of routine product and
environmental testing under the preventive controls regulations is to
verify that preventive controls are consistently implemented and are
effective (Sec. Sec.  117.165(a) and 507.49(a)). Accordingly, such
testing does not address an identified or suspected food safety
problem, and is not covered by this subpart.
    (Comment 36) In the proposed rule, we tentatively concluded that
although section 422(b)(1)(B)(i) of the FD&C Act requires testing, ``in
support of admission of an article of food under section 801(a)'' to be
conducted under this subpart, it was reasonable not to apply section
422(b)(1)(B)(i) to food testing related to FSVP. We explained that
under section 801(a)(3) of the FD&C Act, FDA may refuse admission of an
article of food if the food is, or appears to be, adulterated or
misbranded. When FDA determines that an article of food is, or appears
to be, adulterated or misbranded, we must notify the owner or consignee
of our determination, and state the reason(s) for such determination
(Sec.  1.94(a)). FDA must also specify a period of time during which
the owner or consignee may introduce testimony relevant to the
admissibility of the article of food. Id. Owners or consignees often
engage laboratories to test the food and then introduce the test
results (along with associated data and analysis) as evidence that the
food is admissible. If FDA determines that the sampling methods and
testing results are valid and indicate that the article of food does
not appear to violate the FD&C Act, FDA will determine that the article
of food is admissible, release it from detention, and permit its
entrance into the United States. Thus, the focus of section
422(b)(1)(B)(i) of the FD&C Act is the characteristics of an article of
food that is pending at the border. Under Sec.  1.1107(a)(4) of this
final rule, the testing obtained by the owner or consignee and
submitted as testimony to support release of the article of food from
detention, must be conducted under this subpart.
    FSMA amended the FD&C Act to add section 805, ``Foreign Supplier
Verification Program,'' to require persons who import food into the
United States to perform risk-based foreign supplier verification
activities for the purpose of verifying that imported food meets
applicable U.S. safety requirements. The FSVP regulation, codified in
Sec. Sec.  1.500 through 1.514, specifies the foods and importers to
which the FSVP regulation applies and establishes requirements related
to supplier verification. Depending on the circumstances, sampling and
testing of a food may be an appropriate supplier verification activity.
See Sec.  1.506(d)(1)(ii)(B). If an FSVP importer fails to comply with
the FSVP regulations for a particular food, that food may be refused
admission under section 801(a)(3) of the FD&C Act.\4\ However, such
refusal is not because the article of food pending at the border is, or
appears to be, adulterated or misbranded. Instead, the refusal is a
consequence of the importer's failure to comply with its FSVP
obligations. Testing the article of food detained at the border in this
instance would have no impact on its admissibility under section
801(a)(3) of the FD&C Act, because the detention is due to the
characteristics of the importer. In the proposed rule we tentatively
concluded that, because the focus of the FSVP provision in section
801(a)(3) of the FD&C Act is entirely different than the focus of the
circumstances addressed by section 422(b)(1)(B)(i) of the FD&C Act, it
is reasonable not to apply the latter subpart to the testing of food
conducted under FSVP.
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    \4\ For more information on FSVP, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
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    Several comments agree with our reasoning regarding testing under
FSVP and our proposal that such testing not require use of a LAAF-
accredited laboratory. However, other comments disagree, expressing the
perspective that as the proposed rule would cover testing to support
removal from import alert, it seems more consistent with the FSMA
framework to also require testing related to FSVP to be conducted under
this subpart. We understand these comments to mean that, because FSVP
addresses the safety of food imports, and testing related to import
alerts also addresses the safety of food imports, FDA is being
inconsistent in covering import alert testing under this subpart, but
not testing related to FSVP. These comments further suggest that we not
require test results related to FSVP to be sent directly to FDA. The
comments do not explain why FSVP tests, which they argue should be
subject to this subpart, should nevertheless be excepted from the
requirement that all test results under this subpart be submitted
directly to FDA.
    (Response 36) We disagree that our determinations regarding testing
related to FSVP are inconsistent with covering testing to support
removal from import alert under this subpart. As an initial matter, the
section of the statute authorizing the LAAF program explicitly directs
that testing to support removal from import alert be subject to this
program, and does not mention FSVP. Further, for the reasons discussed
in the proposed rule and briefly described in the comment summary
above, we conclude that it is reasonable not to apply section
422(b)(1)(B)(i) of the FD&C Act to food testing related to FSVP. These
comments do not explain why FSVP test results would warrant an
exception from the Sec.  1.1152(b) requirement to submit all tests
results under this program directly to FDA, and as the final rule will
not cover testing related to FSVP, the suggestion is inapplicable.
    (Comment 37) Some comments agree with our tentative conclusion in
the proposed rule that the routine product and environmental testing
that occurs pursuant to a preventive controls food safety plan should
not require the use of a LAAF-accredited laboratory. Some of these
comments encourage FDA to make explicit in the final rule that routine
product testing under the preventive control regulations is performed
to verify that applied controls have been

effective, and not to address an identified or suspected food safety
problem, and therefore is not covered by the laboratory accreditation
final rule. Some comments also request that FDA clarify that
environmental testing conducted in response to routine environmental
monitoring results indicating the presence of a pathogen or indicator
organism would not typically be considered testing conducted to address
an identified or suspected food safety problem, and would therefore
typically fall outside the scope of the laboratory accreditation final
rule. According to these comments, facilities should have an
opportunity to perform an analysis of the root cause for the
environmental positive, take corrective actions and conduct additional
testing as needed, before FDA determines that an identified or
suspected food safety problem exists and possibly warrants testing by a
LAAF-accredited laboratory.
    On the other hand, some comments urge FDA to include within the
purview of this final rule all food testing required by our
regulations, and at a minimum the verification testing and followup
testing conducted under the preventive controls and FSVP
regulations.\5\ Some of these comments contend that FDA has
misinterpreted the statute, and claim that section 422(b)(1)(A) of the
FD&C Act grants broad discretion to FDA to require use of a
participating laboratory in such circumstances.\6\ Some comments
highlight the language in section 422(b)(1)(A)(ii) of the FD&C Act,
which states in relevant part, ``as the Secretary deems appropriate, to
address an identified or suspected food safety problem,'' and argue
that such language grants FDA ``expansive'' authority for the final
rule to cover circumstances where either FDA or facilities themselves
have identified a food safety hazard and are using testing as part of
the approach to address the hazard. Such comments express the view that
if FDA does not require more domestic food testing to be conducted
under this program, FDA is failing to address food safety problems as
Congress intended. Comments encourage the Agency to adopt a broader
statutory interpretation of section 422(b)(1)(A) of the FD&C Act even
if we do not expand the testing subject to the final rule, so that we
may preserve the authority to add more testing to Sec.  1.1107 in the
future.
---------------------------------------------------------------------------

    \5\ Some comments refer to ``corrective action testing;'' we
have changed the phrase to ``explicit followup testing.'' See
Response 31.
    \6\ Some comments imply that the testing required under section
422(b)(1)(A) of the FD&C Act is limited to domestic food production
circumstances. However there is nothing in the statute that limits
section 422(b)(1)(A) to testing of food produced domestically, and
accordingly Sec.  1.1107(a)(1)-(3) of this final rule also refrains
from imposing that limitation.
---------------------------------------------------------------------------

    In support of their contentions, some comments offer an example of
a Georgia food processing facility that was conducting environmental
testing as required by the preventive controls for human food
regulation but whose products (boiled eggs) nevertheless caused an
outbreak, which, according to the comments, calls into question the
accuracy of the test results and the quality of the facility's testing
program.
    These comments posit that perhaps FDA did not propose to include
testing related to the preventive controls or FSVP regulations within
the scope of this subpart because testing under those regulations is
not always required; depending on the circumstances the facility or
importer may find other actions sufficient. These comments find such
reasoning unpersuasive because in their view, whenever testing is
required as a verification or followup activity under the preventive
controls or FSVP regulations, the testing is being conducted ``in
response'' to a regulatory requirement and so is covered by section
422(b)(1)(A) of the FD&C Act.
    These comments alternatively posit that perhaps FDA did not propose
to cover preventive controls and FSVP testing because this approach
might be burdensome for industry. According to these comments, if that
is the case, then such concerns could be addressed by providing
additional time for implementation; further, any such concerns would be
offset by the positive health and economic benefits that they suggest
testing would create by preventing outbreaks.
    (Response 37) Some comments contend that section 422(b)(1)(A) of
the FD&C Act grants FDA broad discretion to require testing to be
conducted under this subpart. We address the two subparagraphs of
section 422(b)(1)(A) in turn.
Section 422(b)(1)(A)(i) of the FD&C Act
    Section 422(b)(1)(A)(i) of the FD&C Act provides that testing must
be covered by this program when the testing is conducted, ``in response
to a specific testing requirement under this Act or implementing
regulations, when applied to address an identified or suspected food
safety problem.'' We discussed our interpretation of ``identified and
suspected food safety problem'' in Response 35, above, and concluded
that routine product and environmental testing that occurs pursuant to
a preventive controls food safety plan (Sec. Sec.  117.165(a) and
507.49(a)) is not covered by this subpart. We turn now to our
interpretation of the phrase, ``in response to a specific testing
requirement under this Act or implementing regulations.''
    In the proposed rule, we tentatively interpreted, ``specific
testing requirement under this Act or implementing regulations'' to
mean that this subpart would cover food testing explicitly required by
a statutory or regulatory provision. 84 FR 59452 at 59462. We
identified nine testing requirements in FDA regulations that were both
explicit and address an identified or suspected food safety problem:
Five testing requirements in the egg safety rule (Sec. Sec.
118.4(a)(2)(iii), 118.5(a)(2)(ii), 118.5(b)(2)(ii), 118.6(a)(2), and
118.6(e)), three in the standards for the growing, harvesting, packing,
and holding of sprouts (Sec.  112.146(a), (c), and (d)), and one in our
regulations on the processing and bottling of bottled drinking water
(Sec.  129.35(a)(3)(i)).
    Comments do not directly dispute our proposed interpretation of the
term, ``specific,'' but some contend that all food testing requirements
in our regulations should be covered by this subpart. However, the
statute only authorizes testing to be covered by this subpart if it is
both an explicit testing requirement and a testing requirement that
addresses an identified or suspected food safety problem. Not all food
testing requirements in FDA regulations satisfy those two prongs of
section 422(b)(1)(A)(i) of the FD&C Act. Indeed, if Congress had
intended for all food testing required by FDA regulations to be covered
by this program, they could have said so.
    Some comments argue that testing under the preventive controls and
FSVP regulations falls within the purview of section 422(b)(1)(A)(i) of
the FD&C Act. More specifically, these comments identify the testing
done to verify the effectiveness of controls, or as part of corrective
actions taken when issues are identified, as testing that should be
covered by this subpart.
    First, these comments discuss testing in relation to FSVP jointly
with testing under the preventive controls regulations. However, we
have already concluded that testing related to FSVP is not covered by
this subpart (see Response 36); for the remainder of this response we
consider comments just in relation to the preventive controls
regulations.
    Some comments acknowledge that the preventive controls regulations
do not always require testing. Briefly, the preventive controls
regulations apply to most registered food facilities. A wide variety of
registered food facilities process, manufacture, pack, or hold all

kinds of foods, so these regulations are structured to address a
plethora of circumstances. Under the preventive controls regulations,
facilities are responsible for analyzing food safety hazards to
determine if there are hazards requiring a control and then developing
and implementing a plan for the control of those hazards. The
regulations are written to provide significant flexibility to
facilities, and that flexibility is reflected in the provisions that
address testing.
    For example, facilities must verify that their controls are being
consistently implemented and are effective at minimizing or preventing
the identified hazards. The regulations identify testing as one
verification activity, but the facility is responsible for determining
which verification activities are appropriate in their particular
circumstances. By way of another example, facilities must establish and
implement corrective action procedures that must be taken if a
preventive control was not properly implemented. See Sec. Sec.
117.150(a) and 507.42(a). A routine verification test indicating the
presence of a pathogen or indicator organism in a ready-to-eat product
would signal that a preventive control was not properly implemented.
See Sec.  117.150(a)(1). In certain circumstances, followup testing
would be one appropriate corrective action a facility could take in
response to such a signal. However, the regulations do not prescribe
exactly when followup testing is required, instead placing the
responsibility for making that determination on the facility.
    Comments argue that because any verification or followup testing
that occurs under the preventive controls regulations is ``in
response'' to the regulations, such tests fall within the purview of
section 422(b)(1)(A)(i) of the FD&C Act. These comments may prefer that
the word, ``specific'' not appear in section 422(b)(1)(A)(i) of the
FD&C Act, but it does, and it must be given meaning. Regulatory
provisions that confer significant discretion on regulated entities for
determining when food testing is necessary, are not explicit testing
requirements and therefore are not covered by this subpart. We finalize
our proposed interpretation of ``specific'' testing requirements
without change and conclude that neither routine verification testing
nor followup testing under the preventive controls regulations is
covered by this subpart using our section 422(b)(1)(A)(i) authority.
    Some comments opposing our interpretation of section
422(b)(1)(A)(i) of the FD&C Act discuss whether we chose not to include
verification and followup testing under the preventive controls
regulations because it would place a greater burden on those
facilities. Comments state that if that is the case, our concerns could
be addressed by providing more time for such entities to comply with
this final rule. Comments also state that there would be public health
benefits from requiring the use of a LAAF-accredited laboratory for
such testing. However, as discussed above, we have determined that the
regulatory provisions describing verification and followup testing in
the preventive controls regulations are not explicit testing
requirements, and therefore we do not interpret them to satisfy the
statutory requirements of section 422(b)(1)(A)(i).
    For the foregoing reasons, we conclude that we have properly
identified the nine FD&C Act testing requirements that are currently
covered by this subpart under our section 422(b)(1)(A)(i) authority. It
is possible that in the future, FDA may require additional specific
followup testing in FD&C Act regulations, and that testing would be
covered by this subpart. However for now, we finalize Sec.
1.1107(a)(1) without change.
Section 422(b)(1)(A)(ii) of the FD&C Act
    Section 422(b)(1)(A)(ii) authorizes FDA to require testing to be
conducted under this subpart, ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' In the final rule we rely on this statutory provision
to require that testing conducted pursuant to a directed food
laboratory order be conducted under this subpart; see Sec.  1.1108.
Very briefly, as we interpret this statutory provision, directed food
laboratory orders will generally be limited to the rare situations when
we have reason to question the accuracy or reliability of past or
present test results, and an identified or suspected food safety
problem exists. (The directed food laboratory order is discussed in
Comment 41 through Comment 56 and Responses, below.) We also rely on
our section 422(b)(1)(A)(ii) authority to require in the final rule
that testing related to certain administrative proceedings be conducted
under this subpart; see Sec.  1.1107(a)(3). (For discussion of the use
of section 422(b)(1)(A)(ii) authority to cover certain administrative
proceedings testing under this subpart, see the proposed rule (84 FR
59452 at 59463-64)). We agree with those aspects of comments noting
that the language of section 422(b)(1)(A) of the FD&C Act is broad
enough that, in the future, we could cover additional testing under
this subpart by relying on that authority. This could occur if we deem
it appropriate to expand this program to cover additional testing, and
the additional testing addresses an identified or suspected food safety
problem. Further, we intend to make such a change only through notice-
and-comment rulemaking.
    Some comments request that FDA clarify that environmental testing
conducted in response to routine environmental monitoring results
indicating the presence of a pathogen or indicator organism would not
typically be considered testing conducted to address an identified or
suspected food safety problem, and would therefore typically fall
outside the scope of the laboratory accreditation final rule. We have
determined that the routine verification and followup testing
provisions in the preventive controls regulations do not state explicit
testing requirements and are therefore not appropriate to include in
Sec.  1.1107(a)(1); therefore, they will typically fall outside the
scope of this final rule. We have also determined that routine
verification testing that occurs pursuant to a preventive controls food
safety plan (Sec. Sec.  117.165(a) and 507.49(a)) does not address an
identified or suspected food safety problem (Response 35). However,
followup testing in response to routine verification test results
indicating the presence of a pathogen or indicator organism in either a
food product or the food production environment may qualify as testing
that addresses an identified or suspected food safety problem,
depending on the circumstances. We affirm the statement we made in the
proposed rule that, depending on the circumstances, a positive
indicator organism test would not necessarily constitute a suspected
food safety problem; for example, a single positive Listeria spp. on a
food contact surface in a facility would not necessarily constitute a
suspected food safety problem. However, when a routine verification
test of a food product indicates the presence of a pathogen, in many
circumstances we would conclude that there is at least a suspicion of a
food safety problem. For example, the presence of Salmonella in nuts
indicates a suspicion of a food safety problem, but the presence of
Bacillus cereus in tree nuts is not likely to indicate a food safety
problem, since the organism cannot grow to the high numbers needed to
cause illness due to the low water activity of tree nuts. Additionally,
in many circumstances a

routine environmental monitoring test result indicating the presence of
a pathogen in a facility producing a ready-to-eat product could be
classified at least as a suspected food safety problem.
    Followup testing that addresses an identified or suspected food
safety problem under the preventive controls regulations--or in the
context of the FD&C Act, or any FDA food safety regulation--may fall
within the purview of section 422(b)(1)(A)(ii) of the FD&C Act. Under
this final rule, this means that such testing may be the subject of a
directed food laboratory order under Sec.  1.1107(a)(2), and may be the
subject of the testing in certain administrative proceedings described
in Sec.  1.1107(a)(3). We do not anticipate frequent testing under
Sec.  1.1107(a)(2) or (3); as a result, under this final rule, followup
testing that addresses an identified or suspected food safety problem,
but that is not expressed in an explicit testing requirement, will
typically fall outside the scope of this subpart. Again, were we to
seek to expand the testing subject to this final rule, we would go
through the rulemaking process. (For discussion of the circumstances in
which we anticipate issuing a directed food laboratory order, see
Response 47.)
    We do not agree that the 2019 foodborne illness outbreak linked to
hard-boiled eggs and cited in comments is evidence that this final rule
should generally cover routine verification and followup testing under
the preventive controls regulations. In the above-referenced situation,
the facility was processing shell eggs into hard-boiled egg products;
the hard-boiled eggs were linked to an outbreak of Listeria
monocytogenes infections. The facility was processing a ready-to-eat
product that was exposed to the facility environment prior to
packaging; in those circumstances, the preventive controls for human
food regulation generally requires that the facility establish
sanitation controls verified in part by an environmental monitoring
program that involves regularly testing the facility environment. See
Sec.  117.165(a)(3). We thus maintain the view that the existing
preventive controls for human food regulation adequately covers this
situation. When FDA collected environmental samples as part of its
investigation, the facility did as well. There would be no point in
requiring tests such as those taken by the facility to be subject to
this subpart when FDA was onsite to conduct its own investigational
tests. Indeed, the tests of environmental samples the facility
collected alongside FDA inspectors would not be categorized as
verification or followup tests, and thus would not fall within the
purview of this final rule, even if the rule did cover these test
categories.\7\
---------------------------------------------------------------------------

    \7\ Comments also state that the facility in question engaged a
laboratory to validate a process control, but comments do not
suggest that this final rule should cover such testing.
---------------------------------------------------------------------------

    As support for their argument that FDA is applying section
422(b)(1)(A) of the FD&C Act too narrowly, some comments state that the
economic analysis accompanying the proposed rule indicated that many
more tests would be conducted under this subpart stemming from section
422(b)(1)(B) than section 422(b)(1)(A). The economic analysis
accompanying a rule simply reflects the rule it analyzes; this point
appears to be another facet of the argument that we have misinterpreted
the statute. We disagree for the reasons already stated.
    We also disagree that in issuing this final rule FDA is falling
short of addressing important food safety problems. For the reasons
discussed throughout this response, we believe we have interpreted the
statute appropriately, and we look forward to achieving significant
public health benefits as a result of this rule (Ref. 4).
    (Comment 38) Some comments generally urge a broader scope for the
laboratory accreditation final rule. Some of these comments discuss the
critical role food laboratories play in helping to keep the food supply
safe, including the corresponding need for accurate and reliable
results, and therefore seek Federal oversight of all food testing
laboratories. Some of these comments advocate for a requirement that
all food testing laboratories be accredited, which we understand to
mean either that these comments express the belief that all food
testing laboratories should be required to be accredited to ISO/IEC
17025:2017, or should be subject to LAAF-accreditation under this
subpart. Other comments suggest that all laboratories that test food
for human consumption should be required to satisfy the baseline
requirement of this final rule and be accredited to ISO/IEC 17025:2017.
These latter comments suggest that the additional requirements of this
final rule could then be reserved just for the testing identified in
Sec.  1.1107(a).
    (Response 38) We appreciate the critical role that all food testing
laboratories play in helping to keep the food supply safe, and we
acknowledge the importance of accurate and reliable test results.
However, section 422 of the FD&C Act does not contemplate FDA
regulation of all food testing laboratories, or of all laboratories
that test food for human consumption. We therefore do not require that
all food testing, or human food testing, laboratories be accredited to
ISO/IEC 17025:2017 or comply with the laboratory requirements in this
subpart.
    (Comment 39) Some comments request additional information about the
role the LAAF-accredited laboratories will play in relation to food
manufacturing facilities that are subject to required product or
environmental testing under the final rule. These comments assert that
the proposed rule was ``not clear regarding the level of authority an
accredited lab has in order to perform on-site collection activities at
food manufacturing facilities.'' These comments recommend that FDA
clarify in the final rule the roles and responsibilities of the
participating laboratory and facility, such as which information and
records the facility would be required to make available to the
laboratory.
    (Response 39) We believe these comments misunderstood the proposed
rule. When food testing is required to be conducted under this subpart,
an owner or consignee must use a LAAF-accredited laboratory. However,
the owner or consignee will select a LAAF-accredited laboratory from
the online registry (see Sec.  1.1109), and engage the laboratory, and
that laboratory will have no more authority over the owner or consignee
than specified in the business arrangement between the parties. The
final rule requires that the sample be collected by a person qualified
by training or experience to do so, and requires certain sampling
documents (Sec.  1.1149), but the owner or consignee may select any
sampler or sampling firm it likes, as long as the entity or person is
qualified and will provide the documentation required under the final
rule. Sometimes owners or consignees collect their own samples,
sometimes they engage third-party sampling firms, and sometimes they
pay the laboratory that will analyze the sample to collect the sample.
Under this subpart, that choice remains with the owner or consignee.
Therefore, FDA declines to further articulate any roles or
responsibilities of these parties beyond the requirements of the final
rule.
    (Comment 40) In the proposed rule, for imported food, we provided
that testing under this rule generally could only be conducted on
samples taken after the articles of food have arrived in the United
States. We proposed one exception to that policy, where FDA determines
that a sample taken prior to arrival is representative of the article
of food offered for import. We said that we would make such a
determination on a

case-by-case basis. We received several comments on this aspect of our
proposal.
    First, some comments appear to understand that we proposed that
sampling prior to arrival may be allowed in certain circumstances, but
they seem unsure whether testing prior to arrival may also be allowed.
These comments ask whether foreign laboratories could participate in
this program and encourage FDA to clarify the extent to which the
requirements of this final rule would apply to such foreign
laboratories.
    Some comments support allowing sampling and testing prior to
arrival in certain circumstances, such as sampling for removal from
import alert. Other comments maintain that we should allow no
exceptions to the policy that sampling of imports occur after arrival
in the United States. These comments opine that allowing sampling prior
to entry would amount to ``self-policing'' by the owner or consignee.
They also argue that allowing sampling prior to entry would ignore the
risk that changes may occur during transit that would impact the test
results. They view the proposed exception as creating a public health
concern.
    Additionally, some comments in favor of the proposed policy suggest
that when FDA determines that a sample taken prior to entry is or would
be representative of the article of food offered for import, FDA should
make its determination publicly and widely available (i.e., ``publish''
it).
    (Response 40) To clarify, foreign laboratories may seek LAAF-
accreditation to conduct food testing under this subpart. All
laboratories that choose to participate, whether foreign or domestic,
must meet the same accreditation standards and comply with all
provisions of the final rule (see section 422(a)(5) of the FD&C Act).
There is no requirement that testing of imports subject to this rule
must be conducted by a laboratory in the United States; testing may be
conducted by any LAAF-accredited laboratory, regardless of location.
However, we are finalizing the proposed policy that under this subpart,
sampling generally must occur after arrival in the United States,
unless FDA has granted an exception. This requirement protects public
health by helping to ensure that the test results we are relying on to
make admissibility decisions accurately reflect the conditions of the
article of food when offered for import into the United States.
    At the same time, we disagree with the comments contending that all
import sampling should occur after arrival without exception. We are
finalizing the proposed exception for those situations in which we
determine that food sampled prior to export is representative of the
article offered for import (Sec.  1.1107(c)). The FDA determination to
grant the exception must be received by the owner or consignee, in
writing, prior to testing of samples taken prior to arrival in the
United States (id.). We generally would base such a determination on
specific circumstances of each shipment (e.g., characteristics of the
product and analyte, specifics of packaging and transportation) and
grant any exceptions on a case-by-case basis. We decline the suggestion
to publish our determinations of scenarios where a sample taken prior
to arrival is or would be representative of the article of food offered
for import because we expect our determinations to be situation-
specific. We may consider issuing guidance in the future on the factors
we evaluate in making such determinations, which we believe would be
more useful to our constituents than case-by-case publication.
    It is possible that we could make such a determination for an
article of food subject to DWPE (on an import alert). Again, any such
determination generally would be made on a case-by-case basis, based on
clear evidence that the product sampled is representative of the
product offered for import (see Sec.  1.1107(c); 84 FR 59452 at 59465).
In the proposed rule, we solicited feedback on whether circumstances
warrant application of the exception broadly, for instance, to a
particular commodity or analyte generally. We received no comments with
suggestions for broader applications of the exception.
    As discussed in Response 101, the rule does not prohibit owners or
consignees from collecting a sample or conducting their own test, as
long as all the requirements of the rule are satisfied.
2. When and how will FDA issue a directed food laboratory order (Sec.
1.1108)?
    Proposed Sec.  1.1108 described the circumstances under which we
would issue a food testing order. Paragraph (a) described when we would
require an owner or consignee to have food testing conducted under this
subpart (``. . . to address an identified or suspected food safety
problem related to the article of food.'') Proposed Sec.  1.1108(b) and
(c) also specified what we would include in the order (e.g., the food
product or environment to be tested, any particular methods, and other
elements required by part 16 (21 CFR part 16) related to a regulatory
hearing). As previously discussed, we have changed the terminology in
this section from ``food testing order'' to ``directed food laboratory
order,'' and to avoid confusion we use the new term throughout this
document, even when referring to discussions in the proposed rule.
    On our own initiative, we made a few revisions to this section. We
revised the proposed rule section title, ``When and how will FDA issue
a food testing order?'' to ``When and how will FDA issue a directed
food laboratory order?'' in the final rule and made changes in the
section to incorporate revised terminology. We removed the unnecessary
phrase, ``related to the article of food'' in Sec.  1.1108(a). We also
removed the phrase, ``of an article of food'' from Sec.  1.1108(a)
since the definition of owner or consignee in Sec.  1.1102 specifies
interest related to the food product or environment subject to food
testing. We also made minor editorial changes to this section.
    Many comments support the rulemaking and the Agency's efforts to
implement section 422 of the FD&C Act; however, they do not support the
directed food laboratory order provision. Some comments raise
``substantial'' concerns with the Agency's proposal, specifically
legal, policy, and practical aspects of the proposed rule with respect
to directed food laboratory orders. We address these comments below.
    (Comment 41) A number of comments argue that the Agency lacks
explicit and implied statutory authority in FSMA and the FD&C Act to
issue directed food laboratory orders. The comments conclude that the
Agency is limited by the authority delegated by Congress in FSMA and
under the FD&C Act, and that because neither the plain terms nor the
core purpose of the relevant sections of the statute contemplate
directed food laboratory orders, there is no explicit authority to
issue a directed food laboratory order.
    The comments further argue that the Agency has misinterpreted
section 422(b)(1)(A)(ii) of the FD&C Act as providing implied authority
to issue directed food laboratory orders. Comments explain that section
422(b)(1)(A)(ii) is limited by section 422(b)(1)(A)(i) because the
clauses are linked by the word, ``and'' and therefore must be read
conjunctively. To support this interpretation, several comments cite
the plain language of the statute and case law in support of the
associated canon of statutory interpretation. Comments assert a
presumption that Congress intended ``and'' to be read

conjunctively. Some comments indicate that even though sections
422(b)(1)(A)(i) and 422(b)(1)(A)(ii) of the FD&C Act repeat the phrase,
``to address an identified or suspected food safety problem,'' this
repetition does not support reading the ``and'' disjunctively to
signify ``or.'' To support this position, the comments cite the case of
Loving v. IRS (917 F. Supp.2d 67), in which the D.C. Circuit Court
rejected the IRS argument that existence of overlapping or redundant
statutory language should override the plain meaning of ``and.'' The
comments thus conclude that the statute may only be read to require
food testing under this subpart in two circumstances, as opposed to the
five circumstances specified in Sec.  1.1107 of the proposed rule.
    Interpreting the statute in this way to require food testing in
only two circumstances, some comments claim that the two circumstances
when LAAF-accredited laboratories must be used are when food testing is
conducted: (1) In response to a specific testing requirement under the
FD&C Act or implementing regulations, when applied to address an
identified or suspected food safety problem and as required by the
Secretary, as the Secretary deems appropriate, to address an identified
or suspected food safety problem or (2) in support of admission of an
article of food under section 801(a) of the FD&C Act and under an
import alert that requires successful consecutive tests. Comments add
that even if the plain meaning is proven otherwise to read the ``and''
disjunctively, it still does not provide the Agency with discretionary
authority to issue directed food laboratory orders. Comments urge that
this authority cannot be expanded even if the intent is to further the
goals of Congress.
    Comments explain that the plain language of the statute requires
that section 422(b)(1)(A) of the FD&C Act apply only ``in response to''
and ``to address'' a food safety problem, not to seek one out. Were
directed food laboratory orders implemented as proposed, comments argue
that this approach would create an additional investigative tool not
contemplated by the statute. Comments express that FDA already has the
authority to conduct food testing and to choose a laboratory. Comments
state further that there is no evidence that Congress intended to shift
the Agency's responsibilities to owners and consignees.
    Some comments state that any authority provided under section 422
of the FD&C Act to require food testing under this subpart, absent an
explicit requirement in statute or regulation to conduct testing, must
only apply in narrow circumstances where the basis for the food safety
problem has been established. These comments state they would support
testing by accredited laboratories as part of evidence for a hearing
prior to the issuance of a mandatory recall order, an order suspending
a food facility's registration, or an administrative detention order.
Likewise, other comments add support for the Agency to issue a directed
food laboratory order as part of the corrective action plan after a
facility's registration has been suspended.
    Some comments echo the call for FDA to keep the scope of the rule
narrow and support applying the rule to specific testing requirements
in FDA's regulations, e.g., certain post-remediation testing after E.
coli has been identified in the source water for bottled drinking
water.
    A few comments characterize Congress's grant of authority to the
FDA to address an ``identified or suspected food safety problem'' in
FSMA as broad and state that these terms were not defined; however, the
comments do not support the use of the statute to add what they view as
a new enforcement tool, namely, the directed food laboratory order.
These comments seek additional background regarding how this tool fits
with other FDA authorities as they did not anticipate the Agency
implementing the statute through the use of directed food laboratory
orders as set forth in the proposed rule.
    (Response 41) We disagree with the assertions in the comments that
the Agency lacks the statutory authority to issue directed food
laboratory orders. Section 422(b)(1)(A)(ii) provides authority for
testing under this subpart ``as required by the Secretary, as the
Secretary deems appropriate, to address an identified or suspected food
safety problem.'' The ``and'' joining the two clauses in sections
422(b)(1)(A) and (B) is appropriately read as joining lists containing
two separate and distinct circumstances. Reading the ``and''
conjunctively as some comments urge would create an absurd result since
both clauses of 422(b)(1)(A) repeat the phrase, ``to address an
identified or suspected food safety problem.''
    We also disagree with the notion that directed food laboratory
orders would inappropriately shift the burden of testing to owners or
consignees. The responsibility to produce safe food rests with the food
producers. Food testing by LAAF-accredited laboratories under this
subpart will provide assurance of the accuracy of the results conducted
in response to identified or suspected food safety problems of
significance to public health and will better enable both the Agency
and the owner or consignee to act in the best interest of public
health.
    As we discuss below in Response 47, we believe the circumstances in
which we anticipate using a directed food laboratory order and the
examples provided demonstrate that a directed food laboratory order
will be used ``to address'' an identified or suspected food safety
problem.
    We also disagree with aspects of comments asserting that the basis
for the food safety problem must be ``established'' in order for food
testing to be subject to this subpart. The statutory standard for when
the Agency may issue a directed food laboratory order is explicitly set
forth in section 422(b)(1)(A)(ii) of the FD&C Act: Such an order may be
issued ``as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.''
    As proposed, we agree that this subpart will apply to testing in
relation to certain administrative proceedings. Under Sec.
1.1107(a)(3), certain testing as part of evidence for a hearing prior
to the issuance of a mandatory recall order, as part of the corrective
action plan after a food facility's registration has been suspended, as
well as an appeal of an administrative detention order, is subject to
this subpart.
    (Comment 42) Several comments argue that the directed food
laboratory order provision violates the Administrative Procedure Act (5
U.S.C. 551 et seq.) (APA), because the proposal lacked a reasoned
explanation for the provision and contained insufficient detail to
facilitate meaningful public comment. These comments conclude that
finalizing the directed food laboratory order provision as proposed
would put this tool at risk of being invalidated if challenged as
arbitrary and capricious under the APA. Some comments state that the
Agency can finalize the laboratory accreditation rule and meet all
statutory obligations without issuing directed food laboratory orders
and therefore conclude directed food laboratory orders are not ``fit
for purpose.''
    Many comments state that directed food laboratory orders are not
aligned with the purpose and principles of FSMA and the intent of
section 422 of the FD&C Act. Comments state that Congress's purpose in
section 422 of the FD&C Act is to address the practice of importers
engaging in ``laboratory shopping'' (i.e., a practice whereby an owner
or consignee sends samples to several laboratories in hopes that one
will return results indicating the sample complies with FDA
requirements and if

so, the owner or consignee submits only that result to FDA) by
requiring that food testing results be sent directly to the Agency;
these comments argue that the directed food laboratory order provision
of the proposed rule does not advance this objective.
    Other comments frame the purpose of section 422 of the FD&C Act as
ensuring reliable and accurate test results. These comments counter
that instead of supporting this purpose, the proposed directed food
laboratory order creates a new investigatory and enforcement tool for
FDA, which is unnecessary given the Agency's existing enforcement
tools; namely, that FDA may already sample the product and the
environment and choose the laboratory to conduct the analysis. Comments
state that Congress carefully considered which additional tools were
necessary through FSMA and did not contemplate a duplicative
enforcement tool. Comments state that there is no indication that
Congress intended to shift this burden to industry through directed
food laboratory orders in section 422 of the FD&C Act and that doing so
would be unfair. Comments suggest that additional Agency funding is the
more appropriate solution to address limited Agency resources. Several
comments offer revisions to the directed food laboratory order
provision that they consider necessary to link the proposed provision
to the purpose of the statute. Additionally, some comments indicate
that facilities must implement environmental and product testing
according to food safety plans under other FSMA provisions and FDA may
review this information during routine inspections; comments express
the belief that this represents sufficient oversight into testing
methodology, laboratory choice, procedures, and test results. In sum,
comments argue that without a demonstrated concern with laboratory
integrity and a public health need, directed food laboratory orders are
inappropriate and outside the scope of section 422 of the FD&C Act.
    Comments argue that the proposed rule preamble provided limited
information regarding the Agency's need or justification for directed
food laboratory orders, such as historical events or situations when
such orders would have been useful. Regarding the justification, many
comments state that the preamble fails to explain the problem directed
food laboratory orders are intended to address, as there is no
documented issue regarding the reliability of test results that would
warrant testing by LAAF-accredited laboratories. Some comments state
that without a clear explanation for the Agency's need for what they
perceive as a potentially expansive enforcement tool, comments cannot
support the directed food laboratory order provision. Additionally,
some comments state that the Agency has not considered how the proposed
directed food laboratory order provision would harm industry, including
by increasing costs to food companies associated with the use of LAAF-
accredited laboratories and disrupting production to hold product while
waiting for test results.
    Some comments state that in the proposed rule we did not address
operational details of the directed food laboratory order such as who
in FDA would issue such orders, how the orders would be delivered; how
long the directed food laboratory order would be in place; and when and
how a directed food laboratory order would be lifted. We understand
some comments to argue that it was legally necessary for FDA to
describe these operational details in the proposed rule. Finally,
according to some comments, the proposed rule should have reflected
that we considered alternative approaches to the directed food
laboratory order.
    (Response 42) The proposed rule contained a reasoned explanation
and sufficient detail on this topic to facilitate meaningful comment
and therefore fully satisfied APA requirements. In the proposed rule we
articulated the legal authority for the directed food laboratory order,
a description of the tool, and the substantive issues involved. We
stated that we were interpreting section 422(b)(1)(A)(ii) of the FD&C
Act to give FDA authority to propose the directed food laboratory
order. We described the proposed content of the directed food
laboratory order (e.g., it will specify the timeframe for the testing,
and any method that must be used). We communicated that the proposed
directed food laboratory order addresses an identified or suspected
food safety problem, and we discussed the meaning of that phrase at
some length. We made clear that the proposed tool could be used to
compel either product or environmental testing and explained our basis
for including environmental testing within the proposed definition of
``food testing.'' We also explained that under the proposed rule owners
or consignees subject to a directed food laboratory order may request a
regulatory hearing.
    Comments also argue that the proposed rule was insufficient because
the Agency failed to explain a need for the directed food laboratory
order, for example by describing past enforcement cases in which the
Agency would have found it helpful to employ such a tool. It is true
that we did not describe a past case, but it was clear from the
proposed rule that the tool is directed at unreliable test results in
circumstances where we have reason to suspect, or have identified, a
particular food safety problem for which a particular owner or
consignee is responsible. Further, although we did not discuss our
consideration of alternative approaches in the proposed rule, based on
our knowledge and experience implementing FSMA, we have determined that
the directed food laboratory order is an appropriate application of
section 422(b)(1)(A)(ii) of the FD&C Act. See also, Response 41 and the
analysis of regulatory alternatives to this rule in the FRIA (Ref. 4).
    With regard to comments expressing concern that we did not justify
an expansive new tool in the proposed rule, we believe this reflects a
misperception: The directed food laboratory order is a precise new tool
that will help us protect public health in a relatively narrow set of
circumstances. Section 422(b)(1)(A)(ii) of the FD&C Act gives FDA
authority to require testing to be conducted under this subpart as we
deem appropriate, to address an identified or suspected food safety
problem. As we interpret this statutory provision, directed food
laboratory orders will generally be limited to the rare situations when
we have reason to question the accuracy or reliability of past or
present test results, and an identified or suspected food safety
problem exists. (See Response 47 for discussion of the standard; see
Response 35 for discussion of ``identified or suspected food safety
problem.'')
    Some comments appear to express doubt that there are ever any
problems with the reliability of food testing conducted by or for
owners or consignees, and claim that because the proposed rule did not
document that such problems exist, and threaten public health, there is
insufficient justification for the directed food laboratory order. We
suspect that this reflects the misperception in some comments regarding
the directed food laboratory order as an expansive new tool, which in
turn may have created a belief that the proposed rule should contain a
lengthy description of widespread problems with the validity of an
array of test results. As clarified above, however, the directed food
laboratory order is not a tool that we expect to apply broadly or
frequently. Rather, it will be applied in particularized circumstances.
If there were never any particularized problems

with the reliability of food testing conducted by or for owners and
consignees, Congress would not have enacted section 422 of the FD&C
Act. However, in this provision of the FD&C Act, Congress has
specifically reserved for the Agency the authority to require testing
to be conducted under this subpart in circumstances beyond just those
defined by Congress. And, given some of the egregious situations and
behaviors FDA has encountered in enforcing the food safety provisions
of the FD&C Act, many of which have been widely publicized, we do not
believe anyone could reasonably doubt the existence of particular
circumstances in which owners or consignees failed to use a quality,
reliable laboratory and where public health harm resulted. (See
Response 47 for examples of situations in which a directed food
laboratory order may be appropriate.)
    Similarly, some comments claim that registered food facilities
conduct routine testing consistent with their obligations under the
preventive controls regulations, and there is no evidence that, ``as a
general matter,'' those test results are unreliable. Again, the
directed food laboratory order is not intended to be applied generally;
it will be applied in response to a particular set of circumstances.
Unfortunately, some registered food facilities do not perform routine
testing in a manner that is consistent with their preventive controls
obligations. We also note that the directed food laboratory order may
be applied to entities that are not subject to the preventive controls
regulations.
    One piece of evidence indicating the sufficiency of the proposed
rule with respect to the directed food laboratory order is the quality
of the public comments on the topic. We appreciate commenters' robust
feedback and assure them we have carefully considered their input.
Several comments contained questions, suggestions, and requests
regarding the details of the application of the directed food
laboratory order; to the extent possible, we respond to those comments
in the subsequent responses in this section of the preamble. However,
the fact that such details, including operational details, did not
appear in the proposed rule does not call into question the legal
sufficiency of the proposal. In sum, the proposal adequately apprised
the public of the proposal under consideration in a manner that allowed
for meaningful comment on the directed food laboratory order.
    We reject the contention that, because it would be possible to
implement other portions of section 422 of the FD&C Act without the
directed food laboratory order, the tool must not be ``fit for
purpose.'' The degree to which the directed food laboratory order
affects the success of the overall LAAF program framework does not
define its fitness for purpose. The relevant question is whether the
statute authorizes FDA to implement the directed food laboratory order,
which it does, as discussed in Response 41.
    In contrast to the contention of some comments, the directed food
laboratory order squarely aligns with both the purpose of FSMA and the
intent of section 422 of the FD&C Act. We particularly agree with those
aspects of comments stating that a central purpose of section 422 of
the FD&C Act is to help ensure accurate and reliable test results in
certain circumstances identified in the statute. Directed food
laboratory orders will serve that purpose by increasing confidence in
testing results in particular circumstances when we have reason to
question the accuracy or reliability of past or present test results
and an identified or suspected food safety problem exists. To the
extent that preventing ``laboratory shopping'' was a purpose of section
422(b)(2) of the FD&C Act, which requires all test results to be
submitted directly to FDA, such purpose must be consistent with the
rest of section 422, including the provision granting discretion to the
Agency to include in this final rule testing, ``as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.'' Section 422(b)(1)(A)(ii) of the FD&C Act.
    The central purpose of FSMA was to shift the focus of food safety
efforts to preventing contamination of the food supply, rather than
primarily responding to problems after they occur. Directed food
laboratory orders serve this purpose by addressing the need for
reliable food testing when there are particular circumstances where
past or current testing is suspect and FDA has determined there is an
identified or suspected food safety problem. Testing in such
circumstances would be aimed at gathering trustworthy scientific
information to help FDA and others avoid or mitigate a food safety
event.
    Some comments categorize the proposed directed food laboratory
order as a new investigatory and enforcement tool, and maintain that
FDA already has the authority to collect samples and send those samples
to the laboratory of the Agency's choosing. They also state that,
through the preventive controls regulations, FDA already has the
authority to review records of test results when inspecting a
registered food facility, which provides sufficient oversight of such
testing. Again, the directed food laboratory order is a tool that may
be applied to owners and consignees that are not registered food
facilities subject to the preventive controls regulations. Further,
section 422(b)(1)(A) of the FD&C Act makes plain that Congress intended
to require entities to be subject to this subpart even though FDA
already regulates testing for that industry. Accordingly, it is
irrelevant that FDA may already have the authority to collect samples
at an enterprise or review the enterprise's testing records; the
directed food laboratory order is an appropriate new tool authorized by
section 422(b)(1)(A)(ii) of the FD&C Act.
    It is also irrelevant whether Congress specifically contemplated
the existence of the directed food laboratory order because Congress
delegated authority to the FDA to require testing to be conducted under
this subpart, as we deem appropriate, when an identified or suspected
food safety problem exists and the codified use of directed food
laboratory orders is fully consistent with the text and purpose of the
statute. We disagree that the directed food laboratory order is a
mechanism to shift the burden of enforcement and investigation onto
private industry or stretch FDA's budget; it is a precise tool that
will be rarely used and is not anticipated to impose significant burden
on regulated entities. We discuss comments on the estimated costs of
the directed food laboratory order in the FRIA (Ref. 4). (For more
information on all the estimated costs and benefits of the final rule,
see the FRIA (Ref. 4).)
    (Comment 43) Several comments raise concerns that directed food
laboratory orders will have negative policy implications that the
Agency has not considered. These comments state the belief that
directed food laboratory orders could disincentivize facilities from
implementing ``seek and destroy'' pathogen environmental monitoring.
These comments assert that in response to FSMA, the industry already
has implemented robust environmental monitoring programs. These
comments further argue that the food safety and public health benefits
of these programs could be jeopardized by directed food laboratory
orders and the possibility that a facility's own routine testing could
result in issuance of a directed food laboratory order. These comments
state that uncertainty regarding the timing, duration, and cost
associated with directed food laboratory orders will cause facilities
to avoid routine testing for fear of triggering such an order. A few
comments state that some firms may modify their environmental testing
programs to avoid finding

positive results, negating what the comments characterize as the
``positive steps'' FDA has taken ``to encourage aggressive
environmental sampling in the 2017 publication of the (``Control of
Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry''
draft guidance (Ref. 11)), through the acknowledgment that a finding
for Listeria species on a food contact surface does not render product
adulterated.'' \8\
---------------------------------------------------------------------------

    \8\ The ``Control of Listeria monocytogenes in Ready-To-Eat
Foods: Guidance for Industry'' draft guidance describes followup
actions a facility should take in response to a finding of Listeria
spp. on a food contact surface. Although it is true that the draft
guidance indicates that we expect to find Listeria in certain food
facilities, we also expect that such facilities will implement
environmental monitoring plans to find Listeria when present and
take followup actions to ensure that Listeria does not contaminate
food. Our investigators will inspect a facility's environmental
monitoring results and the followup activities the facility performs
in the event of an environmental positive, to ensure that product
does not become adulterated. If we have concerns about the
facility's application of current good manufacturing practices and
preventive controls with respect to L. monocytogenes, we may perform
our own sampling of the facility's environment and may also take
food samples.
---------------------------------------------------------------------------

    Some comments express concern that basing a directed food
laboratory order on environmental results increases the risk that the
test results could be taken out of context; several of these comments
mention that there would be a lack of information connecting the test
result to a product. A few comments request that FDA reiterate that
routine testing of product and environment related to a facility's food
safety plan is not required to be performed by LAAF-accredited
laboratories under this subpart and that followup sampling and testing
in response to routine environmental monitoring positive results for
pathogen/indicator organisms should not be covered by this subpart.
    Some comments express concern that the LAAF program will cause
testing by laboratories not participating in the program to be devalued
or viewed as suspect. Some comments warn that widespread use of
directed food laboratory orders could cause testing performed by
laboratories not LAAF-accredited under FDA's program to be scrutinized.
These comments assert that many in-house and external laboratories are
not ISO-accredited; however, the laboratories still ensure integrity
and accuracy of test results and data. These comments stress the
important role in-house and other laboratories play in providing timely
test results on which food safety decisions are made. These comments
suggest that these laboratories may choose not to participate in the
LAAF program. Further, some comments are concerned that FDA and
investigators may question analytical results from non-LAAF-accredited
laboratories. Overall, comments assert there is no evidence to suspect
that non-ISO-accredited laboratories produce inaccurate or suspect
results.
    Some comments urge FDA to consider the potential significant costs
associated with directed food laboratory orders as well as the
potential business disruption that may occur if product subject to
testing is placed on hold pending results. A few comments explain that
holding product under a directed food laboratory order could challenge
the company's hold capacity and disrupt both production and the supply
chain, as well as have additional costs for industry. Several comments
state that the preliminary economic impact analysis did not include any
costs for directed food laboratory orders and should be revised
accordingly.
    (Response 43) We disagree that the directed food laboratory order
provision, as clarified, will have negative policy implications. The
authority under section 422 of the FD&C Act is intended to increase
confidence in receiving accurate and reliable test results. As stated
in Response 35, the purpose of routine environmental testing under the
preventive controls regulations (Sec. Sec.  117.165(a) and 507.49(a))
is to verify that preventive controls are consistently implemented and
are effective. Therefore, such testing does not address an identified
or suspected food safety problem and is not covered by this subpart.
The additional clarity we are providing in this final rule regarding
the directed food laboratory order in terms of the standard of
issuance, authority to issue such orders, and procedural details,
should provide sufficient boundaries to enable firms to continue or
expand robust environmental monitoring programs developed in the wake
of FSMA and in support of an overall culture of food safety, without
fearing that such programs will invite issuance of a directed food
laboratory order. We expect that it will be uncommon for us to issue a
directed food laboratory order. Further, we expect that facilities that
have implemented robust environmental monitoring programs and that are
taking appropriate corrective actions in response to positive findings
(``seek and destroy'') generally are not likely to be subject to such
an order.
    However, as discussed in Response 37, followup testing in response
to routine environmental test results that indicate the presence of a
pathogen or indicator organism in the food production environment may
qualify as testing that addresses an identified or suspected food
safety problem, and therefore could warrant issuance of a directed food
laboratory order, depending on the circumstances. We disagree with the
contention that use of a directed food laboratory order for
environmental testing could cause results to be taken out of context.
As explained in Response 47, the use of a directed food laboratory
order is appropriate only in a narrowly defined set of circumstances.
Accordingly, in our view, the context (including relevant product(s))
for any environmental tests required by a directed food laboratory
order) will be sufficiently clear.
    Absent a specific reason to question the reliability and accuracy
of results from a particular firm or laboratory, we do not believe that
testing from an in-house, third-party private, or other laboratory that
is not LAAF-accredited would be questioned solely based on the decision
of that laboratory not to participate in this program, and certainly
not as a result of the directed food laboratory order tool. We discuss
examples of circumstances in which we would employ a directed food
laboratory order in Response 47. As reiterated throughout our
discussion of the directed food laboratory order in this preamble, and
as reflected in the FRIA, we do not expect widespread use of such
orders (Ref. 4). We address costs related to a directed food laboratory
order in the FRIA, see (Ref. 4).
    (Comment 44) Several comments state that the proposed rule does not
specify who has the authority to issue a directed food laboratory
order, nor does it indicate whether such authority could be delegated.
These comments recommend that the authority to issue a directed food
laboratory order remain a non-delegable function of the FDA
Commissioner. A subset of these comments mentions that this
recommendation aligns with section 415(b)(7) of the FD&C Act (regarding
the authority to issue an order to suspend a registration or vacate an
order of suspension [of a food facility]) and mandatory recall
authority. Some comments assert that the authority to issue a directed
food laboratory order would not be appropriate for FDA investigators or
State inspectors. A few comments ask whether State regulators
inspecting farms under the produce safety rule would have authority to
issue a directed food laboratory order.
    (Response 44) In proposed Sec.  1.1108, we stated that a directed
food laboratory order may be issued by FDA. Although we agree that the
authority to issue a directed food laboratory order would

not be delegated to FDA investigators or State inspectors, we decline
to make the issuance of a directed food laboratory order a non-
delegable function of the FDA Commissioner. Section 415(b)(7) of the
FD&C Act and section 423(h) of the FD&C Act contain explicit provisions
limiting certain authority to the Commissioner. Section 422 of the FD&C
Act (21 U.S.C. 350k) does not include a similar limitation. Absent an
explicit statutory limitation regarding delegation, we find no reason
to impose one for the issuance of a directed food laboratory order.
Consistent with longstanding Agency practice and the APA, we intend to
limit the delegation of authority to issue a directed food laboratory
order under this subpart to FDA officials with the appropriate level of
responsibility. See 5 U.S.C. 553(a)(2).
    (Comment 45) Several comments state that the proposed directed food
laboratory order procedures raise due process concerns for the
potential recipient of such an order. In support of this position, the
comments describe their perception of the uncertain standards and the
Agency's unfettered discretion to issue a directed food laboratory
order. Some comments urge FDA to have a transparent process and clear
standards with a documented sound scientific basis for issuance of a
directed food laboratory order. Some comments request more specific
examples of when the Agency would issue a directed food laboratory
order. These comments argue that without specifying who in the Agency
may issue a directed food laboratory order, it appears that FDA
investigators could issue them. The comments state that the perceived
lack of a process prior to issuance and the perceived lack of a
guaranteed process once a directed food laboratory order has been
received contribute to the overall insufficient due process associated
with the proposed provision.
    (Response 45) We address several aspects of these concerns
elsewhere in this preamble, in Response 44 and Response 47.
Specifically, we clarify the standard of issuance for a directed food
laboratory order, who has the authority to issue such an order, and
certain procedural aspects associated with issuance of such an order.
With these details and the applicable procedures of part 16 in place,
we believe there is sufficient due process associated with the directed
food laboratory order provision.
    (Comment 46) Several comments state that food testing pursuant to a
directed food laboratory order should be limited to product testing and
should not include environmental testing. These comments state that
FSMA section 202, Laboratory Accreditation for Analyses of Foods,
refers only to ``food testing'' and ``testing of food,'' without
defining these terms. The comments indicate that while environmental
testing is not specifically mentioned in section 202, Congress
explicitly refers to environmental testing elsewhere in FSMA (section
103, which creates section 418(f)(4) of the FD&C Act). Further, some
comments suggest that including environmental testing would create the
potential for test results to be taken out of context; several of these
comments state that there would be a lack of information connecting the
test result to a product. A few comments explain that routine testing,
including environmental testing, is covered by FDA guidance and
considers multiple variables; these comments state that it is not clear
whether and how all variables will be considered in determining when a
directed food laboratory order is issued. Some comments conclude that
there is no legal basis for requiring environmental testing under a
directed food laboratory order and that directed food laboratory orders
must only be used for food product testing.
    (Response 46) We decline to limit directed food laboratory orders
to product testing. As already discussed in Response 19, FDA defines
``food testing'' and ``testing of food'' to include environmental
testing for purposes of this subpart. As stated in Response 19 and
discussed further in Response 35, routine environmental testing
(Sec. Sec.  117.165(a)(3) and 507.49(a)(3)) is not covered by this
subpart. As we noted in Response 43, we do not believe the directed
food laboratory order will cause environmental test results to be taken
out of context. For these reasons, in light of our legal authorities
under section 422 of the FD&C Act, and for the policy reasons already
discussed in relation to both environmental testing and the directed
food laboratory order, under this final rule and as appropriate, FDA
may issue a directed food laboratory order subjecting either product
testing or environmental testing to the requirements of this subpart.
    (Comment 47) Some comments state that the proposed rule did not
provide enough information regarding the standard for issuance of a
directed food laboratory order. These comments express concern that the
proposed standard, an identified or suspected food safety problem,
could be present regardless of whether the article of food violates the
FD&C Act. Comments state that the examples provided in the preamble to
the proposed rule suggest that mere suspicion of a food safety problem,
such as the presence of Listeria monocytogenes on a food contact
surface, could lead to issuance of a directed food laboratory order
when there is no violative article involved. Comments argue that
issuance of a directed food laboratory order when there is no violative
product would exceed FDA's authority. Otherwise, comments suggest the
results of a food facility's routine testing could inappropriately
trigger a directed food laboratory order. Comments propose instead that
an identified or suspected food safety problem should only give rise to
a directed food laboratory order when there is a public health need or
when the food has a reasonable probability of serious adverse health
consequences or death to humans or animals (SAHCODHA).
    A few comments express concerns that although FDA notes the
suspicion will ``typically be particularized'' as it relates to
specific articles of food or a specific portion of the food production
environment, it is not clear that this will always be the case. Several
comments suggest that the suspicion standard could lead to bias or
subjective determinations by an investigator where no problem exists.
Some comments propose instead that directed food laboratory orders
should include a direct reference to a violation. Other comments state
that issuance of a directed food laboratory order should require a
reasonable belief that the food is violative, similar to the standard
set forth in FSMA section 101 (relating to inspections of records).
    These comments recommend that if the directed food laboratory order
provision remains in the final rule, it should be limited to
circumstances when both of the following factors are met: (1) An
identified or suspected food safety problem representing a SAHCODHA
hazard is established and (2) a substantiated concern exists regarding
the adequacy of the laboratory used by the owner or consignee such that
testing by an accredited laboratory under this program is necessary to
determine the food safety problem has been resolved. Comments state
that a concern about laboratory adequacy is necessary as Congress
intended section 202 of FSMA to address ``laboratory shopping'' and
other situations which raise questions about the validity of laboratory
results. The comments state that the directed food laboratory order
should not be used by FDA as an investigative tool.
    Some comments recommend that issuance of the directed food
laboratory order be limited to cases where the pathogen risk is
immediate and FDA's

existing enforcement tools are not adequate to address the situation.
    A few comments ask FDA to specifically exempt from a directed food
laboratory order pathogen/indicator organism positive results from
routine environmental testing since the manufacturer should have the
opportunity to resolve any associated concerns through corrective
actions.
    A few comments request that the Agency provide additional
information, guidance, and examples for when a food safety problem is
``suspected'' in animal food, as well as more specific examples of when
a directed food laboratory order would be issued under the rule.
    (Response 47) Per section 422(b)(1)(A)(ii) of the FD&C Act, the
standard for issuance of a directed food laboratory order is ``as
required by the Secretary, as the Secretary deems appropriate, to
address an identified or suspected food safety problem.'' We disagree
that SAHCODHA should be the standard, as Congress explicitly specified
a different standard here. For the same reason, we decline to use the
standard set forth in FSMA section 101 (reasonable belief that the food
is violative). The statutory clause in the section related to the LAAF
program, ``identified or suspected food safety problem'' specifically
allows for issuance of a directed food laboratory order when there is
no violative product.
    Regarding the standard of issuance, we believe the phrase, ``as the
Secretary deems appropriate,'' in the context of the FSMA laboratory
accreditation program, generally would limit our issuance of a directed
food laboratory order to situations where we have evidence or
experience with a firm or laboratory which calls test results into
question, i.e., situations in which we have reason to question the
accuracy or reliability of past or present test results. In such
circumstances, there would be a clear benefit to receiving analytical
results directly from a LAAF-accredited laboratory. Ensuring accurate
and reliable test results is the precise issue Congress intended to
address in section 202 of FSMA. In the final rule, we have revised the
language in Sec.  1.1108(a) to better align with the statutory text by
adding the qualifying language, ``as FDA deems appropriate.''
    In terms of the comment expressing apprehension that FDA will use
the directed food laboratory order as a tool to gather testing
information in the absence of heightened food safety concerns, we
reiterate that the order is only appropriate to address an identified
or suspected food safety problem. Similarly, regarding the contention
in some comments that a directed food laboratory order should only be
issued if there are concerns with laboratory adequacy, as just noted,
we interpret, ``as the Secretary deems appropriate'' to mean that the
tool would generally only be appropriate if we have reason to question
past or present test results.
    Further, we intend to use a directed food laboratory order within
the context of other Agency authorities and tools, FSMA-related and
otherwise; accordingly, positive results from routine testing would not
normally trigger a directed food laboratory order absent other
circumstances (e.g., suspect test results) necessitating a directed
food laboratory order. Therefore, we decline to include specific
exemptions for pathogen/indicator organism positive results from
routine environmental testing or to limit issuance of a directed food
laboratory order to cases when the pathogen risk is immediate and the
Agency's other enforcement tools are not adequate to address the
situation.
    We offer the following examples of the types of situations in which
we believe a directed food laboratory order would be useful and
appropriate ``as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food safety
problem.'' Some of these descriptions are modeled on our experience
with past compliance cases.
     Following a for-cause inspection of a human food firm with
a documented history of falsified laboratory reports, after the
Agency's receipt of information from an employee informant indicating
that the firm continued to provide false or misleading certificates of
analysis to conceal the production of adulterated human food;
     Following a recall by an animal food firm because the
firm's laboratory historically used an inappropriate method and
reported results that differed from FDA laboratory results; and
     If FDA laboratories have on multiple occasions obtained
positive pathogen results on food products in past years that conflict
with the company's contract laboratory's results. Given a pattern of
past ineffective monitoring by the company, coupled with the public
health risk, on the next positive finding by FDA that leads to a
voluntary recall for pathogen adulteration in this company's food
products, FDA might issue a directed food laboratory order.
    In light of the additional parameters for issuance of a directed
food laboratory order discussed above and limitations on who can issue
a directed food laboratory order (discussed in Response 44), we believe
issuance of directed food laboratory order would be insulated from
bias.
    (Comment 48) A few comments state that pathogens in not ready to
eat (NRTE) food, and specifically in raw agricultural commodities such
as grains, which do not undergo a kill step in the mill, should not be
considered an identified or suspected food safety problem subject to a
directed food laboratory order. These comments state further that the
preamble to the proposed rule offered few examples of circumstances
that could generate a suspected food safety problem and mentioned
``potential contamination events'' as an example although we did not
define this phrase. These comments request that the Agency define that
phrase and explicitly state that the presence of pathogens in NRTE
foods is not considered an identified or suspected food safety problem.
The comments express the concern that directed food laboratory orders
could be used as a basis for requiring the milling industry generally
to sample food manufacturing environments or products through use of
LAAF-accredited laboratories. The comments suggest that any testing in
these circumstances would not be appropriate, regardless of whether the
use of a LAAF-accredited laboratory is required.
    (Response 48) The proposed rule explored the meaning of the
statutory phrases, ``identified food safety problem,'' and ``suspected
food safety problem.'' (84 FR 59452 at 59455, 59462). In Response 35,
above, we finalize our tentative conclusions about the meaning of those
phrases.
    A number and variety of factors impact food safety risk (e.g., the
pathogen, the history of foodborne illness outbreaks associated with
the pathogen in the food, whether the food undergoes further processing
with a kill step at a registered food facility). In some circumstances
a pathogen in an NRTE food may be considered an identified or suspected
food safety problem. For example, foodborne illness outbreaks have been
associated with Salmonella in raw tuna (https://www.cdc.gov/salmonella/newport-04-19/index.html) and Shiga-toxin producing E. coli in raw
bison burgers (https://www.cdc.gov/ecoli/2019/bison-07-19/index.html).
The strains of pathogens associated with the outbreaks are capable of
causing severe illnesses (both outbreaks resulted in hospitalizations),
and these raw foods were consumed without a treatment to significantly
minimize the hazard and

prevent illnesses. Consistent with the broader food safety regulatory
framework, which includes the preventive controls for human food
regulation and the preventive controls for animal food regulation, FDA
will consider all applicable regulations and relevant circumstances in
determining whether an identified or suspected food safety problem
exists. As explained in Response 47, a directed food laboratory order
is appropriate in situations in which an identified or suspected food
safety problem exists along with specific evidence or experience with a
firm or laboratory which calls past or present test results into
question. Accordingly, we expect to employ the directed food laboratory
order rarely. In many cases involving a pathogen in an NRTE food, other
food safety regulations or tools outside the scope of the LAAF program
may adequately address the risk.
    We decline the request to define ``potential contamination event.''
We have defined the terms that describe the standard of issuance for a
directed food laboratory order (see Response 35). Consistent with these
definitions, a directed food laboratory order may be appropriate in
circumstances related to potential contamination events; e.g., where a
pathogen in the food production environment is transmitted to the food,
thereby causing the food to be adulterated, and where we have specific
evidence or experience with a firm or laboratory which calls past or
present test results into question.
    (Comment 49) A few comments suggest that neither chemical nor
physical hazards would be appropriate for a directed food laboratory
order. According to such comments, the directed food laboratory order
should be limited to circumstances where there is a reasonable
likelihood of serious adverse health consequences or death to humans or
animals due to the potential for pathogens to be present in the food
product.
    (Response 49) We decline to exempt chemical or physical hazards
from a potential directed food laboratory order. As previously stated,
a directed food laboratory order will generally be limited to the rare
situation when we have reason to question the accuracy or reliability
of past or present test results and where an identified or suspected
food safety problem exists. In addition to biological hazards, both
chemical and physical hazards are capable of causing food safety
problems. Therefore it is possible that any of the three types of
hazard could, in certain circumstances, form the basis for issuance of
a directed food laboratory order.
    We also note that chemical and physical hazards are specifically
covered by other FSMA regulations such as the preventive controls
regulations (Sec. Sec.  117.130 and 507.33). We believe it is
appropriate to align coverage of a potential directed food laboratory
order with the potential hazards covered by those regulations.
    (Comment 50) Several comments raise questions about operational
details related to the issuance of directed food laboratory orders.
These comments ask about the intended recipient of the directed food
laboratory order (corporate parent, facility, or both), means of
transmission (electronic, in-person, mail), and whether the issuance
would change based on multiple owner or consignee scenarios. Comments
state that these details are critical given the proposed 24-hour appeal
deadline for directed food laboratory order recipients.
    (Response 50) FDA intends to provide the most legally responsible
person at the firm that day with written notice of a directed food
laboratory order, generally via email. We will make every attempt to
call to inform the firm of the order prior to its arrival.
    In the imports context, there are sometimes multiple owners or
consignees. In such a case, we would generally deliver the written
notice to the importer of record. (See Response 26 for additional
discussion of multiple owner or consignee scenarios.)
    As discussed in Response 138, we have extended the appeal deadline
from 24 hours to within 3 business days of receipt of a directed food
laboratory order.
    (Comment 51) Several comments suggest that the lack of detail
surrounding the duration and termination of directed food laboratory
orders raises due process issues. These comments recommend that a
directed food laboratory order should be ``closed'' once the identified
or suspected food safety problem has been resolved. These comments also
request that FDA include a hearing process to permit owners or
consignees to submit evidence in support of the resolution to terminate
a directed food laboratory order or to have the directed food
laboratory order vacated. Additionally, some comments request that
directed food laboratory orders include a timeframe for the order and
frequency for testing. Further, a few comments suggest that FDA use a
hearing process if the Agency seeks to modify a directed food
laboratory order once issued. Some comments request that FDA provide
additional information on what is considered a reasonable timeline to
conduct testing required by a directed food laboratory order.
    (Response 51) In general, a directed food laboratory order would
last until we have adequate assurances that the underlying known or
suspected food safety problem has been resolved. However, we agree that
the order will be ``closed'' once the identified or suspected food
safety problem has been resolved. We anticipate that this approach will
incentivize firms to resolve issues quickly. However, details regarding
the duration and termination of a directed food laboratory order will
be contingent on the specific facts and circumstances of the order,
which will vary greatly. For example, whether the order covers product
or environmental testing, whether it is designed to address a very
discrete issue or a system-wide issue, the applicable regulations, and
the role of other resources and tools applied to the circumstances, are
just a few of the factors that may impact the length of time a directed
food laboratory order would be appropriate. Some orders may initially
define the timeframe and testing frequency, but again, we will
determine these matters on a case-by-case basis.
    At present we do not believe it necessary to create a hearing
process around the conclusion of a directed food laboratory order;
however, we expect to be in dialogue with the entity subject to the
order and intend to take their feedback into consideration.
    (Comment 52) Some comments state that the proposed rule did not
include details regarding whether or how directed food laboratory
orders would be made public. These comments request that FDA clarify
that directed food laboratory orders will not be made public. The
comments argue that only the owner or consignee must take action under
a directed food laboratory order, so there is no need to make a
directed food laboratory order public.
    (Response 52) We may include directed food laboratory orders on an
Agency website such as the data dashboard (see https://www.fda.gov/about-fda/transparency/fda-data-dashboard), so that other entities in
the supply chain can be aware of their existence as they research and
evaluate suppliers. We similarly publicize injunctions, seizures, and
warning letters on the data dashboard and believe that inclusion of
directed food laboratory orders would contribute to the overarching
goals of FDA's food safety communication strategy.
    We also note that a directed food laboratory order generally would
be subject to the Freedom of Information

Act (FOIA). Any disclosures would be made in accordance with our
regulations in part 20 (21 CFR part 20) (i.e., redacting any
confidential commercial information as necessary).
    (Comment 53) A few comments request additional information