not indicate a frequency (Ref. 3). We remain committed to the frequent
nature of this requirement and therefore the final rule requires that a
LAAF-accredited laboratory must successfully pass a proficiency test
(or where one is not available or practicable, a comparison program)
for each LAAF-accredited method at least once every 12 months. For
additional discussion of the proficiency testing requirements under
this subpart, see Responses 92-94, below.
    (Comment 85) Some comments support the proposed policy that LAAF-
accreditation should be awarded on a method-by-method basis. In fact,
some comments consider method-specific LAAF-accreditation so important
that they suggest we communicate that requirement more clearly in the
final rule. Some comments encourage us to clarify the use of open or
flexible scopes under this subpart.
    (Response 85) We agree that it is essential that the competency of
laboratories be assessed, and LAAF-accreditation awarded, on a method-
specific basis. Test methods vary widely and even within the same
discipline, competence to one method does not correlate or imply
competence to another method. Further, laboratory competence to the
particular method employed is integral to the validity of the test
result. Accordingly, we accept the suggestion in the comments
summarized above and have revised Sec.  1.1138 to include ``each
method'' in paragraph (a) and (a)(1).
    ISO/IEC 17011:2017 defines a flexible scope (sometimes referred to
as an open scope), as a ``scope of accreditation . . . expressed to
allow [laboratories] to make changes in methodology and other
parameters which fall within the competence of the [laboratory] . . .
as confirmed by the accreditation body.'' (ISO/IEC 17011:2017 section
3.7, (Ref. 2)). Flexible scopes can have flexibility for analytes,
matrices, and methods. ISO/IEC 17011:2017 requires accreditation bodies
to have written procedures describing how the accreditation body will
administer flexible scopes. As relevant to this discussion, these
written procedures must include a description of how the accreditation
body will maintain for the laboratories they LAAF-accredit certificates
of scope that include matrix (materials or products); analyte(s)
(component, parameter or characteristic); and method or technology
(Ref. 2).
    An open or flexible scope is employed when an accreditation body
assesses a laboratory's competency in using a particular technology or
technique. Once the laboratory proves that competency, it is able to
add methods, analytes, or matrices to its scope without the need for an
additional assessment by the accreditation body as long as those
additions fall within the broader scope of the accredited technology
and meet the requirements of ISO/IEC 17025:2017.
    Given that ISO/IEC 17011:2017 requires accreditation bodies to
maintain certificates of accreditation that communicate which analytes,
matrices, and methods are covered by the flexible scope, and Sec.
1.1123(c)(2) requires that a recognized accreditation body must
immediately notify FDA when it grants or extends a laboratory's LAAF-
accreditation, we are prepared to accommodate open or flexible scopes
under this subpart.
    (Comment 86) We proposed in Sec.  1.1138(a)(2) that, as a baseline
matter, laboratories wishing to conduct testing under this subpart must
be accredited to ISO/IEC 17025:2017, and we proposed to incorporate
ISO/IEC 17025:2017 by reference into our regulation. We proposed in
Sec.  1.1138(b) to exclude three portions of ISO/IEC 17025:2017 from
the incorporation by reference, and from the requirements under this
subpart. First, we proposed to exclude provisions of ISO/IEC 17025:2017
that relate to the relationship between the laboratory and its
customers, to the extent that such provisions establish obligations
that conflict with the requirements of this subpart. Second, we
proposed to exclude section 7.3

because, we reasoned, it addresses sampling and we did not propose to
require the accreditation of samplers. Finally, we proposed to exclude
section 7.8, which describes requirements for reporting test results to
customers, based on a concern that it might conflict with the test
reporting requirements in this subpart (Ref. 3).
    Many comments support the baseline laboratory requirement of
accreditation to ISO/IEC 17025:2017. Some comments commend the use of
this standard, noting that it may be a means to improve the quality of
tests, and is accepted globally. Some comments maintain that
accreditation to ISO/IEC 17025:2017 increases confidence in a
laboratory's data. Some comments indicate that many laboratories that
test imported food have already sought ISO/IEC 17025:2017 accreditation
voluntarily to improve the quality of their test results. Some comments
assert that conformance to ISO/IEC 17025:2017 helps ensure scientific
integrity in food testing. Some comments state that relying on ISO/IEC
17025:2017 accreditation will be more efficient for FDA. A few comments
express the belief that all private laboratories should be required to
be ISO/IEC 17025:2017-accredited.
    A few comments agree that ISO/IEC 17025:2017 is currently the
predominant standard for the type of laboratory that would conduct
testing under this subpart, but encourage FDA to allow more
flexibility, stating that over time ISO/IEC 17025:2017 might become
less predominant.
    Some comments encourage FDA to rely solely and entirely on ISO/IEC
17025:2017; we understand these comments to discourage us from adding
any additional requirements or varying at all from ISO/IEC 17025:2017.
(To the extent that some comments reference ISO/IEC 17065, which is a
conformity assessment standard for bodies that certify products, that
standard does not apply here.) These comments express preference for a
single uniform accreditation standard and contend that varying
standards can present challenges both to laboratories attempting to
maintain multiple differing accreditation schemes and to their
customers. Some comments state a risk that variations in standards,
even different standards based on ISO/IEC 17025:2017, may result in a
need for laboratories to be accredited by more than one accreditation
body, and encourage FDA to reduce or eliminate redundant
accreditations. Some comments encourage FDA to work with leading
standard and scientific organizations so that the various standards
align and have scientific integrity.
    With regard to the ISO/IEC 17025:2017 sections that we proposed to
exclude from our requirements, some comments support some or all the
exclusions. Some of these comments agree with our proposal not to
require the accreditation of samplers and express consequent support
for the exclusion of ISO/IEC 17025:2017 section 7.3, which addresses
sampling. Some comments concur with our proposed exclusion of customer-
related ISO/IEC 17025:2017 provisions, but disagree with the proposed
exclusions related to sampling and reporting results because these
comments state the belief that FDA should require the accreditation of
samplers and better align its reporting requirements with those of ISO/
IEC 17025:2017.
    On the other hand, many comments encourage us not to exclude
certain or any ISO/IEC 17025:2017 provisions. Some comments
specifically suggest that we include ISO/IEC 17025:2017 requirements
related to customers, as owners and consignees under this rule could be
considered the customers of LAAF-accredited laboratories. Some of these
comments disagree that the provisions we proposed to exclude conflict
with the requirements in this subpart, and suggest that even if they
do, any conflicts can be effectively addressed without excluding ISO/
IEC 17025:2017 provisions.
    Relatedly, some comments state that adherence to certain
requirements contained in ISO/IEC 17025:2017 is required only by
specific customers; these comments request that we clarify who is the
customer of a LAAF-accredited laboratory (i.e., FDA or the owner or
consignee). These comments also ask whether ISO/IEC 17025:2017
requirements with which the customer requires adherence will apply to
State laboratories that become LAAF-accredited.
    A few comments express the belief that documents can be developed
to supplement ISO/IEC 17025:2017 accreditation, and that such documents
would cover the additional requirements codified in this subpart. Some
comments argue that excluding certain parts of the ISO/IEC 17025:2017
standard from our requirements while still labeling a laboratory,
``accredited,'' would cause confusion and would conflict with
established business and operational models in laboratories fully
compliant with ISO/IEC 17025:2017. Similarly, some comments request
that FDA require ISO/IEC 17025:2017 as a baseline matter, and then
indicate additional requirements to clarify or expand upon the
standard. Comments also state that FDA should stay current with any
changes to ISO/IEC 17025:2017.
    (Response 86) We remain committed to ISO/IEC 17025:2017 as a
baseline requirement for laboratories that wish to conduct food testing
under this subpart. Many comments agree with that aspect of the
proposed rule and identify various benefits of this policy such as
improved test quality; greater scientific integrity; and global
acceptance of, and increased confidence in, the test results. We
concur. As described in the FRIA (Ref. 4), we also agree that FDA will
experience certain efficiencies as a result of this rule. And while we
encourage all food testing laboratories to consider becoming accredited
to ISO/IEC 17025:2017, we lack the authority to compel such action.
    Regarding the possibility that ISO/IEC 17025:2017 may not always be
the predominant standard for food testing laboratories, we are
confident that ISO/IEC 17025:2017 will be an appropriate baseline for
the foreseeable future. Other parts of FDA, and many other Federal
Agencies, also rely on ISO/IEC 17025:2017 to establish baseline
requirements for their laboratory accreditation programs (e.g., FDA
Center for Devices and Radiological Health Accreditation Scheme for
Conformity Assessment, CPSC, Department of Defense Environmental
Laboratory Program). Every time ISO/IEC updates the 17025 standard, we
will consider whether to update this subpart (through notice-and-
comment rulemaking) to require accreditation to the updated standard.
If during those considerations we conclude that ISO/IEC 17025:2017 is
no longer an appropriate baseline for our requirements, we will revise
this subpart accordingly (through notice-and-comment rulemaking).
    Some comments encourage us to simply rely on ISO/IEC 17025:2017 and
neither add nor subtract any requirements. Comments advocating that we
not add requirements to ISO/IEC 17025:2017 discuss the advantages of a
uniform standard. We do not discount those advantages or the challenges
that laboratories face in satisfying varying accreditation schemes.
Nevertheless each laboratory requirement that we add to the ISO/IEC
17025:2017 baseline serves an important program purpose. For example,
requiring successful proficiency tests for each method at least every
12 months (Sec.  1.1138(a)(2)) provides increased quality assurance,
and requiring at least the creation and retention of the records that
comprise a full analytical report will preserve FDA's ability to
conduct a meaningful

indepth scientific review of the test (Sec. Sec.  1.1150(d),
1.1154(a)(2)). As a reminder, all the food testing that takes place
under this subpart occurs in the context of heightened public health
concern. Laboratories that wish to conduct food testing under this
subpart will be required to satisfy requirements in addition to those
specified in ISO/IEC 17025:2017 (Ref. 3).
    After carefully considering the comments, we have decided not to
exclude any provisions of ISO/IEC 17025:2017. Comments successfully
argued that our proposed exclusions would unnecessarily complicate the
work of the recognized accreditation bodies and LAAF-accredited
laboratories and provide limited benefit. We also appreciate the
comments remarking that market confusion could result from our
exclusion of portions of ISO/IEC 17025:2017 while labeling laboratories
``accredited.'' Although we doubt our proposed exclusion of a small
number of ISO/IEC 17025:2017 provisions would result in a need for
duplicative accreditation body assessments, we need not belabor that
issue raised in the comments, given our decision.
    In particular, we are persuaded that we do not need to formally
exclude from our regulation ISO/IEC 17025:2017 section 7.3, which
addresses sampling, even though we are not requiring sampling
accreditation (Ref. 3). Section 7.3 is not necessary to ISO/IEC
17025:2017 accreditation. Indeed, many laboratories are accredited to
ISO/IEC 17025 for diverse types of methods and yet not for sampling.
When a recognized accreditation body assesses a laboratory for LAAF-
accreditation, the recognized accreditation body may simply note
section 7.3 as not applicable.
    We also proposed to exclude any provisions of ISO/IEC 17025:2017
that relate to the relationship between the laboratory and its
customer, to the extent that the provision would conflict with the
requirements of this subpart. For example, in the preamble to the
proposed rule we expressed concern that including ISO/IEC 17025:2017
section <IP_ADDRESS>, which indicates that the customer may specify the test
method, could create a conflict for the laboratory (see 84 FR 59452 at
59477 to 59478). We are now convinced that provisions of ISO/IEC
17025:2017 that mention the customer do not conflict with obligations
under this subpart because under ISO/IEC 17025:2017, ``customer'' has a
broader meaning than simply the entity who pays the laboratory, and FDA
qualifies as a customer alongside the owner or consignee that engages
the laboratory (Ref. 3). We appreciate comments noting that the owners
or consignees are customers and we should therefore not exclude the
ISO/IEC 17025:2017 customer provisions on that basis. We agree that
owners and consignees are appropriately considered customers of the
laboratory and appreciate that under this subpart, LAAF-accredited
laboratories will fulfill their obligations to owners and consignees,
as well as their obligations to FDA. This is ensured by the requirement
in ISO/IEC 17025:2017 section 5.4 that ``Laboratory activities shall be
carried out in such a way as to meet the requirements of this document,
the laboratory's customers, regulatory authorities and organizations
providing recognition'' (Ref. 3). Regarding the question of whether
state or other public laboratories that become LAAF-accredited will be
bound by the customer provisions in ISO/IEC 17025:2017, we confirm that
they will. The many public laboratories that are or will become ISO/IEC
17025:2017-accredited are required to meet the same requirements of
ISO/IEC 17025:2017 as private laboratories, including both customer
provisions and the requirements of section 5.4.
    Finally, we proposed to exclude ISO/IEC 17025:2017 section 7.8,
which addresses reports, based on a concern that it would conflict with
the reporting requirements under this subpart. Again, we have come to
appreciate that a laboratory's reporting duties under ISO/IEC
17025:2017 do not present any conflict for the laboratory also
fulfilling the reporting requirements under this subpart (Ref. 3).
    Accordingly, the final rule incorporates ISO/IEC 17025:2017 in its
entirety.
    (Comment 87) Some comments recommend that FDA allow the bottled
drinking water tests in Sec.  1.1107(a)(1)(iii) (i.e., the requirement
in Sec.  129.35(a)(3)(i) to test five samples from the same sampling
site that originally tested positive for E. coli) to be conducted by
laboratories certified or accredited to other water-related laboratory
accreditation or oversight programs such as the National Environmental
Laboratory Accreditation Program, or EPA or State water testing
certification programs. From the perspective of these comments, the EPA
and State water testing certification programs are an existing
laboratory oversight system and FDA should leverage those
certifications, in place of LAAF-accreditation, for purposes of the
bottled drinking water testing subject to this final rule. These
comments predict that if we fail to do so, an insufficient number of
laboratories will become LAAF-accredited to conduct the bottled
drinking water testing required by Sec.  1.1107(a)(1)(iii). Relatedly,
these comments disagree with our proposed conforming revision in the
bottled drinking water regulations. Instead of revising the bottled
drinking water regulation to require that the testing required in Sec.
129.35(a)(3) be conducted under this subpart, these comments recommend
that the bottled drinking water regulations be revised to require that
the testing in Sec.  129.35(a)(3) be conducted by a competent
commercial water testing laboratory that is EPA or State-certified for
E.coli testing and sends the results directly to FDA.
    (Response 87) For a variety of reasons, we decline this request.
    First, FDA lacks the authority under section 422 of the FD&C Act to
directly accredit laboratories or otherwise approve them to conduct the
food testing described in Sec.  1.1107. FSMA section 202 directed that
FDA recognize accreditation bodies, establish standards for
laboratories, and create a public registry of recognized accreditation
bodies and LAAF-accredited laboratories (section 422(a)(1)(b) and
(a)(6) of the FD&C Act). FSMA section 202 describes only the recognized
accreditation bodies as having the ability to accredit a laboratory
(see, e.g., section 422(a)(1)(B), (a)(2), (a)(5), (a)(6), and (b)(1) of
the FD&C Act). In contrast, FSMA section 307 directed FDA to establish
a very similar program: ``a system for the recognition of accreditation
bodies that accredit third-party auditors'' \9\ (Section
808(b)(1)(A)(i) of the FD&C Act). However FSMA section 307 specifically
granted FDA authority to directly accredit third-party auditors if, 2
years after establishing the required system, FDA had not recognized an
accreditation body (section 808(b)(1)(A)(ii) of the FD&C Act). As
Congress specifically provided FDA with authority to directly accredit
third-party auditors in FSMA section 307, we presume their decision not
to provide FDA with similar authority in FSMA section 202 was
intentional. Accordingly, we lack the authority to directly accredit or
otherwise approve laboratories for inclusion in the LAAF program
generally or the public registry in particular.
---------------------------------------------------------------------------

    \9\ Under that authority we issued the ``Accreditation of Third-
Party Certification Bodies To Conduct Food Safety Audits and To
Issue Certifications Final Rule,'' 80 FR 74569 (Nov. 27, 2015) which
established the Accredited Third-Party Certification Program (see
https://www.fda.gov/food/importing-food-products-united-states/accredited-third-party-certification-program).
---------------------------------------------------------------------------

    The only way a laboratory may conduct the food testing described in

Sec.  1.1107, then, is through a favorable assessment by a recognized
accreditation body. In conducting such an assessment, a recognized
accreditation body assesses the laboratory against the model laboratory
standards we are creating in this final rule. Theoretically we could
tailor our model standards to allow for sector-specific standards, if
we were confident that those sector-specific standards provided equal
rigor and public health protections. For example, theoretically we
could allow laboratories that conduct the testing described in Sec.
1.1107(a)(1)(iii) to substitute our laboratory requirements based on
accreditation to ISO/IEC 17025:2017 with a sector-specific
accreditation standard such as the standard of the National
Environmental Laboratory Accreditation Program, or the standard of the
EPA water testing certification programs. However, FDA lacks the
resources to perform indepth comparisons of various program standards,
whether related to bottled drinking water or any other sector, with
ISO/IEC 17025:2017 and the remainder of our requirements. Indeed, a
prime advantage of relying on an international voluntary consensus
standard for our baseline requirement is uniformity. ISO/IEC 17025:2017
is a single standard that addresses technical competency and quality
management universally; its requirements mean the same thing in every
country and context in which it is used. For those practical and
philosophical reasons, we decline the comments' suggestion that we
allow bottled drinking water sector-specific laboratory standards in
place of the model laboratory standards established in this subpart.
    In declining this suggestion, we offer a few additional notes. To
the extent a sector-specific standard is also based on ISO/IEC
17025:2017, it should not be difficult or costly for a laboratory
accredited to such a sector-specific standard to become LAAF-
accredited. Further, the tests described in Sec.  1.1107(a)(1)(iii)
(and methods deemed acceptable under Sec.  129.35(a)(3)(ii)) involve
analyzing water for the presence of E. coli, which is not an uncommon
capability among food laboratories accredited to biological methods.
Meanwhile, we estimate that there will be one testing occasion per year
resulting in five separate tests under Sec.  1.1107(a)(1)(iii). (Ref.
4). We therefore believe it is reasonable to anticipate sufficient
capacity among LAAF-accredited laboratories to handle the bottled
drinking water testing covered by this final rule.
    (Comment 88) Some comments describe the positive features of the
American Association of Veterinary Laboratory Diagnosticians (AAVLD)
laboratory accreditation standard. These comments state that results
from AAVLD laboratories are accepted by Federal Agency laboratory
networks focused on disease surveillance, and that AAVLD laboratories
already perform research and emergency response work for FDA. These
comments further state that the AAVLD standard is aligned with ISO/IEC
17025:2017.
    (Response 88) AAVLD-accredited laboratories play a critical role in
FDA programs. Many of the veterinary diagnostic laboratories that are
part of FDA's Veterinary Laboratory Investigation and Response Network
(Vet-LIRN) are AAVLD-accredited. Vet-LIRN laboratories enhance public
health by providing testing of food and animal feed products for
zoonotic pathogens. These laboratories also perform pathogen and
chemical toxin testing in response to foodborne and animal
feed[hyphen]associated illnesses. Vet[hyphen]LIRN laboratories respond
to requests for testing as directed by FDA resulting from consumer
complaints, and participate in surveillance studies, method development
activities, and proficiency tests. These laboratories primarily analyze
animal samples (e.g., stool, urine, blood, tissue) and nonregulatory
animal food samples (e.g., leftover opened foods and feed) to help
FDA's Center for Veterinary Medicine (CVM) investigate potential
problems with CVM-regulated products (such as animal feeds or animal
drugs). Use of a LAAF-accredited laboratory is required for those tests
described in Sec.  1.1107, but the vast majority of the analyses
performed as part of the Vet-LIRN do not fall under Sec.  1.1107.
Accordingly, it is not necessary for laboratories participating in the
Vet-LIRN to become LAAF-accredited.
    To the extent that an AAVLD-accredited laboratory wishes to
participate in the food testing described in Sec.  1.1107, it would
need to meet all the requirements for a LAAF-accredited laboratory in
this subpart. For reasons discussed above in Response 87, FDA cannot
admit laboratories meeting other standards into this program. The only
way a laboratory may become LAAF-accredited is through a favorable
assessment by an accreditation body recognized under this subpart. That
construct does not comport with the structure of the AAVLD laboratory
accreditation program. AAVLD laboratory accreditation is awarded by
AAVLD itself, following an assessment by a committee of laboratory
professionals from other AAVLD laboratories. However, AAVLD is not an
ILAC-MRA signatory accreditation body that comports with ISO/IEC
17011:2017. Accordingly, it is not eligible for recognition under this
subpart.
    Moreover, our analysis of the AAVLD standard indicates that
although the AAVLD standard is aligned with ISO/IEC 17025:2017,
differences remain. For example, the AAVLD standard is designed to
assess the laboratory as a whole, rather than particular testing
methods. Also, the AAVLD reassessments occur at least once every 5
years, whereas ISO/IEC 17011:2017 section 7.9.3 requires that
laboratories be reassessed at least every 2 years (Ref. 2).
    For the foregoing reasons, an AAVLD laboratory wishing to conduct
the food testing described in Sec.  1.1107 would need to be accredited
to ISO/IEC 17025:2017 and satisfy the other laboratory requirements
described in this final rule. However, LAAF-accreditation is not
required for an AAVLD laboratory to continue to participate in the Vet-
LIRN.
    (Comment 89) Some comments request that we consider a modified set
of requirements for small specialized laboratories such as those that
solely analyze DWPE samples to determine the presence of filth and
decomposition in seafood. These comments suggest that we not require
ISO/IEC 17025:2017 accreditation for small specialized laboratories;
instead, such laboratories should be required to provide the laboratory
analyst's qualifications, the materials and methods used to conduct the
test, and be subject to random FDA audits. A subset of these comments
states that, for small specialized laboratories, the ISO/IEC 17025:2017
accreditation requirement would be too onerous for such laboratories to
continue operating. Specifically, comments list the cost of initial
certification, annual fee, training, internal program writing, and
corrective action responses as examples of particularly onerous
requirements. These comments emphasize the over-representation of small
laboratories in the total number of laboratories that conduct analyses
of food subject to DWPE by referring to estimates reported in the
preamble to the proposed rule that 84 percent of the current DWPE
analyses are performed by 10 laboratories, while about 90 laboratories
performed the remaining 16 percent of the analyses. The comments assert
that providing modified requirements for small businesses would be
consistent with other FSMA regulations.

    (Response 89) We decline to provide a modified set of requirements
for specialized laboratories of any size. The purpose of the LAAF
program is to help ensure quality testing in the context of heightened
food safety concerns. To achieve this public health goal, we have
determined that without exception, only laboratories that satisfy all
applicable laboratory standards may conduct the tests covered by this
subpart. We reach the same conclusion when we consider the specific
testing mentioned in some of these comments: DWPE testing of seafood
for filth and decomposition. FDA places products on DWPE when we have
evidence that such products appear to be in violation of FDA's laws and
regulations. Moreover, seafood products which were filthy and
decomposed have been implicated in past foodborne illness outbreaks
(e.g., scombrotoxin fish poisoning; (Ref. 12)). Filth and decomposition
are specified as the reasons some seafood products are subject to DWPE
(e.g., https://www.accessdata.fda.gov/cms_ia/importalert_19.html;
https://www.accessdata.fda.gov/cms_ia/importalert_43.html). We cannot
find any basis for concluding that DWPE testing of seafood for filth
and decomposition should be subject to different quality standards.
    ISO/IEC 17025:2017 includes technical competency, impartiality, and
quality management system standards, and we view these components as
critical in the context of testing covered by this subpart. By way of
example, section 4.1 of ISO/IEC 17025:2017 provides that laboratory
activities must be managed to safeguard impartiality and states that
the laboratory may not allow commercial and financial pressures to
compromise its impartiality (Ref. 3). The testing covered by this
subpart involves heightened food safety concerns, and we can find no
basis to justify modifying these standards or the other protections
included in ISO/IEC 17025:2017 accreditation.
    Next we address the data analysis supporting the proposed rule,
which indicated that 96 laboratories conducted about 16 percent of the
analyses on food products detained when offered for import because the
food was or appeared to be violative (84 FR 59452 at 59457) (Ref. 15).
The same data analysis indicated that 34 of those 96 laboratories were
accredited to ISO/IEC 17025, and that 44 laboratories already
accredited to ISO/IEC 17025 conducted about 95 percent of the analyses.
The same data analysis indicated that 62 unaccredited laboratories
accounted for the remaining 5 percent of import-related analyses.
    To the extent that comments requesting modified standards for
specialized laboratories intend to imply that most or all of the 62
unaccredited laboratories that conducted import-related food testing
were small, we do not have enough information to reach this conclusion.
In addition, we have no way of knowing how specialized these 62
laboratories are; some may conduct only DWPE testing, but we cannot
tell the range of analyses each conducts.
    Even if we assume a high proportion of small, specialized
laboratories that focus on DWPE testing, we expect the costs for such
laboratories to become ISO/IEC 17025:2017-accredited to be less than
the costs for larger laboratories and those with a more diverse set of
testing capabilities. Reasoned assumptions which may reduce the cost of
ISO/IEC 17025 accreditation for small, specialized laboratories
include: (1) The ability to efficiently manage data collection and
maintenance using relatively simpler in-house databases, particularly
for seafood filth and decomposition testing, which generates discrete
data; (2) lower onsite assessment costs since an accreditation body
necessarily will spend less time assessing a smaller scope of
accreditation (e.g., 1-3 methods); \10\ and (3) reduced costs for
equipment and proficiency samples due to the small number of methods
performed.
---------------------------------------------------------------------------

    \10\ A laboratory that is ``specialized'' necessarily performs a
narrow range of methods.
---------------------------------------------------------------------------

    All testing covered by this subpart, including filth and
decomposition testing in seafood for DWPE purposes, is of critical
public health significance. As described above, we estimate that the
costs of ISO/IEC 17025:2017 accreditation generally should be lower for
laboratories with very few methods in their scope. On balance, we do
not think the costs of requiring relatively small laboratories that
conduct specialized testing to become ISO/IEC 17025:2017-accredited to
perform covered testing outweigh the benefits that will be derived from
doing so.
    For these reasons, we decline the request to modify LAAF program
standards for certain laboratories.
    (Comment 90) Some comments recommend that FDA require laboratories
wishing to conduct food testing under this subpart to be accredited to
both ISO/IEC 17025:2017 and the supplemental document, ``AOAC
International Guidelines for Laboratories Performing Microbiological
and Chemical Analyses of Food, Dietary Supplements, and
Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2017'' (the
AOAC 17025 Guidelines) (Ref. 13). Other comments maintain that the AOAC
17025 Guidelines are not appropriate for laboratories that test only
animal food or feed, and not human food. Instead, these latter comments
suggest that for laboratories testing animal food or feed, FDA should
require the accreditation to ISO/IEC 17025:2017 and ``Quality
Assurance/Quality Control Guidelines for Feed Laboratories,'' the
guidance on interpreting ISO/IEC 17025:2017 issued by the Association
of American Feed Control Officials (AAFCO) (Ref. 14). For laboratories
that test both human food and animal food or feed, these comments
recommend FDA require accreditation to both supplemental guidelines.
    (Response 90) In several places in the preamble to the proposed
rule, FDA took note of how a matter is addressed in the AOAC 17025
Guidelines. For example, in our discussion of our proposed requirement
that laboratories pass a proficiency test (or a comparison program if
no proficiency test is available or practicable) annually for each
method to which they are LAAF-accredited, we noted that the AOAC 17025
Guidelines contain a similar requirement and exception (84 FR 59452 at
59477). It appears that some readers may have misunderstood these
discussion points, and mistakenly believed that we proposed to require
laboratories to comply with all AOAC 17025 Guidelines or to be
accredited to both ISO/IEC 17025:2017 and the AOAC 17025 Guidelines.
Although we found it instructive to consider the approach taken by the
AOAC 17025 Guidelines on certain matters, we did not propose that
laboratories must be accredited to both ISO/IEC 17025:2017 and the AOAC
17025 Guidelines. In addition, we acknowledge the AAFCO guidelines
provide equally useful supplemental information in animal food testing
matters. The AAFCO guidelines share best practices which would assure
that data of appropriate quality are generated by laboratories for feed
programs and may be useful for producing reliable and defensible
analytical test results. After careful consideration, we decline the
suggestion to require either the AOAC or AAFCO guidelines in this
subpart, but agree that both provide useful supplemental information.
We do not presently perceive a need for such a requirement, and as some
comments have pointed out, there may be challenges around the breadth
of the AOAC 17025 Guidelines considering the wide variety of tests
required to be conducted by LAAF-accredited laboratories under this
subpart.

    (Comment 91) A few comments seek clarification of the roles of
Federal, State, and local regulatory laboratories with respect to this
rule. Some comments seek clarification on whether State and local
regulatory laboratories that are already accredited to ISO/IEC
17025:2017 by an ILAC-MRA signatory and may have agreements with FDA
for testing related to food safety inspections, will need to do
anything differently as a result of this rule. Some comments posit that
only a few public laboratories are conducting the testing covered by
this subpart, and those laboratories may already operate under quality
management systems, and perhaps even ISO/IEC 17025:2017.
    Some comments suggest that Federal laboratories (e.g., a laboratory
within a Federal Agency) should be considered equivalent to LAAF-
accredited laboratories. Stated differently, these comments recommend
that if an owner or consignee uses a Federal laboratory, the result
should be acceptable to FDA even if the laboratory is not LAAF-
accredited.
    (Response 91) Federal, State, and local regulatory laboratories
perform the vital function of testing product samples of human food,
and animal food and feed, collected by public health officials either
in the course of an investigation or as part of routine market
surveillance. Over the years great strides have been made at all levels
of government to build an integrated food safety system; improving
coordination with and among public regulatory laboratories has been an
important part of that work. This subpart does not impact those tests
and so it may be irrelevant to many public regulatory laboratories.
    On the other hand, in addition to testing samples collected by
public health officials, some public regulatory laboratories may also
currently conduct some of the food testing that is covered by this
subpart. For full details see Sec.  1.1107, but the bulk of the testing
covered by this subpart falls within the categories of certain tests of
bottled drinking water, shell eggs, and sprouts; testing to support
removal from import alert; and testing to support admission of an
imported food product detained at the border because FDA has determined
that the food is, or appears to be, adulterated or misbranded. Once
this subpart is fully implemented, all testing covered by this rule
must be conducted by a LAAF-accredited laboratory. Public regulatory
laboratories may become LAAF-accredited laboratories; indeed, the
statute specifically contemplates public laboratories participating in
this program (``laboratories, including independent private
laboratories and laboratories run and operated by a Federal Agency
(including the Department of Commerce), State, or locality'' (section
422(a)(2) of the FD&C Act)). All laboratories, including public
regulatory laboratories, that wish to become LAAF-accredited must
satisfy the requirements of this subpart.
    Similarly, an array of laboratories throughout the Federal
government conduct a variety of tests in service to the missions of
their organizations. Any Federal laboratories that wish to become LAAF-
accredited to conduct the testing covered by this subpart will need to
satisfy the requirements of this subpart.
    (Comment 92) We received several comments regarding the frequency
with which we should require proficiency testing (or a comparison
program, where no proficiency test is available or practicable). Some
comments applaud the proposed requirement for an annual proficiency
test for each method (or comparison program, where no proficiency test
is available or practicable). Some comments suggest that the annual
frequency be set as a minimum requirement, as even more frequent
proficiency testing would allow for trending of results. Other comments
suggest FDA defer to ISO/IEC 17025:2017 for proficiency testing
frequency. Some of these comments seek to clarify how the FDA will
handle the annual proficiency testing requirement in the case of open
or flexible scopes. Some comments express that it is hard to find a
proficiency test provider that includes all analytes for such a method.
Other comments state that owners or consignees may have a difficult
time finding laboratories that are both ISO/IEC 17025:2017-accredited
and have performed a proficiency test for the analyte/method
combination within the last year for emerging issues, new methods, or
novel matrices being sampled and tested.
    (Response 92) Proficiency testing is a quality assurance mechanism
provided by an independent provider that results in an indication of a
laboratory's performance of a method. A successful proficiency test
round indicates that a laboratory can competently analyze samples by
that method whereas an unsatisfactory result indicates that the
laboratory needs to investigate and correct the cause(s) of the
unsatisfactory result.
    Although participation in proficiency testing provided by an
outside, independent provider is desired for all testing, we recognize
that it is not available for all test methods, specific analytes, or
matrices; or that, where available, it may not occur at the required
frequency. Therefore, we allow as an option a similarly designed
comparison program which will provide a demonstration of the
laboratory's competence to perform a method not covered by an available
proficiency test program. The comparison program should be an
independent or blind test of the laboratory's performance of a method
that is evaluated against the expected performance of the method
resulting in a conclusion of the laboratory's performance as acceptable
or unacceptable. All the testing covered by this subpart is occurring
in the context of heightened public health concern. We must therefore
be assured that LAAF-accredited laboratories are producing accurate
test results. For example, the results of testing conducted under Sec.
1.1107(a)(4) are used as evidence to overcome an appearance that a
product detained at the border violates FDA laws and regulations.
    We agree that requiring LAAF-accredited laboratories to
successfully complete an annual proficiency test (or a comparison
program, where no proficiency test is available or practicable) for
each LAAF-accredited method is important to support the testing under
this subpart. We have determined that deferring to the proficiency test
requirement in ISO/IEC 17025:2017 will not meet the needs of this
program, given the context of heightened public health concern. As
noted in the proposed rule, our proficiency testing frequency
requirement is similar to that of the AOAC 17025 Guidelines.\11\
Although even more frequent proficiency testing may be instructive, we
are not requiring it under this subpart. Accordingly, we are finalizing
the requirement that a LAAF-accredited laboratory must successfully
complete a proficiency test or comparison program for each method every
12 months. We avoid stating the requirement must be satisfied every
``year,'' to avoid implying that the proficiency tests or comparison
programs requirement applies per calendar-year.
---------------------------------------------------------------------------

    \11\ Some comments explain that although we stated in the
proposed rule that section 5.9.1 of the AOAC 17025 Guidelines
addresses proficiency testing, the AOAC 17025 Guidelines have been
updated. The updated AOAC 17025 Guidelines address proficiency
testing in section 7.7.2. FDA appreciates the comments.
---------------------------------------------------------------------------

    In light of the comments, and considering the critical role that
proficiency testing plays in the context of this final rule to help
ensure both the integrity of specific tests conducted under this
subpart and this laboratory accreditation program as a whole, we are
revising the proficiency testing provisions so that positive results
are

explicitly required. In the language of the proposed rule LAAF-
accredited laboratories were required to ``participate'' and
``conduct'' a proficiency test annually, per method. The final rule
requires that a proficiency test for each method must be ``successfully
passed'' within a 12-month cycle, unless one is not available or
practicable. Sec.  1.1138(a)(2)(i). In that case, the final rule
requires that the LAAF-accredited laboratory ``demonstrate competency
through participation in [a] comparison program.'' Sec.
1.1138(a)(2)(ii). As we discuss further below in (Response 96, the
LAAF-accredited laboratory must submit all proficiency test and
comparison program results, regardless of outcome, to the recognized
accreditation body within 30 calendar days of receipt. Sec.
1.1138(a)(2)(iii).
    For laboratories LAAF-accredited to an open or flexible scope, the
requirement would be for a proficiency test or comparison program
within 12 months for each method within the open or flexible scope.
    With regard to comments expressing concern that it may be hard for
an owner or consignee to find a laboratory that is ISO/IEC 17025:2017-
accredited and meets our proficiency test requirements, we note that we
will be maintaining an public registry of all LAAF-accredited
laboratories (and recognized accreditation bodies) online; see Sec.
1.1109 for additional discussion of the public registry.
    (Comment 93) Some comments express confusion regarding whether FDA
expects each analyst performing a method in the LAAF-accredited
laboratory to annually fulfill the proficiency testing requirement for
that method. These comments reference the requirement proposed at Sec.
1.1152(g)(12)(iv) that a full analytical report include, ``[i]ndividual
proficiency test worksheets'' and suggest that we clarify our
requirement.
    (Response 93) The requirement is for the laboratory to successfully
pass a proficiency test for each LAAF-accredited method within the last
12 months. We have revised the full analytical report requirement to
clarify; for more information see the discussion of Sec.  1.1152,
below.
    (Comment 94) Some comments express confusion regarding whether FDA
expects the LAAF-accredited laboratory to inform the recognized
accreditation body that the laboratory has determined that a
proficiency test is either not available or practicable, and so the
laboratory intends to participate in a comparison program instead.
Comments speculate regarding whether FDA might have intended that the
recognized accreditation body review such determinations when it audits
the laboratory.
    (Response 94) The LAAF-accredited laboratory's determination that a
proficiency test is not available or practicable must be approved by
its recognized accreditation body; we revised the proficiency test
provisions of the final rule to clarify this requirement; see Sec.
1.1138(a)(2)(ii). The LAAF-accredited laboratory's proposed alternative
to a proficiency test also must be approved by its recognized
accreditation body, prior to the laboratory's participation in the
alternative.
    We consider quality assurance measures vital to the integrity of
the LAAF program and the testing that occurs under this subpart.
Although one aspect of that quality assurance is requiring proficiency
testing for each LAAF-accredited method within each 12-month period, an
additional aspect is having the recognized accreditation body concur
with both the laboratory's determination that no proficiency test is
available to the laboratory, and the alternative proposed by the
laboratory.
    (Comment 95) In the proposed rule, we noted that ISO/IEC 17043:2010
``Conformity Assessment--General Requirements for Proficiency Testing''
(Ref. 16) provides specific standards for proficiency test providers.
We requested comment on whether FDA should require the use of
proficiency test providers accredited to ISO/IEC 17043:2010.
    Some comments support the proposed requirement that proficiency
testing providers must be ``competent,'' and do not recommend that we
specify accreditation to ISO/IEC 17043:2010. Some comments state that
many proficiency test providers that are not accredited to the ISO/IEC
17043:2010 standard have equivalent quality systems and are established
programs in the industry or in government organizations. Some comments
state that international proficiency test providers are less likely to
be accredited to ISO/IEC 17043:2010 as this standard is not utilized
very much outside of the United States. Some comments suggest that
recognized accreditation bodies can institute processes for determining
equivalency for such proficiency test providers.
    Other comments recommend that we require the use of proficiency
test providers accredited to ISO/IEC 17043:2010. Some assert that
accreditation of proficiency test providers provides assurances
regarding both the accuracy of the proficiency test and the technical
competence of the laboratories that successfully participate. Some
comments suggest that FDA could require the use of ISO/IEC 17043:2010
accredited proficiency test providers when available. Other comments
suggest that the FDA adopt the stance taken in AOAC 17025 Guidelines
section 7.7.2 which states that an ISO/IEC 17043 accredited proficiency
test provider should be given preference. Some comments ask FDA to
clarify which steps should be taken if we require ISO/IEC 17043:2010
accreditation for proficiency test providers, but where none is
available for certain methods.
    (Response 95) FDA appreciates the detailed responses to our
question on this matter.
    Having considered the comments, we have decided against requiring
the use of proficiency test providers accredited to ISO/IEC 17043:2010.
We agree with the specification in the AOAC 17025 Guidelines that such
providers should be given preference, and we encourage laboratories to
seek providers with such accreditation. However, at the present time
there are many methods for which no proficiency test provider exists at
all, let alone one accredited to ISO/IEC 17043:2010. Given the
importance of an independent, third-party evaluation of a laboratory's
competence--as provided by a proficiency test within every 12-month
cycle--we have decided to allow a wide selection of proficiency test
providers to cover as many of the testing methods covered by this
regulation as possible. Although the use of an ISO/IEC 17043:2010
accredited proficiency test provider may give the laboratory confidence
in the quality and consistency of the proficiency test material and the
evaluation of laboratory test results, at the present time, the breadth
of testing covered by ISO/IEC 17043:2010 providers is not sufficient to
support making this a requirement.
    (Comment 96) Some comments disagree with the proposed requirements
in Sec.  1.1153(b)(1) and (2) that within 30 days of receipt, the LAAF-
accredited laboratory must submit proficiency test results to the
recognized accreditation body and that failing proficiency test results
must also be submitted to the FDA; comments state that this deviates
from current ISO/IEC 17025:2017 procedures. Comments explain that
proficiency test results for an ISO/IEC 17025:2017-accredited
laboratory are assessed annually by an accrediting body. Comments
further explain that ISO/IEC 17025:2017-accredited laboratories address
unsatisfactory results by conducting a

root cause analysis and taking corrective action.
    Some comments agree with proposed Sec.  1.1153(b)(2), which
required the LAAF-accredited laboratory to submit failing proficiency
test results to FDA within 30 days of receipt. Other comments state
that requiring recognized accreditation bodies to review proficiency
test results without specified timeframes is not efficient, and the 30-
day timeframe may not provide enough time for the laboratory to
complete its corrective action process. Comments express concern that
failing results submitted to the recognized accreditation body and FDA
could be used against the laboratory without consideration of the
laboratory's corrective action procedures.
    Comments state that FDA should defer to ISO/IEC 17025:2017
proficiency test reporting requirements and that recognized
accreditation bodies can submit non-conforming laboratory results to
the FDA during their onsite assessments. Comments also state that some
accreditation bodies require that the proficiency testing data be
submitted directly to the accreditation body from the proficiency test
provider and that procedures already are in place for review of
proficiency testing schemes. A few comments have asked FDA to clarify
what would be considered a ``questionable'' or failing proficiency test
result. Comments state that some proficiency test providers consider
consecutive questionable results when determining a laboratory's
proficiency test performance and comments ask for clarification on how
FDA would evaluate consecutive questionable results.
    (Response 96) We have moved the proficiency test result reporting
requirements from Sec.  1.1153(b) to Sec.  1.1138(a)(2)(iii) so that
they appear alongside the main proficiency test requirements.
    After considering the comments, we have decided to revise the
requirements regarding LAAF-accredited laboratories' sharing results of
proficiency tests (or a comparison program, where no proficiency test
is available or practicable) with the recognized accreditation body and
FDA. First, we have determined that it is sufficient for the LAAF-
accredited laboratory to share results with the recognized
accreditation body and have therefore deleted the requirement that
failing results also be submitted to FDA. Upon consideration of the
comments on these provisions, the comments encouraging greater
delineation of FDA's role, and the requirements in Sec.
1.1138(a)(2)(ii) that recognized accreditation bodies must concur in
both the determination that no proficiency test is available and the
alternative chosen, we conclude that it better suits the role of the
accreditation body to review proficiency test results.
    We acknowledge that current ISO/IEC procedures only require the
accreditation body to review a laboratory's proficiency test results
annually, and that reviewing all results, and on an ongoing basis, will
not be as efficient for the accreditation body. (According to the
comments, some accreditation bodies go beyond what is required under
the ISO/IEC standard and so, may already receive results of all
proficiency test results, sometimes directly from the proficiency test
provider itself; our requirements may not be as much of a change for
those accreditation bodies.) However, we view proficiency testing (or
comparison programs, where no proficiency test is available or
practicable) as a very important tool to either reflect the continued
competence of a laboratory with regard to a particular method or
provide an opportunity for the laboratory to determine why it did not
receive a fully acceptable result and address any related need for
process improvements. We believe that providing the recognized
accreditation body with proficiency test results on an ongoing basis
will allow the recognized accreditation body to maintain greater and
more timely awareness of a laboratory's competency.
    At the same time, we take the point of the comments stating that if
the result is less than fully acceptable, it is unlikely that the LAAF-
accredited laboratory will complete its corrective action process
within 30 calendar days of receiving the result. In addition, as
explained above, we want recognized accreditation bodies to be in
possession of additional information about laboratory competency in a
timelier fashion than annual reviews provide. Therefore in the final
rule we are retaining the 30 calendar day timeframe for submission to
the recognized accreditation body of the results of the proficiency
test (or comparison program, where no proficiency test is available or
practicable).
    We note that a LAAF-accredited laboratory must successfully pass a
proficiency test (or comparison program, if a proficiency test is not
available or practicable) as described in Sec.  1.1138(a)(2) to gain or
maintain LAAF-accreditation for a particular method.
    Finally, with regard to the proposed requirement that a LAAF-
accredited laboratory submit to FDA results of ``failed'' proficiency
tests, comments request that we clarify what would be considered a
failing result. We acknowledge and agree with comments indicating that
proficiency test results generally are phrased in terms such as
``satisfactory'' or ``fully acceptable,'' or ``unsatisfactory'' or
``questionable.'' We have revised the requirement in the final rule to
require that a laboratory submit all proficiency test and comparison
program results, regardless of outcome, to the recognized accreditation
body within 30 calendar days of receipt (see Sec.  1.1138(a)(2)(iii)).
    (Comment 97) We received several comments regarding the quality
assurance requirements in proposed Sec.  1.1148. Some comments agree
with the proposed requirement that reference materials or quality
control samples be used with each test conducted under this subpart.
Some comments ask that FDA provide more details of the requirements for
a quality assurance process, including how quality is assured and by
whom, who performs audits and how they are issued, and, regarding
proposed Sec.  1.1148, who is accountable for findings and corrective
action. Some comments include for FDA's consideration examples of how
quality assurance is defined and implemented in other organizations,
including mention of the AOAC 17025 Guidelines' treatment of reference
materials and quality control samples.
    (Response 97) FDA considers quality assurance to be vital to the
integrity of this program and the testing that occurs under this
subpart. We have included various requirements throughout this subpart
that address quality assurance precisely because confidence in LAAF-
accredited testing is essential. One example is the requirement that
LAAF-accredited laboratories ensure that policies and procedures for
monitoring the validity of the results of testing they conduct under
this subpart include the use of reference materials or quality control
samples with each batch of samples tested under this subpart (Sec.
1.1138(a)(3)), a policy that aligns with the AOAC 17025 Guidelines
(Ref. 13). Relatedly, we have revised the final rule to require
submission of quality control results even with abridged analytical
reports, again, because of the importance we place on quality
assurance. ISO/IEC 17025:2017 similarly contains quality assurance
requirements, and not as a stand-alone provision, but integrated
throughout the standard (Ref. 3).
    In our view, quality assurance is most effective when it is not
treated as a distinct activity or addendum, but rather as a commitment
that should be

reflected in many facets of laboratory operations. Accordingly, we
decline the invitation to include a definition of ``quality
assurance.'' We do not believe a definition would significantly advance
the degree to which LAAF-accredited laboratories pursue and conduct
quality assurance.
    Commenters interested in additional details about the quality
assurance process under this subpart need only become more familiar
with its provisions. Both the recognized accreditation bodies and LAAF-
accredited laboratories are subject to requirements that we believe
will promote quality assurance.
    (Comment 98) We received many comments regarding whether FDA should
require LAAF-accreditation for the entities that collect the samples
that get tested under this subpart.
    In the proposed rule we chose not to include requirements for the
accreditation of samplers. We acknowledged the importance of proper
sampling procedures and that accreditation for sampling could
potentially help ensure the collection of representative samples. We
stated that although only laboratories were eligible for ISO/IEC 17025
accreditation under the 2005 version of that standard, the 2017 version
of the standard allows for the accreditation of entities that only
collect and do not analyze samples (``stand-alone sampling entities'')
(see 84 FR 59452 at 59476). As the revision was relatively new at the
time of the proposed rule, we were not able to adequately assess the
accreditation of such entities. We solicited comments on several
related issues, such as the capacity of accredited samplers (both
laboratories and stand-alone sampling entities), which international
voluntary consensus standard would serve as the optimal basis for a
consensus sampling standard, and which standards are currently employed
to assess samplers and whether such standards are effective and
sufficient. We proposed instead, in Sec.  1.1149, to require LAAF-
accredited laboratories to develop or obtain certain sampling documents
that would allow FDA to exercise oversight of the sampling conducted as
part of this program. Comments on proposed Sec.  1.1149 are addressed
below.
    Several comments endorse not requiring the accreditation of
samplers at the present time. Some of these comments contend samplers
are adequately qualified and therefore an accreditation requirement is
not warranted. These comments consider that the FDA oversight of
samples made possible by proposed Sec.  1.1149 will provide adequate
assurance of samplers' qualification and will provide helpful
flexibility in allowing different entities to collect the sample. Some
comments claim that for many food facilities, the preventive controls
regulations already require that sampling activities be performed by a
qualified individual and be overseen by a person with specialized
training in food safety preventive controls (i.e., a preventive
controls qualified individual).
    We understand some comments to argue that without substantive
sampling protocols to which samplers could refer, it would be difficult
for accreditation bodies to accredit samplers to ISO/IEC 17025:2017 or
assess against proposed Sec.  1.1149. These comments recommend that, at
a minimum, FDA should provide a mechanism whereby samplers could verify
sampling protocols with FDA. See discussion of this point with respect
to Sec.  1.1149, below.
    Some comments agree with our assessment in the proposed rule that
accreditation of stand-alone samplers is still relatively new. Some
comments agree that we should review this issue in the future. Some
comments contend that requiring the accreditation of samplers would
necessitate significant investments of time and expense by industry to
obtain such accreditation but would not result in significant public
health benefit.
    Other comments disagree with FDA's proposed decision and instead
argue that the final rule should require the accreditation of samplers.
Some of these comments contend that the statute requires samplers to be
accredited under this subpart; comments specifically quoted or
referenced section 422(a)(6)(A)(iv) and (b)(1) of the FD&C Act.
    Some comments contend that allowing sampling by unaccredited
entities would fail to provide the clarity needed for proper sample
collection, which can have a significant impact on the quality of the
test results and related uncertainty. These comments state that
analysis of an improper sample can invalidate the test results, and
argue that requiring accredited samplers is crucial to the integrity of
both the sample itself and the resulting test data. A few comments
claim that requiring the accreditation of samplers would ensure
traceability, which we understand to mean the ability to connect the
sample back to a lot or shipment.
    Some comments contend that aspects of ISO/IEC 17025:2017 are
necessary to ensure quality sampling. Some comments reason that, if
samplers are not required to be ISO/IEC 17025:2017-accredited, there is
a risk they may be connected to owners and consignees, and thus have an
interest in the outcome of the sampling and food testing. These
comments express the concern that allowing unaccredited samplers may
lead to the analysis of biased, substituted, or manipulated samples.
Comments suggest that accreditation to the ISO/IEC 17025:2017 standard
would protect against such conflict of interest concerns. Some comments
also champion the value of ISO/IEC 17025:2017 to establish standards
for sampler qualifications.
    Some comments disagree with the Agency's assessment in the proposed
rule that ISO/IEC 17025:2017 accreditation for stand-alone sampling
entities is relatively new and the FDA does not have enough information
to assess their accreditation. Comments disagree that accreditation
bodies do not have the experience or bandwidth to satisfy a requirement
under this subpart that samplers be ISO/IEC 17025:2017-accredited.
    Regarding current capacity among ISO/IEC 17025:2017-accredited
samplers, some comments assert that there is more than sufficient
accredited-sampler capacity to conduct all the DWPE sampling that would
be required under this subpart. They claim that current ISO/IEC
17025:2017-accredited sampling providers can expand their workforce as
needed to meet increased demand. They also contend that if we were to
require the accreditation of samplers under this subpart, we would be
creating additional incentive for sampling entities to become ISO/
IEC17025:2017-accredited, which would further increase capacity. Other
comments seem to suggest that accredited sampling capacity will
increase over time for market reasons (as accreditation generates
revenue), regardless of whether we incentivize by requiring sampling
accreditation under this subpart.
    Certain comments suggest that the sampling requirements in ISO/IEC
17025:2017 in conjunction with FDA's Investigations Operations Manual
(IOM) (Ref. 17) would provide comprehensive standards for sampling.
Comments also maintain that ILAC is in the process of considering the
circumstances in which it may be appropriate to require accredited
sampling.
    (Response 98) As discussed at some length in the proposed rule,
proper sampling procedures are essential to meaningful test results.
Accordingly, it is important that this subpart address samplers'
training and procedures. After careful consideration of the comments,
we have decided that the most appropriate way to support those goals at
the present time is through the

oversight provisions at Sec.  1.1149 rather than by requiring ISO/IEC
17025:2017-accreditation of samplers.
    Although we have decided not to require the accreditation of
sampling at this time, it should be noted that with the adoption of
ISO/IEC 17025:2017 without exclusions, those laboratories that include
sampling on their scope of accreditation will be assessed by their
accreditation body to the requirements of ISO/IEC 17025:2017 section
7.3 on sampling. Even though many sampling entities are not part of an
ISO/IEC 17025:2017-accredited laboratory, we conclude that the general
requirements in ISO/IEC 17025:2017 section 7.3 are sufficiently
addressed in Sec.  1.1149 (Ref. 3). There currently is no other
consensus standard specific to sampling of which we are aware; nor is
there a single, widely accepted sampling standard for us to incorporate
or on which to rely. Instead, there are several publications that
address the appropriate statistical sampling that is required to obtain
the representative sample referred to in Sec.  1.1149. Some comments
suggest that the FDA IOM could serve as the substantive standard.
However, while the FDA Compliance Programs \12\ and the IOM define the
general process for all sampling to ensure that the sample is
representative of the entire lot and in conformance with FDA sampling
procedures and methods, many of the instructions in these documents are
specific to FDA operations and would not be appropriate for
incorporation within this subpart. We also acknowledge the point of the
comments that argue that the 2017 version of ISO/IEC 17025 is not still
``new,'' and the comments that maintain that accreditation bodies have
the capacity to accredit entities for sampling. Nevertheless, in the
absence of any other consensus standard specific to sampling of which
we are aware; nor a single, widely accepted standard on sampling
criteria and specifications, we believe more time is needed for
industry to flesh out, and for us to assess, the ISO/IEC 17025:2017
accreditation of entities (including non-testing entities) for
sampling. Additionally, due to the absence of a predominant substantive
sampling standard, we do not agree with the position expressed in
comments that accreditation alone would provide sufficient clear
direction on sampling protocols to ensure proper sample collection. For
additional discussion regarding FDA substantive sampling resources, see
FDA Compliance Programs and IOM Ch. 4.
---------------------------------------------------------------------------

    \12\ For more information on FDA Compliance Programs, see
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-guidance-manual-cpgm.
---------------------------------------------------------------------------

    Despite the contentions of some comments, the statute does not
specify that FDA must require the accreditation of samplers in this
subpart. Comments point to section 422(a)(6)(A)(iv) and (b)(1) of the
FD&C Act to support the argument that sampling accreditation is
necessary. Section 422(a)(6)(A)(iv) of the FD&C Act states that the
model standards established in this subpart must include methods to
ensure that (among other things), ``individuals who conduct the
sampling and analysis are qualified by training and experience to do
so.'' This language does not mention accreditation; instead, it
provides (in relevant part) that FDA require samplers to be qualified.
We are fulfilling that obligation in Sec.  1.1149. Section 422(b)(1) of
the FD&C Act lists the tests that must be covered by this subpart; the
introductory text reads (in relevant part), ``food testing shall be
conducted by Federal laboratories or non-Federal laboratories that have
been accredited for the appropriate sampling or analytical testing
methodology or methodologies.'' This provision refers to accreditation,
but the ``or'' is important; by stating ``sampling or analytical
testing methodology,'' the statute allows for the satisfaction of just
one type of accreditation. Thus, this language explicitly allows for
testing to be conducted by laboratories accredited for just the
appropriate test method.
    As we stated in the proposed rule, in the 2-year period from 2016-
2017, about 63 percent of DWPE sampling was conducted by 5 entities
accredited for sampling under ISO/IEC 17025:2017 (see 84 FR 59452 at
59476). About 37 percent of DWPE sampling was conducted by more than
300 entities not accredited for sampling (see id.). In the proposed
rule, we specifically solicited feedback regarding the current capacity
of accredited samplers. Some comments respond that there is sufficient
capacity among already-accredited samplers to conduct all DWPE
sampling, and that it would be relatively easy for such entities to
expand capacity much further. We appreciate the time taken by
commenters to thoroughly address our specific inquiries.
    This subpart reaches beyond testing to support removal from import
alert, and entities focused on the sampling and testing needs at ports
of entry may not be convenient choices for non-import related owners
and consignees needing the services of a LAAF-accredited entity. We
note incidentally that some of the non-import sampling needs under this
subpart are unique; there are serious biosecurity concerns that would
need to be addressed by any outside entity collecting the shell egg
samples the testing of which is covered by this subpart under Sec.
1.1107(a)(1)(ii). See, e.g., Biosecurity Basics for Poultry Growers
(Ref. 18). We did not receive any comments describing the current
capacity of accredited samplers to collect non-import samples, though
as stated, some comments express the view that it would be relatively
easy to expand capacity, and some comments make the point that if we
require the accreditation of samplers we would be creating an incentive
to become accredited for sampling.
    Some comments suggest that there is no indication current samplers
are unqualified. For current purposes it is sufficient to acknowledge
that the statute directs FDA to address sampler qualifications in this
subpart. Some comments claim that sampling that takes place pursuant to
the FSMA preventive controls regulations is already required to be
conducted by a trained individual, and overseen by another person with
specialized food safety preventive controls training. (See the
definition of preventive controls qualified individual in Sec. Sec.
117.3 and 507.3.) It is true that each of those regulations requires
sampling to be conducted by an individual qualified by education,
training, or experience to carry out such sampling (Sec. Sec.  117.3,
117.4(b); Sec. Sec.  507.3, 507.4(b)), but the preventive controls
regulations only require a preventive controls qualified individual to
prepare or oversee the preparation of the food safety plan that would
detail the sampling regimen, not to oversee the sampling activity
(Sec. Sec.  117.180, 507.53). In addition, very few of the samples that
must be tested by a LAAF-accredited laboratory would be collected from
registered food facilities subject to either of the preventive controls
regulations; we estimate that almost all of the laboratory analytical
reports submitted in accordance with this subpart will be related to
sprouts (see Sec.  1.1107(a)(1)(i)), shell eggs (see Sec.
1.1107(a)(1)(ii)), and imports under section 801(a) (see Sec.
1.1107(a)(4), (5)) (Ref. 4).
    Some comments raise concerns about biased sampling. These comments
contend that the conflict of interest provisions in ISO/IEC 17025:2017
protect against samplers that have an interest in the outcome of the
test from submitting unrepresentative (e.g., ``cherry picked'' or
manipulated) samples. Although we also appreciate that ISO/IEC
17025:2017 contains conflict of interest provisions, the requirements
in Sec.  1.1149(a)(2) and (3)

for a sampling plan and collection report will ensure that the sample
collection procedures and preparation techniques, as well as the chain
of custody including controlling for the representative nature of the
sample, are documented and reviewed by FDA. For more information on the
sampling documentation required by this final rule, see the discussion
of Sec.  1.1149, below.
    Regarding sampler qualifications, ISO/IEC 17025:2017 section 6.2
requires accredited entities to document (among other things) the
educational, training, and experiential needs of each position and
ensure that personnel possess the necessary competence to perform their
function (Ref. 3). Although we do not dispute that these aspects of
ISO/IEC 17025:2017's quality management system are valuable, we are
addressing sampler qualifications, albeit using a different approach,
in this rule. Section 1.1149(a)(1) requires the qualifications of each
sampler to be submitted to FDA. Reviewing the documentation of
samplers' training and experience will provide FDA with a means of
helping to ensure that each sampler possesses qualifications sufficient
for the task.
    A few comments claim that requiring the accreditation of samplers
would facilitate connecting a sample back to a lot or shipment.
However, the requirements in Sec.  1.1149(a)(1) through (3) for the
written documentation of the sampler's qualifications by training and
experience, the written sampling plan used to conduct the sampling, and
the collection report combined should include the information required
to allow for tracing back to the lot or shipment.
    A number of pending developments may cause us to revisit this
issue. Contrary to the assertion of some comments, our understanding is
that ILAC is not considering developing standards or advice regarding
the circumstances in which it would be appropriate to require sampling
accreditation. However, a number of other developments may cause us to
revisit this issue, including our experience administering this
program, which will include reviewing sampling documents from both
LAAF-accredited laboratories and unaccredited samplers. Any change we
propose to this subpart will be effected through rulemaking and include
an opportunity for public comment.
2. How does a laboratory apply for LAAF-accreditation or extend its
scope of LAAF-accreditation (Sec.  1.1139)?
    This topic appeared in Sec.  1.1158 of the proposed rule. In the
proposed rule, paragraph (a) of this section directed a laboratory
seeking LAAF-accreditation to apply to a recognized accreditation body.
It also noted that a laboratory that had previously been disqualified
from the program by FDA or had its LAAF-accreditation withdrawn by a
recognized accreditation body must meet additional requirements to be
reinstated; those requirements are contained in Sec.  1.1142 of the
final rule (proposed Sec.  1.1165).
    In the proposed rule, paragraph (b) of this section stated that a
laboratory seeking LAAF-accreditation may use documentation of
conformance with ISO/IEC 17025:2017 in meeting the requirements of this
subpart.
    In the proposed rule, paragraph (c) of this section provided that
LAAF-accreditation endures as long as the laboratory maintains
compliance with all requirements of this subpart, unless the laboratory
relinquishes its LAAF-accreditation, FDA disqualifies the laboratory
from the program, or the recognized accreditation body withdraws the
laboratory's LAAF-accreditation.
    On our own initiative, we specified the relevant paragraph in the
cross-reference to Sec.  1.1142 and made other conforming and minor
editorial changes. Conforming terminology changes include adding the
phrase, ``reduced in scope,'' and the term, ``disqualified'' to the
list of ways LAAF-accreditation may end, in paragraph (c). Whereas in
the proposed rule, the words, ``withdrawn'' and ``revoked'' included
``in part'' withdrawal or reduction, in the final rule we use the word,
``reduce,'' to mean that some (but not all) methods are removed from
the scope of LAAF-accreditation and we use ``disqualify'' to refer to
the action FDA takes with respect to a LAAF-accredited laboratory.
Additionally, we have revised the section to remove reference to
``modification of scope,'' instead referring to extension of scope in
the final rule. We also revised the section title accordingly to read,
``How does a laboratory apply for LAAF-accreditation or extend its
scope of LAAF-accreditation?'' Comments regarding this section are
discussed below.
    (Comment 99) We received a few comments on this section; they
concern paragraph (c). Comments state that as proposed, LAAF-
accreditation would continue indefinitely, and accreditation bodies may
approach this policy differently. Some accreditation bodies take a
proactive approach and prompt laboratories to begin the renewal
accreditation process for ISO/IEC 17025:2017 well in advance of
expiration.
    (Response 99) We acknowledge that accreditation bodies vary in
their approaches to the duration and renewal of ISO/IEC 17025:2017
accreditation. Nevertheless, we are comfortable with the policy that
LAAF-accreditation for a particular method endures indefinitely for a
variety of reasons including that ISO/IEC 17011:2017 section 7.9.1
prescribes that ISO/IEC 17025:2017 accreditation may be for a maximum
of 5 years (Ref. 2); Sec.  1.1120(e) of this subpart requires
recognized accreditation bodies to conduct an onsite assessment of a
sample of the laboratory's scope every 2 years; and we have included
various quality assurance requirements in this subpart such as the
requirement in Sec.  1.1138(a)(2) for a successful proficiency test at
least every 12 months for each method to which a laboratory is LAAF-
accredited.
3. What must a LAAF-accredited laboratory do to voluntarily relinquish
its LAAF-accreditation (Sec.  1.1140)?
    This topic appeared in Sec.  1.1163 in the proposed rule. We
proposed to title this section, ``What if a laboratory wants to
voluntary relinquish its accreditation?'' For precision and in keeping
with the terminology changes described above at Response 10, the title
has been reworded to read, ``What must a LAAF-accredited laboratory do
to voluntarily relinquish its LAAF-accreditation?''.
    In the proposed rule, paragraph (a) of this section provided that a
LAAF-accredited laboratory must notify FDA and its recognized
accreditation body at least 60 days before relinquishing its LAAF-
accreditation either in whole or in part. We proposed that the notice
must include the date on which the relinquishment will occur, and if
the laboratory is relinquishing its LAAF-accreditation in whole,
certain information on a records custodian.
    In the proposed rule, paragraph (b) stated that FDA will provide
notice of the relinquishment on the public registry described in Sec.
1.1109.
    On our own initiative, we made a few changes to this section.
First, we removed the language requiring the notice of relinquishment
to be electronic and in English; requirements for submitting
information to FDA under this subpart are now addressed in Sec.
1.1110. We also removed mention of the fact that the relinquishing
laboratory must make its records available to FDA as required by Sec.
1.1153 because it was superfluous. We also made minor editorial changes
and specified ``calendar'' days in paragraph (a).
    We received no comments solely related to this section and made no
further changes to it.

4. What is the effect on a LAAF-accredited laboratory if its recognized
accreditation body is no longer recognized by FDA (Sec.  1.1141)?
    This topic appeared in Sec.  1.1164 in the proposed rule. We
proposed to title this section, ``What is the effect on accredited
laboratories if their accreditation body voluntarily or involuntarily
loses its recognition?'' We rephrased the title for efficiency and in
keeping with the terminology changes described above at Response 10 so
that it now reads, ``What is the effect on a LAAF-accredited laboratory
if its recognized accreditation body is no longer recognized by FDA?''.
    In the proposed rule, paragraph (a)(1) of this section explained
the actions a LAAF-accredited laboratory must take if its recognized
accreditation body departs the program. Within 30 days of FDA issuing a
notice informing the LAAF-accredited laboratory of the recognized
accreditation body's departure, the laboratory must submit to FDA its
most recent internal audit (see Sec.  1.1154(a)(5) of the final rule),
documentation showing compliance with the conflict of interest
requirements in Sec.  1.1147, and documentation of the most recent
proficiency test for each method to which the laboratory is LAAF-
accredited (see proposed Sec.  1.1148(a), (b)). Proposed paragraph
(a)(2) stated that within 1 year of receiving FDA's notice informing
the laboratory of its accreditation body's departure from the program,
the laboratory must become LAAF-accredited by a recognized
accreditation body.
    In the proposed rule, paragraph (b) provided that the laboratory
need not comply with paragraph (a) if, within 15 days of receiving
FDA's notice informing the laboratory of its accreditation body's
departure from the program, the laboratory initiates relinquishment of
its LAAF-accreditation in whole (see proposed Sec.  1.1163, final rule
Sec.  1.1140) with the relinquishment to occur within no more than 90
days.
    In addition to changes made in response to comments discussed
below, we made several changes to this section on our own initiative in
the final rule. We restructured the section to change proposed
paragraph (a) to a chapeau introducing paragraphs (a) and (b) of the
final rule and reordered the language of the chapeau to match the order
in which the notifications are listed in the final rule. On our own
initiative we replaced the phrase, ``30 days after FDA issues the
notice to the accredited laboratory'' with, ``30 calendar days after
receiving the notice,'' because these notices do not always come from
FDA and it is clearer to specify ``calendar'' days here and in
paragraph (b) of this section. In the case of a recognized
accreditation body that chooses to allow its recognition to expire or
voluntarily relinquishes its recognition, Sec.  1.1116(b) requires the
recognized accreditation body to notify the laboratories it has LAAF-
accredited. We also updated cross-references to the sections requiring
notice to the LAAF-accredited laboratories. In addition, we corrected
the reference to the section addressing a recognized accreditation body
allowing expiration of, or voluntarily relinquishing, its recognition.
Comments regarding this section are discussed below.
    (Comment 100) Comments state that the 15-day timeframe proposed in
Sec.  1.1164(b), during which time a LAAF-accredited laboratory
``orphaned'' by its recognized accreditation body may inform FDA that
the laboratory intends to relinquish its LAAF-accreditation, instead of
taking the actions required by paragraph (a), is inconsistent with the
timeframes established in the section on relinquishment (see Sec.
1.1140 of the final rule). Section 1.1140 of the final rule states that
a LAAF-accredited laboratory that chooses to voluntarily relinquish its
LAAF-accreditation must provide at least 60 calendar days advance
notice of the intention to relinquish. Comments indicate that the 15-
day timeframe in proposed Sec.  1.1164(b) seems irrelevant because a
laboratory could decide to depart the program on the 25th day after
receiving FDA's notice and still comply with the timeframes established
in Sec.  1.1140.
    (Response 100) We agree with these aspects of the comments and so
have revised the introduction of this section to provide that the LAAF-
accredited laboratory has 30 calendar days to either provide to FDA the
required documentation (i.e., its most recent internal audit (see Sec.
1.1154(a)(5)), documentation showing compliance with the conflict of
interest requirements in Sec.  1.1147, and documentation of the most
recent proficiency test for each method to which the laboratory is
LAAF-accredited (see Sec.  1.1138(a)) or inform FDA of its intent to
relinquish under Sec.  1.1140(a).
5. How does a laboratory request reinstatement of LAAF-accreditation
(Sec.  1.1142)?
    This topic appeared in Sec.  1.1165 in the proposed rule. In the
proposed rule, paragraph (a) of this section provided that a laboratory
that had any portion of its LAAF-accreditation withdrawn by the
recognized accreditation body or was disqualified by FDA for any
portion of its LAAF-accreditation, may seek reinstatement by submitting
a new application for LAAF-accreditation. We also proposed that the
laboratory take additional actions: Notify FDA of certain information
prior to submitting the application to the recognized accreditation
body and demonstrate to the recognized accreditation body to which the
laboratory is newly applying that the grounds for the withdrawal or
disqualification have been resolved and the laboratory has implemented
measures to prevent recurrence.
    In the proposed rule, paragraph (b) of this section stated that a
LAAF-accredited laboratory that voluntarily relinquished any portion of
its LAAF-accreditation may seek reaccreditation by submitting a new
application to a recognized accreditation body.
    We revised the section and section title to reflect updated
terminology and made other conforming and minor editorial changes
within the section. In this section and throughout the final rule, we
removed ``legal'' as a modifier for certain names required to be
submitted (for example, names of the laboratory and recognized
accreditation body in this section and the analyst names in other
sections) as the distinction was unnecessary and inconsistently used in
the proposed rule. We also removed ``valid'' as a modifier for contact
information in Sec.  1.1142(a)(1) as it was also unnecessary. We
received no comments solely related to this section.

I. Comments Regarding Requirements for LAAF-Accredited Laboratories

Table 10--Changes to Sections Regarding Requirements for LAAF-Accredited
                              Laboratories
------------------------------------------------------------------------
           Final rule                Proposed rule           Notes
------------------------------------------------------------------------
Requirements for LAAF-Accredited  Requirements for    Revised to reflect
 Laboratories.                     Accredited          new terminology.
                                   Laboratories.

N/A.............................  Sec.   1.1146 What  Merged contents of
                                   are the general     proposed section
                                   requirements for    with Sec.
                                   accredited          1.1138.
                                   laboratories to
                                   remain
                                   accredited?
Sec.   1.1147 What are the        Sec.   1.1147 What  Revised to reflect
 impartiality and conflict of      impartiality and    new terminology
 interest requirements for a       conflict of         and to improve
 LAAF-accredited laboratory?       interest            clarity.
                                   requirements must
                                   accredited
                                   laboratories
                                   meet?
N/A.............................  Sec.   1.1148 What  Removed this
                                   quality assurance   section and
                                   requirements must   relocated content
                                   accredited          to Sec.   1.1138.
                                   laboratories
                                   meet?
Sec.   1.1149 What oversight      Sec.   1.1149 What  Section title
 standards apply to sampling?      oversight           remains the same.
                                   standards apply
                                   to sampling?
Sec.   1.1150 What are the        Sec.   1.1150 What  Revised to reflect
 requirements for analysis of      requirements        new terminology
 samples by a LAAF-accredited      apply to analysis   and to improve
 laboratory?                       of samples by an    clarity.
                                   accredited
                                   laboratory?
Sec.   1.1151 What requirements   Sec.   1.1151 What  Revised to reflect
 apply to the methods of           requirements        new terminology.
 analysis a LAAF-accredited        apply to the
 laboratory uses to conduct food   methods of
 testing under this subpart?       analysis an
                                   accredited
                                   laboratory uses
                                   to conduct food
                                   testing under
                                   this subpart?
Sec.   1.1152 What                Sec.   1.1152 What  Revised to reflect
 notifications, results,           notifications,      new terminology
 reports, and studies must a       results, and        and include
 LAAF-accredited laboratory        reports must        ``studies''.
 submit to FDA?                    accredited
                                   laboratories
                                   submit to FDA?
Sec.   1.1153 What are the        New section.......  Created new stand-
 requirements for submitting                           alone section for
 abridged analytical reports?                          the portions of
                                                       Sec.   1.1152
                                                       related to
                                                       abridged reports.
Sec.   1.1154 What other records  Sec.   1.1153 What  Relocated records
 requirements must a LAAF-         other records       section and
 accredited laboratory meet?       requirements must   revised to
                                   an accredited       reflect new
                                   laboratory meet?    terminology.
------------------------------------------------------------------------

1. What are the impartiality and conflict of interest requirements for
a LAAF-accredited laboratory (Sec.  1.1147)?
    In the proposed rule, Sec.  1.1147(a) required LAAF-accredited
laboratories to generally prohibit employees, contractors, and agents
involved in food testing and related activities from accepting any
money or other item of value from the owner or consignee of the food
that is being, or will be, tested by the laboratory. Proposed paragraph
(b) excepted from the general prohibition the payment of fees for
testing services; reimbursement of direct costs associated with the
testing; and for laboratories owned by the owner or consignee, payment
of salary. Proposed paragraph (c) required that payment by the owner or
consignee for the testing service, and any direct reimbursement related
to the testing, must be independent of the test outcome.
    On our own initiative we revised paragraph (b)(1). In the proposed
rule, paragraph (b)(1) excepted, ``payment of fees for food testing
services.'' In the final rule, it excepts, ``[p]ayment of fees for food
testing under this subpart and related services,'' because owners and
consignees may pay a LAAF-accredited laboratory for services incidental
to testing, such as to collect a sample or for shipping and handling
costs.
    We have revised the text of this section to update terminology and
to make other conforming and editorial changes. We also revised the
section title to read, ``What are the impartiality and conflict of
interest requirements for a LAAF-accredited laboratory?'' We discuss
additional changes to the section made in response to comments below.
    (Comment 101) We proposed to allow laboratories owned by the owner
or consignee (``in-house'' laboratories) to become LAAF-accredited. We
received several comments regarding this proposed policy.
    Some comments express support for the proposed policy. These
comments state that the LAAF-accreditation process and other
requirements in the proposed rule would protect against potential
conflicts of interest. Some of these comments express the view that
although in-house laboratories should be permitted to become LAAF-
accredited, they should not be required to do so.
    Some comments oppose the proposed policy. Some of these comments
contend in-house laboratories cannot be free from conflicts of
interest. Some comments contend that this conflict of interest may
place public health at risk since owners or consignees testing their
food would have a vested interest in the outcome of the food testing;
some comments cite a widely-publicized foodborne illness outbreak and
state that the risk of our proposed policy is the recurrence of such
situations. Some comments also seem to argue that in-house laboratories
do not, or inherently cannot, satisfy the conflict of interest
provisions in ISO/IEC 17025:2017. These comments may have been
attempting to address our statement in the proposed rule that we were
unaware of any information indicating that laboratories owned by owners
or consignees are less able to become LAAF-accredited than independent
laboratories.
    Some comments opposing the proposed policy argue that the statute
precludes in-house laboratories from conducting at least import-related
testing under the LAAF program. These comments disagree with FDA's
interpretation of ``on behalf of'' in 422(b)(1)(B) of the FD&C Act.
These comments argue that when Congress used such language it was
clearly Congress's intent to prohibit in-house laboratories from
testing their own products under that 422(b)(1)(B) of the FD&C Act.
    In the proposed rule, we said that reading the statute such that
in-house laboratories would be ineligible for import-related testing
under this program could raise potential concerns under U.S.
international trade obligations. (see 84 FR 59452 at 59461 through
59462). We tentatively concluded that such a reading would not comport
with section 404 of FSMA, which states that nothing in the FD&C Act
shall be construed in a manner inconsistent with the agreement
establishing the WTO or any other treaty or international agreement to
which the United States is a party. Some comments that oppose the
proposed policy disagree with our proposed reasoning, and state that
there is insufficient evidence that treaties or international
agreements apply in this instance or that they are sufficient to

justify, according to these comments, risking public health by allowing
in-house laboratories to be eligible for LAAF-accreditation.
    (Response 101) After considering the comments and reviewing the
statute, we are retaining the proposed policy such that in-house
laboratories may become LAAF-accredited to conduct any of the testing
described in Sec.  1.1107 as long as those laboratories meet all the
laboratory requirements of this subpart.
    We acknowledge that opportunities may exist for owners and
consignees to exert undue influence over an in-house laboratory; owners
and consignees generally do not have the same amount of power and
control over an independent or third-party laboratory. However, as we
discussed in the proposed rule, ISO/IEC 17025:2017 contains several
requirements relevant to conflict of interest and impartiality (see 84
FR 59452 at 59478). For example, ISO/IEC 17025:2017 section 4.1
requires the laboratory to conduct its activities impartially and to be
structured and managed so as to safeguard impartiality, to not allow
commercial, financial, or other pressures to compromise its
impartiality, and, if a risk to impartiality is identified, the
laboratory must be able to demonstrate how the laboratory eliminates or
minimizes the risk (Ref. 3). We are aware that in-house laboratories
are accredited to ISO/IEC 17025:2017, indicating that accreditation
bodies have found sufficient safeguards in place to allow such
laboratories to be impartial. We have no basis to question those
accreditation body determinations.
    To further protect the integrity of the testing conducted under
this subpart, Sec.  1.1147 imposes on laboratories impartiality and
conflict of interest requirements that supplement those contained in
ISO/IEC 17025:2017. With limited exceptions, we require laboratory
employees, contractors, and agents not to accepts gifts or other items
of value from owners or consignees whose food is tested by the
laboratory. We also require that the owners' or consignees' payment to
the laboratory be independent of the testing outcome. This final rule
also contains oversight provisions which allow accreditation bodies to
assess, and FDA to review, the performance of, laboratories. Recognized
accreditation bodies and FDA both have the authority and the
responsibility to exercise their oversight to help ensure that
laboratories comply with the requirements of this subpart including the
requirements of Sec.  1.1147.
    Some comments point to a widely publicized foodborne illness
outbreak case as an example of the risk presented by in-house
laboratories. In that case, several executives and employees were
convicted and sentenced for Federal crimes related to selling peanut
butter products that the defendants knew had tested positive for
Salmonella. Among other misdeeds, the defendants fabricated test
results. That is, the testing accurately indicated that the product
contained Salmonella but the owners produced fraudulent test
certificates stating the opposite. In addition, the firm did not use an
in-house laboratory; rather, it sent its product to two different
independent laboratories for analysis. Accordingly, the facts of that
case have no direct bearing on the integrity of in-house laboratories.
Furthermore, section 422(b)(2) of the FD&C Act, implemented by Sec.
1.1152(b) of this final rule, requires laboratories to send the results
of all tests covered by this subpart directly to FDA, thus protecting
against the opportunity for owners or consignees to fabricate test
results of independent or third-party laboratories.
    We disagree that the statute precludes in-house laboratories from
conducting any or all testing covered by this subpart. Section
422(b)(1) of the FD&C Act contains two paragraphs. Paragraph (A) states
that certain testing ``by or on behalf of an owner or consignee'' must
be conducted by a LAAF-accredited laboratory; this paragraph describes
specific followup testing required by existing FDA regulations and
testing ``as the Secretary deems appropriate,'' in both cases to
address an identified or suspected food safety problem. Paragraph (B)
states that certain testing, ``on behalf of an owner or consignee''
must be conducted by a LAAF-accredited laboratory; paragraph (B)
describes testing in support of admission of detained imported food.
    First, section 422 of the FD&C Act explicitly contemplates the
participation of in-house laboratories when it states that ``food
testing shall be conducted . . . by or on behalf of an owner or
consignee'' (section 422(b)(1)(A)). As we discussed in the proposed
rule, section 422(b)(1)(B) of the FD&C Act is silent with respect to
testing conducted on imports by owners or consignees. Under one
possible interpretation, the absence of ``by or'' in paragraph (B)
would mean that only independent laboratories may be accredited to
conduct food testing on detained imports (84 FR 59452 at 59461 through
59462).\13\ Under this interpretation, laboratories owned by owners or
consignees would be prohibited from conducting such import-related food
testing, but laboratories owned by owners or consignees would be
eligible to conduct food testing under section 422(b)(1)(A) of the FD&C
Act. That would raise the prospect that section 422(b)(1) would not
apply equally to domestic and foreign goods (section 422(b)(1)(A) of
the FD&C Act would generally apply to domestic owners or consignees and
potentially foreign owners or consignees). Such a difference in
treatment could raise potential concerns under U.S. international trade
obligations. In this regard, we note that section 404 of FSMA provides
that nothing in the FD&C Act shall be construed in a manner
inconsistent with the agreement establishing the WTO or any other
treaty or international agreement to which the United States is a
party.
---------------------------------------------------------------------------

    \13\ Under another possible interpretation of section 422(b)(1),
the phrase, ``on behalf of'' may be read as sufficiently broad to
encompass in-house laboratories (i.e., an in-house laboratory
conducts testing on behalf of the entity that owns the laboratory).
In that case, the absence of ``by or'' is inconsequential, and we
would again reach the conclusion that allowing in-house laboratories
to conduct any testing under this subpart is consistent with the
statute.
---------------------------------------------------------------------------

    In considering section 422(b)(1)(B) of the FD&C Act and section 404
of FSMA together, we finalize the proposed conclusion that it is
reasonable to interpret section 422(b)(1)(B) of the FD&C Act to allow
laboratories owned by owners or consignees to conduct food testing that
falls under section 422(b)(1)(B) of the FD&C Act, provided that such
laboratories meet the accreditation requirements proposed.
    We understand some comments to question whether treaties or
international agreements are relevant to the food testing circumstances
covered by this subpart. Other comments appear to question whether the
existence of such treaties or international agreements justifies
permitting in-house laboratories to participate despite the purported
public health risks posed by such participation. It is undisputed that
the United States is a party to the WTO, and two WTO agreements are
relevant to FDA's regulatory authorities: (1) The Agreement on the
Application of Sanitary and Phytosanitary Measures and (2) the
Agreement on Technical Barriers to Trade. More significantly, however,
we believe we have addressed the fundamental issue at the heart of the
opposing comments, i.e., the concern that allowing in-house
laboratories (whether foreign or domestic) to become LAAF-accredited
jeopardizes public health because in-house laboratories have such a
vested interest in vouching

for their products that their test results are inherently suspect.
Above, we have explained our view that robust requirements in ISO/IEC
17025:2017 and in the final rule address conflict of interest and
impartiality such that in-house laboratories may qualify to become
LAAF-accredited. We also have explained our view that the statute
appropriately may be read to permit participation by such laboratories.
We therefore conclude that owners or consignees may become LAAF-
accredited as long as they satisfy all the relevant requirements of
this subpart.
    Finally, to clarify, no laboratory is required to participate in
this program; it is entirely voluntary for both accreditation bodies
and laboratories.
    (Comment 102) Some comments agree with the requirement in Sec.
1.1147(c) that payment for laboratory services must be independent of
the testing result; these comments indicate that it is routine
commercial practice to require payment in advance of testing to prevent
non-payment for violative samples.
    (Response 102) We appreciate comments concurring with the proposed
provision and are pleased that it is common practice for laboratories
to require payment prior to conducting the test. On our own initiative
and because the section discusses impartiality and conflict of interest
requirements for a LAAF-accredited laboratory, we have clarified in
Sec.  1.1147(c) of the final rule that the LAAF-accredited laboratory
must require the owner's or consignee's payment to be independent of
the outcome of the test results.
2. What are the quality assurance requirements for LAAF-accredited
laboratories (Sec.  1.1148)?
    Proposed Sec.  1.1148 concerned the quality assurance requirements
beyond those in ISO/IEC 17025:2017 for LAAF-accredited laboratories.
Paragraph (a) described the annual proficiency test requirement and
provided for the opportunity to use a comparison program if an annual
proficiency test for the method was not available or was otherwise
impracticable. Paragraph (b) provided that LAAF-accredited laboratories
ensure procedures for monitoring the validity of the results of testing
conducted under this subpart include the use of reference materials or
quality control samples with each batch of samples it tests under this
subpart.
    On our own initiative, we determined that the requirements in
proposed Sec.  1.1148 are more appropriately categorized as eligibility
requirements for LAAF-accredited laboratories. As such, these
provisions are in Sec.  1.1138 of the final rule.
3. What oversight standards apply to sampling (Sec.  1.1149)?
    In the proposed rule, Sec.  1.1149(a) required a LAAF-accredited
laboratory to develop (if the laboratory collected the sample) or
obtain (if the laboratory was not the entity responsible for collecting
the sample) certain documents related to sampling, prior to analyzing
the sample. Proposed paragraph (b) provided that if the sampling
documentation requirements were not met, we might consider the test to
be invalid.
    Proposed paragraph (a)(1) required documentation of the sampler's
qualifications by training and experience. We proposed that such
qualification documentation need only be obtained the first time an
individual collects a sample, unless the qualifications had changed
significantly. Proposed paragraph (a)(2) required a written sampling
plan that identified the sampler and listed factors the sampler would
control to ensure sample validity. Proposed paragraph (a)(3) required a
written sample collection report to include at least the following five
elements: The product code or, if collecting an environmental sample,
the location and a description of the environment; the date of
sampling; the size, identity, and quantity of the sample; documentation
of the sample collection procedures and any sample preparation
techniques; and documentation of the chain of custody and measures
taken to secure the validity of the subsequent test, including
controlling for the representational nature of the sample. On our own
initiative, we added, ``lot number'' to the information required in a
sample collection report. This information is consistent with the other
types of information required in a sample collection report and will
provide us with better visibility into how the sample was collected, as
well as additional information to allow us to trace the sample back to
its origin.
    In terms of the requirement that the sample collection report
include a product code, for domestic products we mean the product code
assigned by the manufacturer, packager, or labeler, as applicable. In
the import context, a product code is a string of letters and numbers
that represent certain information such as which industry produced the
item. For more information on product codes for imports, see https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-builder#whatcode. On our own initiative, we moved the
provisions addressing the advance notice of sampling from proposed
Sec.  1.1152(i) to a new paragraph (c) in Sec.  1.1149 of the final
rule. In the proposed rule, these provisions required that in certain
circumstances FDA may require a LAAF-accredited laboratory to request
and obtain from a sampler advance notice of sampling. We proposed that
we may require advance notice of sampling if we determine that sampling
may materially differ from the sampling documented in the associated
sampling plan or sample collection report, or, if we determine that the
sampling may otherwise have been improper.
    When we require advance notice of sampling, either the LAAF-
accredited laboratory must submit, or it must require the sampler to
submit, the notice to FDA 48 hours before each of that sampler's next
10 LAAF program sampling collections. We proposed that the notice must
contain:
     A unique identification code for the advance notice of
sampling;
     The name of the accredited laboratory that will conduct
analysis of the sample;
     The name and street address of the sampler that will
conduct the sampling;
     A primary contact (name and phone number) for the sampler;
     The reason(s) why the food product or environment will be
sampled;
     The location of the food product or environment that will
be sampled, including sufficient information to identify the food
product or environment to be sampled;
     As applicable, the U.S. Customs and Border Protection
entry and line number(s) and the FDA product code(s) of the food; and
     The date and approximate time the sampling will begin.
    We also proposed that FDA may, as appropriate, specify the type of
food product or environment that requires advance notice of sampling.
We proposed that we might specify an amount of time other than 48 hours
advance notice is required, between 24 hours and 7 business days. We
proposed that we might require a number of sampling occasions other
than 10, between 1 and 20. Finally, we proposed that we might notify
the LAAF-accredited laboratory that additional advance notice is not
required.
    As discussed previously in Response 22, we added the term,
``sampling firm'' in Sec.  1.1102 and defined it to mean an entity that
provides sampling services. We have updated the references to sampler
in Sec.  1.1149 to more accurately distinguish between requirements for
the sampler and the sampling firm.

    On our own initiative, for clarity, we added the phrase, ``at
least'' before ``48 hours.'' We clarify in Sec.  1.1149(c)(2)(i) that
FDA may, as appropriate, specify that the requirement regarding the
advance notice of sampling applies to samples collected by a particular
sampler. We also deleted the word, ``code,'' after, ``identification,''
because it was unnecessary and inconsistent with other uses of
``identification'' in this subpart. We also clarify in the final rule
that ``the FDA product code(s) of the food'' contained in proposed
Sec.  1.1152(i)(3)(vii) must include the product code of the food
product (if product is being sampled) or the location and a description
of the environment (if environment is being sampled). See Sec.
1.1149(c)(3)(viii) of the final rule. Finally, we made terminology,
conforming, and minor editorial changes to this section. We discuss
changes made in response to comments below.
    (Comment 103) Some comments ask FDA to clarify what constitutes an
acceptable sampling plan. Some comments state that our sampling
requirements are different for different types of commodity and test,
that FDA commonly rejects results due to sampling variations, and that
we should publish all FDA Laboratory Information Bulletin methods and
refer to them in import alerts as applicable. Some comments recommend
that we align sampling requirements under this subpart with certain
existing documents that describe a scientific approach to creating or
assessing sampling protocol: The AAFCO/Association of Public Health
Laboratories/Association of Food and Drug Officials documents
``GOODSamples'' (Ref. 19) and ``GOOD Test Portions'' (Ref. 20).
    (Response 103) As we discussed in the proposed rule, proper
sampling procedures are essential to meaningful test results and it is
therefore important that this subpart address the training and
procedures of samplers. After careful consideration of the comments, we
have decided that the most appropriate way to support those goals at
the present time is through the oversight provisions in this section,
rather than by requiring ISO/IEC 17025:2017-accreditation of samplers.
Accordingly, we are not establishing model standards for sampling in
this subpart. For more information on our decision not to require the
accreditation of samplers, see (Response 98.
    Regarding comments' suggestion that FDA publish all Laboratory
Information Bulletin methods, we note that although we have published
some (see https://www.fda.gov/science-research/field-science-and-laboratories/laboratory-information-bulletins), Laboratory Information
Bulletins typically do not include sampling collection information.
However, there are a variety of other publicly available FDA resources
concerning sampling. Generally applicable sampling procedures and
methods are described in the FDA Food Compliance Programs (https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs)
and the sampling chapter of the IOM, Ch. 4. The IOM section <IP_ADDRESS>
addresses random sampling. A random representative sample should
reflect the average composition of the entire lot to ensure that
analytical results are meaningful. This is particularly imperative when
potential foodborne adulterants that pose a public health risk are not
homogeneous in the product.
    FDA also provides more specific information on sampling in certain
circumstances.
    Some import alerts contain more customized information on sampling
(see https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing). Sampling for the testing of
bottled drinking water, shell eggs, and sprouts required under Sec.
1.1107(a)(1) is impacted by the product-specific regulations and/or may
be informed by product-specific guidance. See e.g., Sec. Sec.  118.7
(addresses shell egg sampling); 129.35(a)(3)(ii) (addresses bottled
drinking water sampling); and ``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 for Industry,'' available at https://www.fda.gov/media/102430/download (addresses product and environmental sampling for
sprouts). When finalized, this guidance will represent FDA's current
thinking on this issue.
    FDA appreciates the suggestion that we consult reputable industry
sampling guidance documents. We note that the ``GOODSamples'' and
``GOOD Test Portions'' documents were generally written for use by
State and local regulatory laboratories and not for private laboratory
use. Nevertheless, we are aware of these documents and agree they are
helpful resources.
    (Comment 104) Some comments disagree with, or request additional
clarification about, certain provisions within Sec.  1.1149. Some
comments express concern that requirements in Sec.  1.1149(a) for
documentation before analyzing the sample will lead to delays in
testing and obtaining results, and some comments express concern that
the delay could interfere with the sample's integrity. Some of those
comments suggest that instead, FDA should have a mechanism in place to
approve the sampling method or plan prior to sample collection.
    A few comments ask FDA to clarify how a laboratory is to evaluate
the effectiveness of a sampling plan. Comments also request that FDA
clarify what would constitute a ``significant change'' in a sampler's
qualifications and how a laboratory would learn about such a change.
    Some comments contend that FDA should not collect all the proposed
sampling documentation in Sec.  1.1149(a) in every instance, and argue
that the documentation need not be collected if the sample is collected
at a domestic food facility, because such entities are subject to
preventive controls regulations and we could allow the preventive
controls qualified individual to attest to the sufficiency of the
sampler's qualifications and the sampling procedures.
    Other comments suggest the documentation in Sec.  1.1149(a) should
be submitted to the laboratory's recognized accreditation body. Some
comments express the view that recognized accreditation bodies are
noticeably absent from the sample document collection process and this
could be rectified by either requiring that samplers be accredited or
by establishing clear substantive sampling requirements against which
recognized accreditation bodies could assess sampling documents.
    (Response 104) The submission to FDA of the sampler's
qualifications, the sampling plan, and the sampling collection report
will allow the Agency to exercise oversight over the sampling that
occurs under this subpart. We acknowledge that the proposed rule could
have been clearer on this point, but there is no requirement that the
sampling documents be submitted to or approved by FDA prior to the
LAAF-accredited laboratory conducting the test. Nor does the LAAF-
accredited laboratory need to evaluate the documents or do anything
with them prior to conducting the test; the laboratory need only submit
the documents to FDA with the analytical report, after the testing is
complete (see Sec.  1.1152(c)). As long as the LAAF-accredited
laboratory possesses the documents, it can proceed to conduct the test,
and we presume that in most instances the documents will either be
developed by the laboratory (if it collected the sample) or delivered
with the sample (if another entity collected

the sample). Either way, once the LAAF-accredited laboratory possesses
the sample we expect it will usually also possess the documentation
required under Sec.  1.1149(a). Relatedly, at the present time the
Agency does not perceive a need to require or create a pathway for
routine preapproval of the sample method or plan prior to sampling.
    After considering the comments, we are removing from the final rule
the requirement that the LAAF-accredited laboratory obtain
documentation of an individual sampler's qualifications more than once
if that person's qualifications have ``significantly changed.'' We no
longer view the information as necessary and agree that often the LAAF-
accredited laboratory would be unaware of it. We have also clarified
that a LAAF-accredited laboratory may refer to the previously submitted
qualifications if the LAAF-accredited laboratory has previously
submitted them to FDA under Sec.  1.1152(c). We do not expect many
samples collected under this program to come from food facilities
subject to the preventive controls regulations and so decline the
invitation to create an exception to Sec.  1.1149(a) for such
establishments. We discourage samplers and LAAF-accredited laboratories
from submitting to us an individual's social security number, or other
unnecessary personally identifiable information.
    For the reasons discussed above at Response 98, we have decided not
to require the accreditation of samplers at the present time, and we
also do not perceive a reviewing role for the recognized accreditation
bodies with regard to the documents required under Sec.  1.1149(a). As
noted above, submission of those documents to FDA is the mechanism
whereby we may exercise oversight of the sampling that occurs under
this subpart.
    (Comment 105) Some comments express concern with the proposed
provisions on advance notice of sampling. Comments ask for
clarification regarding how these requirements might work in the
context of the directed food laboratory order and the other testing
conducted under this subpart. Comments also indicate that delays
associated with this requirement could lead to significant losses for
entities, particularly regarding perishable foods. A few comments
suggest that requiring advance notice of sampling may not be
appropriate when resolving a food safety issue that needs rapid testing
and that it is commercially and logistically impractical to regularly
specify an exact date and approximate time of sampling.
    (Response 105) FDA has concluded it is reasonable for public health
reasons to require advance notice of sampling when the Agency suspects
a sampler previously has failed to follow proper protocols. Again,
utilizing appropriate sampling techniques is essential to generating a
representative sample, which is in turn essential to producing a
meaningful test result. FDA generally will require the advance notice
of sampling to be submitted to us at least 48 hours prior to collection
of the sample(s) to allow us time to determine whether to observe the
sampling or to take an audit sample and assign appropriate personnel to
the task. However, under Sec.  1.1149(c)(2)(iii), we may require an
amount of time other than 48 hours, perhaps as little as 24. In
tailoring the requirements to a particular situation, we would consider
a variety of factors including product shelf life.
    It is possible that we could require advance notice of sampling in
connection with any test required to be conducted by a LAAF-accredited
laboratory, including a directed food laboratory order. As the
circumstances in which we might require advance notice of sampling vary
widely, it is impossible to predict or generalize regarding how these
requirements will be implemented, e.g., depending on the provision of
Sec.  1.1107 under which the testing falls. However, FDA will take into
consideration such factors as the type of product, its shelf life,
timing requirements of the test method, public health context for the
testing, etc., and will use the options under Sec.  1.1149(c)(2) to
customize the requirements accordingly.
    (Comment 106) Some comments recommend that FDA clarify how we will
notify a LAAF-accredited laboratory that a sampler must provide advance
notice of sampling under Sec.  1.1149(c) (proposed Sec.  1.1152(i)),
and how we will track the subsequent 10 samples from that sampler. Some
comments suggest that we share with owners or consignees the pending
requirement for advance notice of sampling. Some comments emphasize the
logistical and operational challenges of several entities coordinating
around the collection of a sample. With regard to the requirements in
Sec.  1.1149(c)(3)(iii) (proposed Sec.  1.1152(i)(3)(iii)) that the
advance notice include the sampler's name and street address, some
comments seek clarification as to why we would require the sampler's
street address. Some comments recommend that we clarify that the
requirement is for a business name and address for the sampling entity,
and not an individual's name and address. In addition, these comments
suggest we clarify that the primary contact required by Sec.
1.1149(c)(3)(iv) (proposed Sec.  1.1152(i)(3)(iv)) should be the
individual managing the sampling operation.
    (Response 106) First, we note that under Sec.  1.1149(c), the LAAF-
accredited laboratory is not simply communicating a requirement to the
sampler. Instead, the LAAF-accredited laboratory is the entity required
either to obtain the advance notice of sampling from the sampler and
submit it to FDA itself, or to require the sampler to submit the notice
directly to FDA.
    In terms of our communications with LAAF-accredited laboratories
regarding Sec.  1.1149(c), such communications may occur by email but
regardless, will be tailored to the circumstances. Further, we may use
a variety of methods to track subsequent collections by a sampler
identified under Sec.  1.1149(c); one method will be to review the
documents we receive under Sec.  1.1149(a).
    Regarding the suggestion that we inform owners and consignees when
we will require advance notice of sampling from a particular sampler,
we have revised the codified text to state that we may, as appropriate,
notify the owner or consignee that advance notice of sampling applies
to food testing conducted on its behalf. Such notification is
consistent with current FDA practice in the context of reviewing
import-related private laboratory analytical packages (PLAPs), which we
have been doing for years. If FDA identifies a deficiency in a PLAP, we
routinely inform the owner or consignee the basis for FDA's concern
(i.e., we would inform the owner or consignee if we identified a
sampling problem that may have impacted the test result).
    FDA has experience auditing samplers and we acknowledge that it can
be a logistical challenge. Nevertheless, when we have cause for concern
with a particular sampler, especially given the public health context
in which testing under this subpart occurs, it is reasonable to require
advance notice of sampling.
    Finally, after considering the comments regarding the sampler's
name and address required by Sec.  1.1149(c)(3)(iii) and the primary
contact required by Sec.  1.1149(c)(3)(iv), we note that we have
revised this section to incorporate the new term, ``sampling firm''
(see Sec.  1.1102). We have revised these sections to refer instead to
the sampling firm information in the final rule.
    Our general purpose in requiring a sampling entity's address in an
advance

notice of sampling is to clearly identify the commercial operation
responsible for conducting the sampling. Again, we would only require
an individual sampler's name and street address if that person has been
contracted to provide sampling services for testing conducted under
this subpart. If an individual has assumed responsibility for that
task, then we have an interest in ensuring that we can properly
identify that individual and a street address helps us to do so. We
again emphasize that all the tests required to be conducted by a LAAF-
accredited laboratory occur in the context of heightened public health
concern. Although we are not requiring the accreditation of samplers,
we nevertheless require that any individuals collecting samples under