Changes to Accreditation of Non-Federal Analytical Testing Laboratories.

Published date14 December 2020
Citation85 FR 80668
Record Number2020-27016
SectionProposed rules
CourtFood Safety And Inspection Service
80668
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
interfere with or adversely affect the law
enforcement and counterintelligence
purposes of this system and the overall
law enforcement process, the applicable
exemptions may be waived on a case by
case basis.
A notice of system of records DHS/
ALL–046 Counterintelligence Program
System of Records is also publishing
elsewhere in this issue of the Federal
Register.
List of Subjects in 6 CFR Part 5
Freedom of information; Privacy.
For the reasons stated in the
preamble, DHS proposes to amend
chapter I of title 6, Code of Federal
Regulations, as follows:
PART 5—DISCLOSURE OF RECORDS
AND INFORMATION
1. The authority citation for part 5
continues to read in part as follows:
Authority: 6 U.S.C. 101 et seq.; Pub. L.
107–296, 116 Stat. 2135; 5 U.S.C. 301.
* * * * *
2. In appendix C to part 5, add
paragraph 83 to read as follows:
Appendix C to Part 5—DHS Systems of
Records Exempt From the Privacy Act
* * * * *
83. The DHS/ALL–046 Counterintelligence
Program System of Records consists of
electronic and paper records and will be used
by DHS and its components. The DHS/ALL–
046 Counterintelligence Program System of
Records covers information held by DHS in
connection with various missions and
functions, including, but not limited to the
enforcement of civil and criminal laws;
investigations, inquiries, and proceedings
there under; and national security and
intelligence activities. The system of records
covers information that is collected by, on
behalf of, in support of, or in cooperation
with DHS and its components and may
contain personally identifiable information
collected by other federal, state, local, tribal,
foreign, or international government
agencies.
The Secretary of Homeland Security,
pursuant to 5 U.S.C. 552a(j)(2), has exempted
this system from the following provisions of
the Privacy Act: 5 U.S.C. 552a(c)(3), (c)(4);
(d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H),
(e)(4)(I), (e)(5), (e)(8), (e)(12); (f); and (g)(1).
Additionally, the Secretary of Homeland
Security, pursuant to 5 U.S.C. 552a(k)(1),
(k)(2), and (k)(5), has exempted this system
from the following provisions of the Privacy
Act: 5 U.S.C. 552a(c)(3); (d); (e)(1), (e)(4)(G),
(e)(4)(H), (e)(4)(I); and (f).
Where a record received from another
system has been exempted in that source
system under 5 U.S.C. 552a(j)(2), 5 U.S.C.
552a(k)(1), (k)(2), and (k)(5), DHS will claim
the same exemptions for those records that
are claimed for the original primary systems
of records from which they originated and
claims any additional exemptions set forth
here.
Exemptions from these particular
subsections are justified on a case-by-case
basis and determined at the time a request is
made, for the following reasons:
(a) From subsection (c)(3) and (4)
(Accounting for Disclosures) because release
of the accounting of disclosures could alert
the subject of an investigation of an actual or
potential criminal, civil, or regulatory
violation to the existence of that investigation
and reveal investigative interest on the part
of DHS and the recipient agency. Disclosure
of the accounting would therefore present a
serious impediment to law enforcement
efforts and efforts to preserve national
security. Disclosure of the accounting would
also permit the subject of a record to impede
the investigation, to tamper with witnesses or
evidence, and to avoid detection or
apprehension, which would undermine the
entire investigative process. When an
investigation has been completed,
information on disclosures made may
continue to be exempted if the fact that an
investigation occurred remains sensitive after
completion.
(b) From subsection (d) (Access and
Amendment to Records) because providing
access or permitting amendment to the
records contained in this system of records
could inform the subject of an investigation
of an actual or potential criminal, civil, or
regulatory violation to the existence of that
investigation and reveal investigative interest
on the part of DHS or another agency. Access
to the records could permit the subject of a
record to impede the investigation, to tamper
with witnesses or evidence, and to avoid
detection or apprehension. Amendment of
the records could interfere with ongoing
investigations and law enforcement activities
and would impose an unreasonable
administrative burden by requiring
investigations to be continually
reinvestigated. In addition, permitting access
and amendment to such information could
disclose security-sensitive information that
could be detrimental to homeland security.
(c) From subsection (e)(1) (Relevancy and
Necessity of Information) because in the
course of investigations into potential
violations of federal law, the accuracy of
information obtained or introduced
occasionally may be unclear, or the
information may not be strictly relevant or
necessary to a specific investigation. In the
interests of effective law enforcement, it is
appropriate to retain all information that may
aid in establishing patterns of unlawful
activity.
(d) From subsection (e)(2) (Collection of
Information from Individuals) because
requiring that information be collected from
the subject of an investigation would alert the
subject to the nature or existence of the
investigation, thereby interfering with that
investigation and related law enforcement
activities.
(e) From subsection (e)(3) (Notice to
Subjects) because providing such detailed
information could impede law enforcement
by compromising the existence of a
confidential investigation or reveal the
identity of witnesses or confidential
informants.
(f) From subsections (e)(4)(G), (e)(4)(H),
and (e)(4)(I) (Agency Requirements) and (f)
(Agency Rules), because portions of this
system are exempt from the individual access
provisions of subsection (d) for the reasons
noted above, and therefore DHS is not
required to establish requirements, rules, or
procedures with respect to such access.
Providing notice to individuals with respect
to existence of records pertaining to them in
the system of records or otherwise setting up
procedures pursuant to which individuals
may access and view records pertaining to
themselves in the system would undermine
investigative efforts and reveal the identities
of witnesses, and potential witnesses, and
confidential informants.
(g) From subsection (e)(5) (Collection of
Information) because with the collection of
information for law enforcement purposes, it
is impossible to determine in advance what
information is accurate, relevant, timely, and
complete. Compliance with subsection (e)(5)
would preclude DHS agents from using their
investigative training and exercise of good
judgment to both conduct and report on
investigations.
(h) From subsection (e)(8) (Notice on
Individuals) because compliance would
interfere with DHS’s ability to obtain, serve,
and issue subpoenas, warrants, and other law
enforcement mechanisms that may be filed
under seal and could result in disclosure of
investigative techniques, procedures, and
evidence.
(i) From subsection (e)(12) (Matching
Agreements) because requiring DHS to
provide notice of a new or revised matching
agreement with a non-Federal agency, if one
existed, would impair DHS operations by
indicating which data elements and
information are valuable to DHS’s analytical
functions, thereby providing harmful
disclosure of information to individuals who
would seek to circumvent or interfere with
DHS’s missions.
(j) From subsection (g)(1) (Civil Remedies)
to the extent that the system is exempt from
other specific subsections of the Privacy Act.
Constantina Kozanas,
Chief Privacy Officer, U.S. Department of
Homeland Security.
[FR Doc. 2020–27314 Filed 12–11–20; 8:45 am]
BILLING CODE 9110–9N–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 439
[Docket No. FSIS–2016–0026]
RIN 0583–AD70
Changes to Accreditation of Non-
Federal Analytical Testing
Laboratories.
AGENCY
: Food Safety and Inspection
Service, USDA.
ACTION
: Proposed rule.
SUMMARY
: FSIS is proposing to revise
the regulations prescribing the statistical
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80669
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
methods used in measuring the
performance of chemistry laboratories in
its voluntary Accredited Laboratory
Program (ALP) and to expand the scope
of accreditations offered by the program.
Currently, participants in the ALP are
accredited for the analysis of food
chemistry (moisture, protein, fat, and
salt), specific chemical residues, and
classes of chemical residues. FSIS is
proposing to change the statistical
method it uses to evaluate laboratory
proficiency testing (PT) sample results
to the z score approach for those
accreditations that are currently
evaluated by Cumulative Summation
(CUSUM). FSIS also is proposing to
accredit non-Federal laboratories for
microbiological indicator organisms and
pathogen testing, in response to
industry interest. Additionally, the
Agency is proposing to make various
minor edits and changes to the
regulation for the sake of clarity and to
incorporate all sample types under the
jurisdiction of FSIS (e.g., to include egg
products), as appropriate for the
associated analyte, and to improve
program flexibility. Improving program
flexibility includes updating definitions
to remove specific references that are
currently limiting the program.
DATES
: Comments on this proposed rule
must be received on or before February
12, 2021.
ADDRESSES
: FSIS invites interested
persons to submit comments on this
proposed rule. Comments may be
submitted by one of the following
methods:
Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field on this web page or
attach a file for lengthier comments. Go
to http://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758,
Washington, DC 20250–3700.
Hand- or courier-delivered
submittals: Deliver to 1400
Independence Avenue SW, Jamie L.
Whitten Building, Room 350–E,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2016–0026. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to http://
www.regulations.gov.
Docket: For access to background
documents or comments received, call
(202)720–5627 to schedule a time to
visit the FSIS Docket Room at 1400
Independence Avenue SW, Washington,
DC 20250–3700.
FOR FURTHER INFORMATION CONTACT
:
Rachel Edelstein, Assistant
Administrator, Office of Policy and
Program Development, Food Safety and
Inspection Service, U.S. Department of
Agriculture; Telephone: (202) 720–0399.
SUPPLEMENTARY INFORMATION
:
Background
FSIS accredits non-Federal analytical
laboratories under its Accredited
Laboratory Program (ALP). Under this
voluntary program, FSIS accredits
laboratories to conduct analyses of
official meat and poultry samples for
food chemistry (moisture, protein, fat,
and salt), specific chemical residues,
and classes of chemical residues. In
response to the meat and poultry
industries’ need for more rapid
analytical results as food testing
expanded, and because of limitations in
FSIS laboratory capacity at the time of
this need, these programs were
established to accredit non-Federal
laboratories for certain tests of both
meat and poultry products. In 1980 (45
FR 73947) and again in 1985 (50 FR
15435), the Agency proposed to
consolidate these programs and
establish an ALP that contained
standards and procedures for non-
Federal laboratories eligible to analyze
official samples when necessary. A final
rule was issued in 1987 (52 FR 2176).
A subsequent 1993 final rule (58 FR
65254) established user fees for the ALP
and adjusted the standards and
procedures established in the earlier
rule for this program. A non-Federal
laboratory seeking FSIS accreditation
must pay a nonrefundable accreditation
fee to cover the costs of the ALP.
In 2008, a final rule was issued (73 FR
52193) to accommodate the adoption of
newer methods for analyzing chemical
residues and to make editorial changes
to the accredited laboratory regulations
to reflect Agency reorganizations and
program changes. This rule also
consolidated the accredited laboratory
regulations from 9 CFR 318.21 of the
meat inspection regulations and 9 CFR
381.153 of the poultry products
inspection regulations into a single new
part, 9 CFR part 439.
The ALP monitors each non-Federal
laboratory currently accredited under
the program to ensure that these
laboratories are operating at a level of
quality that produces reliable results
that can be used to support decisions in
establishments’ food safety systems. The
PT program administered by the ALP
supports this effort. Monitoring is
achieved by evaluating PT results for
acceptable analytical performance and
assessing quality assurance through on-
site reviews of each laboratory’s
management system and facility assets.
Statistical Methods
To ensure compliance with the
regulatory provisions of the Federal
Meat Inspection Act (21 U.S.C. 601 et
seq.) and the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.),
samples of meat and poultry products
are periodically tested. These tests are
conducted to determine the content of
food chemistry components and the
presence of violative concentrations of
veterinary drugs or other chemical
residues. FSIS’s own laboratories, as
well as accredited non-Federal
laboratories carry out these analyses. To
assess the proficiency of the non-
Federal laboratories participating in the
ALP, testing events are administered by
FSIS, whereby PT samples of meat and
poultry products are prepared and sent
to participating laboratories for
chemical analysis of targeted food
chemistry components as well as
targeted compounds, such as residues of
veterinary drugs, polychlorinated
biphenyls (PCBs), and pesticides. The
concentration of the targeted analytes is
unknown to the non-Federal
laboratories. The laboratories’
performance on the analysis of the PT
sample is then evaluated and scored by
the ALP using a statistical tool
(CUSUM) developed by FSIS. The FSIS
CUSUM, currently defined at 9 CFR
439.1(h), is based on a class of
cumulative summation statistical
procedures for assessing whether a
process is in control.
The use of CUSUM statistics for
scoring laboratory performance in the
ALP was implemented in 1987 (‘‘Meat
and Poultry Inspection; Accredited
Laboratory Program,’’ (52 FR 2176;
January 20, 1987)). At the time that this
rule was published, the analytical
chemistry community did not have
consensus-based guidance and
standards for statistical evaluation of PT
results. Consequently, FSIS developed
the CUSUM PT sample scoring system
specifically to evaluate the analytical
performance of the laboratories in the
ALP. However, Cumulative Summation
statistics do not completely address all
aspects of analytical process quality
control. Instead, z score based statistics
are now considered the appropriate tool
for evaluating PT performance, and are
better suited for the accreditations
currently offered by the ALP. The z
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80670
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
score is widely used for evaluating
laboratory performance on PT sample
analysis and is easily understood. Z
score based statistics are accepted by the
analytical chemistry community and
consensus-based standard-setting
bodies, such as International
Organization for Standardization (ISO)
and The NELAC Institute. Expanding
the ALP to include additional
accreditations could result in
accreditations in which the z score may
not be applicable. In such cases, the
ALP intends to begin using ISO
13528:2015(E) Corrected version 2016
((‘‘ISO 13528’’) ‘‘Statistical methods for
use in proficiency testing by
interlaboratory comparison,’’ October
15, 2016) as the source for statistical
tools and PT performance evaluation.
As the ISO standard is updated, FSIS
will adopt the changes, as appropriate.
Regarding any significant, substantive
changes, FSIS may issue a Federal
Register notice about changes to its
statistical methods.
The intended use of CUSUM
statistics, on which FSIS based its
creation of the customized CUSUM PT
scoring system, is to detect trends,
typically in quality control, for a process
in a single facility. A level of
acceptability (maximum or minimum
CUSUM) is established in each case. If
this level is exceeded, corrective actions
are implemented to bring the process
back in control and then the cumulative
sum is reset. The FSIS CUSUM PT
scoring system has thresholds for
acceptability. Participants receive
CUSUM scores in three different
categories for each PT event. For each
sequential event over the period of one
calendar year, the scores in each
category are added to the scores from
the previous event. If a participant’s
score in any category exceeds the
thresholds for acceptability in the one-
year time period, the participant is
notified and must take corrective
actions. Unlike cumulative summation
statistics that are only reset after
corrective actions, the FSIS CUSUM
scores for each participant are reset to
zero at the beginning of each year
without cause.
FSIS is proposing to amend the ALP
regulations at 9 CFR part 439 to replace
the prescriptive statistics with
requirements presented in the ISO
13528 Standard as the measures it
would use to evaluate chemistry
laboratory performance based on PT-
sample analysis. Z score statistics
consistent with ISO 13528 would be
used where CUSUM scoring is currently
used by the ALP. The z score statistics
are described in detail in ISO 13528 and
are briefly described here along with
reasons why z scores adequately replace
CUSUM scoring for PT evaluation.
The z score and the common variation
zscore (which includes uncertainty in
the calculation of the performance
score) are widely used and easy to
calculate. The z score is currently
calculated as:
z
i
= (x
i
¥x
pt
)/s
pt
where x
i
is the participant’s result, x
pt
is the
assigned value of the PT sample analyte,
and s
pt
is the standard deviation for the
proficiency assessment.
The zscore is calculated as:
z
i
= (x
i
¥x
pt
)/(s
2pt
+ m
2
(x
pt
))
0.5
where m is the uncertainty of the assigned
value.
For the purposes of the ALP, the z
score is considered part of z score
statistics.
CUSUM scoring, as currently set forth
in 9 CFR 439.1(h) and 439.20(h)(3)–(5),
addressed three main categories in
evaluating PTs:
(1) Systematic Laboratory Difference:
Which is consistent positive or negative
bias for a single laboratory’s results over
time. Both positive and negative biases
are determined in the same manner
(only changing for the direction of the
bias). Scoring for Systematic Laboratory
Difference is represented by CUSUM P
for positive bias and CUSUM N for
negative bias.
(2) Variability: Which is the
combination of random fluctuations and
systematic differences. Scoring for
Variability is represented by CUSUM V.
(3) Individual Large Discrepancy:
Which is the magnitude and frequency
of large differences between the results
of an accredited laboratory and the
accepted value of the PT. Scoring for
Individual Large Discrepancy is
represented by CUSUM D.
All of the ALP CUSUM scoring (P, N,
V, and D) is performed on the
individual laboratory-reported PT
results relative to the accepted or
assigned value of the PT material. Each
ALP CUSUM category has a limit that,
if exceeded, incurs a penalty. Scores are
monitored over the calendar year to
detect exceedances.
The proposed change from the use of
CUSUM scoring to z score procedures
for statistical evaluation of laboratory
performance would not affect the ability
of FSIS to address these three main
categories (Systemic Laboratory
Difference, Variability, and Individual
Large Discrepancy) in evaluating PTs
and would provide evaluation of
equivalent purpose and depth.
First, with regard to Systematic
Laboratory Difference, CUSUM analyzes
for both the direction and magnitude of
bias via positive and negative scores.
The z score equivalently provides this
information by the value of the score.
The sign of the z score value (positive
or negative) indicates the direction of
the bias relative to the accepted value of
the PT sample. Because z score statistics
are based on standard deviation, the
score is normalized around the accepted
value of the sample (represented by
zero). A participant’s PT result that
exactly matches the accepted value
incurs a zero z score. A PT result that
is slightly greater than the accepted
value will have a z score that is slightly
greater than zero. This presents an
advantage over CUSUM scoring because
one can easily visualize the z scores
compared to zero in graphic form.
CUSUM scoring often returns a zero
score, even for deviations from the
accepted value. CUSUM scoring will
accept PT results up to a threshold and
return a zero score. The threshold is
dynamic and depends on the magnitude
of difference between the PT result and
the accepted value and also on the
concentration of the analyte in the PT
sample. Therefore, CUSUM P and N do
not allow the same level of preciseness
that z scores do in evaluating closeness
of the reported result to the accepted
value of the PT sample.
Second, with regard to Variability, z
score statistics provide the magnitude of
the deviation from the accepted value.
This would successfully replace
CUSUM V for Variability. The z score
has the added benefit of being
directional (it indicates both positive
and negative variation), while CUSUM
V is not. The variations are also easier
to detect visually because the z scores
are normalized relative to the PT
accepted value and graphs generated
from these data are easily understood.
Third, with regard to Individual Large
Discrepancy, CUSUM D is readily
replaceable by z score statistics. For z
scores, typically a value greater than 3.0
or less than ¥3.0 indicates an
unacceptable value and may indicate
performance problems. The z score has
the added benefit of being directional (it
indicates both positive and negative
deviation). The CUSUM D is not
directional. Currently, the CUSUM D is
monitored over time in order to detect
repeated failures. It is expected that any
laboratory will occasionally report a PT
sample result that falls outside the
acceptable range for the sample
accepted value, which results in an
individual failing score that is random
in nature. Repeated failures are not
random and constitute a trend. Under
this proposed rule, FSIS would continue
to monitor the z scores for each
accredited laboratory to detect trends
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80671
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
1
The FSIS ALP Evaluation Report comparing
samples using z scores and CUSUM statistics is
available on the FSIS website at: http://
www.fsis.usda.gov/wps/wcm/connect.
2
Citation of 7 U.S.C. 1622(o) was inadvertently
omitted from the regulations at 9 CFR part 439.
FSIS proposes to add it to the regulations with this
proposed rule.
3
Like accreditation for food chemistry testing,
this new accreditation for microbiological testing
would be authorized by the AMA at 7 U.S.C.
Continued
that indicate performance issues. As
stated above, FSIS monitors CUSUM
scores for one calendar year for
exceedances. After this period of time,
FSIS resets CUSUMs. Because z scores
are not reset, changing from CUSUMs to
z score statistics offers the advantage of
detecting repeated exceedances over an
extended period of time.
Updating the ALP statistical tools
would also eliminate the need for
employing a standardizing value, which
is a number used to transform the result
of a computation to a unitless measure,
representing the performance standard
deviation of an individual result. The z
score is already unitless and is directly
based on standard deviation statistics.
Eliminating the need for a standardizing
value would have the added benefit of
making it easier to add relevant
chemical residues of current concern to
the PT sample program. The added
flexibility for the ALP to create and offer
PT samples that contain veterinary drug
and chemical residues of current
concern would increase the
opportunities for laboratories to prove
that they can successfully analyze
samples for these compounds.
Standardizing values are specific to
each matrix/residue combination and
require the evaluation of extensive
background information in order to
calculate each standardizing value. The
z score approach does not involve such
a requirement and is readily adaptable
to the addition of new residues.
Another limitation of the current ALP
PT structure has been that analytes in
samples must be easy to detect, with
minimal measurement uncertainty, for
the CUSUM statistics to remain viable.
It is common to have some chemical
elements and compounds that are
difficult to measure in a sample, even
under the best of circumstances.
Laboratory PT sample results for these
difficult analytes are expected to be
relatively poor, exhibiting large
measurement uncertainty. The z score
would allow the ALP to take the
uncertainty into account when scoring
laboratory performance for these
difficult analytes. There is no such
consideration with CUSUM scoring. As
a result, the PT samples in the past
largely excluded difficult analytes,
regardless of the food safety concerns
that those residues might have. Because
the z score takes the uncertainty into
account, the ALP would be able to
include analytes that are difficult to
analyze in PT samples and generate
resulting scores that do not penalize
laboratories for an issue that lies with
the analyte instead of the laboratory.
Furthermore, when there is more than
one residue analyte in a single PT
sample, the ALP has been combining
the results for a single score. Combining
results is not an accepted practice in the
PT community. Changing to the z score
approach would easily allow scoring for
individual analytes.
A comparison of z scores and CUSUM
scores from seventeen separate ALP
food chemistry PT sample events with
a focus on outliers shows that it is a
good replacement for CUSUM scoring.
1
When using both CUSUM scoring and z
scores, individual results are evaluated
for outliers. The outliers are removed to
determine the study comparison mean
and then placed back into the study
evaluation for scoring the individual
laboratories. The ALP evaluation, which
used 61 individual ALP CUSUM scores
and 61 individual z scores for the same
sets of laboratory results, showed that
when CUSUM scoring indicated the
presence of an outlier, the z scores
either also indicated the outlier or
returned a score warning that the result
was close to becoming an outlier.
Conversely, when the z scores indicated
an outlier that CUSUM scoring did not,
the result still sustained a relatively
large ALP CUSUM score increase. One
of the 61 results that was an outlier
among the ALP CUSUMs was not an
outlier among the z scores and there was
no warning that the result was close to
becoming an outlier. However, the z
score was very close to the warning
limit. Warning limits are z scores
between –3 and –2, and also between 2
and 3. Results that incur a z score in the
warning limit are not considered
outliers, but are a signal to the
laboratory that it may have an emerging
problem and should be prepared to
troubleshoot the analytical system.
The ALP evaluation also considered
use of the product code, which is
currently part of CUSUM calculations,
to determine if it needed to be retained
in any capacity within the ALP. This
was done by examining the percent
relative standard deviation (Percent
RSD) of the PT comparison means
within and among product classes
(classes are defined by meat type and fat
content, e.g., low-fat ham). Product
classes are represented numerically by
product codes, which are assigned by
product type, salt content, and moisture
content. Product codes are then used in
selecting the standardizing values for
calculating CUSUMs. Not all product
codes were available for this
assessment. In the evaluation, the
Percent RSD appears to be largely
affected by the relative amount of a
constituent, just as the product code is
determined, in part, by the relative
amount of a target analyte. As expected,
the lower the constituent content, the
larger the Percent RSD. All Percent RSD
values were less than 8, which is well
within accepted norms for inter-
laboratory studies of this type. If the
Percent RSD results for the evaluation
had approached 20, it may have
indicated the need to retain product
codes. No other trends were detected
related to the product codes. The
product codes are only needed for
CUSUM scoring and are not required for
any other purpose in the ALP.
Therefore, removing the use of product
codes from the program is supported.
Expansion of the ALP To Include
Foodborne Pathogen Testing
Under the Agricultural Marketing Act
of 1946, as amended (7 U.S.C. 1621 et
seq.) (AMA), FSIS provides certain
laboratory services, for a fee, to
establishments and others upon request.
FSIS provides four general types of
analytic testing to industry:
Microbiological testing (i.e., indicator
organisms and foodborne pathogens),
chemical residue and contaminant
testing, food composition testing
including speciation, and pathology
testing. As discussed throughout this
proposal, FSIS also accredits non-
Federal laboratories, for a fee, to
conduct analytic testing of meat and
poultry. Under the AMA at 7 U.S.C.
1622(o),
2
FSIS accredits non-Federal
laboratories to conduct food chemistry
testing, i.e., testing of a food’s
nutritional components. Additionally,
under the Food, Agriculture,
Conservation, and Trade Act (1990 Farm
Bill), FSIS accredits non-Federal
laboratories, for a fee, to conduct testing
for chemical residues on food (7 U.S.C.
138–138i).
FSIS’s current regulations provide for
accreditation of non-Federal laboratories
to conduct only the chemical analysis of
the nutritional components of and
specific chemical residues in food. This
limits the opportunities for industry to
use analytical results from accredited
non-Federal laboratories as part of their
food safety systems in support of the
Agency’s food safety mission. FSIS is
thus proposing to accredit non-Federal
laboratories for microbiological testing,
3
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80672
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
1622(o). Notably, that provision directs and
authorizes the Secretary to conduct any activities
and provide any services (such as accreditation
services) necessary to facilitate the marketing,
distribution, processing, and utilization of
agricultural products, including meat and poultry
products.
4
Fees and charges for laboratory accreditation are
provided in 9 CFR 391.
5
This cost is based on publicly listed industry
prices provided by N.P Analytical Laboratories,
https://www.npal.com/#/Services/OurServices,
accessed on 1/9/2018.
6
In 2016, there were 2 new applicants and 4
probation applicants, in 2017, there were no new
applicants and 1 probation applicant.
in response to industry interest. In the
future, these changes would potentially
allow ALP-accredited laboratories that
conduct process control laboratory
testing, already done by regulated
establishments to support their food
safety systems, to include those results
in future FSIS databases for Agency
consideration in process performance
categorizations. Participating
laboratories that join the ALP as a result
of this expansion would be required to
participate in the program PT events
and undergo on-site audits just as ALP-
accredited laboratories currently do.
Request for Stakeholder Comments
The Agency is interested in comments
concerning this proposal. The Agency
specifically requests comments from
regulated industry and non-Federal
laboratories on (1) how to best manage
data associated with an expanded ALP
program, (2) any food matrix and
analyte pairs they are interested in
seeing offered in a possible expanded
ALP accreditation program, (3) whether
ISO 17025 accreditation should be a
prerequisite to membership in the ALP
since it is recognized as providing the
general requirements for the
competence of testing and calibration
laboratories, and (4) ways to incentivize
membership in the ALP, to include a
possible annual fee reduction for
laboratories already ISO 17025
accredited if not a requirement.
Additional Regulatory Changes
Most of the proposed changes to 9
CFR part 439 are associated with the
removal of the ALP CUSUM statistics
and expanding the program to include
microbiological testing (e.g., indicator
organisms and foodborne pathogens).
Expanding the program would
potentially allow FSIS to include data
from industry, in addition to data from
official samples, for Agency
consideration in assessing an
establishment’s process performance.
The Agency is proposing to remove the
‘‘official sample’’ definition from the
regulation because this will allow the
Agency the flexibility to consider data
from industry to assess process
performance. The proposed changes
also provide the flexibility to add
matrices of interest to industry that are
under FSIS jurisdiction, such as egg
products, and would better align the
program description and requirements
with the way the program currently
operates and with future program
updates. A robust ALP can provide
industry with additional accredited
non-federal analytical laboratories to
perform their testing in order to provide
quality and reliable results to support
their food safety systems. Other existing
ALP requirements in 9 CFR part 439 for
obtaining and maintaining
accreditation, including education,
experience, and legal requirements,
would remain the same.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order (E.O.)13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This
proposed rule has been designated a
‘‘non-significant’’ regulatory action
under section 3(f) of E.O. 12866.
Accordingly, the rule has not been
reviewed by the Office of Management
and Budget under E.O. 12866.
Need for the Rule
According to Agency experts, there
were approximately 55 food chemistry
laboratories participating in the ALP in
2012. Since then, participation has
declined to 38 laboratories in 2019. Of
those laboratories, 29 were accredited
for food chemistry, 13 for chemical
residue chlorinated pesticides analysis,
and 4 for chemical residue PCBs
analysis. Participation in the ALP might
be bolstered by expanding the ALP to
include additional analytes, such as
indicator organisms and foodborne
pathogens. In addition, switching from
the CUSUM PT sample scoring system
currently used by the ALP to z score-
based statistics should simplify the
accreditation process for both the
laboratories and the Agency.
Expected Industry Cost Savings
Although the proposed rule does not
change the accreditation fee structure,
4
it would reduce the number of samples
non-Federal food chemistry laboratories
would have to analyze to attain and
maintain food chemistry accreditation.
Based on industry data, laboratories
charge approximately $67
5
per sample.
Current criteria for obtaining
accreditation (9 CFR 439.10(d)(2)(i))
require that laboratories analyze a set of
36 samples (9 CFR part 439.1 (k) ‘‘Initial
accreditation check sample’’) for food
chemistry to obtain initial accreditation
or to remove probationary status in food
chemistry. The estimated cost for
analyzing the sample set (also known as
qualification set) is approximately
$2,412 (36 × $67 = $2,412). This number
of samples is not necessary to
statistically evaluate laboratory
performance for admittance to the
program. FSIS is proposing to permit
the ALP to offer laboratories smaller sets
for food chemistry accreditation. The
smaller qualification sets would reduce
costs for laboratories and still be large
enough to evaluate laboratory
performance. Agency experts provided
an estimated cost of analysis of
approximately $938 when using 14
samples per set (14 × $67 = $938), a
reduction of $1,474 ($2,412¥$938 =
$1,474) per qualification set for food
chemistry. This analysis assumes that
between 1 and 6 establishments would
have to complete qualification sets in
any given year.
6
The Agency seeks
comment on this assumption. Based on
this assumption the annual savings
ranges from $1,474 (1 × $1,474) to
$8,844 (6 × $1,474), with a mid-point of
$5,159 (3.5 × $1,474).
Additionally, the proposed changes to
the accreditation process (9 CFR
439.10(d)(4)(ii)) are expected to reduce
industry costs. Current criteria state that
if a laboratory’s second set of
qualification samples do not meet the
criteria for obtaining accreditation,
laboratories must submit a new
application, all fees, and all
documentation of corrective action
required for accreditation. FSIS is
proposing to no longer require food
chemistry laboratories to reapply and
pay the fees again before receiving the
third qualification sample set. Instead,
fees would be paid after the third set or
if the initial accreditation process is not
completed within eleven months. This
is expected to reduce an applicable
laboratory’s accreditation cost between
$2,100 and $5,000.
Regulatory Flexibility Analysis
The FSIS Administrator
(Administrator) has made a preliminary
determination that this proposed rule
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80673
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
would not have a significant economic
impact on a substantial number of small
entities in the United States, as defined
by the Regulatory Flexibility Act (5
U.S.C. 601 et seq.). First, this rule’s
impact is limited to a small number of
entities and participation in the program
is voluntary. Second, while the
proposed changes are expected to
reduce accreditation costs, these cost
savings are not anticipated to be
significant and would apply to
accredited laboratories regardless of
size.
Executive Order 13771
Consistent with E.O. 13771 (82 FR
9339, February 3, 2017), we have
estimated that this proposed rule would
yield cost savings. Therefore, if finalized
as proposed, this rule is expected to be
an E.O. 13771 deregulatory action.
Paperwork Reduction Act
FSIS has reviewed this rule under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520) and has determined
that there is no new information
collection related to this proposed rule.
FSIS collects information for the ALP
under OMB approval numbers 0583–
0082 and 0583–0163.
E-Government Act
FSIS and USDA are committed to
achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et
seq.) by, among other things, promoting
the use of the internet and other
information technologies and providing
increased opportunities for citizen
access to Government information and
services.
Executive Order 13175
This proposed rule has been reviewed
in accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this proposed regulation will not have
substantial and direct effects on Tribal
governments and will not have
significant Tribal implications.
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, FSIS will
announce this Federal Register
publication on-line through the FSIS
web page located at: http://
www.fsis.usda.gov/federal-register.
FSIS will also announce and provide
a link to this Federal Register
publication through the FSIS
Constituent Update, which is used to
provide information regarding FSIS
policies, procedures, regulations,
Federal Register notices, FSIS public
meetings, and other types of information
that could affect or would be of interest
to our constituents and stakeholders.
The Constituent Update is available on
the FSIS web page. Through the web
page, FSIS can provide information to a
much broader, more diverse audience.
In addition, FSIS offers an email
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at:
http://www.fsis.usda.gov/subscribe.
Options range from recalls to export
information, regulations, directives, and
notices. Customers can add or delete
subscriptions themselves and have the
option to password protect their
accounts.
USDA Non-Discrimination Statement
No agency, officer, or employee of the
USDA shall, on the grounds of race,
color, national origin, religion, sex,
gender identity, sexual orientation,
disability, age, marital status, family/
parental status, income derived from a
public assistance program, or political
beliefs, exclude from participation in,
deny the benefits of, or subject to
discrimination any person in the United
States under any program or activity
conducted by the USDA.
How To File a Complaint of
Discrimination
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed online at http://
www.ocio.usda.gov/sites/default/files/
docs/2012/Complain_combined_6_8_
12.pdf, or write a letter signed by you
or your authorized representative.
Send your completed complaint form
or letter to USDA by mail, fax, or email:
Mail: U.S. Department of Agriculture,
Director, Office of Adjudication, 1400
Independence Avenue SW, Washington,
DC 20250–9410, Fax: (202) 690–7442,
Email: program.intake@usda.gov.
Persons with disabilities who require
alternative means for communication
(Braille, large print, audiotape, etc.),
should contact USDA’s TARGET Center
at (202) 720–2600 (voice and TDD).
List of Subjects in 9 CFR Part 439
Laboratories.
For the reasons discussed in the
preamble, FSIS is proposing to amend 9
CFR Chapter III by revising part 439 to
read as follows:
PART 439—ACCREDITATION OF NON-
FEDERAL LABORATORIES FOR
ANALYTICAL TESTING OF MEAT,
POULTRY, AND EGG PRODUCTS
Sec.
439.1 Definitions.
439.5 Applications for accreditation.
439.10 Criteria for obtaining accreditation.
439.20 Criteria for maintaining
accreditation.
439.50 Refusal of accreditation.
439.51 Probation of accreditation.
439.52 Suspension of accreditation.
439.53 Revocation of accreditation.
439.60 Notifications and hearings.
Authority: 7 U.S.C. 138f, 450, 1901–1906,
1622(o); 21 U.S.C. 451–470, 601–695; 7 CFR
2.18, 2.53.
§ 439.1 Definitions.
(a) Accredited Laboratory Program
(ALP)—The voluntary FSIS program in
which non-Federal laboratories are
accredited as capable of performing
analyses with the level of quality that is
necessary to maintain accreditation in
the program, on samples of raw or
processed meat, poultry, and egg
products, and through which a
proficiency testing sample program for
quality assurance is conducted.
(b) Food chemistry—Analysis of raw
or processed meat or poultry products
for the components moisture, protein,
fat, and salt.
(c) Initial accreditation proficiency
testing sample—A sample provided by
the ALP to a non-Federal laboratory to
determine whether the laboratory’s
analytical capability meets the
standards for acceptance into the
program. The concentration or presence
of the targeted analyte(s) and the
composition of the components in the
sample is unknown to the laboratory.
(d) Inter-laboratory accreditation
maintenance proficiency testing
sample—A sample provided by FSIS to
an accredited laboratory to assist in
determining whether the laboratory is
maintaining acceptable analytical
performance for a given analyte or
component. The concentration or
presence of the targeted analyte(s) and
the composition of the components in
the sample is unknown to the
laboratory.
(e) ISO 13528—ISO 13528:2015(E)
Corrected version 2016, ‘‘Statistical
methods for use in proficiency testing
by interlaboratory comparison,’’ October
15, 2016, or updated versions.
(f) Probation—The period
commencing with official notification to
an accredited laboratory that it no
longer satisfies the ALP performance
requirements specified in this part, and
ending with official notification that
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80674
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
accreditation is fully restored, is
suspended, or is revoked.
(g) Refusal of accreditation—An
action taken by FSIS when a laboratory
that is applying for accreditation is
denied the accreditation.
(h) Responsibly connected—Any
individual, or entity, that is a partner,
officer, director, manager, or owner of
10 percent or more of the voting stock
of the applicant or recipient of
accreditation or an employee in a
managerial or executive capacity or any
employee who conducts or supervises
the analysis of FSIS samples.
(i) Revocation of accreditation—An
action taken by FSIS against a laboratory
thereby removing the laboratory’s
certification of accreditation and
participation in inter-laboratory
accreditation maintenance proficiency
testing sample events.
(j) Suspension of accreditation—An
action taken by FSIS against a laboratory
thereby temporarily removing the
laboratory’s certification of accreditation
and participation in the inter-laboratory
accreditation maintenance proficiency
testing sample events. Suspension of
accreditation ends when accreditation
either is fully restored or is revoked.
(k) z score—A statistically derived
number representing a laboratory’s
performance for analyzing proficiency
testing samples. The ALP calculates and
interprets z scores consistent with ISO
13528.
§ 439.5 Applications for accreditation.
(a) Participation in the ALP is
voluntary. Application for accreditation
must be made on designated paper or
electronic forms provided by FSIS, or
otherwise in writing, by the owner or
manager of a non-Federal analytical
laboratory. Application forms may be
obtained by contacting the ALP at ALP@
usda.gov. The forms must be sent to the
ALP or may be submitted electronically.
The application must specify the kinds
of accreditation sought by the owner or
manager of the laboratory. A laboratory
whose accreditation has been refused, or
revoked for performance reasons may
reapply for accreditation after 60 days
from the effective date of that action,
and must provide written
documentation specifying what
corrections were made and illustrate to
FSIS that the corrections are effective or
would reasonably be expected to be
effective.
(b) At the time that an application for
accreditation is filed with the ALP, the
laboratory must submit a check, bank
draft, or money order in the amount
specified by FSIS as directed in 9 CFR
391.5, made payable to the U.S.
Department of Agriculture, along with
the completed application for the
accreditation(s).
(c) Application for Accreditation will
not be processed or allowed to advance,
without further procedure, if the
accreditation fee(s) is delinquent.
(d) FSIS will issue a bill annually in
the amount specified by FSIS in 9 CFR
391.5 for each accreditation held and
are due by the date required. Bills are
payable by check, bank draft, or money
order made payable to the U.S.
Department of Agriculture.
§ 439.10 Criteria for obtaining
accreditation.
(a) Analytical laboratories may be
accredited for the analyses of foodborne
indicator and pathogen analytes, or a
specified chemical residue or a class of
chemical residues, in raw or processed
meat, poultry, and egg products.
Analytical laboratories may be
accredited for the analyses of food
chemistry components in raw or
processed meat and poultry products.
(b) Accreditation will be granted only
if the applying laboratory successfully
satisfies FSIS requirements that are
stated in this part.
(c) To obtain FSIS accreditation, an
analytical laboratory must:
(1) Be supervised by a person holding,
at a minimum, a bachelor’s degree in
biology, chemistry, microbiology, food
science, food technology, or a related
field.
(i) For food chemistry accreditation,
the supervisor must also have one year
of experience in food chemistry
analysis, or equivalent qualifications.
(ii) For chemical residue
accreditation, either the supervisor or
the analyst assigned to analyze the
sample must also have three years of
experience determining analytes at or
below part per million levels, or
equivalent qualifications.
(iii) For indicator organisms or
pathogen accreditation, either the
supervisor or the analyst assigned to
analyze the sample must also have three
years of experience in foodborne
pathogen analyses, or equivalent
qualifications.
(2) Demonstrate the capability to
achieve quality assurance levels that are
within acceptable limits as determined
by evaluation that is consistent with ISO
13528 for the analysis of initial
accreditation proficiency testing
samples, in the analyte category for
which accreditation is sought. FSIS and
AOAC analytical test procedures are
acceptable for use in this program. FSIS
procedures may be found on the USDA
FSIS website at www.fsis.usda.gov.
AOAC procedures may be found on the
AOAC website at www.aoac.org.
(3) Complete a second set of
proficiency testing samples if the results
of the first set of proficiency testing
samples are unsuccessful.
(i) The second set of proficiency
testing samples will be provided within
30 days following the date of receipt by
FSIS of a request from the applying
laboratory. The second set of
proficiency testing samples will be
analyzed only for the analyte(s) for
which unacceptable initial results had
been obtained by the laboratory.
(ii) If the results of the second set of
proficiency testing samples are
unsuccessful, the laboratory may
request a third set of proficiency testing
samples after a 60-day waiting period,
commencing from the date of
notification by FSIS of unsuccessful
results. The third set of proficiency
testing samples will be analyzed only
for the analyte(s) for which
unacceptable initial results had been
obtained by the laboratory.
(iii) If the laboratory is unsuccessful
for the third set and still wishes to
pursue accreditation, the ALP will
require a new application and an
application fee if the initial
accreditation process is not completed
within eleven months. Documentation
of corrective action(s) related to the
previous unsuccessful accreditation
attempt must be submitted to and
accepted by the ALP.
(4) Allow inspection of the laboratory
facility and pertinent documents by
FSIS officials prior to the determination
of granting accredited status.
(5) Pay the accreditation fee by the
date required.
§ 439.20 Criteria for maintaining
accreditation.
(a) Accreditation. To maintain
accreditation, an analytical laboratory
must fulfill the requirements of this
section.
(b) Records. To demonstrate traceable
and appropriate application of
equipment, standards, procedures,
analysts, and approvals related to
accreditation, an accredited laboratory
must:
(1) Maintain laboratory quality control
records for the most recent three years
that samples have been analyzed.
(2) Maintain complete records of the
receipt, analysis, and disposition of
samples for the most recent three years
that samples have been analyzed.
(3) Maintain in a secure electronic
format or in a standards book, all
records, readings, and calculations for
prepared standards. Entries are to be
dated and the analyst identified at the
time of the entry, and manual
calculations verified and documented
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80675
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
by the supervisor, or by the supervisor’s
designee, before use of the standard.
The standards records are to be retained
for three years after the last recorded
entry. The certificates of analysis are to
be kept on file for purchased standards
for at least the period of time that the
materials are in use.
(4) Maintain records of instrument
maintenance and calibration. The
records are to be retained for three years
after the last recorded entry.
(5) As provided in paragraph (e) of
this section, records are to be made
available for review by any duly
authorized representative of the
Secretary of Agriculture, including ALP
personnel or their designees.
(c) Samples. Inter-laboratory
accreditation maintenance proficiency
testing sample.
(1) An accredited laboratory must
analyze inter-laboratory accreditation
maintenance proficiency testing
samples and return the results to the
ALP by the due date, which is usually
within approximately three weeks of
sample receipt. This must be done
whenever requested by FSIS and at no
cost to FSIS.
(2) Results must be those of the
accredited laboratory. Analyses of
proficiency testing samples must not be
contracted out by the accredited
laboratory.
(d) Corporate changes. The ALP must
be informed within 30 days of any
change of address or in the laboratory’s
ownership, officers, directors,
supervisory personnel, or other
responsibly connected individual or
entity.
(e) On-site review. An accredited
laboratory must permit any duly
authorized representative of the
Secretary to perform both announced
and unannounced on-site laboratory
reviews of facilities and records, both
hard copy and electronic, during normal
business hours, and to copy any records
pertaining to the laboratory’s
participation in the ALP.
(f) Analytical test procedures. An
accredited laboratory must use
analytical test procedures designated by
the FSIS ALP as being acceptable. FSIS
and AOAC analytical test procedures
are acceptable.
(g) Quality assurance levels. An
accredited laboratory must demonstrate
the capability to maintain quality
assurance levels that are within
acceptable limits as evaluated by the
ALP in the analysis of inter-laboratory
accreditation maintenance proficiency
testing samples for the analyte category
for which accreditation was granted. An
accredited laboratory will successfully
demonstrate the maintenance of these
capabilities if its results from inter-
laboratory accreditation maintenance
proficiency testing samples satisfy ALP
evaluation criteria based on ISO 13528,
to include performance evaluation by z
score statistics.
(h) Fees. An accredited laboratory
must pay the annual required
accreditation fee when it is due.
(i) Probation. If placed on probation,
an accredited laboratory must meet the
ALP requirements as prescribed in this
section in order to remove the probation
status.
(1) The laboratory must successfully
analyze a set of initial accreditation
proficiency testing samples for the
analyte(s) that triggered the probation
and submit the analytical results to FSIS
by the due date, which is typically
within approximately three weeks of
receipt of the samples.
(2) Similarly satisfy criteria for
accreditation maintenance proficiency
testing samples specified by the ALP in
this part.
(3) Provide written corrective action
documentation, related to the issue that
triggered the probation, to the ALP by
the date required.
(j) Suspension. If placed on
suspension, an accredited laboratory
must meet the ALP requirements as
prescribed in this section in order to
remove the suspension status. If the
laboratory is unsuccessful in meeting
the requirements to remove the
suspension status, accreditation will be
revoked.
(1) Laboratories that are suspended
due to performance or response issues
enter a waiting period of 60 days from
the effective date of that action. After
the 60-day period has passed and if the
laboratory wishes to pursue
reinstatement to the ALP, the laboratory
must submit a written corrective action
plan specifying what corrections were
made and illustrate to FSIS that the
corrections are effective or would
reasonably be expected to be effective.
(i) After the corrective action plan has
been accepted by the ALP, the
laboratory must successfully analyze a
set of initial accreditation proficiency
testing samples for the analyte(s) that
triggered the suspension and meet all
other program requirements including
payment of any annual fees that are due.
The ALP may perform an on-site
inspection at the laboratory’s facility
and/or require the laboratory to provide
documentation to confirm that it meets
the requirements of the program.
(ii) The suspended laboratory is
allowed two attempts to successfully
analyze the initial accreditation
proficiency testing set(s) of samples.
(2) Laboratories that are suspended
due to indictment or charges as
described in § 439.52 may not seek
removal of suspension status until being
cleared of said indictment or charges.
§ 439.50 Refusal of accreditation.
Upon a determination by the
Administrator, a laboratory will be
refused accreditation for the following
reasons:
(a) A laboratory will be refused
accreditation for failure to meet the
requirements of the ALP as stated in this
part.
(b) A laboratory will be refused
accreditation if the laboratory or any
individual or entity responsibly
connected with the laboratory has been
convicted of, or is under indictment for,
or has charges on any information
brought against them in a Federal or
State court concerning any of the
following violations of law:
(1) Any felony.
(2) Any misdemeanor based upon
acquiring, handling, or distributing of
unwholesome, misbranded, or
deceptively packaged food or upon
fraud in connection with transactions in
food.
(3) Any misdemeanor based upon a
false statement to any governmental
agency.
(4) Any misdemeanor based upon the
offering, giving or receiving of a bribe or
unlawful gratuity.
(5) Altering any official sample or
analytical finding; or substituting any
analytical result from any other
laboratory and representing the result as
its own.
§ 439.51 Probation of accreditation.
Upon a determination by the
Administrator, a laboratory will be
placed on probation for the following
reasons:
(a) If the laboratory fails to complete
more than one inter-laboratory
accreditation maintenance proficiency
testing sample analysis within 12
consecutive months, unless written
permission is granted by the
Administrator.
(b) If the laboratory does not respond
to ALP inquiries related to its
participation in the program or fails to
meet any of the requirements or criteria
set in this part.
(c) If the laboratory does not
successfully demonstrate the
maintenance of quality assurance
capabilities including its results from
inter-laboratory accreditation
maintenance proficiency testing
samples. ALP evaluation criteria are
based on ISO 13528, to include
performance evaluation by z score
statistics.
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS
80676
Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules
§ 439.52 Suspension of accreditation.
A laboratory will be suspended from
the program if probation status is not
rectified according to program
requirements stated in this part. The
accreditation of a laboratory will be
immediately suspended if the laboratory
or any individual or entity responsibly
connected with the laboratory is
indicted or has charges on information
brought against them in a Federal or
State court for any of the following
violations of law. A laboratory must
notify the ALP within 30 calendar days
if any of these situations occur.
(a) Any felony.
(b) Any misdemeanor based upon
acquiring, handling, or distributing of
unwholesome, misbranded, or
deceptively packaged food or upon
fraud in connection with transactions in
food.
(c) Any misdemeanor based upon a
false statement to any governmental
agency.
(d) Any misdemeanor based upon the
offering, giving or receiving of a bribe or
unlawful gratuity.
(e) Altering any official sample or
analytical finding; or substituting any
analytical result from any other
laboratory and representing the result as
its own.
§ 439.53 Revocation of accreditation.
A laboratory will have its
accreditation revoked from the program
if suspension status is not rectified. The
accreditation of a laboratory will also be
revoked for the following reasons:
(a) An accredited laboratory will have
its accreditation revoked if the
Administrator determines that the
laboratory or any responsibly connected
individual or any agent or employee
has:
(1) Altered any official sample or
analytical finding; or
(2) Substituted any analytical result
from any other laboratory and
represented the result as its own.
(b) An accredited laboratory will have
its accreditation revoked if the
laboratory or any individual or entity
responsibly connected with the
laboratory is convicted in a Federal or
State court of any of the following
violations of law. A laboratory must
notify the ALP within 30 calendar days
if any of these situations occur.
(1) Any felony.
(2) Any misdemeanor based upon
acquiring, handling, or distributing of
unwholesome, misbranded, or
deceptively packaged food or upon
fraud in connection with transactions in
food.
(3) Any misdemeanor based upon a
false statement to any governmental
agency.
(4) Any misdemeanor based upon the
offering, giving or receiving of a bribe or
unlawful gratuity.
§ 439.60 Notification and hearings.
Accreditation of any laboratory will
be refused, suspended, or revoked under
the conditions previously described in
this part 439. The owner or operator of
the laboratory will be sent written
notice of the refusal, suspension, or
revocation of accreditation by the
Administrator. In such cases, the
laboratory owner or operator will be
provided an opportunity to present,
within 30 days of the date of the
notification, a statement challenging the
merits or validity of such action and to
request an oral hearing with respect to
the denial, suspension, or revocation
decision. An oral hearing will be
granted if there is any dispute of
material fact joined in such responsive
statement. The proceeding will be
conducted thereafter in accordance with
the applicable rules of practice, which
will be adopted for the proceeding. Any
such refusal, suspension, or revocation
will be effective upon the receipt by the
laboratory of the notification and will
continue in effect until final
determination of the matter by the
Administrator.
Paul Kiecker,
Administrator.
[FR Doc. 2020–27016 Filed 12–11–20; 8:45 am]
BILLING CODE 3410–DM–P
SMALL BUSINESS ADMINISTRATION
13 CFR Parts 120 and 123
RIN 3245–AG98
Regulatory Reform Initiative:
Streamlining and Modernizing the 7(a),
Microloan, and 504 Loan Programs To
Reduce Unnecessary Regulatory
Burden
AGENCY
: U.S. Small Business
Administration.
ACTION
: Notice of proposed rulemaking.
SUMMARY
: The Small Business
Administration (SBA) is proposing to
remove or revise various regulations
affecting its business loan programs
because these regulations are obsolete,
unnecessary, ineffective, or
burdensome. In addition, one of the
regulations that SBA is proposing to
remove is cross-referenced in a
regulation in SBA’s Disaster Loan
Program; SBA is proposing to make a
conforming change to that regulation.
SBA also is making several technical
amendments to the regulations to
incorporate recent statutory changes and
other non-substantive changes. These
changes are being proposed to carry out
the mandate in various Executive
Orders to reduce the number and costs
of the regulations that Federal agencies
impose on the public.
DATES
: Comments are requested on or
before February 12, 2021.
ADDRESSES
: You may submit comments,
identified by RIN 3245–AG98, using any
of the following methods:
Federal eRulemaking Portal: http://
www.regulations.gov. Search for the rule
by RIN number 3245–AG98 and follow
the instructions for submitting
comments.
Mail: Linda Reilly, Chief, 504 Loan
Program Division, Office of Financial
Assistance, U.S. Small Business
Administration, 409 Third Street SW,
Washington, DC 20416.
SBA will post all comments on http://
www.regulations.gov. If you wish to
submit confidential business
information (CBI) as defined in the User
Notice at http://www.regulations.gov,
please submit the information to Linda
Reilly, Chief, 504 Loan Program
Division, U.S. Small Business
Administration, 409 Third Street SW,
Washington, DC 20416. Highlight the
information that you consider to be CBI
and explain why you believe this
information should be held confidential.
SBA will review the information and
make the final determination as to
whether to publish the information.
FOR FURTHER INFORMATION CONTACT
:
Linda Reilly, Chief, 504 Loan Program
Division, Office of Financial Assistance,
U.S. Small Business Administration,
409 Third Street SW, Washington, DC
20416; phone: (202) 205–9949; email
address: linda.reilly@sba.gov.
SUPPLEMENTARY INFORMATION
:
A. General Information
The mission of SBA is to maintain
and strengthen the Nation’s economy by
enabling the establishment and viability
of small businesses, and by assisting in
economic recovery of communities after
disasters. In carrying out this mission,
SBA has developed a regulatory policy
that is implemented primarily through
several core program offices: Office of
Capital Access, Office of Disaster
Assistance, Office of Entrepreneurial
Development, Office of Government
Contracting and Business Development,
Office of International Trade, and Office
of Investment and Innovation. SBA’s
regulations are codified at title 13 of the
Code of Federal Regulations (CFR),
VerDate Sep<11>2014 20:48 Dec 11, 2020 Jkt 253001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\14DEP1.SGM 14DEP1
jbell on DSKJLSW7X2PROD with PROPOSALS

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT