[Federal Register Volume 85, Number 240 (Monday, December 14, 2020)]
[Proposed Rules]
[Pages 80668-80676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27016]
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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.
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SUMMARY: FSIS is proposing to revise the regulations prescribing the
statistical
[[Page 80669]]
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
[[Page 80670]]
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 z' score (which includes
uncertainty in the calculation of the performance score) are widely
used and easy to calculate. The z score is currently calculated as:
zi = (xi-xpt)/[sigma]pt
where xi is the participant's result, xpt is
the assigned value of the PT sample analyte, and
[sigma]pt is the standard deviation for the proficiency
assessment.
The z' score is calculated as:
z'i = (xi-xpt)/
([sigma]\2\pt + [micro]\2\(xpt))0.5
where [micro] 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
[[Page 80671]]
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.
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\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.
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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).
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\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.
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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\
[[Page 80672]]
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.
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\3\ Like accreditation for food chemistry testing, this new
accreditation for microbiological testing would be authorized by the
AMA at 7 U.S.C. 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.
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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 x $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 x $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 x $1,474) to $8,844 (6 x $1,474), with a mid-point of
$5,159 (3.5 x $1,474).
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\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.
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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
[[Page 80673]]
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
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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
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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: [email protected].
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.
Sec. 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
[[Page 80674]]
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.
Sec. 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 [email protected]. 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.
Sec. 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.
Sec. 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
[[Page 80675]]
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 Sec. 439.52 may not seek removal of suspension status
until being cleared of said indictment or charges.
Sec. 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.
Sec. 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.
[[Page 80676]]
Sec. 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.
Sec. 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.
Sec. 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]
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