Changes to Accreditation of Non-Federal Analytical Testing Laboratories., 80668-80676 [2020-27016]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[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 https://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 https://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: 
https://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: 
https://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: https://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.

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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 https://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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