80668 Federal Register / Vol. 85, No. 240 / Monday, December 14, 2020 / Proposed Rules 

interfere with or adversely affect the law 

enforcement and counterintelligence 

purposes of this system and the overall 

law enforcement process, the applicable 

exemptions may be waived on a case by 

case basis. 

A notice of system of records DHS/ 

ALL–046 Counterintelligence Program 

System of Records is also publishing 

elsewhere in this issue of the Federal 

Register. 

List of Subjects in 6 CFR Part 5 

Freedom of information; Privacy. 

For the reasons stated in the 

preamble, DHS proposes to amend 

chapter I of title 6, Code of Federal 

Regulations, as follows: 

PART 5—DISCLOSURE OF RECORDS 

AND INFORMATION 

■ 1. The authority citation for part 5 

continues to read in part as follows: 

Authority: 6 U.S.C. 101 et seq.; Pub. L. 

107–296, 116 Stat. 2135; 5 U.S.C. 301. 

* * * * * 

■ 2. In appendix C to part 5, add 

paragraph 83 to read as follows: 

Appendix C to Part 5—DHS Systems of 

Records Exempt From the Privacy Act 

* * * * * 

83. The DHS/ALL–046 Counterintelligence 

Program System of Records consists of 

electronic and paper records and will be used 

by DHS and its components. The DHS/ALL– 

046 Counterintelligence Program System of 

Records covers information held by DHS in 

connection with various missions and 

functions, including, but not limited to the 

enforcement of civil and criminal laws; 

investigations, inquiries, and proceedings 

there under; and national security and 

intelligence activities. The system of records 

covers information that is collected by, on 

behalf of, in support of, or in cooperation 

with DHS and its components and may 

contain personally identifiable information 

collected by other federal, state, local, tribal, 

foreign, or international government 

agencies. 

The Secretary of Homeland Security, 

pursuant to 5 U.S.C. 552a(j)(2), has exempted 

this system from the following provisions of 

the Privacy Act: 5 U.S.C. 552a(c)(3), (c)(4); 

(d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), 

(e)(4)(I), (e)(5), (e)(8), (e)(12); (f); and (g)(1). 

Additionally, the Secretary of Homeland 

Security, pursuant to 5 U.S.C. 552a(k)(1), 

(k)(2), and (k)(5), has exempted this system 

from the following provisions of the Privacy 

Act: 5 U.S.C. 552a(c)(3); (d); (e)(1), (e)(4)(G), 

(e)(4)(H), (e)(4)(I); and (f). 

Where a record received from another 

system has been exempted in that source 

system under 5 U.S.C. 552a(j)(2), 5 U.S.C. 

552a(k)(1), (k)(2), and (k)(5), DHS will claim 

the same exemptions for those records that 

are claimed for the original primary systems 

of records from which they originated and 

claims any additional exemptions set forth 

here. 

Exemptions from these particular 

subsections are justified on a case-by-case 

basis and determined at the time a request is 

made, for the following reasons: 

(a) From subsection (c)(3) and (4) 

(Accounting for Disclosures) because release 

of the accounting of disclosures could alert 

the subject of an investigation of an actual or 

potential criminal, civil, or regulatory 

violation to the existence of that investigation 

and reveal investigative interest on the part 

of DHS and the recipient agency. Disclosure 

of the accounting would therefore present a 

serious impediment to law enforcement 

efforts and efforts to preserve national 

security. Disclosure of the accounting would 

also permit the subject of a record to impede 

the investigation, to tamper with witnesses or 

evidence, and to avoid detection or 

apprehension, which would undermine the 

entire investigative process. When an 

investigation has been completed, 

information on disclosures made may 

continue to be exempted if the fact that an 

investigation occurred remains sensitive after 

completion. 

(b) From subsection (d) (Access and 

Amendment to Records) because providing 

access or permitting amendment to the 

records contained in this system of records 

could inform the subject of an investigation 

of an actual or potential criminal, civil, or 

regulatory violation to the existence of that 

investigation and reveal investigative interest 

on the part of DHS or another agency. Access 

to the records could permit the subject of a 

record to impede the investigation, to tamper 

with witnesses or evidence, and to avoid 

detection or apprehension. Amendment of 

the records could interfere with ongoing 

investigations and law enforcement activities 

and would impose an unreasonable 

administrative burden by requiring 

investigations to be continually 

reinvestigated. In addition, permitting access 

and amendment to such information could 

disclose security-sensitive information that 

could be detrimental to homeland security. 

(c) From subsection (e)(1) (Relevancy and 

Necessity of Information) because in the 

course of investigations into potential 

violations of federal law, the accuracy of 

information obtained or introduced 

occasionally may be unclear, or the 

information may not be strictly relevant or 

necessary to a specific investigation. In the 

interests of effective law enforcement, it is 

appropriate to retain all information that may 

aid in establishing patterns of unlawful 

activity. 

(d) From subsection (e)(2) (Collection of 

Information from Individuals) because 

requiring that information be collected from 

the subject of an investigation would alert the 

subject to the nature or existence of the 

investigation, thereby interfering with that 

investigation and related law enforcement 

activities. 

(e) From subsection (e)(3) (Notice to 

Subjects) because providing such detailed 

information could impede law enforcement 

by compromising the existence of a 

confidential investigation or reveal the 

identity of witnesses or confidential 

informants. 

(f) From subsections (e)(4)(G), (e)(4)(H), 

and (e)(4)(I) (Agency Requirements) and (f) 

(Agency Rules), because portions of this 

system are exempt from the individual access 

provisions of subsection (d) for the reasons 

noted above, and therefore DHS is not 

required to establish requirements, rules, or 

procedures with respect to such access. 

Providing notice to individuals with respect 

to existence of records pertaining to them in 

the system of records or otherwise setting up 

procedures pursuant to which individuals 

may access and view records pertaining to 

themselves in the system would undermine 

investigative efforts and reveal the identities 

of witnesses, and potential witnesses, and 

confidential informants. 

(g) From subsection (e)(5) (Collection of 

Information) because with the collection of 

information for law enforcement purposes, it 

is impossible to determine in advance what 

information is accurate, relevant, timely, and 

complete. Compliance with subsection (e)(5) 

would preclude DHS agents from using their 

investigative training and exercise of good 

judgment to both conduct and report on 

investigations. 

(h) From subsection (e)(8) (Notice on 

Individuals) because compliance would 

interfere with DHS’s ability to obtain, serve, 

and issue subpoenas, warrants, and other law 

enforcement mechanisms that may be filed 

under seal and could result in disclosure of 

investigative techniques, procedures, and 

evidence. 

(i) From subsection (e)(12) (Matching 

Agreements) because requiring DHS to 

provide notice of a new or revised matching 

agreement with a non-Federal agency, if one 

existed, would impair DHS operations by 

indicating which data elements and 

information are valuable to DHS’s analytical 

functions, thereby providing harmful 

disclosure of information to individuals who 

would seek to circumvent or interfere with 

DHS’s missions. 

(j) From subsection (g)(1) (Civil Remedies) 

to the extent that the system is exempt from 

other specific subsections of the Privacy Act. 

Constantina Kozanas, 

Chief Privacy Officer, U.S. Department of 

Homeland Security. 

[FR Doc. 2020–27314 Filed 12–11–20; 8:45 am] 

BILLING CODE 9110–9N–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Part 439 

[Docket No. FSIS–2016–0026] 

RIN 0583–AD70 

Changes to Accreditation of NonFederal Analytical Testing 

Laboratories. 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Proposed rule. 

SUMMARY: FSIS is proposing to revise 

the regulations prescribing the statistical 


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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 nonFederal 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 onsite 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 nonFederal 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 


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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 oneyear 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 PTsample 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)/spt

where xi is the participant’s result, xpt is the 

assigned value of the PT sample analyte, 

and spt is the standard deviation for the 

proficiency assessment. 

The z′ score is calculated as: 

z′i = (xi¥xpt)/(s2

pt + m2(xpt))0.5

where m is the uncertainty of the assigned 

value. 

For the purposes of the ALP, the z′ 

score is considered part of z score 

statistics. 

CUSUM scoring, as currently set forth 

in 9 CFR 439.1(h) and 439.20(h)(3)–(5), 

addressed three main categories in 

evaluating PTs: 

(1) Systematic Laboratory Difference: 

Which is consistent positive or negative 

bias for a single laboratory’s results over 

time. Both positive and negative biases 

are determined in the same manner 

(only changing for the direction of the 

bias). Scoring for Systematic Laboratory 

Difference is represented by CUSUM P 

for positive bias and CUSUM N for 

negative bias. 

(2) Variability: Which is the 

combination of random fluctuations and 

systematic differences. Scoring for 

Variability is represented by CUSUM V. 

(3) Individual Large Discrepancy: 

Which is the magnitude and frequency 

of large differences between the results 

of an accredited laboratory and the 

accepted value of the PT. Scoring for 

Individual Large Discrepancy is 

represented by CUSUM D. 

All of the ALP CUSUM scoring (P, N, 

V, and D) is performed on the 

individual laboratory-reported PT 

results relative to the accepted or 

assigned value of the PT material. Each 

ALP CUSUM category has a limit that, 

if exceeded, incurs a penalty. Scores are 

monitored over the calendar year to 

detect exceedances. 

The proposed change from the use of 

CUSUM scoring to z score procedures 

for statistical evaluation of laboratory 

performance would not affect the ability 

of FSIS to address these three main 

categories (Systemic Laboratory 

Difference, Variability, and Individual 

Large Discrepancy) in evaluating PTs 

and would provide evaluation of 

equivalent purpose and depth. 

First, with regard to Systematic 

Laboratory Difference, CUSUM analyzes 

for both the direction and magnitude of 

bias via positive and negative scores. 

The z score equivalently provides this 

information by the value of the score. 

The sign of the z score value (positive 

or negative) indicates the direction of 

the bias relative to the accepted value of 

the PT sample. Because z score statistics 

are based on standard deviation, the 

score is normalized around the accepted 

value of the sample (represented by 

zero). A participant’s PT result that 

exactly matches the accepted value 

incurs a zero z score. A PT result that 

is slightly greater than the accepted 

value will have a z score that is slightly 

greater than zero. This presents an 

advantage over CUSUM scoring because 

one can easily visualize the z scores 

compared to zero in graphic form. 

CUSUM scoring often returns a zero 

score, even for deviations from the 

accepted value. CUSUM scoring will 

accept PT results up to a threshold and 

return a zero score. The threshold is 

dynamic and depends on the magnitude 

of difference between the PT result and 

the accepted value and also on the 

concentration of the analyte in the PT 

sample. Therefore, CUSUM P and N do 

not allow the same level of preciseness 

that z scores do in evaluating closeness 

of the reported result to the accepted 

value of the PT sample. 

Second, with regard to Variability, z 

score statistics provide the magnitude of 

the deviation from the accepted value. 

This would successfully replace 

CUSUM V for Variability. The z score 

has the added benefit of being 

directional (it indicates both positive 

and negative variation), while CUSUM 

V is not. The variations are also easier 

to detect visually because the z scores 

are normalized relative to the PT 

accepted value and graphs generated 

from these data are easily understood. 

Third, with regard to Individual Large 

Discrepancy, CUSUM D is readily 

replaceable by z score statistics. For z 

scores, typically a value greater than 3.0 

or less than ¥3.0 indicates an 

unacceptable value and may indicate 

performance problems. The z score has 

the added benefit of being directional (it 

indicates both positive and negative 

deviation). The CUSUM D is not 

directional. Currently, the CUSUM D is 

monitored over time in order to detect 

repeated failures. It is expected that any 

laboratory will occasionally report a PT 

sample result that falls outside the 

acceptable range for the sample 

accepted value, which results in an 

individual failing score that is random 

in nature. Repeated failures are not 

random and constitute a trend. Under 

this proposed rule, FSIS would continue 

to monitor the z scores for each 

accredited laboratory to detect trends 


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1The 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. 

2Citation 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. 

3Like accreditation for food chemistry testing, 

this new accreditation for microbiological testing 

would be authorized by the AMA at 7 U.S.C. 

Continued 

that indicate performance issues. As 

stated above, FSIS monitors CUSUM 

scores for one calendar year for 

exceedances. After this period of time, 

FSIS resets CUSUMs. Because z scores 

are not reset, changing from CUSUMs to 

z score statistics offers the advantage of 

detecting repeated exceedances over an 

extended period of time. 

Updating the ALP statistical tools 

would also eliminate the need for 

employing a standardizing value, which 

is a number used to transform the result 

of a computation to a unitless measure, 

representing the performance standard 

deviation of an individual result. The z 

score is already unitless and is directly 

based on standard deviation statistics. 

Eliminating the need for a standardizing 

value would have the added benefit of 

making it easier to add relevant 

chemical residues of current concern to 

the PT sample program. The added 

flexibility for the ALP to create and offer 

PT samples that contain veterinary drug 

and chemical residues of current 

concern would increase the 

opportunities for laboratories to prove 

that they can successfully analyze 

samples for these compounds. 

Standardizing values are specific to 

each matrix/residue combination and 

require the evaluation of extensive 

background information in order to 

calculate each standardizing value. The 

z score approach does not involve such 

a requirement and is readily adaptable 

to the addition of new residues. 

Another limitation of the current ALP 

PT structure has been that analytes in 

samples must be easy to detect, with 

minimal measurement uncertainty, for 

the CUSUM statistics to remain viable. 

It is common to have some chemical 

elements and compounds that are 

difficult to measure in a sample, even 

under the best of circumstances. 

Laboratory PT sample results for these 

difficult analytes are expected to be 

relatively poor, exhibiting large 

measurement uncertainty. The z score 

would allow the ALP to take the 

uncertainty into account when scoring 

laboratory performance for these 

difficult analytes. There is no such 

consideration with CUSUM scoring. As 

a result, the PT samples in the past 

largely excluded difficult analytes, 

regardless of the food safety concerns 

that those residues might have. Because 

the z ′ score takes the uncertainty into 

account, the ALP would be able to 

include analytes that are difficult to 

analyze in PT samples and generate 

resulting scores that do not penalize 

laboratories for an issue that lies with 

the analyte instead of the laboratory. 

Furthermore, when there is more than 

one residue analyte in a single PT 

sample, the ALP has been combining 

the results for a single score. Combining 

results is not an accepted practice in the 

PT community. Changing to the z score 

approach would easily allow scoring for 

individual analytes. 

A comparison of z scores and CUSUM 

scores from seventeen separate ALP 

food chemistry PT sample events with 

a focus on outliers shows that it is a 

good replacement for CUSUM scoring.1

When using both CUSUM scoring and z 

scores, individual results are evaluated 

for outliers. The outliers are removed to 

determine the study comparison mean 

and then placed back into the study 

evaluation for scoring the individual 

laboratories. The ALP evaluation, which 

used 61 individual ALP CUSUM scores 

and 61 individual z scores for the same 

sets of laboratory results, showed that 

when CUSUM scoring indicated the 

presence of an outlier, the z scores 

either also indicated the outlier or 

returned a score warning that the result 

was close to becoming an outlier. 

Conversely, when the z scores indicated 

an outlier that CUSUM scoring did not, 

the result still sustained a relatively 

large ALP CUSUM score increase. One 

of the 61 results that was an outlier 

among the ALP CUSUMs was not an 

outlier among the z scores and there was 

no warning that the result was close to 

becoming an outlier. However, the z 

score was very close to the warning 

limit. Warning limits are z scores 

between –3 and –2, and also between 2 

and 3. Results that incur a z score in the 

warning limit are not considered 

outliers, but are a signal to the 

laboratory that it may have an emerging 

problem and should be prepared to 

troubleshoot the analytical system. 

The ALP evaluation also considered 

use of the product code, which is 

currently part of CUSUM calculations, 

to determine if it needed to be retained 

in any capacity within the ALP. This 

was done by examining the percent 

relative standard deviation (Percent 

RSD) of the PT comparison means 

within and among product classes 

(classes are defined by meat type and fat 

content, e.g., low-fat ham). Product 

classes are represented numerically by 

product codes, which are assigned by 

product type, salt content, and moisture 

content. Product codes are then used in 

selecting the standardizing values for 

calculating CUSUMs. Not all product 

codes were available for this 

assessment. In the evaluation, the 

Percent RSD appears to be largely 

affected by the relative amount of a 

constituent, just as the product code is 

determined, in part, by the relative 

amount of a target analyte. As expected, 

the lower the constituent content, the 

larger the Percent RSD. All Percent RSD 

values were less than 8, which is well 

within accepted norms for interlaboratory 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 nonFederal laboratories, for a fee, to 

conduct analytic testing of meat and 

poultry. Under the AMA at 7 U.S.C. 

1622(o),2 FSIS accredits non-Federal 

laboratories to conduct food chemistry 

testing, i.e., testing of a food’s 

nutritional components. Additionally, 

under the Food, Agriculture, 

Conservation, and Trade Act (1990 Farm 

Bill), FSIS accredits non-Federal 

laboratories, for a fee, to conduct testing 

for chemical residues on food (7 U.S.C. 

138–138i). 

FSIS’s current regulations provide for 

accreditation of non-Federal laboratories 

to conduct only the chemical analysis of 

the nutritional components of and 

specific chemical residues in food. This 

limits the opportunities for industry to 

use analytical results from accredited 

non-Federal laboratories as part of their 

food safety systems in support of the 

Agency’s food safety mission. FSIS is 

thus proposing to accredit non-Federal 

laboratories for microbiological testing,3


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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. 

4Fees and charges for laboratory accreditation are 

provided in 9 CFR 391. 

5This cost is based on publicly listed industry 

prices provided by N.P Analytical Laboratories, 

https://www.npal.com/#/Services/OurServices, 

accessed on 1/9/2018. 

6 In 2016, there were 2 new applicants and 4 

probation applicants, in 2017, there were no new 

applicants and 1 probation applicant. 

in response to industry interest. In the 

future, these changes would potentially 

allow ALP-accredited laboratories that 

conduct process control laboratory 

testing, already done by regulated 

establishments to support their food 

safety systems, to include those results 

in future FSIS databases for Agency 

consideration in process performance 

categorizations. Participating 

laboratories that join the ALP as a result 

of this expansion would be required to 

participate in the program PT events 

and undergo on-site audits just as ALPaccredited laboratories currently do. 

Request for Stakeholder Comments 

The Agency is interested in comments 

concerning this proposal. The Agency 

specifically requests comments from 

regulated industry and non-Federal 

laboratories on (1) how to best manage 

data associated with an expanded ALP 

program, (2) any food matrix and 

analyte pairs they are interested in 

seeing offered in a possible expanded 

ALP accreditation program, (3) whether 

ISO 17025 accreditation should be a 

prerequisite to membership in the ALP 

since it is recognized as providing the 

general requirements for the 

competence of testing and calibration 

laboratories, and (4) ways to incentivize 

membership in the ALP, to include a 

possible annual fee reduction for 

laboratories already ISO 17025 

accredited if not a requirement. 

Additional Regulatory Changes 

Most of the proposed changes to 9 

CFR part 439 are associated with the 

removal of the ALP CUSUM statistics 

and expanding the program to include 

microbiological testing (e.g., indicator 

organisms and foodborne pathogens). 

Expanding the program would 

potentially allow FSIS to include data 

from industry, in addition to data from 

official samples, for Agency 

consideration in assessing an 

establishment’s process performance. 

The Agency is proposing to remove the 

‘‘official sample’’ definition from the 

regulation because this will allow the 

Agency the flexibility to consider data 

from industry to assess process 

performance. The proposed changes 

also provide the flexibility to add 

matrices of interest to industry that are 

under FSIS jurisdiction, such as egg 

products, and would better align the 

program description and requirements 

with the way the program currently 

operates and with future program 

updates. A robust ALP can provide 

industry with additional accredited 

non-federal analytical laboratories to 

perform their testing in order to provide 

quality and reliable results to support 

their food safety systems. Other existing 

ALP requirements in 9 CFR part 439 for 

obtaining and maintaining 

accreditation, including education, 

experience, and legal requirements, 

would remain the same. 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order (E.O.)13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This 

proposed rule has been designated a 

‘‘non-significant’’ regulatory action 

under section 3(f) of E.O. 12866. 

Accordingly, the rule has not been 

reviewed by the Office of Management 

and Budget under E.O. 12866. 

Need for the Rule 

According to Agency experts, there 

were approximately 55 food chemistry 

laboratories participating in the ALP in 

2012. Since then, participation has 

declined to 38 laboratories in 2019. Of 

those laboratories, 29 were accredited 

for food chemistry, 13 for chemical 

residue chlorinated pesticides analysis, 

and 4 for chemical residue PCBs 

analysis. Participation in the ALP might 

be bolstered by expanding the ALP to 

include additional analytes, such as 

indicator organisms and foodborne 

pathogens. In addition, switching from 

the CUSUM PT sample scoring system 

currently used by the ALP to z scorebased statistics should simplify the 

accreditation process for both the 

laboratories and the Agency. 

Expected Industry Cost Savings 

Although the proposed rule does not 

change the accreditation fee structure,4

it would reduce the number of samples 

non-Federal food chemistry laboratories 

would have to analyze to attain and 

maintain food chemistry accreditation. 

Based on industry data, laboratories 

charge approximately $67 5 per sample. 

Current criteria for obtaining 

accreditation (9 CFR 439.10(d)(2)(i)) 

require that laboratories analyze a set of 

36 samples (9 CFR part 439.1 (k) ‘‘Initial 

accreditation check sample’’) for food 

chemistry to obtain initial accreditation 

or to remove probationary status in food 

chemistry. The estimated cost for 

analyzing the sample set (also known as 

qualification set) is approximately 

$2,412 (36 × $67 = $2,412). This number 

of samples is not necessary to 

statistically evaluate laboratory 

performance for admittance to the 

program. FSIS is proposing to permit 

the ALP to offer laboratories smaller sets 

for food chemistry accreditation. The 

smaller qualification sets would reduce 

costs for laboratories and still be large 

enough to evaluate laboratory 

performance. Agency experts provided 

an estimated cost of analysis of 

approximately $938 when using 14 

samples per set (14 × $67 = $938), a 

reduction of $1,474 ($2,412¥$938 = 

$1,474) per qualification set for food 

chemistry. This analysis assumes that 

between 1 and 6 establishments would 

have to complete qualification sets in 

any given year.6 The Agency seeks 

comment on this assumption. Based on 

this assumption the annual savings 

ranges from $1,474 (1 × $1,474) to 

$8,844 (6 × $1,474), with a mid-point of 

$5,159 (3.5 × $1,474). 

Additionally, the proposed changes to 

the accreditation process (9 CFR 

439.10(d)(4)(ii)) are expected to reduce 

industry costs. Current criteria state that 

if a laboratory’s second set of 

qualification samples do not meet the 

criteria for obtaining accreditation, 

laboratories must submit a new 

application, all fees, and all 

documentation of corrective action 

required for accreditation. FSIS is 

proposing to no longer require food 

chemistry laboratories to reapply and 

pay the fees again before receiving the 

third qualification sample set. Instead, 

fees would be paid after the third set or 

if the initial accreditation process is not 

completed within eleven months. This 

is expected to reduce an applicable 

laboratory’s accreditation cost between 

$2,100 and $5,000. 

Regulatory Flexibility Analysis 

The FSIS Administrator 

(Administrator) has made a preliminary 

determination that this proposed rule 


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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 EGovernment Act (44 U.S.C. 3601, et 

seq.) by, among other things, promoting 

the use of the internet and other 

information technologies and providing 

increased opportunities for citizen 

access to Government information and 

services. 

Executive Order 13175 

This proposed rule has been reviewed 

in accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this proposed regulation will not have 

substantial and direct effects on Tribal 

governments and will not have 

significant Tribal implications. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, FSIS will 

announce this Federal Register 

publication on-line through the FSIS 

web page located at: http://

www.fsis.usda.gov/federal-register. 

FSIS will also announce and provide 

a link to this Federal Register 

publication through the FSIS 

Constituent Update, which is used to 

provide information regarding FSIS 

policies, procedures, regulations, 

Federal Register notices, FSIS public 

meetings, and other types of information 

that could affect or would be of interest 

to our constituents and stakeholders. 

The Constituent Update is available on 

the FSIS web page. Through the web 

page, FSIS can provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an email 

subscription service which provides 

automatic and customized access to 

selected food safety news and 

information. This service is available at: 

http://www.fsis.usda.gov/subscribe. 

Options range from recalls to export 

information, regulations, directives, and 

notices. Customers can add or delete 

subscriptions themselves and have the 

option to password protect their 

accounts. 

USDA Non-Discrimination Statement 

No agency, officer, or employee of the 

USDA shall, on the grounds of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, 

disability, age, marital status, family/ 

parental status, income derived from a 

public assistance program, or political 

beliefs, exclude from participation in, 

deny the benefits of, or subject to 

discrimination any person in the United 

States under any program or activity 

conducted by the USDA. 

How To File a Complaint of 

Discrimination 

To file a complaint of discrimination, 

complete the USDA Program 

Discrimination Complaint Form, which 

may be accessed online at http://

www.ocio.usda.gov/sites/default/files/ 

docs/2012/Complain_combined_6_8_

12.pdf, or write a letter signed by you 

or your authorized representative. 

Send your completed complaint form 

or letter to USDA by mail, fax, or email: 

Mail: U.S. Department of Agriculture, 

Director, Office of Adjudication, 1400 

Independence Avenue SW, Washington, 

DC 20250–9410, Fax: (202) 690–7442, 

Email: program.intake@usda.gov. 

Persons with disabilities who require 

alternative means for communication 

(Braille, large print, audiotape, etc.), 

should contact USDA’s TARGET Center 

at (202) 720–2600 (voice and TDD). 

List of Subjects in 9 CFR Part 439 

Laboratories. 

For the reasons discussed in the 

preamble, FSIS is proposing to amend 9 

CFR Chapter III by revising part 439 to 

read as follows: 

PART 439—ACCREDITATION OF NONFEDERAL LABORATORIES FOR 

ANALYTICAL TESTING OF MEAT, 

POULTRY, AND EGG PRODUCTS 

Sec. 

439.1 Definitions. 

439.5 Applications for accreditation. 

439.10 Criteria for obtaining accreditation. 

439.20 Criteria for maintaining 

accreditation. 

439.50 Refusal of accreditation. 

439.51 Probation of accreditation. 

439.52 Suspension of accreditation. 

439.53 Revocation of accreditation. 

439.60 Notifications and hearings. 

Authority: 7 U.S.C. 138f, 450, 1901–1906, 

1622(o); 21 U.S.C. 451–470, 601–695; 7 CFR 

2.18, 2.53. 

§ 439.1 Definitions. 

(a) Accredited Laboratory Program 

(ALP)—The voluntary FSIS program in 

which non-Federal laboratories are 

accredited as capable of performing 

analyses with the level of quality that is 

necessary to maintain accreditation in 

the program, on samples of raw or 

processed meat, poultry, and egg 

products, and through which a 

proficiency testing sample program for 

quality assurance is conducted. 

(b) Food chemistry—Analysis of raw 

or processed meat or poultry products 

for the components moisture, protein, 

fat, and salt. 

(c) Initial accreditation proficiency 

testing sample—A sample provided by 

the ALP to a non-Federal laboratory to 

determine whether the laboratory’s 

analytical capability meets the 

standards for acceptance into the 

program. The concentration or presence 

of the targeted analyte(s) and the 

composition of the components in the 

sample is unknown to the laboratory. 

(d) Inter-laboratory accreditation 

maintenance proficiency testing 

sample—A sample provided by FSIS to 

an accredited laboratory to assist in 

determining whether the laboratory is 

maintaining acceptable analytical 

performance for a given analyte or 

component. The concentration or 

presence of the targeted analyte(s) and 

the composition of the components in 

the sample is unknown to the 

laboratory. 

(e) ISO 13528—ISO 13528:2015(E) 

Corrected version 2016, ‘‘Statistical 

methods for use in proficiency testing 

by interlaboratory comparison,’’ October 

15, 2016, or updated versions. 

(f) Probation—The period 

commencing with official notification to 

an accredited laboratory that it no 

longer satisfies the ALP performance 

requirements specified in this part, and 

ending with official notification that 


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accreditation is fully restored, is 

suspended, or is revoked. 

(g) Refusal of accreditation—An 

action taken by FSIS when a laboratory 

that is applying for accreditation is 

denied the accreditation. 

(h) Responsibly connected—Any 

individual, or entity, that is a partner, 

officer, director, manager, or owner of 

10 percent or more of the voting stock 

of the applicant or recipient of 

accreditation or an employee in a 

managerial or executive capacity or any 

employee who conducts or supervises 

the analysis of FSIS samples. 

(i) Revocation of accreditation—An 

action taken by FSIS against a laboratory 

thereby removing the laboratory’s 

certification of accreditation and 

participation in inter-laboratory 

accreditation maintenance proficiency 

testing sample events. 

(j) Suspension of accreditation—An 

action taken by FSIS against a laboratory 

thereby temporarily removing the 

laboratory’s certification of accreditation 

and participation in the inter-laboratory 

accreditation maintenance proficiency 

testing sample events. Suspension of 

accreditation ends when accreditation 

either is fully restored or is revoked. 

(k) z score—A statistically derived 

number representing a laboratory’s 

performance for analyzing proficiency 

testing samples. The ALP calculates and 

interprets z scores consistent with ISO 

13528. 

§ 439.5 Applications for accreditation. 

(a) Participation in the ALP is 

voluntary. Application for accreditation 

must be made on designated paper or 

electronic forms provided by FSIS, or 

otherwise in writing, by the owner or 

manager of a non-Federal analytical 

laboratory. Application forms may be 

obtained by contacting the ALP at ALP@

usda.gov. The forms must be sent to the 

ALP or may be submitted electronically. 

The application must specify the kinds 

of accreditation sought by the owner or 

manager of the laboratory. A laboratory 

whose accreditation has been refused, or 

revoked for performance reasons may 

reapply for accreditation after 60 days 

from the effective date of that action, 

and must provide written 

documentation specifying what 

corrections were made and illustrate to 

FSIS that the corrections are effective or 

would reasonably be expected to be 

effective. 

(b) At the time that an application for 

accreditation is filed with the ALP, the 

laboratory must submit a check, bank 

draft, or money order in the amount 

specified by FSIS as directed in 9 CFR 

391.5, made payable to the U.S. 

Department of Agriculture, along with 

the completed application for the 

accreditation(s). 

(c) Application for Accreditation will 

not be processed or allowed to advance, 

without further procedure, if the 

accreditation fee(s) is delinquent. 

(d) FSIS will issue a bill annually in 

the amount specified by FSIS in 9 CFR 

391.5 for each accreditation held and 

are due by the date required. Bills are 

payable by check, bank draft, or money 

order made payable to the U.S. 

Department of Agriculture. 

§ 439.10 Criteria for obtaining 

accreditation. 

(a) Analytical laboratories may be 

accredited for the analyses of foodborne 

indicator and pathogen analytes, or a 

specified chemical residue or a class of 

chemical residues, in raw or processed 

meat, poultry, and egg products. 

Analytical laboratories may be 

accredited for the analyses of food 

chemistry components in raw or 

processed meat and poultry products. 

(b) Accreditation will be granted only 

if the applying laboratory successfully 

satisfies FSIS requirements that are 

stated in this part. 

(c) To obtain FSIS accreditation, an 

analytical laboratory must: 

(1) Be supervised by a person holding, 

at a minimum, a bachelor’s degree in 

biology, chemistry, microbiology, food 

science, food technology, or a related 

field. 

(i) For food chemistry accreditation, 

the supervisor must also have one year 

of experience in food chemistry 

analysis, or equivalent qualifications. 

(ii) For chemical residue 

accreditation, either the supervisor or 

the analyst assigned to analyze the 

sample must also have three years of 

experience determining analytes at or 

below part per million levels, or 

equivalent qualifications. 

(iii) For indicator organisms or 

pathogen accreditation, either the 

supervisor or the analyst assigned to 

analyze the sample must also have three 

years of experience in foodborne 

pathogen analyses, or equivalent 

qualifications. 

(2) Demonstrate the capability to 

achieve quality assurance levels that are 

within acceptable limits as determined 

by evaluation that is consistent with ISO 

13528 for the analysis of initial 

accreditation proficiency testing 

samples, in the analyte category for 

which accreditation is sought. FSIS and 

AOAC analytical test procedures are 

acceptable for use in this program. FSIS 

procedures may be found on the USDA 

FSIS website at www.fsis.usda.gov. 

AOAC procedures may be found on the 

AOAC website at www.aoac.org. 

(3) Complete a second set of 

proficiency testing samples if the results 

of the first set of proficiency testing 

samples are unsuccessful. 

(i) The second set of proficiency 

testing samples will be provided within 

30 days following the date of receipt by 

FSIS of a request from the applying 

laboratory. The second set of 

proficiency testing samples will be 

analyzed only for the analyte(s) for 

which unacceptable initial results had 

been obtained by the laboratory. 

(ii) If the results of the second set of 

proficiency testing samples are 

unsuccessful, the laboratory may 

request a third set of proficiency testing 

samples after a 60-day waiting period, 

commencing from the date of 

notification by FSIS of unsuccessful 

results. The third set of proficiency 

testing samples will be analyzed only 

for the analyte(s) for which 

unacceptable initial results had been 

obtained by the laboratory. 

(iii) If the laboratory is unsuccessful 

for the third set and still wishes to 

pursue accreditation, the ALP will 

require a new application and an 

application fee if the initial 

accreditation process is not completed 

within eleven months. Documentation 

of corrective action(s) related to the 

previous unsuccessful accreditation 

attempt must be submitted to and 

accepted by the ALP. 

(4) Allow inspection of the laboratory 

facility and pertinent documents by 

FSIS officials prior to the determination 

of granting accredited status. 

(5) Pay the accreditation fee by the 

date required. 

§ 439.20 Criteria for maintaining 

accreditation. 

(a) Accreditation. To maintain 

accreditation, an analytical laboratory 

must fulfill the requirements of this 

section. 

(b) Records. To demonstrate traceable 

and appropriate application of 

equipment, standards, procedures, 

analysts, and approvals related to 

accreditation, an accredited laboratory 

must: 

(1) Maintain laboratory quality control 

records for the most recent three years 

that samples have been analyzed. 

(2) Maintain complete records of the 

receipt, analysis, and disposition of 

samples for the most recent three years 

that samples have been analyzed. 

(3) Maintain in a secure electronic 

format or in a standards book, all 

records, readings, and calculations for 

prepared standards. Entries are to be 

dated and the analyst identified at the 

time of the entry, and manual 

calculations verified and documented 


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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 interlaboratory accreditation maintenance 

proficiency testing samples satisfy ALP 

evaluation criteria based on ISO 13528, 

to include performance evaluation by z 

score statistics. 

(h) Fees. An accredited laboratory 

must pay the annual required 

accreditation fee when it is due. 

(i) Probation. If placed on probation, 

an accredited laboratory must meet the 

ALP requirements as prescribed in this 

section in order to remove the probation 

status. 

(1) The laboratory must successfully 

analyze a set of initial accreditation 

proficiency testing samples for the 

analyte(s) that triggered the probation 

and submit the analytical results to FSIS 

by the due date, which is typically 

within approximately three weeks of 

receipt of the samples. 

(2) Similarly satisfy criteria for 

accreditation maintenance proficiency 

testing samples specified by the ALP in 

this part. 

(3) Provide written corrective action 

documentation, related to the issue that 

triggered the probation, to the ALP by 

the date required. 

(j) Suspension. If placed on 

suspension, an accredited laboratory 

must meet the ALP requirements as 

prescribed in this section in order to 

remove the suspension status. If the 

laboratory is unsuccessful in meeting 

the requirements to remove the 

suspension status, accreditation will be 

revoked. 

(1) Laboratories that are suspended 

due to performance or response issues 

enter a waiting period of 60 days from 

the effective date of that action. After 

the 60-day period has passed and if the 

laboratory wishes to pursue 

reinstatement to the ALP, the laboratory 

must submit a written corrective action 

plan specifying what corrections were 

made and illustrate to FSIS that the 

corrections are effective or would 

reasonably be expected to be effective. 

(i) After the corrective action plan has 

been accepted by the ALP, the 

laboratory must successfully analyze a 

set of initial accreditation proficiency 

testing samples for the analyte(s) that 

triggered the suspension and meet all 

other program requirements including 

payment of any annual fees that are due. 

The ALP may perform an on-site 

inspection at the laboratory’s facility 

and/or require the laboratory to provide 

documentation to confirm that it meets 

the requirements of the program. 

(ii) The suspended laboratory is 

allowed two attempts to successfully 

analyze the initial accreditation 

proficiency testing set(s) of samples. 

(2) Laboratories that are suspended 

due to indictment or charges as 

described in § 439.52 may not seek 

removal of suspension status until being 

cleared of said indictment or charges. 

§ 439.50 Refusal of accreditation. 

Upon a determination by the 

Administrator, a laboratory will be 

refused accreditation for the following 

reasons: 

(a) A laboratory will be refused 

accreditation for failure to meet the 

requirements of the ALP as stated in this 

part. 

(b) A laboratory will be refused 

accreditation if the laboratory or any 

individual or entity responsibly 

connected with the laboratory has been 

convicted of, or is under indictment for, 

or has charges on any information 

brought against them in a Federal or 

State court concerning any of the 

following violations of law: 

(1) Any felony. 

(2) Any misdemeanor based upon 

acquiring, handling, or distributing of 

unwholesome, misbranded, or 

deceptively packaged food or upon 

fraud in connection with transactions in 

food. 

(3) Any misdemeanor based upon a 

false statement to any governmental 

agency. 

(4) Any misdemeanor based upon the 

offering, giving or receiving of a bribe or 

unlawful gratuity. 

(5) Altering any official sample or 

analytical finding; or substituting any 

analytical result from any other 

laboratory and representing the result as 

its own. 

§ 439.51 Probation of accreditation. 

Upon a determination by the 

Administrator, a laboratory will be 

placed on probation for the following 

reasons: 

(a) If the laboratory fails to complete 

more than one inter-laboratory 

accreditation maintenance proficiency 

testing sample analysis within 12 

consecutive months, unless written 

permission is granted by the 

Administrator. 

(b) If the laboratory does not respond 

to ALP inquiries related to its 

participation in the program or fails to 

meet any of the requirements or criteria 

set in this part. 

(c) If the laboratory does not 

successfully demonstrate the 

maintenance of quality assurance 

capabilities including its results from 

inter-laboratory accreditation 

maintenance proficiency testing 

samples. ALP evaluation criteria are 

based on ISO 13528, to include 

performance evaluation by z score 

statistics. 


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§ 439.52 Suspension of accreditation. 

A laboratory will be suspended from 

the program if probation status is not 

rectified according to program 

requirements stated in this part. The 

accreditation of a laboratory will be 

immediately suspended if the laboratory 

or any individual or entity responsibly 

connected with the laboratory is 

indicted or has charges on information 

brought against them in a Federal or 

State court for any of the following 

violations of law. A laboratory must 

notify the ALP within 30 calendar days 

if any of these situations occur. 

(a) Any felony. 

(b) Any misdemeanor based upon 

acquiring, handling, or distributing of 

unwholesome, misbranded, or 

deceptively packaged food or upon 

fraud in connection with transactions in 

food. 

(c) Any misdemeanor based upon a 

false statement to any governmental 

agency. 

(d) Any misdemeanor based upon the 

offering, giving or receiving of a bribe or 

unlawful gratuity. 

(e) Altering any official sample or 

analytical finding; or substituting any 

analytical result from any other 

laboratory and representing the result as 

its own. 

§ 439.53 Revocation of accreditation. 

A laboratory will have its 

accreditation revoked from the program 

if suspension status is not rectified. The 

accreditation of a laboratory will also be 

revoked for the following reasons: 

(a) An accredited laboratory will have 

its accreditation revoked if the 

Administrator determines that the 

laboratory or any responsibly connected 

individual or any agent or employee 

has: 

(1) Altered any official sample or 

analytical finding; or 

(2) Substituted any analytical result 

from any other laboratory and 

represented the result as its own. 

(b) An accredited laboratory will have 

its accreditation revoked if the 

laboratory or any individual or entity 

responsibly connected with the 

laboratory is convicted in a Federal or 

State court of any of the following 

violations of law. A laboratory must 

notify the ALP within 30 calendar days 

if any of these situations occur. 

(1) Any felony. 

(2) Any misdemeanor based upon 

acquiring, handling, or distributing of 

unwholesome, misbranded, or 

deceptively packaged food or upon 

fraud in connection with transactions in 

food. 

(3) Any misdemeanor based upon a 

false statement to any governmental 

agency. 

(4) Any misdemeanor based upon the 

offering, giving or receiving of a bribe or 

unlawful gratuity. 

§ 439.60 Notification and hearings. 

Accreditation of any laboratory will 

be refused, suspended, or revoked under 

the conditions previously described in 

this part 439. The owner or operator of 

the laboratory will be sent written 

notice of the refusal, suspension, or 

revocation of accreditation by the 

Administrator. In such cases, the 

laboratory owner or operator will be 

provided an opportunity to present, 

within 30 days of the date of the 

notification, a statement challenging the 

merits or validity of such action and to 

request an oral hearing with respect to 

the denial, suspension, or revocation 

decision. An oral hearing will be 

granted if there is any dispute of 

material fact joined in such responsive 

statement. The proceeding will be 

conducted thereafter in accordance with 

the applicable rules of practice, which 

will be adopted for the proceeding. Any 

such refusal, suspension, or revocation 

will be effective upon the receipt by the 

laboratory of the notification and will 

continue in effect until final 

determination of the matter by the 

Administrator. 

Paul Kiecker, 

Administrator. 

[FR Doc. 2020–27016 Filed 12–11–20; 8:45 am] 

BILLING CODE 3410–DM–P 

SMALL BUSINESS ADMINISTRATION 

13 CFR Parts 120 and 123 

RIN 3245–AG98 

Regulatory Reform Initiative: 

Streamlining and Modernizing the 7(a), 

Microloan, and 504 Loan Programs To 

Reduce Unnecessary Regulatory 

Burden 

AGENCY: U.S. Small Business 

Administration. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Small Business 

Administration (SBA) is proposing to 

remove or revise various regulations 

affecting its business loan programs 

because these regulations are obsolete, 

unnecessary, ineffective, or 

burdensome. In addition, one of the 

regulations that SBA is proposing to 

remove is cross-referenced in a 

regulation in SBA’s Disaster Loan 

Program; SBA is proposing to make a 

conforming change to that regulation. 

SBA also is making several technical 

amendments to the regulations to 

incorporate recent statutory changes and 

other non-substantive changes. These 

changes are being proposed to carry out 

the mandate in various Executive 

Orders to reduce the number and costs 

of the regulations that Federal agencies 

impose on the public. 

DATES: Comments are requested on or 

before February 12, 2021. 

ADDRESSES: You may submit comments, 

identified by RIN 3245–AG98, using any 

of the following methods: 

Federal eRulemaking Portal: http://

www.regulations.gov. Search for the rule 

by RIN number 3245–AG98 and follow 

the instructions for submitting 

comments. 

Mail: Linda Reilly, Chief, 504 Loan 

Program Division, Office of Financial 

Assistance, U.S. Small Business 

Administration, 409 Third Street SW, 

Washington, DC 20416. 

SBA will post all comments on http:// 

www.regulations.gov. If you wish to 

submit confidential business 

information (CBI) as defined in the User 

Notice at http://www.regulations.gov, 

please submit the information to Linda 

Reilly, Chief, 504 Loan Program 

Division, U.S. Small Business 

Administration, 409 Third Street SW, 

Washington, DC 20416. Highlight the 

information that you consider to be CBI 

and explain why you believe this 

information should be held confidential. 

SBA will review the information and 

make the final determination as to 

whether to publish the information. 

FOR FURTHER INFORMATION CONTACT: 

Linda Reilly, Chief, 504 Loan Program 

Division, Office of Financial Assistance, 

U.S. Small Business Administration, 

409 Third Street SW, Washington, DC 

20416; phone: (202) 205–9949; email 

address: linda.reilly@sba.gov. 

SUPPLEMENTARY INFORMATION: 

A. General Information 

The mission of SBA is to maintain 

and strengthen the Nation’s economy by 

enabling the establishment and viability 

of small businesses, and by assisting in 

economic recovery of communities after 

disasters. In carrying out this mission, 

SBA has developed a regulatory policy 

that is implemented primarily through 

several core program offices: Office of 

Capital Access, Office of Disaster 

Assistance, Office of Entrepreneurial 

Development, Office of Government 

Contracting and Business Development, 

Office of International Trade, and Office 

of Investment and Innovation. SBA’s 

regulations are codified at title 13 of the 

Code of Federal Regulations (CFR), 


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