Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 52193 

1FSIS laboratories are not part of the ALP. FSIS 

laboratories are ISO17025 accredited. The methods 

that FSIS laboratories use are found on the FSIS 

Web site. 

licensed scale repair firm or person, and 

it must meet all accuracy requirements 

as specified in NIST Handbook 44. If a 

USDA inspector has put a ’’Retain’’ tag 

on a scale, the tag can only be removed 

by a USDA inspector. As long as the tag 

is on the scale, it shall not be used. 

§ 442.4 Testing of scales. 

(a) The operator of each official 

establishment that weighs meat or 

poultry food products will cause such 

scales to be tested for accuracy in 

accordance with the technical 

requirements of NIST Handbook 44, at 

least once during the calendar year. In 

cases where the scales are found not to 

maintain accuracy between tests, more 

frequent tests may be required and 

verified by an authorized USDA 

program official. 

(b) The operator of each official 

establishment shall display on or near 

each scale a valid certification of the 

scale’s accuracy from a State or local 

government’s weights and measures 

authority or from a State registered or 

licensed scale repair firm or person, or 

shall have alternative documented 

procedures showing that the scale has 

been tested for accuracy in accordance 

with the requirements of NIST 

Handbook 44. 

§ 442.5 Handling of failed product. 

Any lot of product that is found to be 

out of compliance with net weight 

requirements upon testing in 

accordance with the methods prescribed 

in § 442.2 of this subchapter shall be 

handled as follows: 

(a) A lot tested in an official 

establishment and found not to comply 

with net weight requirements may be 

reprocessed and must be reweighed and 

remarked to satisfy the net weight 

requirements of this section in 

accordance with the requirements of 

this part. 

(b) A lot tested outside an official 

establishment and found not to comply 

with net weight requirements must be 

reweighed and remarked with a proper 

net weight statement, provided that 

such reweighing and remarking will not 

deface, cover, or destroy any other 

marking or labeling required under this 

subchapter, and the net quantity of 

contents is shown with the same 

prominence as the most conspicuous 

feature of a label. 

Done in Washington, DC, on August 13, 

2008. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. E8–20559 Filed 9–8–08; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 318, 381, and 439 

[FSIS Docket No. 03–020F; FDMS Docket 

No. 2005–0023] 

RIN # 0583–AD09 

Accredited Laboratory Program 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is revising, 

editing, and consolidating provisions of 

the standards and procedures for the 

accreditation of non-Federal analytical 

chemistry laboratories. Laboratories in 

the Accredited Laboratory Program 

(ALP) are accredited to analyze official 

meat and poultry samples for (1) 

specific chemical residues or classes of 

chemical residues, and (2) moisture, 

protein, fat, and salt. In particular, FSIS 

is amending its current regulations 

regarding the accreditation of nonFederal analytical chemistry 

laboratories to accommodate the 

adoption of newer methods for 

analyzing chemical residues and to 

correct some data. In addition, FSIS is 

making editorial changes to its 

accredited laboratory regulations to 

reflect Agency reorganizations and 

program changes and to improve the 

clarity and consistency of application 

for all laboratories participating in the 

ALP. Finally, FSIS is consolidating 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. 

DATES: This rule will be effective 

October 9, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Eugene Vickers, Chief of the ALP, Office 

of Public Health Science, FSIS, at (202) 

690–6407 or fax (202) 690–6632, or by 

writing to the ALP, Box 17 Aerospace 

Center, Room 377, 901 D Street, SW., 

Washington, DC 20024. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 17, 2006, FSIS proposed 

to amend the Federal meat and poultry 

products inspection regulations by 

revising, editing, and consolidating 

provisions of the standards and 

procedures for the accreditation of nonFederal analytical chemistry 

laboratories (71 FR 2483).1 This final 

rule is consistent with the proposed 

rule, except for the following technical 

revisions. First, FSIS had proposed to 

codify the Internet and mailing 

addresses for obtaining information on 

the ALP and minimum proficiency 

levels. In the final rule, FSIS is not 

codifying this address information 

because it is subject to change. 

However, Internet and mailing 

addresses for obtaining information are 

included in this preamble. 

In addition, FSIS had also proposed to 

establish a new § 439.60 that would 

have consolidated all references to 

‘‘violations of law’’ contained in 

§§ 318.21(d)(4), 318.21(f), 318.21(g)(4), 

381.153(d)(4), 381.153(f), and 

381.153(g)(4)). These regulations 

prescribe the conditions under which a 

laboratory will have its accreditation 

denied, suspended, or revoked. FSIS 

had proposed to consolidate references 

to violations of law to eliminate 

duplicative provisions within the 

regulations. The Agency did not intend 

to propose substantive changes to these 

regulations. 

However, when developing this final 

rule, FSIS determined that, as proposed, 

§ 439.60 did not adequately delineate 

the circumstances in which the Agency 

would deny, suspend, or revoke a 

laboratory’s accreditation for reasons 

associated with certain violations of 

law. Therefore, instead of consolidating 

all references to violations of law into 

new § 439.60 as proposed, this final rule 

describes the reasons that FSIS will 

deny, suspend, or revoke a laboratory’s 

accreditation under separate sections 

that include specific paragraphs that 

contain provisions for violations of law. 

Thus, under this final rule, instead of 

providing a cross-reference to § 439.60 

as proposed, § 439.50(c) describes the 

conditions under which FSIS will refuse 

to provide an accreditation to a 

laboratory for reasons associated with 

violations of law. In addition, instead of 

providing a cross-reference to § 439.60 

as proposed, § 439.52 of this final rule 

provides a complete description of the 

reasons that FSIS will suspend a 

laboratory’s accreditation. Finally, 

instead of providing a cross-reference to 

§ 439.60 as proposed, § 439.53(c) of this 

final rule describes the conditions under 

which FSIS will revoke a laboratory’s 

accreditation for reasons associated with 

violations of law. This final rule also 

removes proposed § 439.60, which 

proposed to consolidate the provisions 

for violations of law, and re-designates 

proposed § 439.70, the provisions for 

notification and hearings, as § 439.60. 


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52194 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 

As discussed in the proposed 

rulemaking, this rule updates the 

regulations governing the ALP and 

clarifies and corrects some data. 

Issuance of this regulation will give 

FSIS more flexibility in keeping up with 

current and future scientific changes 

without having to reissue new 

regulations periodically. This rule 

deletes all references and footnotes to 

the Association of Official Analytical 

Chemists (AOAC) official methods 

contained in the current food chemistry 

accreditation regulations and the 

definitions. The AOAC methods will no 

longer be specifically cited. Instead, the 

ALP will advise accredited laboratories, 

as provided in the accreditation 

regulations, about suitable methods that 

are available from various compendia, 

such as FSIS guidebooks or current 

AOAC manuals. 

This rule deletes all references to split 

samples because they are no longer part 

of the ALP program. In addition, this 

rule modifies Table 1 of the current 

regulations in §§ 318.21 and 381.153 by 

moving its footnote information into the 

main body of the table. The rule 

modifies Table 2 and provisions for 

Quality Assurance (QA) and Quality 

Control (QC) recovery throughout the 

regulations by removing explicit figures 

for minimum proficiency levels (MPLs) 

and recoveries. Information on current 

recoveries established by FSIS for 

laboratory quality assurance and quality 

control is available from the ALP Web 

site at http://www.fsis.usda.gov/ 

Science/Accredited_Laboratories/ 

index.asp. 

A link to information on current 

MPLs is available on the ALP Web site 

or it can be accessed directly at http:// 

www.fsis.usda.gov/PDF/ 

2003_Red_Book_Appendix3-4.pdf. 

FSIS is also making editorial changes 

to its accredited laboratory regulations 

to reflect Agency reorganizations and 

program changes, and to improve the 

clarity and consistency of application 

for all laboratories participating in the 

ALP. 

Finally, this rule eliminates 

duplicative provisions within the 

current regulations, and consolidates 

§§ 318.21 and 381.153 into a single set 

of regulations in new Part 439. For 

example, new § 439.20 contains the 

criteria for maintaining either a food 

chemistry accreditation or a chemical 

residue accreditation for both meat and 

poultry products. A summary of the 

changes made is contained in the 

following table: 

Meat Poultry New Changes 

318.21 ...................................... 381.153 ................................... Part 439 ......... Editorial and conforming changes are made throughout the 

regulations, along with certain other revisions. 

318.21(a) .................................. 381.153(a) .............................. 439.1 .............. Amended to delete specific references to AOAC, to delete 

the definition of split samples, to modify Tables 1 and 2 to 

revise performance standards, and to add new definitions 

and revise certain current definitions. 

318.21(b)(1), 318.21(c)(1) ........ 381.153(b)(1), 381.153(c)(1) .. 439.5 .............. Updated and consolidated application requirements. 

318.21(b)(2), 318.21(c)(2) ........ 381.153(b)(2), 381.153(c)(2) .. 439.10 ............ Revised, consolidated, and clarified accreditation criteria. 

318.21(b)(3), 318.21(c)(3) ........ 381.153(b)(3), 381.153(c)(3) .. 439.20 ............ Revised and consolidated criteria for maintaining accreditation. 

318.21(d) .................................. 381.153(d) .............................. 439.50 ............ Editorial changes. 

318.21(e) .................................. 381.153(e) .............................. 439.51 ............ Updated to cross-reference sections of new § 439.20 and to 

make certain other revisions. 

318.21(f) ................................... 381.153(f) ............................... 439.52 ............ Editorial changes. 

318.21(g) .................................. 381.153(g) .............................. 439.53 ............ Updates and consolidates bases for revocation of accreditation and makes certain editorial changes. 

318.21(h) .................................. 381.153(h) .............................. 439.60 ............ Editorial changes. 

Expansion of the Laboratory Program 

Although recent rulemakings and 

Agency policy decisions address a range 

of chemical contaminants, including 

most that present biosecurity concerns, 

FSIS does not intend to expand the ALP 

at this time. Expansion of the program 

to other analytes would require a 

statistical evaluation of historical data 

in order to develop the appropriate 

algorithms and correction factors 

needed to implement the same type of 

quality assurance procedures that are 

applied to the analytes currently 

included in the program. It would also 

require FSIS to make policy decisions 

regarding the acceptance of test results 

from non-Federal laboratories for these 

new analytes. The Agency does not 

intend to include additional analytes 

(e.g., pesticide or drug residues) by 

laboratories in the ALP until such 

policy decisions have been made and 

the necessary scientific foundation is 

established for them. 

Discussion of Comments 

The Agency received a total of five 

comments in response to the proposed 

rule, four from consumers and one from 

a representative of a trade industry 

association. Two of the comments were 

supportive, one was both supportive 

and critical, and two were opposed to 

the proposed rule. 

Comment: The commenter supported 

no changes to the current rules. The 

commenter claimed that USDA changes 

often harm and hurt the public and only 

help the profiteers. 

Response: No evidence was presented 

by the commenter to show that the 

proposed changes will have adverse 

effects on the public. FSIS has carefully 

evaluated all changes and determined 

they will improve the ALP. 

Comment: The commenter supported 

the ALP and asked for clarification of 

the standardized values in classes of 

residue. The commenter wanted to 

know if the values are for various 

species. 

Response: The standardized values 

are for various species. The chlorinated 

hydrocarbons (CHC) and 

polychlorinated biphenyls (PCB) are 

measured in the fat of various species, 

such as beef, pork, and chicken. 

Comment: The commenter stated 

there is no need for the FSIS ALP. The 

commenter suggested that FSIS 

recognize analytical results produced by 

any laboratory accredited according to 

International Organization for 

Standardization (ISO) 17205, which is 

the ISO laboratory accreditation 

standard. The commenter would like 

the resources currently expended on the 

ALP to be re-directed within FSIS. 

Response: The FSIS ALP is a user fee 

program mandated by the Food, 

Agriculture, Conservation, and Trade 

Act of 1990 (the 1990 Farm Bill). The 

user fees cover the cost of administering 

the ALP program. ISO accreditation is a 

third party evaluation of laboratory 

quality and capability. FSIS’ ALP is a 

separate program. While ISO 


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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 52195 

accreditation requires, but does not 

provide, proficiency testing, such 

testing is a cornerstone of the FSIS 

program. Thus, there are differences in 

the two programs. The ALP is a 

voluntary program. Many of the 

accredited laboratories are ISO 

accredited, and they choose to be in the 

FSIS ALP to satisfy their clients’

requirements. 

Comment: The commenter supported 

the proposed rule to the extent that it 

will bring more clarity and consistency 

to the process of analyzing and 

obtaining results and increase the 

rapidity of analytical results. In 

addition, this commenter stated that 

private laboratories may well have 

increased business opportunities, thus 

possibly reducing government cost. The 

concern expressed by this commenter 

was that consumers may question the 

accuracy of testing by private 

laboratories as opposed to ‘‘more 

experienced’’ government laboratories. 

Also, the commenter stated that 

consumers may be concerned that the 

meat and poultry industries will pass 

the increased cost of testing in private 

laboratories on to the consumers. This 

same commenter asked if it would be 

possible to do random sampling to 

ensure the private labs are consistently 

meeting Federal standards. 

Response: Accredited laboratories are 

held to the same procedures and 

standards as FSIS laboratories. The 

laboratories’ analytical performance is 

continually monitored by proficiency 

samples and periodic on-site reviews. 

Some meat and poultry plants have 

their own laboratories. Having these 

laboratories accredited by FSIS will 

facilitate testing without costing the 

industry extra money. 

Comment: An additional commenter 

supported the proposal without 

qualification. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. States and local 

jurisdictions are preempted by the 

Federal Meat Inspection Act (FMIA) and 

the Poultry Products Inspection Act 

(PPIA) from imposing any requirements 

on federally inspected premises, 

facilities, and operations that are in 

addition to, or different than, those 

imposed under the FMIA and the PPIA. 

States and local jurisdictions may, 

however, exercise concurrent 

jurisdiction over meat and poultry 

products that are outside official 

establishments for the purpose of 

preventing the distribution of meat and 

poultry products that are misbranded or 

adulterated under the FMIA and PPIA, 

or, in the case of imported products, 

that are not at such an establishment, 

after their entry into the United States. 

This final rule is not intended to have 

retroactive effect. 

When this final rule is adopted, 

administrative proceedings will not be 

required before parties may file suit in 

court challenging this rule. However, 

the administrative procedures specified 

in 9 CFR 306.5 and 381.35 must be 

exhausted prior to any judicial 

challenge of the application of the 

provisions of this final rule, if the 

challenge involves any decision of an 

FSIS employee relating to inspection 

services provided under the FMIA or 

PPIA. 

Executive Order 12866 

This final rule has been reviewed 

under Executive Order 12866. The rule 

has been determined to be not 

significant for the purpose of Executive 

Order 12866 and, therefore, has not 

been reviewed by the Office of 

Management and Budget. 

Effect on Small Entities 

The Administrator has made a 

determination that this rule would not 

have a significant economic impact on 

a substantial number of small entities, 

as defined by the Regulatory Flexibility 

Act (5 U.S.C. 601). There are about 77 

laboratories that have a total of about 92 

accreditations in the FSIS ALP. About 

three-quarters of these are large entities, 

based on their volume of business, or 

are part of entities such as large 

business corporations, State 

universities, or State governments. The 

smaller laboratories participating in the 

ALP range from medium-sized 

laboratory facilities to one- or twoperson operations. These laboratories 

provide analytical services of official 

samples to large and small 

establishments. 

The effects of this rule on the 

laboratories and on the establishments 

they serve will not be significant and 

will apply equally to large and small 

entities. Participation in the Agency’s 

ALP is voluntary. It is expected that a 

decision to participate would be based 

on a calculation of the benefits and costs 

to the firm, including a determination 

whether the resulting loss of business as 

a result of non-participation in ALP 

would be significant. 

The rule does not involve a change in 

the accreditation fee, but rather 

adjustments and clarifications in the 

operational procedures and standards. 

The cost savings brought about by 

improved efficiencies in the 

requirements for participation in the 

ALP are likely to be small. 

Paperwork Requirements 

FSIS has reviewed the paperwork and 

recordkeeping requirements in this rule 

in accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). The Agency has determined 

that the paperwork requirements for the 

regulations that govern the accreditation 

of non-Federal analytical chemistry 

laboratories have already been 

accounted for in the Application for 

Inspection, Sanitation, and Accredited 

Laboratories information collection 

approved by OMB. The OMB approval 

number for the Application for 

Inspection, Sanitation, and Accredited 

Laboratories information collection is 

0583–0082. 

E-Government Act Compliance 

FSIS is committed to complying with 

the E-Government Act, to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this notice, FSIS will announce it online 

through the FSIS Web page located at 

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

regulations_&_policies/ 

2008_Interim_&_Final_Rules_Index/ 

index.asp. FSIS will also make copies of 

this Federal Register publication 

available 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 

constituents and stakeholders. The 

Update is communicated via Listserv, a 

free electronic mail subscription service 

for industry, trade groups, consumer 

interest groups, health professionals, 

and other individuals who have asked 

to be included. The Update is also 

available on the FSIS Web page. 

Through the Listserv and Web page, 

FSIS is able to provide information to a 

much broader and 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/ 

news_and_events/email_subscription/. 

Options range from recalls to export 

information to regulations, directives 


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52196 Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations 

and notices. Customers can add or 

delete subscriptions themselves, and 

have the option to password protect 

their accounts. 

List of Subjects 

9 CFR Part 318 

ALP, Meat inspection, Recordkeeping 

and reporting requirements. 

9 CFR Part 381 

ALP, Poultry and poultry products 

inspection, Recordkeeping and 

reporting requirements. 

9 CFR Part 439 

Meat inspection, Poultry and poultry 

products inspection, Laboratory 

accreditation. 

■ Accordingly, Title 9, Chapter III of the 

Code of Federal Regulations is amended 

as follows: 

PART 318—ENTRY INTO OFFICIAL 

ESTABLISHMENTS; REINSPECTION 

AND PREPARATION OF PRODUCTS 

■ 1. The authority citation for Part 318 

would continue to read as follows: 

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

21 U.S.C. 601–695; 7 CFR 2.18, 2.53. 

§ 318.21 [Removed and Reserved] 

■ 2. Remove and reserve § 318.21. 

PART 381—POULTRY PRODUCTS 

INSPECTION REGULATIONS 

■ 3. The authority citation for Part 381 

would continue to read as follows: 

Authority: 7 U.S.C., 138f, 450; 21 U.S.C., 

451–470; 7 CFR 2.7, 2.18, 2.53. 

§ 381.153 [Removed and Reserved] 

■ 4. Remove and reserve § 381.153. 

Subchapter E—Requirements Under the 

Federal Meat Inspection Act and the Poultry 

Products Inspection Act 

■ 5. Subchapter E is amended by adding 

a new Part 439 to read as follows: 

PART 439—ACCREDITATION OF NONFEDERAL CHEMISTRY 

LABORATORIES 

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; 

21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 

2.53. 

§ 439.1 Definitions. 

(a) Accreditation—Determination by 

FSIS that a laboratory is qualified to 

analyze official samples of raw or 

processed meat and poultry products, 

because it has met the requirements for 

accreditation specified in this part, for 

the presence and amount of all four food 

chemistry analytes (protein, moisture, 

fat, and salt); or a determination by FSIS 

that a laboratory is qualified to analyze 

official samples of raw or processed 

meat and poultry products, because it 

has met the requirements for 

accreditation in this part, for the 

presence and amount of a specified 

chemical residue of any one of several 

classes of chemical residues. A 

laboratory may hold more than one 

accreditation. 

(b) Accredited laboratory—A nonFederal analytical laboratory that has 

met the requirements for accreditation 

specified in this Part and, therefore, at 

an establishment’s discretion, may be 

used in lieu of an FSIS laboratory for 

analyzing official regulatory samples. 

Payment for the analysis of official 

samples is to be made by the 

establishment using the accredited 

laboratory. 

(c) Accredited Laboratory Program 

(ALP)—The FSIS program in which 

non-Federal laboratories are accredited 

as eligible to perform analyses on 

official regulatory samples of raw or 

processed meat and poultry products, 

and through which a check sample 

program for quality assurance is 

conducted. 

(d) Chemical residue 

misidentification—see ‘‘Correct 

chemical residue identification’’

definition. 

(e) Coefficient of variation (CV)—The 

standard deviation of a distribution of 

analytical values multiplied by 100 and 

divided by the mean of those values. 

(f) Comparison mean—The average 

result, for a sample, obtained from all 

submitted results that have a large 

deviation measure of zero. When only 

two laboratories perform the analysis 

and the large deviation measure is not 

zero, alternative procedures for 

establishing a comparison mean may be 

employed by FSIS. For purposes of 

computing the comparison mean, a 

laboratory’s ‘‘result’’ for a food 

chemistry analyte is the obtained 

analytical value; a laboratory’s ‘‘result’’

for a chemical residue is the logarithmic 

transformation of the obtained 

analytical value. 

(g) Correct chemical residue 

identification—Reporting by a 

laboratory of the presence and analytical 

value of a chemical residue that was 

included in the ALP check sample 

above the minimum reporting level. 

Failure of a laboratory to report the 

presence of such a chemical residue is 

considered a misidentification. In 

addition, reporting the presence of and 

analytical value for a residue that was 

not included in the ALP check sample 

above the minimum reporting level is 

considered a misidentification. 

(h) CUSUM—A class of statistical 

procedures for assessing whether or not 

a process is ‘‘in control.’’ Each CUSUM 

value is constructed by accumulating 

incremental values obtained from 

observed results of the process, and then 

determined to either exceed or fall 

within acceptable limits for that 

process. The initial CUSUM values for 

each laboratory whose application for 

accreditation is accepted are set at zero. 

The CUSUM values are reset to zero at 

the beginning of each year; that is, the 

CUSUM values associated with the first 

maintenance check sample each year are 

set equal to the CUSUM increment for 

that sample. The four CUSUM 

procedures are: 

(1) Positive systematic laboratory 

difference CUSUM (CUSUM–P)—

monitors how consistently an accredited 

laboratory gets numerically greater 

results than the comparison mean; 

(2) Negative systematic laboratory 

difference CUSUM (CUSUM–N)—

monitors how consistently an accredited 

laboratory gets numerically smaller 

results than the comparison mean; 

(3) Variability CUSUM (CUSUM–V)—

monitors the average ‘‘total deviation’’

(i.e., the combination of the random 

fluctuations and systematic differences) 

between an accredited laboratory’s 

results and the comparison mean; and 

(4) Individual large deviation CUSUM 

(CUSUM–D)—monitors the magnitude 

and frequency of large differences 

between the results of an accredited 

laboratory and the comparison mean. 

(i) Food chemistry—For the purposes 

of Part 439, ‘‘food chemistry’’ will refer 

to analysis of raw or processed meat or 

poultry products for the analytes 

moisture, protein, fat, and salt. All four 

analytes must be determined when a 

food chemistry analysis is conducted, 

unless otherwise advised by the ALP. 

(j) Individual large deviation—An 

analytical result that differs from the 

sample comparison mean by more than 

would be expected assuming normal 

laboratory variability. 

(k) Initial accreditation check 

sample—A sample provided by the ALP 

to a non-Federal laboratory to determine 

whether the laboratory’s analytical 

capability meets the standards for 

granting accreditation. 

(l) Inter-laboratory accreditation 

maintenance check sample—A sample 


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provided by FSIS to an accredited 

laboratory to assist in determining 

whether the laboratory is maintaining 

acceptable levels of analytical 

capability. 

(m) Large deviation measure—A 

measure that quantifies an unacceptably 

large difference between a laboratory’s 

analytical result and the sample 

comparison mean. 

(n) Minimum proficiency level 

(MPL)—The minimum concentration of 

a residue at which an analytical result 

will be used to assess a laboratory’s 

quantification capability. This 

concentration is an estimate of the 

smallest concentration for which the 

average coefficient of variation (CV) for 

reproducibility (i.e., combined within 

and between laboratory variability) does 

not exceed 20 percent. 

(o) Minimum reporting level (MRL)—

The number such that if any obtained 

analytical value for a residue in a check 

sample or official sample equals or 

exceeds this number, then the residue is 

reported together with the obtained 

analytical value. 

(p) Official sample—A sample 

selected by an inspector or inspection 

service employee in accordance with 

FSIS procedures for regulatory use. 

(q) Probation—The period 

commencing with official notification to 

an accredited laboratory that its check 

sample results no longer satisfy the 

performance requirements specified in 

this rule, and ending with official 

notification that accreditation either is 

fully restored, is suspended, or is 

revoked. 

(r) QA (See Quality assurance 

recovery). 

(s) QC (See Quality control recovery). 

(t) Quality assurance (QA) recovery—

The ratio of a laboratory’s analytical 

value for a check sample residue to the 

established level of the analyte in the 

check sample, multiplied by 100. As 

dictated by the procedures for the 

analyte, the analytical value may be 

adjusted prior to the recovery 

computation. 

(u) Quality control (QC) recovery—

The ratio of a laboratory’s analytical 

value of a quality control standard to the 

established level of the analyte in the 

standard, multiplied by 100. As dictated 

by the procedures for the analyte, the 

analytical value may be adjusted prior 

to the recovery computation. 

(v) Refusal of accreditation—An 

action taken by FSIS when a laboratory 

that is applying for accreditation is 

denied the accreditation. 

(w) 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 chemical analysis of FSIS official 

samples. 

(x) Revocation of accreditation—An 

action taken by FSIS against a 

laboratory, removing the laboratory’s 

right to analyze official samples. 

(y) Standardizing constant—A 

number that results from a mathematical 

adjustment to the ‘‘standardizing value’’

and is used to compute the standardized 

difference for a check sample result. The 

number takes into consideration the 

expected variance of the difference 

between the accredited or applying 

laboratory’s result(s) and the 

comparison mean for a sample, the 

standardizing value, the correlation and 

number of repeated results by a 

laboratory on a sample, and the number 

of laboratories that analyzed a sample. 

(z) Standardized difference—The 

quotient of the difference between a 

laboratory’s result on a sample and the 

comparison mean of the sample divided 

by the standardizing constant. 

(aa) Standardizing value—A number 

representing the performance standard 

deviation of an individual result. The 

number is given, or computed by, the 

information provided in Tables 1 and 2 

to this paragraph (aa). 

TABLE 1 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR FOOD CHEMISTRY

[By product class and analyte] 

Product/class Moisture Protein 1

Fat 1 Salt 1

<12.5% ≥12.5% <1% 1–4% ≥4% 2

Cured Pork/Canned Ham ................ 0.50 0.060 (X0.65) 0.26 (X0.25) 0.30 (X0.25) 0.127 0.127 (X0.25) 0.22 

Ground Beef ..................................... 0.71 0.060 (X0.65) N/A 0.35 (X0.25) 0.127 0.127 (X0.25) 0.22 

Other Meat Products ........................ 0.57 0.060 (X0.65) 0.26 (X0.25) 0.30 (X0.25) 0.127 0.127 (X0.25) 0.22 

Poultry Products ............................... 0.57 0.060 (X0.65) 0.26 (X0.25) 0.30 (X0.25) 0.127 0.127 (X0.25) 0.22 

1The standardizing value is either the value given in the table or is computed by the formula set forth in the table, where X is the comparison 

mean of the sample. Standardizing values are provided for different percentages of fat and salt as indicated in the table. 2For dry salami and pepperoni products. 

TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL

RESIDUES

Class of residues Standardizing value 3

Chlorinated Hydrocarbons: 1

Aldrin ..................................... 0.20 

Benzene Hexachloride .......... 0.20 

Chlordane .............................. 0.20 

Dieldrin .................................. 0.20 

DDT ....................................... 0.20 

DDE ....................................... 0.20 

TDE ....................................... 0.20 

Endrin .................................... 0.20 

Heptachlor ............................. 0.20 

Heptachlor Epoxide ............... 0.20 

Lindane ................................. 0.20 

Methoxychlor ......................... 0.20 

TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL

RESIDUES—Continued 

Class of residues Standardizing value 3

Toxaphene ............................ 0.20 

Hexachlorobenzene .............. 0.20 

Mirex ..................................... 0.20 

Nonachlor .............................. 0.20 

Polychlorinated Biphenyls: 0.20 

Arsenic 2 ................................ 0.25 

Sulfonamides 2 .......................... 0.25 

Volatile Nitrosamine 2 ............ 0.25 

1 Laboratory statistics are computed over all 

results (excluding PCB results), and for specific chemical residues. 2 Laboratory statistics are only computed for 

specific chemical residues. 

3The standardizing value of all initial accreditation and probationary check samples 

computations is 0.15. 

(bb) Suspension of accreditation—

Action taken by FSIS against a 

laboratory that temporarily removes the 

laboratory’s right to analyze official 

samples. Suspension of accreditation 

ends when accreditation either is fully 

restored or is revoked. 

(cc) Systematic laboratory 

difference—A comparison of one 

laboratory’s results with the comparison 

mean for samples that show, on average, 

a consistent relationship. A laboratory 

that is reporting, on average, 

numerically greater results than the 

comparison mean has a positive 

systematic laboratory difference. 


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Conversely, numerically smaller results 

indicate a negative systematic laboratory 

difference. 

(dd) Variability—Random fluctuations 

in a laboratory’s processes that cause its 

analytical results to deviate from a true 

value. 

(ee) Variance—The expected average 

of the squared differences of sample 

results from an expected sample mean. 

§ 439.5 Applications for accreditation. 

(a) Application for accreditation shall 

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. The forms shall be sent to 

the ALP or may be submitted 

electronically when so provided for by 

FSIS. The application shall specify the 

kinds of accreditation that are wanted 

by the owner or manager of the 

laboratory. A laboratory whose 

accreditation has been refused or 

revoked may reapply for accreditation 

after 60 days from the effective date of 

that action, and must provide written 

documentation specifying what 

corrections were made. 

(b) At the time that an Application for 

Accreditation is filed with the ALP, the 

management of a laboratory shall, for 

each accreditation sought, submit a 

check, bank draft, or money order in the 

amount specified in 9 CFR 391.5, made 

payable to the U.S. Department of 

Agriculture, along with the completed 

application for the accreditation(s). 

When so provided for by FSIS, 

electronic transfer of funds may be 

accepted. 

(c) Accreditation will not be granted 

or continued, without further 

procedure, for failure to pay the 

accreditation fee(s). The fee(s) paid will 

be nonrefundable and will be credited 

to the account from which the expenses 

of the laboratory accreditation program 

are paid. 

(d) Annually on the anniversary date 

of each accreditation, FSIS will issue a 

bill in the amount specified in 9 CFR 

391.5 for each accreditation held. Bills 

are payable upon receipt by check, bank 

draft, or money order made payable to 

the U.S. Department of Agriculture and 

become delinquent 30 days from the 

date of the bill. 

(e) Accreditation will be terminated 

without further procedure for having a 

delinquent account. The fee(s) paid will 

be nonrefundable and will be credited 

to the account from which the expenses 

of the ALP are paid. 

§ 439.10 Criteria for obtaining 

accreditation. 

(a) Analytical laboratories may be 

accredited for the analyses of food 

chemistry analytes, as defined in § 439.1 

of this part, or a specific chemical 

residue or a class of chemical residues 

in raw or processed meat and poultry 

products. 

(b) Accreditation will be given only if 

the applying laboratory successfully 

satisfies the requirements presented 

below. For food chemistry accreditation, 

the requirements must be satisfied for 

all four analytes. 

(c) This accreditation authorizes 

official FSIS acceptance of the analytical 

test results provided by these 

laboratories on official samples. 

(d) To obtain FSIS accreditation, an 

analytical laboratory must: 

(1) Be supervised by a person holding, 

at a minimum, a bachelor’s degree in 

chemistry, food science, food 

technology, or a related field. 

(i) For food chemistry accreditation, 

the supervisor must also have one year’s 

experience in food chemistry analysis, 

or equivalent qualifications, as 

determined by the Administrator. 

(ii) For chemical residue 

accreditation, either the supervisor or 

the analyst assigned to analyze the 

sample must also have three years’

experience determining analytes at or 

below part per million levels, or 

equivalent qualifications, as determined 

by the Administrator. 

(2) Demonstrate an ability to achieve 

quality assurance levels that are within 

acceptable limits for systemic laboratory 

difference, variability, and individual 

large deviations, in the analyte category 

for which accreditation is sought, using 

analytical procedures designated by the 

FSIS ALP as being acceptable. An 

applying laboratory will successfully 

demonstrate these capabilities for: 

(i) Food chemistry if its results from 

a 36 check sample accreditation study 

each satisfy the criteria presented in 

paragraph (e) of this section. 

(ii) Chemical residues if its analytical 

results for each specific chemical 

residue provided in a check sample 

accreditation study containing a 

minimum of 14 check samples satisfy 

the criteria presented in paragraph (e) of 

this section, including criteria for QA 

and QC recovery and for residue 

identification. In addition, if the 

laboratory is requesting accreditation for 

the analysis of chlorinated 

hydrocarbons, all analytical results for 

the residue class must collectively 

satisfy the criteria. [Conformance to 

criteria in paragraph (e) of this section 

will only be determined when six or 

more analytical results with associated 

comparison means at or above the 

logarithm of the minimum proficiency 

level are available.] 

(3) Round all check sample statistical 

computations to the nearest tenth, 

except where otherwise noted. 

(4) Complete a second set of the 

requisite number of check samples if the 

results of the first set of check samples 

do not meet the criteria for obtaining 

accreditation. 

(i) The second set of check 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 food chemistry check 

samples will be analyzed for only the 

analyte(s) for which unacceptable initial 

results had been obtained by the 

laboratory. 

(ii) If the results of the second set of 

check samples do not meet the criteria 

for obtaining accreditation, the 

laboratory may reapply after a 60-day 

waiting period, commencing from the 

date of refusal of accreditation by FSIS. 

At that time, a new application, all fees, 

and all documentation of corrective 

action required for accreditation must 

be submitted. 

(5) Allow inspection of the laboratory 

by FSIS officials prior to the 

determination of granting accredited 

status. 

(6) Pay the accreditation fee by the 

date required. 

(e) Quality assurance levels—(1) 

Systematic laboratory difference: The 

absolute value of the average 

standardized difference must not exceed 

the following: 

(i) For food chemistry, 0.73 minus the 

product of 0.17 and the standard 

deviation of the standardized 

differences; and 

(ii) For chemical residues, 1.67 (2.00 

if there are less than 12 analytical 

results) minus the product of 0.29 and 

the standard deviation of the 

standardized differences. 

(2) Variability: The estimated 

standard deviation of the standardized 

difference must not exceed the 

following: 

(i) For food chemistry, 1.15; and 

(ii) For chemical residues, a computed 

limit that is a function of the number of 

analytical results used in the 

computation of the standard deviation, 

and of the amount of variability. 

(3) Individual large deviations: One 

hundred times the average of the large 

deviation measures of the individual 

samples must be less than 5.0. A result 

will have a large deviation measure 

equal to zero when the absolute value of 

the result’s standardized difference, (d), 

is less than 2.5 and otherwise a measure 

equal to 1–(2.5/d). 


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(4) For residue analyses, the following 

additional quality assurance 

requirements must be met. 

(i) QA recovery: The average of the 

QA recoveries of the individual check 

sample analytical results must lie 

within ranges established by FSIS. 

(ii) QC recovery: All QC recoveries 

must lie within ranges established by 

FSIS. Supporting documentation must 

be made available to FSIS upon request. 

(iii) Correct identification: There must 

be correct identification of all chemical 

residues in all samples. 

§ 439.20 Criteria for maintaining 

accreditation. 

(a) To maintain accreditation, an 

analytical laboratory must fulfill the 

requirements of paragraphs (b) through 

(i) of this section. 

(b) Official samples. 

(1) An accredited laboratory must 

expeditiously report analytical results, 

in the analyte category for which 

accreditation was granted, of official 

samples on designated forms to the Data 

Center Staff, USDA/FSIS Eastern 

Laboratory, Russell Research Center, 

P.O. Box 6085, Athens, GA 30604 (for 

U.S. Postal Service delivery), or Data 

Center Staff, USDA/FSIS Eastern 

Laboratory, Russell Research Center, 

950 College Station Road, Athens, GA 

30605 (for commercial carrier delivery). 

When so provided for by FSIS, 

analytical results may be reported to the 

Data Center Staff by facsimile at (706) 

546–3589, or electronically. The Federal 

inspector at any establishment may 

assign the analysis of official samples to 

an FSIS laboratory if, in the inspector’s 

judgment, there are delays in receiving 

test results on official samples from an 

accredited laboratory. 

(2) Every QC recovery associated with 

reporting of official samples must lie 

within ranges established by FSIS. 

Supporting documentation must be 

made available to FSIS upon request. 

(c) Records. An accredited laboratory 

must: 

(1) Maintain laboratory quality control 

records for the most recent three years 

that samples have been analyzed under 

this Program. 

(2) Maintain complete records of the 

receipt, analysis, and disposition of 

official samples for the most recent 

three years that samples have been 

analyzed under this Program. 

(3) Maintain in a secure electronic 

format or in a standards book, which is 

preferably a permanently bound book 

with sequentially numbered pages, all 

records, readings, and calculations for 

standard solutions. All entries are to be 

dated and signed by the analyst 

immediately upon completion of the 

entry, and by the supervisor, or in the 

absence of the supervisor by the 

supervisor’s designee, before use of the 

standard solution but no later than 

within one week. The standards book is 

to be retained for three years after the 

last recorded entry. 

(4) Maintain records and supervisor 

approvals of recoveries, and of 

instrument maintenance and 

calibration. The records are to be 

retained for three years after the last 

recorded entry. 

(5) As provided in paragraph (f) of 

this section, records should be available 

for review by any duly authorized 

representative of the Secretary of 

Agriculture, including ALP personnel or 

their designees. 

(d) Check samples. 

(1) An accredited laboratory must 

analyze interlaboratory accreditation 

maintenance check samples and return 

the results to FSIS within 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 

maintenance check samples shall not be 

contracted out by the accredited 

laboratory. 

(3) As provided by the requirements 

in paragraph (h) of this section, a check 

sample report will be considered 

complete only if laboratories report all 

analytes present in the check sample for 

the analyte category in which 

accreditation was granted. 

(e) 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. 

(f) 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. 

(g) Analytical procedures. An 

accredited laboratory must use 

analytical procedures designated by the 

FSIS ALP as being acceptable. 

(h) Quality assurance levels. 

(1) An accredited laboratory must 

demonstrate an ability to maintain 

quality assurance levels that are within 

acceptable limits for systematic 

laboratory difference, variability, and 

individual large deviations in the 

analysis of interlaboratory check 

samples for the analyte category for 

which accreditation was granted. An 

accredited laboratory will successfully 

demonstrate the maintenance of these 

capabilities if its analytical results from 

interlaboratory accreditation 

maintenance check samples satisfy the 

criteria presented in this paragraph (h). 

All statistical computations are to be 

rounded to the nearest tenth, except 

where otherwise noted. 

(2) In addition, a laboratory accredited 

for a specific chemical residue or a 

chemical residue class: 

(i) Must satisfy criteria presented in 

this paragraph for chemical residue 

recoveries and proper identification; 

(ii) Must demonstrate the 

maintenance of its capabilities by 

reporting its analytical results for each 

specific chemical residue found above 

the minimum proficiency level; and 

(iii) Must, if accredited for the 

analysis of chlorinated hydrocarbons, 

obtain analytical results that collectively 

satisfy the criteria. 

(3) Systematic laboratory difference: 

The standardized difference between 

the accredited laboratory’s result and 

the comparison mean for each 

interlaboratory accreditation 

maintenance check sample is used to 

determine two CUSUM values, 

designated as CUSUM–P and CUSUM–

N. 

(i) When determining compliance 

with this criterion for all chlorinated 

hydrocarbon results in a sample 

collectively, the following statistical 

procedure must be followed to account 

for the correlation of analytical results 

within a sample: The average of the 

standardized differences of the 

analytical results within the sample, 

divided by a constant, is used in place 

of a single standardized difference to 

determine the CUSUM–P (or CUSUM–

N) value for the sample. The constant is 

a function of the number of analytical 

results used to compute the average 

standardized difference. 

(ii) Positive systematic laboratory 

difference: This value is computed and 

evaluated as follows: 

(A) Determine the CUSUM–P 

increment for the sample. 

(1) The CUSUM–P increment for food 

chemistry, as defined in § 439.1 of this 

part, is set equal to: 

2.0, if the standardized difference is 

greater than 2.4, 

¥2.0, if the standardized difference is 

less than ¥1.6, or 

the standardized difference minus 0.4, 

if the standardized difference lies 

between ¥1.6 and 2.4, inclusive. 

(2) The CUSUM–P increment for 

chemical residues is set equal to: 

2.0, if the standardized difference is 

greater than 2.5, 


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¥2.0, if the standardized difference is 

less than ¥1.5, or 

the standardized difference minus 0.5, 

if the standardized difference lies 

between ¥1.5 and 2.5, inclusive. 

(B) Compute the new CUSUM–P 

value. The new CUSUM–P value is 

obtained by adding, algebraically, the 

CUSUM–P increment to the last 

previously computed CUSUM–P value. 

If this computation yields a value 

smaller than 0, the new CUSUM–P 

value is set equal to 0. 

(C) Evaluate the new CUSUM–P 

value. The new CUSUM–P value must 

not exceed: 

(1) 5.2 for food chemistry. 

(2) 4.8 for chemical residues. 

(iii) Negative systematic laboratory 

difference: This value is computed and 

evaluated as follows: 

(A) Determine the CUSUM–N 

increment for the sample. 

(1) The CUSUM–N increment for food 

chemistry is set equal to: 

2.0, if the standardized difference is 

greater than 1.6, 

¥2.0, if the standardized difference is 

less than ¥2.4, or 

the standardized difference plus 0.4, 

if the standardized difference lies 

between ¥2.4 and 1.6, inclusive. 

(2) The CUSUM–N increment for 

chemical residues is set equal to: 

2.0, if the standardized difference is 

greater than 1.5, 

¥2.0, if the standardized difference is 

less than ¥2.5, or 

the standardized difference plus 0.5, 

if the standardized difference lies 

between ¥2.5 and 1.5, inclusive. 

(B) Compute the new CUSUM–N 

value. The new CUSUM–N value is 

obtained by subtracting, algebraically, 

the CUSUM–N increment from the last 

previously computed CUSUM–N value. 

If this computation yields a value 

smaller than 0, the new CUSUM–N 

value is set equal to 0. 

(C) Evaluate the new CUSUM–N 

value. The new CUSUM–N value must 

not exceed: 

(1) 5.2 for food chemistry. 

(2) 4.8 for chemical residues. 

(4) Variability: The absolute value of 

the standardized difference between the 

accredited laboratory’s result and the 

comparison mean for each 

interlaboratory accreditation 

maintenance check sample is used to 

determine a CUSUM value, designated 

as CUSUM–V. 

(i) When determining compliance 

with this criterion for all chlorinated 

hydrocarbon results in a sample 

collectively, the following statistical 

procedure must be followed to account 

for the correlation of analytical results 

within a sample: The square root of the 

sum of the within sample variance and 

the average standardized difference of 

the sample, divided by a constant, is 

used in place of the absolute value of 

the standardized difference to determine 

the CUSUM–V value for the sample. 

The constant is a function of the number 

of analytical results used to compute the 

average standardized difference. 

(ii) The variability value is computed 

and designated as follows: 

(A) Determine the CUSUM–V 

increment for the sample. The CUSUM 

increment is set equal to the larger of 

¥0.4 or the absolute value of the 

standardized difference minus 0.9. If 

this computation yields a value larger 

than 1.6, the increment is set equal to 

1.6. 

(B) Compute the new CUSUM–V 

value. The new CUSUM–V value is 

obtained by adding, algebraically, the 

CUSUM–V increment to the last 

previously computed CUSUM–V value. 

If this computation yields a value less 

than 0, the new CUSUM–V value is set 

equal to 0. 

(C) Evaluate the new CUSUM–V 

value. The new CUSUM–V value must 

not exceed 4.3. 

(5) Large deviations: The large 

deviation measure of the accredited 

laboratory’s result for each 

interlaboratory accreditation 

maintenance check sample is used to 

determine a CUSUM value, designated 

as CUSUM–D. 

(i) A result will have a large deviation 

measure equal to zero when the absolute 

value of the result’s standardized 

difference, (d), is less than 2.5, and 

otherwise a measure equal to 1¥(2.5/d). 

(ii) The large deviation value is 

computed and evaluated as follows: 

(A) Determine the CUSUM–D 

increment for the sample. The CUSUM 

increment is set equal to the value of the 

large deviation measure minus 0.025. 

(B) Compute the new CUSUM–D 

value. The new CUSUM–D value is 

obtained by adding, algebraically, the 

CUSUM–D increment to the last 

previously computed CUSUM–D value. 

If this computation yields a value less 

than 0, the new CUSUM–D value is set 

equal to 0. 

(C) Evaluate the new CUSUM–D 

value. The new CUSUM–D value must 

not exceed 1.0. 

(6) For chemical residues: 

(i) Each QC recovery must lie within 

ranges established by FSIS. 

Supporting documentation must be 

made available to FSIS upon request. 

(ii) Not more than one residue 

misidentification may be made in any 

two consecutive check samples. 

(iii) Not more than two residue 

misidentifications may be made in any 

eight consecutive check samples. 

(i) Fees. An accredited laboratory 

must pay the required accreditation fee 

when it is due. 

(j) Probation. An accredited laboratory 

must meet the following requirements if 

placed on probation pursuant to 

§ 439.51 of this part: 

(1) Send all official samples that have 

not been analyzed as of the date of 

written notification of probation to a 

specified FSIS laboratory by certified 

mail or private carrier or, as an 

alternative and as directed by FSIS, to 

a laboratory accredited by FSIS for the 

designated analyte(s). Mailing expenses 

will be paid by FSIS. 

(2) Analyze a set of check samples 

similar to those used for initial 

accreditation, and submit the analytical 

results to FSIS within three weeks of 

receipt of the samples. 

(3) Satisfy criteria for accreditation 

check samples specified in § 439.10 of 

this part. 

§ 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 § 439.5 or § 439.10 of 

this part. 

(b) A laboratory will be refused 

subsequent accreditation for failure to 

return to an FSIS laboratory, by certified 

mail or private carrier, or, as an 

alternative and as directed by FSIS, to 

a laboratory accredited by FSIS for the 

designated analytes, all official samples 

that have not been analyzed as of the 

notification of a loss of accreditation. 

(c) 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 an 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. 


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§ 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 interlaboratory 

accreditation maintenance check sample 

analysis as required by § 439.20(d) of 

this part within 12 consecutive months, 

unless written permission is granted by 

the Administrator. 

(b) If the laboratory fails to meet any 

of the criteria set forth in §§ 439.20(d) 

and 439.20(h) of this part. 

§ 439.52 Suspension of accreditation. 

The accreditation of a laboratory will 

be 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) 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. 

§ 439.53 Revocation of accreditation. 

The accreditation of a laboratory will 

be revoked for the following reasons: 

(a) An accredited laboratory that is 

accredited to perform analysis under 

§§ 439.5, 439.10 and 439.20 of this part 

will have its accreditation revoked for 

failure to meet any of the requirements 

of § 439.20 of this part, except for the 

following circumstances. If the 

accredited laboratory fails to meet any 

of the criteria set forth in §§ 439.20(d) 

and 439.20(h) of this part and it has not 

failed during the 12 months preceding 

its failure to meet the criteria, it shall be 

placed on probation, but if it has failed 

at any time during those 12 months, its 

accreditation will be revoked. 

(b) 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. 

(c) 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) 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. 

§ 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. 

Done in Washington, DC, on August 27, 

2008. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. E8–20582 Filed 9–8–08; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2007–28059; Directorate 

Identifier 2007–NE–13–AD; Amendment 39–

15665; AD 2008–18–08] 

RIN 2120–AA64 

Airworthiness Directives; Rolls-Royce 

plc (RR) RB211 Trent 500, 700, and 800 

Series Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for the 

products listed above. This AD results 

from mandatory continuing 

airworthiness information (MCAI) 

issued by an aviation authority of 

another country to identify and correct 

an unsafe condition on an aviation 

product. The MCAI describes the unsafe 

condition as: 

This action is necessary following the 

discovery of IP Compressor Rotor rear 

balance land cracking on an in-service Trent 

800 engine. Stress analysis of the damaged 

rotor has shown a possible threat to the rotor 

integrity, the cracking therefore presents a 

potential unsafe condition. 

We are issuing this AD to detect 

cracking on the intermediate pressure 

(IP) compressor rotor rear balance land. 

IP compressor rotor rear balance land 

cracking can lead to uncontained failure 

of the rotor and damage to the airplane. 

DATES: This AD becomes effective 

October 14, 2008. The Director of the 

Federal Register approved the 

incorporation by reference of certain 

publications listed in this AD as of 

October 14, 2008. 

ADDRESSES: The Docket Operations 

office is located at Docket Management 

Facility, U.S. Department of 

Transportation, 1200 New Jersey 

Avenue SE., West Building Ground 

Floor, Room W12–140, Washington, DC 

20590–0001. 

FOR FURTHER INFORMATION CONTACT: 

James Lawrence, Aerospace Engineer, 

Engine Certification Office, FAA, Engine 

and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; e-mail: james.lawrence@faa.gov; 

telephone (781) 238–7176; fax (781) 

238–7199. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to include an AD that would 


yshivers on PROD1PC62 with RULES