Accredited Laboratory Program, 52193-52201 [E8-20582]
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Federal Register / Vol. 73, No. 175 / Tuesday, September 9, 2008 / Rules and Regulations
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.
1 FSIS 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.
DEPARTMENT OF AGRICULTURE
§ 442.4
RIN # 0583–AD09
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.
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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
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52193
Food Safety and Inspection Service
9 CFR Parts 318, 381, and 439
[FSIS Docket No. 03–020F; FDMS Docket
No. 2005–0023]
Accredited Laboratory Program
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
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:
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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 https://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 https://
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 .........
318.21(a) ..................................
381.153(a) ..............................
439.1 ..............
318.21(b)(1), 318.21(c)(1) ........
318.21(b)(2), 318.21(c)(2) ........
318.21(b)(3), 318.21(c)(3) ........
381.153(b)(1), 381.153(c)(1) ..
381.153(b)(2), 381.153(c)(2) ..
381.153(b)(3), 381.153(c)(3) ..
439.5 ..............
439.10 ............
439.20 ............
318.21(d) ..................................
318.21(e) ..................................
381.153(d) ..............................
381.153(e) ..............................
439.50 ............
439.51 ............
318.21(f) ...................................
318.21(g) ..................................
381.153(f) ...............................
381.153(g) ..............................
439.52 ............
439.53 ............
318.21(h) ..................................
381.153(h) ..............................
439.60 ............
Editorial and conforming changes are made throughout the
regulations, along with certain other revisions.
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.
Updated and consolidated application requirements.
Revised, consolidated, and clarified accreditation criteria.
Revised and consolidated criteria for maintaining accreditation.
Editorial changes.
Updated to cross-reference sections of new § 439.20 and to
make certain other revisions.
Editorial changes.
Updates and consolidates bases for revocation of accreditation and makes certain editorial changes.
Editorial changes.
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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.
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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.
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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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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,
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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.
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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
https://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
https://www.fsis.usda.gov/
news_and_events/email_subscription/.
Options range from recalls to export
information to regulations, directives
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§ 439.1
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.
I 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:
I
Authority: 7 U.S.C. 138f, 450, 1901–1906;
21 U.S.C. 601–695; 7 CFR 2.18, 2.53.
§ 318.21
I
[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:
I
Authority: 7 U.S.C., 138f, 450; 21 U.S.C.,
451–470; 7 CFR 2.7, 2.18, 2.53.
§ 381.153
I
[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:
I
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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.
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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
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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
52197
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]
Fat 1
Product/class
Moisture
Protein 1
<12.5%
Cured Pork/Canned Ham ................
Ground Beef .....................................
Other Meat Products ........................
Poultry Products ...............................
0.50
0.71
0.57
0.57
0.060
0.060
0.060
0.060
(X 0.65)
(X 0.65)
(X 0.65)
(X 0.65)
0.26 (X 0.25)
N/A
0.26 (X 0.25)
0.26 (X 0.25)
Salt 1
≥12.5%
0.30
0.35
0.30
0.30
<1%
(X 0.25)
(X 0.25)
(X 0.25)
(X 0.25)
0.127
0.127
0.127
0.127
1–4%
0.127
0.127
0.127
0.127
(X 0.25)
(X 0.25)
(X 0.25)
(X 0.25)
≥4% 2
0.22
0.22
0.22
0.22
1 The 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.
2 For dry salami and pepperoni products.
TABLE 2 TO PARAGRAPH (aa)—STAND- TABLE 2 TO PARAGRAPH (aa)—STANDARDIZING VALUES FOR CHEMICAL
ARDIZING VALUES FOR CHEMICAL
RESIDUES
RESIDUES—Continued
yshivers on PROD1PC62 with RULES
Class of residues
Standardizing value 3
Chlorinated Hydrocarbons: 1
Aldrin .....................................
Benzene Hexachloride ..........
Chlordane ..............................
Dieldrin ..................................
DDT .......................................
DDE .......................................
TDE .......................................
Endrin ....................................
Heptachlor .............................
Heptachlor Epoxide ...............
Lindane .................................
Methoxychlor .........................
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0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
0.20
Jkt 214001
Standardizing value 3
Class of residues
Toxaphene ............................
Hexachlorobenzene ..............
Mirex .....................................
Nonachlor ..............................
Polychlorinated Biphenyls:
Arsenic 2 ................................
Sulfonamides 2 ..........................
Volatile Nitrosamine 2 ............
0.20
0.20
0.20
0.20
0.20
0.25
0.25
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.
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3 The 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.
yshivers on PROD1PC62 with RULES
§ 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.
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Jkt 214001
§ 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
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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.
yshivers on PROD1PC62 with RULES
§ 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
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Jkt 214001
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
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52199
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
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Jkt 214001
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.
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(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.
yshivers on PROD1PC62 with RULES
§ 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
VerDate Aug<31>2005
15:16 Sep 08, 2008
Jkt 214001
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
PO 00000
52201
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
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
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
Frm 00031
Fmt 4700
Sfmt 4700
E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Rules and Regulations]
[Pages 52193-52201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20582]
-----------------------------------------------------------------------
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 non-Federal 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 non-Federal 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.
---------------------------------------------------------------------------
\1\ FSIS 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.
---------------------------------------------------------------------------
In addition, FSIS had also proposed to establish a new Sec. 439.60
that would have consolidated all references to ``violations of law''
contained in Sec. Sec. 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, Sec. 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 Sec. 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 Sec. 439.60 as proposed, Sec. 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 Sec. 439.60 as proposed,
Sec. 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 Sec. 439.60 as proposed,
Sec. 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 Sec.
439.60, which proposed to consolidate the provisions for violations of
law, and re-designates proposed Sec. 439.70, the provisions for
notification and hearings, as Sec. 439.60.
[[Page 52194]]
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 Sec. Sec. 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 https://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 https://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 Sec. Sec. 318.21 and 381.153
into a single set of regulations in new Part 439. For example, new
Sec. 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), 439.5................. Updated and consolidated
381.153(c)(1). application requirements.
318.21(b)(2), 318.21(c)(2)......... 381.153(b)(2), 439.10................ Revised, consolidated, and
381.153(c)(2). clarified accreditation
criteria.
318.21(b)(3), 318.21(c)(3)......... 381.153(b)(3), 439.20................ Revised and consolidated
381.153(c)(3). 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 Sec.
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
[[Page 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 two-person
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 https://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 e-mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at https://
www.fsis.usda.gov/news_and_events/email_subscription/. Options range
from recalls to export information to regulations, directives
[[Page 52196]]
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.
0
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
0
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.
Sec. 318.21 [Removed and Reserved]
0
2. Remove and reserve Sec. 318.21.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
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.
Sec. 381.153 [Removed and Reserved]
0
4. Remove and reserve Sec. 381.153.
Subchapter E--Requirements Under the Federal Meat Inspection Act and
the Poultry Products Inspection Act
0
5. Subchapter E is amended by adding a new Part 439 to read as follows:
PART 439--ACCREDITATION OF NON-FEDERAL 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.
Sec. 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 non-Federal 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
[[Page 52197]]
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]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fat \1\ Salt \1\
Product/class Moisture Protein \1\ -------------------------------------------------------------------
<12.5% >=12.5% <1% 1-4% >=4% \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cured Pork/Canned Ham.................................. 0.50 0.060 (X 0.65) 0.26 (X 0.30 (X 0.127 0.127 (X 0.25) 0.22
0.25) 0.25)
Ground Beef............................................ 0.71 0.060 (X 0.65) N/A 0.35 (X 0.127 0.127 (X 0.25) 0.22
0.25)
Other Meat Products.................................... 0.57 0.060 (X 0.65) 0.26 (X 0.30 (X 0.127 0.127 (X 0.25) 0.22
0.25) 0.25)
Poultry Products....................................... 0.57 0.060 (X 0.65) 0.26 (X 0.30 (X 0.127 0.127 (X 0.25) 0.22
0.25) 0.25)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The 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.
\2\ For dry salami and pepperoni products.
Table 2 to Paragraph (aa)--Standardizing Values for Chemical Residues
------------------------------------------------------------------------
Standardizing
Class of residues 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
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.
\3\ The 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.
[[Page 52198]]
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.
Sec. 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.
Sec. 439.10 Criteria for obtaining accreditation.
(a) Analytical laboratories may be accredited for the analyses of
food chemistry analytes, as defined in Sec. 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).
[[Page 52199]]
(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.
Sec. 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 Sec.
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,
[[Page 52200]]
-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 Sec. 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
Sec. 439.10 of this part.
Sec. 439.50 Refusal of accreditation.
Upon a determination by the Administrator, a laboratory will be
refused accreditation for the following reasons:
(a) A laboratory will be refused accreditation for failure to meet
the requirements of Sec. 439.5 or Sec. 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.
[[Page 52201]]
Sec. 439.51 Probation of accreditation.
Upon a determination by the Administrator, a laboratory will be
placed on probation for the following reasons:
(a) If the laboratory fails to complete more than one
interlaboratory accreditation maintenance check sample analysis as
required by Sec. 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 Sec. Sec. 439.20(d) and 439.20(h) of this part.
Sec. 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.
Sec. 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 Sec. Sec. 439.5, 439.10 and 439.20 of this part will have its
accreditation revoked for failure to meet any of the requirements of
Sec. 439.20 of this part, except for the following circumstances. If
the accredited laboratory fails to meet any of the criteria set forth
in Sec. Sec. 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.
Sec. 439.60 Notification and hearings.
Accreditation of any laboratory will be refused, suspended, or
revoked under the conditions previously described in this Part 439. The
owner or operator of the laboratory will be sent written notice of the
refusal, suspension, or revocation of accreditation by the
Administrator. In such cases, the laboratory owner or operator will be
provided an opportunity to present, within 30 days of the date of the
notification, a statement challenging the merits or validity of such
action and to request an oral hearing with respect to the denial,
suspension, or revocation decision. An oral hearing will be granted if
there is any dispute of material fact joined in such responsive
statement. The proceeding will be conducted thereafter in accordance
with the applicable rules of practice, which will be adopted for the
proceeding. Any such refusal, suspension, or revocation will be
effective upon the receipt by the laboratory of the notification and
will continue in effect until final determination of the matter by the
Administrator.
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