Source: https://www.federalregister.gov/documents/2008/09/09/E8-20582/accredited-laboratory-program
Timestamp: 2018-07-23 08:31:29
Document Index: 38411677

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This rule will be effective October 9, 2008.
52193-52201 (9 pages)
FSIS Docket No. 03-020F
FDMS Docket No. 2005-0023
0583-AD09
Expansion of the Laboratory Program
Subchapter E—Requirements Under the Federal Meat Inspection Act and the Poultry Products Inspection Act
https://www.federalregister.gov/d/E8-20582 https://www.federalregister.gov/d/E8-20582
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.
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.
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.
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. Start Printed 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 §§ 318.21 and 381.153 by moving its footnote information into the main body of the table. The rule modifies Table 2 and provisions for Quality Assurance (QA) and Quality Control (QC) recovery throughout the regulations by removing explicit figures for minimum proficiency levels (MPLs) and recoveries. Information on current recoveries established by FSIS for laboratory quality assurance and quality control is available from the ALP Web site at http://www.fsis.usda.gov/​Science/​Accredited_​Laboratories/​index.asp.
A link to information on current MPLs is available on the ALP Web site or it can be accessed directly at http://www.fsis.usda.gov/​PDF/​2003_​Red_​Book_​Appendix3-4.pdf.
FSIS is also making editorial changes to its accredited laboratory regulations to reflect Agency reorganizations and program changes, and to improve the clarity and consistency of application for all laboratories participating in the ALP.
Finally, this rule eliminates duplicative provisions within the current regulations, and consolidates §§ 318.21 and 381.153 into a single set of regulations in new Part 439. For example, new § 439.20 contains the criteria for maintaining either a food chemistry accreditation or a chemical residue accreditation for both meat and poultry products. A summary of the changes made is contained in the following table:
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(d) 381.153(d) 439.50 Editorial changes.
318.21(e) 381.153(e) 439.51 Updated to cross-reference sections of new § 439.20 and to make certain other revisions.
318.21(f) 381.153(f) 439.52 Editorial changes.
318.21(g) 381.153(g) 439.53 Updates and consolidates bases for revocation of accreditation and makes certain editorial changes.
318.21(h) 381.153(h) 439.60 Editorial changes.
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.
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 Start Printed Page 52195accreditation 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.
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.
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.
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.
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.
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.
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it online through the FSIS Web page located at http://www.fsis.usda.gov/​regulations_​&​_​policies/​2008_​Interim_​&​_​Final_​Rules_​Index/​index.asp. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an e-mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/​news_​and_​events/​email_​subscription/​. Options range from recalls to export information to regulations, directives Start Printed Page 52196and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.
Accordingly, Title 9, Chapter III of the Code of Federal Regulations is amended as follows:
2. Remove and reserve § 318.21.
Authority: 7 U.S.C., 138f, 450; 21 U.S.C., 451-470; 7 CFR 2.7, 2.18, 2.53.
4. Remove and reserve § 381.153.
5. Subchapter E is amended by adding a new Part 439 to read as follows:
(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:
(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 Start Printed Page 52197provided 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).
≥4% 2
Cured Pork/Canned Ham 0.50 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22
Ground Beef 0.71 0.060 (X 0.65) N/A 0.35 (X 0.25) 0.127 0.127 (X 0.25) 0.22
Other Meat Products 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 0.22
Poultry Products 0.57 0.060 (X 0.65) 0.26 (X 0.25) 0.30 (X 0.25) 0.127 0.127 (X 0.25) 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.
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. Start Printed Page 52198Conversely, 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.
(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.
(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.
(e) Quality assurance levels—(1) Systematic laboratory difference: The absolute value of the average standardized difference must not exceed the following:
(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). Start Printed Page 52199
(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.
(b) Official samples.
(d) Check samples.
(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.
(h) Quality assurance levels.
(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.
(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 2.5, Start Printed Page 52200
(j) Probation. An accredited laboratory must meet the following requirements if placed on probation pursuant to § 439.51 of this part:
(3) Satisfy criteria for accreditation check samples specified in § 439.10 of this part.
(a) A laboratory will be refused accreditation for failure to meet the requirements of § 439.5 or § 439.10 of this part.
(b) If the laboratory fails to meet any of the criteria set forth in §§ 439.20(d) and 439.20(h) of this part.
(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.
Done in Washington, DC, on August 27, 2008.
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.
[FR Doc. E8-20582 Filed 9-8-08; 8:45 am]