SuptStmt 073117 FINAL

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Laboratory Approval Programs

OMB: 0581-0251

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2017 SUPPORTING STATEMENT


Laboratory Approval Programs

OMB No. 0581-0251


  1. Justification.


  1. EXPLAIN THE CIRCUMSTANCES THAT MAKE THE COLLECTION OF INFORMATION NECESSARY. IDENTIFY ANY LEGAL OR ADMINISTRATIVE REQUIREMENTS THAT NECESSITATE THE COLLECTION.


Under the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), AMS provides analytical testing services that facilitate marketing and allow products to obtain grade designations or meet marketing or quality standards. Pursuant to this authority, AMS develops and maintains laboratory approval programs (7CFR parts 90-91) as needed by the agricultural industry, to support domestic and international marketing of U.S. products. However, changes in the import requirements of foreign countries and proposed regulatory changes make it likely that requests for laboratory approval will increase and need to comply with the Paperwork Reduction Act requirements. The laboratory approval programs will remain voluntary, fee for service, and for admission into one of these programs a laboratory must have a client who requires the specific testing.


To ensure that a laboratory is capable of accurately performing the specified analyses, it must adhere to certain good laboratory practices and show technical proficiency in the required areas. Laboratories are asked to provide a letter requesting entrance to program, analyses documentation, information concerning the physical facility, analyses of proficiency testing samples, corrective actions, and employee training documentation to conduct an audit of laboratory operations. These questions also serve as a reminder to the laboratory of those elements that will be examined and verified during an on-site audit of their laboratory. AMS will not approve a laboratory unless we are sure that the laboratory is capable of performing accurate analyses. A sloppy laboratory could produce faulty results and cause a foreign country to reject thousands of pounds of U.S. product or even reject that product from all U.S. producers. This is particularly important if the offending product causes disease. Consequently, it is absolutely necessary to collect and require a laboratory to attest to the performance elements necessary to determine the credibility of the laboratory. To do less would be a disservice to the agricultural community we are here to serve.



  1. INDICATE HOW, BY WHOM, AND FOR WHAT PURPOSE THE INFORMATION IS TO BE USED. EXCEPT FOR A NEW COLLECTION, INDICATE THE ACTUAL USE THE AGENCY HAS MADE OF THE INFORMATION RECEIVED FROM THE CURRENT COLLECTION.


The information is collected by degreed scientists in the Laboratory Approval and Testing Division (LATD) of Science & Technology Program, Agricultural Marketing Service (AMS), USDA. Individual scientists are responsible for specific laboratory approval programs. The scientists are assigned programs in response to their technical expertise. The scientists set up files and billing accounts for each applicant.


The information collection processes are as follows:


  1. The scientists review the information submitted by the laboratory on the initial letter requesting entrance.

  2. The laboratory then submits analyses documentation for entry into program(s). The laboratory must submit legal name, address, ownership, authorized representative’s contact information, designated signatories of test reports, quality manual (or equivalent), SOPs, equipment list, equipment calibrations, analysts qualifications and training documents, method verification, and proficiency testing sample results. If the laboratory paperwork shows that the laboratory follows good laboratory practices, appears to understand how to perform the required analyses, and agrees to use the methods specified in the program the scientist will visit the laboratory and verify the analytical activities being performed.

  3. Scientists conduct an initial on-site laboratory review. This is done by observation, conversation and review of written documentation. If the laboratory has deficiencies, they must correct them, and provide a written statement to AMS that they have done so.

  4. At this time, the laboratory may be accepted into the program. To remain in the program the laboratory must perform analyses on proficiency test samples at spaced intervals, and provide AMS with their analytical results. They must also submit to yearly or biennial on-site laboratory reviews and provide the Agency with updates if they change their methods or their personnel.


Above gathered information has been used to examine laboratories for entrance into and maintaining the following programs:


          1. Export Program: (previously submitted as Trichinae in Pork, Pork Exported in Russia, and Beta Agonists program) (combined in this submission): The previous separate programs are now aligned under one program designated as Export Programs. One document with program requirements for all export programs has been created to streamline efficiency. The requested information is needed for acceptance into and maintain acceptance in the program. The information collected allows scientists to verify analytical results reported are precise and accurate.

                1. Laboratory Certification Program for the Detection of Trichinae in Pork [export program requested by Food Safety and Inspection Service and U.S. Pork Producers Association]

                2. Poultry and Pork Exported From the United States to Russia [export program requested by Food Safety and Inspection Service]

                3. Beta Agonists Program [export program requested by Food Safety and Inspection Service]

          2. Microbiological Program (Federal Purchase Program) (NEW): This is a new program requested by Commodity Procurement Staff, AMS, USDA. Its purpose is to approve and verify results of laboratories testing diced cooked chicken (DCC) for the school lunch program. The requested information is needed for acceptance into and maintain acceptance in the program. The information collected allows scientists to verify analytical results reported are precise and accurate.

          3. Aflatoxin Program:

                1. Aflatoxin in Pistachios Program [exporting pistachios to European Union requested by California Pistachio Committee, the domestic program identified in the Pistachio Marketing Order (7CFR Part 983) and (7 CFR part 999, Section 999.6)];

                2. Aflatoxin in Peanuts Program (7 CFR Part 996 Parts 996.1 – 996.75); and

                3. Aflatoxin in Almonds Program [requested by the Almond Board of California].

          4. Recordkeeping: Needed for record review for on-site auditing of laboratory. Record review is one of the pillars of auditing.

          5. ST-212 Alternate Payment Form: (Obsoleted): No longer needed due to the fact that all laboratories in programs have access to World Wide Web. Laboratories are using the automated website: https://www.pay.gov.


The information collection involved in these programs is necessary to maintain the credibility of the USDA. If we are not rigorous in our demands for entrance into our programs, then foreign governments will not be willing to accept the results generated by these laboratories.



  1. DESCRIBE WHETHER, AND TO WHAT EXTENT, THE COLLECTION OF INFORMATION INVOLVES THE USE OF AUTOMATED, ELECTRONIC, MECHANICAL, OR OTHER TECHNOLOGICAL COLLECTION TECHNIQUES OR OTHER FORMS OF INFORMATION TECHNOLOGY, E.G. PERMITTING ELECTRONIC SUBMISSION OF RESPONSES, AND THE BASIS FOR THE DECISION FOR ADOPTING THIS MEANS OF COLLECTION. ALSO, DESCRIBE ANY CONSIDERATION OF USING INFORMATION TECHNOLOGY TO REDUCE BURDEN.


The USDA AMS S&T Laboratory Approval and Testing Division (LATD) web site provides the user with direct access to the source of laboratory approval programs information and is accessible by anyone with a computer.

A new laboratory can access the types of laboratory approval programs offered by accessing: https://www.ams.usda.gov/services/lab-testing/lab-approval. After receiving a requesting admission letter, the LATD program manager would then send an admission kit as an e-mail attachment, fax, or postal delivery for the new customer.


AMS is committed to complying with the E-Government Act, which requires Government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. At this time electronic signatures are accepted and electronically signed documents can be received electronically. A hard copy with signatures of the responsible persons may be required to attest to the truthfulness of the provided information if electronic signatures are not used by the laboratory.



  1. DESCRIBE EFFORTS TO IDENTIFY DUPLICATION. SHOW SPECIFICALLY WHY ANY SIMILAR INFORMATION ALREADY AVAILABLE CANNOT BE USED OR MODIFIED FOR USE FOR THE PURPOSE(S) DESCRIBED IN ITEM 2 ABOVE.


Our laboratory approvals are unique to the Government in that they are specific to enhance the marketing of U.S. agricultural products. Other Federal government entities capable of this type of work deal with regulatory issues will not consider involvement in a program where the need is a marketing issue. Since our programs are so specific to a commodity and to a test or tests, the likelihood of any other government agency having these data is remote. It is possible that a laboratory may have an ISO 17025:2005 accreditation for one or more of the analyses, but that information would be held by an accrediting body from outside Government that will not share it with us. In addition, our programs frequently require specifications that are unique to export to a specific country. These would not be required in an ISO 17025:2005 accreditation situation. In some instances such as the pre-export certification program authorized by the European Union (EU), the EU requirement is that laboratories have both ISO 17025:2005 accreditation and an approval by a government agency.



  1. IF THE COLLECTION OF INFORMATION IMPACTS SMALL BUSINESSES OR OTHER SMALL ENTITIES (ITEM 5 OF THE OMB FORM 83-1), DESCRIBE THE METHODS USED TO MINIMIZE BURDEN.


The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service businesses as those having annual receipts of no more than $6.5 million. Under these definitions, some of our participants are considered small laboratories. We currently have 56 respondents for these collections and we estimate that 30 are considered small businesses.


However, the information collected from small laboratories is the same as that collected from large laboratories. There is no additional burden placed on small laboratories to participate. In fact, the only reason a laboratory would participate in one of the programs is to provide additional service to its clients.



  1. DESCRIBE THE CONSEQUENCE TO FEDERAL PROGRAM OR POLICY ACTIVITIES IF THE COLLECTION IS NOT CONDUCTED OR IS CONDUCTED LESS FREQUENTLY, AS WELL AS ANY TECHNICAL OR LEGAL OBSTICLES TO REDUCING BURDEN.


If the information is not collected, the agency cannot determine if the laboratory is capable of performing the required analyses in a manner which meets good laboratory practices and/or the requirements specified by a foreign government. Therefore, the agency cannot approve the laboratory. If there are no approved laboratories for the specific commodity and test, then that industry loses a market for its product. Any reduction in the quantity of data collected could result in the purchaser determining that the program is not stringent enough, and therefore they might reject the results produced by the laboratory and lose any confidence they may have had in the USDA approval process. In the case of the Aflatoxin in Almonds program, without the approved laboratory program, every lot of almonds shipped to the EU would be tested for aflatoxin in an EU laboratory before being accepted for importation. This would cause considerable expense to the almond growers since they would have to pay for storage of the product, the laboratory analysis, and any penalty for delay in delivery required. With the program in place, ≤1% of the lots will be held and retested by the EU. Without the Trichina program in place, the EU, Russia, Chile, and Singapore will not accept U.S. pork unless every lot is held frozen for 30 days or more prior to shipment. These freezing and holding causes considerable expense to the processor and reduces the marketability of the product since customers prefer fresh (not frozen) product. In regards to the Russian program, only through lengthy negotiations was the U.S. government able to arrange for the export of poultry and pork to Russia. Key to those negotiations was the development of a USDA laboratory approval program to test product for a list of microorganisms and chemical residues determined by Russia. In short, when a foreign government reviews the USDA approved laboratories, if they are not convinced that the approval process was stringent enough to protect their citizens, they will no longer accept the U.S. product.



  1. EXPLAIN ANY SPECIAL CIRCUMSTANCES THAT WOULD CAUSE AN INFORMATION COLLECTION TO BE CONDUCTED IN A MANNER:


  • REQUIRING RESPONDENTS TO REPORT INFORMATION TO THE AGENCY MORE OFTEN THAN QUARTERLY;


Proficiency sample results for some commodity tests may be required more often than quarterly since they frequently parallel the growing and testing season. There are then gaps in the year when proficiency sampling does not occur. In addition, for some programs which are quantitative, the number of the proficiency tests per year will not be exactly the same for all laboratories. A data analysis of the proficiency sample results must be performed to determine if the laboratory is meeting the performance criteria. More than four analyses per year are needed, since the number of laboratories in each program tends to be quite small.


  • REQUIRING RESPONDENTS TO PREPARE A WRITTEN RESPONSE TO A COLLECTION OF INFORMATION IN FEWER THAN 30 DAYS AFTER RECEIPT OF IT;


Due to the biological nature of some proficiency samples, it is necessary for the analyses to be performed as quickly as possible upon receipt of the samples. If they are held for 30 days, the organisms may die or the toxins degrade, and the laboratory will be unable to isolate the appropriate culture or detect the appropriate amount of toxin. This could be the basis for removal of the laboratory from the program. The laboratories are informed prior to shipment that the samples are coming. Marking the results on the sample response sheet takes 30 seconds and it is to the laboratories advantage to submit the results quickly so they know if they have a problem in their laboratory and must repeat the analysis.


  • REQUIRING RESPONDENTS TO SUBMIT MORE THAN AN ORIGINAL AND TWO COPIES OF ANY DOCUMENT;


There are no special circumstances that would require respondents to submit more than and original and two copies of any document.


  • REQUIRING RESPONDENTS TO RETAIN RECORDS, OTHER THAN HEALTH, MEDICAL, GOVERNMENT CONTRACT, GRANT-IN-AID, OR TAX RECORDS FOR MORE THAN 3 YEARS;


There are no special circumstances that would require respondents to retain records more than three years.


  • IN CONNECTION WITH A STATISTICAL SURVEY, THAT IS NOT DESIGNED TO PRODUCE VALID AND RELIABLE RESULTS THAT CAN BE GENERALIZED TO THE UNIVERSE OF STUDY;


The data collected is not designed to be generalized to the universe of study. It is designed to determine if the specific laboratory is capable of determining the expected outcome of the proficiency sample analysis. The statistical calculations performed are to determine if the specific laboratory’s results vary significantly different from that obtained by other laboratories in the program. These results are called “outliers” and are an indication that the laboratory is not conducting the analysis correctly.


  • REQUIRING THE USE OF A STATISTICAL DATA CLASSIFICATION THAT HAS NOT BEEN REVIEWED AND APPROVED BY OMB;


The statistical methods used in some of these programs are specifically for scientific data. At present, the Cusum analysis is used to detect a bias in the analysis, and the Grubb analysis is used to detect “outliers”. These statistical methods are routinely used in the scientific community.


  • THAT INCLUDES A PLEDGE OF CONFIDENTIALITY THAT IS NOT SUPPORTED BY AUTHORITY ESTABLISHED IN STATUE OR REGULATION, THAT IS NOT SUPPORTED BY DISCLOSURE AND DATA SECURITY P OLICIES THAT ARE CONSISTENT WITH THE PLEDGE, OR WHICH UNNECESSARILY IMPEDES SHARING OF DATA WITH OTHER AGENCIES FOR COMPATIBLE CONFIDENTIAL USE; OR


There are no pledges of confidentiality given that are not supported by authority established in statue or regulation.


  • REQUIRING RESPONDENTS TO SUBMIT PROPRIETARY TRADE SECRET, OR OTHER CONFIDENTIAL INFORMATION UNLESS THE AGENCY CAN DEMONSTRATE THAT IT HAS INSTITUTED PROCEDURES TO PROTECT THE INFORMATION’S CONFIDENTIALITY TO THE EXTENT PERMITTED BY LAW.


The confidentiality of the collected information is maintained in accordance with the Privacy Act of 1974 and subsequent amendments. The LATD works as a U.S. Government entity under the laws and subsequent regulations specified in 7 CFR Parts 1.110-1.123.



  1. IF APPLICABLE, PROVIDE A COPY AND IDENTIFY THE DATE AND PAGE NUMBER OF PUBLICATION IN THE FEDERAL REGISTER OF THE AGENCY”S NOTICE, REQUIRED BY 5 CFR 1320.8(D), SOLICITING COMMENTS ON THE INFORMATION COLLECTION PRIOR TO SUBMISSION TO OMB. SUMMARIZE PUBLIC COMMENTS RECEIVED IN RESPONSE TO THAT NOTICE AND DESCRIBE ACTIONS TAKEN BY THE AGENCY IN RESPONSE TO THESE COMMENTS. SPECIFICALLY ADDRESS COMMENTS RECEIVED ON COST AND HOUR BURDEN.


A 60-day notice concerning this information collection was published in the Federal Register on April 4, 2017 (Vol. 82, No. 63, pages 16334 - 16335), which invited comments from interested persons through June 5, 2017.  No comments were received.


DESCRIBE EFFORTS TO CONSULT WITH PERSONS OUTSIDE THE AGENCY TO OBTAIN THEIR VIEWS ON THE AVAILABILITY OF DATA, FREQUENCY OF COLLECTION, THE CLARITY OF INSTRUCTIONS AND RECORDKEEPING, DISCLOSURE, OR REPORTING FORMAT (IF ANY), AND ON THE DATA ELEMENTS TO BE RECORDED, DISCLOSED OR REPORTED.


The LATD has consulted with interested industries or other agency on the programs’ requirements. Once a program is developed, the protocol is sent to representatives of the industry and/or agency requesting its development. The industry and/or agency representatives are required to review the protocol and accept or reject the program.


Industry/agency representatives contacted:

Director, FSIS, Import/Export Coordination & Policy Development Staff; (202) 720-0082

Deputy Administrator, FAS, Office of Agreements and Scientific Affairs; (202) 720-4434

Vice President, Global Technical & Regulatory Affairs, Almond Board of California; (209) 549-8262

Peanut Standards Board, AMS, Marketing Orders and Agreements Division; (863) 324-3375

President, American Peanut Council; (703) 838-9500

Manager, Administrative Committee for Pistachios; (559) 255-6480, ext. 103

Director, AMS, Commodity Procurement Staff; (202) 720-4517

Director, AMS, Food Safety and Commodity Specification Division, Livestock, Poultry and Seed Program; (202) 692-0342


CONSULTATION WITH REPRESENTATIVES OF THOSE FROM WHOM INFORMATION IS TO BE OBTAINED OR THOSE WHO MUST COMPILE RECORDS SHOULD OCCUR AT LEAST ONCE EVERY 3 YEARS—EVEN IF THE COLLECTION OF INFORMATION ACTIVITY IS THE SAME AS IN PRIOR PERIODS. THERE MAY BE CIRCUMSTANCES THAT MAY PRECLUDE CONSULTATION IN A SPECIFI SITUATION. THESE CIRCUMSTANCES SHOULD BE EXPLAINED.


The program managers are in constant contact with the laboratories in the programs.



9. EXPLAIN ANY DECISION TO PROVIDE ANY PAYMENT OR GIFT TO RESPONDENTS, OTHER THAN REMUNERATION OF CONTRACTORS OR GRANTEES.


No payments or gifts are provided to respondents.



10. DESCRIBE ANY ASSURANCE OF CONFIDENTIALITY PROVIDED TO RESPONDENTS AND THE BASIS FOR THE ASSURANCE IN STATUTE, REGULATION, OR AGENCY POLICY.


The confidentiality of the collected information is maintained in accordance with the Privacy Act of 1974 and subsequent amendments. The Laboratory Approval and Testing Division Staff works as a U.S. Government entity under the laws and subsequent regulations specified in 7 CFR Parts 1.110-1.123.



11. PROVIDE ADDITIONAL JUSTIFICATION FOR ANY QUESTIONS OF A SENSITIVE NATURE, SUCH AS SEXUAL BEHAVIOR AND ATTITUDES, RELIGIOUS BELIEFS, AND OTHER MATTERS THAT ARE COMMONLY CONSIDERED PRIVATE. THIS JUSTIFICATION SHOULD INCLUDE THE REASONS WHY THE AGENCY CONSIDERS THE QUESTIONS NECESSARY, THE SPECIFIC USES TO BE MADE OF THE INFORMATION, THE EXPLANATION TO BE GIVEN TO PERSONS FORM WHOM THE INFORMATION IS REQUESTED, AND ANY STEPS TO BE TAKEN TO OBTAIN THEIR CONSENT.


Questions of a sensitive nature are not found in this information collection.



12. PROVIDE ESTIMATES OF THE HOUR BURDEN OF THE COLLECTION OF INFORMATION.


THE STATEMENT SHOULD:

  • INDICATE THE NUMBER OF RESPONDENTS, FREQUENCY OF RESPONSE, ANNUAL HOUR BURDEN, AND AN EXPLANATION OF HOW THE BURDEN WAS ESTIMATED. UNLESS DIRECTED TO DO SO, AGENCIES SHOULD NOT CONDUCT SPECIAL SURVEYS TO OBTAIN INFORMATION ON WHICH TO BASE HOUR BURDEN ESTIMATES. CONSULTATION WITH A SAMPLE (FEWER THAN 10) OF POTENTIAL RESPONDENTS IS DISIRABLE. IF THE HOUR BURDEN ON RESPONDENTS IS EXPECTED TO VARY WIDELY BECAUSE OF DIFFERENCE IN ACTIVITY, SIZE OR COMPLEXITY, SHOW THE RANGE OF ESTIMATED HOUR BURDEN, AND EXPLAIN THE REASONS FOR THE VARIANCE. GENERALLY, ESTIMATES SHOULD NOT INCLUDE BURDEN HOURS FOR CUSOMARY AND USUAL BUSINESS PRACTICES.


  • IF THIS REQUEST FOR APPROVAL COVERS MORE THAN ONE FORM, PROVIDE SEPARATE HOUR BURDEN ESTIMATES FOR EACH FORM AND AGGREGATE THE HOUR BURDENS IN ITEM 13 OF OMB FORM 83-I.


  • PROVIDE ESTIMATES OF ANNUALIZED COST TO RESPONDENTS FOR THE HOUR BURDENS FOR COLLECTIONS OF INFORMATION, IDENTIFYING AND USING APPROPRIATE WAGE RATE CATEGORIES.


The respondents’ (56 laboratories) estimated annual cost of providing information to AMS for laboratory approval programs is approximately $145,195. This total has been estimated based on:

(a) $1011 -- by multiplying 28 burden hours (an applicant spent about 30 minutes to prepare an initial letter requesting entrance) by $36.09;

(b) $144,184 -- by multiplying 4112.5 burden hours (including the laboratory analyses documentation, proficiency test sample analyses, and was interviewed by the LATD program manager during an on-site laboratory review) by $35.06;

(c) Based upon the Bureau of Labor Statistics data, the average hourly earnings are $35.06 for life, physical, and social science occupations (including chemist, microbiologist, and physical science technician) and $36.09 for business and financial operations occupations.


Wages were obtained from the U.S. Department of Labor Statistics, Occupational Employment Statistics “Occupational Employment and Wages – May 2016”. This publication can also be found at the following website: http://www.bls.gov/news.release/ocwage.htm.



13. PROVIDE AN ESTIMATE OF THE TOTAL ANNUAL COST BURDEN TO RESPONDENTS OR RECORDKEEPERS RESULTING FROM THE COLLECTION OF INFORMTION. (DO NOT INCLUDE THE COST OF ANY HOUR BURDEN SHOWN IN ITEMS 12 AND 14).


There are no capital/start-up or ongoing operation/maintenance costs associated with this information collection.



14. PROVIDE ESTIMATES OF ANNUALIZED COST TO THE FEDERAL GOVERNMENT. ALSO PROVIDE A DESCRIPTION OF THE METHOD USED TO ESTIMATE COST, WHICH SHOULD INCLUDE QUANTIFICATION OF HOURS, OPERATION EXPENSES (SUCH AS EQUIPMENT, OVERHEAD, PRINTING, AND SUPPORT STAFF), AND ANY OTHER EXPENSE THAT WOULD NOT HAVE BEEN INCURRED WITHOUT THIS COLLECTION OF INFORMATION. AGENCIES ALSO MAY AGGREGATE COST ESTIMATES FROM ITEMS 12, 13, AND 14 IN A SINGLE TABLE.


The Federal Government recovers all costs thru a fee for service for these laboratory approval programs.



15. EXPLAIN THE REASON FOR ANY PROGRAM CHANGES OR ADJUSTMENTS REPORTED IN ITEMS 13 OR 14 OF THE OMB FORM 83-1.


Due to the marketing conditions, participating laboratories are increased in Microbiological and Aflatoxin Programs and are decreased among other programs (such as Trichinae in Pork and Poultry and Pork Exported to Russia Programs) since the last submission. The Microbiological Program is new with 2 respondents and a program increase of 2 responses and 152 burden hours. All laboratories now use the automated website: https://www.pay.gov and form ST-212 is obsoleted for a program decrease of 85 responses and 4.25 burden hours. Remaining differences are adjustments due to program requirements. Overall, the number of respondents decreased from 85 to 56; the number of burden hours decreased from 6,290 to 4,157; and the number of annual responses decreased from 680 to 380 because of various program requirements. The reasons for the number changes for the three different laboratory approval programs are described in Attachment #1.


16. FOR COLLECTIONS OF INFORMATION WHOSE RESULTS WILL BE PURBLISHED, OUTLINE PLANS FOR TABULATION, AND PUBLICATION. ADDRESS ANY COMPLEX ANALYTICAL TECHNIQUES THAT WILL BE USED. PROVIDE THE TIME SCHEDULE FOR THE ENTIRE PROJET, INCLUDING BEGINNING AND ENDING DATES OF THE COLLECTION OF INFORMATION, COMPLETION OF REPORT, PUBLICATION DATES, AND OTHER ACTIONS.


The information collected will not be published. It is strictly to assess the quality of a laboratory seeking to perform certain work under a USDA approval. The only thing that will be available to the public is a list of the approved laboratories in each program.



17. IF SEEKING APPROVAL TO NOT DISPLAY THE EXPIRATION DATE FOR OMB APPROVAL OF THE INFORMATION COLLECTION, EXPLAIN THE REASONS THAT DISPLAY WOULD BE INAPPROPRIATE.


New programs that come along always start small and some even are canceled when the marketing need disappears. We therefore do not want to print an expiration date of OMB approval on this collection.



18. EXPLAIN EACH EXCEPTION TO THE CERTIFICATION STATEMENT IDENTIFIED IN ITEM 19, “CERTIFICATION FOR PAPERWORK RESUCTION AT SUBMISSIONS,” OF OMB FORM 83-1.


The agency is able to certify compliance with all provisions under Item 19 of OMB Form 83-I.


B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

This information collection does not employ statistical methods.


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