2020-11187. Notice of Request for Extension and Revision of a Currently Approved Information Collection

AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Notice and request for comments.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Agricultural Marketing Service's (AMS) intention to request approval, from the Office of Management and Budget (OMB), for an extension of and revision to the currently approved information collection “Laboratory Approval Programs.”

DATES:

Comments on this notice must be received by July 27, 2020 to be assured of consideration.

Additional Information or Comments: Interested persons are invited to submit comments concerning this notice by using the electronic process available at http://www.regulations.gov. Written comments may also be submitted to Laboratory Approval and Testing Division, Science and Technology Program, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue SW, Stop 0272, Washington, DC 20250-0272; or by facsimile to [phone]. All comments should reference the docket number AMS-ST-20-0050, the date, and page number of this issue of the Federal Register. All comments will become a matter of public record and will be made available for public inspection at the above address during regular business hours and may be viewed at http://www.regulations.gov.

SUPPLEMENTARY INFORMATION:

Title: Laboratory Approval Programs.

OMB Number: 0581-0251.

Expiration Date of Approval: September 30, 2020.

Type of Request: Extension and revision of a currently approved information collection.

Abstract: Under the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), AMS' Laboratory Approval Service (LAS) approves, or accredits, laboratories to perform testing services in support of domestic and international trade. At the request of industry, other Federal agencies, or foreign governments, AMS develops and administers laboratory approval programs (LAPs) to verify that the analysis of food and agricultural products meet country or customer-specified requirements. LAS ensures the testing of products marketed is conducted by qualified and approved laboratories. LAPs requirements include good laboratory, quality assurance and control practices; applicable domestic and international standards (such as ISO/IEC 17025); established methods and accepted equipment; and on-site audits. Laboratories voluntarily participate in the program and pay program fees. Currently, LAS administers four LAPs with 60 participants.

The information collection includes customer/business information and quality management system (QMS) documentation essential to examine laboratories for entrance and continual participation in the following programs:

(1) Aflatoxin Program—this program approves laboratories to perform aflatoxin testing in support of domestic and/or export trade of almonds, peanuts, and pistachio nuts. (a) Almond. At the request of the Almond Board of California (ABC), AMS administers the program for aflatoxin testing of almonds destined for export to the European Union (EU) through the Pre-Export Certification program of ABC. (b) Peanuts. AMS administers Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States (7 CFR 996 Parts 996.1-996.75). The regulation requires domestically marketed peanuts for human consumption to be analyzed for aflatoxin by a USDA or USDA-approved laboratory. AMS consults with the Peanut Standards Board on program requirements. (c) Pistachio Nuts. AMS administers mandatory domestic and import aflatoxin requirements for pistachio nuts under Pistachios Grown in California, Arizona, and New Mexico (7 CFR part 983) and Specialty Crops, Import Regulations (7 CFR part 999, Section 999.600), respectively. All domestic and import shipments of pistachio nuts intended for human consumption must be tested for aflatoxin contamination. At the request of the Administrative Committee for Pistachios (ACP), laboratories may also participate in the program for pistachio nuts destined for EU through the Pistachio Export Aflatoxin Reporting (PEAR) program of ACP.

(2) Export Program—this program approves laboratories to perform testing of meat and poultry products offered for export certification by the Food Safety and Inspection Service (FSIS). LAS collaborates with FSIS, the Foreign Agricultural Service, and the meat and poultry industries to administer a flexible and comprehensive program to provide reliable analyses of pesticide residues, environmental contaminants, veterinary drug residues, antibiotic residues, microorganisms, and parasites.

(3) Microbiological Testing of Poultry Products for the Federal Purchase Program (FPP)—this program approves laboratories to perform microbiological testing of frozen, cooked, diced chicken procured for the Federal Purchase Program and is limited to the analysis of aerobic plate counts, coliform counts, coagulase positive Staphylococcus aureus, generic Escherichia coli, Salmonella species, and Listeria monocytogenes.

(4) Dairy Program—this program supports the Dairy Grading Branch for laboratories testing butter for quality and grading standards. LAS collaborates with the Dairy Grading Branch and the dairy industry to administer an audit program to provide reliable analysis for the grading of butter.

All LAPs follow similar general procedures for application process and evaluations for continual participation. Applicants (laboratories applying to be approved or accredited by AMS) and participants (laboratories approved or accredited under a LAP) are responsible for paying applicable program fees. An applicant or participant may withdraw or voluntarily request suspension at any time and if deemed necessary LAS can suspend or dismiss a participant.

The greatest information collection burden is during the application process. The application process can occur when an applicant seeks approval into a program and when a participant seeks to expand their scope of approval. Generally, the application process includes, submission of an application letter and application package, including customer/business information for billing and QMS documentation; and receive an audit by AMS. The customer/business information collected includes business legal name, Federal Tax ID Number, mailing address, billing address, management contacts and accounts payable contact. The burden hours incurred for an applicant to submit application package materials for application or expansion of scope is typically a one-time occurrence and is essential for evaluating an applicant's ability to meet program requirements and gain approval.

Once an applicant is approved into the program, the information collection burden decreases for the continual participation process. A participant verifies intent to continue participation and its customer/business information annually, and on a periodic basis submits proficiency testing reports to evaluate analytical proficiency, and QMS documentation in response to audits by AMS. The information listed is essential to examine a participant's ability to continually meet program requirements and maintain program status.

Occasionally, a participant withdraws, is suspended, or is dismissed from a program. When a participant withdraws it submits a letter of request. When a participant requests voluntary suspension or is suspended by LAS it may request reinstatement of approval and must demonstrate its ability to meet program requirements through the continual participation process. On the rare occasion a participant fails to continually meet program requirements the participant may be notified of its danger of being dismissed. The dismissal process includes an evaluation using the continual participation process to substantiate reason for dismissal.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2.24 hours per response.

Respondents: Laboratories.

Estimated Number of Respondents: 60.

Estimated Total Annual Responses: 538.

Estimated Number of Responses per Respondent: 8.97.

Estimated Total Annual Burden on Respondents: 1204.00.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information including completion of analyses related documentation; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.

Bruce Summers,

Administrator, Agricultural Marketing Service.