Federal Laboratory Accreditation/Acceptance and Recognition Programs
Laboratory Accreditation is formal confirmation by a third-party that a laboratory has demonstrated its competence to carry out specific laboratory tasks. Laboratory Acceptance generally involves a less rigorous evaluation of a laboratory's competence. In some cases, federal agencies do not accredit laboratories directly. Instead, the agencies recognize laboratory accreditation bodies and the laboratories accredited by those bodies.
Requirements for laboratory acceptance/accreditation/recognition programs within the federal government vary greatly by program. While some programs are quite comprehensive, others involve only minimal review of a laboratory's or the laboratory accreditation body's qualifications. The requirements and scope of each program generally are tailored to meet specific agency needs. In some cases, the laboratories provide only an initial product screening, with federal laboratories maintaining final responsibility for producing the test data used in enforcing regulations. Eligibility requirements for acceptance/accreditation as well as for the recognition of laboratory accreditation programs also vary among programs.
Below are websites for various federal laboratory accreditation/acceptance and recognition programs.
The DNA Initiative
Audits DNA labs.
U.S. Consumer Product Safety Commission (CPSC)
The Laboratory Accreditation Registration System for Third Party Testing Laboratories is a web-based application supporting the registration of third party laboratories seeking accreditation to test children's products for conformity with the Commission's regulations. These laboratories must be accredited by an International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement (ILAC-MRA) signatory accrediting body and the accreditation must be registered with, and accepted by, the Commission.
U.S. Department of Agriculture
- AMS (Agricultural Marketing Service): Technical Services
Technical Services providse laboratory approval and certification programs for US agricultural commodities such as almonds, peanuts, pistachios, poultry, trichinae export program, and dairy.
- APHIS (Animal and Plant Health Inspection Service) The APHIS approves laboratories to conduct tests for certain types of diseases where such tests must be performed at either the National Veterinary Services Laboratories or other APHIS-approved facilities. Some testing is performed only by laboratories in the National Animal Health Laboratory Network.
- FSIS (Food Safety and Inspection) The FSIS operates a pilot program involving federal food laboratories at FDA, and the US Army; and some state food laboratories to become accredited under ISO 17025.
- FSIS: Accredited Laboratory Program FSIS accredits analytical chemistry laboratories to analyze meat and poultry food products for moisture, protein, fat, and salt content and/or certain classes of chemical residues.
- GIPSA (Grain Inspection, Packers and Stockyards Administration) The GIPSA authorizes agencies/ laboratories to provide official inspection and/or weighing services on GIPSA's behalf.
- National Seed Health System Accredits public and private entities to perform laboratory seed health tests and phytosanitary inspections to meet international import regulations.
U.S. Department of Commerce, National Institute of Standards and Technology (NIST)
- Standard Reference Materials (SRM) Program Operates NIST's Gas Mixture Traceable Reference Material NTRM® program that consists of commercially produced reference materials with a well-defined traceability linkage to existing NIST standards.
- USGv6 Testing Program OMB Memorandum M-05-22 directs NIST to develop the technical infrastructure (standards and testing) necessary to support wide sIPv6 in the US Government.
U.S. Department of Defense
- Environmental Laboratory Accreditation Program Using third-party Accreditation Bodies (ABs), the DoD ELAP provides a unified DoD program through which laboratories can demonstrate competency and document conformance to the DoD Quality Systems Manual for Environmental Laboratories (DoD QSM).
U.S. Department of Health and Human Services (HHS)
- Workplace Drug Testing Program HHS notifies Federal agencies of the laboratories currently certified by the HHS National Laboratory Certification Program (NLCP) to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs.
- FDA: Good Laboratory Practice (GLP) for Nonclinical Laboratories Nonclinical laboratory studies are experiments that study test articles (food additives, color additives, drug or biological products, electronic products, medical devices for human use) in test systems (animals, plants, microorganisms, or subparts thereof) under laboratory conditions to determine their safety. FDA inspects facilities that conduct nonclinical laboratory studies to determine compliance with Part 58 (GLP for Nonclinical Laboratory Studies) of Title 21 of the Code of Federal Regulations.
U.S. Department of Homeland Security
- U.S. Coast Guard Independent laboratories conduct initial (approval) and follow-up (production) testing of equipment and materials that require Coast Guard Approval. Accepted and recognized independent laboratories act on behalf of the Coast Guard during the approval of lifesaving and fire protection equipment and materials.
U.S. Department of Transportation
- Federal Highway Administration (FHWA): Quality Assurance: Laboratory Qualification The FHWA regulation for construction requires accreditation of the central laboratory of each State Department of Transportation (DOT) and all Non-State-DOT laboratories that perform independent assurance testing or testing for dispute resolution. The regulation requires accreditation "by the American Association of State Highway and Transportation Officials (AASHTO) Accreditation Program or a comparable laboratory accreditation program approved by the FHWA."
- Office of Hazardous Materials Safety: UN Third Party Certification Agencies Approval may be granted to an organization or a person to conduct package testing as a DOT Approved UN Third Party Certification Agency. Package testing may be conducted for either manufacturers of packagings or for shippers of hazardous materials and a certification made that the packagings are in full compliance with requirements. Approvals are granted based upon the technical qualifications of the applicant as well as the results of an in-person inspection to determine the capability of the laboratory in which the package testing would be taking place
- Office of Drug & Alcohol Policy & Compliance DOT publishes rules on who must conduct drug and alcohol tests, how to conduct those tests, and what procedures to use when testing. Laboratories are certified by the Substance Abuse and Mental Health Services Administration/HHS.
U.S. Environmental Protection Agency
- UCMR Laboratory Approval Program EPA approves laboratories to conduct analyses of contaminants covered in its Unregulated Contaminant Monitoring Regulation (UCMR).
- Other Drinking Water-Related Laboratory Approval Programs - EPA approves laboratories to test for contaminants not covered under State drinking water certification programs. Laboratories that analyze source water samples for Cryptosporidium must be approved by EPA under its Cryptosporidium Laboratory Quality Assurance Program.
- ENERGY STAR Program EPA established the Conditions and Criteria for Recognition of Laboratories Accreditation Bodies (ABs) for the ENERGY STAR program. Recognized ABs must be a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA), meet the requirements of ISO 17011, and comply with the specific conditions of the ENERGY STAR Laboratory Accreditation Requirements.
- WaterSense Program EPA develops criteria for the inspection, labeling, and oversight of new homes for the WaterSense program.
U.S. Department of the Treasury