The list of conformity assessment program examples is being provided to help facilitate best practice sharing between Federal Agencies and programs on ways to utilize conformity assessment to meet federal agency missions, objectives, and regulatory requirements. It is not an exhaustive list of all Federal Agency conformity assessment programs. To add additional programs or update the current list, please contact Cheryl Levey.
Center for Devices and Radiological Health Standards and Conformity Assessment Program
The Standards and Conformity Assessment Program supports the FDA's mission of protecting and promoting public health through the development, recognition and use of voluntary consensus standards in regulating medical devices, radiation-emitting products and emerging technologies. The Center for Devices and Radiological Health (CDRH) is committed to making safe and effective medical devices available to patients in an efficient and least burdensome manner. An important element of our regulatory framework is a robust standards program. CDRH encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their submissions, as conformity to relevant standards streamlines regulatory review and fosters quality.
CPSC Testing & Certification
Federal law requires manufacturers and importers to test many consumer products for compliance with consumer product safety requirements. Based on passing test results, the manufacturer or importer must certify the consumer product as compliant with the applicable consumer product safety requirements in a written or electronic certificate. Certificates are required to accompany the applicable product or shipment of products covered by the certificate, and a copy must be provided to retailers, distributors and, upon request, to the government. Note that requirements for children’s products are different from those for non-children’s products.
List of CPSC-Accepted Testing Laboratories
Section 14(a)(3)(E) of the Consumer Product Safety Act, as amended, requires the Commission to 'maintain on its Internet website an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules. Third party testing is required to support a certification of compliance to the rules for children’s products that are enforced by the Commission. The laboratories in this list have been accepted as accredited to test products to one or more of these children’s product safety rules, as identified in the accreditation scope for each laboratory. A manufacturer of a children's product that must comply with one or more of these rules must support its certification of compliance with test results from one of these laboratories.
ENERGY STAR Program, U.S. Environmental Protection Agency
ENERGY STAR® is the U.S. Environmental Protection Agency (EPA) symbol for energy efficiency and is a voluntary program that makes it easy for consumers and businesses to purchase products that save them money and protect the environment. EPA ensures that each product that earns the label is independently certified to deliver the quality, performance, and savings that consumers have come to expect. There have been more than 5.8 billion ENERGY STAR products sold since 1992.
In 2017, EPA oversaw robust third-party certification of ENERGY STAR products, administered by 23 independent certification bodies and more than 600 labs. Certification is based on international standards for conformity assessment including testing in labs accredited to ISO 17025 and certification by certification bodies accredited to ISO 17065. In addition, EPA also requires that a sample of products be tested directly off retailers’ shelves. In 2017, EPA-recognized certification bodies administered post-market verification testing on more than 1,700 products, resulting in 115 unique disqualifications for a compliance rate of 93%, affirming consumer confidence in the label.
Environmentally Preferable Purchasing Program, U.S. Environmental Protection Agency
EPA’s Environmentally Preferable Purchasing Program provides Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. This involves an assessment of a standard’s or ecolabel’s development process, environmental effectiveness, conformity assessment procedures, and management of the mark/label in the marketplace. Multi-stakeholder developed EPA Guidelines serve as the basis for these assessments and Section III of the Guidelines would be useful to other federal agencies in assessing the competency of Conformity Assessment Bodies (even those outside of the environmental and public health fields).
Federal Communication Commission Equipment Authorization Approval
The FCC Office of Engineering and Technology (OET) administers a Radio Frequency (RF) Device equipment authorization program to ensure that RF devices used in the United States operate without causing harmful interference and comply with FCC rules. All RF devices subject to equipment authorization must comply with the FCC’s technical requirements prior to importation or marketing. Equipment that contains an RF device must be authorized in accordance with the appropriate procedures specified in 47 CFR part 2, subpart J (with certain limited exceptions). FCC has two different approval procedures for equipment authorization – Certification and Supplier’s Declaration of Conformity (SDoC). The required procedure depends on the type of equipment being authorized as specified in the applicable FCC rule part. In some instances, a device may have different functions resulting in the device being subject to more than one type of approval procedure.
The National Organic Program (NOP), U.S. Department of Agriculture (USDA) Agricultural Marketing Service
The National Organic Program (NOP) is a regulatory program housed within the USDA Agricultural Marketing Service. USDA is responsible for developing national standards for organically-produced agricultural products. These standards assure consumers that products with the USDA organic seal meet consistent, uniform standards. The regulations do not address food safety or nutrition.
Nationally Recognized Testing Laboratories Program
The Nationally Recognized Testing Laboratory (NRTL) Program recognizes private sector organizations to approve (i.e., test and certify) certain type products to help ensure that they can be used safely in the workplace. The U.S. Occupational Safety and Health Administration (OSHA) requires NRTL approval for 37 different types of products. Electric equipment is the largest of these product categories. The requirements for NRTL approval apply where these type products are used in workplaces subject to OSHA's jurisdiction. The related certification activities involve the NRTL ensuring that all manufactured units of the product meet the necessary safety specifications. Proper product testing and certification require a great deal of special expertise, effort, and resources. OSHA does not perform any product approvals; OSHA relies on third parties, NRTLs, to do this work.
WaterSense , U.S. Environmental Protection Agency
WaterSense, a voluntary partnership program sponsored by the U.S. Environmental Protection Agency (EPA), is both a label for water-efficient products and a resource for helping consumers save water. The WaterSense label makes it simple to find water-efficient products, new homes, and programs that meet EPA’s criteria for efficiency and performance. WaterSense-labeled products and services are certified to use at least 20 percent less water, save energy, and perform as well as or better than regular models.
WaterSense has developed a conformity assessment framework for the program based on international standards which has been used as a model by other federal programs. All products bearing the WaterSense label are certified for efficiency and performance by one of seven independent licensed certification bodies which are accredited to ISO/IEC 17065. In addition to initial certification, the certification bodies also perform annual surveillance on certified products, carry out post-market verification of a percentage of labeled products, and assist WaterSense with on-going brand monitoring. Since 2007, certification bodies have certified close to 30,000 models of products in eight product categories.
Certification Program for Access to Death Master File
The U.S. National Technical Information Service (NTIS) established a certification program for those seeking access to the Limited Access Death Master File (LADMF) pursuant to Section 203 of the Bipartisan Budget Act of 2013 (Pub. L. 113-67).
Cryptographic Module Validation Program
On July 17, 1995, NIST established the Cryptographic Module Validation Program (CMVP) that validates cryptographic modules to Federal Information Processing Standards (FIPS)140-1, Security Requirements for Cryptographic Modules, and other FIPS cryptography based standards. FIPS 140-2, Security Requirements for Cryptographic Modules, was released on May 25, 2001 and supersedes FIPS 140-1. The CMVP is a joint effort between NIST and the Communications Security Establishment (CSE). Modules validated as conforming to FIPS 140-2 are accepted by the Federal Agencies of both countries for the protection of sensitive information. Vendors of cryptographic modules use independent, accredited Cryptographic and Security Testing (CST) laboratories to test their modules. The CST laboratories use the Derived Test Requirements (DTR), Implementation Guidance (IG) and applicable CMVP programmatic guidance to test cryptographic modules against the applicable standards. NIST's Computer Security Division (CSD) and CSE jointly serve as the Validation Authorities for the program, validating the test results and issuing certificates.
Federal Acquisition Certification and Career Development Program
Federal certification programs, operated by the Office of Federal Policy and the Federal Acquisition Institute, are designed to establish consistent competencies and standards for those performing acquisition-related work in civilian agencies. For example, the Federal Acquisition Certification in Contracting (FAC-C) Program is for contracting professionals in the Federal Government performing contracting and procurement activities and functions. The purpose of this program is to establish general education, training, and experience requirements for those contracting professionals. The FAC-C applies to all executive agencies, except the Department of Defense (DoD).
Respirator Approval Program
The U.S. National Personal Protective Technology Laboratory (NPPTL) administers the Respirator Approval Program (RA Program) for the National Institute for Occupational Safety and Health (NIOSH). The RA Program is a conformity assessment program for respiratory protection devices used in occupational settings. Per the authorities in Title 42, Code of Federal Regulations, Part 84 (42 CFR 84), the RA Program develops performance, quality, and labeling requirements; reviews applications submitted by manufacturers to determine if they meet the performance, quality, and labeling requirements; physically tests respirator assemblies, reviews quality and labeling documentation, and performs inspections of proposed manufacturing facilities. NPPTL grants the use of the NIOSH mark for respirators that are approved as meeting requirements and maintains a listing of approved respirator configurations (i.e., approved assembly, quality documentation and practices, and labeling). NPPTL conducts post-market audits of approved respirator configurations and associated manufacturing sites to ensure continued compliance with approval requirements for performance, quality, and labeling. Enforcement agencies, such as OSHA, require employers to provide NIOSH-approved respirators. In addition, private sector certification scheme owners such as the National Fire Protection Association use the NIOSH approval as the basis for their certification.