DNDO Guidance for Laboratories on the GRaDER Program

This summary introduces the guidance necessary to involve and qualify laboratories to support the Graduated Radiation/Nuclear Detector Evaluation and Reporting (GRaDER) program by providing accredited independent testing services to manufacturers and vendors of targeted radiation detectors.

The Domestic Nuclear Detection Office (DNDO) is in the process of establishing a "fee-for testing" program to test and evaluate commercially available technology for detecting nuclear explosive devices, and fissile or radiological material as directed by the Security and Accountability For Every (SAFE) Port Act of 2006. This program will be used to verify the radiation detector performance claims of manufacturers and drive the market to improve the capabilities offered to DHS components, law enforcement and first responders. The GRaDER program establishes the current American National Standards Institute (ANSI) / Institute of Electrical and Electronic Engineers (IEEE) N42 series consensus standards as the initial acceptable performance baseline for radiation detectors, and incorporates government unique technical capability standards currently under development as the next overall performance objective.

The GRaDER program is working with Department of Energy (DOE) laboratories and the National Institute of Standards and Technology (NIST) to establish the National Voluntary Laboratory Accreditation Program (NVLAP) as the program by which DNDO assures independent and consistent testing of the commercial-off-the-shelf radiation detectors. Results of the GRaDER program testing will be made available to Department of Homeland Securuty components and state, local, and tribal law enforcement and first responder agencies for more informed procurement decisions. It is envisioned that the GRaDER program will establish a simplified performance test results reporting protocol that may be used to develop procurement and grants award criteria.

The Department helped create and accepted ANSI/IEEE N42 consensus standards for six (6) categories of radiation detection equipment used in the prevention mission role, as well as for data formats and training. Additional ANSI/IEEE standards are being developed to address non-intrusive imaging and other technologies, and to address the response and recovery mission roles. the Department of Homeland Security/DNDO also funded development of NIST Handbook 150-23:2007 (DRAFT) NVLAP Radiation Detection Instruments.

A manufacturer or vendor may have its radiation detection product tested at DNDO-accepted or NVLAP-accredited laboratories. Testing laboratories must be DNDO-accepted or NVLAP-accredited in accordance with NIST Handbooks 150:2006, NVLAP Procedures and General Requirements and 150-23:2007 (DRAFT) NVLAP Radiation Detection Instruments, and the specific ANSI/IEEE N42 standards. DNDO may accept a test facility without NVLAP accreditation for a limited period of time or on a permanent basis based on testing resource availability. Laboratories that are not appropriately NVLAP accredited must self-declare their conformity with the above requirements to DNDO. Labs must also conform with ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories. A checklist used by DNDO to determine laboratory acceptance is attached with this guidance.

Laboratories wishing to support manufacturers/vendors that desire product listings in the GRaDER program must submit accreditation applications to NIST before submitting Self-Declarations of Conformity to DNDO. In addition, these laboratories must provide a letter to the NVLAP manager that authorizes the NIST/NVLAP to exchange information on the details and status of the application with DNDO.

Once the applicant laboratory has submitted an application for NVLAP accreditation to NIST, it should assemble a Self-Declaration of Conformity to the NIST Handbooks 150 and 150-23-2007 (DRAFT), and ISO/IEC 17025:2005 packet with the standards for which the laboratory will offer accredited testing services. This packet shall include a signed declaration page on laboratory letterhead, a completed copy of an assessment report that attests to the satisfaction of all accreditation conditions (e.g., NIST Handbook 150 Annex C), a description of the scope of testing that the laboratory intends to perform, identification of any and all exceptions to the handbook and ANSI/IEEE N42 standards, a copy of the laboratory's quality control/quality assurance manual and work instructions/procedures for the ANSI/IEEE N42 standards, and a description of the facilities in which testing will be conducted. The Self-Declaration of Conformity packet should be submitted to the DNDO GRaDER Program Manager for consideration.

DNDO will review these conformity claims and, with NIST's assistance, determine if test results from these facilities will be accepted on a temporary or permanent basis. Only test results from DNDO-accepted or fully accredited NVLAP facilities will be considered for evaluation. DNDO reserves the right to conduct site visits of applicant laboratories that submit a Self-Declaration of Conformity, and review and observe testing in progress that supports the GRaDER program. Once a determination has been made as to the acceptance of a laboratory, DNDO will add the facility to its list on the Department of Homeland Security/DNDO GRaDER Program Web site. DNDO will periodically confirm the NVLAP application status, and the laboratory's accreditation status with the NVLAP Program Manager at NIST. In addition, the laboratory will be subject to any NVLAP surveillance that NIST conducts. Loss of NVLAP accreditation will jeopardize the acceptance of test results reporting for the products under consideration for the GRaDER program, and may impact the retention of existing GRaDER program products.

Testing and Evaluation Process

The testing process includes two phases.

GRaDER Program Overview
Radiation/Nuclear Detectors for Prevention

The first phase will involve testing by DNDO accepted laboratories participating in the NIST NVLAP accreditation process against existing unclassified, consensus based ANSI/IEEE N42 standards. Subsets of the requirements in these consensus standards will be used to determine DNDO compliance levels. These subsets emphasize radiation detection performance capability first and then environmental and operational capabilities and limitations.

The second phase will entail testing at DNDO sponsored government facilities against more challenging threat based Government unique technical capability standards (to be published), and sources under realistic operational and environmental conditions.

In addition to these two phases of GRaDER testing, DNDO will implement a product surveillance program that will be conducted by NIST. This will involve subsequent post-market testing and assessments of radiation detectors that have already been tested and evaluated under the GRaDER program. Results of these post-market assessments may impact the standing of the radiation detectors identified within the GRaDER program.

All testing is voluntary and at the vendor's expense.

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Reporting Conventions

DNDO will assign compliance levels based on test results and observations. Laboratories report results as prescribed by the NVLAP. DNDO will require an original signed copy of the test results issued by the NVLAP accredited laboratory.

Observations from testing that relate to radiation detector suitability for missions and DHS component environmental conditions will be captured in comment form and will be provided for the consideration of the users.

Manufacturers may elect to have their test results included in a DNDO-published listing made available to interested parties outside the federal government. This listing may be used by federal, state and local authorities in making procurement and grant decisions. If a manufacturer does not agree to such publication, the test results will not be released outside the federal government. The incentive to participate comes from government procurement and gant programs award criteria. Only equipment that meets the designated criteria will receive government funding.

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Laboratory Participation Process

Once the applicant laboratory has submitted an application for NVLAP accreditation to NIST, it should assemble a Self-Declaration of Conformity to the NIST Handbooks 150 and 150-23-2007 (DRAFT), and International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025:2005 packet with the standards for which the laboratory will offer accredited testing services. This packet shall include a signed declaration page on laboratory letterhead, a completed copy of an assessment report that attests to the satisfaction of all accreditation conditions (e.g., NIST Handbook 150 Annex C), a description of the scope of testing that the laboratory intends to perform, identification of any and all exceptions to the handbook and ANSI/IEEE N42 standards, a copy of the laboratory's quality control/quality assurance manual and work instructions/procedures for the ANSI/IEEE N42 standards, and a description of the facilities in which testing will be conducted. The Self-Declaration of Conformity packet should be submitted to the DNDO GRaDER Program Manager for consideration.

DNDO will review these conformity claims and, with NIST's assistance, determine if test results from these facilities will be accepted on a temporary or permanent basis. Only test results from DNDO-accepted or fully accredited NVLAP facilities will be considered for evaluation. DNDO reserves the right to conduct site visits of applicant laboratories that submit a Self-Declaration of Conformity, and review and observe testing in progress that supports the GRaDER program. Once a determination has been made as to the acceptance of a laboratory, DNDO will add the facility to its list on the Department of Homeland Security/DNDO GRaDER Program Web site. DNDO will periodically confirm the NVLAP application status and the laboratory's accreditation status with the NVLAP Program Manager at NIST. In addition, the laboratory will be subject to any NVLAP surveillance that NIST conducts. Loss of NVLAP accreditation will jeopardize the acceptance of test results reporting for the products under consideration for the GRaDER program, and may impact the retention of existing GRaDER program products.

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Test and Evaluation Interest Areas

A complete and independently verifiable detector configuration description must be provided with the application, to include software and firmware version identification and instructions. Applications must include manufacturer or vendor points of contact names, mailing and shipping addresses, telephone number, and electronic mail addresses.

DNDO requires that vendors provide information relating to conformance to other industry and Government standards, including those identified below. The GRaDER program examines certifications from recognized organizations and agencies, and original signed declarations of conformity to these standards. GRaDER verification may include audit and/or testing at the Government’s discretion, and as part of the GRaDER post-market surveillance program.

Training Capabilities. DNDO assesses the vendor provided training capabilities and materials as part of the Government unique technical capability standards phase of GRaDER testing. DNDO uses portions of ANSI/IEEE N42.37-2006 American National Standard for Training Requirements for Homeland Security Purposes Using Radiation Detection Instrumentation for Interdiction and Prevention as the standard with which to evaluate training.

Electrical Safety. Electrical equipment that is intended to be used in a regulated workplace will be "certified" to the appropriate safety requirements by an Occupational Safety and Health Administration (OSHA)-accredited Nationally Recognized Testing Laboratory (NRTL), under the General Industry Standards (Part 1910 of Title 29, Code of Federal Regulations - 29 CFR Part 1910). Please vist OSHA for a listing of NRTL facilities:

      http://www.osha.gov/dts/otpca/nrtl/index.html

GRaDER compliance verification for these Test and Evaluation interest areas may include audit and/or testing at the government's discretion, and as part of the GRaDER post-market surveillance program. Any additional costs for government verification of conformity will be at the manufacturer's expense.

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