Specifications for EPA and Non-EPA Organizations

The EPA Quality Program encompasses management and technical activities related to the planning, implementation, assessment and improvement of environmental programs that involve the collection, production, evaluation, or use of environmental information and the design, construction and operation of environmental technology.

On this page:

Agency Quality Directives

Policies for EPA and Non-EPA Organizations are defined in the internal Agency policies listed below.

Relevant Federal Regulations

The quality-related sections of the following Federal Regulations are contained below:

48 CFR Part 46 Quality Assurance

Describes policies and procedures to ensure that supplies and services acquired under Government contract conform to the contract's quality and quantity requirements.

2 CFR 1500.12: Quality Assurance

Describes the applicability of quality assurance for assistance agreements that involve environmentally related data operations, including environmental information collection, production and use.

40 CFR Part 35: State and Local Assistance

Note: QA requirements are contained throughout 40 CFR Part 35. Only the major sections are listed below.

General Specifications

There are 11 quality management specifications defined in the Environmental Information Quality Policy for all EPA organizations covered by the EPA Quality Program. It is EPA policy that EPA organizations conform to the minimum specifications of ASQ/ANSI E4 (current version of this American National Standard) and:

  • Identify a QA Manager and ensure that this individual can function independently from environmental information collection and use and has access to the top management with the organization. (See Quality Assurance Managers for a list of EPA QA Managers.)
     
  • Develop a Quality Management Plan and implement this plan following Agency approval - see Quality Management Tools for projects  for examples, training, guidance, and other resources.
     
  • Provide sufficient resources to implement the quality program.
     
  • Assess the effectiveness of the quality program at least annually and implement corrective actions based on assessment results in a timely manner.
  • Implement Agency-wide Quality Program specifications in all applicable EPA-funded extramural agreements. See Chapter 46 of the EPA Acquisition Guide. 
  • Provide appropriate training for all levels of management and staff to assure that quality-related responsibilities and requirements are understood.
  • Use a systematic planning approach to develop acceptance or performance criteria for all work covered by the EPA Quality Program- see Quality Management Tools - Systematic Planning for examples, training, guidance, and other resources.
     
  • Have approved QA Project Plans, or equivalent documents, for all applicable projects and tasks involving environmental information - see Quality Management Tools - QA Project Plans for examples, training, guidance, and other resources.
     
  • Assess existing data, when used to support Agency decisions or other secondary purposes, to verify that they are of sufficient quantity and adequate quality for their intended use.

The Environmental Information Quality Policy also contains program-specific specifications and responsibilities for EPA managers and staff.

Agreement Quality Specifications

Specific questions about quality specifications should be directed to the EPA QA Manager of the organization sponsoring the work (see Quality Assurance Managers for a list of the EPA QA Managers.)

Identify which Federal regulation applies to you using the table below and then read the description of that regulation in the summary that follows the Table.

Refer to the  FY 23 Revised Term and Condition (pdf) (125.86 KB)  to incorporate into your extramural activities.

EPA's Quality-Related Regulations

 
Contract
Cooperative Agreement
Grant*
Inter-
Agency Agreement
Contractor
48 CFR 46 46.202-4
N/A
N/A
N/A
Other Federal Agency
48 CFR
N/A
N/A
Negotiated into each agreement
Institute of Higher Education
48 CFR 46
2 CFR 1500.12
2 CFR 1500.12
N/A
Local Government
48 CFR 46
2 CFR 1500.12
40 CFR 35
2 CFR 1500.12
40 CFR 35
N/A
Non-profit Organization
48 CFR 46
2 CFR 1500.12
2 CFR 1500.12
N/A
Regulated Entity
N/A
N/A
N/A
N/A
State Government
48 CFR 46
2 CFR 1500.12
40 CFR 35
2 CFR 1500.12
40 CFR 35
N/A
Tribal Government
48 CFR 46
2 CFR 1500.12
40 CFR 35
2 CFR 1500.12
40 CFR 35
N/A
*Grants include Performance Partnership Grants and Performance Partnership Agreements.

Organizational Implementation

Because of the diversity and dispersion of programs within EPA, the EPA Quality Program is decentralized. EPA organizations have individual quality programs that specifically address their needs. As a result, the EPA Quality Program is composed of individual quality programs developed and implemented by the various EPA Regions, National Program Offices, and the National Research Centers and Laboratories in the Office of Research and Development.

Overall, there are more than 20 EPA organizations that maintain quality programs. These organizations are usually at the Regional Office level, at the level immediately below each National Program Office, and at the National Research Center and Laboratory level. Specialized, complex, large, or highly-visible programs may also may have their own quality programs. Typically, such programs cut across organizational lines and have their own organizational infrastructure.

The Chief Information Officer (CIO) and Deputy Assistant Administrator (DAA) for Information Technology and Information Management (IT/IM) in the Office of Mission Support (OMS) is responsible for developing and coordinating the EPA Quality Program in addition to directing its implementation within EPA. This role is performed by the Enterprise Quality Management Division. See our Quality Program Directives for more information on the Enterprise Quality Management Division (EQMD).

The Graded Approach

Because of the diversity of work conducted through procurements and assistance agreements, EPA recognizes that a "one size fits all" approach to quality specifications will not work. Therefore, the implementation of the EPA Quality Program is based on a graded approach. A graded approach means that quality programs for different organizations and programs will vary according to the specific objectives and needs of the organization. For example, the quality practices needed in a research program are different from those in a regulatory compliance program because the purpose or intended use of the data is different.

The graded approach applies to the development of a quality program and the resulting documentation. Example applications of a graded approach to documentation include:

  • Documentation of the Organization's Quality Program (Quality Management Plan): The documentation should describe a Quality Program that is designed to support the objectives of the organization. The level of effort expended to develop and document a Quality Program should be based on the scope of the program. For example, large grants to a State government may require a comprehensive quality program and documentation, whereas smaller grants for programs with relatively less significant impacts may require less substantial documentation.
  • Documentation of the application of quality assurance and quality control activities to an activity-specific effort (Quality Assurance Project Plan): The level of detail of the Quality Assurance Project Plan should be based on a graded approach so that the level of detail varies according to the nature of the work being performed and the intended use of the data. As a result, an acceptable plan for some environmental information operations may require a qualitative discussion of the experimental process and its objectives while others may require extensive documentation to adequately describe a complex environmental program.

Example Activities

Environmental information collections are any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology.

For EPA, environmental information include both primary data (i.e., information collected directly from measurements) and secondary/existing data (i.e., data that were collected for other purposes or obtained from other sources). These include, but are not limited to:

  • literature,
  • industry surveys,
  • models,
  • databases,
  • and information systems.

Example activities covered by the EPA Quality Program that involve environmental information include, but are not limited to:

  • Characterizing and/or evaluating the states and/or conditions of environmental or ecological systems and the health of human populations;
  • Characterizing and/or evaluating chemical, biological, physical, or radioactive constituents in environmental and ecological systems, and their behavior and associated interfaces in those systems, including exposure assessment, transport, and fate; 
  • Establishing the ambient conditions in air, water, sediments, soil, etc. in terms of physical, chemical, radiological, or biological characteristics;
  • Determining and/or categorize radioactive, hazardous, toxic, and mixed wastes in the environment and to establish their relationships with and/or impact on human health and ecological systems;
  • Quantifying and/or monitor the waste and effluent discharges to the environment from processes and operations (e.g., energy generation, metallurgical processes, chemicals production), during either normal or upset conditions (i.e., operating conditions that cause pollutant or contaminant discharges);
  • Developing and/or evaluate environmental technology for waste treatment, storage, remediation, and disposal; pollution prevention; and pollution control and the use of the technology to generate and/or collect data (e.g., treatability and pilot studies);
  • Mapping environmental processes and conditions, and/or human health risk data, etc. (e.g., geographic information system);
  • Supporting enforcement and/or compliance monitoring efforts
  • Developing or evaluate methods for use in the collection, analysis, and use of environmental information;
  • Developing and/or evaluate models of environmental processes and conditions and use models to characterize environmental processes or conditions;
  • Developing, revising, or using information technology and management system operations that impact the quality of the results of environmental programs (e.g., electronic databases with environmental information including data entry, handling, transmission and analysis and laboratory information management systems); and

  • Monitoring or addressing concerns over the occupational health and safety of personnel in EPA facilities (e.g., indoor air quality measurements) and in the field (e.g., chemical dosimetry, radiation dosimetry).

Relationship to EPA's Information Quality Guidelines

EPA's quality program policy includes procedures for developing and implementing program-specific quality-related activities. These activities then serve as a framework for information product developers to ensure that information products meet the specifications of the Information Quality Guidelines (IQG). For more information, see EPA's Information Quality Guidelines.

Managing the Quality of Environmental Information

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Last updated on August 30, 2024