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Quality Specifications for non-EPA Organizations to do business with EPA

While EPA collects environmental data through a variety of internal activities, most environmental data are collected on behalf of EPA by other organizations. In this case, EPA specifies necessary quality assurance activities to be performed to ensure that data are of sufficient quantity and adequate quality for their intended use.

EPA specifications are broadly defined in the Federal procurement and financial assistance regulations for each type of extramural agreement that EPA uses to collect data. The following topics are discussed here:


General Specifications

Through Federal Regulations, EPA requires that recipients of funds for work involving environmental data comply with either the EPA quality policy or the American National Standard ASQ/ANSI E4-2014, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs." EPA requires two forms of documentation:

  1. Documentation of the organization's quality system usually called a Quality Management Plan (EPA Quality Management Tools), R-2, or EPA Requirements for Quality Management Plans defines EPA specifications.
  2. Documentation of the application of quality assurance and quality control activities to a project-specific effort (usually called a Quality Assurance Project Plan), or R-5, or EPA Requirements for Quality Assurance Project Plans defines EPA specifications

Usually organizations document the quality system once using R-2 (with schedued updates) and then document the quality assurance activities for each project using R-5

Use of existing quality system documentation, such as documentation that a company is ISO 9000 certified, may be an acceptable alternative.

For small grants and contracts, these two documents may be combined into a single document with permission of the EPA QA Manager of the organization sponsoring the work.

The combined document must address all elements defined by the EPA QA Manager and will include documentation of both the organization's quality system and the application of this system to the work performed under the grant or contract.

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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 System is based on a graded approach.

A graded approach means that quality systems 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 system, and the resulting documentation. Example applications of a graded approach to documentation include:

  • Documentation of the Organization's Quality System (Quality Management Plan): The documentation should describe a Quality System that is designed to support the objectives of the organization. The level of effort expended to develop and document a Quality System should be based on the scope of the program.

    For example, large grants to a State government may require a comprehensive quality system 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 data 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.

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Determining the Quality Specifications for Your Agreement with EPA

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.

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

EPA's Quality-Related Regulations

 
Contract
Cooperative Agreement
Grant*
Inter-
Agency Agreement
Agency
Mandate
Contractor
48 CFR 46
N/A
N/A
N/A
N/A
Federal Agency
N/A
N/A
N/A
Negotiated into each agreement
Contained
in specific
Federal Reg.
Hospital
N/A
N/A
N/A
N/A
Contained
in specific
Federal Reg.
Institute of Higher Education
48 CFR 46
2 CFR 1500.11
2 CFR 1500.11
N/A
Contained
in specific
Federal Reg.
Local Government
48 CFR 46
2 CFR 1500.11
40 CFR 35
2 CFR 1500.11
40 CFR 35
N/A
Contained
in specific
Federal Reg.
Non-profit Organization
48 CFR 46
2 CFR 1500.11
2 CFR 1500.11
N/A
Contained
in specific
Federal Reg.
Regulated Entity
N/A
N/A
N/A
N/A
Contained
in specific
Federal Reg.
State Government
48 CFR 46
2 CFR 1500.11
40 CFR 35
2 CFR 1500.11
40 CFR 35
N/A
Contained
in specific
Federal Reg.
Tribal Government
48 CFR 46
2 CFR 1500.11
40 CFR 35
2 CFR 1500.11
40 CFR 35
N/A
Contained
in specific
Federal Reg.
*Grants include Performance Partnership Grants and Performance Partnership Agreements.

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Relevant Federal Regulations

Quality Assurance for Contracts

Quality Assurance for Contracts (48 CFR 46): Allows Federal Agencies to select a national consensus standard as a basis for their quality specifications. For the full text of 48 CFR 46, see General Specifications for doing business with EPA.

EPA has selected ASQ/ANSI E4 as the basis for its quality specifications and, through tailoring language to 48 CFR 46, requires that applicants/contractors submit a Quality Management Plan (or equivalent) and a Quality Assurance Project Plan (or equivalent) to demonstrate conformance to the standard.

Higher-Level Contract Quality (46.202-4):  Allows Federal Agencies to establish procedures for:

  • determining when higher-level contract quality requirements are necessary,
  • determining the risk (both the likelihood and the impact) of nonconformance,
  • and advising the contracting officer about which higher-level standards should be applied and included in the solicitation and contract.

Quality Assurance for Assistance Agreements (Grants, Cooperative Agreements, Interagency Agreements):

Quality Assurance (2 CFR § 1500.11): Describes the applicability of quality assurance for assistance agreements that involve environmentally related data operations, including environmental data collection, production and use.

40 CFR 35: Establishes administrative requirements for all grants awarded to State, interstate, and local agencies and other entities for the environmental programs listed in §35.101.

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Example Activities

Environmental data 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 data 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, including:

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

Example activities covered by the EPA Quality System that involve environmental data 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 data;
  • 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).

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