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Doing Business with EPA:
Quality Specifications for non-EPA Organizations

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:

In addition, some common questions asked by non-EPA organizations are answered under FAQ #4 - Non-EPA Organizations.

General Specifications

Through Federal Regulations, EPA requires that recipients of funds for work involving environmental data comply with the American National Standard ANSI/ASQC E4-1994, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs." (ANSI/ASQC E4) (A list of some example activities are contained in Example Activities.) To demonstrate conformance to this standard, EPA requires two forms of documentation:
  1. Documentation of the organization's quality system (usually called a Quality Management Plan), and

  2. Documentation of the application of quality assurance and quality control activities to a project-specific effort (usually called a Quality Assurance Project Plan).
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:

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Consistency with Specifications for EPA Organizations

The specifications for non-EPA organizations are consistent with the specifications for EPA organizations defined in EPA Order CIO 2105.0 (PDF 12pp, 94K About PDF) (see Policies and Procedures for EPA Organizations) and described in the Overview of the EPA Quality System for Environmental Data and Technology (PDF 35pp, 160K About PDF). This Order, an internal policy document, requires EPA organizations to develop, implement, and maintain a quality system that conforms to the minimum specifications of ANSI/ASQC E4, to document these systems in a Quality Management Plan, and to document the application of quality assurance and quality control activities to an project -specific effort in a Quality Assurance Project Plan.

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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
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
Contained
in specific
Federal Reg.
Institute of Higher Education
N/A
Contained
in specific
Federal Reg.
Local Government
N/A
Contained
in specific
Federal Reg.
Non-profit Organization
N/A
Contained
in specific
Federal Reg.
Regulated Entity
N/A
N/A
N/A
N/A
Contained
in specific
Federal Reg.
State Government
N/A
Contained
in specific
Federal Reg.
Tribal Government
N/A
Contained
in specific
Federal Reg.
*Grants include Performance Partnership Grants and Performance Partnership Agreements.

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Summary of the Relevant Federal Regulations

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 qa_cfrs.html#48PART46. EPA has selected ANSI/ASQC 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.

40 CFR 30: Grantee/cooperative agreement holder must comply with the American National Standard, ANSI/ASQC E4. EPA requires that recipient submit a Quality Management Plan and a Quality Assurance Project Plan to demonstrate conformance. For the full text of 40 CFR 30, see qa_cfrs.html#40PART30.

40 CFR 31: Requires grantee/cooperative agreement holder to develop and implement quality assurance practices to produce data of adequate quality to meet project objectives. For the full text of 40 CFR 31, see qa_cfrs.html#40PART31. To clarify this specification, EPA has issued clarifying language, posted at www.epa.gov/ogd/grants/assurance.htm, which is consistent with 40 CFR Part 30. In essence, the clarifying language states that the recipient must have a quality system that conforms to the American National Standard, ANSI/ASQC E4-1994 and is required to submit a Quality Management Plan and a Quality Assurance Project Plan.

40 CFR 35: Requires grantee/cooperative agreement holder to comply with 40 CFR 31. For the full text of 40 CFR 35, see qa_cfrs.html#40PART35.

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Training

The following courses provide a general overview of the EPA Quality System and the activities that non-EPA organizations perform under this system. More focused training courses and upcoming training sessions are provided under the Quality Staff Training Program.

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