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EPA's Quality System-Related Regulations

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


48 CFR Part 46 Quality Assurance

46.202-4 Higher-level contract quality requirements.

(a) Requiring compliance with higher-level quality standards is appropriate in solicitations and contracts for complex or critical items (see 46.203(b) and (c)) or when the technical requirements of the contract require:

  1. Control of such things as work operations, in-process controls and inspection; or
  2. Attention to such factors as:
    1. organization
    2. planning
    3. work instructions
    4. documentation control
    5. advanced metrology

(b) When the contracting officer, in consultation with technical personnel, finds it is in the Government's interest to require that higher-level quality standards be maintained, the contracting officer shall use the clause prescribed at 46.311. The contracting officer shall indicate in the clause which higher-level quality standards will satisfy the Government's requirement. Examples of higher-level quality standards are:

  • ISO 9001, 9002 or 9003 
  • ANSI/ASQC Q9001, Q9002 or Q9003 
  • QS-9000
  • AS-9000
  • ANSI/ASQC E4
  • ANSI/ASME NQA-1

46.311 Higher-level contract quality requirement.

The contracting officer shall insert the clause at 52.246-11, Higher-Level Contract Quality Requirement, in solicitations and contracts when the inclusion of a higher-level contract quality requirement is appropriate (see 46.202-4).

52.246-11 Higher-Level Contract Quality Requirement.

As prescribed in 46.311, insert the following clause:

Higher-Level Contract Quality Requirement (Feb 1999)

The Contractor shall comply with the higher-level quality standard selected below. [If more than one standard is listed, the offeror shall indicate its selection by checking the appropriate block.]

Title Numbering Date Tailoring
* _______ _______ _______ _______
* _______ _______ _______ _______
* _______ _______ _______ _______
* _______ _______ _______ _______

[Contracting Officer insert the title, number (if any), date, and tailoring (if any) of the higher-level quality standards.]

(End of clause)

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

Quality Assurance (2 CFR § 1500.11Exit): 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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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.

35.260 Limitations.

(a) The Regional Administrator will not award section 106 funds to any State which does not monitor and compile, analyze, and report water quality data as described in section 106(e)(1) of the Clean Water Act. The Regional Administrator may award section 106 funds to eligible Indian Tribes even if they do not meet this requirement. However, all monitoring and analysis activities performed by a Tribe must meet the applicable quality assurance, quality control requirements as specified in 40 CFR Part 31. [page 11]

35.6015 Definitions.

(39) Quality Assurance Project Plan. A written document, associated with remedial site sampling, which presents in specific terms the organization (where applicable), objectives, functional activities, and specific quality assurance and quality control activities and procedures designed to achieve the data quality objectives of a specific project(s) or continuing operation(s). [page 154]

35.6055 State-lead pre-remedial Co-operative Agreements.

(b) Pre-remedial Cooperative Agreement requirements. The recipient must comply with all terms and conditions in the Cooperative Agreement, and with the following requirements:
(2) Quality assurance. 
(i) The recipient must comply with the quality assurance requirements described in 40 CFR 31.45.
(ii) The recipient must have an EPA-approved non-site-specific quality assurance plan in place before beginning field work. The recipient must submit the plan to EPA in adequate time (generally 45 days) for approval to be granted before beginning field work.
(iii) The quality assurance plan must comply with the requirements regarding split sampling described in section 104(e)(4)(B) of CERCLA, as amended.

35.6055 State-lead remedial Co-operative Agreements.

To receive a State-lead remedial Cooperative Agreement, the applicant must submit the following items to EPA: 
(a) Application form, as described in 35.6055(a) of this subpart, accompanied by the following: 
(2) A Project narrative statement including the following: 
(vi) Quality assurance-(A) General. If the project involves environmentally related measurements or data generation, the recipient must comply with the requirements regarding quality assurance described in 40 CFR 31.45. 
(B) Quality assurance plan. The applicant must have a separate quality assurance project plan and/or sampling plan for each site to be covered by the Cooperative Agreement. The applicant must submit the quality assurance project plan and sampling plan, which incorporates results of any site investigation performed at that site, to EPA with its Cooperative Agreement application. However, at the option of the EPA award official with program concurrence, the applicant may submit with its application a schedule for developing the detailed site-specific quality assurance plan (generally 45 days before beginning field work). Field work may not begin until EPA approves the site-specific quality assurance plan. 
(C) Split sampling. The quality assurance plan must comply with the requirements regarding split sampling described in section 104(e)(4)(B) of CERCLA, as amended.

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