[Code of Federal Regulations]
[Title 40, Volume 24]
[Revised as of July 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR194.22]

[Page 46-47]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 194_CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF THE WASTE 
ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART 191 DISPOSAL 
REGULATIONS--Table of Contents
 
         Subpart C_Compliance Certification and Re-certification
 
Sec. 194.22  Quality assurance.

    (a)(1) As soon as practicable after April 9, 1996, the Department 
shall adhere to a quality assurance program that implements the 
requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 
2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding 
Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference 
as specified in Sec. 194.5.)
    (2) Any compliance application shall include information which 
demonstrates that the quality assurance program required pursuant to 
paragraph (a)(1) of this section has been established and executed for:
    (i) Waste characterization activities and assumptions;
    (ii) Environmental monitoring, monitoring of the performance of the 
disposal system, and sampling and analysis activities;
    (iii) Field measurements of geologic factors, ground water, 
meteorologic, and topographic characteristics;
    (iv) Computations, computer codes, models and methods used to 
demonstrate compliance with the disposal regulations in accordance with 
the provisions of this part;
    (v) Procedures for implementation of expert judgment elicitation 
used to support applications for certification or re-certification of 
compliance;
    (vi) Design of the disposal system and actions taken to ensure 
compliance with design specifications;
    (vii) The collection of data and information used to support 
compliance application(s); and
    (viii) Other systems, structures, components, and activities 
important to the containment of waste in the disposal system.
    (b) Any compliance application shall include information which 
demonstrates that data and information collected prior to the 
implementation of the quality assurance program required pursuant to 
paragraph (a)(1) of this section have been qualified in accordance with 
an alternate methodology, approved by the Administrator or the 
Administrator's authorized representative, that employs one or more

[[Page 47]]

of the following methods: Peer review, conducted in a manner that is 
compatible with NUREG-1297, ``Peer Review for High-Level Nuclear Waste 
Repositories,'' published February 1988 (incorporation by reference as 
specified in Sec. 194.5); corroborating data; confirmatory testing; or 
a quality assurance program that is equivalent in effect to ASME NQA-1-
1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 
edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c) 
and Section 17.1). (Incorporation by reference as specified in Sec. 
194.5.)
    (c) Any compliance application shall provide, to the extent 
practicable, information which describes how all data used to support 
the compliance application have been assessed for their quality 
characteristics, including:
    (1) Data accuracy, i.e., the degree to which data agree with an 
accepted reference or true value;
    (2) Data precision, i.e., a measure of the mutual agreement between 
comparable data gathered or developed under similar conditions expressed 
in terms of a standard deviation;
    (3) Data representativeness, i.e., the degree to which data 
accurately and precisely represent a characteristic of a population, a 
parameter, variations at a sampling point, or environmental conditions;
    (4) Data completeness, i.e., a measure of the amount of valid data 
obtained compared to the amount that was expected; and
    (5) Data comparability, i.e., a measure of the confidence with which 
one data set can be compared to another.
    (d) Any compliance application shall provide information which 
demonstrates how all data are qualified for use in the demonstration of 
compliance.
    (e) The Administrator will verify appropriate execution of quality 
assurance programs through inspections, record reviews and record 
keeping requirements, which may include, but may not be limited to, 
surveillance, audits and management systems reviews.