[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.