vvEPA
Environmental Protection
Agency
Office of Water
4303
EPA-821-F-97-001
January 1997
Fact Sheet
Streamlining EPA's Test Methods Approval
Program
Summary
EPA is proposing a regulation to streamline EPA's program for approving laboratory test procedures
and quality control measures that are used to gather data and monitor compliance under the Clean
Water Act (CWA) and the Safe Drinking Water Act (SDWA). It demonstrates EPA's commitment to
reducing the regulatory burden imposed on industries and municipalities, the technology development
community, and the laboratory services community. It also demonstrates EPA's commitment to
lowering the barriers to innovative technology.
The proposed regulation will make it easier for the affected communities to modify an approved
reference method by streamlining the regulatory requirements and it will provide an opportunity for non-
EPA organizations to develop and gain approval of entirely new methods. The objective of the
proposal is to encourage early introduction and use of innovative technologies that reduce costs,
overcome analytical difficulties, and enhance data quality. The proposal provides safeguards to ensure
that method modifications produce data of equivalent or superior quality to the data produced by
approved methods.
Background
The U.S. Environmental Protection Agency
(EPA) publishes laboratory analytical methods
that are used by industrial and municipal
facilities in analyzing the chemical and
biological compo- nents of wastewater, drinking
water, sediment, and other environmental
samples that are required by EPA regulations
under the authority of the Clean Water Act and
the Safe Drinking Water Act.
Almost all of these methods are published by
EPA as regulations at Title 40 of the Code of
Federal Regulations (CFR). As regulations,
however, they have been considered
prescriptive and, as a result, have limited the
ability of facilities to incorporate procedures that
would account for unique situations. They also
have not allowed for the incorporation of recent
advances in measurement technology.
Reducing the Burden
Recently there has been a growing awareness
within both EPA and the analytical community
that compliance with the Agency's regulations
imposes an unintended regulatory burden on
the regulated community and that this
potentially creates a barrier to innovation in
environmental monitoring. This proposed
regulation is intended to change this situation.
The Proposed Regulation
The proposed streamlining rule (1) increases
the flexibility of affected parties to modify
existing test procedures without regulatory
action, (2) expedites approval of new and
modified test procedures, (3) establishes and
requires the use of standardized Quality Control
(QC) and QC acceptance criteria, and (4)
recommends use of standard data elements for
reporting test results. This proposal sets the
stage for harmonization of wastewater and
drinking water test procedures.
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BENEFITS OF THE PROPOSED RULE
> New incentives for developing new analytical
techniques
> Improved performance in specific wastewater
discharge or drinking water situations
> Lower costs of environmental measurements
and improved laboratory productivity
> Increased consistency among analytical
methods, appropriate validation testing levels
and timely approval of methods
Public Participation
EPA is developing this proposed regulation with
the help of representatives from municipal
water and wastewater treatment utilities,
industries, laboratories, instrument vendors,
equipment manufacturers, consensus standards
organizations, educational institutions, other
Federal agencies, and other interested parties.
EPA held four public meetings on the
streamlining proposal between September 1995
and July 1996.
Additional Information and Copies
EPA developed three supporting documents to
help the regulated community implement this
regulation: Guide to Method Flexibility and
Approval of EPA Water Methods (EPA-821-D-
96-004), Guidelines and Format for Methods to
Be Proposed at 40 CFR Part 136 or Part 141
(EPA-821-B-96-003), and Methods for Organic
Chemical Analysis of Municipal and Industrial
Wastewater (EPA-821-B-96-005). These
documents provide a detailed description of the
streamlining proposal and provide
implementation guidance.
For additional information concerning this
action, you may contact Marion Thompson at
the U.S. Environmental Protection Agency,
Office of Water, Engineering and Analysis
Division (4303), 401 M Street, S.W.,
Washington, D.C. 20460. You may also phone
her at 202/260-7117 or send an e-mail:
Thompson .Marion@epamail .epa .gov.
The Federal Register notice contains
instructions on how to obtain additional
information and how to review the public record
for this rulemaking.
The complete text of the Federal Register
notice containing the streamlining proposal and
the full text of the supporting documents may
be viewed or downloaded on the Internet at
http://www.epa.gov/OST.
You may also obtain copies of the three
supporting documents through the U.S. EPA
National Center for Environmental Publications
and Information (NCEPI), 11029 Kenwood
Road, Cincinnati, OH 45242 (ph. 513/489-
8190).
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Laboratory name:
Laboratory ICR ID (if applicable):
Method 1622 Giardia Report Form
Episode number:
Internal laboratory sample ID (if applicable):
Volume examined (in L) (do not include rinsate volume):
Slide-scanning analyst:
Object
located
by FA
No.
1
2
3
4
5
6
7
8
9
10
Shape
(oval
or
round)
Size
LxW
(Mm)
DAPI +
Number of nuclei
stained sky blue
(A)
Intense blue
internal staining
(B)
FA count (well 1):
Total count DAPI + (A):
Total count DAPI + (B):
Total count DAPI - (C):
Total count DAPI + (A) that are a/so D.I.C. (F):
December 7, 1998, Revision - Draft
EPA sample ID:
10-mL subsample ID (if packed pellet > 0.5 mL and entire sample was examined):
Pos. staining control acceptable n YES n NO Neg. staining control acceptable a YES a NO
Confirmation analyst:
DAPI-
Light blue internal
staining, no distinct
nuclei, green rim
(C)
D.I.C.
Empty cysts
(D)
Cysts with
amorphous
structure
(E)
Cysts with internal structure (F)
Number of
nuclei
Median
body
Axonemes
Examination/confirmation completion date:
Exam./confirm. completion time (must be complete within 72 hours of staining):
Total number of empty cysts (D):
Total number with amorphous structure (E):
Total number with one internal structure (F):
Total number with >one internal structure (F):
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Laboratory name:
Laboratory ICR ID (if applicable):
Method 1622 Bench Sheet
Episode number
EPA sample number
Internal laboratory sample ID (if applicable)
Matrix (reagent water, raw surface water, finished water, groundwater)
Sample turbidity, in NTU
Sample type (field, IPR, OPR, MS, method blank, PE, MDL)
Spiking suspension enumeration ID number (for IPR, OPR, MS, and MDL only)
Spiking suspension volume (in jA.) (for IPR, OPR, MS, and MDL only)
Estimated number of oocysts/cysts spiked (for IPR, OPR, MS, and MDL only)
Sample spiking date
Sample spiking time (samples must be spiked within 24 hours of suspension enumeration)
Type of filter used: Lot number
Analyst performing filtration
Sample volume filtered, to nearest % L
Rinsate volume, to nearest % L (for IPR, OPR, MS, and MDL only)
Did filter clog? (Use second filter only if first filter clogged before 8 L were filtered)
Sample volume filtered through second filter, to nearest % L (if applicable)
Total sample volume filtered, to nearest % L (if applicable) (do not include rinsate vol.)
Analyst performing elution
Laureth-12 lot number
Analyst performing centrifugation
Centrifugation completion date
Centrifugation completion time (must be complete within 72 hours of sample collection)
Initial pellet volume after centrifugation, in mL
Initial resuspended volume (Section 13.2.2.2.1)
Final resuspended volume (only for analysis of entire pellets; Section 1 3.2.2.2.2)
Number of 10-mL subsamples to be processed independently through remainder of method
IMS system used: Lot number
Analyst performing IMS procedure
Detection kit used: Lot number
Analyst performing staining procedure
Staining completion date
Staining completion time (must be complete within 24 hours of sample concentration)
Ciypto Giardia
Ciyplo Giardia
Crypto Giardia
(Line 26*10)
Crypto- Giardia-.
Crypto: Giardia:
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
Comments:
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Laboratory name:
Laboratory ICR ID (if applicable):
Method 1622 Cryptosporidium Report Form
Episode number:
Internal laboratory sample ID (if applicable):
Volume examined (in L) (do not include rinsate volume):
Slide-scanning analyst:
Object located
by FA
No.
1
2
3
4
5
6
7
8
9
10
Shape
(oval
or
round)
Size
LxW
Cum)
DAPI +
Number of nuclei
stained sky blue
(A)
Intense blue
internal staining
(B)
Total FA count:
DAPI +: Total count (A):
DAPI +: Total count (B):
DAPI -: Total count (C):
Total count DAPI + (A) that are a/so D.I.C. (F):
EPA sample ID:
1 0-mL subsample ID (if packed pellet > 0.5 mL and entire sample was examined):
Positive staining control acceptable nYES nNO Negative staining control acceptable DYES nNO
Confirmation analyst:
DAPI-
Light blue internal
staining, no distinct
nuclei, green rim
(C)
D.I.C.
Empty oocysts
(D)
Oocysts with
amorphous
structure
(E)
Oocysts with internal structure (F)
Number of sporozoites
Examination/confirmation completion date:
Exam./confirm. completion time (must be complete within 72 hours of staining):
D.I.C. - Total count of empty oocysts (D):
D.I.C. - Total count with amorphous structure (E):
D.I.C. - Total count with internal structure (F):
December 9, 1998, Revision - Draft
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EPA/821/F-97/001
Streamlining EPA's test methods
approval program: EPA fact
sheet
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