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. ------- 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). ------- 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): ------- 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: ------- 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 ------- EPA/821/F-97/001 Streamlining EPA's test methods approval program: EPA fact sheet ------- |