Environmental Protection Agency.
Notice; request for comment.
Today's notice invites comment on the U.S. Environmental Protection Agency's (EPA's) proposed Laboratory Quality Assurance Evaluation Program for Analysis of
The Agency requests comments on today's notice. Comments must be received or post-marked by midnight May 3, 2002. If EPA does not receive adverse comments on or before April 3, 2002 regarding EPA's request for an emergency clearance, the Agency intends to seek a 90-day emergency clearance from OMB to begin collecting data from laboratories that are interested in participating in the Lab QA Program.
Please send an original and three copies of your written comments and enclosures (including references) to the W–01–17 Comment Clerk, Water Docket (MC–4101), EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. Due to the uncertainty of mail delivery in the Washington, DC area, in order to ensure that all comments are received please send a separate copy of your comments
For a copy of the ICR, contact Sharon Gonder at EPA by phone at (202) 564–5256 or by email at
Individuals who want EPA to acknowledge receipt of their comments should enclose a self-addressed, stamped envelope. No facsimiles (faxes) will be accepted. Comments may also be submitted electronically to
The record for this notice has been established under docket number W–01–17, and includes supporting documentation as well as printed, paper versions of electronic comments. The record is available for inspection from 9 a.m. to 4 p.m., Monday through Friday, excluding legal holidays at the Water Docket, EB 57, EPA Waterside Mall, 401 M Street, SW., Washington, DC 20460. For access to docket materials, please call (202) 260–3027 to schedule an appointment.
In September 2000, the Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee (Committee) signed an Agreement in Principle (Agreement) (65 FR 83015, Dec. 29, 2000) (EPA, 2000) with consensus recommendations for two future drinking water regulations: The Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) and the Stage 2 Disinfectants and Disinfection Byproducts Rule. The LT2ESWTR is to address risk from microbial pathogens, specifically
To support
Another factor that warrants initiation of the Lab QA Program prior to promulgation of the LT2ESWTR is grandfathering of monitoring data. The Agreement recommends that systems with “historical”
EPA's Office of Ground Water and Drinking Water plans to request from OMB an emergency clearance that would enable expeditious implementation of a voluntary Lab QA Program to support
As part of today's notice, EPA is inviting comment on the Lab QA Program. Under the Lab QA Program, EPA would evaluate labs on a case-by-case basis through evaluating their capacity and competency to reliably measure for the occurrence of
EPA has not yet proposed rulemaking on use of such “historical” data nor on the methods themselves under the LT2ESWTR. As noted above, EPA intends to propose allowing systems to use equivalent “historical” data in lieu of collecting new data. EPA anticipates the data generated by labs which meet the evaluation criteria would be very high quality, thus increasing the likelihood that such data would warrant consideration as acceptable “grandfathered” data. However, lab evaluation would not guarantee that data generated will be acceptable as “grandfathered” data, nor would failure to meet evaluation criteria necessarily preclude use of “grandfathered” data. For these reasons, EPA is not establishing the Lab QA Program through rulemaking, but rather as a discretionary and voluntary program under the Safe Drinking Water Act, section 1442 (42 USC 300j–1(a)).
The purpose of the Lab QA Program is to identify laboratories that can
EPA Method 1622 and EPA Method 1623 were developed as improved alternatives to the ICR Protozoan Method (EPA, 1996). EPA validated Method 1622 for the determination of
In April 2001, EPA revised and updated Method 1622 (EPA–821–R–01–026) (EPA, 2001a) and Method 1623 (EPA–821–R–01–025) (EPA, 2001b) based on the following: laboratory feedback, the development of equivalent filters and antibodies for use with the methods, and method performance data generated during the ICR Supplemental Surveys (EPA, 2001e). The results of these studies are documented in the Method 1622 interlaboratory validation study report (EPA–821–R–01–027) (EPA, 2001c) and the Method 1623 interlaboratory validation study report (EPA–821–R–01–028) (EPA, 2001d).
A laboratory that is interested in participating in the Lab QA Program currently should be operating in accordance with its QA plan (developed by the laboratory) for
• BS/BA in microbiology or closely related field.
• A minimum of one year of continuous bench experience with
• A minimum of six months experience using EPA Method 1622 and/or EPA Method 1623.
• A minimum of 100 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 50 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method (EPA, 1996)) for the specific analytical procedure they will be using.
• Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed principal analyst/supervisor.
• Two years of college (or equivalent) in microbiology or closely related field.
• A minimum of six months of continuous bench experience with
• A minimum of three months experience using EPA Method 1622 and/or EPA Method 1623.
• A minimum of 50 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 25 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method) for the specific analytical procedures they will be using.
• Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed other analysts.
• Three months experience with the specific parts of the procedure they will be performing.
• A minimum of 50 samples analyzed using EPA Method 1622 and/or EPA Method 1623 (minimum 25 samples if the person was an analyst approved to conduct analysis for the ICR Protozoan Method) for the specific analytical procedures they will be using.
• Submit to EPA, along with the application package, resumes detailing the qualifications of the laboratory's proposed technician(s).
• Appropriate instrumentation as described in EPA Methods 1622 and 1623 (EPA, 2001a,b).
• Equipment and supplies as described in EPA Methods 1622 and 1623 (EPA 2001a, 2001b).
• Detailed laboratory standard operating procedures for each version of the method that the laboratory will use to conduct the
• Laboratory should provide a current copy of the table of contents of their laboratory's quality assurance plan for protozoa analyses.
• EPA Method 1622 or EPA Method 1623 initial demonstration of capability (IDC) data, which include precision and recovery (IPR) test results and matrix spike/matrix spike duplicate (MS/MSD) test results for
After the OMB clearance described above, EPA plans to make applications available on EPA's website at
After the laboratory submits to EPA an application package including supporting documentation, EPA intends to conduct the following steps to complete the process:
1. Upon receipt of a complete package, EPA contacts the laboratory for follow-up information and to schedule participation in the performance testing program.
2. EPA sends initial proficiency testing (IPT) samples to the laboratory (unless the laboratory has already successfully analyzed such samples under EPA's Protozoan PE program). IPT samples packets consist of eight spiked samples shipped to the laboratory within a standard matrix.
3. The laboratory analyzes IPT samples and submits data to EPA.
4. EPA conducts an on-site evaluation and data audit.
5. The laboratory analyzes ongoing proficiency testing (OPT) samples three
6. EPA contacts laboratories by letter within 60 days of their laboratory on-site evaluation to confirm whether the laboratory has demonstrated its capacity and competency for participation in the program.
No. If a laboratory currently participates in the EPA Protozoan PE Program and acceptable IDC and IPT data have already been submitted (for the version of the method that the laboratory will use to conduct
The information collection requirements in this notice have been submitted for approval to the OMB under the
Since the EPA would solicit information in application packages, including supporting documentation, analytical data, and other pertinent information from laboratories that are interested in participating in the voluntary Lab QA Program, the Agency is required to submit an ICR to OMB for review and approval. Entities potentially affected by this action include public and private laboratories that wish to be evaluated to determine if they can reliably measure for the occurrence of
The burden estimate for the Lab QA Program information collection includes all the burden hours and costs required for gathering information, and developing and maintaining records associated with the Lab QA Program. The annual public reporting and recordkeeping burden for this collection of information is estimated for a total of 60 respondents and an average 78 hours per response for a total of 4,676 hours at a cost of $123,650. This estimate assumes that laboratories participating in the Lab QA program have the necessary equipment needed to conduct the analyses. Therefore, there are no start-up costs. The estimated total annual capital costs is $0.00. The estimated Operation and Maintenance (O&M) costs is $133,880.
Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Comments are requested on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments on the ICR to the Director, Collection Strategies Division; EPA (2822); 1200 Pennsylvania Ave., NW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th St., NW., Washington, DC 20503, marked “Attention: Desk Officer for EPA.” Include the ICR number in any correspondence. Because OMB is required to make a decision concerning the ICR between 30 and 60 days after March 4, 2002, a comment to OMB is best assured of having its full effect if OMB receives it by April 3, 2002. The final ICR approval notice will respond to any OMB or public comments on the information collection requirements contained in today's notice.