March 6, 2002 -- The Environmental Protection Agency (EPA) has posted a notice in the Federal Register of a proposal to more closely monitor laboratory cryptosporidium analysis in drinking water.
The agency is calling the proposed program the Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium and is tying it to the Safe Drinking Water Act.
The notice invites comment on the U.S. Environmental Protection Agency's (EPA's) proposed Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium under the Safe Drinking Water Act.
EPA also plans to submit to the Office of Management and Budget (OMB) for review and approval an Information Collection Request (ICR) associated with information collections under the proposed Lab QA Program.
EPA is requesting comments on specific aspects of the proposed Lab QA Program and the ICR, and also on its intention to seek an emergency clearance from OMB to begin collecting data from laboratories that are interested in participating in the Lab QA Program prior to OMB's final approval of the ICR.
The purpose of the Lab QA Program is to identify laboratories that can reliably measure for the occurrence of Cryptosporidium in surface water. Existing laboratory certification programs do not include Cryptosporidium analysis. This program is designed to assess and confirm the capability of laboratories to perform Cryptosporidium analyses. The program will assess whether laboratories meet the recommended personnel and laboratory criteria in today's notice. This evaluation program is voluntary for laboratories. In the LT2ESWTR, however, EPA intends to require systems to use approved (or certified) laboratories when conducting Cryptosporidium monitoring under the LT2ESWTR.
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 Cryptosporidium, and the Stage 2 DBPR is to address risk from disinfection byproducts. The committee recommended that the LT2ESWTR require public water systems (PWSs) to monitor their source water for Cryptosporidium using EPA Method 1622 or EPA Method 1623. Additional Cryptosporidium treatment requirements for PWSs would be based on the source water Cryptosporidium levels. EPA intends to take into account the committee's advice and recommendations embodied in the agreement when developing the regulations.
To support Cryptosporidium monitoring under the LT2ESWTR, the committee agreement recommended that "compliance schedules for the LT2ESWTR ... be tied to the availability of sufficient analytical capacity at approved laboratories for all large and medium-size affected systems to initiate Cryptosporidium and E.coli monitoring ... " (65 FR 83015, Dec. 29, 2000) (EPA, 2000).
Further, the agreement recommended that cryptosporidium monitoring by large and medium systems begin within six months following rule promulgation. Given the time necessary for EPA to approve a sufficient number of laboratories to assure adequate capacity for LT2ESWTR monitoring, EPA would need to begin laboratory evaluation prior to promulgation of the rule in order to accommodate such an implementation schedule.
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" cryptosporidium data that are equivalent to data that would be collected under the LT2ESWTR be afforded the opportunity to use those "historical" (grandfathered) data in lieu of collecting new data under LT2ESWTR.
EPA intends to propose such grandfathering provisions in the LT2ESWTR. If EPA indicates that laboratories meet the criteria in the Lab QA Program described today prior to finalizing the LT2ESWTR, systems could develop monitoring data prior to the LT2ESWTR in anticipation of using it as grandfathered data.
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 Cryptosporidium monitoring under the LT2ESWTR. As such, the Agency could begin to evaluate laboratories that can reliably measure for Cryptosporidium using EPA Method 1622 and Method 1623. During the effective period of the emergency clearance, EPA intends to submit to OMB for review and approval a final ICR in order to continue data collection for 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 Cryptosporidium in surface water using EPA Method 1622 or EPA Method 1623. The intent of this notice is not to propose establishing the Lab QA Program through a rulemaking. Rather, the criteria described in section I.C. are intended to provide guidance to laboratories that are interested in participating in the Lab QA Program.
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)).
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 [[Page 9732]] via electronic mail (e-mail) to Mary Ann Feige, EPA, Office of Ground Water and Drinking Water, [email protected], or mail to the attention of Mary Ann Feige, EPA, Technical Support Center, 26 West Martin Luther King Drive (MS-140), Cincinnati, Ohio 45268.
Hand deliveries should be delivered to: EPA's Water Docket at 401 M Street, SW., Room EB57, Washington, DC 20460. Please make certain to reference EPA ICR No. 2052.02 and OMB Control No. 2040-0229.
For more information
For a copy of the ICR, download off the Internet at http:// www.epa.gov/icr and refer to EPA ICR No. 2052.02.
To read the full Federal Register entry, visit http://www.epa.gov/fedrgstr/EPA-WATER/2002/March/Day-04/w5078.htm.
