UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WSG49
Date Signed: December 27, 1989
Revised: December 1998
Revised by: Wendy Warren
MEMORANDUM
SUBJECT: Analytical Methods for Compliance and Limited
Alternate Test Procedures Approvals
FROM: Michael B. Cook, Director (signed by A. Kuzurade, Acting)
Office of Drinking Water, WH-550D
TO: Environmental Services Division Directors
Regions I-X
For many years, limited alternate test procedures (ATPs) for drinking water compliance
analyses have been approved by the Office of Drinking Water (ODW) after favorable review by
the Environmental Monitoring Systems Laboratory (EMSL), under 40 CFR 141.27. The
petitions were usually initiated by a single laboratory and were forwarded by the State to EMSL.
The approval extended only to the specific laboratory approved by the petitioning State, thus, the
"limited" status.
There are several problems with this procedure. 40 CFR 141.27 Alternate Analytical
Techniques reads:
"With the written permission of the State, concurred in by the
Administrator, an alternate analytical technique may be
employed..."
A careful reading of 40 CFR 141.21 (a) indicates that only the Administrator has the
authority to approve an alternate analytical technique after a request from the State. According to
the Office of General Counsel (OGC), there is no officially delegated authority to the ODW
Director to grant these approvals. Apparently, a delegation was never sought when Sec. 141.27
was promulgated in 1980. This raised a question of the validity of past approvals, and leaves the
ODW Director without authority to issue new approvals. This authority was not officially
delegated to any Regional official.
Furthermore, OGC has advised that, under the SDWA, compliance analyses must be
performed utilizing methods listed in the regulations and that any changes to the regulations must
be processed through the normal rulemaking procedure. In OGC's opinion, Section 1450 of the
SDWA prohibits the Administrator from delegating this authority to anyone.
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Section 1450(a) of SDWA reads:
"(1) The Administrator is authorized to prescribe such regulations
as are necessary or appropriate to carry out his functions ..."
"(2) The Administrator may delegate any of his functions under
this title (other than prescribing regulations) to any officer or
employee of the Agency..."
There are also philosophical problems with continuing this process. The advisability of
allowing a single lab to deviate from the national uniform regulations is questionable. This may
have been a useful mechanism to allow for the use of newer techniques and methods adapting for
unusual matrixes between 1980 and 1987. However, since 1987, we have been actively revising
all the regulations, including examining all appropriate methodologies.
For the above reasons, ODW will no longer consider and approve limited ATPs, and will
propose to repeal 40 CFR 141.27. In place of the limited ATP procedure, ODW is establishing a
two-tiered system for rapidly adopting new and revised analytical technologies for use by all
laboratories.
The first tier is for new methods, significantly modified methods or new applications of
currently approved methods. These will be evaluated by EMSL and become candidates for
accelerated regulation development. This is important because laboratory technology is changing
rapidly and we should be as close to the cutting edge as the data will allow. Through formal
proposal, public comment and promulgation in the Federal Register, the list of methods approved
for use under the regulations will be amended accordingly, thus making appropriate changes
available to all laboratories. ODW expects to be able to process changes at least as frequently as
twice per year.
The second tier covers minor improvements to existing methods which are optional and
do not substantially alter the method. These will also be evaluated by EMSL and become
candidates for inclusion in periodic Federal Register notices. Rather than formally amending the
regulations, this notice will interpret the existing regulatory methods to include the minor
optional changes. Analysts may use these minor changes or continue to use the methods as
originally promulgated. The relatively minor adjustments that will be made through this process
(i.e., matrix modifications, alternates to extraction specifications, preservation changes, etc.)
have been the subject of many ATP applications received in the past. Hence, the need for ATPs
will be greatly reduced.
This new two-tiered process provides an avenue for evaluating all methodology changes
which were handled under the old alternate test procedures program. The new streamlined
system will be more desirable because it will:
• rapidly update NPDWRs to include the latest analytical technologies;
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• make changes available to all laboratories;
• allow everyone to benefit from the changes;
• provide for a more uniform system for compliance determinations; and
• allow for ease of enforcement.
Please share this information with the State program and laboratory directors. If you have
any questions or need further information, please contact Herb Brass on (513) 569-7936.
cc: Water Division Directors, Regions I-X
Tom Clark, EMSL-CI
Lee Schroer, OGC
Bob Blanco, SPD
Herb Brass, TSD
*Note: Guidance will need to be updated after PBMS revisions are finalized.
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