95-30555. A Public Meeting on Method Flexibility and Streamlining Approval of Analytical Methods

[Federal Register Volume 60, Number 242 (Monday, December 18, 1995)]
[Proposed Rules]
[Pages 65207-65208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30555]



      

Federal Register / Vol. 60, No. 242 / Monday, December 18, 1995 / 
Proposed Rules

[[Page 65207]]


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 136 and 141

[FRL-5346-3]


A Public Meeting on Method Flexibility and Streamlining Approval 
of Analytical Methods

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: The Office of Science and Technology within EPA's Office of 
Water is conducting two public meetings on approaches to method 
flexibility and streamlining the proposal and promulgation of 
analytical methods at 40 CFR Part 136 under Section 304(h) of the Clean 
Water Act and 40 CFR Part 141 of the Safe Drinking Water Act. These 
304(h) streamlining public meetings will be held in conjunction with 
the Trace Metals Workshops announced concurrently in the Federal 
Register.
    These two public meetings follow the first public meeting on this 
topic held on September 28, 1995, in Seattle, Washington. The Seattle 
meeting was announced in an FR notice titled, ``A Public Meeting and 
Availability of Documents on Streamlining Approval of Analytical 
Methods at 40 CFR Part 136 and flexibility in Existing Test Methods'' 
[FRL-5294-6]. This FR notice provided extensive supplementary 
information regarding the 304(h) streamlining effort and made available 
several supporting documents. The supporting documents and a summary of 
the Seattle meeting can be obtained through the address given in this 
notice.

DATES: EPA will conduct the public meetings on 304(h) streamlining on 
Thursday, January 25, 1996, in Boston, Massachusetts and on Wednesday, 
February 14, 1996, in Chicago, Illinois. Registration for each meeting 
will begin at 8:00 AM. Each meeting will be held from 9:00 AM to 5:00 
PM.

ADDRESSES: The meeting on January 25, 1996, will be held in the O'Neill 
Auditorium, Thomas P. O'Neill Jr. Federal Building, 10 Causeway Street, 
Boston, Massachusetts. The meeting on February 14, 1996, will be held 
in the Morrison Room, Metcalfe Building, 77 West Jackson, Chicago, 
Illinois.

FOR FURTHER INFORMATION CONTACT: Questions concerning this notice can 
be directed to Marion Thompson by phone at [phone] or by 
facsimile at [phone].

SUPPLEMENTARY INFORMATION: Meeting arrangements are being coordinated 
by DynCorp, Inc. For information on registration, contact Cindy 
Simbanin, 300 N. Lee Street, Suite 500, Alexandria, VA 22314. Phone: 
[phone]. Facsimile number: [phone]. Space is limited and 
reservations are being taken on a first come, first served basis. No 
fees will be charged to attend.
    Hotel reservations for Massachusetts may be made by contacting the 
Holiday Inn-Government Center in Boston at [phone]. Guest rates 
are $101 single and $121 double occupancy, including tax. Reservations 
must be made by January 5, 1996. When making reservations, you must 
specify that you are affiliated with USEPA/TM to qualify for the quoted 
rate.
    For the Chicago meeting, hotel reservations may be made by 
contacting Marriott Reservations at [phone]. Guest rates are $91 
single and double occupancy. These rates are subject to applicable 
state and local taxes. Reservations must be made by January 20, 1996, 
and you must reference the event as the EPA TM Meeting and request the 
Chicago Marriott-Downtown in order to qualify for the group rate.
    Accommodations are limited at each location, so please make your 
reservations early. The hotels are located within walking distance of 
the meeting facilities.

Background

    Under Section 304(h) of the Clean Water Act, EPA is responsible for 
promulgating analytical methods at 40 CFR Part 136 for use in 
monitoring pollutant discharges. EPA uses these methods to support 
development of effluent guidelines promulgated at 40 CFR Parts 400-499, 
and both EPA and the regulated community use the methods for 
establishing compliance with National Pollutant Discharge Elimination 
System (NPDES) permits and other monitoring purposes. The methods 
approved for use at 40 CFR Part 136 have been developed by EPA, by 
industrial associations such as the American Society for Testing 
Materials, and by other governmental agencies such as the U.S. 
Geological Survey. In the past, the methods proposal and promulgation 
process has been cumbersome, and has not provided the flexibility to 
take advantage of new analytical technologies in a timely manner. In 
response to the Administration's Environmental Technology Initiative, 
EPA is proposing a comprehensive Section 304(h) streamlining initiative 
to increase method flexibility to allow use of emerging technologies 
and to expedite the method approval process, to encourage development 
of new methods and technologies by organizations outside of EPA.

Agenda Topics

    The purpose of the public meetings on 304(h) streamlining is to 
outline plans for method flexibility and for streamlining proposal and 
promulgation of new methods at 40 CFR Part 136 under Section 304(h) of 
the Clean Water Act, and to elicit stakeholder views regarding these 
plans. The following topics will be addressed at the public meetings:
     Increasing method flexibility to allow use of new 
technologies and to identify modifications that are acceptable within 
the scope of existing methods and do not require proposal of an 
alternate method--

--Interpretation of flexibility in existing 40 CFR part 136 methods
--Advantages and disadvantages of method flexibility (no flexibility, 
limited flexibility, and unlimited flexibility)
--Proposal to allow nearly unlimited ``front-end'' method modifications 
as long as the determinative technique is not changed and method 
performance is demonstrated to be equivalent

     Establishing standardized quality control (QC) and QC 
acceptance criteria to support determination of method equivalency
     Streamlining the method proposal process to take advantage 
of emerging analytical technologies in a timely manner--

--Standardized format for preparing new methods
--Three-tiered method validation process based on method use
--OST coordination of method submission and approval

     Harmonization of 40 CFR Part 136 methods with other EPA 
methods to allow standardization of methods across EPA programs
     Other streamlining issues--

--Standardized data elements for reporting, to allow access to Agency 
databases in a standardized data format
--Withdrawal of 40 CFR Part 136 methods that contain outdated 
technologies
--Incorporating new methods into the Federal Register by reference and 
making them available through other suitable venues, to reduce 
publication expense

    The Office of Ground Water and Drinking Water, which is within 
EPA's Office of Water, is also developing approaches to increasing 
method flexibility and streamlining the approval of analytical methods 
at 40 CFR Part 141 

[[Page 65208]]
under sections 1401 and 1445 of the Safe Drinking Water Act (SDWA). To 
better coordinate these efforts within the Office of Water, EPA will 
discuss flexibility and streamlining approaches for 304(h) and drinking 
water methods at these two public meetings. EPA believes the public 
will benefit from a joint meeting, because the flexibility and method 
approval issues, the regulated contaminants and the methods currently 
approved at Parts 136 and 141 are very similar. EPA notes, however, 
that the supporting documents that are available with this notice were 
developed only for 304(h) methods and within the requirements of the 
CWA. The approaches and specifically allowing unlimited ``front-end'' 
modifications might not be appropriate for methods approved under the 
SDWA. In contrast to the 304(h) documentation, less front end 
flexibility in sample collection and work-up procedures and more 
flexibility in the determinative measurement steps may be appropriate 
for SDWA compliance methods. Despite these potential differences in 
method flexibility approaches between 304(h) and SDWA methods, EPA 
believes there is a significant benefit in conducting public meetings 
on the perspectives of both programs.
Tudor T. Davies,
Director, Office of Science and Technology.
[FR Doc. 95-30555 Filed 12-15-95; 8:45 am]
BILLING CODE 6560-50-P