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1.Signed on February 3, 2010 and January 19, 2010; Entered into Force on February 3, 2010.
Implementing Arrangement #8 (IA#8) to the Agreement between the
Taipei Economic and Cultural Representative Office (TECRO) in
the United States and the American Institute in Taiwan (AIT) for
Technical Cooperation in the Field of Environmental Protection
was signed by AIT and TECRO in December 2008.

Activity 13 of IA#8 is to “ Establish a Good Laboratory
Practices (GLP) program in Taiwan for industrial chemicals and
pesticide products ” that is compatible with the GLP program in
the United States, to enable the exchange of research/study data
between the AIT ’ s and TECRO ’ s designated representatives.

Implementation of Activity 13 involved collaboration between the
designated representatives of AIT and TECRO, the US
Environmental Protection Agency (US EPA) and the Environmental
Protection Administration in Taipei (EPAT), respectively, to
complete the following tasks:
- US EPA conducted Good Laboratory Practices training in Taiwan;
- Taiwan Good Laboratory Practices Monitoring Authority, as
designated representative of EPAT, visited and evaluated US
EPA ’ s GLP program; and
- US EPA visited and evaluated Taiwan ’ s GLP inspection
program to determine compatibility with US EPA ’ s GLP
inspection program.

US EPA and EPAT, through its designated representatives [1], the
Ministry of Economic Affairs (MOEA), the Council of Agriculture
(COA) and the Taiwan Accreditation Foundation (TAF), completed
these tasks, and confirmed the compatibility of their respective
GLP programs in June 2009. The designated representatives found
and confirmed that:
[1 EPAT and the Council of Agriculture (COA) have delegated
implementation of the Taiwan GLP Program to the Bureau of
Standards, Metrology and Inspection (within the Ministry of
Economic Affairs - MOEA), which has re-delegated it to TAF as
the Good Laboratory Practices Monitoring Authority. Letters of
delegation are attached to this letter.]

i) U.S. and Taiwan test facilities are required to adhere to
respective Agency GLP requirements [Good Laboratory Practice
Standards Regulations at 40 CFR part 160 for US EPA and
Organization for Economic Cooperation and Development (OECD)
Principles of GLP for EPAT];
ii) US EPA and EPAT have established Compliance monitoring
procedures which operate in accordance with OECD guidelines,
“ Revised Guides for Compliance Monitoring Procedures for
Good Laboratory Practice ” [OCDE/GD(95)66] and “ Revised
Guidance for the Conduct of Laboratory Inspection and Study
Audits ” [OCDE/GD(95)67]. In addition, pre-inspection and
inspection activities are conducted in a consistent manner
by appropriately trained inspectors. Although the
post-inspection activities of the designated representatives
differ administratively, both include procedures for the
review of inspection reports and correspondence compliance
decisions as well as actions available to address test
facility non-Compliance. Each program is thoroughly
described in published documents, in accordance with OECD
requirements, providing readily accessible information and
guidance to both test facilities and inspectors;
iii) Comparable electronic/hard copy records are maintained to
track and obtain information related to GLP inspections,
data audits and test facility status to satisfy the
compatibility of record keeping of the designated
representatives and for information sharing; and,
iv) Each designated representative is able to respond, or ensure
a response, to requests for test facility inspection/study
audits and to requests to participate in such

This document serves as acknowledgment by AIT and TECRO and
their designated representatives that the necessary conditions
have been met to confirm that EPA Taiwan and US EPA have
compatible GLP programs.

IN WITNESS WHEREOF, the undersigned, being duly authorized, have
signed this Letter of Confirmation.

DONE in duplicate, in the English language.

Name: TaTung Chang Name: Barbara J.
Title: Deputy Title: Managing
Representative Director
Date: February 3, 2010 Date: January 19, 2010
Place: Washington D.C. Place: Washington D.C.

ATTACHMENT: Letters of delegation