International Pesticide Product Registration Requirements. The Road to Harmonization

330 Pages·1999·30.838 MB·English

by  Willa Garner, Patricia Royal, and Francisca Liem (Eds.)

International Pesticide Product
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In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
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In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
ACS S Y M P O S I UM SERIES 724
International Pesticide Product
Registration Requirements
g The Road to Harmonization
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American Chemical Society, Washington, DC
In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Library of Congress Cataloging-in-Publication Data
International pesticide product registration requirements : the road to
harmonization / Willa Garner, editor, Patricia Royal, editor, Francisca Liem,
editor.
p. cm.—(ACS symposium series , ISSN 0097-6156 ; 724)
Includes bibliographical references and index.
g
s.or01 ISBN 0-8412-3599-6 (alk. paper)
ubs.ac4.fw0 1. Pesticides—Toxicology. 2. Pesticides—Environmental aspects.
12 | http://pk-1999-072 PSeersIite.i csGi.d aersn—erL, Wawil laan Yd. ,l e1g9is3l6at-i on.. II. Royal, Patricia. III. Liem, Francisca. IV.
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ber 23, 210.1021/ R61A51.92'7.501.P—4Id5c92 1 1999 99-241C3IP0
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163.e: Ju Copyright © 1999 American Chemical Society
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PRINTED IN THE UNITED STATES OF AMERICA
In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Advisory Board
ACS Symposium Series
Mary E. Castellion Omkaram Nalamasu
ChemEdit Company AT&T Bell Laboratories
g Arthur B. Ellis Kinam Park
s.or01 University of Wisconsin at Madison Purdue University
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er 23, 20.1021/ NLaabwiscroe nFcooed Ps G. rKoulpem ann MEasatmrtainn CRh.e mTicaanl tC o.
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11 R. W. Johnson Pharmaceutical
34.ne Research Institute Leroy Β. Townsend
9.163.ate: Ju Roger A. Minear University of Michigan
ed by 8ation D Unaivte rUsritbya noaf -ICllhinaomisp aign WDuPilolniat mCo mCp.a nWy alker
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In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Foreword
IHE ACS SYMPOSIUM SERIES was first published in 1974 to pro
vide a mechanism for publishing symposia quickly in book form. The
purpose of the series is to publish timely, comprehensive books de
veloped from ACS sponsored symposia based on current scientific
g research. Occasionally, books are developed from symposia spon
s.or01 sored by other organizations when the topic is of keen interest to the
ubs.ac4.fw0 chemBisetfroyr ea uadgireenecine.g to publish a book, the proposed table of contents
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emoi: As a rule, only original research papers and original review pa
Sept9 | d pers are included in the volumes. Verbatim reproductions of previ
36 on 6, 199 ously published papers are not accepted.
11
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In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Preface
The symposium on which this book is based helped to build an understanding of the
different perspectives in international pesticide product registration procedures. It
focused discussion on harmonizing data quality, technical procedures, and the regulatory
process with the goal of minimizing barriers to universal data acceptance and usage. So,
as we traveled together down this road toward mutual acceptability, we found the
similarities to be numerous and the differences to be relatively few.
Our intent and focus was manifold: First, to raise the level of understanding in the
different registration procedures ongoing today; second, to discuss the international
pesticide product registration process; and third, to provide a forum to synchronize
technical and regulatory requirements for producing universal data quality standards.
Our speakers came from India, Australia, Japan, the Netherlands, Germany, France,
s.acs.org pr001 Eirnencsgelualadrncedhd, cSgoownvtiertzraencrmtl alenanbdto , rBoafrtfoaircziiieal,sl ,s A arangndedn f tiireneladp, r Ccesoaennnsatuadlttaiav,n eMtss .e fxrioTcmoh,e yain npddru etshstereny tU,e dns iutace hdc oSamtsa pterssep.ho enTnshsoirevsye,
n September 23, 2012 | http://pub999 | doi: 10.1021/bk-1999-0724. tgTGpasShtuceeaeaecrircnnd rsvhdaepefinadducleirioicetnotdutrAlaesiorisvsst ag ei ,e o yyc nyf ot oos o CofuorA Dr e bfwgnp pemlahgstraoneeaooibysrrirmoozos,er dire oooEar wtTnlstneoo e e vl ro aciriRuafbrnee rnoosutiqeh.ncirr uv oaeamteiot ,lrr ,osdee syrnmaMaDymtyl e ie pCnrwxdpoetaiasisrccnt,tiatho auaic)d om pt oainrecu a, ese (rntcsaGa iid,ccnlp oeui ddrnnrto ieegrhnAc re ecianmwt lpyltui ao e.tdp dddhliioeaic ntlR yTiogVc Sir oicsêeaahp lqsnsaei usicozradeas,fd nas l isddSTtitmny heutc cVhierlrsneulee ae tdgts,dv,a see toirutdhrilaarea uenalc ,mtEnd tdeic cneoDeeh, vni innAi rrttiwegeoocacrra ennntim lmcdi aou ottenhslivtontIa uuenStnd rdaaOikaelynl
3.34.136 oJune 16, 1 bpcoronoogtkrr iabamu tsov. raslAu asan bedlde ir teorvreisef eworfee rntshc,ei s w pfhouorbs leitc heaoxtispoeen r,tw iwsoeer kaanirndeg g ineidnnee eridons tigetrryna tawetfiiouthnl.a tlhW epiere sgtiiitmvcieed eswp ielrcl eimaglias ttkrheaa tntihokinss
16e: to the editorial staff of ACS books for their support in this effort.
89.Dat We also express our appreciation to American Agricultural Services, Inc., the
by on American Crop Protection Association, American Cyanamid, Centre Analytical
oaded blicati LCaobnogrraetsosr ioefs ,N Ionrct.h, DAmower iAcag,r oLsocnieznac eIsn,c . DRuePsoeanrtc hA garnicdu lDtuervael loPprmodenutc,t s,a nFdif tNh oCvahretmis icfoarl
wnl Pu their abiding interest and financial support and to the Division of Agrochemicals of the
o
D American Chemical Society for sponsoring this forum.
Willa Garner Patricia Royal
GARNDAL Associates, Inc. Quality Systems Consutants
17485 Sierra Way 80 Main Street
Monument, CO 80132 Plympton, MA 02367
Francisca Liem
Laboratory Data Integrity Branch
Office of Compliance, Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
XI
In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
Chapter 1
Overview
Richard Turle
Environmental Technology Centre, Environment Canada,
Ottawa K1A 0H3, Canada
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11 associated data. Certainly, in the area of pesticide registration, the quest continues
3.34.June unabated, and it is not just the analytical chemist who is concerned. It is the
16e: toxicologist, the field and animal scientist, the regulator, and the environmentalist who
9.at
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ed by ation The answer lies in the need for the public to be assured that the products that
oadblic they use are safe. Safe is a big word in the context of pesticide registration. Safe can
wnl Pu be defined as safe in terms of specificity of effect, safe against harmful effects for the
o transporter, applicator or bystander; safe against health effects for the consumer of the
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target organism , whether it be a direct or incidental application; and finally, safe for
the environment in that a healthy ecosystem will remain after application and the pest
has been eliminated. Given that pesticides, unlike pharmaceutical products, are
designed to kill something, this indeed a tall order. The responsibility for ensuring a
pesticide is safe falls in most countries to a form of regulating body. Such regulating
bodies have the responsibility to make a judgment on the validity of scientific data
generated by pesticide producers. In Canada, this is now the Pest Management
Regulatory Agency that reports to the federal Minister of Health. In the USA, it is the
Environmental Protection Agency which administers the Federal Insecticide,
Fungicide and Rodenticide Act. In Mexico, the responsibility falls to the Departments
© 1999 American Chemical Society 1
In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
2
of Agriculture and Health. Other OECD member countries have similar agencies for
pesticide registration. Just to complicate a technically complex problem, pesticides
are often developed in one country, manufactured in a second, and then shipped to a
third before final use. Obviously, any system to ensure safety of pesticides must
recognize these realities of a global economy.
Is the public right to be concerned with safety? Undoubtedly, yes! Ever since
Rachel Carson's far-seeing book, "The Silent Spring" (7), described the effects of
organochlorine pesticides, there has been an increasing awareness that it has not been
acceptable for a pesticide manufacturer, user or regulating body to say a pesticide is
safe without a considerable quantity of data being generated to prove it. Producing
such data is expensive and time consuming. The registration process is costly, and
without registration, a pesticide is without commercial value or benefit to the farmer.
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ber 23, 210.1021/ have beGene ngeartahlelyre, d twunod ers yas tqeumalsi tyh mavaen agbeemeenn t dseyvsetelompe. d to ensure that scientific
emoi: measurements and test results are accurate. These two systems, while not
Sept9 | d incompatible in a single laboratory, have different aims and are driven by different
36 on 6, 199 tneecehdnsi.c aTl hstea nmdoasrdt cfoomr mao qnu oanliety i ns yusstee mto dwayhi cish biass euds eodn bIyS Om Ganuyid ceo 2u5n tr(i2e)s. tToh aisll oisw a
3.34.1June 1 rlaebgourlaattionrgie sb otdoi egs,a iwn haicchc remdaityat iroence. iveT hthise ira sdsuartae,s tbhoatth thceli elnatbso roafto lrayb ohraasto raie qsu aalnitdy
16e: system in place, with written test methods and standard operating procedures, which is
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ed by 8ation D manageTd hbey c ae rqtiufaicliattye a ossf uarcacnrceed iotaftfiiocner, .g iven by a national accrediting organization, is
oadblic given only after a site inspection conducted by qualified auditors. Inherently, such
wnl Pu accreditation is most suitable where statistical quality assurance can be applied. In
o other words, it best applies to situations where there are many samples for each test.
D
It is the most common quality system used by laboratories which have to confirm that
products in trade meet established standards. Accredited laboratories are used by
regulatory bodies in many countries, post registration, to ensure that food does not
contain unacceptable levels of pesticides. No attempt is made in such accredited
laboratories to ensure that all data can be subject to a later audit or reconstruction.
Good Laboratory Practice Standards (GLPS) is another quality management
system that has been applied to both laboratory and field testing for pesticide
registration, as well as to the pharmaceuticals, chemical substances, and food additives
registration processes. The driving force behind GLPS as a quality system is to ensure
the regulators that all of the data produced are accurate and that, if required, it is
possible to reconstruct the results from the raw data. Inherently, this system works
best when applied to a situation of having many tests applied to one substance. In
In International Pesticide Product Registration Requirements; Garner, W., et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 1999.