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Supplement to Minutes _ CF IS 103
” _ Agricultural Biotechnology .
~~” Research Advisory Committee
Performance Standards for
Safely Conducting Research
With Genetically Rone? Fish
_and Shellfish
et Part I. Introduction Aad Supporting
Text for Flowcharts |
eee July 31, 1995
For more information or additional copies, please contact:
United States Department of Agriculture
Otfice of Agricultural Biotechnology
Rm. 3868-South Building
14th and Independence Ave., S.W.
_ Washington, DC 20250- 0904 |
_ Telephone: (202) 720-5853
Document No. 95-04
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Tuskegee University
Founded by Booker T. Washington
School of
August 2, 1995
Agriculture & Home Economics
Dr. Karl N. Stauber
Under Secretary
Research, Education, and Economics
U.S. Department of Agriculture
14th and Independence Avenue S.W.
Washington, D.C. 20250
Dear Dr. Stauber:
Enclosed herewith is a copy of the Performance Standards for Safely Conducting
Research with Genetically Modified Fish and Shellfish developed by the Agricultural
Biotechnology Research Advisory Committee (ABRAC) which I chair. This was a
multi-year effort involving over 200 representatives of the aquatic research community,
industry, environmental groups, and natural resource officials.
Domestic aquaculture is a rapidly growing component of U.S. agriculture. Research and
development involving genetically modified aquatic organisms present special challenges
for assessment of environmental effects and, when necessary, appropriate containment
and control. Special credit goes to Dr. Anne Kapuscinski of the University of Minnesota
who chaired the ABRAC Working Group of Aquatic Biotechnology and Environmental
Safety. Dr. Kapuscinski deftly coordinated divergent views on diverse issues and
personally shepherded these performance standards through multiple revisions to their
final present form.
The ABRAC, at its meeting of June 26, 1995, approved the following three
recommendations concerning implementation of the performance standards.
1. The performance standards should be voluntary and their implementation flexible
enough that revised versions can be easily incorporated.
2. Convert the performance standards into a user-friendly computerized expert
system for dissemination to the aquatic research community and other interested
parties.
3. Sponsor a series of Federal/State workshops to introduce the performance
standards to aquatic researchers and State natural resource agency officials.
Dr. Karl N. Stauber Page 2
The ABRAC appreciates the opportunity to develop these science based performance
standards for aquatic biotechnology research. ABRAC members sincerely hope that the
Department can implement the performance standards so that research and development
in this area can move forward and help to maintain the global competitiveness of U.S.
aquaculture.
Sincerely,
PVs feW AL
Walter A. Hill, Chair
Agriculture Biotechnology
Research Advisory Committee
Enclosure
Performance Standards
for Safely Conducting Research with
Genetically Modified Fish and Shellfish
Introduction
and
Supporting Text for Flowcharts
Prepared by
U. S. Department of Agriculture
Agricultural Biotechnology Research Advisory Committee
Working Group on Aquatic Biotechnology
and Environmental Safety
Juntyi3 11995
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TABLE OF CONTENTS
EOeB O G IVITEIN DS wiesdaeri eet Wiaceasiacuiraal esa ssaeaseeas cvev se weer atae oveesh cs 1
Bee eT CRE LG)IN alt oe fares tie ool oaea 654 chav ested set avasiventasasseasiesssiacivasaidccees 1
Leb ke ee EPO ahs IEE AO, Se | eo Oe 1
Importance of fostering environmentally safe research....... 2
ese atehsanc nde VEIODMENE:, shoyu 4 tceives essen tvtaseers. Ane 2
PlexibilitysoLpertormance.standards 2... ...2...+..22.3éevse00e00s00- 2
Encourage research on environmental effects......... DALIAS. ;5
Pate OITLETIC SALLY Rites EA RIOAE eT SORIA TAA elses 3
Components of the Performance Standards............ccccceeeeeeeeeees 4
Bonversion: (O-als EXpert system Wher«e Waliess .ee, te 4
OVERVIEW OF PERFORMANCE STANDARDS FLOWCHARTS...... 4
I. APPLICABILITY OF PERFORMANCE STANDARD. .................. 5
ATIC SULTS FESTIVE Nef oes ae ak eS ee 6
Remaecn au c MOAnCi SI NS ihe. ca ee-s eStse.ledee vies ok celveka dence css if
Rationale for Applicable and Non-applicable Organisms.............. 8
WWeliberate weneichangesi.) nth iMtiene.. Me Men nstek tet eran 8
Deliberate chromosomal manipulations.....................ceceeees 9
Weliberate interspeciicehy brdization®. 0.22t, BO. a ! 10
Intraspecific selective breeding and captive breeding.......... 11
IL.A, I.B, 1.C. SURVIVAL AND REPRODUCTION ASSESSMENT .. 12
MOLI ba Ole LOlIN Sada, viteri: ririvericae Tingd esdsevaaelce sneenr cd eat 12
pre m SUS OINS 4/528 itt oles ca? Gee eh Sea ae Fay, NEAR 13
Assessing survivability of GMO in accessible ecosystems.... 13
GMOs withvabilitytOidisperse.t 5.7 2.2, Sheree A ae Best a Sens eee 14
isalatedvaccessible.eGOsystemlanfictc. cdtec ieanctet tsa ke 14
I.A.1. IMPACT OF DELIBERATE GENE CHANGEG.............0.0.000.. U5
eliberate-Gene Changes,Posing No Concern «2.0.sd.ewe0 le2e.s 15
Deliberate Gene Changes Needing Further Assessment................ 16
Interbreeding with Conspecifics or Closely Related Species.......... i
Potential for interbreeding with closely related species....... 17
PLHARSE TO NNE UeAT RIS 7 EV Gl reels Uso lee y inP anne OE yO TERE 17
Impact on Threatened, Endangered, or Special Concern
PepeL LG Om the a Nght Trent cy ty en Cr Saeco t ns enn 18
When Genetically Modified Organism is a Non-indigenous
STEGITSEE S. athe oot eS. RE ea eee RS Roti Nir ec Re a 19
II.B.1. IMPACT OF DELIBERATE CHROMOSOMAL
MANIPULATIONS |...3 .5.25 scsi. ss tenet eens tines eee ee ee 20
Interbreeding or Mating / Permanent Sterility / Non-indigenous
SPECIES «55 cceiaesecpeaees desesecaes those See ee ee eee eee 20
Extremely Low Survival of Certain Polyploids.......................00. 21
II.C.1. IMPACT OF INTERSPECIFIC HYBRIDIZATION .................. 21
Il. POTENTIAL INTERFERENCE WITH NATURAL
REPRODUCTION. c.cciateccseeveceuenutetcee Nueic ceeeeaseeeed s 22
Steroidogenesis and Reproductive Behaviot...............:ccccccceesseeees 22
Impact:on Protected Populations 75 .¢0-2ge eee 2) eee 23
Numbers of GMOs Relative to Potentially Interfered Populations. 23
IV.A. ECOSYSTEM EFFECTS - DELIBERATE GENE CHANGES ....24
Familiarity with Overall Performance of the GMO...................... 24
IV.A.1. ECOSYSTEM EFFECTS - IMPACTS OF INTROGRESSION
OF MODIFIED GENE(S) \g ies teee-eeeet. ene. Gee 25
Estimation of Reproductiye Potential.....acce annccasny. 26
Estimation of Gene Flow 12.21.) ecient. eee ee 26
Estimation of Fitness of Introgressed Descendants....................6 Ag |
Genetic Load of Introgressed Modified Genes ..................:.:0ece0es ZY,
IV.B. POTENTIAL BARRIERS ASSOCIATED WITH ACCESSIBLE
ECOSYSTEM '. oos23 cy: ance enka ede nerece seetcndads tae eee deg eae 28
Familiarity with Reproductive Biology of the GMO..................... 29
IV.B.1. ECOSYSTEM EFFECTS - POTENTIAL FOR NON-
REPRODUCTIVE INTERACTION siece ete oie eee 29
IV.C. ECOSYSTEM EFFECTS - IMPACTS OF REPRODUCTIVE
INTERFE...<:.RsythsyiEgeecneNast aCd ucaEti, .aesm .us ia.d iee e eee 30
Density-Dependent, Factors <: se4 cet eet ian wis ose ee ee 30
Assess if density dependence in stock-recruitment can offset
population jdecline:ttacs>. GoesomenueWamk ecvenrt erese 30
V. EFFECTS ON ECOSYSTEM STRUCTURE AND PROCESSES ...... 31
Interactions with Threatened, Endangered, or Special Concern
ASSORULA ESV AE S ncn asae hence bape ill at al: ahh Prva ii ide ded i aii
sean ey aw le AOCCSSIDIC VECOSYS(CIN sti iret. tierscveseeecc ataes r e: 32
Assess Interactions Between GMOs and Other Organisms............ 33
Sh pheH U LCeuaL ESW ELS SW ETO LIU A) ARORA lea Ot paar Ns ARE 33
Pe Tera UO OUICE OL Allismis 7 evictc at tat ete 34
Assess Potential for Interactions to Adversely Alter Ecosystems... 34
Decreased predictability of ecosystem state....................668 2),
ree taccurstate Ol CCOSVSICINS 6 6.-.20/treccescctstastessaieofn sB ieta 35
VI. RISK MANAGEMENT RECOMMENDATIONS PROJECT SITING,
DESIGN, OPERATIONS “AND REVIEW ro... cancceccesccecccentsnceavre s 36
TEAS TEE AOL es i aa a he NY Wi RD AD RP SUR ARI Ht 36
Case-specific approach complemented by review ............... 36
Research projects versus commercial operations................ Suh
HPS ant Sa NREI S ger ceee depe plein tise A ag tie ee yeti ila eae ia 37
Different criteria for freshwater and marine sites.............. Ov,
Pro fceiesitiner tora vOld, Cellaln TISKS iraeer.e ie.ts .eere t ees3 8
Mee PMS AECL Seer etter rn nee ese ere rete eee cere h seca 39
Petbysicd M OD. CHEIMICANs DAITICTS sep1c-- csc :02 Ss hs ce aca co ens teseshe be ues 40
NieetaiiealaBalliclst stn te cscs hi te et es 40
9 10)C OAP CC ng BYU (LE ore sete a eel g ned ila thing pda gliaed esa 40
PC AICTOMCXDCEINCUU ds at aILICh tree trttte: ott r, tt, ocr eee 4]
Barriers for all possible escape paths of the water system ...41
Prevent escape Via, DOM-daGUALIC DAUIS...- 0... <)...c--csoencS ecnesc da e- 42
TE. tolla | ose ties ear a) aaa a tr sa al ett he Sale 43
OV IIPEAS = 6 aie ARR USAC ca Me apes SARE MR BierC pa re 44
SvS LLD nt LERCHS TB ay saber tie e apvaranel scale ult a alone Pret a eae iat a Pak 5 INLa 45
oye LaF efi 2 essa ape eal aa eg ea Ae IAP 45
{CTWRTD C E apace three tary CN nr mend Pie A ERR Seo ARNE TARRR ey 45
Pei TCOMUO seer re tise te erat wee ie eee 46
Tee OLR CODI Ohi tt ere ments vrs h sears eescers tons s tse esa 46
EARPTS L ENE TSNO) ETON 0)E i aR penn an le ele ope emda es4 6
Reese VIC W GUC Site ROVICW ose cr her trte rear cressetes coors ease 48
Peer review, prior to start-up of project..7-. 2.2... oe... 48
Site reviews dite SLatt-Up 1Ol PIOJOCE,.-c....senesscecneasscanscace 49
Documentation to submit to proposal and site reviewers.....49
BTOTEC IAD PLOVd leea ee estar es eee eee iss are these tha: 49
1 UR NTA RS Be GtE T Ba et este aie 9s ee Cia peeve Noe meyers creer 50
Ree oie Crh RRM IS soa ietn coer ceegtpctosomte ecitoress tpitnen tasnA tcdenc Weseecsone ae 58
APPENDIX A
EXCERPTS FROM THE AQUATIC NUISANCE SPECIES
PROGRAM (ANS) .....cc:fsGasn sGsocs aosei oaes seaerh Al
APPENDIX B
ASSESSMENT OF GENETICALLY MODIFIED FINFISH AND
SHELLFISH WITH NON-DIOECIOUS MODES OF
REPRODUCTION iar iestuteeac epee thee etree nase, ancien Bl
APPENDIX C
CHEMICAL STERILIZATION OF SEA WATER....................... Cl
APPENDIX D
SCHEMATIC DIAGRAMS OF EXAMPLES OF MECHANICAL
BARRIERS | 2005 javilsrss'essnans fr peitars jeapinhiey og hah os cde aes oe ee D1
APPENDIX E
ABRAC WORKING GROUP ON AQUATIC BIOTECHNOLOGY
AND ENVIRONMETNAL SAFETY |..........5.: c.vcecennes outa El
APPENDIX F
PARTICIPANTS IN THE WORKSHOP ON PERFORMANCE
STANDARDS FOR RESEARCH WITH GENETICALLY
MODIFIED: FISH AND ‘SHEELEISH ic0%....%...0is.ccno mee Fl
