Regulatory Regulatory Structure for GE Structure for GE

CropsCrops

Alan McHughen, D.Phil., Alan McHughen, D.Phil., University of CaliforniaUniversity of California

Riverside, Ca USARiverside, Ca USA

alanmc@ucr.edualanmc@ucr.edu

Arguments to ban GMOs…Arguments to ban GMOs…

GMOs are hazardous because…GMOs are hazardous because… GE breaks the “species barrier”; Nature GE breaks the “species barrier”; Nature never allows genes from one species to never allows genes from one species to move to anothermove to another

GE involves random insertions into genomeGE involves random insertions into genome GE crops and foods are untested and GE crops and foods are untested and unregulatedunregulated

Once released, GMOs can never be recalledOnce released, GMOs can never be recalled ……or other claims of danger?or other claims of danger?

USA: Theory of risk USA: Theory of risk assessmentassessment

Science based risk analysesScience based risk analyses Other factors applied laterOther factors applied later

Product vs processProduct vs process rDNA processes are not inherently rDNA processes are not inherently riskyrisky

Any breeding process may result in Any breeding process may result in risky productsrisky products

LabellingLabelling Product composition, not processProduct composition, not process

Foreign Genes in WheatForeign Genes in Wheat

Friebe et al., Crop Science 39:1692-1696 (1999)

Variety release Variety release requirements: requirements:

genetically engineered genetically engineered cropscrops

USDA (APHIS) - environmental USDA (APHIS) - environmental issuesissues

HHS (FDA)- food and feed safetyHHS (FDA)- food and feed safety

EPA- pesticide usage issuesEPA- pesticide usage issues

Variety release Variety release requirements: requirements:

genetically engineered genetically engineered cropscrops

USDA- environmental issuesUSDA- environmental issues Plant Protection Act (PPA, Plant Protection Act (PPA, 2000); 2000); also administersalso administers

Plant Patent Act (Plant Patent Act (for asexually for asexually propagated plantspropagated plants))

Plant Variety Protection Act Plant Variety Protection Act (PVPA)(PVPA)

USDA/APHIS proceduresUSDA/APHIS procedures NotificationNotification

Simplest means for least hazardous GE plantsSimplest means for least hazardous GE plants Must meet six criteria (non-weedy; stable; Must meet six criteria (non-weedy; stable; known function; known function; non-infectious/toxic/pharmaceutical/industrianon-infectious/toxic/pharmaceutical/industrial; non-virulent; non-human or animal l; non-virulent; non-human or animal pathogenic source)pathogenic source)

Permit (for field testing release)Permit (for field testing release) More complex GE plants, requires greater More complex GE plants, requires greater scrutinyscrutiny

Petition for nonregulated status Petition for nonregulated status (commercialization)(commercialization) Complete risk analysisComplete risk analysis

US field trials, 1986-US field trials, 1986-presentpresent

12,000+ 12,000+ http://nbiap.biochem.vt.edu/http://nbiap.biochem.vt.edu/cfdocs/fieldtests1.cfmcfdocs/fieldtests1.cfm

47,00047,000 Environment Maine (PR 8/18/2005)Environment Maine (PR 8/18/2005) “…“…once released, can never be once released, can never be recalled.”recalled.”

Variety release Variety release requirements: requirements:

genetically engineered genetically engineered cropscrops

FDA- food and feed safetyFDA- food and feed safety Federal Food, Drug, and Cosmetic Act Federal Food, Drug, and Cosmetic Act (FFDCA)(FFDCA) GRAS (substantially equivalent)GRAS (substantially equivalent) Food AdditiveFood Additive

Variety release Variety release requirements: requirements:

genetically engineered genetically engineered cropscrops

EPA- pesticide usage, food safety EPA- pesticide usage, food safety issuesissues Federal Insecticide, Fungicide, and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Rodenticide Act (FIFRA)

Federal Food, Drug, and Cosmetic Act Federal Food, Drug, and Cosmetic Act (FFDCA) and (FFDCA) and

Toxic Substances Control Act (TSCA) Toxic Substances Control Act (TSCA)

Arguments to ban GMOs…Arguments to ban GMOs…

GMOs are hazardous because…GMOs are hazardous because… GE breaks the “species barrier”; Nature GE breaks the “species barrier”; Nature never allows genes from one species in never allows genes from one species in anotheranother

GE involves random insertions into genomeGE involves random insertions into genome GE crops and foods are untested and GE crops and foods are untested and unregulatedunregulated

Once released, GMOs can never be recalled…Once released, GMOs can never be recalled… The same “hazards” as other breeding The same “hazards” as other breeding methods.methods.