Historic, Archive Document Do assume not content reflects current scientific knowledge, policies, or practices. E Iture Animal and Plant Health Inspection Service Proqram Aid No. 1841 Biotechnology Regulatory Services Ensuring Safety in the Development of Genetically Engineered Organisms Here,GEcottonissurroundedbyothertypesofcropstoensure thatconfinementmeasuresareachieved. BIOTECHNOLOG BRS MISSION To protect America's agriculture and environment using a dynamic and science-based regulatory frameworkthat allows forthe safe development and use of genetically engineered organisms APHISregularlyinspectsGEfieldteststoensurethatcompaniesarecomplyingwith BRS'confinementconditions. Here,anAPHISemployeeinspectsGEcotton. - , nr I hrough its strong regulatory framework, JL Biotechnology Regulatory Services (BRS) protects America's agriculture and the environment by allowing for the safe development and introduc- tion (importation, interstate movement, and field testing) ofgenetically engineered (GE) organisms. Under the authority ofthe Plant Protection Act, the U.S. Department ofAgriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) has regulated GE organisms since 1987. In 2002, APHIS established BRS to take over this role. The agency has authorized more than 10,000 permits and notifications for the introduction of GE organ- isms and deregulated more than 60 products for use, establishing itselfas an international leader in the safe regulation of GE products. 7^. BR&JBeaching Its Vision Itis thevisionofBRS towork openly and cooperatively toprovide a clear, timely, and strategic regulatory system thatresponds to the rapidlyevolving field ofbiotechnol- ogy and fosters public confidence. Fulfillingthis vision requires manythings, among themthe flexibilityto respond. APHIS writes its biotechnologyregulations with flexibilitysuchthatmeasures imposed onpermits can vary based oncase-by-case assessments. BRS regula- tions mayalso be revised and strengthened as needed, based on newtrends in biotechnology, changes in the field, and experience gained. Also as part ofits vision, BRS makes it a priorityto ensure thatits processes, decisions, and activities are transparentto the public and to its stakeholders. As part ofthis initiative, BRS makes available on itsWeb site all environmental assessments for GEcrops thatproduce pharmaceutical and industrial compounds; it announces the findings in the FederalRegister and allows for a commentperiod. The BRSWeb site alsoprovides acces- sibilitytopermits and decisions and news and upcoming events. In addition, BRS has a stakeholderregistrythat allows interestedparties toreceive updates and other informationrelevantto selected topics ofinterest, such as regulation activities, communication and outreach, capacity building, and compliance issues. Science Guiding BRS BRS performs all aspects ofits regulatoryrolewith sci- ence as its basis. A diversified collection ofscientific expertise enables BRS to make sound, science-based decisions that ensure the safe development ofnew GE organisms thatare themselves as safe as their non-GE counterparts. BRS has experts in scientific fields (e.g., plantpathology, botany, animal science, entomology, virology, ecology, environmental science, molecular biol- ogy, and biochemistry) who conductextensive scientific review ofpermit applications, petitions for deregulation, potential permit infractions, and proposed regulatory changes. To keep pace with the ever-evolvingtechnolo- gy, BRS staffand scientists attend and host scientific meetings and workshops, read literature, and interact with outside scientists, stakeholders, and the public. BRSnfntemati^ BRS alsoplays an activeroleininternational standards setting andregulatorycapacity building. In fulfilling these functions, alongwith other international activities, BRS supports otherUSDA agencies and Federal depart- ments thatare directlyinvolved intrade activities bypro- vidingthe technical and scientific expertise ofits staff. BRSw^orkswith keyinternational organizations to devel- op international biotechnologystandards thatare science based andconsistentwithU.S. regulatorypoHcy and standards. BRS also works with developingcountriesto establish their own regulatoryframework. The BRS Permit System APHIS regulations are mandatory, and developers must seek APHIS approval through its permit system before introducing a GE organism. Developers must also complywith the regulations and permit condi- tions throughout the duration ofthe approved permit. Applicants must submit all plans for movement, importation, or field testing for thorough review by regulatory scientists, who evaluate the risks and the procedures that the developerwill use. Depending on the nature ofthe GE crop, an applicant files either a notification or a permit application for APHIS review. BRS also works closely with State departments ofagri- culture to ensure that they are aware ofevents taking place within their jurisdiction and to allow them to apply any additional safeguards they may require. The Notification Process Mostplants are field-tested under notification, a stream- lined approval process that is often used for plants that are altered with common agronomic traits, such as pest resistance or herbicide tolerance. Applicants may use the notification process only for plants that meet all six ofthe following eligibility criteria, based on their plant pest potential: 1. The GE plant is not listed as a Federal noxious weed and is not considered a weed in the area of introduction. 2. The genetic material must be "stablyintegrated" into theplantgenome. 3. The newly introduced gene's function must be known and not resultin plant disease. 4. The genetic material mustnotcauseproduction ofa plantpest; causethe plantto produce substancesthat are toxic to nontarget organisms; or be genetically engineered for the purpose ofproducing compounds intended forpharmaceutical or industrial use. 5. The newlyintroducedgene must notcause the cre- ation ofa newplantvirus. 6. The plant must not have been modified to contain genes from animal or humanpathogens. In2003,roughly81 percentofthesoybeansgrowninthe UnitedStates weregeneticallyengineered,nearlyallforherbicidetolerance. Applicants must also sign a statement indicating that theywill conduct the testin a manner that meets the per- formance standards listed in APHIS biotechnolog}'regu- lations. For example, one performance standard states thatthe field trial must be conducted in such a waythat the regulated articlewill notpersist in the environment and no offspringcan beproduced thatcouldpersistin the environment. Aspart ofthe notificationprocess, BRS requires that appHcants provide detailed data, such as information aboutthe plant; descriptions ofgenetic modifications; the source and identit}' ofanygenes introduced; and the size, duration, and location ofthe field test. Ifa plant does notmeetthe criteria for notification, the apphcant mustfollowthe full permittingprocess. Th^Perm^ The permittingprocess involves a more comprehensive review and is used for GE plants that could pose an elevated risk, such as plants thatproduce pharmaceuti- cal or industrial compounds, as well as for any GE organism other than plants. As part ofthe permit application process, applicants must provide the same data as required in the notification process and, in addition, mustprovide a detailed description ofhow the developer will perform the test. When applying for a permit, applicants must include specific measures to reduce the risk ofharm to other organisms to ensure that the plants being tested do not pose a signif icant plantpest risk. BRS often works with applicants on design protocols and may impose additional meas- ures and supplemental permit conditions. 2% Rice 6% Tomato Cornfollowedbysoybeans, 2% Rapeseed Cotton potatoes,cotton,andtoma- 3% Tobacco 8% Potato toesarethemostcommon 4% Alfalfa 9% Soybean cropsforwhichdevelopers Wheat 54% Corn requestpermits.