GLOSSARY OF SELECTED TERMS, ABBREVIATIONS AND ACRONYMS USED IN THE OFFICE OF PESTICIDE PROGRAMS AA - Assistant Administrator AAPCO - Association of American Pesticide Control Officials. An association of state pesticide regulatory officials dedicated to the effective enforcement of laws and implementation of programs that relate to proper and safe use of pesticide chemicals. ACB - The Analytical Chemistry Branch (ACB) within the Biological and Economic Analytical Division (BEAD) of the Office of Pesticide Programs (OPP). ACB provides analytical and environmental chemistry services in support of pesticide registration, special review, and tolerance petition programs. ACB also provides support to the Office of General Counsel, the EPA Regional Enforcement Program, and the National Ground Water Monitoring Program. There are two laboratories in this branch, one in Beltsville, Maryland and one in Bay St. Louis, Mississippi. ACCELERATED REREGISTRATION BRANCH - The Accelerated Reregistration Branch (ARB) within the Special Review and Reregistration Division (SRRD) of the Office of Pesticide Programs (OPP) is responsible for the reregistration activities of List B, C, And D Chemicals. ARB staff manage data requirements, issue Data Call-In Notices, process industry's data and requests, and coordinate internal reregistration eligibility decisions. ACCEPTABLE DAILY INTAKE - ADI. A now defunct term for reference dose. ACCESSION NUMBER - An identification number that used to be assigned (for cataloging purposes) to physical volumes of studies submitted to the Office of Pesticide Programs; this numbering system has been replaced by the Master Record Identification (MRID) system, which identifies each individual study. ACTIVE INGREDIENT - In any pesticide product, the active ingredient is the component which kills, or other wise controls, the target pests and includes any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel, or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA section 2(a). Pesticides are regulated primarily on the basis of active ingredients. Abbreviated AI. ACUTE TOXICITY - The ability of a substance to cause poisonous effects resulting in harm or death soon after exposure. Acute toxicity is established through scientifically verifiable data from animal or human exposure tests. Values are usually expressed as LD50 or LC50 and mg/kg. Acute toxicity studies include oral, dermal, and inhalation studies. ADI - See Acceptable Daily Intake. ADDRESS OF RECORD - The applicant's or registrant's United States address for correspondence purposes. It is the address to which the Agency will send certain notices (i.e., those imposing legal requirements) concerning the application and any subsequent registration information. It is the responsibility of the applicant or registrant to ensure that the Agency has a current and accurate address. ADJUVANT - A subsidiary ingredient or additive in a mixture which contributes to the effectiveness of the primary ingredient. Adjuvants are added to pesticides use dilutions in tank mixes by growers or applicators prior to application to the crop to be treated. Agricultural chemical adjuvants are grouped according to their intended purpose in the tank mix and include but are not limited to the following groups: acidifying agents, buffering agents, anti-foam agents, defoaming agents, anti-transpirants, color adjuvants, dyes, brighteners, compatibility agents, crop oil concentrates, oil surfactants, deposition agents, drift reduction agents, foam markers, gustatory stimulants, feeding stimulants, herbicide safeners, spreaders, extenders, adhesive agents, suspension agents, gelling agents, synergists, tank and equipment cleaners, neutralizers, water absorbants, and water softeners. Adjuvants intended for pesticidal use in tank mixes are required to be cleared under the Federal Food, Drug and Cosmetic Act prior to being used. Adjuvants intended for non-pesticidal uses are to be cleared with the FDA prior to being used. ADMINISTRATIVE PORTION OF APPLICATION FOR REGISTRATION - That portion of the Application Package comprised of the administrative paperwork, i.e., the Application for Registration/Amendment (EPA Form 8570-1); the Confidential Statement of Formula (EPA Form 8570- 4); the Certification with Respect to Citation of Data (EPA Form 8570-29); the Formulator's Exemption Statement (EPA Form 8570-27); the Draft Labeling; the Statement identifying the "substantially similar" or "identical" product (if a "me-too" amendment); and the Data Matrix Chart (if the selective method of support is used). The administrative documents are not to be bound together. ADMINISTRATOR - The Administrator of the United States Environmental Protection Agency or his/her delegate. AGENCY - The United States Environmental Protection Agency (EPA), unless otherwise specified. AI - See Active ingredient. ANALYTICAL CHEMISTRY BRANCH - See ACB. AOAC - Association of Official Analytical Chemists. APPLICANT - A pesticide chemical company or person who intends to or has applied to the Agency (Office of Pesticide Programs, Registration Division) for a registration, amended registration, or reregistration for registration of a pesticide product, under FIFRA section 3. ARB - See Accelerated Reregistration Branch. ASTHO - Association of State and Territorial Health Officials. ASSOCIATION OF AMERICAN PESTICIDE CONTROL OFFICIALS - See AAPCO. ASSOCIATION OF OFFICIAL ANALYTICAL CHEMISTS - See AOAC. AUTHORIZED AGENT - A person residing in the United States who is designated by an applicant or registrant to act as their agent in matters pertaining to pesticide registration. BAB - The Biological Analysis Branch (BAB) within the Biological and Economic Analysis Division (BEAD) of the Office of Pesticide Programs (OPP). BAB is responsible for the preparation of use-data software programs for exposure assessments, qualitative use assessments, and biological analyses of pesticides. Bilingual labeling. BEAD - The Biological and Economic Analysis Division (BEAD) is one of the seven Divisions that constitutes the Office of Pesticide Programs (OPP). BEAD conducts analyses on pesticide use and benefits; acquires, validates, and interprets technical data relative to pesticide use; conducts economic analyses on the impacts of regulatory options; and validates analytical chemistry methods. BEAD is comprised of the Planning and Evaluation Staff, and three branches: Biological Analysis Branch (BAB), Economic Analysis Branch (EAB), and Analytical Chemistry Branch (ACB). BIOCHEMICAL PESTICIDES - Biochemical pesticides include, but are not limited to, products such as semiochemicals (e.g., insect pheromones), hormones (e.g., insect juvenile growth hormones), natural plant and insect growth regulators, and enzymes. BIOLOGICAL ANALYSIS BRANCH - See BAB. BIOLOGICAL AND ECONOMIC ANALYSIS DIVISION - See BEAD. CB - The Communications Branch (CB) within the Field Operations Division (FOD) of the Office of Pesticide Programs (OPP) develops and operates programs that disseminate pesticide and OPP information to the public. CB also manages the OPP public docket (see docket file). CB I - See Chemistry Branch I and II. CB II - See Chemistry Branch I and II. CBI - Confidential Business Information - material that contains trade secrets or commercial or financial information that has been claimed as confidential by the submitter (usually the registrant). Procedures for handling CBI material can be found in the OPP and the OPTS CBI manuals. CBI material should not be sent over FAX machines unless the sender wants to clearly waive his or her CBI rights and so states on the CBI material being FAXed. CERCLA - The Comprehensive, Environmental, Response, Compensation, and Liability Act (CERCLA). Commonly known as "Superfund," this statute includes provisions for the cleanup of existing hazardous waste sites and requires that releases of hazardous substances in quantities greater than established reportable quantities be reported to the National Response Center. Under CERCLA section 103, the application of a pesticide product registered under FIFRA is exempt from regulation. CERCLA in implemented by the Office of Solid Waste and Emergency Response, Office of Emergency and Remedial Response. Also see the Superfund Amendments and Reauthorization Act of 1986 (SARA). CERTIFICATION AND TRAINING BRANCH - The Certification and Training Branch (CTB) within the Field Operation Division (FOD) of the Office of Pesticide Programs (OPP) is responsible for directing and implementing the Agency's regulatory and non-regulatory pesticide applicator training and certification activities under section 4 and section 23 of FIFRA. CTB also acts as OPP's liaison to state governments and tribal governments. CFR - The Code of Federal Regulations. A codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. Regulations that pertain to EPA are at 40 CFR. Thus, 40 CFR 152.40 refers to title 40, part 152, section 40; the section on who may apply for new registration of a pesticide product. Each volume of the Code is revised at least once each calendar year and issued on a quarterly basis approximately as follows: Title 1 through Title 16................as of January 1 Title 17 through Title 27.................as of April 1 Title 28 through Title 41..................as of July 1 Title 42 through Title 50...............as of October 1 The appropriate revision date is printed on the cover of each volume. CHEMICAL CASE - For purposes of review and regulation, individual active ingredients that are chemically similar (e.g., salts and esters of the same chemical) are grouped into chemical cases by the Agency. CHEMICAL MANUFACTURERS ASSOCIATION - The Chemical Manufacturers Association (CMA). CHEMICAL PESTICIDES - Synthetic or natural occurring chemicals that exhibit pesticidal properties and are formulated into products intended for preventing, destroying, repelling, or mitigating a pest, or intended for use as a plant regulator, defoliant, or desiccant. CHEMICAL PRODUCERS AND DISTRIBUTORS ASSOCIATION - The Chemical Producers and Distributors Association (CPDA). CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION - The Chemical Specialties Manufacturers Association (CSMA); was originally named the National Association of Insecticide and Disinfectant Manufacturers. CHEMISTRY BRANCH I AND II - Chemistry Branch I (CB I) -- Tolerance Support and Chemistry Branch II (CB II) -- Reregistration Support are two branches within the Health Effects Division (HED) of the Office of Pesticide Programs (OPP) that were formerly known as the Dietary Exposure Branch (DEB). CB I and CB II evaluate analytical methods and residue, metabolism, and dietary exposure data. These analyses are used to estimate dietary exposure to pesticides and may lead to recommendations for or against proposed pesticide residue tolerances in food or feed, and reassessment of tolerances. CHILD-RESISTANT PACKAGING - (CRP) - Packaging that is designed and constructed to be significantly difficult for young children to open. Registrants of pesticide products required to be in child- resistant packaging are required to certify to the Agency that the package meets the standards of 40 CFR 157.32. CHRONIC TOXICITY - The capacity of a substance to cause long-term poisonous human health effects. CITE-ALL METHODS OF SUPPORT - One of two methods by which an applicant for registration may comply with the data compensation requirements of FIFRA section 3(c)(1)(F). Under this method the applicant, where "exclusive use" data is involved, cites all pertinent data in the Agency's files only with the written permission of the exclusive use data submitter; where there is no exclusive use data involved, the applicant cites all pertinent data in the Agency's files with permission of the original data submitter or by offering to pay compensation for use of the data in accordance with FIFRA sections 3(c)(1)(F) and submits a general offer to pay statement to the Agency stating his or her offer and agreeing to pay compensation to other data submitters t the extent required by FIFRA section 3(c)(1)(F). CMA - See Chemical Manufacturers Association. CODE OF FEDERAL REGULATIONS - See CFR. COLLATERAL LABELING - Collateral labeling must be submitted along with the application for registration and includes bulletins, leaflets, circulars, brochures, data sheets, flyers or other written, printed or graphic matter which is referred to on the label or which is to accompany the product. COMMUNICATIONS BRANCH - See CB. COMPREHENSIVE ENVIRONMENTAL, RESPONSE, COMPENSATION, AND LIABILITY ACT - See CERCLA. CONFIDENTIAL BUSINESS INFORMATION - See CBI. CONFIDENTIAL STATEMENT OF FORMULA - (CSF). A list showing the identity of the ingredients contained in a pesticide formulation. The list is submitted by a registrant or applicant, on the Confidential Statement of Formula form (EPA Form 8570-4), at the time of application for registration or change in formulation. CORT STUDIES - The set of toxicology studies of chronic feeding, oncogenicity (which is now referred to as carcinogenicity), reproduction, and teratology. These studies are required for all food/feed use pesticides and one or more may also be required for nonfood/feed use pesticides. CPDA - See Chemical Producers and Distributors Association. CRP - See Child-Resistant Packaging. CSF - See Confidential Statement of Formula. CSMA - See Chemical Specialties Manufacturers Association. CTB - See Certification and Training Branch. DAA - Deputy Assistant Administrator. DATA CALL-IN NOTICE - (DCI). As provided by FIFRA section 3(c)(2)(B), data call in is a notice/letter that is issued by the Reregistration Division and/or Registration Division to pesticide registrants requiring them to submit specific data or scientific studies to support the registration of a pesticide. Failure to submit this data can result in suspension of the registered products. DATA GAP - The absence of any valid study or studies in the Agency's files which would satisfy a specific data requirement for a particular pesticide product. DATA MATRIX CHART - A matrix chart showing all of the data required to support the application for registration. The applicant indicates on the matrix how he/she is satisfying the data requirements, i.e., by submitting the actual data or by referencing EPA's Master Record Identification (MRID) number. The Data Matrix Chart is required to be submitted only if the applicant elects to use the Selective Method of Support for his/her application. DATA PORTION OF APPLICATION FOR REGISTRATION - The portion of the Application Package comprised of the actual data required to support your application for registration, i.e., product specific chemistry data, acute toxicity data, efficacy data, generic data (if the application is for a new use or a new active ingredient). Applicants are required to submit three copies of the data, properly bound and formatted in accordance with PR Notice 86-5. DATA REVIEW RECORD - A form attached to material (e.g., data submitted by a registrant) transferred from one Office of Pesticide Programs (OPP) Division to another for review. The material is assigned a record number and a bar code which are used to track the material in the Pesticide Registration Action Tracking System (PRATS) (formerly the On-Line Tracking System (OLTS)). DATA SUBMITTER'S LIST - The current Agency list, entitled Pesticide Data Submitters by Chemical," of persons who have submitted data to the Agency. DCI - See Data Call-In Notice. DEB - See Chemistry Branch I and II. DESIGNATED U.S. AGENT - See Authorized Agent. DEVICE - Any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately. DIETARY EXPOSURE BRANCH - (DEB) - See Chemistry Branch I and II. DIETARY RISK EVALUATION SYSTEM - The Dietary Risk Evaluation System (DRES) is a computerized tool for analyzing human dietary exposures to individual pesticides and comparing the exposures to known toxicity levels. The DRES is the responsibility of the Science Analysis and Coordination Branch (SACB) within the Health Effects Division (HED) of the Office of Pesticide Programs (OPP). DRES was formerly known as the Tolerance Assessment System (TAS). DOCKET FILE - A file maintained in the public docket (Room 1128, Crystal Mall Building 2 (CM2), for the Office of Pesticide Programs (OPP)) for materials that pertain to Special Review and Reregistration of pesticides. Instructions for docketing can be found in 40 CFR 155. Materials in the docket are available for public inspection unless they are marked as confidential business information. It is the responsibility of the OPP product managers and review managers to submit materials to the docket. DOMESTIC APPLICATION - Pesticide application in and around houses, office buildings, motels and other living or working areas; now termed residential use. See residential use. DRES - See Dietary Risk Evaluation System. EAB - The Economic Analysis Branch (EAB) within the Biological and Economic Analysis Division (BEAD) provides economic analyses for EPA's pesticide regulatory program, including analyses of economic impacts of pesticide regulatory policies and of individual program actions under the various sections of FIFRA. EC - An Emulsifiable Concentrate (EC) is a type of pesticide formulation that contains the active ingredient, one or more petroleum solvents, and an emulsifier that allows the formulation to be mixed with water. The strength of this concentrate usually is stated in pounds of active ingredient per gallon of concentrate. ECOLOGICAL EFFECTS BRANCH - The Ecological Effects Branch (EEB) within the Environmental Fate and Effects Division (EFED) of the Office of Pesticide Programs (OPP) is responsible for assessing pesticide effects on non-target species including fish, birds, small mammals, beneficial insects, and plants. ECONOMIC ANALYSIS BRANCH - See EAB. EDF - The Environmental Defense Fund (EDF). EEB - See Ecological Effects Branch. EEC - Estimated Environmental Concentration. An estimate of the concentration of a pesticide occurring in or on various media (i.e., soil, water, air) after pesticide application, as determined from the results of environmental fate or environmental expression testing. EFED - The Environmental Fate and Effects Division (EFED) is one of seven Divisions that constitutes the Office of Pesticide Programs (OPP) and is responsible for assessment of pesticide effects on non-target animal and plant species in the natural environment and groundwater. EFED is made up of the Science Analysis and Coordination Staff (SACS), the Ecological Effects Branch (EEB), and the Environmental Fate and Groundwater Branch (EFGWB). This Division was created by the OPP reorganization of July 1988 when the Hazard Evaluation Division was split into the Environmental Fate and Effects Division (EFED) and the Health Effects Division (HED). EFFICACY DATA - Data showing that the pesticide is effective in controlling the pests for which control claims are made on the product label. EFGWB - The Environmental Fate and Groundwater Branch (EFGWB) within the Environmental Fate and Effects Division (EFED) of the Office of Pesticide Programs reviews and evaluates data on : pesticide fate and transport; aspects of pesticide leachability; and ground water effects. EFGWB also manages and coordinates human and environmental monitoring activities in support of the pesticide regulatory program. ELI - The Environmental Law Institute (ELI) conducts research on current developments in environmental law; publishes the "Environmental Reporter." EMERGENCY EXEMPTION - A provision in FIFRA (Section 18) which permits the Administrator to exempt any Federal or State agency form any of the requirements of FIFRA if emergency conditions exist. The term "emergency conditions" is defined at 40 CFR 166.3(d). Pursuant to the provisions of FIFRA section 18, EPA has promulgated regulations at 40 CFR Part 166 under which EPA can grant an emergency exemption to a state or another federal agency that allows, subject to certain restrictions, the use for a limited period (usually one year) of a pesticide product that is not registered for that particular use. EMERGENCY SUSPENSION - Suspension of registration under FIFRA section 6(c) due to an imminent hazard. See Suspension of Registration also. EMULSIFIABLE CONCENTRATE - See EC. EMULSIFIER - A chemical that aids in suspending one liquid in another, usually an organic chemical in an aqueous solution. END-USE PRODUCT - EP - A pesticide product whose labeling bearing instructions for using or applying the product (as packaged and sold, or after dilution by the applicator) for controlling pests or regulating plant growth. The term excludes products with labeling which allows use of the product to formulate other pesticide products. ENVIRONMENTAL DEFENSE FUND - See EDF. ENVIRONMENTAL EXPRESSION - The extent and manner in which a microorganism establishes and maintains its presence in an ecological habitat. ENVIRONMENTAL FATE DATA - Scientific data that characterize a pesticide's fate in the ecosystem, considering its degradation inducers (light, water, microbes), pathways, and resultant degradation products. ENVIRONMENTAL FATE AND EFFECTS DIVISION - See EFED. ENVIRONMENTAL FATE AND GROUNDWATER BRANCH - See EFGWB. ENVIRONMENTAL LAW INSTITUTE - See ELI. EP - See End-Use Product. EPA - The Environmental Protection Agency. EPA COMPENDIUM OF ACCEPTABLE USES - A list of federally registered pesticides with their uses and approved maximum acceptable application rates and other use restrictions; this outdated system was replaced by the use index. The use index has subsequently been replaced by LUIS. See LUIS. EPA ENDANGERED SPECIES BULLETIN - A bulletin that contains lists of endangered species (including birds, fish, mammals, and plants) which may be exposed to a pesticide or pesticides in a given county. The bulletin also contains pesticide use information necessary to protect the species from exposure to pesticides. ESTABLISHMENT REGISTRATION - The assignment of a registration number to a site where a pesticide or device is produced. The number is a two part hyphenated number referred to as an EPA Establishment Number. The first part of the number is series of numerals that identifies the company and the second part is a two letter code identifying the state or country in which the establishment is located. The establishment number is required to be on the product label. ESTIMATED ENVIRONMENTAL CONCENTRATION - See EEC. EUP - See Experimental Use Permits. EXCLUSIVE USE DATA - Beginning September 30, 1978, Exclusive Use Data pertains to those data that were submitted to the Agency in support of the registration of a new active ingredient, a new combination of active ingredients, or an application to amend the original registration to add a new use, for a period of 10 years after the initial registration has been issued. In order for the Agency to consider such data in support of an applicant's application for registration or amendment, the applicant must obtain for each data submitter listed on the Data Submitters List, as an exclusive use data submitter, written authorization identifying the applicant as the applicant to whom authorization has been granted to allow the Agency to use all applicable data to satisfy the data requirements for the application in question. EXPERIMENTAL USE PERMITS - EUP - A permit authorized under FIFRA, section 5, which is granted to applicants allowing them to conduct testing of a new proposed pesticide product and/or use outside of the laboratory and generally on 10 acres or more of land or water surface. EUPs are most commonly used for larger scale testing of efficacy and gathering of crop residue chemistry data. EUPs are processed by Product Manager (PM) Teams in the Office of Pesticide Programs' Registration Division Product Branches. FACTA - Food, Agriculture, Conservation, and Trade Act of 1990. FDA - The Food and Drug Administration. This agency is responsible for carrying out the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), which includes pesticide tolerance enforcement. See FFDCA. FEDERAL FOOD, DRUG, AND COSMETIC ACT - FFDCA - The Federal Food, Drug and Cosmetic Act. The law which regulates, among other things, the use of drugs (human and veterinary), chemicals in cosmetics, and human and animal foods; this includes the legal requirement of tolerances for pesticide residues (Sections 408 and 409) in or on food and feed items. These tolerances are established by EPA. FEDERAL INSECTICIDE, FUNGICIDE AND RODENTICIDE ACT - The Federal Insecticide, Fungicide And Rodenticide Act. The law which sets forth the regulation of the sale, distribution and use of pesticides in the United States. FEDERAL RECORD CENTER - The Federal Records Center provides economical storage of and access to noncurrent records. The agency stores noncurrent, inactive, and permanent records at the Center. FEDERAL REGISTER - (FR) A daily government publication where all federal regulatory actions, including proposed rules, final rules, and notices are published. FEEDING STIMULANT - When Included in a pesticide formulation, feeding stimulants are treated as inert ingredients and are required to go through the same Agency clearance under FIFRA and the FFDCA that inert ingredients are subject to. When feeding stimulants are added to a pesticide in a tank mix at a use site they do not require registration but are subject to the FFDCA. FFDCA - See Federal Food, Drug, and Cosmetic Act. FHB - The Fungicide-Herbicide Branch (FHB) within the Registration Division (RD) of the Office of Pesticide Programs (OPP) carries out regulatory responsibilities on herbicide and fungicide products. FHB is responsible for processing applications for registration, experimental-use permits, and petitions for tolerances for these classes of pesticides. FIELD OPERATIONS DIVISION - The Field Operations Division (FOD) is one of seven Divisions that constitutes the Office of Pesticide Programs (OPP). It oversees implementation of OPP regulatory actions, directs pesticide applicator training and certification, and manages the public docket. Within FOD there are five branches: the Regional Operations Branch (ROB); the Public Response and Program Resources Branch (PRPRB); the Communications Branch (CB); the Occupational Safety Branch (OSB); and the Certification and Training Branch (CTB). FIFRA - See Federal Insecticide, Fungicide and Rodenticide Act. FIFRA SCIENTIFIC ADVISORY PANEL - The FIFRA Scientific Advisory Panel (SAP) is an independent group of scientists, authorized under FIFRA, to comment on notices of intent issued under FIFRA section 6 and final form regulations issued under FIFRA section 25(a). The SAP also comments, evaluates, and makes recommendations regarding the scientific analyses made by the Agency. FIFRA SECTION 18 - See Emergency Exemption. FIFRA SECTION 24(C) - (Special Local Need (SLN)) - Authorizes a state lead agency to register additional uses of federally registered pesticides. Special Local Needs (SLNs) may only be used in the registering state, but otherwise have full federal registration status. All SLNs must be submitted to EPA for review subsequent to registration by a state. FINAL PRINTED LABELING - The label or labeling which will accompany the pesticide product when distributed or sold. FLOWABLE - A formulation in which the active ingredients are finely ground insoluble solids mixed with a liquid as a suspension. Flowables are mixed with water for application. FOD - See Field Operations Division. FOIA - The Freedom of Information Act (FOIA); legislation that generally makes available to the public, documents possessed by the federal government. FR - See Federal Register. FREEDOM OF INFORMATION ACT - See FOIA. FUNGICIDE-HERBICIDE BRANCH - See FHB. GENETIC ENGINEERING - Directed transfer of permanent genetic information between species. This may include organisms that the Agency considers to be microbial pest control agents. Some higher plants have been "genetically engineered" to produce a pesticide or other compound not produced by the native plant. GENERIC DATA - Generic Data pertain to the properties or effects of a particular active ingredient. Such data are relevant to an evaluation of all products containing that active ingredient regardless of whether the product contains other ingredients. Generic Data may also be data on a "typical formulation" of a product. "Typical formulation" testing is often required for ecological effects studies and applies to all products having that formulation type. Any registrant who does not qualify for the formulator's exemption (FIFRA section 3(c)(2)(D) and 40 CFR 152.85) is required to submit generic data to support the his/her product registration. GLP - Good Laboratory Practices (GLP) are standards established in 40 CFR 160 to assure the quality and integrity of data submitted by registrants. Provisions of the GLP standards include record keeping, personnel, and laboratory equipment requirements. GOOD LABORATORY PRACTICE - See GLP. GPO - U.S. Government Printing Office, 16-2 HEALTH EFFECTS DIVISION - The Health Effects Division (HED) is one of the seven Divisions that constitutes the Office of Pesticide Programs (OPP). It is responsible for assessment of pesticide effects on human health. This Division was created by the OPP reorganization of July 1988 when the Hazard Evaluation Division was split into the Environmental Fate and Effects Division (EFED) and the Health Effects Division (HED). HED is made up of six branches: the Science Analysis And Coordination Branch (SACB); the Toxicology -- Insecticide and Rodenticide Support Branch; Toxicology -- Herbicide, Fungicide, and Antimicrobial Support Branch; Chemistry Branch I -- Tolerance Support; Chemistry Branch II -- Reregistration Support; and the Occupational and Residential Exposure Branch (OREB). HED - See Health Effects Division. ICR - An Information Collection Request (ICR) is prepared pursuant to the requirements of the Paperwork Reduction Act (PRA) for rules, proposed rules, surveys, or other documents that contain information gathering requirements. The ICR is a description of what information is needed, why the information is needed, how it will be collected, and how much the information collection will cost. An ICR is submitted to OMB for approval. IDS - Incident Data System. A computerized system, currently under development in the Information Services Branch of the Office of Pesticide Programs' Program Management Support Division, for receiving incident reports. INCIDENT DATA SYSTEM - See IDS. IMMINENT HAZARD - A situation that exists when the continued use of a pesticide during the time required for a cancellation proceeding would be likely to result in unreasonable adverse effects on humans or the environment or will involve unreasonable hazard to the survival of an endangered species. INDEMNIFICATION - A provision of FIFRA section 15 that requires EPA to pay certain persons for the cost of stock on hand at the time a pesticide registration is suspended. INERT INGREDIENT - Pesticide components such as solvents, carriers, and surfactants that are not active against target pests and includes any substance (or group of structurally similar substances if designated by the Agency), other than an active ingredient, which is intentionally included in a pesticide product. Inert ingredients in pesticide product formulations are regulated under both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended and the Federal Food, Drug, and Cosmetic Act (FFDCA). INFORMATION COLLECTION REQUEST - See ICR. INFORMATION SERVICES BRANCH - The Information Services Branch (ISB) within the Program Management and Support Division (PMSD) of the Office of Pesticide Programs (OPP) provides information management support to the OPP regulatory program. These services include assessing information needs, directing the OPP security program, and maintaining liaison with information contacts and organizations outside OPP. INSECTICIDE-RODENTICIDE BRANCH - The Insecticide-Rodenticide Branch (IRB) within the Registration Division (RD) of the Office of Pesticide Programs is responsible for processing applications for registration, experimental-use permits, and petitions for tolerances for pesticides in these use classes. INSTITUTIONAL USE - Any application of a pesticide in or around any property or facility that functions to provide a service to the general public or to public or private organizations, including but not limited to hospitals and nursing homes; schools other than preschools and day care facilities; museums and libraries; sports facilities; and office buildings. INTEGRATED PEST MANAGEMENT - Integrated Pest Management (IPM) is the concept and practice of using a variety of methods (cultural, pesticidal, biological, etc.) to control pests. INTERMEDIATES: Pesticide intermediates are substances which are not themselves pesticides, but which undergo chemical reactions resulting in the formation of a pesticide. Pesticide intermediates are subject to regulation under TSCA. Pesticide intermediates include any beginning or intermediate material which is a chemical precursor to a pesticide active ingredient, whether produced in situ or obtained from other sources. INTERREGIONAL RESEARCH PROJECT NO. 4 - The Interregional Research Project Number 4 (IR-4) is a program sponsored by the U.S. Department of Agriculture (USDA). IR-4 provides national leadership and coordination for information on the clearance of minor use pesticides and generates data to support minor-use registrations. INTRASTATE PRODUCT - A pesticide product that was registered by a state for sale and use only in that state. New intrastate registrations are no longer permitted, and existing products must be converted to full federal registration or canceled. Because these products are not federally (EPA) registered, they may only distributed or sold in the state of registration. Intrastate products were identified by a product number greater than 3000 (e.g., 1573-4880). IPM - See Integrated Pest Management. IR-4 - See Interregional Research Project No. 4. IRB - See Insecticide-Rodenticide Branch. ISB - See Information Services Branch. LABEL USE INFORMATION SYSTEM - See LUIS. LUIS - The Label Use Information System (LUIS) is a computer data base of label directions for pesticide usage. Information contained in LUIS includes: use sites, application type, timing, equipment, dosage, application frequency, reentry and preharvest restrictions, geographic limitations, and selected limitations to use. Data are extracted by product but may be aggregated by active ingredient. The system currently focuses on information needed to support reregistration. Additional information (e.g., pests, more use limitations) will be added to the system to support special reviews and other reregistration activities. MAINTENANCE FEE - An annual fee required of registrants for each pesticide product retained for registration. MANUFACTURING-USE PRODUCT - A Manufacturing-Use Product (MP or MUP) is any product intended (labelled) for formulation or repackaging into other pesticide products. MARGIN OF SAFETY/MARGIN OF EXPOSURE - The Margin of Safety/Margin of Exposure (MOS/MOE) is a numerical value that characterizes the amount of safety to a toxic chemical -- a ratio of exposure to a toxicological endpoint, usually the NOEL. MASTER RECORD IDENTIFICATION NUMBER - See MRID Number. "ME-TOO" PRODUCT - An application for registration of a pesticide product that is substantially similar or identical in its uses and formulation to products that are currently registered. See Chapter 6, D., Question 1 of this manual for a more detailed discussion of a "me-too" product. MICROBIAL PESTICIDES - Microbial pesticides are microorganisms and include but are not limited to bacteria, algae, fungi, viruses, and protozoa used as pest control agents (40 CFR 152.20). MISCIBLE - Capable of being mixed. Often used to describe certain pesticide formulations. MOS/MOE - See Margin of Safety/Margin of Exposure. MP- See Manufacturing-Use Product. MRID NUMBER - The Master Record Identification (MRID) Number is a unique cataloging number assigned to an individual study at the time of submission to the Agency. It is EPA's system of tracking studies used in support of pesticide product registration. MUP - See Manufacturing-Use Product. NACA - The National Agricultural Chemicals Association (NACA). NARA - The National Agrichemical Retailers Association. NAS - The National Academy of Sciences (NAS). NASDA - The National Association of State Departments of Agriculture. NATIONAL ACADEMY OF SCIENCES - See NAS. NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION - See NACA. NATIONAL COALITION AGAINST THE MISUSE OF PESTICIDES - The National Coalition Against the Misuse of Pesticides (NCAMP). NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES - As part of the National Institute of Health, the National Institute for Environmental Health Sciences (NIEHS) performs basic research, including genetic and cancer studies, that relates to environmental health sciences. NATIONAL PEST CONTROL ASSOCIATION - The National Pest Control Association (NPCA). NATIONAL PESTICIDE INFORMATION RETRIEVAL SYSTEM - The National Pesticide Information Retrieval System (NPIRS), located at Purdue University, is the commercially-available version of the Pesticide Product Information System (PPIS). In addition to PPIS information, NPIRS also includes Pesticide Document management System data (e.g., MRID number, study title, title page from submitted study). Also see Pesticide Product Information System. NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK - The National Pesticide Telecommunications Network (NPTN), located at Texas Tech University, is a network from which the public can get answers to their pesticide-related questions by calling a toll-free phone number (1-800-858-7378) that is funded by EPA. NATIONAL TECHNICAL INFORMATION SERVICE - (NTIS). An organization that sells certain government publications including EPA documents such as testing guidelines. Orders can be placed at NTIS, Attention: Order Desk, 5285 Port Royal Road, Springfield, VA 22161. Telephone: (703) 487-4650. NATURAL RESOURCES DEFENSE COUNCIL - The Natural Resources Defense Council (NRDC). NCAMP - See National Coalition Against the Misuse of Pesticides. NEW CHEMICAL - An application for registration of a product containing a new pesticide (active ingredient) that is not an active ingredient in a product currently registered with the Agency (40 CFR 152.114). NEW USE - An application for registration of a use for an active ingredient(s), or formulation type, not currently included in the directions for use of any product that contains such active ingredient(s) or formulation type. When used with respect to a product containing a particular active ingredient "New Use" means (1) any proposed use pattern that would require the establishment of, increase in, or exemption from the requirement of a tolerance or food additive regulation under section 408 or 409 of the FFDCA; (2) any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern; or (3) any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure, to the active ingredient of man or other organisms. (See 40 CFR 152.3(p)). NIEHS - See National Institute for Environmental Health Sciences. NOAEL - No Observable Adverse Effect Level. NOEC - No Observed Effects Concentration. NOEL - No Observed Effects Level. NOIC - The Notice of Intent to Cancel (NOIC). NOIS - The Notice of Intent to Suspend (NOIS). NOMINAL CONCENTRATION - The amount of an ingredient which is expected to be present in a typical sample of a pesticide product at the time the product is produced, expressed as a percentage by weight. NO OBSERVED ADVERSE EFFECT LEVEL - See NOAEL. NO OBSERVED EFFECT CONCENTRATION - See NOEC. NO OBSERVED EFFECT LEVEL - See NOEL. NOTICE OF INTENT TO CANCEL - See NOIC. NOTICE OF INTENT TO SUSPEND - See NOIS. NPCA - See National Pest Control Association. NPIRS - See National Pesticide Information Retrieval System. NPTN - See National Pesticide Telecommunications Network. NRDC - See Natural Resources Defense Council. NTIS - See National Technical Information Service. OCCUPATIONAL AND RESIDENTIAL EXPOSURE BRANCH - The Occupational and Residential Exposure Branch (OREB), within the Health Effects Division (HED) of the Office of Pesticide Programs (OPP) is responsible for review and evaluation of data in the exposure of people to pesticides. OCCUPATIONAL SAFETY BRANCH - The Occupational Safety Branch (OSB) within the Field Operations Division (FOD) of the Office of Pesticide Programs (OPP) develops and recommends Agency policy and implements a strategy for pesticide occupational safety programs. Through cooperative agreements, grants, or contracts, OSB manages external efforts that contribute to a better understanding of the phenomena of worker exposure to pesticides, the health problems created, and identification and demonstration of practicable and effective means to reduce exposure. OCM - The Office of Compliance Monitoring. OD - Office Director. ODW - Office of Drinking Water (ODW) is the former name of the Office of Drinking Water and Ground Water. The Office of Drinking Water and Ground Water promulgates drinking water standards (MCLs) and/or issues Health Advisories for pesticides known or suspected to contaminate groundwater. OECD GUIDELINES - Guidelines prepared by the Organization of Economic and Cooperative Development of the United Nations; these guidelines assist in the preparation of protocols for toxicological, environmental fate, etc. studies. OES - The Office of Endangered Species (OES) is part of the Fish and Wildlife Service of the Department of Interior. OFFICE OF DRINKING WATER - See ODW. OFFICE OF DRINKING WATER AND GROUND WATER - See ODW. OFFICE OF ENDANGERED SPECIES - See OES. OFFICE OF PESTICIDE PROGRAMS - The Office of Pesticide Programs (OPP) and the Office of Pollution Prevention and Toxics comprise the two offices within the Office of Prevention, Pesticides, and Toxic Substances. OPP is comprised of seven Divisions: the Biological and Economic Analysis Division (BEAD); the Environmental Fate and Effects Division (EFED); the Field Operations Division (FOD); the Health Effects Division (HED); the Program Management and Support Division (PMSD); the Registration Division (RD);and the Special Review and Reregistration Division (SRRD). OLTS - The On-Line Tracking System (OLTS) is a computerized tracking system used to track data review records. OLTS was replaced by the Pesticide Registration Activity Tracking System (PRATS). See PRATS also. OMB - The Office of Management and Budget. ON-LINE TRACKING SYSTEM - See OLTS and PRATS. OPM - The Office of Personnel Management. OPP - See Office of Pesticide Programs. OREB - See Occupational and Residential Exposure Branch. ORGANIZATION OF ECONOMIC AND COOPERATIVE DEVELOPMENT - An organization of the United Nations that prepares guidelines that assist in the preparation of protocols for toxicological, environmental fate, etc. studies. Also see OECD Guidelines. OSB - See Occupational Safety Branch. PAG - Pesticide Assessment Guidelines (PAG) are protocols referenced in 40 CFR 158 that provide registrants with guidance on how to conduct required studies. Copies of the Guidelines can be obtained from the National Technical Information Service. PAI - A Pure Active Ingredient (PAI) is a test substance required for certain pesticide studies. PAIs do not have inert ingredients added. PBA - A Preliminary Benefit Analysis (PBA) is a summary of a pesticide's uses and benefits; developed by the Biological and Economic Analysis Division (BEAD) of the Office of Pesticide Programs (OPP) for the preliminary determination (PD 2/3) stage of a Special Review. PCO - Pest Control Operator. A term not employed by FIFRA which is often used to describe a person or company that applies pesticides as a business (e.g., exterminator); often used to describe such a service for household applications as compared to agricultural applications. PDMS - The Pesticide Document Management System (PDMS) is a collection of documents of regulatory significance to pesticides, including submitted studies, maintained by the Agency. The documents are microfiched and indexed by an on-line retrieval system that anyone in the Office of Pesticide Programs (OPP) can use. PES - The Planing and Evaluation Staff (PES) within the Biological and Economic Analysis Division (BEAD) of the Office of Pesticide Programs (OPP)is primarily responsible for formulating BEAD budgets and program plans, administrative management, science integration and program evaluation, and coordination of preparation for hearings. PEST - any insect, rodent, nematode, fungus, weed, or any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) that is injurious to health or the environment. (See FIFRA section 2(t) and 25(c)(1). PEST CONTROL OPERATOR - see PCO. PESTICIDE - Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant. PESTICIDE ASSESSMENT GUIDELINES - see PAG. PESTICIDE DOCUMENT MANAGEMENT SYSTEM - See PDMS. PESTICIDE INCIDENT MONITORING SYSTEM - The Pesticide Incident Monitoring System (PIMS) is a collection of human and environmental poisoning events related to specific pesticides that were reported to the Office of Pesticide Programs (OPP). PIMS was discontinued in 1981 due to budgetary constraints and the unverifiable nature of its data; it was based on volunteered information. PESTICIDE INTERMEDIATES: See Intermediates. PESTICIDE PRODUCT INFORMATION SYSTEM - The Pesticide Product Information System (PPIS) is a data base that provides information on more than 60,000 currently and formerly federally registered pesticide products and other non-pesticide chemicals. For each federally registered product, PPIS can provide the product name, registrant name and address, EPA registration number, type of formulation, signal word, types of pesticide activity, active ingredient names and percentages, application sites, and pests controlled. PPIS also contains information on whether the product has been classified for restricted or general use. PESTICIDE REGISTRATION ACTIVITY TRACKING SYSTEM - See PRATS. PESTICIDE REGULATION NOTICE - See PR Notice. PHI - The Pre-harvest Interval (PHI) is the time between the last pesticide application and harvest of the treated crop. PIMS - See Pesticide Incident Monitoring System. PLANNING AND EVALUATION STAFF - See PES. PM - Product Manager. See Product Manager Team. PMSD - The Program Management and Support Division (PMSD) is one of the seven Divisions that constitutes the Office of Pesticide Programs (OPP). PMSD provides administrative support to all OPP Divisions; prepares program plans and budget proposals; manages the indemnification process; and provides overall leadership for OPP management program. PMSD is comprised of four branches: the Administrative Branch (AB); the Resources Management and Evaluation Branch (RMEB); the Information Services Branch (ISB); and Systems Branch (SB). POLICY AND SPECIAL PROJECTS STAFF - The Policy and Special Projects Staff (PSPS) within the Office of Pesticide Programs (OPP) serves as the Office Director's primary means for analyzing and responding to external critiques of program activities and policies. PPIS - See Pesticide Product Information System. PRATS - The Pesticide Registration Activity Tracking System (PRATS) is an on-line tracking system to monitor the science reviews of data submissions. PRATS is also used to request actions (e.g., risk assessments, DRES runs, etc.) from the science divisions. PRATS replaced the On-Line Tracking System (OLTS). PRE-HARVEST INTERVAL - See PHI. PRELIMINARY BENEFIT ANALYSIS - See PBA. PR NOTICE - A Pesticide Regulation (PR) Notice is a written notice generally issued by the Registration Division to pesticide registrants that communicates important changes in regulatory policy or procedures. Each PR Notice is assigned a two part number beginning with the year issued and the cardinal number issued within that year (e.g., 87-1, 87-2, 92-1, etc.). The name of the notice derives from the Pesticide Regulation Division, a precursor organization to the Registration Division of the Office of Pesticide Programs. PRODUCT MANAGER TEAM - PM Team - An organizational unit in each of the three Registration Division Product Branches which is primarily responsible for processing applications for new and amended product registration, petitions for tolerances, experimental use permits, special local need applications, and reregistration of currently registered pesticides. There are currently 11 PM Teams, each headed by a product manager and staffed by 4 - 7 reviewers. Each PM Team has a number (e.g., PM 10; PM 21; PM 31). There are currently five teams in the Insecticide- Rodenticide Branch, four teams in the Fungicide-Herbicide Branch, and two teams in the Antimicrobial Branch. PROGRAM MANAGEMENT AND SUPPORT DIVISION - see PMSD. PROTOCOL - A study plan or method. PSPS - See Policy and Special Projects Staff. PURE ACTIVE INGREDIENT - See PAI. RAC - See Raw Agricultural Commodity. RAF - See Risk Assessment Forum. RAW AGRICULTURAL COMMODITY - Raw Agricultural Commodities (RAC) include, among other things, fresh fruits, whether or not they have been washed and colored or otherwise treated in their unpeeled natural form; vegetables in their raw or natural state, whether or not hey have ben stripped of their outer leaves, waxed, prepared into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats, and similar agricultural produce. It does not include foods that have ben processed, fabricated, or manufactured by cooking, freezing, dehydrating, or milling. RB - The Reregistration Branch (RB) within the Special Review and Reregistration Division (SRRD) of the Office of Pesticide Programs (OPP) manages the reregistration process that provides for the review of all List A pesticides. Management of the process includes planning, scheduling, and coordinating Health Effects Division (HED), Environmental Fate and Effects Division (EFED), Program Management and Support Division (PMSD), and Biological and Economic Analysis Division (BEAD) inputs, conducting the administrative review, and preparing and issuing documents. These documents include Reregistration Eligibility Documents (REDs) and Tolerance Reassessments. RCRA - The Resource Conservation and Recovery Act (RCRA) is a law under which EPA regulates the transportation, storage, and disposal of hazardous waste. it is implemented by the Office of Solid Waste and Emergency Response's Office of Solid Waste. RD - Registration Division of the Office of Pesticide Programs. The Registration Division is primarily responsible for implementing the provisions of FIFRA relating to the registration of pesticide products. REBUTTABLE PRESUMPTION AGAINST REGISTRATION - Rebuttable Presumption Against Registration (RPAR) is the former name for Special Review. RED - Reregistration Eligibility Document (RED) - A document issued at the completion of the Agency's reregistration review of a registered pesticide active ingredient. The RED sets forth the Agency's decision on whether products containing a pesticide are eligible for reregistration. The RED also assesses the acceptability of existing tolerances, and describes the need for additional data or other information. It is accompanied by a data call-in if additional data are required. REENTRY INTERVAL - The Reentry Interval (REI) is the time required before human reentry without protective clothing to an area which has been treated with a pesticide; required in order to reduce or avoid real or perceived toxicity risks to field workers. REFERENCE DOSE - The Reference Dose (RfD) is an estimate of the acceptable daily exposure of humans to a pesticide. RfDs are derived for the noncarcinogenic effects of substances which may also be carcinogenic. Formerly called the acceptable daily intake (ADI). REGISTRANT - The term given to a person or entity that has registered a pesticide product under FIFRA. REGISTRATION DIVISION - See RD. REGISTRATION NUMBER - The EPA registration number is a hyphenated, two part number assigned by the Registration Division to identify each product registration (e.g., 1253-79); the first number is the assigned company number and the second number is the specific product number. The registration number is required by FIFRA to appear on the product's label. REGISTRATION PROCESS - The process and final Agency action authorizing the legal sale, distribution, and use of a pesticide product. The process includes OPP's consideration of scientific, legal, and regulatory requirements of the product and results in the Agency issuing either a Notice of Registration or a denial to the applicant. REGISTRATION STANDARD - Registration Standard (RS) is a document issued in connection with the Agency's reregistration program prior to the enactment of FIFRA '88 that characterizes a pesticide's available scientific data base and the Agency's position on the registered uses of that pesticide. Registration Standards were accompanied by data call-ins requiring submission of additional data. All chemical cases that had Registration Standards issued prior to the enactment of FIFRA '88 are on reregistration List A. REGISTRATION SUPPORT BRANCH - The Registration Support Branch (RSB) within the Registration Division (RD) of the Office of Pesticide Programs (OPP) is responsible for: the emergency exemption program under section 18 of FIFRA; review of state issued section 24(c) special local needs registrations; the clearance requests for exemption from a tolerance for inert ingredients; the tolerance revocation program; the management and coordination of minor or specialty use tolerance petitions submitted under the Federal Food, Drug, and Cosmetic Act; and child-resistant packaging. REI - See Reentry Interval. REREGISTRATION - Section 4 of FIFRA requires EPA to reregister all pesticides originally registered before 1984 on specified timetables. Reregistration priority is given to chemicals with the highest potential for exposure -- high-volume and food-use chemicals (i.e., List A chemicals). Through this priority process, four lists of pesticides (Lists A, B, C, and D), were established under FIFRA '88. The reregistration process consists of: the Agency identifying the studies necessary to conduct human health and environmental risks assessments; obtaining and reviewing these studies; and determining whether the pesticide's uses do not pose unreasonable adverse risks. Also see Reregistration Branch; Accelerated Reregistration Branch; Data Call-In; and List A, B, C, and D Pesticides. REREGISTRATION BRANCH - See RB. REREGISTRATION ELIGIBILITY DOCUMENT - See RED. RESIDENTIAL USE - Pesticide application in and around houses, apartment buildings, motels, and other living areas. RESOURCE MANAGEMENT AND EVALUATION BRANCH - The Resource Management and Evaluation Branch within the Program Management and Support Division (PMSD) of the Office of Pesticide Programs (OPP) provides overall management, direction, guidance, and support to divisions and offices on the development and implementation of program and budget plans. RESTRICTED USE PESTICIDE - (RUP) - If the Agency determines that a pesticide, when applied in accordance with its labeling or in accordance with widespread and generally recognized practices may generally cause, without additional restrictions, unreasonable adverse effects on the environment. EPA will classify the pesticide or the particular use or uses to which the determination applies for restricted use. Restricted-use pesticides may generally be applied only by trained, certified applicators or those under their direct supervision, and may be subject to other regulatory restrictions. RESOURCES CONSERVATION AND RECOVERY ACT - See RCRA. REVIEW MANAGER - A Review Manager (RM) is an employee in the Special Review Branch (SRB) or Reregistration Branch (RB) of the Special Review and Reregistration Division (SRRD) whose responsibility is to coordinate the review process for one or more pesticide chemicals. This includes leading review teams for pesticides or issues under review. RFD - See Reference Dose. RISK ASSESSMENT - In general, a risk assessment (RA) is a determination of the likelihood of a hazard to occur from population exposed to pesticide chemicals. This likelihood may be expressed as a numerical probability or as a margin of safety/margin of exposure. Simply stated: RISK = Hazard x Exposure. RISK ASSESSMENT COUNCIL - The Risk Assessment Council reviews the policy and procedural aspects of the Risk Assessment Forum's (RAF) technical findings. After approval by the RAC and the Administrator, the Forum's findings become policy. RISK ASSESSMENT FORUM - The Risk Assessment Forum (RAF) consists of Agency risk assessment (RA) expert scientists who study technical Agency-wide RA issues and refer their findings to the Risk Assessment Council. The RAF was established to promote consensus on RA issues within the Agency. RM - See Review Manager. RMEB - See Resource Management and Evaluation Branch. RPAR - See Rebuttable Presumption Against Registration. RS - See Registration Standard. RSB - See Registration Support Branch. RUP - See Restricted use Pesticide. SAB - The Science Advisory Board (SAB) is an Agency-wide series of committees that advises the Administrator on scientific issues. SACB - The Science Analysis and Coordination Branch (SACB) within the Health Effects Division (HED) of the Office of Pesticide Programs (OPP) coordinates and integrates human and domestic animal toxicological data along with dietary and non-dietary exposure to determine the risk for pesticides. SACS - The Science Analysis and Coordination Staff (SACS) within the Environmental Fate and Effects Division (EFED) of the Office of Pesticide Programs supports the assessment of environmental pesticide hazards by integrating individual discipline-specific review components into an overall statement of risk. The SACS also generally reviews EFED's scientific output, analyzes science policy issues, and recommends resolution of issues. SAFE DRINKING WATER ACT - The Safe Drinking Water Act (SDWA) requires the Agency to set health standards for water sources used for public drinking water systems. It directs the EPA administrator to develop: (1) National primary drinking water regulations that incorporate maximum contaminant levels; (2) Underground Injection Control regulations to protect underground sources of drinking water; and (3) Groundwater protection grant programs for the administration of sole source aquifer demonstration projects and for wellhead protection area programs. SAP - See FIFRA Scientific Advisory Panel. SARA - The Superfund Amendments and Reauthorization Act of 1986 (SARA) is the legislation that reauthorized the Superfund program in 1986. In addition, this law made several amendments to CERCLA and established the provisions for SARA Title III -- Emergency Planning and Community Right-to-Know. SB - The Systems Branch (SB) within the Program Management and Support Division (PMSD) of the Office of Pesticide Programs (OPP) is the central point within OPP for automatic data processing systems analysis and design. Services provided include: Automated Data Processing (ADP) facilities and hardware, data input, and retrieval support from the computerized data bases. SCIENCE ADVISORY BOARD - See SAB. SCIENCE ANALYSIS AND COORDINATION BRANCH - See SACB. SCIENCE ANALYSIS AND COORDINATION STAFF - See SACS. SDWA - See Safe Drinking Water Act. SECTION 18 - See FIFRA Section 18 (Emergency Exemption). SECTION 24(c) - See FIFRA section 24(c) (special local need). SELECTIVE METHOD OF SUPPORT - One of two methods by which an applicant for registration or amended registration may comply with the data compensation requirements of FIFRA section 3(c)(1)(F). Under this method the applicant lists the specific data requirements that apply to his or her product, its active ingredients, and use patterns, and demonstrates compliance with the data requirements by either submitting the actual studies, or citing individual studies, or by demonstrating that no study has been previously submitted to the Agency (a data gap). SETAC - The Society for Environmental Toxicology and Chemistry (SETAC) is a professional society for environmental toxicologists and chemists; publishes a journal entitled Environmental Toxicology and Chemistry and sponsors symposia on various environmental issues that relate to toxicology and chemistry. SFIREG - The State FIFRA Issues, Research Evaluation Group (SFIREG) is a group of state regulatory officials who work with Office of Pesticide Programs (OPP) staff to identify and resolve overlapping state and federal regulatory and research issues. SLN - See FIFRA Section 24(c). SMALL BUSINESSES - The term "small business" in regard to eligibility for reduced registration maintenance fees means a business that employees 150 or fewer people and, during the three year period prior to the most recent maintenance fee billing cycle (i.e., December 31, 1990) had average annual gross revenue from chemical sales not exceeding $40 million, taking into account nay parents' and subsidiaries' employees and gross revenues. SOCIETY FOR ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY - see SETAC. SOLUTION - A formulation or use dilution of a pesticide that dissolves in the carrier liquid or diluent and will not settle out or separate in an aqueous medium. SOP - A Standard Operating Procedure (SOP) is a written procedure that conveys procedures for various functions performed by Office of Pesticide Programs (OPP) staff. SOPs address both technical and administrative matters. SPECIAL LOCAL NEED - See FIFRA Section 24(c). SPECIAL REVIEW - The purpose of the Special Review (SR), formerly known as Rebuttable Presumption Against Registration (RPAR), process is to help the Agency determine whether to initiate procedures to cancel, deny, or reclassify registration of a pesticide product because uses of that product may cause unreasonable adverse effects on the environment, in accordance with sections 3(c)(6) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The process is intended to ensure that the Agency assesses risks that may be posed by pesticides, and the benefits of use of those pesticides, in an open and responsive manner. The issuance of a Notice of Special Review means that the Agency has determined that one or more uses of a pesticide may pose significant risks and that, following completion of the Special Review process, the Agency expects to initiate formal proceedings seeking to cancel, deny, reclassify, or require modifications to the registration of the product(s) in question unless it has been shown during the Special Review that the Agency's initial determination was erroneous, that the risks can be reduced to acceptable levels without the need for formal proceedings, or that the benefits of the pesticide's use outweigh the risks. Following completion of the Special Review process, a pesticide in question may be returned to the registration process. Regulations pertaining to Special Review procedures are at 40 CFR 154. SPECIAL REVIEW BRANCH - The Special Review Branch (SRB) within the Special Review and Reregistration Division (SRRD) of the Office of Pesticide Programs (OPP) is responsible for managing the Special Review process for chemicals that have been placed in Special Review. The Special Review process provides a framework for risk/benefit reviews of pesticide products and preparation of documents stating the Agency's position (i.e., Position Documents). Subsequent action may include risk reduction measures, cancellation of some or all uses, emergency suspension/cancellation. SPECIAL REVIEW AND REREGISTRATION DIVISION - The Special Review and Reregistration Division (SRRD) is one of the seven Divisions that constitutes the Office of Pesticide Programs (OPP). It manages special reviews and reregistration of pesticide products; issues data call-ins related to the special review and reregistration processes; and issues position documents and follow-up reports. This Division is comprised of the immediate office staff and three branches: the Special Review Branch (SRB); the Reregistration Branch (RB); and the Accelerated Reregistration Branch (ARB). SR - See Special Review. SRB - See Special Review Branch. SRRD - See Special Review and Reregistration Division. STANDARD OPERATING PROCEDURES - See SOP. STATE FIFRA ISSUES, RESEARCH EVALUATION GROUP - See SFIREG. SUPERFUND AMENDMENTS AND REAUTHORIZATION ACT OF 1986 - See SARA. SUPPLEMENTAL REGISTRATION - Common term for a process through which a registrant may permit the distribution or sale of his or her registered product under another's name and address. Such distribution or sale is termed a supplemental distribution under EPA regulations at 40 CFR 152.132. Also called distributor registrations/products. A supplemental registration is identified by a three part number (e.g.,1342-6-2) in which the first and second numbers make up the primary registrant's registration number, followed by the third part which is the supplemental registrant's company number. SURROGATE DATA - Data from studies which involve test organisms on a test substance that are used to estimate the characteristics or effects on another organism or of another substance. SUSPENSION - Finely divided solid particles mixed in a liquid. SUSPENSION OF REGISTRATION - An action authorized under FIFRA section 3(c)(2)(B) or section 4 that temporarily halts further distribution and sales of a pesticide product. Suspension under 3(c)(2)(B) or section 4 is imposed because the registrant has failed to meet data submission requirements. The registrant can request a hearing to challenge the notice. Suspension can be lifted when the requirements are met. A suspension of registration also can be issued under FIFRA section 6(c) due to an imminent hazard. The registrant has the right to an expedited hearing on the question of whether an imminent hazard exists. Also see NOIS and Emergency Suspension. SYSTEMS BRANCH - See SB. TECHNICAL GRADE ACTIVE INGREDIENT - A Technical Grade Active Ingredient (TGAI) is the pesticide chemical in pure form (usually 95 - 100% active ingredient) as it is manufactured by a chemical company prior to being formulated (i.e., wettable powders, granules, emulsifiable concentrates). TECHNICAL GRADE PRODUCT - A registered manufactured-use product that is composed of technical grade active ingredient. TEP - A Typical End-use Product (TEP) is a term used in data requirements to convey direction to a data producer to use a commonly used end-use product as the test substance. TGAI - See Technical Grade Active Ingredient. THE ACT - In this manual this term refers to FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act). THEORETICAL MAXIMUM RESIDUE CONTRIBUTION - The Theoretical Maximum Residue Contribution (TMRC) is the theoretical maximum amount of a pesticide in the daily diet of an average human. This theoretical amount assumes that the diet is composed of all food items for which there are tolerance-level residues of the pesticide. The TMRC unit is expressed as mg (of pesticide)/kg (of body weight)/day. TMRC - See Theoretical Maximum Residue Contribution. TOLERANCE - The maximum permissible residue levels for pesticides in raw agricultural produce and processed foods. Whenever a pesticide is registered for use on a food or a feed crop, a tolerance (or exemption from the tolerance requirement) must be established. EPA establishes the tolerance levels, which are enforced by the Food and Drug Administration and the Department of Agriculture. Whenever a pesticide is registered for use on a food or feed crop, a tolerance or an exemption from the tolerance must be established. Established tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities are listed in 40 CFR Section 180; tolerances for food additives in food for human consumption are listed in 40 CFR Section 185; and tolerances for feed additives in animal feed are listed in 40 CFR Section 186. TOLERANCE PETITION - A formal request to establish a new tolerance or modify (raise, lower or revoke) existing tolerances. TOXIC SUBSTANCES CONTROL ACT - The Toxic Substances Control Act (TSCA) is a law administered by the Office of Pollution Prevention and Toxics that governs the manufacture processing distribution, use and disposal of chemical substances. Pesticides, tobacco and tobacco products, nuclear materials, foods, food additives, drugs and cosmetics are excluded from TSCA's coverage. TSCA - See Toxic Substances Control Act. TYPICAL END-USE PRODUCT - See TEP. USE INDEX - A compilation of everything on a label for each pesticide product including the sites the pesticide is used on and the application rate. The Use Index is prepared by the Biological and Economic Analysis Division (BEAD). VOLATILITY - The property of a substance to become a vapor or gas without chemical change. WATER SOLUBLE PACKAGING - Packaging that dissolves in water; this type of packaging is used to reduce exposure risks to mixers and loaders. "WEIGHT OF EVIDENCE" APPROACH - Evaluation based on a qualitative assessment of the available scientific evidence. WETTABLE POWDER - Wettable Powder (WP) is a dry formulation materials that must be mixed with water or other liquid before it is applied. WP - See Wettable Powder.