INDEX Page Active Ingredient (AI) Claiming formulator's exemption for...................6-16 Formulating products with unregistered source of......6-16 Requirement for registration..........................1-2 Acute toxicity data........................................2-18; 4-4 Additional brand names must not be false or misleading.......................4-13 Address of record..........................................2-2 Adjuvants..................................................1-3 Administrative amendments; types of Labeling changes......................................4-2 Formula changes.......................................4-2 Administrative portion of application for registration.....2-9 Administrative Processing Section, RSB, RD, OPP...........18-20 Agency screening of applications for expedited review......2-17; 4-8 Amendments to product registration.........................1-8 Not requiring a formal application Notifications....................................4-13 Requiring notification but not approval..........4-13 Labeling changes..............................4-13 Additional or substitution of brand names...4-13 Use of bilingual labeling...................4-15 Changes in warranty.........................4-15 Other labeling revisions....................4-15 Final printed labeling......................4-15 Product chemistry changes.....................4-17 Active ingredient...........................4-17 Inert ingredients...........................4-18 Starting materials for integrated system products.................................4-19 Change in formulation process...............4-19 Requiring a formal application "Me-Too" amendments..............................4-1 New use amendments...............................4-10 Labeling for.....................................4-22 Annual registration maintenance fees.......................8-1 Antimicrobial fuel additives Who to contact.......................................15-4 Antimicrobial Program Branch, RD, OPP.....................18-11; 18-18 Applicant's name...........................................2-2 Application for Experimental Use Permit (EPA Form 8570-17)....................................9-2 Application for Pesticide Amendment (EPA Form 8570-1)......2-2; 4-2; 4-10; 7-5 Application for Registration of Pesticide-Producing Establishments (EPA Form 3540-8).....................11-1 Application, transmittal of...............................12-4 Applications which Do not qualify for expedited review...................2-14 Qualify for expedited review..........................2-14 Authorized agent...........................................2-3 Bilingual labeling Use of................................................2-28 Biochemical pesticides.....................................2-1 Considerations for registration; general information..3-1 Exempt from registration..............................3-2 Biological control agents Not subject to FIFRA..................................1-4 Certification of products as Restricted Use................2-8 Certification with Respect to Citation of Data (EPA Form 8570-29)................................................2-7; 4-4; 4-11 Changes that can be made to a registration without notifying the Agency Changes in the net contents to accommodate changing package sizes or contents variability if such changes do not require changes in the use directions.........................................4-21 Correction of typographical or printing errors in labeling........................................4-21 Use of metric units in addition to standard U.S. units for net contents, dosages and other numeric expressions................................4-21 Redesign of label format that does not modify approved label text, consistent with 40 CFR 156.10 format requirements................................4-22 Revision, addition, or deletion of non-mandatory label elements.....................................4-21 Chemical pesticides........................................2-1 Child-resistant packaging.................................10-5 Certification relating to.............................2-7 Cite-all method of support.................................6-7; 6-14 Comparison with selective method of support...........6-23 Claims not allowed to be used on product labeling..........4-13 Classification of products as restricted use...............2-8 Collateral labeling........................................2-21 Completeness of applications for registration..............2-9 Completeness of applications for petitions for tolerance...7-4 Conditional registration...................................1-9 Confidential Business Information.........................12-1 How to submit........................................12-2 Information that can not be released to the public...12-1 Confidential Statement of Formula (EPA Form 8570-4)........2-3; 4-3 Contact.....................See "Who To Contact" in this Index Contents of an application for registration................2-2 Data Chemicals for which waivers have been granted........16-3 Compensation charges/payment disputes.................6-10 Compensation requirements.............................2-5; 6-1 In support of products first registered after 9/30/78.................................6-2 Regarding data submitted after 12/31/69..........6-2 Methods for complying with; The cite-all method of support..............6-7 The selective method of support.............6-8 Compensation procedures applicable to Applications for an amendment of a registration..................................6-2 (Also see "Data compensation procedures do not apply".) Applications for registration of a new product...6-2 Compensation procedures not applicable to Applications adding or deleting deliberately added inert ingredients.......................6-3 Applications adding or deleting supplemental registrants (distributors)....................6-3 Applications to increase or decrease the percentage of one or more active ingredients or deliberately added inert ingredients.......6-3 Applications making a change in the package or container size................................6-3 Applications making a change in the product name, or adding an additional brand name......6-3 Applications making a change in the registrant's name and address.................6-3 Applications making a change in the source of supply of active ingredients..................6-3 Applications making a change in the warranty, warranty disclaimer, or liability limitation statements, or addition or deletion of such statements....................................6-3 Applications clarifying the directions for use...6-3 Applications correcting typographical errors.....6-3 Applications deleting an active ingredients......6-3 Applications to delete an approved use from the label.....................................6-3 Applications for experimental use permits........6-3 Applications to redesign the label format, which involves no substantive changes in the directions for use, claims, representations, or precautionary statements..6-3 Applications to revise the identity or amount of impurities in the product..................6-3 Applications for amendment where the Agency determines that scientific data would not be needed in order to approve the amendment...6-4 Applications "splitting" the label for the purpose of marketing the product in different geographic regions with appropriate labels, where each amended label will contain previously approved use instructions appropriate to a particular geographic region........................................6-3 Efficacy data requirements............................2-5; 2-11 Format for data.........................................2-4 for submittal package...........................12-3 for submitted studies...........................12-4 Generic...............................................2-11 How to submit........................................12-1; 12-2 In support of the petition for tolerance..............7-8 Number of copies required.............................2-4 Portion of Application for registration...............2-11 Requirements for efficacy.............................2-5 2-11 Requirements for experimental use permits.............9-5 Transmittal document.................................12-4 Data Matrix Chart..........................................4-4; 4-11 Designated U.S. agent......................................2-3 Devices Child-resistant packaging for........................10-5 Definition of.........................................1-4; 10-1 Establishment registration and reporting, books and records.......................................10-4 Importation and exportation of.......................10-4 Inspection of establishments.........................10-4 Labeling requirements................................10-2 Not subject FIFRA.....................................1-4; 10-2 Registration requirements for........................10-1 Subject to FIFRA.....................................10-1 Violations, enforcement activities and penalties.....10-4 Distributor product Labeling Must be same as basic registered product (see exceptions also)..............................5-2 Exceptions to being the same as the basic registered product............................5-2; 5-3 May not be repackaged.................................5-2 Must be produced, packaged, and labeled in a registered establishment operated by basic registrant.........................................5-2 Document Management Section, ISB, PMSD, OPP...............18-10 Documents Available from the Environmental Protection Agency...16-2 Available from the National Technical Information Service...........................................16-1 Available from the U.S. Government Printing Office...16-2 Dosage rate................................................2-2 Draft labeling.............................................2-4 Efficacy data Required for pesticide products that control pests of public health significance................4-2; 4-4; 4-11 Requirements for......................................2-5; 2-11 Emergency exemptions......................................14-4 Emergency Response and Minor Use Section, RSB, RD, OPP....18-11; 18-20 Enforcement................................................4-23 Environmental Protection Agency (EPA) Documents available from.............................16-2 EPA Regional Offices......................................18-28 Establishment number Application for......................................11-1 How to obtain........................................11-1 Information required.................................11-2 Where to obtain application forms....................11-2 Where to submit application: For Domestic establishments.....................11-1 For Foreign establishments......................11-2 Establishment of tolerance.................................2-1 Exclusive use data certification...........................6-5 Exemption from requirement of tolerance....................2-1 Expedited review Agency screening of applications for..................4-8 How to submit an application for......................4-6 Of "Me-Too" applications for amended registration.....2-14; 4-4 "Me-Too" Applications which do not qualify for........4-5 "Me-Too" Applications which qualify for...............4-5 Experimental Use Permits Application requirements..............................9-2 Data requirements for.................................9-5 Extension or renewal of...............................9-6 Fee requirements for..................................9-6 How to apply for......................................9-1 Labeling requirements for.............................9-6 Required for Animal treatments................................9-2 Aquatic use......................................9-2 Before conducting large scale field testing......9-1 Laboratory testing, greenhouse testing, or limited replicated field trials..............9-1 Land use.........................................9-1 Small scale field testing for "novel" microbial pesticides...................................9-2 Summary worksheet for.................................9-3 State issuance of....................................14-1 Tolerance requirements for............................9-5 Exportation of pesticides.........................................1-6 Facsimile directory.......................................18-27 FACTA......................................................2-5; 2-7; 4-1; 6-1 Federal Insecticide, Rodenticide and Fungicide Act (FIFRA)................................................16-2 State regulatory authority under.....................14-1 Federal Register Notices..................................16-4 Fees Annual registration maintenance.......................8-1 For experimental use permits..........................9-6 Requirements for SLNs................................14-2 Reregistration........................................8-2 Small businesses......................................8-1 Definition of small business................... .8-1 Tolerance petition....................................7-5; 7-6; 7-7; 8-2 Field Operations Division, OPP............................18-8 Final printed labels Submission of.........................................4-22 Food Additive regulation...................................2-1 Food, Agriculture, Conservation, and Trade Act of 1990 (FACTA).................................................2-5; 2-7; 4-1; 6-1 Foods Not subject to FIFRA..................................1-4 Format For Administrative Portion of Application.............2-33 For Data Portion of Application.......................2-33 For Restricted Use Product Label......................2-30; 2-31 For Unrestricted Use Product Label....................2-32 Forms How to obtain them...................................17-1 Formulator's Exemption Statement (EPA Form 8570-27)........2-10; 4-4; 4-11; 6-4 Front End Processing Staff, RSB, RD, OPP..................18-11; 18-19 Fungicide-Herbicide Branch, RD, OPP.......................18-11; 18-18 Generic data...............................................2-11 Government Printing Office (GPO) Documents available from.............................16-2 Guideline for determining an application's eligibility for fast track (expedited) review...........................2-15; 4-7 How to Amend the registration of a product...................4-1 Apply for an experimental use permit..................9-1 Apply for registration of a pesticide.................2-1 Apply for supplemental registration...................5-1 Obtain an EPA establishment number...................11-1 Obtain Forms.........................................17-1 Obtain publications..................................16-1 Submit an exemption from the requirement of a tolerance..........................................7-1 Submit "Me-Too" applications for expedited review.....2-15; 4-6 Submit notifications..................................4-20 Submit petitions for a tolerance......................7-1 Human drugs Not subject FIFRA.....................................1-4 Importation of pesticides.........................................1-6 Incomplete applications....................................2-11; 4-21 Incomplete petitions.......................................7-11 Inert ingredients..........................................1-6; 4-17 Information Resources Development Section, ISB, PMSD, OPP.18-10 Information Services Branch, PMSD, OPP....................18-10 Insect predators Not subject FIFRA.....................................1-4 Insecticide-Rodenticide Branch, RD, OPP...................18-11; 18-17 Intermediates..............................................1-4 Labeling Changes that cannot be submitted as a notification....4-13 Claims not allowed to be used on......................4-14 Deletions not permitted by Notification...............4-2; 4-15 Submission of final printed labeling for Notifications and non-notifications................4-22 For amendments requiring a formal application.........4-22 Requirements for experimental use permits.............9-6 Listing of Federally registered pesticide products classified as "Restricted Use Pesticides (RUP)...............16-3 Registration Standards issued........................16-3 Reregistration Eligibility Documents issued..........16-3 Macroscopic parasites Not subject to FIFRA..................................1-4 Material Safety Data Sheets (MSDS).........................2-29 Matrix format for data requirements listing Sample of.............................................6-29 "Me-too" registration Amendments that require supporting data...............4-3 Applications not qualifying for expedited review......4-5 Applications qualifying for expedited review..........4-5 Definition of.........................................2-1 Expedited review of "Me-Too" applications for amended registration...............................4-4 How to submit an application for expedited review.....4-6 "Me-too product"? , What is a.............................................6-11 Methods for complying with the data compensation requirements of FIFRA...................................6-7 Cite-all..............................................6-7 Selective.............................................6-8 Microbial pesticides.......................................2-1 Considerations for registration; general information..3-1 Considered under Level I reporting....................3-3 Considered under Level II notification for small-scale field testing..........................3-4 Exempt from registration..............................3-2 MRID number...............................................12-3 National Technical Information Service (NTIS) Documents available from.............................16-1 Nematodes Not subject to FIFRA..................................1-4 New chemical. Definition............................................2-1 New use. Definition............................................2-1 Amendments............................................4-10 Non-indigenous and genetically engineered microbial products Who to contact........................................15-5; 15-6 Non-notifications..........................................4-21 Notice of Supplemental Registration of Distributor (EPA Form 8570-5).......................................5-1 Notifications How to submit.........................................4-20 Label deletions not permitted by......................4-2; 4-15 Labeling changes that cannot be submitted as Actions concerning an unregistered product.......4-16 Addition of sites or uses........................4-16 Deletion of precautionary language or restrictions..................................4-16 Deletion of use patterns, pests, claims, or sites of use...............................4-16 Submission of final printed labeling for..............4-22 Not subject to FIFRA Biological control agents.............................1-4 Devices...............................................1-4 Foods.................................................1-4 Human drugs...........................................1-4 Insect predators......................................1-4 Macroscopic parasites.................................1-4 Nematodes.............................................1-4 Pheromones in pheromone traps.........................1-4 Preservatives for biological specimens................1-4 Treated articles......................................1-4 Vitamin-hormone horticultural products................1-4 Other types of registrations and/or approvals that may be needed from federal or state agencies other than EPA's pesticides program....................................15-1 Pest Definition of.........................................1-1 Pesticide Definition of.........................................1-1 Labeling requirements General guidance.................................2-22 Specific guidance Child hazard warning statement..............2-24 Company name and address....................2-23 Directions for use..........................2-28 Environmental hazard........................2-25 EPA establishment number....................2-23 EPA registration number.....................2-23 Hazard to humans and domestic animals.......2-25 Inert ingredients reclassified as active ingredients...............................2-24 Ingredients statement.......................2-23 Minimum type size...........................2-24 Misuse statement............................2-27 Name to be used in ingredient statement.....2-23 Net contents................................2-23 Nominal concentration.......................2-24 Physical or chemical hazard - flammability..2-26 Pounds per gallon statement.................2-23 Product name................................2-22 Reentry statement...........................2-27 Referral statement..........................2-25 Restricted use classification...............2-26 All uses restricted......................2-26 Some but not all uses restricted.........2-27 Side/back precautionary labeling............2-25 Signal word.................................2-24 Skull & crossbones and word "Poison"........2-25 Statement of practical treatment............2-25 Storage and disposal block..................2-28 Warnings and precautionary statements.......2-24 Registrations/approvals needed from other federal state agencies..................................15-1 Shipping (Transportation) of.........................15-5 State regulation of federally registered.............15-1 Use of in/on Antimicrobial fuel additives....................15-4 Beet sugar mills................................15-2; 15-4 Cane sugar mills................................15-2; 15-4 Food contact surfaces...........................15-2 Sanitizers.................................15-3 As Human and animal drugs.......................15-2; 15-3; 15-4 Medical devices.................................15-3 Antimicrobials.............................15-3 Microbials Non-indigenous and genetically engineered..15-5; 15-6 Paper and paperboard (food uses)................15-2 Microbiocides..............................15-3 Meat and poultry plants.........................15-1 Pesticide Intermediates....................................1-4 Petition for a tolerance How to submit an application to request...............7-1 Pheromones In pheromone traps; not subject to FIFRA..............1-4 Precautionary Labeling Review Section, RSB, RD, OPP.......18-11; 18-19 Pre-harvest interval (PHI).................................2-2 Preservatives For biological specimens; not subject to FIFRA........1-4 PR Notices................................................16-4 Product Chemistry Review Section, RSB, RD, OPP............18-11; 18-19 Product Manager Team 10...................................18-11; 18-17 Product Manager Team 13...................................18-11; 18-17 Product Manager Team 14...................................18-11; 18-17 Product Manager Team 18...................................18-11; 18-17 Product Manager Team 19...................................18-11; 18-17 Product Manager Team 21...................................18-11; 18-18 Product Manager Team 22...................................18-11; 18-18 Product Manager Team 23...................................18-11; 18-18 Product Manager Team 25...................................18-11; 18-18 Product Manager Team 31...................................18-11; 18-18 Product Manager Team 32...................................18-11; 18-18 Product specific chemistry data............................2-11 Project Coordination Section, RSB, RD, OPP................18-20 Publications How to obtain........................................16-1 Public Response and Program Resources Branch, FOD, OPP....18-8 Questions and answers about data compensation..............6-11 RED (Registration Eligibility Document)....................2-8 Listing of issued....................................16-3 Regional Offices - EPA....................................18-28 Region 1...........................................18-28 Region 2...........................................18-28 Region 3...........................................18-28 Region 4...........................................18-28 Region 5...........................................18-28 Region 6...........................................18-29 Region 7...........................................18-29 Region 8...........................................18-29 Region 9...........................................18-29 Region 10...........................................18-29 Regional Operations Branch, FOD, OPP......................18-8 Registration Changes allowed without Agency notification In the net contents to accommodate changing package sizes or contents variability if such changes do not require changes in the use directions............................4-21 Correction of typographical or printing errors in labeling............................4-21 Use of metric units in addition to standard U.S. units for net contents, dosages and other numeric expressions.....................4-21 Redesign of label format that does not modify approved label text, consistent with 40 CFR 156.10 format requirements........4-22 Revision, addition, or deletion of non-mandatory label elements..................4-21 Of a date that indicates date of manufacture or label approval.................4-22 Addition of State-required analysis of fertilizer component of pesticide- fertilizer products...........................4-21 Addition of State-required analysis of wood-preservative product.....................4-22 Inclusion of the DOT hazard diamond..............4-21 Inclusion of lot or batch codes, or other production identifiers........................4-21 Routine changes in the name and address of the registrant on the label.......................4-21 Of your own product...................................1-7 How to amend the registration of a product............4-1 Registration Division, OPP................................18-11 Registration Standard Listing of issued....................................16-3 Registration Support Branch, RD, OPP......................18-11; 18-19 Reregistration Eligibility Documents (REDs)................2-8 Listing of issued....................................16-3 Reregistration Fees........................................8-2 Restricted use Classification of products as.........................2-8 List of..............................................16-3 Screening of applications for expedited review.............4-8 Selective method of support................................6-8; 6-15 Comparison with cite-all method of support............6-23 Who has to cite or submit residue chemistry data?.....6-18 Small businesses Definition of.........................................8-1 Small-scale field testing Level I reporting requirements for....................3-3 Level II notification requirements for................3-4 Special Local Needs Fee requirements for.................................14-2 State registration of................................14-1 State agencies with lead pesticide responsibility.........18-30 Alabama.............................................18-30 Alaska..............................................18-30 American Samoa......................................18-30 Arizona.............................................18-30 Arkansas............................................18-30 California..........................................18-30 Colorado............................................18-30 Commonwealth of the Northern Mariana Islands........18-30 Connecticut.........................................18-31 Delaware............................................18-31 District of Columbia................................18-31 Florida.............................................18-31 Georgia.............................................18-31 Guam................................................18-31 Hawaii..............................................18-31 Idaho...............................................18-31 Illinois............................................18-32 Indiana.............................................18-32 Iowa................................................18-32 Kansas..............................................18-32 Kentucky............................................18-32 Louisiana...........................................18-32 Maine...............................................18-32 Maryland............................................18-32 Massachusetts.......................................18-33 Michigan............................................18-33 Minnesota...........................................18-33 Mississippi.........................................18-33 Missouri............................................18-33 Montana.............................................18-33 Nebraska............................................18-33 Nevada..............................................18-33 New Hampshire.......................................18-34 New Jersey..........................................18-34 New Mexico..........................................18-34 New York............................................18-34 North Carolina......................................18-34 North Dakota........................................18-34 Ohio................................................18-34 Oklahoma............................................18-34 Oregon..............................................18-35 Pennsylvania........................................18-35 Puerto Rico.........................................18-35 Republic of Palau...................................18-35 Rhode Island........................................18-35 South Carolina......................................18-35 South Dakota........................................18-35 Tennessee...........................................18-35 Texas...............................................18-36 Utah................................................18-36 Vermont.............................................18-36 Virginia............................................18-36 Virgin Islands......................................18-36 Washington..........................................18-36 West Virginia.......................................18-36 Wisconsin...........................................18-36 Wyoming.............................................18-37 State issuance of experimental use permits................14-1 State registration of special local needs.................14-1 State regulation of federally registered pesticides Who to contact.......................................15-1 State regulatory authority under FIFRA....................14-1 Grounds for EPA disapproval of State registrations...14-3 Shipping (Transportation) of pesticides...................15-4 Who to contact.......................................15-5 Statement of data confidentiality claims..................12-5 Statement of substantiality, similarity, or identicality...4-3 Studies Bind separately......................................12-5 Format of............................................12-3 Identifying supplements to previously submitted......12-5 What to include in...................................12-5 Submission of final printed labeling Notifications and non-notifications...................4-21 Amendments requiring a formal application.............4-22 Supplemental registration..................................1-8 How to apply for......................................5-1 Requirements for approval of..........................5-1 Timeframes for Agency response to expedited "Me-Too" applications 45 day response.......................................2-18; 4-9 90 day response.......................................2-19; 4-9 Tolerance Data in support of the petition for...................7-8 Establishment of......................................2-1 Exemption from requirement of.........................2-1 Fees Requirements for.................................7-8; 8-2 Adjusted annually................................7-9 For establishment of a new tolerance.............7-9 For establishment of a tolerance at a lower numerical level........................7-9 For an exemption from the requirement of a tolerance...............................7-9 For a temporary tolerance........................7-10 For a temporary tolerance exemption..............7-9 For waiver or refund request.....................7-8 How to submit an exemption from the requirement of a tolerance.......................................7-1 How to submit a petition for a tolerance..............7-1 Incomplete petitions..................................7-11 Procedures for filing a petition for..................7-4 Requirements for experimental use permits.............9-5 When required.........................................7-2 Transfer of Product registrations................................13-1 Data rights..........................................13-4 Treated articles Not subject to FIFRA..................................1-4 Types of pesticide registration Amendment to your own registration....................1-7 To distribute a product registered by someone else....1-8 Registration of your own product......................1-7 Unconditional registration.................................1-8 Use of bilingual labeling..................................2-4; 2-28 Use of pesticides in meat and poultry plants..............15-1 Application for USDA authorization...................15-2 Labeling requirements................................15-2 Who to contact.......................................15-2 Use of pesticides on food contact surfaces, for paper and paperboard (food uses), on medical devices, as human and animal drugs, and in cane-sugar and beet sugar mills...........................................15-2 Sanitizers (pesticides used on food contact surfaces).....................................15-3 Who to contact..............................15-3 Microbiocides in paper and paperboard (food use).15-3 Who to contact..............................15-3 Antimicrobial pesticides used on medical devices.15-3 Who to contact..............................15-3 Human and animal drugs...........................15-4 Who to contact..............................15-4 Cane-sugar and beet-sugar mills..................15-4 Who to contact..............................15-4 Vitamin-hormone horticultural products Not subject to FIFRA..................................1-4 What to include in a study................................12-5 When is an experimental use permit required................9-1 When is a petition for tolerance required..................7-2 Amended registration for use on food/feed crops.......7-2 Experimental use permit for food/feed crops...........7-2 Importation of pesticide treated food.................7-3 Inerts in products labeled for food use...............7-3 Adjuvants for application to food crops...............7-4 When must data compensation procedures be complied with....6-2 Where to hand deliver applications........................18-1 Where to mail applications................................18-1 Where to obtain application forms.........................11-2 Where to request a company number and establishment registration............................................5-3 Where to submit applications or resubmissions..............4-7; 4-8 Where to submit applications for expedited review..........2-17; 2-19 Where to submit applications for supplemental registration.5-3 Who must apply for registration of a pesticide.............1-1 Who to contact for assistance for: Antimicrobials (Antimicrobial Program Branch)........18-11 Data formatting requirements (Program Management and Support Division).................................18-10 Disinfectants (Antimicrobial Program Branch)........18-11 Document distribution (Program Management and Support Division).................................18-10 Document management (Program Management and Support Support Division).................................18-10 Freedom of Information (Field Operations Division)...18-8 Fumigants (Antimicrobial Program Branch)............18-11 Fungicides (Fungicide-Herbicide Branch)..............18-11 Herbicides (Fungicide-Herbicide Branch)..............18-11 Inert ingredient clearance (Registration Support Branch)...........................................18-11 Insecticides (Insecticide-Rodenticide Branch)........18-11 Minor use petitions (Registration Support Branch)....18-11 Precautionary labeling review (Registration Support Branch)...........................................18-11 Product chemistry review (Registration Support Branch)...........................................18-11 Regional Services (Field Operations Division)........18-8 Rodenticides (Insecticide-Rodenticide Branch)........18-11 Section 18 emergency exemptions (Registration Support Branch)...................................18-11