CHAPTER 4 - HOW TO AMEND THE REGISTRATION OF A PRODUCT THAT IS ALREADY REGISTERED A. GENERAL INFORMATION Except as provided below, any proposed modifications in the composition, labeling or packaging of a registered product must be submitted, with an application for amended registration (EPA Form 8570-1), to the Agency for prior approval. The application must contain the information required by 40 CFR 152.50, as applicable to the change requested. If an application for amended registration is required, the application must be approved by the Agency before the product, as modified, may be legally distributed or sold. B. AMENDMENTS THAT REQUIRE A FORMAL APPLICATION TO AMEND THE REGISTRATION OF YOUR PRODUCT The following types of amendments that you may wish to make to your product registration, require that you 1) submit a formal application to amend the registration of your product, 2) submit or cite supporting data, as applicable, and 3) address the data compensation requirements of FIFRA section 3(c)(1)(F) [formerly 3(c)(1)(D)] to the extent that they apply to your proposed amendment. 1. "Me-Too" Amendments - "Me-too" amendments are those that you wish to make to your product registration which include for example, the addition of uses, revised dosage rates, or application methods that appear on the labeling of other currently registered products that are substantially similar or identical to your product. Changes to your basic formulation, other than those identified in section C. of this Chapter, also require a formal application (EPA Form 8570-1) and Confidential Statement of Formula (EPA Form 8570-4) to amend your registration. Some of the more general types of "me-too" amendments are discussed below. As you read this information, you should refer to the appropriate Appendices which are located after section H of this Chapter. a. Administrative types of amendments - those amendments, for example labeling changes (such as a product name change) or revisions to your products formulation which do not require supporting data, require the following documentation. Refer to Appendix 4-1 which follows section H of this Chapter, for a schematic representation of what documentation is required with your application. 1) Labeling changes, other than those identified in section C., require an Application for Pesticide Amendment (EPA Form 8570-1), and 5 copies of the proposed labeling. Labeling changes must comply with current regulations, policies and format. (See Appendices 2-1 and 2-2) IMPORTANT NOTE: The deletion of use patterns, pests, claims, or sites of use from your registered labeling can no longer be accomplished as a Notification under PR Notice 88-6. The 1988 revisions to FIFRA [section 6 (f)], require the Agency to publish in the Federal Register, notice of receipt of requests to amend a registration by deleting one or more uses from the product labeling, in order to provide the public with knowledge of the potential loss of a product or a specific use of a product. This provision of the 1988 amended FIFRA supersedes this part of PR Notice 88-6. Your application to delete uses from your labeling must be submitted as a formal application to amend your registration. IMPORTANT NOTE: FIFRA section 6(F) does not apply when a registrant simply chooses to market a product with a subset of approved uses, but does not formally delete the uses from its registration. [40 CFR 152.130.] Guidance for the content and format of labels and labeling is provided in Appendix 2-1 and Figures 1 and 2, which are located after section H. of Chapter 2. 2) Formula changes, revisions to your basic formulation or alternate formula requests, other than those identified in section C., require an Application for Pesticide Amendment (EPA Form 8570-1), and a Confidential Statement of Formula (EPA Form 8570-4). Five (5) copies of draft labeling will be required if the formula revision results in a change in the ingredient statement on the label. IMPORTANT NOTE: Revisions to the formulation of pesticide products that control pests of public health significance, i.e., products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice, which routinely require the submission of efficacy data to support the revised formulation are not considered to be an administrative amendment. Refer to the following section on "me-too" amendments. b. "Me-too" amendments that require supporting data - as indicated in 1. above, these are amendments you want to make to your product, that already exists on another currently registered substantially similar or identical product. Refer to Appendix 4-2, which follows section H of this Chapter, for a schematic representation of what documentation is required with your application. Depending upon your proposed amendment, your application will require an administrative portion and a data portion. IMPORTANT NOTE: The discussion provided below concerning the information to be submitted with a "me- too" amendment is general in nature and does not cover all possible types of "me-too" amendments. If you have any questions as to what information should be submitted with your application, you should contact the appropriate Product Manager for your product. 1) Administrative portion - includes the following: - Application for Pesticide Amendment (EPA Form 8570-1) - Statement identifying the "substantially similar" or "identical" product (by EPA Registration No.) that is currently registered and is labeled for the change you are proposing for your product. - Confidential Statement of Formula (EPA Form 8570-4), if required. This is not normally required unless you are proposing a change in your formulation. - Five (5) copies of your proposed draft labeling.It would make the Agency's review go more quickly if you highlight those changes on your proposed labeling. A light colored felt tip marker could be used to highlight the proposed changes. - Certification with Respect to Citation of Data (EPA Form 8570-29). - Formulator's Exemption Statement (EPA Form 8570- 27), if needed. [This is not needed if you have already submitted it and the information is still current and if your source is registered and your application is not affected by PR Notice 91-8.] - Data Matrix Chart. Required if you elect to use the Selective Method of data compensation. The data required to support the application may be addressed by either submitting the actual data, or by referencing EPA's Master Record Identification (MRID) number on the Data Matrix Chart. 2) Data portion - includes the following data, as applicable: - Acute toxicity data - required if you propose a change in the precautionary labeling or the signal word for your product. - Efficacy (product performance) data - may be required if you are proposing to add a new pest to a pesticide product that controls pests of public health significance, i.e., products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice. In addition, changes to your basic formulation may require additional efficacy data. You may wish to contact the appropriate Product Manager to determine if additional efficacy data are needed to support your proposed amendment. - Use specific data - may be required if you choose not to compensate the original submitter of the data or if the data are exclusive use. IMPORTANT NOTE: When submitting data, 3 copies - properly bound and formatted in accordance with PR Notice 86-5 are required. Refer also to Chapter 12 of this manual for additional information on submitting data. c. Expedited Review of "Me-too" Applications for Amended Registration Section 3(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act requires EPA to expedite the review of "me-too" applications for registration, i.e., products that are "substantially similar" or "identical" to other EPA registered pesticide products. In addition, EPA is required to (1) notify the applicant within 45 days of receipt of the application whether or not the application is complete and, if it is found to be incomplete, deny it, (2) notify the applicant within 90 days after receiving a complete application if the application has been granted or denied, and (3) if the application is denied, notify the applicant in writing of the specific reasons for the denial. 1) Applications Which Qualify for Expedited Review "Me-too" applications for amended registration qualify for expedited registration under section 3(c)(3)(B) of FIFRA. A "me-too" application for amended registration is one that is "substantially similar" or "identical" to another EPA registered product, not only in the active and inert ingredients, but also bears the same use pattern(s) and essentially the same use directions as another currently registered product. You must provide the EPA Registration Number of the currently registered product you believe is "substantially similar" or "identical" to your product. A "me-too" application for amended registration would require only minimal supporting data (provided, of course, that the "me-too" registrant cites existing data for that use) depending on the type of amendment: product chemistry, acute toxicity, or efficacy data, as applicable. 2) Applications Which DO NOT Qualify for Expedited Review - EPA will not expedite applications for amended registration of products for which the formulation or labeling vary from that of currently registered products, i.e., it is not "substantially similar" or "identical" to another EPA registered product, unless the amendment is of a nature that review of scientific data would not be required [see FIFRA section 3(c)(3)(B)(i)(II)]. Some examples of products that may not be considered substantially similar are those which involve inerts that are (a) not currently included in registered products or (b) will change the precautions of those required for "similar" products; changed percentages of active ingredients; new pests; new dosage rates; different frequency and timing of applications; geographical locations other than those previously registered; new sites; and new methods of application. These types of changes may increase the risk to humans or the environment through increased exposure and therefore may require more data to assess the risks. - EPA will not expedite applications for amended registration of "me-too" products proposing an unregistered source(s) of the active ingredient, since extensive product chemistry and often toxicology data are required for these types of amendments. These data are more complex and require more time to review then the data associated with the "me-too" applications for amended registration described above in item 1. - EPA will not expedite applications to amend the labeling of your registered product to delete use patterns, pests, claims, or sites of use. The 1988 amendments to FIFRA require the Agency to publish in the Federal Register a notice of receipt of such amendments, in order to provide the public with knowledge of the potential loss of a product or a specific use of a product. 3) How to Submit Your "Me-too" Application for Expedited Review If you believe your "me-too" application for registration qualifies for amended expedited (fast track) review, you should print "EXPEDITE" at the top of the application above the words "Application for Pesticide Registration/Amendment" (EPA Form 8570-1). All applications must be on the EPA form 8570-1 which carries a red unique identification number in the upper right-hand corner. You must also identify in Section II of the application form, the EPA Registration Number and name of the product to which you believe your product is "substantially similar" or "identical". You must also enclose two self-addressed, stick-on labels for EPA to use in responding to your application. If you are resubmitting in response to an objection letter from EPA, your resubmission (on EPA Form 8570-1) must be marked "Expedite- Resubmission" at the top of the application form and must include a copy of EPA's objection letter. GUIDELINE FOR DETERMINING AN APPLICATION'S ELIGIBILITY FOR FAST TRACK REVIEW: Amendments are entitled to fast track review under two (2) conditions: 1) Any amendment (end-use product or manufacturing-use product) that does not require scientific review of data; 2) If minimal* data submitted with the amendment for an end-use product are for the purpose of confirming that the changed formula or label are identical or substantially similar to a currently registered pesticide cited in your amendment application. * Minimal data could include product chemistry, acute toxicity, or efficacy data. Note: If your original application qualifies for expedited review, a resubmission of that application will likely also qualify for expedited review. EXAMPLES OF AMENDMENTS THAT QUALIFY FOR FAST TRACK REVIEW - Any amendment which asserts that the proposed change in labeling or formula is not significant. - Either no data are required to be submitted or confirming chemistry/ acute/efficacy data are submitted to support the assertion. - Any administrative amendment (not requiring review of data). EXAMPLE OF AMENDMENTS THAT DO NOT QUALIFY FOR FAST TRACK REVIEW - Any amendment not identified above as qualifying for fast track review will be reviewed as a non-fast track submission. You must direct your application or resubmission to the appropriate address listed below and identify the type of application in the address by using the abbreviation shown below: (AMEND) - to amend a currently registered product By Mail: Document Processing Desk (AMEND)3 Office of Pesticide Programs (H7504C) U.S. EPA 401 M Street, S.W. Washington, D.C. 20460 By courier or hand delivery: Office of Pesticide Programs Document Processing Desk (AMEND)3 Room 258, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 4) Agency Screening of Your Application for Expedited Review A Front End Processing Staff (FEPS) unit has been formed to screen and process your application for amended registration. The FEPS will provide an initial screen of your application to determine if 1) it qualifies for an expedited review in accordance with section 3(c)(3)(B); and 2) it is a complete application, i.e., it contains the administrative information and/or applicable data identified in section B.1.b. of this Chapter; and 3) the data are in compliance with the data formatting requirements of PR Notice 86-5. If your application passes the initial screening process, it will be sent to the appropriate Product Manager Team for further processing. The Product Manager Team will screen the application again, to determine that it is indeed a "me-too" application which qualifies for the expedited review. In addition, for those amendments that require efficacy data to be submitted, i.e., antimicrobial products and vertebrate pest control products, the Product Manager Team will determine if these data requirements have been addressed. If the application is determined to be complete, the application will be placed in review. If it is determined to be incomplete, the deficiencies will be identified and the entire application will be returned. 5) Timeframes for Agency Response to Expedited "Me-too" Applications for Amended Registration a. 45 Day Response - Within 45 days of receipt of your application, EPA will notify you whether your application is complete or incomplete. If your application is determined to be complete, you will receive a letter acknowledging receipt. If your application is determined to be incomplete, you will informed in writing of what is needed to make the application complete. For an incomplete application, the entire application will normally be returned to the address of record or to the address on the self-addressed label, if provided. (It is your responsibility for notifying EPA of any changes in name or address, or of a change in designated agent, if any, to avoid correspondence being sent to the wrong address). If an application is too large to be easily mailed, EPA will contact you by telephone and request that the application be picked up within 10 days. If the application is not picked up within 10 days it may be destroyed. IMPORTANT NOTE: If it is determined that your application does not qualify for an expedited review, you will be notified and the application will be processed according to the regular review procedures. Resubmissions in response to an Agency denial letter will initiate a new 45/90 day response cycle. a. 90 Day Response - Within 90 days of receipt of your application which qualifies for expedited review, EPA will conduct a full review of the application and notify you of the results of the review. If the initial application was complete, the reviews are favorable and no additional information is required, the amendment will be accepted. If additional information is necessary in order to complete our review, the application will be denied and you will be notified in writing of the deficiencies. IMPORTANT NOTE: Although FIFRA requires EPA to review applications for expedited registration within 90 days of receipt, this turnaround time may not be met immediately due to a continuing backlog of applications. However, EPA is increasing automated resources, developing instructional aids (this manual is one of those aids) for applicants and making necessary procedural changes in order to eliminate the backlog and to meet the 90 day response time for expedited reviews as soon as possible. 2. New Use Amendments - These are amendments to add "new uses" to your product labeling that are not currently registered for the active ingredient or combination of active ingredients contained in your product, for example, a new food or feed use or a change in use pattern from indoor to outdoor use. New uses are defined in 40 CFR 152.3(p). Your application to amend your registration should contain an administrative portion and a data portion. Refer to Appendix 4-3 which follows section H of this Chapter, for a schematic representation of the types of documentation required with your application. Your proposed amendment will require an administrative portion and a data portion. IMPORTANT NOTE: The discussion provided below concerning the information to be submitted with a new use amendment is general in nature and does not cover all possible types of new use amendments. If you have any questions as to what information should be submitted with your application, you should contact the appropriate Product Manager for your product. You should also be aware that applications proposing the registration of the first food use for a previously registered active ingredient are subject to the screening procedures in PR Notice 86-4. Under these procedures if your application is determined to be incomplete your application will not be processed and will be returned. 1) Administrative portion of Amendment Application includes the following: - Application for Pesticide Amendment (EPA Form 8570-1). - Five (5) copies of your proposed draft labeling. In addition submit one (1) label clearly marked to show the addition(s), deletion(s), or change(s) you plan to make on your amended labeling. This marked up label can be done on a copy of your proposed label or on the label which was previously registered. It would make the Agency's review go more quickly, if you were to highlight your proposed changes with a light colored felt tip marker. IMPORTANT NOTE: All other parts of the label requiring prior EPA approval and not included in your proposed amended label must remain as previously accepted by the Agency. - Certification with Respect to Citation of Data (EPA Form 8570-29). - Formulator's Exemption Statement (EPA Form 8570-27). - Data Matrix Chart. Required if you elect to use the Selective Method of data compensation. The data required to support the application may be addressed by either submitting the actual data, or by referencing EPA's Master Record Identification (MRID) number on the Data Matrix Chart. 2) Data portion of Amendment Application - You should refer to 40 CFR sections 158.202 thru 158.740 to determine what data are required to support your proposed use. You may be required to submit data on both the technical grade of the active ingredient and on your formulated product. In addition, new food or feed uses will require a petition for a tolerance or an exemption from a tolerance. Refer to Chapter 7 of this manual for a discussion of tolerance petitions. IMPORTANT NOTE: Efficacy (product performance) data are routinely required to be submitted to support your proposed use if you are proposing a new product that controls pests of public health significance, i.e., products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice. However, for most uses, i.e., insecticides, fungicides, and herbicides, the Agency does not require that these data be submitted. Each registrant must, however, ensure through testing that its products are efficacious when used in accordance with label directions and commonly accepted pest control practices. In order to generate efficacy data for your proposed new use, it is usually necessary to conduct large scale testing. It is necessary to obtain an experimental use permit (EUP) in order to carry out this testing, and if a food or feed use is involved, temporary tolerances or exemption from tolerance are also required. Refer to Chapter 9 of this manual for a discussion of EUP's. You may wish to contact the appropriate Product Manager to determine if additional efficacy data and EUP's are needed to support your proposed amendment. IMPORTANT NOTE: When submitting data, 3 copies, properly bound and formatted in accordance with PR Notice 86-5 are required. Refer also to Chapter 12 of this manual for additional information on submitting data. C. AMENDMENTS THAT DO NOT REQUIRE A FORMAL APPLICATION TO AMEND THE REGISTRATION OF YOUR PRODUCT As provided in 40 CFR 152.46, there are certain changes or amendments that can be made to your registered product that do not require you to make a formal application to amend your registration, and are not subject to the data compensation provisions of FIFRA section 3(c)(1)(F). Refer also to PR Notice 88-6. 1. NOTIFICATIONS - Changes that you can make to your registered product that require Agency notification, but not approval. As provided in 40 CFR section 152.46(a), there are certain changes, or amendments, you may make to your registration, provided that you notify the Agency that you have made the change before the product with the changes is distributed or sold. You need not obtain Agency approval of such changes, or amendments, and you may distribute or sell the product, as changed, as soon as you submit your notification of the change to the Agency. You should note, however, that with each notification the Agency reserves the right to require that you submit a formal application for amended registration. If a formal application is required, the Agency will notify you and state the reasons for requiring a formal application for amended registration in lieu of your notification. If, as a result of our request you fail to submit a formal application for amended registration without good cause, the Agency may determine that the product is no longer in compliance with the requirements of FIFRA, and initiate cancellation proceeding under FIFRA section 6. In addition, you should be aware that your notification to the Agency is considered to be a report filed under FIFRA for the purposes of FIFRA section 12(a)(2)(M). In part, FIFRA section 12 (a)(2)(M) states that it is unlawful for you to distribute or sell your pesticide product, if you have knowingly falsified any part of any application for registration submitted to the Agency. a. LABELING CHANGES The following label revisions may be accomplished by notification. Notification of these changes must be accomplished by submission of an Application for Pesticide Registration/Amendment (EPA Form 8570-1) marked "Notification". 1) Addition or substitution of brand names. You may market your product under separate brand names provided you notify the Agency of the additional brand name(s) you intend to use. Each name must differ from the name of any other product that you have registered, so as to permit clear identification of the product in case of emergency. However, you should continue to refer to the product by its official name of record (i.e., the name of your product as it appears on the Notice of Registration, unless a product name change was approved by the Agency) in all correspondence with the Agency. IMPORTANT NOTE: The additional brand name must not be false or misleading. In accordance with 40 CFR 156.10(a)(5) and (b)(2), a product is considered to be misbranded if its labeling is false or misleading in any particular way. Accordingly, product names may not contain words such as i.e., "safe" or "natural" which are considered to be implied safety claims. In addition, product names may not contain words which imply additional unapproved uses or efficacy claims that are more promising than the product can actually produce, such as the kinds of pest the product will control, i.e., "ABC Fireant Control" where the product will not control fireants and fireant is not one of the pests on the product label; "XYZ Six Month Roach Spray", where there is no data to support the "six month" efficacy claim; or "AZ Total Control Insecticide" where the product does not offer total control. Where appropriate data exists to support such claims they may be submitted for consideration to the appropriate Product Manager as a formal application for amended registration. In addition, claims such as "professional strength", "extra strength" and similar statements may not be used on your product labeling, including in the product name. (Refer to PR Notice 91-7 for more information). Note that the addition of a brand name should not be confused with supplemental registration by a different company under agreement with you (Refer to Chapter 5 - Supplemental Registration). Also note that you may not change the actual product name of record (as opposed to the brand name) without making a formal application to amend your registration and receiving approval prior to sale or distribution. 2) Use of bilingual labeling. If bilingual labeling is not required by the Agency, you may add such text to your labeling after notification to the Agency. Implicit in a notification of bilingual labeling is an assurance that the bilingual text is an accurate translation of the English labeling text. The Agency recognizes that translating English language terms to Spanish may be a problem because Spanish terms from different parts of the Spanish speaking world may have a whole different meaning. Registrants should use the appropriate Spanish translation for their labeling. Note that the Agency believes the Spanish language translations to be used for "Caution", "Warning", and "Danger" are "Precaucion", Aviso", and "Peligro", respectively. 3) Changes in warranty. You may, after notification to the Agency, make changes in the warranties or warranty disclaimers on the label. 4) Other labeling revisions. You may, after notification to the Agency, make changes in labeling language consistent with 40 CFR Part 156, provided the changes do not involve changes in the ingredients statement, precautionary statements or directions for use. 5) Final printed labeling. After acceptance of a new product registration or labeling amendment, final printed labeling must be submitted before the product is sold or distributed. Such labeling may be submitted as a notification provided that three (3) copies of the final labeling are submitted which incorporate any labeling changes required by the acceptance letter. Final printed labeling is the label or labeling which will accompany the pesticide product when distributed or sold and includes not only the container label, but also all accompanying technical information, brochures, etc., but does not include the package of the product, unless the labeling is an integral part of the package. Final printed labeling for the Agency's files should be of a size that can be stored conveniently in 8 1/2 x 11 inch files. The label may be mounted or photoreduced to meet the size requirements provided the printing is legible and is of microfilm reproduction quality. Should photoreduction make any of the text illegible, the text must be typed out on an accompanying sheet of paper. Paste on labeling should be submitted as is, unless it requires photoreduction. Screen printed labeling should be printed by taping paper on the container as it goes through the printing process. The actual container should not be submitted. Embossed labeling should be photocopied. Unusual size labeling, such as large bags or boxes, must be photoreduced either in one reduction or in sections so that each section is 8 1/2 x 11 inches. IMPORTANT NOTE: The following labeling changes cannot be submitted as a notification. A formal Application for Amended Registration (EPA Form 8570-1) must be submitted for Agency approval. a) The deletion of use patterns, pests, claims, or sites of use from your registered labeling can not be accomplished as a notification. The 1988 revisions to FIFRA [section 6 (f)], require the Agency to publish in the Federal Register, notice of receipt of requests to amend a registration by deleting one or more uses from the product labeling, in order to provide the public with knowledge of the potential loss of a product or a specific use of a product. In order to delete uses from your labeling, other than for the distribution or sale of a product under labeling bearing any subset of any subset of the approved directions for use as provided for under 40 CFR 152.130, you must submit a formal application to amend your registration and receive Agency approval. b) Addition of sites or uses. c) Deletion of precautionary language or restrictions. d) Any actions concerning an unregistered product or an application for amended registration which has not been accepted by the Agency. b. PRODUCT CHEMISTRY CHANGES The following product chemistry changes may be accomplished by notification. Notification of these changes must be accomplished by submission of a revised Confidential Statement of Formula (EPA Form 8570-4), together with an Application for Pesticide Registration/Amendment Form (EPA Form 8570-1), marked "NOTIFICATION". 1) Active ingredient - You may change the source of an active ingredient in your product by notification to the Agency, provided that the alternate source(s) is an EPA-registered product. This applies whether the alternate source is purchased by you from another company, or is part of an integrated system [as defined in 40 CFR 158.153(g)] used by you. IMPORTANT NOTE: The following changes are not acceptable as notifications; a formal Application for Amended Registration (EPA Form 8570-1), and EPA approval must be obtained prior to sale and distribution: a. You may not make any change in the source of an active ingredient, or any other change in the formulation, This change will require a formal application for amended registration and Agency approval. b. You may not make any change in the source of an active ingredient which necessitates changing either the nominal concentration of a solvent or that of any other inert ingredient so that it would exceed its certified limits. This would be considered an alternate formulation and require a formal application for amended registration and Agency approval. Such a change may result in significant changes in the toxicological or chemical properties of the product. c. You may not change to an unregistered source of an active ingredient without submitting a formal application for amended registration, with the required product chemistry data, and obtaining EPA approval prior to sale and distribution. d. You may not add, delete or substitute active ingredients by notification. The addition, deletion, or substitution of active ingredients constitutes a new formulation which requires a separate registration. e. You may not make a change in the stated nominal concentration of any active ingredient, or add certified limits not shown on the previously submitted Confidential Statement of Formula (EPA Form 8570-4). Such changes require a formal application for amended registration and Agency approval. 2) Inert ingredients a) If for any reason, you have been required by the Agency to identify the source of an individual inert ingredient whose identity and composition are known to you, you may change the source of that inert ingredient by notification to the Agency. If you have not been required by the Agency to identify the source of an individual inert ingredient, you may change sources freely, without notification to the Agency. b) You may change, by notification, the stated nominal concentration of any other inert ingredient provided the certified limits for that ingredient are not exceeded and the composition of the ingredient is known to you. IMPORTANT NOTE: Note particularly that all of the above changes in a), b), and c) are limited to inert ingredients whose complete identity or specific composition is known to you, such as specific solvents or common commodity diluents. Changes in proprietary ingredients, which generally are composed of a mixture of ingredients and whose composition is not disclosed to you, may not be made by notification but must be made by a formal application for amended registration and Agency approval. Since you do not know the composition of such inert ingredients, the Agency must determine its acceptability based upon information on its composition supplied by the producer. 3) Starting materials for integrated system products If you produce a product by an integrated system, [defined in 40 CFR 158.153(g)], you are required to supply the Agency with the sources of the starting materials for each such ingredient. If you propose to change the source of your starting materials, you may do so by notification to the Agency if the change will not result in: a) a significant increase in the level of any existing impurity of toxicological concern (to exceed the upper certified limit of that impurity), or b) the formation of any new impurity at a level greater than 0.1 percent by weight of the technical grade active ingredient. 4) Change in formulation process You may, by notification, modify a formulating operation [defined in 40 CFR 158.153(c)], i.e., a unit operation such as blending, diluting or drying, as distinguished from a unit process involving a chemical reaction, provided that the certified limits of the active and inert ingredients will not change as a result. c. HOW TO SUBMIT NOTIFICATIONS 1) To submit a notification, you must use the Application for Registration/Amendment Form (EPA Form 8570-1), and write the word "NOTIFICATION PER PR NOTICE 88-6" Prominently in the explanation part of Section II. A separate application (EPA Form 8570-1) must be submitted for each product registration for which you are submitting a notification. If a product chemistry notification is being made, a new Confidential Statement of Formula (EPA Form 8570-4) must accompany the notification application, together with a copy of the latest accepted Confidential Statement of Formula. If a labeling change notification is being made, the revised label text should be included as an attachment, including "before" and "after" text for comparison. On the "after" labeling, text which has been revised should be highlighted, preferably with a light colored felt tip marker, for easy comparison. A final printed label and the latest accepted labeling are required for this purpose. 2) Certification of Compliance - each notification must bear in Section II of the Application for Pesticide Registration/Amendment (EPA Form 8570-1) the statement "This is to certify that this notification meets every requirement of PR Notice 88-6". IMPORTANT NOTE: Only you, the registrant or your authorized agent may submit a notification. Each notification must be properly signed and dated. In accordance with 40 CFR 152.46(a) if the Agency determines that formal application for amended registration must be submitted rather than a notification your application will be returned and the Agency will require that it be resubmitted as a formal application for amended registration. You are also responsible for ensuring that the labeling of any distributor or supplementally registered product you may have is in compliance with FIFRA. (Refer also to 40 CFR section 156.10.) 2. NON-NOTIFICATIONS - Changes to your registration that can be made without notifying the agency. In accordance with 40 CFR section 152.46(b), the following changes can be made in the product's labeling or packaging without notification to or approval by the Agency: a. Correction of typographical or printing errors in the labeling. b. Changes in the net contents necessary to accommodate changing package sizes or contents variability, provided such changes would not require changes in the use directions, or the requirement for child-resistant packaging under 40 CFR Part 157, or other Agency requirements pertaining to size. c. The use of metric units in addition to standard U.S. units for net contents, dosages and other numeric expressions. d. Routine changes in the name and address of the registrant on the label. A registrant is required to keep the Agency current as to his address of record; therefore an address change necessitates informing the Agency. However, such changes may be made on labeling as soon as they occur. A separate letter must be sent to the Information Services Branch (ISB), Program Management and Support Division (PMSD), notifying the Agency of the changed company name and/or address. See Chapter 18 for the address. IMPORTANT NOTE: If you change your name and/or address, and fail to notify the Agency, and the Agency's good faith attempts to contact you are not successful, the Agency will issue in the Federal Register a notice of intent to cancel all of your products under FIFRA section 6(b). e. Revision, addition, or deletion of non-mandatory label elements, such as the following: 1) Inclusion of the DOT hazard diamond when a shipping container is also the immediate container offered for sale, 2) Addition of State-required analysis of the fertilizer component of a pesticide/fertilizer product, 3) Inclusion of lot or batch codes, or other production identifiers, or 4) A date that indicates date of manufacture or label approval. 5) Addition of State-required analysis of a wood- preservative product. IMPORTANT NOTE: Any statement directly or indirectly implying that the pesticide or device is recommended or endorsed by any agency of the Federal Government constitutes misbranding under FIFRA section (2)(q)(1)(A) and 40 CFR 156.10(a) (5)(v), and is a violation of section 12(a)(1)(F) of FIFRA. f. Redesign of label format that does not modify approved label text, consistent with the format requirements of 40 CFR section 156.10. These may include, among other things, changes in label color, type size or style, use of space, configuration or placement of label elements. IMPORTANT NOTE: Changes in color or type size should not reduce the readability of the labeling text or minimize the precautionary statements. D. SUBMISSION OF FINAL PRINTED LABELING When submitting final printed labeling for Notifications or Non-Notifications, you must use the Application for Registration/Amendment (EPA Form 8570-1). A separate application must be submitted for each product registration. Indicate the reason for the submission in the explanation part of Section II. 1. Notifications and non-notifications The final printed labeling for all notifications must be submitted before the product, as revised, is sold or distributed. The final printed labeling may be submitted as the notification, thereby requiring only one submission. The Agency expects that final printed labeling for a notification, or a formal amendment under FIFRA section 3, will include non-notification changes also. However, no submission of final printed labeling is required for changes that are only "non-notifications". 2. Labeling for amendments requiring a formal application to amend the registration After approval of an amendment based upon draft labeling, final printed labeling must be submitted before the product, as revised, is sold or distributed. The Agency expects that this final printed labeling will include non-notification changes that may have been made after submission of the approved draft labeling, but prior to printing the final printed labeling for submission to the Agency. E. INCOMPLETE APPLICATIONS If you submit an incomplete application, the processing of your application will not begin until the deficiencies are corrected. Incomplete applications will be returned, with the deficiencies identified, for correction. F. LEGAL COMPLIANCE - ENFORCEABLE You are reminded that you are entirely responsible for the content and accuracy of labeling, and for compliance with labeling requirements, whether or not the Agency chooses to review and approve labeling changes. Any product that is misbranded under FIFRA section 2(q), or that is in violation of FIFRA section 12 may be the subject of an enforcement action. G. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions or require any additional information as to whether the changes you propose to make under this chapter are appropriate, contact the Product Manager assigned to the product in question. A listing of Product Managers may be found in Chapter 18. If you have any questions concerning the status of your "Me- too" Application for Amended Registration within the 45 day timeframe for the Agency's notifying you of whether the application is complete or has been rejected, you should contact the Front End Processing Staff. Refer to Chapter 18 for the telephone number. H. REFERENCES CITED IN CHAPTER 4 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide registration and classification procedures Part 156 - Labeling requirements for pesticides and devices Part 157 - Packaging requirements for pesticides and devices Part 158 - Data requirements for registration 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988. Section 2 - Definitions Section 3 - Registration of pesticides Section 6 - Administrative review; suspension Section 12 - Unlawful acts 3. PR Notice 86-4 - Submission of Incomplete Applications for Registration of Pesticides Under Section 3 of FIFRA, Issued by the Registration Division, Office of Pesticide Programs, EPA, April 15, 1986. 4. PR Notice 88-6 - Change in Registration Procedures - Agency Approval Not Required for Certain Amendments. Issued by the Registration Division, Office of Pesticide Programs, EPA, August 12, 1988. 5. PR Notice 89-2 - Expedited Review of Applications for Registration or Amended Registration. Issued by the Registration Division, Office of Pesticide Programs, EPA, June 6, 1989. 7. PR Notice 91-5 - Instructions for Transmitting Information to the Office of Pesticide Programs. Issued by the Program Management and Support Division, Office of Pesticide Programs, EPA, September 6, 1991. 6. PR Notice 91-7 - False and Misleading Statements. Issued by the Registration Division, Office of Pesticide Programs, EPA, December 30, 1991. 7. PR Notice 92-3 - Pesticides and the Clean Air Act: Stratospheric Ozone Protection. Issued by the Office of Pesticide Programs, EPA, March 19, 1992. APPENDIX 4-1 TYPICAL ADMINISTRATIVE AMENDMENTS FOR A LABELING CHANGE OR A REVISION TO THE BASIC FORMULATION REQUIRE THE FOLLOWING DOCUMENTS A. AMENDMENT FOR AN ADMINISTRATIVE LABELING CHANGE: (DO NOT BIND DOCUMENTS OR PAGES TOGETHER) +-----------+ Application for Pesticide Amendment | o------ (EPA Form 8570-1) | |----+ | | |+ | | o---------- Draft labeling (5 copies) | | |||+ |DOCUMENT 1 | ||||+ +-----------+ |||||- -+ 1 marked up copy of label | ||||| o------ showing where additions, | ||||| | deletions, and changes |DOCUMENT 2 ||||| | have been made +-----------+|||| | +-----------+||| | +-----------+|| | +-----------+| | +-----------+ | +- - - - - - -+ B. AMENDMENT FOR REVISION TO YOUR BASIC FORMULATION *: (DO NOT BIND DOCUMENTS OR PAGES TOGETHER) +-----------+ Application for Pesticide Registration | o------- (EPA Form 8570-1) | |----+ | | | | | o------- Confidential Statement of Formula | | |-- -+ (EPA Form 8570-4) |DOCUMENT 1 | | |-+ +-----------+ | | |-+ | | | | |-+ |DOCUMENT 2 | o---|---|-------- Draft Labeling (5 copies), +-----------+ | | | | | if required | | | | | |- + |DOCUMENT 3 | | | | | | +-----------+ | | | | o------ (1 marked up copy of +-----------+ | | | | label if labels are +-----------+ | | | required) +-----------+ | | +-----------+ | +- - - - - - + --------------------------------------------------------------- * Revisions to the basic formulation for antimicrobial and vertebrate pesticide products generally require supporting efficacy (product performance) data, and are not considered to be administrative amendments. (Refer to Appendix 4-2) APPENDIX 4-2 A TYPICAL "ME-TOO" APPLICATION TO AMEND THE REGISTRATION OF A REGISTERED PRODUCT, REQUIRES THE FOLLOWING DOCUMENTS A. ADMINISTRATIVE PORTION OF APPLICATION: (DO NOT BIND DOCUMENTS OR PAGES TOGETHER) +-----------+ Application for Pesticide Amendment | o---------- (EPA Form 8570-1) | | | |----+ | | o------ Statement identifying the "substantially | | | similar" or "identical" product |DOCUMENT 1 | | +-----------+ |----+ | | o------------ Confidential Statement of |DOCUMENT 2 | |----+ Formula (EPA Form 8570-4), +-----------+ | | if required | | |+ | | ||+ |DOCUMENT 3 | |||+ +-----------+ o----------- Draft Labeling (5 copies) | |||| | | |||| o----- 1 marked-up copy of label |DOCUMENT 4 |||| |--+ +-----------+||| | | Certification with +-----------+|| | o------ Respect to Citation +-----------+| | | of Data (EPA Form +-----------+ | |---+ 8570-29) +-----------+ | |- - |DOCUMENT 5 | | | +-----------+ć | | Formulator's ----------------o | | Exemption Statement | | | (EPA Form 8570-27) |DOCUMENT 6 | o-------- Data Matrix +-----------+ | Chart |DOCUMENT 7 | +- - - - - -+ (Required under the selective method of support ONLY) B. DATA PORTION OF APPLICATION: (FORMAT AS DESCRIBED IN PR NOTICE 86-5) +- - - - - -+ | o-------------- Product Specific Acute | | + Toxicity Data * (3 copies) if required | | |-+ | | | | | | | |-- -+ | | | | | + |DOCUMENT 1 | | | | | + +- - - - - -+ | | | | | +- - - - - -+ | o--------- Efficacy Date * (3 copies) +- - - - - -+ | | | if required | | | | |DOCUMENT 2 | | | +- - - - - -+| | +- - - - - -+ | +- - - - - -+ ---------------------------------------------------------------- * Under the selective method of support these data requirements may be addressed by either submitting the actual data, or by referencing EPA's Master Record Identification (MRID) number on the Data Matrix Chart. APPENDIX 4-3 A TYPICAL APPLICATION TO AMEND THE REGISTRATION OF A REGISTERED PRODUCT TO ADD A NEW USE, REQUIRES THE FOLLOWING DOCUMENTS A. ADMINISTRATIVE PORTION OF APPLICATION: (DO NOT BIND DOCUMENTS OR PAGES TOGETHER) +-----------+ Application for Pesticide Amendment | o---------- (EPA Form 8570-1) | |----+ | | o---------- Draft labeling (5 copies) | | ||+ | | |||+ |DOCUMENT 1 | ||||+ +-----------+ ||||o------ 1 marked copy of label | |||||| |DOCUMENT 2 ||||||---+ Certification with Respect to +-----------+||||| o---------- Citation of Data (EPA Form +-----------+|||| | 8570-29) +-----------+||| | +-----------+|| |-----+ +-----------+| | | |DOCUMENT 3 | | +-----------+ |- - + | | | Formulator's ---------o | o--------- Data Matrix Chart Exemption Statement |DOCUMENT 4 | | (Required under the (EPA Form 8570-27) +-----------+ | Selective method of | | Support ONLY) |DOCUMENT 5 | +-----------+ B. DATA PORTION OF APPLICATION: (FORMAT AS DESCRIBED IN PR NOTICE 86-5) +-----------+ | |+ | o------------ Data as required by 40 CFR 158.202 thru | |||-- -+ 158.740 * (3 copies) | ||| |-+ | ||| o---|------ Efficacy Data * (3 copies) if required žDOCUMENT 1 ||| | | | +-----------+|| | | | +-----------+| | | | +-----------+ | | | |DOCUMENT 2 | | | +-----------+ | | +-----------+ | +-----------+ ---------------------------------------------------------------- * Under the selective method of support these data requirements may be addressed by either submitting the actual data, or by referencing EPA's Master Record Identification (MRID) number on the Data Matrix Chart.