(1) Within 60 days of the effective labeling should be mounted on 842 by date of $ 162.17, each registrant of a 11 inch paper. product registered solely under state (c) Final printed labels should also law must submit a notice of applica- be prepared for storage in 842 by 11 tion for federal registration on EPA inch files by mounting or by photoreForm 8570-8. Pending solicitation of a duction, where reduction would not full application for federal registration significantly impair readability. When and the final registration decision screen printing is used to print labeleither approving or denying the regis- ing directly on the container, do not tration application, the state regis- submit the container; copies may be trant may continue to sell and distrib- obtained by taping a piece of paper on ute the product subject to the require- the container as it goes through the ments of g 162.17(f).

printing process. Photocopies of em(2) Applications for federal registra- bossed labeling should be submitted. tion of products previously registered Paste-on labeling should be submitted solely under state pesticide registra- as is, unless it requires photoreduction tion laws will be solicited in batches of or mounting. products similar to each other in chemistry and broad use pattern, just

$ 162.45 Supporting data [8 162.8). as applications for reregistration. (a) Format. (1) Two full sets of all Before soliciting the applications for data submitted are required, and must federal registration of these products, be bound separately. A bound volume the Administrator will make similar of data should contain all individual findings as discussed immediately studies of a single data type, such as above for solicitation of applications environmental chemistry data or toxifor reregistration, provided that since cology data or efficacy data. For a list these products have not previously of data types see the face of the Applibeen registered by the EPA, thes cation for New Registration (EPA products will have to satisfy the data Form 8570-1). On the cover of each requirements for new registration. volume of data should be the product ($ 162.8(b)). However, the requirement name, EPA Registration Number or of $ 162.8(b)(2) for efficacy data may File Symbol (if known), the type of be waived on the basis of scientific data contained in the volume, and the data or findings and recommendations date of the submission. In the front of of a state or federal agency authorized each volume should be included in this by law to conduct pesticide research, order: pest control activities or programs for (i) A full table of contents; the protection of environmental qual- (ii) A copy of the application form; ity or natural resources. (8 162.17(a)). (iii) A copy of the labeling;

(iv) A tabular summary of the data $ 162.44 Labeling (88 162.10, 162.71–.76).

contained in the volume, on forms pro(a) As a general rule, labeling initial- vided by the Agency where approprily submitted with the application ate. should be in draft form. Final printed (2) When large amounts of data are labeling need not be submitted until contained in one volume, it may be the proposed labeling has been condi- necessary to subsection by tabbing tionally accepted by the Registration groups of data; for example, efficacy Division. If an applicant chooses, how- data by crop or geographical location, ever, he may submit final printed la- or human safety data by type of study. beling with his initial application. If The material must be page numbered. such labeling is unacceptable, the ap- The preferred pagination is a dual plicant bears full responsibility for numbering system, with a capital providing correct labeling.

Roman numeral indicate the (b) Draft labeling may be either volume number and Arabic numerals typewritten label text on 842 by 11 assigned consecutively within the inch paper or a mock-up of the label volume to indicate page numbers. prepared so that it can be stored in 842 (3) Section 10 of FIFRA, as amendby 11 inch files. Significantly smaller ed, provides that an applicant may

to

clearly mark any data considered con- waived and briefly state the basis for fidential and submit it separately. such waiver. This data may be separately identified (ii) Reregistration. The registrant by using different colored paper or by may submit written argument that a stamping each page Confidential.

data requirement should be waived or (b) Compensation for use of previ- the Administrator may initiate the ously submitted data in support of reg- waiver of a data requirement in the so

a istration (8 162.9) (Reserved).

licitation of an application for reregis(c) Waiver of data requirement tration, pursuant to the above stand(88 162.8(a)(3), 162.17(a))–(1) Stand- ard. If the applicant submits argument ard. The Regulations and Registration that a data requirement should be Guidelines set forth the data require- waived, the Administrator will considments for registration of a pesticide. er the argument submitted and proThe Agency recognizes that the indi- ceed in accordance with the procecated data requirements may not have dures discussed above for waiver of a taken account all relevant factors for data requirement for new registration. all pesticides. Therefore, a data re- If the Administrator waives a data requirement may be waived if it estab- quirement in the solicitation of an aplished that the composition, degrada- plication for reregistration, the notice bility, proposed patterns of use and of solicitation shall list any data resuch other chemical or physical prop- quirement which has been waived and erties of a specific pesticide, or prod- briefly state the basis for such waiver. uct relating to an evaluation of the ef- (iii) Intrastate products. The applifects on man or the environment are cant may submit written argument fundamentally different from the fac- that a data requirement should be tors considered by the Agency in the waived or the Administrator may initiestablishment of the data requirement ate the waiver of a data requirement of the Registration Guidelines.

in his notice to the applicant to submit (i) New registration. The applicant a full application for federal registramay submit written argument that a tion, pursuant to the above standard. data requirement should be waived If the applicant submits argument pursuant to the above standard. The that a data requirement should be Administrator will consider the argu- waived, the Administrator will considment submitted by the applicant and er the argument submitted and prosuch other information as may be ceed in accordance with the proceavailable to him, and make a written dures discussed above for waiver of a finding with respect to whether the data requirement for new registration. properties of the specific pesticide or If the Administrator waives a data reproduct are fundamentally different quirement in the solicitation of an apfrom the factors considered by the plication for full federal registration, Agency in establishing the data re- the notice of solicitation shall list any quirement of the Registration Guide- data requirement which has been lines. If the Administrator so deter- waived and briefly state the basis for mines, he may waive a data require- such waiver. ment of the Registration Guidelines (d) Rebuttable presumption against when he determines that the data so registration. (1) A rebuttable presumprequired is not necessary in order for tion against registration or continued him to determine whether such specif- registration arises if a pesticide meets ic pesticide product will generally or exceeds the criteria for risk of cause unreasonable adverse effects on 162.11(a)(3). Upon so determining, man or the environment. In the case the Administrator shall issue notice by of the approval of any application in certified mail to the applicant or regiswhich the Administrator has deter- trant stating that he may submit evimined to waive a data requirement dence in rebuttal of the presumption. specified in the Registration Guide- (8 162.11(a)(1)). The applicant or regislines, the notice of approval issued trant has 45 days to submit such evi. pursuant to 162.7(d)(2) shall list any dence; however, for good cause shown, data requirement which has been the Administrator may grant an addi.

resubmissions, renewals, petitions for (3) A File Symbol is a reference code tolerance, and, if necessary, cancella- composed of the applicant's company tions or suspensions. Exceptions in- number, followed by a dash and a clude enforcement case reviews, dis- letter or series of letters designating tributor brand applications, and ex- the individual product, for example, perimental use permits; even in these 9151-AER. All correspondence relating cases, the Product Manager is kept in- to the product must reference the File formed of actions affecting his prod- Symbol (or, if registered, the Registrauct. The Product Manager is the con- tion Number). trol point for information concerning (d) Completeness check (8 162.6(a) a particular product and all questions (5)). (1) The application then underor problems pertaining to an applica- goes a preliminary review to assure tion should be directed to him.

that all required materials and infor(2) The acknowledgment copy of mation are present and correct. A the application which is returned to review is also made of the chemistry of the applicant will have the Product the product. Manager's name and telephone (2) If deficiencies are found which number. The applicant should retain preclude further review of the applicathese, since both the Application for tion, or if it is incomplete in any reAmended Registration (EPA Form spect, the applicant will be notified as 8570-11) and the Resubmission of a soon as possible by the Product ManPesticide Product Application (EPA ager, either by telephone if the defiForm 8570-12) request that the name ciencies are minor and can be correctof the appropriate Product Manager ed easily, or by letter if extensive revi. be included on the form.

sion is necessary. in extreme cases, the (b) Notice of application (§ 162.26(b) entire application may be returned to (6)). The Administrator will publish in the applicant. the FEDERAL R ISTER notice of receipt (e) Scientific review. Complete apof an application for new or amended plications, together with accompanyregistration if the pesticide formula- ing labels and data, are routed to the tion contains any active ingredient not designated Product Manager and reregistered at the time of the applica- viewed to determine if the pesticide tion or if a changed use pattern is pro- and product labeling meet the require. posed. Section 162.6(b)(6) lists the con- ments of the Act, the Regulations, and tents of this notice. The notice will these Registration Guidelines. The provide a period of 30 days within review includes ascertaining (1) if the which any interested party may directed use of the product can reasonsubmit comment regarding the regis- ably be expected to result in any level tration of the pesticide for the indicat- of residues on food or feed; (2) if the ed uses.

directed application of the product is (c) Acknowledgment of application effective for the claims made and the (8 162.7(b)). (1) Applications may be directions for use are adequate, and mailed or delivered personally to the practical; and (3) if the proposed labelRegistration Division. An application ing bears necessary precautionary for registration will be acknowledged statements which, if complied with, as soon as possible after receipt by re- will be adequate to prevent unreasonturning the “Acknowledgment” copy able injury to man, beneficial animals of the form. The applicant should and the environment. (8 162.7(d)). keep the triplicate copy of the form for his own records.

$ 162.47 Disposition of applications. (2) The acknowledgment copy will (a) Notice of deficiency contain the date of receipt of the ap- ($ 162.6(a)(5)). (1) If the application is plication, the Product Manager's name deficient, the Product Manager will and the telephone number, the antici- notify the applicant, by letter, of the pated time for completion of the deficiencies in data or labeling. The review, and, in the case of a new prod applicant will be afforded an opportuuct, will assign the product a “File nity to correct the deficiencies or Symbol.”

submit additional information to com