(a) The Agency will follow the procedures in this subpart for all applications for registration, except an application for registration of a pesticide that has been the subject of a previous Agency cancellation or suspension notice under FIFRA sec. 6.

(b) The Agency will follow the procedures of subpart D of part 164 of this chapter in evaluating any application for registration of a pesticide involving use of the pesticide in a manner that is prohibited by a suspension or cancellation order, to the extent required by subpart D of part 164.

The Agency will issue in the Federal Register a notice of receipt of each application for registration of a product that contains a new active ingredient or that proposes a new use. After registration of the product, the Agency will issue in the Federal Register a notice of issuance. The notice of issuance will describe the new chemical or new use, summarize the Agency's regulatory conclusions, list missing data and the conditions for their submission, and respond to comments received on the notice of application.

The applicant is responsible for the accuracy and completeness of all information submitted in connection with the application. The Agency will review each application to determine whether it is complete. An application is incomplete if any pertinent item specified in § 152.50 has not been submitted, or has been incorrectly submitted (for example, data required by part 158, or part 161 of this chapter, as applicable, and not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).

The Agency will not begin or continue the review of an application that is incomplete. If the Agency determines that an application is incomplete or that further information is needed in order to complete the Agency's review, the Agency will notify the applicant of the deficiencies and allow the applicant 75 days to make corrections or additions to complete the application. If the applicant believes that the deficiencies cannot be corrected within 75 days, he must notify the Agency within those 75 days of the date on which he expects to complete the application. If, after 75 days, the applicant has not responded, or if the applicant subsequently fails to complete the application within the time scheduled for completion, the Agency will terminate any action on such application, and will treat the application as if it had been withdrawn by the applicant. Any subsequent submission relating to the same product must be submitted as a new application.

(a) The Agency normally will review data submitted with an application that have not previously been submitted to the Agency.

(b) The Agency normally will review other data submitted or cited by an applicant only:

(1) As part of the process of reregistering currently registered products;

(2) When acting on an application for registration of a product containing a new active ingredient;

(3) If such data have been flagged in accordance with § 158.34 or 161.34 of this chapter; or

(4) When the Agency determines that it would otherwise serve the public interest.

(c) If the Agency finds that it needs additional data in order to determine whether the product may be registered, it will notify the applicant as early as possible in the review process.

The Agency will review all draft labeling submitted with the application. If an applicant for amended registration submits only that portion of the labeling proposed for amendment, the Agency may review the entire label, as revised by the proposed changes, in deciding whether to approve the amendment. The Agency will not approve final printed labeling, but will selectively review it for compliance.

The Agency will complete its review of applications as expeditiously as possible. Applications subject to specific timeframes under the fee schedule established by FIFRA section 33 will be reviewed within the timeframes established for the application or action type.

The Agency has discretion to review applications under either the unconditional registration criteria of FIFRA sec. 3(c)(5) or the conditional registration criteria of FIFRA sec. 3(c)(7). The type of review chosen depends primarily on the extent to which the relevant data base has been reviewed for completeness and scientific validity. EPA conducts data reviews needed to support unconditional registrations on a chemical-by-chemical basis, according to an established priority list. Except for applications for registration of a new active ingredient or in special cases where it finds immediate review to be warranted, the Agency will not commence a complete review of the existing data base on a given chemical in response to receipt of an application for registration. Instead the Agency will review the application using the criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).

EPA will approve an application under the criteria of FIFRA sec. 3(c)(5) only if:

(a) The Agency has determined that the application is complete and is accompanied by all materials required by the Act and this part, including, but not limited to, evidence of compliance with subpart E of this part;

(b) The Agency has reviewed all relevant data in the possession of the Agency (see §§ 152.107 and 152.111);

(c) The Agency has determined that no additional data are necessary to make the determinations required by FIFRA sec. 3(c)(5) with respect to the pesticide product which is the subject of the application;

(d) The Agency has determined that the composition of the product is such as to warrant the proposed efficacy claims for it, if efficacy data are required to be submitted for the product by part 158 or part 161 of this chapter, as applicable.

(e) The Agency has determined that the product will perform its intended function without unreasonable adverse effects on the environment, and that, when used in accordance with widespread and commonly recognized practice, the product will not generally cause unreasonable adverse effects on the environment;

(f) The Agency has determined that the product is not misbranded as that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, and its labeling and packaging comply with the applicable requirements of the Act, this part, and parts 156 and 157 of this chapter;

(g) If the proposed labeling bears directions for use on food, animal feed, or food or feed crops, or if the intended use of the pesticide results or may reasonably be expected to result, directly or indirectly, in pesticide residues (including residues of any active or inert ingredient of the product, or of any metabolite or degradation product thereof) in or on food or animal feed, all necessary tolerances, exemptions from the requirement of a tolerance, and food additive regulations have been issued under FFDCA sec. 408, and

(h) If the product, in addition to being a pesticide, is a drug within the meaning of FFDCA sec. 201(q), the Agency has been notified by the Food and Drug Administration (FDA) that the product complies with any requirements imposed by FDA.

(a) Except as provided in paragraph (b) of this section, the Agency may approve an application for registration or amended registration of a pesticide product, each of whose active ingredients is contained in one or more other registered peticide products, only if the Agency has determined that:

(1) It possesses all data necessary to make the determinations required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide product which is the subject of the application (including, at a minimum, data needed to characterize any incremental risk that would result from approval of the application);

(2) Approval of the application would not significantly increase the risk of any unreasonable adverse effect on the environment; and

(3) The criteria of § 152.112(a), (d), and (f) through (h) have been satisfied.

(b) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined that the applicant's product and its proposed use are identical or substantially similar to a currently registered pesticide and use, or that the pesticide and its proposed use differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.

(c) Notwithstanding the provisions of paragraph (a) of this section, the Agency will not approve the conditional registration of any pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:

(1) The pesticide is the subject of a special review, based on a use of the product that results in human dietary exposure; and

(2) The proposed new use involves use on a major food or feed crop, or involves use on a minor food or feed crop for which there is available an effective alternative registered pesticide which does not meet the risk criteria associated with human dietary exposure. The determination of available and effective alternatives shall be made with the concurrence of the Secretary of Agriculture.

An application for registration of a pesticide containing an active ingredient not in any currently registered product may be conditionally approved for a period of time sufficient for the generation and submission of certain of the data necessary for a finding of registrability under FIFRA sec. 3(c)(5) if the Agency determines that:

(a) Insufficient time has elapsed since the imposition of the data requirement for those data to have been developed;

(b) All other required test data and materials have been submitted to the Agency;

(c) The criteria in § 152.112(a), (b), (d), and (f) through (h) have been satisfied;

(d) The use of the pesticide product during the period of the conditional registration will not cause any unreasonable adverse effect on the environment; and

(e) The registration of the pesticide product and its subsequent use during the period of the conditional registration are in the public interest.

(a) Substantially similar products and new uses. Each registration issued under § 152.113 shall be conditioned upon the submission or citation by the registrant of all data which are required for unconditional registration of his product under FIFRA sec. 3(c)(5), but which have not yet been submitted, no later than the time such data are required to be submitted for similar pesticide products already registered. If a notice requiring submission of such data has been issued under FIFRA sec. 3(c)(2)(B) prior to the date of approval of the application, the applicant must submit or cite the data described by that notice at the time specified by that notice. The applicant must agree to these conditions before the application may be approved.

(b) New active ingredients. Each registration issued under § 152.114 shall be conditioned upon the applicant's agreement to each of the following conditions:

(1) The applicant will submit remaining required data (and interim reports if required) in accordance with a schedule approved by the Agency.

(2) The registration will expire upon a date established by the Agency, if the registrant fails to submit data as required by the Agency. The expiration date will be established based upon the length of time necessary to generate and submit the required data. If the studies are submitted in a timely manner, the registration will be cancelled if the Agency determines, based on the data (alone, or in conjuction with other data), that the product or one or more of its uses meets or exceeds any of the risk criteria established by the Agency to initiate a special review. If the Agency so determines, it will issue to the registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will specify any provisions for sale and distribution of existing stocks of the pesticide product.

(3) The applicant will submit an annual report of the production of the product.

(c) Other conditions. The Agency may establish, on a case-by-case basis, other conditions applicable to registrations to be issued under FIFRA sec. 3(c)(7).

(d) Cancellation if condition is not satisfied. If any condition of the registration of the product is not satisfied, or if the Agency determines that the registrant has failed to initiate or pursue appropriate action towards fulfillment of any condition, the Agency will issue a notice of intent to cancel under FIFRA sec. 6(e).

(a) Except as provided in paragraph (c) of this section, at least 30 days before registration of a product containing an active ingredient for which a previously submitted study is eligible for exclusive use under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original submitter of the exclusive use study of the intended registration of the product. If requested by the exclusive use data submitter within 30 days, the Agency will also provide the applicant's list of data requirements and method of demonstrating compliance with each data requirement.

(b) Within 30 days after receipt of the Agency's notice, or of the applicant's list of data requirements, whichever is later, the exclusive use data submitter may challenge the issuance of the registration in accordance with the procedures in § 152.99 (b) and (c). If the Agency finds that the challenge has merit, it will issue a notice of denial of the application. The applicant may then avail himself of the hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the challenge is without merit, it will deny the petition and register the applicant's product. Denial of the petition is a final Agency action.

(c) If an applicant has submitted to the Agency a certification from an exclusive use data submitter that he is aware of the applicant's application for registration, and does not object to the issuance of the registration, the Agency will not provide the 30-day notification described in paragraph (a) of this section to that exclusive use data submitter.

The Agency will notify the applicant of the approval of his application by a Notice of Registration for new registration, or by a letter in the case of an amended registration.

(a) Basis for denial. The Agency may deny an application for registration if the Agency determines that the pesticide product does not meet the criteria for registration under either FIFRA sec. 3(c)(5) or (7), as specified in §§ 152.112 through 152.114.

(b) Notification of applicant. If the Agency determines that an application should be denied, it will notify the applicant by certified letter. The letter will set forth the reasons and factual basis for the determination with conditions, if any, which must be fulfilled in order for the registration to be approved.

(c) Opportunity for remedy by the applicant. The applicant will have 30 days from the date of receipt of the certified letter to take the specified corrective action. During this time the applicant may request that his application be withdrawn.

(d) Notice of denial. If the applicant fails to correct the deficiencies within the 30-day period, the Agency may issue a notice of denial, which will be published in the Federal Register, and which will set forth the reasons and the factual basis for the denial.

(e) Hearing rights. Within 30 days following the publication of the notice of denial, an applicant, or any interested person with written authorization of the applicant, may request a hearing in accordance with FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164 of this chapter.

(a) The information submitted to support a registration application shall be part of the official Agency file for that registration.

(b) Within 30 days after registration, the Agency will make available for public inspection, upon request, the materials required by subpart E to be submitted with an application. Materials that will be publicly available include an applicant's list of data requirements, the method used by the applicant to demonstrate compliance for each data requirement, and the applicant's citations of specific studies in the Agency's possession if applicable.

(c) Except as provided by FIFRA sec. 10, within 30 days after registration, the data on which the Agency based its decision to register the product will be made available for public inspection, upon request, in accordance with the procedures in 40 CFR part 2.