40 CFR Part 152

§152.46 Notification and non-notification changes to registrations. (a) Changes permitted by notification.
    (1) EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished by notification to the Agency, without requiring that the registrant obtain Agency approval. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of modifications permitted by notification and any conditions and procedures for submitting notifications.
    (2) A registrant may modify a registration consistent with paragraph (a)(1) of this section and any procedures issued thereunder and distribute or sell the modified product as soon as the Agency has received the notification. Based upon the notification, the Agency may require that the registrant submit an application for amended registration. If it does so, the Agency will notify the registrant and state its reasons for requiring an application for amended registration. Thereafter, if the registrant fails to submit an application the Agency may determine that the product is not in compliance with the requirements of the Act. Notification under this paragraph is considered a report filed under the Act for the purposes of FIFRA section 12(a)(2)(M).
    (b) Changes permitted without notification. EPA may determine that certain minor modifications to registration having no potential to cause unreasonable adverse effects to the environment may be accomplished without notification to or approval by the Agency. If EPA so determines, it will issue procedures following an opportunity for public comment describing the types of amendments permitted without notification (also known as non-notification). A registrant may distribute or sell a product changed in a manner consistent with such procedures without notification to or approval by the Agency.
    (c) Effect of non-compliance. Notwithstanding any other provision of this section, if the Agency determines that a product has been modified through notification or without notification in a manner inconsistent with paragraphs (a) or (b) of this section and any procedures issued thereunder, the Agency may initiate regulatory and/or enforcement action without first providing the registrant with an opportunity to submit an application for amended registration.

[As amended at 58 FR 34198, June 23, 1993; 61 FR 33039, June 26, 1996]


§152.50 Contents of application.

    Each application for registration or amended registration must include the following information, as applicable:
    (a) Application form. An application form must be completed and submitted to the Agency. Application forms are provided by the Agency, with instructions as to the number of copies required and proper completion.
    (b) Identity of the applicant --
    (1) Name. The applicant must identify himself. An applicant not residing in the United States must also designate an agent in accordance with paragraph (b)(3) of this section to act on behalf of the applicant on all registration matters.
    (2) Address of record. The applicant must provide an address in the United States for correspondence purposes. The U.S. address provided will be considered the applicant's address of record, and EPA will send all correspondence concerning the application and any subsequent registration to that address. It is the responsibility of the applicant and any registrant under § 152.122 to ensure that the Agency has a current and accurate address.
    (3) Authorized agent. An applicant may designate a person residing in the United States to act as his agent. If an applicant wishes to designate an agent, he must send the Agency a letter stating the name and United States address of his agent. The applicant must notify the Agency if he changes his designated agent. This relationship may be terminated at any time by the applicant by notifying the Agency in writing.
    (4) Company number. If an applicant has been assigned a company number by the Agency, the application must reference that number. (c) Summary of the application. Each application must include a list of the data submitted with the application, together with a brief description of the results of the studies. The list of data submitted may be the same as the list required by § 158.32 of this chapter. The summary must state that is releasable to the public after registration in accordance with § 152.119.
    (d) Identity of the product. The product for which application is being submitted must be identified. The following information is required:
    (1) The product name;
    (2) The trade name(s) (if different); and
    (3) The EPA Registration Number, if currently registered.
    (e) Draft labeling. Each application for new registration must be accompanied by five legible copies of draft labeling (typescript or mock-up). Each application for amended registration that proposes to make any changes in the product labeling must be accompanied by five legible copies of draft labeling incorporating the proposed labeling changes. If the proposed labeling change affects only a portion of the labeling, such as the use directions, the applicant may submit five copies of that portion of the label which is the subject of the amendment. Upon request, an applicant for amended registration must submit a complete label to consolidate amendments.
    (f) Registration data requirements.
    (1) An applicant must submit materials to demonstrate that he has complied with the FIFRA sec. 3(c)(1)(D) and subpart E of this part with respect to satisfaction of data requirements, to enable the Agency to make the determination required by FIFRA sec. 3(c)(5)(B). Required items are described in subpart E of this part.
    (2) An applicant must furnish any data specified in Part 158 of this chapter which are required by the Agency to determine that the product meets the registration standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
    (i) Section 158.30 of this chapter, with respect to times for submission;
    (ii) Section 158.32 of this chapter, with respect to format of submission;
    (iii) Section 158.33 of this chapter, with respect to studies for which a claim of trade secret or confidential business information is made;
    (iv) Section 158.34 of this chapter, with respect to flagging for potential adverse effects; and
    (v) Section 160.12 of this chapter, if applicable, with respect to a statement of whether studies were conducted in accordance with the Good Laboratory Practices of Part 160.
    (3) An applicant shall furnish with his application any factual information of which he is aware regarding unreasonable adverse effects of the pesticide on man or the environment, which would be required to be reported under FIFRA sec. 6(a)(2) if the product were registered.
    (g) Certification relating to child-resistant packaging. If the product meets the criteria for child-resistant packaging, the applicant must submit a certification that the product will be distributed or sold only in child-resistant packaging. Refer to Part 157 of this chapter for the criteria and certification requirements.
    (h) Request for classification. If an applicant wishes to request a classification different from that established by the Agency, he must submit a request for such classification and information supporting the request.
    (i) Statement concerning tolerances. If the proposed labeling bears instructions for use of the pesticide on food or feed crops, or if the intended use of the pesticide results or may be expected to result, directly or indirectly, in pesticide residues in or on food or feed (including residues of any active ingredient, inert ingredient, metabolite, or degradation product), the applicant must submit a statement indicating whether such residues are authorized by a tolerance, exemption from the requirement of a tolerance, or food additive regulation issued under section 408 or 409 of the Federal Food, Drug and Cosmetic Act (FFDCA). If such residues have not been authorized, the application must be accompanied by a petition for establishment of appropriate tolerances, exemptions from the requirement of a tolerance, or food additive regulations, in accordance with Part 180 of this chapter.

[As amended at 58 FR 34198, June 23, 1993; 60 FR 32094, June 19, 1995]


§152.55 Where to send applications and correspondence.

    Applications and correspondence relating to registration should be mailed to the Registration Division (TS-767C), U.S. Environmental Protection Agency, Washington, DC 20460. Persons who wish to hand-deliver applications should contact the Registration Division to determine the location for delivery.


        Subpart D -- Reregistration Procedures [Removed and Reserved].

    SOURCE: 53 FR 15980, May 4, 1988, unless otherwise noted.

[Removed and reserved at 60 FR 32094, June 19, 1995]

        Subpart E -- Procedures To Ensure Protection of Data Submitters' Rights

§152.80 General.

    This subpart E (§§ 152.80 through 152.119)* describes the information that an applicant must submit with his application for registration, amended registration, or reregistration to comply (and for the Agency to determine compliance) with the provisions of FIFRA section 3(c)(1)(D). This subpart also describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with these procedures. If the Agency determines that an applicant has failed to comply with the requirements and procedures in this subpart, the application may be denied. If the Agency determines, after registration has been issued, that an applicant failed to comply with these procedures and requirements, the Agency may issue a notice of intent to cancel the product's registration.

[As amended at 58 FR 34198, June 23, 1993]

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* EDITORIAL NOTE: Sections 152.116 and 152.119 were transferred to subpart F at 53 FR 15980, May 4, 1988.


§152.81 Applicability.

    (a) Except as provided in paragraph (b) of this section, §§ 152.83 through 152.119* apply to:
    (1) Each application for registration of a new product;
    (2) Each application for an amendment of a registration; and
    (3) Each application for reregistration under FIFRA section 3(g).
    (b) This subpart E does not apply to:
    (1) Applications for registration submitted to States under FIFRA section 24(c);
    (2) Applications for experimental use permits under FIFRA section 5;
    (3) Applications for emergency exemptions under FIFRA section 18;
    (4) Applications to make only one or more of the following types of amendments to existing registrations, unless the Administrator or his designee finds that Agency consideration of scientific data would be necessary in order to approve the amendment under FIFRA section 3(c)(5):
    (i) An increase or decrease in the percentage in the product of one or more of its active ingredients or deliberately added inert ingredients;
    (ii) A revision of the identity or amount of impurities present in the product;
    (iii) The addition or deletion of one or more deliberately added inert ingredients;
    (iv) The deletion of one or more active ingredients;
    (v) A change in the source of supply of one or more of the active ingredients used in the product, if the new source of the active ingredient is a product which is registered under FIFRA section 3;
    (vi) Deletion of approved uses of claims;
    (vii) Redesign of the label format involving no substantive changes, express or implied, in the directions for use, claims, representations, or precautionary statements;
    (viii) Change in the product name or addition of an additional brand name, if no additional claims, representations, or uses are expressed or implied by the changes;
    (ix) Clarification of directions for use;
    (x) Correction of typographical errors;
    (xi) Changes in the registrant's name or address;
    (xii) Adding or deleting supplemental registrants;
    (xiii) Changes in the package or container size;
    (xiv) Changes in warranty, warranty disclaimer, or liability limitation statements, or addition to or deletion of such statements;
    (xv) "Splitting" a label for the sole purpose of facilitating the marketing of a product in different geographic regions with appropriate labels, where each amended label will contain previously approved use instructions (and related label statements) appropriate to a particular geographic region;
    (xvi) Any other type of amendment, if the Administrator or his designee determines, by written finding, that the Agency consideration of scientific data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5); and
    (xvii) Compliance with Agency Regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or cancelled, or that a hearing will be held under FIFRA section 6. (However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.)

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* EDITORIAL NOTE: Sections 152.116 and 152.119 were transferred to subpart F at 53 FR 15980, May 4, 1988.


§152.83 Definitions.

    As used in this subpart, the following terms shall have the meanings set forth in this section:
    (a) "Data gap" means the absence of any valid study or studies in the Agency's files which would satisfy a specific data requirement for a particular pesticide product.
    (b) "Data Submitters List" means the current Agency list, entitled "Pesticide Data Submitters by Chemical," of persons who have submitted data to the Agency.
    (c) "Exclusive use study" means a study that meets each of the following requirements:
    (1) The study pertains to a new active ingredient (new chemical) or new combination of active ingredients (new combination) first registered after September 30, 1978;
    (2) The study was submitted in support of, or as a condition of approval of, the application resulting in the first registration of a product containing such new chemical or new combination (first registration), or an application to amend such registration to add a new use; and
    (3) The study was not submitted to satisfy a data requirement imposed under FIFRA section 3(c)(2)(B);
    Provided that, a study is an exclusive use study only during the 10-year period following the date of the first registration.
    (d) "Original data submitter" means the person who possesses all rights to exclusive use or compensation under FIFRA section 3(c)(1)(D) in a study originally submitted in support of an application for registration, amended registration, reregistration, or experimental use permit, or to maintain an existing registration in effect. The term includes the person who originally submitted the study, any person to whom the rights under FIFRA section 3(c)(1)(D) have been transferred, or the authorized representative of a group of joint data developers.
    (e) "Valid study" means a study that has been conducted in accordance with the Good Laboratory Practice standards of 40 CFR Part 160 or generally accepted scientific methodology and that EPA has not determined to be invalid.


§152.84 When materials must be submitted to the Agency.

    All information required by this subpart should be submitted with the application, but may be submitted at any later time prior to EPA's approval of the application. The Agency will not approve any application until it determines either that the application is not subject to these requirements or that all required materials have been submitted and are acceptable.


§152.85 Formulators' exemption.

    (a) FIFRA section 3(c)(2)(D) excuses an applicant from the requirement to submit or cite data pertaining to the safety of any ingredient (or mixture of ingredients) contained in his product that is derived solely from one or more EPA-registered products which the applicant purchases from another producer.
    (b) If the product contains one or more ingredients eligible for the formulators' exemption, the applicant need not comply with the requirements of §§ 152.90 through 152.96 with respect to any data requirements pertaining to the safety of any such ingredient, provided that he submits to the Agency a certification statement containing the following information (a form for this purpose is available from the Agency):
    (1) Identification of the applicant, and of the product by EPA registration number or file symbol;
    (2) Identification of each ingredient in the pesticide that is eligible for the formulators' exemption, and the EPA registration number of the product that is the source of that ingredient;
    (3) A statement that the listed ingredients meet the requirements for the formulators' exemption;
    (4) A statement that the applicant has submitted (either previously or with the current application) a complete, accurate and current Confidential Statement of Formula; and
    (5) The name, title and signature of the applicant or his authorized representative and the date of signature.
    (c) An applicant for amended registration is not required to submit a new formulators' exemption statement, if the current statement in Agency files is complete and accurate.

[As amended at 58 FR 34198, June 23, 1993; 60 FR 32094, June 19, 1995]


§152.86 The cite-all method.

    An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.
    (a) Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each person listed on the Data Submitters List as an exclusive use data submitter for the chemical in question, a written authorization that contains at least the following information:
    (1) Identification of the applicant to whom the authorization is granted;
    (2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the application in question; and
    (3) The signature and title of the original data submitter or his authorized representative and date of the authorization.
    If the Agency identifies any exclusive use data submitter not on the Data Submitters List, the applicant will be required prior to registration to obtain the necessary written authorization from such person.
    (b) Other studies. The applicant must certify to the Agency that, with respect to each other person on the Data Submitters List for the chemical in question:
    (1) He has obtained from that person a written authorization that contains the information required by paragraphs (a)(1) through (3) of this section; or
    (2) He has furnished to that person:
    (i) A notification of his intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
    (ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D) for any data on which the application relies;
    (iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and
    (iv) His name, address and telephone number.
    (c) General offer to pay statement. The applicant must submit to the Agency the following general offer to pay statement:
    [Name of applicant] hereby offers and agrees to pay compensation to other persons, with regard to the approval of this application, to the extent required by FIFRA section 3(c)(1)(D) of the Federal Insecticide, Fungicide and Rodenticide Act.
    (d) Acknowledgement of reliance on data. Each application filed under this section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(D) the application relies on the following data:
    (1) All data submitted with or specifically cited in the application; and
    (2) Each other item of data in the Agency's files which:
    (i) Concerns the properties or effects of the applicant's product, of any product which is identical or substantially similar to the applicant's product, or of one or more of the active ingredients in the applicant's product; and
    (ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant's product, under the data requirements in effect on the date EPA approves the applicant's present application.


§152.90 The selective method.

    An applicant may comply with this subpart by listing the specific data requirements that apply to his product, its active ingredients, and use patterns, and demonstrating his compliance for each data requirement by submitting or citing individual studies, or by demonstrating that no study has previously been submitted to the Agency. This section summarizes the procedures that an applicant must follow if he chooses the selective method of demonstrating compliance. Sections 152.91 through 152.96 contain specific procedures for citing or submitting a study or demonstrating a data gap.
    (a) List of data requirements. Each applicant must submit a list of the data requirements that would apply to his pesticide, its active ingredients, and its use patterns, if the product were being proposed for registration under FIFRA section 3(c)(5) for the first time. The applicant need not list data requirements pertaining to any ingredient which qualifies for the formulator's exemption.
    (1) If a Registration Standard has been issued for any active ingredient, the applicant must list the applicable data requirements enumerated in that Standard for the active ingredient and, if end use products are covered by the Registration Standard, for such products containing that active ingredient.
    (2) If a Registration Standard has not been issued, or if an issued Registration Standard does not cover all data requirements for products containing the active ingredient in question, the applicant must list the applicable requirements as prescribed by 40 CFR Part 158. All required (R) studies, and any studies that could be conditionally required (CR) based upon composition, use pattern, or the results of required studies, are to be listed. The applicant may demonstrate via the data gap procedures in § 152.96 that a conditional requirement need not be satisfied by the submission or citation of data at the time of application.
    (b) Methods of demonstrating compliance. The applicant must state for each data requirement on the list required by paragraph (a) of this section which of the following methods of compliance with the requirement he is using, and shall provide the supporting documentation specified in the referenced section.
    (1) Existence of or granting of a data waiver. Refer to § 152.91.
    (2) Submission of a new valid study. Refer to § 152.92.
    (3) Citation of a specific valid study previously submitted to the Agency by the applicant or another person, with any necessary written authorizations or offers to pay. Refer to § 152.93.
    (4) Citation of a public literature study. Refer to § 152.94.
    (5) Citation of all pertinent studies previously submitted to the Agency, with any necessary written authorizations or offers to pay. Refer to § 152.95.
    (6) Documentation of a data gap. Refer to § 152.96.


§152.91 Waiver of a data requirement.

    The applicant may demonstrate compliance for a data requirement by documenting the existence of a waiver in accordance with paragraph (a) of this section, or by being granted a new waiver requested in accordance with paragraph (b) of this section.
    (a) Request for extension of an existing waiver. An applicant may claim that a waiver previously granted by the Agency also applies to a data requirement for his product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Registration Standard, and must explain why that waiver should apply to his product.
    (b) Request for a new waiver. An applicant who requests a waiver to satisfy a data requirement must submit the information specified in 40 CFR 158.45.
    (c) Effect of denial of waiver request. If the request for a new waiver or extension of an existing waiver is denied by the Agency, the applicant must choose another method of satisfying the data requirement.


§152.92 Submission of a new valid study.

    An applicant may demonstrate compliance for a data requirement by submitting a valid study that has not previously been submitted to the Agency. A study previously submitted to the Agency should not be resubmitted but should be cited in accordance with § 152.93.


§152.93 Citation of a previously submitted valid study.

    An applicant may demonstrate compliance for a data requirement by citing a valid study previously submitted to the Agency. The study is not to be submitted to the Agency with the application.
    (a) Study originally submitted by the applicant. If the applicant certifies that he is the original data submitter, no documentation other than the citation is necessary.
    (b) Study previously submitted by another person. If the applicant is not the original data submitter, the applicant may cite the study only in accordance with paragraphs (b)(1) through (3) of this section.
    (1) Citation with authorization of original data submitter. The applicant may cite any valid study for which he has obtained the written authorization of the original data submitter. The applicant must obtain written authorization to cite any study that is an exclusive use study. The applicant must certify that he has obtained from the original data submitter a written authorization that contains at least the following information:
    (i) Identification of the applicant to whom the authorization is granted;
    (ii) Identification by title, EPA Accession Number or Master Record Identification Number, and date of submission, of the study or studies for which the authorization is granted;
    (iii) Authorization to the applicant to use the specified study in satisfaction of the data requirement for the application in question; and
    (iv) The signature and title of the original data submitter or his authorized representative, and date of the authorization.
    (2) Citation with offer to pay compensation to the original data submitter. The applicant may cite any valid study that is not subject to the exclusive use provisions of FIFRA section 3(c)(1)(D)(i) without written authorization from the original data submitter if the applicant certifies to the Agency that he has furnished to the original data submitter:
    (i) A notification of the applicant's intent to apply for registration, including the proposed product name and a list of the product's active ingredients;
    (ii) Identification of the specific data requirement involved and of the study for which the offer to pay is made (by title, EPA Accession Number or Master Record Identification Number, and date of submission, if possible);
    (iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D);
    (iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the study; and
    (v) The applicant's name, address and telephone number.
    (3) Citation without authorization or offer to pay. The applicant may cite any valid study without written authorization from, or offer to pay to, the original data submitter, if:
    (i) The study was originally submitted to the Agency on or before December 31, 1969; or
    (ii) The study was originally submitted to the Agency on or before the date that is 15 years before the date of the application for which it is cited, and the study is not an exclusive use study, as defined in § 152.83(c).


§152.94 Citation of a public literature study or study generated at government expense.

    (a) An applicant may demonstrate compliance for a data requirement by citing, and submitting to the Agency, one of the following:
    (1) A valid study from the public literature.
    (2) A valid study generated by, or at the expense of, any government (Federal, State, or local) agency.
    (b) In no circumstances does submission of a public literature study or government-generated study confer any rights on the data submitter to exclusive use of data or compensation under FIFRA section 3(c)(1)(D).


§152.95 Citation of all studies in the Agency's files pertinent to a specific data requirement.

    An applicant normally may demonstrate compliance for a data requirement by citation of all studies in the Agency's files pertinent of that data requirement. The applicant who selects this cite-all option must submit to the Agency:
    (a) A general offer to pay statement having the same wording as that specified in § 152.86(c) except that the offer to pay may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected;
    (b) A certification that:
    (1) For each person who is included on the Data Submitters List as an original data submitter of exclusive use data for the active ingredient in question, the applicant has obtained a written authorization containing the information required by § 152.86(a) for the use the any exclusive use study that would be pertinent to the applicant's product; and
    (2) For each person included on the current Data Submitters List as an original data submitter of data that are not exclusive use for the active ingredient in question, the applicant has furnished:
    (i) A notification of the applicant's intent to apply for registration, including the name of the proposed product, and a list of the product's active ingredients;
    (ii) Identification of the specific data requirement(s) for which the offer to pay for data is being made;
    (iii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(D);
    (iv) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for use of any study; and
    (v) The applicant's name, address and telephone number; and
    (c) An acknowledgment having the same wording as that specified in § 152.86(d), except that it may be limited to apply only to data pertinent to the specific data requirement(s) for which the cite-all method of support has been selected.


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