40 CFR Part 152

§152.96 Documentation of a data gap.

    Except as provided in paragraph (a) of this section, an applicant may defer his obligation to satisfy an applicable data requirement until the Agency requests the data if he can demonstrate, by the procedure in this section, that no other person has previously submitted to the Agency a study that would satisfy the data requirement in question.
    (a) When data gap procedures may not be used.
    (1) An applicant for registration of a product containing a new chemical may not defer his obligation by the procedure in this section, unless he can demonstrate to the Agency's satisfaction that the data requirement was imposed so recently that insufficient time has elapsed for the study to have been completed and that, in the public interest, the product should be registered during the limited period of time required to complete the study. Refer to FIFRA section 3(c)(7)(C).
    (2) An applicant for registration of a product under FIFRA section 3(c)(7)(A) or (B) may not defer his obligation by the procedure in this section if the Agency requires the data to determine:
    (i) Whether the product is identical or substantially similar to another currently registered product or differs only in ways that would not substantially increase the risk of unreasonable adverse effects on the environment;
    (ii) If efficacy data are required, whether the product is efficacious; or
    (iii) Whether the new use would substantially increase the risk of unreasonable adverse effects on the environment, usually required when the application involves a new use of a product which is identical or substantially similar to a currently registered product.
    (b) Data gap listed in a Registration Standard. The applicant may rely on a data gap that is documented by a Registration Standard without submitting the certification required by paragraph (c) of this section. If the data gap listed in the Registration Standard has been filled since the issuance of the Standard, the Agency will notify the applicant and require him to choose another method of demonstrating compliance.
    (c) Certification of a data gap. Except as provided by paragraph (b) of this section, an applicant who wishes to claim that a data gap exists must certify to the Agency that:
    (1) The applicant has furnished, by certified mail, to each original data submitter on the current Data Submitters List for the active ingredient in question, a notice containing the following information:
    (i) The name and address of the applicant;
    (ii) The name of the product, and a statement that the applicant intends to apply for registration of that product;
    (iii) The name(s) of the active ingredient(s) in the product;
    (iv) A list of the data requirements for which the applicant intends to claim under this section that a data gap exists; and
    (v) A request that the data submitter identify, within 60 days of receipt of the notice, any valid study which he has submitted to the Agency that would fulfill any of the data requirement(s) listed.
    (2) The applicant has, within that 60-day period, received no response, or has received a negative response, from each person notified; and
    (3) The applicant has no basis to believe that any data have been submitted to the Agency that would fulfill the data requirement, and is entitled to claim that a data gap exists.
    (d) Requirement to obtain permission or make offer to pay. In responding to a data gap letter, the original data submitter is not deemed to have given his authorization for the applicant to cite any study which the data submitter identifies in his response. The applicant must seek and obtain specific written authorization from, or make an offer to pay to, the original data submitter to cite the identified study in order to demonstrate compliance for the data requirement. Nothing, however, precludes the applicant from requesting written authorization or making an offer to pay at the same time that he requests confirmation of a data gap.


§152.97 Rights and obligations of data submitters.

    (a) Right to be listed on Data Submitters List.
    (1) Each original data submitter shall have the right to be included on the Agency's Data Submitters List.
    (2) Each original data submitter who wishes to have his name added to the current Data Submitters List must submit to the Agency the following information:
    (i) Name and current address;
    (ii) Chemical name and common name (if any) of the active ingredient(s), with respect to which he is an original data submitter;
    (iii) For each such active ingredient, the type(s) of study he has previously submitted (corresponding to Guidelines reference numbers given in tables in 40 CFR Part 158, if applicable), the date of submission, and the EPA registration number, file symbol, or other identifying reference for which it was submitted.
    (3) Each applicant not already included on the Data Submitters List for a particular active ingredient must inform the Agency at the time of submission of a relevant study whether he wishes to be included on the Data Submitters List for that pesticide.
    (b) Obligation to respond to data gap letters. An applicant who chooses to defer his obligation by demonstrating the existence of a data gap must write to each original data submitter for confirmation that the data submitter has not submitted a valid study that would satisfy the requirement. The original data submitter is not required to respond to such letters. However, if he fails to respond, the applicant is entitled to assume (and the Agency will act on the assumption) that the original data submitter has not submitted a study to satisfy the requirement. The data submitter may thereby limit his right to later challenge the applicant's claim if he fails respond in writing delivered to the applicant within 60 days of receipt of the applicant's data gap letter.


§152.98 Procedures for transfer of exclusive use or compensation rights to another person.

    A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(D) may transfer such rights to another person in accordance with this section.
    (a) The original data submitter must submit to the Agency a transfer document that contains the following information:
    (1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);
    (2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee);
    (3) Identification of each item of data transferred including:
    (i) The name of the study or item of data;
    (ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires;
    (iii) The name of the person or laboratory that conducted the study;
    (iv) The date the study was submitted to the Agency;
    (v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data.
    (vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named;
    (vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and (viii) The names, signatures and titles of the transferor and transferee, and the date signed.
    (b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that:
    (1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter;
    (2) No court order prohibits the transfer, and any required court approvals have been obtained; and
    (3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements.
    (c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(D), unless a new transfer agreement is submitted to the Agency.


§152.99 Petitions to cancel registration.

    An original data submitter may petition the Agency to deny or cancel the registration of a product in accordance with this section if he has submitted to the Agency a valid study which, he claims, satisfies a data requirement that an applicant purportedly has failed to satisfy.
    (a) Grounds for petition.
    (1) If an applicant has offered to pay compensation to an original data submitter of a study (either specifically or by filing a general offer to pay statement), the original data submitter may petition the Agency to deny or cancel the registration to which the offer related on any of the following grounds:
    (i) The applicant has failed to participate in an agreed-upon procedure for reaching an agreement on the amount and terms of compensation. The petitioner shall submit a copy of the agreed-upon procedure and describe the applicant's failure to participate in the procedure.
    (ii) The applicant has failed to comply with the terms of an agreement on compensation. The petitioner shall submit a copy of the agreement, and shall describe how the applicant has failed to comply with the agreement.
    (iii) The applicant has failed to participate in an arbitration proceeding. The petitioner shall submit evidence of such failure.
    (iv) The applicant has failed to comply with the terms of an arbitration decision. The petitioner shall submit a copy of the arbitration decision, and describe how the applicant has failed to comply with the decision.
    (2) When no offer to pay has been made, the petitioner shall state in his petition the basis for the challenge, and describe how the failure of the applicant to comply with the procedures of this subpart has deprived him of the rights accorded him under FIFRA section 3(c)(1)(D). Possible grounds for challenge include, but are not limited to, the following:
    (i) The applicant has failed to list a data requirement applicable to his product, or has failed to demonstrate compliance with all applicable data requirements.
    (ii) The applicant has submitted or cited a study that is not valid.
    (iii) The applicant has submitted or cited a study that does not satisfy the data requirement for which it was submitted or cited.
    (iv) The applicant has failed to comply with the procedure for showing that a data gap exists.
    (v) The applicant has improperly certified that a data gap exists. An original data submitter who has failed without good cause to respond to an applicant's request for confirmation of a data gap may not petition the Agency for review on this basis.
    (vi) The applicant has submitted or cited a study originally submitted by the petitioner, without the required authorization or offer to pay.
    (b) Procedure for petition to the Agency --
    (1) Time for filing. A petition under paragraph (a)(1) of this section may be filed at any time that the circumstances warrant. A petition under paragraph (a)(2) of this section must be filed within one year after the Agency makes public the issuance of the registration.
    (2) Notice to affected registrant. At the same time that the petitioner files his petition with the Agency, he shall send a copy by certified mail to the affected applicant or registrant. The applicant or registrant shall have 60 days from the date of his receipt of the petition to submit written comments to the Agency.
    (c) Disposition of petitions. The Agency will consider the material submitted by the petitioner and the response, if any, by the affected applicant or registrant.
    (1) If the Agency determines that the petition is without merit, it will inform the petitioner and the affected applicant or registrant that the petition is denied. Denial of a petition is a final Agency action.
    (2) If the Agency determines that an applicant has acted in any way described by paragraph (a)(1) of this section, the Agency will notify the petitioner and the affected applicant or registrant that it intends to deny or cancel the registration of the product in support of which the data were cited. The affected applicant or registrant will have 15 days from the date of delivery of this notice to respond. If the Agency determines, after considering any response, that the affected applicant or registrant has acted in the ways described by paragraph (a)(1) of this section, the Agency will deny or cancel the registration without further hearing. Refer to FIFRA section 3(c)(1)(D)(ii). Denial or cancellation of a registration is a final Agency action.
    (3) Except as provided in paragraph (c)(2) of this section, if the Agency determines that an applicant for registration of a product has acted in any way that deprives an original data submitter of rights under FIFRA section 3(c)(1)(D), the Agency will take steps to deny the application or cancel the registration, as appropriate. The procedures in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or cancellation is a final Agency action.
    (d) Hearing. Any hearing will be conducted in accordance with the procedures in 40 CFR Part 164. The only matter for resolution at the hearing shall be whether the registrant failed to comply with the requirements and procedures of FIFRA section 3(c)(1)(D) or of this subpart, in the manner described by the petitioner. A decision following a hearing shall be final.


        Subpart F -- Agency Review of Applications

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

§152.100 Scope.

    (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.


§152.102 Publication.

    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.


§152.104 Completeness of applications.

    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 of this chapter not submitted in accordance with the requirements for format, claims of confidential business information, or flagging).


§152.105 Incomplete applications.

    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.


§152.107 Review of data.

    (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 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.


§152.108 Review of labeling.

    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.

§152.110 Time for Agency review.

    The Agency will complete its review of applications as expeditiously as possible. Applications involving new active ingredients, new uses, petitions for tolerance or exemptions, or consultation with other Federal agencies normally will take longer than applications for substantially similar products and uses.


§152.111 Choice of standards for review of applications.

    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).


§152.112 Approval of registration under FIFRA sec. 3(c)(5).

    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 by Part 158 of this chapter for the product;
    (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, sec. 409 or both; 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.


§152.113 Approval of registration under FIFRA sec. 3(c)(7) -- Products that do not contain a new active ingredient.

    (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 pesticide 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.


§152.114 Approval of registration under FIFRA sec. 3(c)(7) -- Products that contain a new active ingredient.

    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.


§152.115 Conditions of registration.

    (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 conjunction 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).

[As amended at 60 FR 32094, June 19, 1995]


§152.116 Notice of intent to register to original submitters of exclusive use data.

    (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)(D)(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.


§152.117 Notification to applicant.

    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.


§152.118 Denial of application.

    (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.


§152.119 Availability of material in support of registration.

    (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.


40 CFR Part 152

        Subpart G -- Obligations and Rights of Registrants

    SOURCE: 53 FR 15983, May 4, 1988, unless otherwise noted.

§152.122 Currency of address of record and authorized agent.

    (a) The registrant must keep the Agency informed of his current name and address of record. If the Agency's good faith attempts to contact the registrant are not successful, the Agency will issue in the Federal Register a notice of intent to cancel all products of the registrant under FIFRA sec. 6(b). The registrant must respond within 30 days requesting that the registrations be maintained in effect, and providing his name and address of record. If no response is received, the cancellations will become effective at the end of 30 days without further notice to the registrant. The Agency may make provision for the sale and distribution of existing stocks of such products after the effective date of cancellation.
    (b) The registrant must also notify the Agency if he changes his authorized agent.


§152.125 Submission of information pertaining to adverse effects.

    If at any time the registrant receives or becomes aware of any factual information regarding unreasonable adverse effects of the pesticide on the environment that has not previously been submitted to the Agency, he shall, in accordance with FIFRA sec. 6(a)(2) provide such information to the Agency, clearly identified as FIFRA 6(a)(2) data.

[As amended at 60 FR 32094, June 19, 1995]


§152.130 Distribution under approved labeling.

    (a) A registrant may distribute or sell a registered product with the composition, packaging and labeling currently approved by the Agency.
    (b) A registrant may distribute or sell a product under labeling bearing any subset of the approved directions for use, provided that in limiting the uses listed on the label, no changes would be necessary in precautionary statements, use classification, or packaging of the product.
    (c) Normally, if the product labeling is amended on the initiative of the registrant, by submission of an application for amended registration, the registrant may distribute or sell under the previously approved labeling for a period of 18 months after approval of the revision, unless an order subsequently issued by the Agency under FIFRA sec. 6 or 13 provides otherwise. However, if paragraph (d) of this section applies to the registrant's product, the time frames established by the Agency in accordance with that paragraph shall take precedence.
    (d) If a product's labeling is required to be revised as a result of the issuance of a Registration Standard, a Label Improvement Program notice, or a notice concluding a special review process, the Agency will specify in the notice to the registrant the period of time that previously approved labeling may be used. In all cases, supplemental or sticker labeling may be used as an interim compliance measure for a reasonable period of time. The Agency may establish dates as follows governing when label changes must appear on labels: (1) The Agency may establish a date after which all product distributed or sold by the registrant must bear revised labeling.
    (2) The Agency may also establish a date after which no product may be distributed or sold by any person unless it bears revised labeling. This date will provide sufficient time for product in channels of trade to be distributed or sold to users or otherwise disposed of.


§152.132 Supplemental distribution.

    The registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is termed "supplemental distribution" and the product is referred to as a "distributor product." The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Supplemental distribution is permitted upon notification to the Agency if all the following conditions are met:
    (a) The registrant has submitted to the Agency for each distributor product a statement signed by both the registrant and the distributor listing the names and addresses of the registrant and the distributor, the distributor's company number, the additional brand name(s) to be used, and the registration number of the registered product.
    (b) The distributor product is produced, packaged and labeled in a registered establishment operated by the same producer (or under contract in accordance with § 152.30) who produces, packages, and labels the registered product. (c) The distributor product is not repackaged (remains in the producer's unopened container).
    (d) The label of the distributor product is the same as that of the registered product, except that:
    (1) The product name of the distributor product may be different (but may not be misleading);
    (2) The name and address of the distributor may appear instead of that of the registrant;
    (3) The registration number of the registered product must be followed by a dash, followed by the distributor's company number (obtainable from the Agency upon request);
    (4) The establishment number must be that of the final establishment at which the product was produced; and
    (5) Specific claims may be deleted, provided that no other changes are necessary.
    (e) Voluntary cancellation of a product applies to the registered product and all distributor products distributed or sold under that registration number. The registrant is responsible for ensuring that distributors under his cancelled registration are notified and comply with the terms of the cancellation.

[As amended at 60 FR 32094, June 19, 1995]


§152.135 Transfer of registration.

    (a) A registrant may transfer the registration of a product to another person, and the registered product may be distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents listed in paragraphs (b) and (c) of this section, and receive Agency approval as described in paragraph (d) of this section.
    (b) Persons seeking approval of a transfer of registration must provide a document signed by the authorized representative of the registrant (the transferor) and of the person to whom the registration is transferred (the transferee) that contains the following information:
    (1) The name, address and State of incorporation (if any) of the transferor;
    (2) The name, address and State of incorporation of the transferee;
    (3) The name(s) and EPA registration number(s) of the product(s) being transferred;
    (4) A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed in the document;
    (5) A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency;
    (6) A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed);
    (7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and
    (8) An acknowledgment by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved.
    (c) In addition, the transferor must submit to the Agency a notarized statement affirming that:
    (1) The person signing the transfer agreement is authorized by the registrant to bind the transferor;
    (2) No court order prohibits the transfer, and that any required court approvals have been obtained; and
    (3) The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements.
    (d) If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration. The Agency will notify the transferor and transferee of its approval. (e) The transfer will be effective on the date of Agency approval. Thereafter the transferee will be regarded as the registrant for all purposes under FIFRA.
    (f) Rights to exclusive use of data or compensation under FIFRA sec. 3(c)(1)(D) are separate from the registration itself and may be retained by the transferor, or may be transferred independently in accordance with the provisions of § 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data.

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


§152.138 Voluntary cancellation. [Removed].

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


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