PART 155—REGISTRATION STANDARDS AND REGISTRATION REVIEW Authority: 7 U.S.C. 136a and 136w. Source: 50 FR 49001, Nov. 27, 1985, unless otherwise noted. Subpart A [Reserved] Subpart B—Docketing and Public Participation Procedures § 155.23 Definitions. For the purposes of this part, confidential business information § 155.25 Schedule. EPA will issue annually in the Federal Register § 155.27 Agency review of data. EPA will independently (or using the services of disinterested contractors or consultants) review available data in preparation for the development of a Registration Standard, and will be responsible for the drafting of the Registration Standard based on such data reviews. The Agency will not permit registrants to prepare, or assist in the preparation of, data reviews or other Registration Standard documents. The Agency may, however, meet with registrants to discuss its pending reviews, decisions, or documents, in accordance with the meeting procedures in § 155.30, and the docketing procedures in § 155.32. § 155.30 Meetings and communications. EPA personnel may, upon their own initiative or upon request of any interested person or party, meet or communicate with persons or parties outside of government concerning a Registration Standard under development. Such meetings or communications will conform to the following policies and procedures: (a) Purpose. (b) Meetings with persons or parties outside of government. (c) Information submitted to the Agency concerning a Registration Standard under development. (2) To assert a claim of confidentiality for all or any part of a written submission concerning a Registration Standard under development, the submitter must furnish three copies of the material. Two copies must be complete, with claimed confidential business information clearly marked in the text. Items in the document that are claimed confidential should be numbered consecutively throughout the document. The third copy must have the claimed confidential business information excised from the text without closing up or paraphrasing the remaining text. The deletions should be consecutively numbered to correspond to the numbering of the complete copies. Each copy must be marked on the cover as to whether it contains claimed confidential business information. (3) Any written material received by the Agency that is not marked as confidential will be deemed to be nonconfidential, and may be made available through the public docket or otherwise disclosed without prior notice to the submitter. (d) Memorandum of meeting. (1) The date and time of the meeting. (2) The name of the person who requested the meeting. (3) The names and affiliations of the participants. (4) The subject matter of the meeting. (5) A full and accurate description of all significant positions taken, facts presented, and arguments made by each participant (except that any discussion of claimed confidential business information will be identified in meeting notes, and referenced in the memorandum). (6) Identification of all documents, proposals, or other materials (other than information claimed to be confidential business information) distributed or exchanged at the meeting. (7) The name of the person who prepared the memorandum. [50 FR 49001, Nov. 27, 1985, as amended at 58 FR 34203, June 23, 1993] § 155.32 Public docket. (a) When created. (2) If the Agency notifies registrants privately in accordance with 40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7 (leading to a special review) may have been exceeded, that notification and any subsequent communications concerning that notification will be placed in a separate docket pertaining to possible special review in accordance with the provisions of § 154.15. (b) Contents of docket. (1) An index of its contents (refer to paragraph (c) of this section). (2) A copy of each comment received in response to the notice described in § 155.25 that pertains to a pesticide for which the notice indicated a Registration Standard was under development (within 10 working days after receipt by the Agency, or 15 working days if the submitter has asserted a confidential business information claim concerning the material). (3) A copy of each memorandum of a meeting between the Agency and persons or parties outside of government, prepared in accordance with § 155.30(d) (within 10 working days after the meeting). (4) A copy of each document, comment, item of correspondence or other written material concerning the Registration Standard submitted to the Agency by any person or party outside of government, whether in a meeting or separately (within 10 working days after receipt, or 15 working days if the submitter has asserted a confidential business information claim concerning the material). (5) A copy of each document, proposal, or other item of written material concerning the Registration Standard provided by the Agency to any person or party outside of government (within 15 working days after the item is made available to such person or party). (6) A copy of the Registration Standard; (7) With respect to a Registration Standard for which the Agency has determined that a substantially complete chronic health and teratology data base exists, a copy of the Federal Register (8) A copy of the Federal Register (c) Index of the docket. (1) A list of each meeting between the Agency and any person or party outside of government, containing the date and subject of the meeting, the names of participants and the name of the person requesting the meeting. (2) A list of each document in the docket by title, source or recipient(s), and the date the document was received or provided by the Agency. (d) Availability of docket and indices. (2) The Agency will establish and maintain a mailing list of persons who have specifically requested that they receive indices for Registration Standard dockets. On a quarterly basis, EPA will distribute the indices of new materials placed in the public docket to these persons. Annually, EPA will require that persons on the list renew their requests for inclusion on the list. (3) The Agency will issue annually in the Federal Register (4) Each Federal Register § 155.34 Notice of availability. (a) The Agency will issue in the Federal Register (1) Concerns a previously unregistered active ingredient; or (2) Concerns a previously registered active ingredient, and the Registration Standard states that registrants will be required (under FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not limited to, chronic feeding, oncogenicity and reproduction) or teratology studies. (b) Interested persons may submit comments concerning any Registration Standard described by paragraph (a) of this section at any time. (c) The Agency will issue in the Federal Register Federal Register Subpart C—Registration Review Procedures Source: 71 FR 45732, Aug. 9, 2006, unless otherwise noted. § 155.40 General. (a) Purpose. (1) Among other things, FIFRA requires that a pesticide generally will not cause unreasonable adverse effects on the environment. Registration review is intended to ensure that each pesticide's registration is based on current scientific and other knowledge regarding the pesticide, including its effects on human health and the environment. (2) If a product fails to satisfy the FIFRA standard for registration, the product's registration may be subject to cancellation or other remedies under FIFRA. (b) Applicability. (c) Limitations. (2) When the Agency determines that new data or information are necessary for a pesticide's registration review, it will require such data under FIFRA section 3(c)(2)(B). [71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75595, Dec. 12, 2008] § 155.42 Registration review cases. (a) Establishing registration review cases. (1) Existing pesticides. (2) New pesticides. The Agency will assign each pesticide registered after the effective date of this regulation to an existing registration review case or to a new registration review case. (3) A pesticide product that contains multiple active ingredients will belong to the registration review cases for each of its active ingredients. (b) Modifying registration review cases. (1) Add a new active ingredient to a registration review case. The Agency may determine that a new active ingredient is chemically and toxicologically similar to active ingredients in an existing registration review case and should be grouped with the ingredients in the existing registration review case. (2) Split a registration review case into two or more registration review cases. For example, new data or information may suggest that active ingredients in a registration review case are not as similar as previously believed and that they belong in two or more separate registration review cases. (3) Move an ingredient from one registration review case to another. For example, new data or information might suggest that an ingredient should not be grouped with the other ingredients in the registration review case and that it belongs in a different registration review case. (4) Merge two or more registration review cases into a single registration review case. For example, new data or information might suggest that the active ingredients in two or more registration review cases should be grouped together for registration review. (5) Delete an active ingredient from a registration review case. For example, the Agency will remove the ingredient from the case if the registrations of all products containing an active ingredient in a registration review case are canceled. (c) Closing a registration review case. (d) Establishing a baseline date for a registration review case. (1) The Agency generally will not change the baseline date for a registration review case when it modifies a case by adding or deleting ingredients or products. (2) When the Agency splits a registration review case into two or more cases, the new case(s) generally will have the baseline date of the original registration review case. (3) When the Agency merges two or more registration review cases into a single case, the Agency generally will use the earliest baseline date as the baseline date for the new case. (e) Announcing registration review cases and baseline dates. § 155.44 Establish schedules for registration review. The Agency will develop schedules for registration review that are generally based on the baseline date of the registration review case or on the date of the latest registration review of the registration review case. The Agency may also take into account other factors, such as achieving process efficiencies by reviewing related cases together, when developing schedules for registration review. The Agency will maintain schedules for the current year and at least two subsequent years on its website. § 155.46 Deciding that a registration review is complete and additional review is not needed. The Agency may determine that there is no need to reconsider a previous decision that a pesticide satisfies the standard of registration in FIFRA. In such cases, instead of establishing a pesticide registration review case docket as described in § 155.50, the Agency may propose that, based on its determination that a pesticide meets the FIFRA standard for registration, no further review will be necessary. In such circumstances, the Agency will publish a notice in the Federal Register Federal Register § 155.48 Data Call-In. The Agency may issue a Data Call-In notice under FIFRA section 3(c)(2)(B) at any time if the Agency believes that the data are needed to conduct the registration review. The provisions in FIFRA section 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, compensation, and exemption of data required to conduct a registration review. § 155.50 Initiate a pesticide's registration review. The Agency will initiate a pesticide's registration review by establishing a docket for each registration review case, except for cases covered under § 155.46, and opening it for public review. (a) Contents of the registration review case docket. (1) An overview of registration review case status; (2) A list of current registrations and registrants, any Federal Register (3) Risk assessment documents; (4) Bibliographies concerning current registrations; (5) Summaries of incident data; and (6) Any other pertinent data or information. (b) Public review of the registration review case docket. Federal Register (c) Submission of data and other information during the comment period. (1) In order to ensure that the Agency will consider data or information in the conduct of a registration review, interested persons must submit the data or information during the comment period established in the notice described in paragraph (b) of this section. The Agency may, at its discretion, consider data or information submitted at a later date. (2) The data or information must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form. (3) Submitters must clearly identify the source of any submitted data or information. (4) Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review. (d) For the purposes of this subpart, the provisions of subpart B do not apply. § 155.52 Stakeholder engagement. In addition to the public participation opportunities described in § 155.50 and § 155.53(c), the Agency may meet with stakeholders regarding a forthcoming or ongoing registration review. For example, before conducting a pesticide's registration review, the Agency may consult with registrants or pesticide users regarding the use and usage of the pesticide. The Agency may consult with registrants, pesticide users, or other persons during a pesticide's registration review with regard to developing risk management options for a pesticide. The Agency may informally consult with officials of Federal, State or Tribal agencies regarding a forthcoming or ongoing registration review. (a) Minutes of meetings with persons outside of government. (1) 45 days after the meeting; or (2) The date of issuance of the registration review decision. (b) Exchange of documents or other written material. (c) Confidential business information. [71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75596, Dec. 12, 2008] § 155.53 Conduct of a pesticide's registration review. The Agency will review data and information described in § 155.50(a), (b), and (c) or submitted in response to a Data Call-In notice that it believes should be considered in the pesticide's registration review. (a) Assess changes since a pesticide's last review. (b) Conduct new assessments as needed. (2) Individual product registrations. If the Agency finds that additional review of an individual product's registration is needed, it will review the pesticide product label, confidential statement of formula, product-specific data, or other pertinent data or information, as appropriate, to determine whether the registration of the individual product meets the FIFRA standard for registration. If the Agency determines that additional data or information are needed to conduct the review, the Agency will issue a Data Call-In notice under FIFRA section 3(c)(2)(B). (c) Public participation during a pesticide's registration review. Federal Register Federal Register (1) The Agency might not request comments on a draft risk assessment in cases where the Agency's initial screening of a pesticide indicates that it has low use/usage, affects few if any stakeholders or members of the public, poses low risk, and/or requires little or no risk mitigation. In such cases, the Agency will make a draft risk assessment available for public review and comment when it issues a proposed decision on the registration review case. (2) If the Agency finds that it is not necessary to conduct a new risk assessment, it will issue a proposed decision on the registration review case as described in § 155.58. § 155.56 Interim registration review decision. The Agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. A FIFRA 3(c)(2)(B) notice requiring the needed data or information may precede, accompany, or follow issuance of the interim registration review decision. The Agency will follow procedures in § 155.58 when issuing an interim registration review decision. § 155.57 Registration review decision. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA. § 155.58 Procedures for issuing a decision on a registration review case. (a) The Agency will publish a notice in the Federal Register (b) In its proposed decision, the Agency will, among other things: (1) State its proposed findings with respect to the FIFRA standard for registration and describe the basis for such proposed findings. (2) Identify proposed risk mitigation measures or other remedies as needed and describe the basis for such proposed requirements. (3) State whether it believes that additional data are needed and, if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such data may be issued in conjunction with a proposed or final decision on the registration review case or a proposed or final interim decision on a registration review case. (4) Specify proposed labeling changes; and (5) Identify deadlines that it intends to set for completing any required actions. (c) After considering any comments on the proposed decision, the Agency will issue a registration review decision or interim registration review decision. This decision will include an explanation of any changes to the proposed decision and the Agency's response to significant comments. The Agency will publish a notice in the Federal Register (d) If the registrant fails to take the action required in a registration review decision or interim registration review decision, the Agency may take appropriate action under FIFRA.