(a) Preliminary notification. If the Administrator decides that he may initiate a Special Review of a pesticide use, he shall send written notice by certified mail to the affected registrant(s) and applicant(s) setting forth his decision and a general description of the information which supports it.

(b) Comment opportunity. Registrant(s) and applicant(s) will be allowed 30 days from the receipt of notification to respond in writing to dispute the validity of the Agency's conclusions or to present information in response to the notification.

If the Administrator proposes not to initiate a Special Review after having given notice under § 154.21, he shall issue a proposed decision for publication in the Federal Register. The proposal shall include a description of the concerns which were the original basis for placement of the pesticide in pre-Special Review status and the Agency's rationale for its proposed decision, announce the availability of a public docket, and provide a period generally not less than 30 days for submission of comments. A notice under § 154.25(b) may not be published unless it has been preceded by a notice under this section. A proposal under this section shall not be based on the benefits of use of a pesticide product.

(a) The Administrator shall evaluate the available information and the comments received in response to the notice under § 154.21 and any notice issued under § 154.23, and shall issue for publication in the Federal Register a notice under paragraph (b) or (c) of this section.

(b) If the Administrator determines after having given notice under § 154.21 not to initiate a Special Review, he shall issue his decision for publication in the Federal Register with a statement of reasons.

(c) If the Administrator determines after having given notice under § 154.21 that one or more of the risk criteria set forth in § 154.7 have been satisfied, the Agency shall issue a notice for publication in the Federal Register which shall include:

(1) Identification of the pesticide uses for which a Special Review has been initiated and an identification of the criteria which have been satisfied.

(2) A brief discussion of the Agency's reasons for determining that the criteria have been satisfied.

(3) A statement indicating that EPA has established a docket for the Special Review, the contents of the docket, the location of the docket, and the times during which the docket will be available for inspection and copying.

(4) An invitation to all interested persons to submit further information concerning the risks and benefits associated with each use of the pesticide subject to the Special Review.

(5) A brief description of the Special Review process and a statement that registrants and applicants bear an affirmative burden of supporting registration of a pesticide product.

(6) A date by which information in response to the Agency's request for further information must be submitted.

(d) In his discretion, the Administrator may request that the Scientific Advisory Panel hold a public meeting to review the scientific issues related to the Special Review.

After issuance of a Notice of Special Review that applies to a use of a pesticide product (or category of products), any person may submit to the Agency any information, argument, or both, pertinent to:

(a) Whether the use of a pesticide product satisfies any of the § 154.7 risk criteria, with respect to the composition, labeling, packaging, and restrictions on use of the product as currently registered.

(b) Whether the use of a pesticide product would satisfy any of the § 154.7 risk criteria if its composition, labeling, packaging, and restrictions on use were approved in accordance with an application for registration or amended registration pending before the Agency. For further information see § 154.27(b).

(c) Whether any risks posed by the use or proposed use of the product that satisfy the § 154.7 risk criteria are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product.

(d) What regulatory action, if any, the Agency should take with respect to the use of the product.

(a) In the Special Review process, to assure openness and responsiveness, no person or party outside of government will be afforded special or preferential access to Agency Special Review decisionmakers or to the Agency's Special Review process. At the same time, however, Agency personnel are free to meet and otherwise communicate with persons or parties outside of government, including registrants and manufacturers, users, trade unions, environmental groups and other interested persons, to obtain information, exchange views, explore factual and substantive positions, or discuss regulatory options concerning Special Review decisions.

(b) Meetings between EPA and any person or party outside of government will not result in undue delay in reaching Special Review decisions. During such meetings, the Agency will not commit to take any particular action concerning a pending decision. The Agency may receive and consider information and recommendations from persons or parties outside of government; however, the Agency will make the final administrative decision on a wholly independent basis and in accordance with law.

(c) Any interested person may ask to meet with Agency officials to discuss factual information available to the Agency, to present any factual information, to respond to presentations by other persons, or to discuss what regulatory actions should be taken regarding a pesticide which is or may be the subject of a Special Review. If, at its discretion, the Agency holds such meetings with any person outside of government concerning a use of a pesticide product, the Agency will prepare and file in the docket a memorandum of such meeting, meeting the requirements specified in § 154.15(b)(7).

(d) Meetings described in this section may include meetings held after issuance of a Notice of Special Review with any registrant who proposes to change voluntarily the composition, packaging, and labeling, or other terms and conditions of registration of his pesticide product in a way which he believes would reduce the risks of use of the product so that it would no longer meet or exceed the risk criteria of § 154.7. Meetings for this purpose will be most helpful and productive for both registrants and the Agency if they are requested by registrants shortly after the issuance of the Notice of Special Review.

(e) If the Agency meets with any person or party outside of government concerning a pending Special Review decision, the Agency will not issue a final Special Review decision until 30 days after inclusion of a memorandum concerning that meeting in the public docket. During those 30 days, any person or party may submit written comments to the Agency regarding the subject matter of the meeting in question. The Agency may issue a final Special Review decision without allowing this 30-day period if expedited action is necessary to protect public health or the environment, or if the Agency has invited other parties with potentially opposing viewpoints to the meeting in question (e.g., registrants, users, labor, and environmental groups).

(f) The Agency may decline to meet subsequently with any person or party who asserts unreasonable confidential business information claims pursuant to § 154.15(c) for the purpose of circumventing the docketing procedures described in § 154.15(b).

(a) Timing. At any time after issuance of a Notice of Special Review and prior to issuance of a Notice of Final Determination, the Administrator may conduct an informal public hearing to gather relevant information or otherwise assist Agency decisionmaking.

(b) Federal Register notice. The Administrator shall issue a notice for publication in the Federal Register of any informal public hearing to be held under this section. The notice shall contain the following information:

(1) The time, date, and place of the hearing.

(2) A brief description of the procedures governing participation in the hearing by interested persons.

(3) The issues to be considered at the hearing.

(c) Transcript. A verbatim transcript of the hearing shall be prepared and filed in the public docket.

The Administrator shall prepare a Notice of Preliminary Determination after the close of the comment period on a Notice of Special Review.

(a) Contents of notice. The Notice of Preliminary Determination shall respond to all significant comments submitted in response to the Notice of Special Review. For each use of a pesticide product that was the subject of the Notice of Special Review, the Notice of Preliminary Determination shall also include, as appropriate:

(1) A determination whether the use satisfies any of the risk criteria set forth in § 154.7, and a discussion of the reasons for the determination.

(2) A determination of whether any changes in the composition, packaging, labeling, or restrictions on use of a pesticide product that were proposed in an application for new or amended registration submitted after issuance of the Notice of Special Review would reduce the risk so that the use no longer would satisfy any of the risk criteria in § 154.7.

(3) If the use satisfies any of the risk criteria set forth in § 154.7, a determination of whether the adverse effects posed by the use are unreasonable, taking into account the economic, social, and environmental costs and benefits of the use of the product, and a discussion of reasons for the determination.

(4) If the use is determined to pose an unreasonable adverse effect, a statement of the regulatory action, if any, which the Agency intends to initiate with respect to the use, and a discussion of the reasons for initiating that regulatory action.

(5) A statement that the Administrator is requesting comments from the Secretary of Agriculture and the Scientific Advisory Panel on the notices and analysis specified in paragraph (b) of this section, and that the notices and analysis are available on request.

(6) Instructions to interested persons on how to submit comments (including the deadline for submission of comments).

(7) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.

(b) Referral to Secretary of Agriculture and Scientific Advisory Panel. If the Administrator proposes to cancel, deny, or change the classification of the registration of a pesticide product which is the subject of a Special Review, or to hold a hearing under FIFRA section 6(b)(2) on whether to take any of those actions, he shall:

(1) Prepare a proposed form of a Notice of Intent to Cancel, a Notice of Intent to Deny Registration, a Notice of Intent to Hold a Hearing, and/or a Notice of Intent to Change Classification, as appropriate.

(2) Prepare an Agricultural Impact Analysis, analyzing the impact of the proposed action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy.

(3) Send the proposed notices and analysis to the Secretary of Agriculture and the Scientific Advisory Panel for comment, as provided by the Act.

(4) Send the Notice of Preliminary Determination and the other notices and analysis prepared under this section to all registrants and applicants for registration of products that are subject to the Special Review.

(c) Publication. The Agency shall issue the Notice of Preliminary Determination for publication in the Federal Register.

(a) Publication and notice to registrants and applicants. The Administrator shall prepare a Notice of Final Determination after the close of the comment period on a Notice of Preliminary Determination. As necessary, the Administrator shall also prepare Notices of Intent to Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under FIFRA section 6(b)(2), or Notices of Intent to Change Classification.

(b) Contents. The Notice of Final Determination shall include:

(1) For each pesticide use subject to the Notice of Preliminary Determination, the Agency's final determination with respect to each use, along with a discussion of the reasons for the determination.

(2) Any comments submitted by the Secretary of Agriculture or the Scientific Advisory Panel, and the responses of the Administrator to these comments.

(3) The response of the Administrator to any significant public comments submitted on the Notice of Preliminary Determination.

(4) Instructions to registrants, applicants for registration, and other interested persons concerning the procedures which will be used to implement any regulatory action which the Administrator has decided upon, including instructions concerning how to request hearings, if hearings are available as of right under the Act or have been made available by the Administrator under the Act.

(5) The location of the docket under § 154.15 and the times during which the docket will be available for inspection and copying.

(c) Publication and notification of registrants and applicants. The Notice of Final Determination and any Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification shall be published in the Federal Register. If the Administrator issues a Notice of Intent to Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to Change Classification, such notice, along with the Notice of Final Determination, also shall be sent by certified mail to all affected registrants and applicants.

(a) The Agency may elect to issue a Notice of Special Review and a Notice of Preliminary Determination simultaneously; or, to initiate cancellation, suspension, or denial proceedings concerning a pesticide or any of its uses without first conducting a Special Review or issuing a Notice of Preliminary Determination.

(b) If the Agency elects to issue a simultaneous Notice of Special Review and Notice of Preliminary Determination, the Agency will make the docket for that decision available for public inspection no more than 3 months after the Agency privately notifies the registrant of its risk concerns pursuant to § 154.21(a).

(a) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:

(1) The application proposes registration of a product for a use which earlier had been the subject of a notice under § 154.21(a);

(2) After the Administrator issued the notice, he determined not to initiate a Special Review, because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for a Special Review; and

(3) The application for registration or amended registration now proposes that the terms and conditions which served as the basis of the earlier determination be eliminated, or be modified in a way which might increase the risk which was the subject of the notice under § 154.21(a).

(b) The Administrator will not approve an application for registration or amended registration of a pesticide product except by use of the procedures specified in paragraph (c) of this section, if:

(1) The application proposed registration of a product for a use which earlier had been the subject of a Notice of Special Review issued under § 154.25;

(2) After the Administrator issued that Notice, he determined not to issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal by an applicant for registration or amended registration to change the terms and conditions of registration of the product in a way which would reduce the risk sufficiently to eliminate the need for issuance of a notice under FIFRA section 3(c)(6) or 6(b); and

(3) The application for registration or amended registration now proposes that the terms and conditions of registration which served as the basis for the earlier determination now be eliminated or be modified in a way which might increase the risk which was the subject of the Notice of Special Review.

(c) An application to which paragraph (a) or (b) of this section applies may not be approved until:

(1) The Administrator issues a notice for publication in the Federal Register which describes why the application is subject to the provisions of this section, states that the Administrator proposes to approve the application and his reasons, solicits public comment on whether the application should be approved, and provides a period not less than 30 days for comments to be submitted; and

(2) If any substantive comments are submitted in response to the notice, the Administrator issues a second notice for publication in the Federal Register responding to the comments.