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gating the regulation to which objections were taken and any report, recommendations, underlying data, and reasons that were certified to the Administrator by an advisory committee pursuant to section 408(d) (3). The report, recommendations, underlying data, and reasons shall be subject to section 7(c) of the Administrative Procedure Act. All documents constituting the record accumulated up to the start of the hearing shall be open for inspection by interested persons during office hours in the office of the hearing clerk of the Agency.
(f) The member of an advisory committee, if any, designated to testify, or any member requested to testify by the petitioner, the Agency, or the presiding officer, or who upon his own initiative requests to be heard, shall appear and testify with respect to the report, recommendations underlying data, and reasons of the committee. The designated member shall receive per diem and travel and subsistence expenses when incurred, as though he were attending a meeting of the advisory committee.
(g) If any person objects to the admission or rejection of any evidence or to other limitation of the scope of any examination or cross-examination, he shall state briefly the grounds for such objection, and the transcript shall not include extended argument or debate thereon except as ordered by the presiding officer. A ruling of the presiding officer on any such objection shall be a part of the transcript, together with such offer of proof as has been made. § 180.21 Transcript of the testimony.
Testimony given at a hearing shall be reported verbatim. All written statements, charts, tabulations, and similar data offered in evidence at the hearing shall be marked for identification and, upon a showing satisfactory to the presiding officer of their authenticity, relevancy, and materiality, shall be received in evidence subject to the Administrative Procedure Act (sec. 7(c), 60 Stat. 238; 5 U.S.C. 1006(c)). Exhibits shall, if practicable, be submitted in quintuplicate. In case the required number of copies are not made available, the presiding oficer shall exercise his discretion as to whether said exhibit shall be read in evidence or whether additional coples shall be required to be submitted within a time to be specified by the presiding officer. Where the testimony of a wit
ness refers to a statute or to a report or document, the presiding oficer shall, after inquiry relating to the identification of such statute, report, or document, determine whether the same shall be produced at the hearing and physically be made a part of the evidence by reference. Where relevant and material matter offered in evidence is embraced in a report or document containing immaterial and irrelevant matter, such immaterial and irrelevant matter shall be excluded and shall be segregated insofar as practicable, subject to the direction of the presiding officer. & 180.22 Oral and written arguments.
(a) Unless the presiding omcer issues an announcement at the hearing authorizing oral argument before him, it shall not be permitted.
(b) The presiding oficer shall announce at the hearing a reasonable period within which interested persons may file written arguments based solely upon the evidence received at the hearing, citing the pages of the transcript of the testimony or properly identified exhibits where such evidence occurs. | 180.23 Indexing of record.
(a) Whenever it appears to the presiding oficer that the record of hearing will be of such length that an index to the record will permit & more orderly presentation of the evidence and reduce delay, the presiding officer shall require counsel for the parties to prepare a daily topical index which will be available to the presiding officer and all parties. Preparation of such an index shall be apportioned among all counsel present in such manner as appears just and proper in the circumstances.
(b) The index should include each topic of testimony upon which evidence is taken, the name of each witness testifying upon the topic, the page of the record at which each portion of his testimony appeared, and the number of each exhibit relating to the topic. The index should also contain the name of each witness, followed by the topics upon which he testified and the page of the record at which such testimony appears. | 180.24 Certification of record.
At the close of the hearing, the presiding officer shall afford interested persons & short time (not longer than 1 week, except in unusual cases) in which to point out errors that may have been made in transcribing the testimony. The presiding officer shall promptly thereafter order such corrections made as in his judgment are required to make the transcript conform to the testimony, and he shall certify the transcript of testimony and the exhibits to the Administrator. § 180.25 Filing the record of the
hearing. As soon as practicable after the close of the hearing, the complete record of the hearing shall be filed in the office of the Hearing Clerk. The record shall in. clude the transcript of the testimony, and exhibits, and any written arguments that may have been filed. § 180.26 Copies of the record of the
hearing. The Agency will make provisions for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purposes. Any person desiring a copy of the record of the hearing or of any part thereof shall be entitled to the same upon payment of the costs thereof. $ 180.27 Proposed order.
As soon as practicable after the time for filing written arguments has ended the Administrator shall prepare and cause to be published in the FEDERAL REGISTER a proposed order which shall incorporate findings of fact, recommend decisions on the objections which were the subject of the hearing and tentative regulations. The proposed order shall specify a reasonable time, ordinarily not to exceed 30 days, within which any interested person may file exceptions. The exceptions shall point out with particularity the alleged errors in said proposed order and shall contain a specific reference to the pages of the transcript of the testimony or to the exhibits on which each exception is based. Such exceptions may be accompanied by a memorandum brief. § 180.28 Final order.
As soon as practicable after the time for filing exceptions has passed, the record and the exceptions shall be presented to the Administrator and he shall cause to be published in the FEDERAL REGISTER his final order promulgating the regulation.
ADOPTION OF TOLERANCE ON INITIATIVE OY
ADMINISTRATOR OR ON REQUEST OF IN-
AND REPEAL OF TOLERANCES; FEES $ 180.29 Adoption of tolerance on ini.
tiative of Administrator or on request
of an interested person. (a) Upon the request of an interested person (other than a person who has registered or who has submitted an application for the registration of an economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135)) furnishing reasonable grounds therefor, and upon advance deposit to cover fees as prescribed in § 180.33, the Administrator may propose the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance. Reasonable grounds shall include an explanation showing wherein the person has & substantial interest in such & tolerance or exemption from tolerance; information, if available, as to why registrant of the pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act has not petitioned for & tolerance or exemption from & tolerance; and adequate data on subjects outlined in clauses (A), (B), (C), (D), (E), and (F) of section 408(d) (1) of the Federal Food, Drug, and Cosmetic Act. If the Administrator concludes upon studying the request that it does not warrant a proposal for the issuance of a regulation, he shall so inform the person making the request and state the reasons for his decision.
(b) The notice of the proposal shall show whether it is made on the initiative of the Administrator or at the request of an interested person, naming such person.
(c) If within 30 days after publication of the proposal a person who has registered, or who has submitted an application for registration of an economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act containing the pesticide chemical named in the proposal, requests in writing that the proposal be referred to an advisory committee and makes advance deposit as provided by $ 180.33(i) (3), the Administrator shall appoint a committee as provided in $ 180.11 and refer the proposal and relevant data to such committee. The Agency and the committee shall
proceed as prescribed in section 408 and Federal Insecticide, Fungicide, and Rothis part.
denticide Act may be published in the (d) If further advance deposits are not FEDERAL REGISTER if the Administrator made upon request of the Administrator, deems such publication desirable. as provided in § 180.33(i) (3), the request (d) A temporary tolerance or exempfor referral of the petition to an ad- tion from a tolerance may be issued for visory committee hall be considered a period designed to allow the orderly withdrawn, and a tolerance shall be marketing of the raw agricultural comestablished within 90 days from the date modities produced while testing a pestion which the Administrator requested cide chemical under an experimental the further advance deposit.
permit issued under authority of the § 180.30 Judicial review.
Federal Insecticide, Fungicide, and Ro
denticide Act when the Administrator (a) The Administrator hereby desig- concludes that the public health can be nates the Deputy General Counsel, En- adequately protected during such marvironmental Protection Agency as the keting. A temporary tolerance or ex. officer upon whom copy of petition for emption from a tolerance may be rejudicial review shall be served. Such of- voked if the experimental permit is ficer shall be responsible for filing in the revoked, or may be revoked at any time court the record on which the order of if it develops that the application for a the Administrator is based. The record temporary tolerance contains a misshall be certified by the Administrator. statement of a material fact or that
(b) Before forwarding the record to new scientific data or experience with the court the Agency shall advise the the pesticide chemical indicates that it petitioner of costs of preparing it and may be hazardous to the public health. as soon as payment to cover fees is (e) Conditions under which a temmade shall forward the record to the porary tolerance is established shall court.
(1) A limitation on the amount of the $ 180.31 Temporary tolerances.
chemical to be used on the designated (a) A temporary tolerance (or exemp- crops permitted under the experimental tion from a tolerance) established under
permit. authority of section 408(j) of the act (2) A limitation for the use of the shall be deemed to be a tolerance (or chemical on the designated crops to bona exemption from the requirement of a fide experimental use by qualified pertolerance) for the purposes of section sons as indicated in the experimental 408(a) (1) or (2) of the act.
permit. (b) (1) A request for a temporary tol- (3) A requirement that the person or erance or a temporary exemption from firm which obtains the experimental a tolerance by a person who has obtained permit for which the temporary toleran experimental permit for a pesticide ance is established will immediately inchemical under the Federal Insecticide, form the Environmental Protection Fungicide, and Rodenticide Act shall be Agency of any reports on findings from accompanied by a copy of such experi- the experimental use that have a bearmental permit, such data as are avail- ing on safety. able on subjects outlined in clauses (A),
(4) A requirement that the person (B), (C), (D), (E), (F), and (G) of sec- or firm which obtained the experimental tion 408(d) (1), and an advance deposit
permit for which the temporary tolerto cover fees as provided in § 180.33(d). ance is established will keep records of
(2) Before an experimental permit has production, distribution, and performbeen obtained, the Pesticides Tolerance ance for a period of 2 years and, on reDivision upon request of the Environ- quest, at any reasonable time, make these mental Protection Agency or a person records available to any authorized ofiwho proposes to appiy for an experi- cer or employee of the Environmental mental permit will consider available Protection Agency. data and discuss its adequacy for the purpose of justifying a tolerance or ex
§ 180.32 Procedure for amending and emption from a tolerance.
repealing tolerances or exemptions (c) A notice of the issuance of a tema
from tolerances. porary tolerance outlining any restric- (a) The Administrator on his own tions as to use of the chemical imposed Initiative or on request from an interunder the experimental permit under the ested person furnishing reasonable
grounds therefor, may propose the issuance of a regulation amending or repealing a tolerance for a pesticide chemical on raw agricultural commodities or granting or repealing an exemption from tolerance for such chemical. Requests for such amendment or repeal shall be made in writing and accompanied by an advance deposit to cover fees as provided in $ 180.33(d).
(b) Reasonable grounds shall include an explanation showing wherein the person has a substantial interest in such tolerance or exemption from tolerance and an assertion of facts (supported by data if available) showing that new uses for the pesticide chemical have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the application of the tolerance or exemption from tolerance may justify its amendment or repeal. Evidence that a person has registered or has submitted an application for the registration of an economic poison under the Federal Insecticide, Fungicide, and Rodenticide Act will be regarded as evidence that he has a substantial interest in a tolerance or exemption from the requirement of a tolerance for a pesticide chemical that consists in whole or in part of the economic poison. New data should be fur. nished in the form specified in $ 180.7(b) for submitting petitions.
(c) The notice announcing the proposal to amend or repeal a regulation shall show whether the proposal was made on the initiative of the Administrator or at the request of an interested person, naming such person. From this point the proceedings shall be the same as prescribed by section 408(e), beginning with the second sentence of that paragraph, and the regulations appllcable to section 408 (d), (e), (f), and (g), $ 180.33 Fees.
(a) Except as noted in paragraphs (b) and (c) of this section, each petition or request for the establishment of a tolerance shall be accompanied by a deposit of $10,000, plus $1,000 for each raw agricultural commodity more than nine on which the establishment of a tolerance is requested.
(b) Except as noted in paragraph (d) (2) of this section, a petition requestIng a temporary tolerance or a temporary exemption from the requirement of & tolerance shall be accompanied by a
deposit of $6,000. A request to renew or extend such temporary tolerance or temporary exemption shall be accompanied by a deposit of $3,000.
(c) Each petition or request for the establishment of a tolerance at a lower numerical level or levels than a tolerance already established for the same pesti. cide chemical, or for the establishment of a tolerance on additional raw agricul. tural commodities at the same numerical level as a tolerance already established for the same pesticide chemical, shall be accompanied by a deposit of $1,000, plus $1,000 for each raw agricultural commodity on which a tolerance is requested.
(d) Each petition or request for an exemption from the requirement of a tolerance or the amendment or repeal of a tolerance or exemption shall be accompanied by a deposit of $10,000, unless it meets the requirements of subparagraph (1) or (2) of this paragraph.
(1) Such deposit is not required when, in connection with the change sought under this paragraph, a petition or request is filed for the establishment of new tolerances to take the place of those sought to be amended or repealed and a deposit is made as required by paragraph (a) of this section.
(2) A request for a temporary tolerance for a pesticide chemical which has a tolerance for other uses at the same numerical level or a higher numerical level shall be accompanied by a deposit of $1,000, plus $1,000 for each raw agri. cultural commodity on which the temporary tolerance is sought.
(e) If a petition or a request proposing the issuance of a regulation is not accepted for filing or processing because it is technically incomplete, the deposit, less a $1,000 fee for clerical handling and initial administrative review, shall be returned unless the petitioner indicates that he wishes to submit a supplement, in which case the deposit will be held by the Administrator, and the supplement shall be accompanied by a nonreturnable fee of $1,000.
(f) When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $3,000, or by a deposit equal to the one originally submitted, whichever is smaller. If resubmitted after 6 months, it shall be accompanied by the deposit that would be required if it were being submitted for the first time.
(g) After a petition has been filed, any additional information or data submitted in support of it (i.e., any substantive amendment) shall be accompanied by a deposit of $3,000 or by a deposit equal to the one originally submitted, whichever is smaller.
(h) Objections under section 408(d) (5) of the Act shall be accompanied by a filing fee of $1,000.
(i) (1) In the event of a referral of a petition or proposal under this section to an advisory committee, the costs shall be borne by the person who requests the referral of the data to the advisory committee.
(2) Costs of the advisory Committee shall include compensation for experts as provided in § 180.11(c) and the expenses of the secretariat, including the costs of duplicating petitions and other related material referred to the committee.
(3) An advance deposit shall be made in the amount of $10,000 to cover the costs. Further advance deposits of $10,000 each shall be made upon request of the Administrator when necessary to prevent arrears in the payment of such costs. Any deposits in excess of actual expenses will be refunded to the depositor.
(1) The person who files a petition for Judicial review of an order under section 408 (d) (5) or (e) of the act shall pay the costs of preparing the record on which the order is based.
(k) All deposits and fees required by the regulations in this part shall be paid by money order, bank draft, or certified check drawn to the order of the Environ. mental Protection Agency, collectible at par at Washington, D.C. All deposits and fees shall be forwarded to the Environmental Protection Agency, Washington, D.C., 20460, whereupon after making appropriate record thereof they will be transmitted to the Chief Disbursing Officer, Division of Disbursement, Treasurer of the United States, for deposit to & special account.
(1) The Administrator may waive or refund such fees in whole or in part when in his judgment such action will promote the public interest.
(m) Any person who believes that payment of these fees will work a hardship on him may petition the Administrator to waive or refund the fees, Ordinarily, fees will not be refundable
after a petition is filed under section 408(d) or after scientific review has begun on a petition submitted under section 408 (e) or (j). (36 FR 22540, Nov. 25, 1971, as amended at 37 FR 13978, July 15, 1972) $ 180.34 Tests on the amount of resi
due remaining. (a) Data in a petition on the amount of residue remaining in or on a raw agricultural commodity should establish the residue that may remain when the pesticide chemical is applied according to directions registered under the Fed. eral Insecticide, Fungicide, and Roden. ticide Act, or according to directions contained in an application for registration. These data should establish the residues that may remain under condi. tions most likely to result in high residues on the commodity.
(b) The petition should establish the reliability of the residue data reported in it. Sufficient information should be submitted about the analytical method to permit competent analysts to apply it successfully.
(c) If the pesticide chemical is absorbed into a living plant or animal when applied (is systemic), residue data may be needed on each plant or animal on which a tolerance or exemption is requested.
(d) If the pesticide chemical is not absorbed into the living plant or animal when applied (is not systemic), it may be possible to make a reliable estimate of the residues to be expected on each commodity in a group of related commodities on the basis of less data than would be required for each commodity in the group, considered separately.
(e) Each of the following groups of crops lists raw agricultural commodities that are considered to be related for the purpose of paragraph (d) of this section. Commodities not listed in this paragraph are not considered as related for the purpose of paragraph (d) of this section. This grouping of crops does not affect the certification of usefulness by the Administrator as contemplated by section 408 (1) of the act.
(1) Apples, crabapples, pears, quinces. (2) Avocados, papayas.
(3) Blackberries, boysenberries, dewberries, loganberries, raspberries.
(4) Blueberries, currants, gooseberries, huckleberries.
(5) Cherries, plums, prunes.