brushing or through weathering or other changes in the chemical itself, prior to introduction of the raw agricultural commodity into interstate commerce. § 180.6 Pesticide tolerances regarding milk, eggs, meat, and/or poultry; statement of policy.

(a) When establishing tolerances for pesticide residues in or on raw agricultural commodities, consideration is always given to possible residues of those pesticide chemicals or their conversion products entering the diet of man through the ingestion of milk, eggs, meat, and/or poultry produced by animals fed agricultural products bearing such pesticide residues. In each instance an evaluation of all available data will result in a conclusion either:

(1) That finite residues will actually be incurred in these foods from feed use of the raw agricultural commodity including its byproducts; or

(2) That it is not possible to establish with certainty whether finite residues will be incurred, but there is a reasonable expectation of finite residues; or

(3) That it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues.

(b) When the data show that finite residues will actually be incurred in milk, eggs, meat, and/or poultry, a tolerance will be established on the raw agricultural commodity used as feed provided that tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues incurred in milk, eggs, meat, and/or poultry. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is a reasonable expectation of finite residues in light of data reflecting exaggerated pesticides levels in feeding studies, a tolerance will be established on the raw agricultural commodity provided that appropriate tolerances can be established at the same time, on the basis of the toxicological and other data available, for the finite residues likely to be incurred in these foods through the feed use of the raw agricultural commodity or its byproducts. When it is not possible to determine with certainty whether finite residues will be incurred in milk, eggs, meat, and/or poultry but there is no reasonable expectation of finite residues in light of data such as those reflect

ing exaggerated pesticide levels in feeding studies and those elucidating the biochemistry of the pesticide chemical in the animal, a tolerance may be established on the raw agricultural commodity without the necessity of a tolerance on food products derived from the animal. (c) The principles outlined in paragraphs (a) and (b) of this section will also be followed with respect to tolerances for residues which will actually be incurred or are reasonably to be expected in milk, eggs, meat, and/or poultry by the use of pesticides directly on the animal or administered purposely in the feed or drinking water.

(d) Tolerances contemplated by paragraphs (a) and (b) of this section will in addition to toxicological considerations be conditioned on the availability of a practicable analytical method to determine the pesticide residue; that is, the method must be sensitive and reliable at the tolerance level or in special cases at a higher level where such level is deemed satisfactory and safe in light of the toxicity of the pesticide residue and of the unlikelihood of such residue exceeding the tolerance. The analytical methods to be used for enforcement purposes will be those set forth in the "Pesticide Analytical Manual" (see § 180.101 (c)). The sensitivities of these methods are expressed in that manual. (Sec. 701 (a), 68 Stat. 511 et seq.; 21 U.S.C. 371(a))

Subpart B-Procedural Regulations

PROCEDURE FOR FILING PETITIONS

§ 180.7

Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities.

(a) Petitions to be filed with the Agency under the provisions of section 408(d) shall be submitted in duplicate to the Pesticides Tolerance Division. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall be accompanied by an advance deposit for fees described in § 180.33. The petition shall state petitioner's mail address to which notice of objection under section 408 (d) (5) may be sent.

(b) Petitions shall include the following data and be submitted in the following form:

mits this petition pursuant to section 408 (d)(1) of the Federal Food, Drug, and Cosmetic Act with respect to the pesticide chemical

Attached hereto, in duplicate and constituting a part of this petition, are the following:

A. The name, chemical identity, and composition of the pesticide chemical. (If the pesticide chemical is an ingredient of an economis poison, the complete quantitative formal of the resulting economic poison should be submitted. The submission of this information does not restrict the application of any tolerance or exemption granted to the specific formula(s) submitted.)

B. The amount, frequency, and time of application of the pesticide chemical,

C. Full reports of investigations made with respect to the safety of the pesticide chemical. (These reports should include, where necessary, detailed data derived from appropriate animal or other biological experiments in which the methods used and the results obtained are clearly set forth.)

D. The results of tests on the amount of residue remaining, including a description of the analytical method used. (See § 180.34 for further information about residue tests.)

E. Practicable methods for removing realdue that exceeds any proposed tolerance.

F. Proposed tolerances for the pesticide chemical if tolerances are proposed.

G. Reasonable grounds in support of the petition.

Enclosed is (money order, bank draft, or certified check) for 8------, payable to the Environmental Protection Agency to cover clerical operations, initial administrative review, and the cost incurred in considering the petition after it has been filled. Very truly yours,

containing the pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act.

(c) Except as noted in paragraph (d) of this section, a petition shall not be accepted for filing if any of the data prescribed by section 408(d) are lacking or are not set forth so as to be readily understood. Data in a petition entitled to protection as a trade secret will be held confidential and not revealed unless it is necessary to do so in administrative or judicial proceedings under section 408.

(d) The Pesticides Tolerance Division shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. Copy of the notice shall be sent to the Pesticides Regulation Division, Environmental Protection Agency. If accepted, the date of notification becomes the date of filing for the purposes of section 408 (d) (1). If petitioner desires, he may supplement a deficient petition after notification as to deficiencies. Each supplement shall be accompanied by a deposit of fees as specified in § 180.33 (e). If the supplementary material or explanation of petition is deemed acceptable, petitioner shall be notified, and date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. The Administrator shall publish in the FEDERAL REGISTER Within 30 days a notice of filing, name of petitioner, and a brief outline of the petition, including description of analytical method or reference to a publication in which it appears, if such publication is generally available.

(e) The Pesticides Tolerance Division may request a sample of the pesticide chemical at any time while a petition is under consideration. The Pesticides Tolerance Division shall specify in its request for a sample of the pesticide chemical, a quantity which it deems adequate to permit tests of analytical methods used to determine residues of the pesticide chemical and of methods proposed by the petitioner for removing any residues of the chemical that exceed the tolerance proposed. The date used for computing the 90-day limit for the purposes of section 408(d)(2) shall be moved forward 1 day for each day in excess of 15 from the mailing date of the request

taken by the petitioner to submit the sample. If the sample is not submitted within 180 days after mailing date of the request, the petition will be considered withdrawn without prejudice.

(f) The date of receipt from the Administration of certification as to usefulness shall be the date used for computing the 90-day limit for the purposes of section 408(d) (2).

(g) Unless the petition is referred to an advisory committee, the Administrator shall publish in the FEDERAL REGISTER Within 90 days after receipt of the certification of usefulness, a regulation establishing a tolerance for residues of the pesticide chemical or exempting such residues from the necessity of a tolerance, as provided in section 408 (d) (2) of the act.

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371)

§ 180.8 Withdrawal of petitions without prejudice.

In some cases the Pesticides Tolerance Division or an advisory committee to which the petition has been referred will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a tolerance or the tolerance requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal may be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refilling or the date of receipt of certification from the Administrator, whichever is later. A deposit for fees as specified in § 180.33 (f) shall accompany the resubmission of the petition.

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371)

§ 180.9 Substantive amendments to pe

titions.

After a petition has been filled or referred to an advisory committee, the petitioner may submit additional information or data in support thereof, but in such cases the petition will be given a new filing date or a new initial date of consideration by the advisory committee, and the time limitation will begin to run anew. The additional data shall be accompanied by a deposit of fees as spectfied in § 180.33(g).

ADVISORY COMMITTEES

§ 180.10 Referral of petition to advisory

committee.

(a) If within the prescribed period a person filing a petition requests that the petition be referred to an advisory committee, he shall make such request in writing to the Administrator and forward with such request an advance deposit for fees prescribed by § 180.33 (i) (3).

(b) If further advance deposits are not made upon request of the Administrator, as provided for in § 180.33 (i) (3), the request for referral of the petition to an advisory committee shall be considered withdrawn, and a tolerance shall be established within 90 days of the date on which the Administrator requested the further advance deposit.

(c) In case the Administrator on his own initiative deems it necessary to refer a petition to an advisory committee, he shall, in writing, so inform the person filing the petition.

§ 180.11 Appointment of advisory committee.

(a) Whenever the referral of a petition or proposal to an advisory committee is requested or the Administrator otherwise deems such referral necessary, the Administrator will request the National Academy of Sciences, National Research Council, to select qualified experts, including at least one representative from land-grant colleges, willing to serve on the advisory committee. All such experts shall have had sufficient training and experience in biology, medicine, physiology, toxicology, pharmacology, veterinary medicine, or other appropriate science to evaluate the safety of pesticide chemicals. The Administrator will request the National Academy of Sciences, when it furnishes the names of such experts, to supply a biographical sketch showing the background of their experience and their connection, if any, with academic and commercial institutions.

(b) Each advisory committee shall consist of not less than three experts. at least one of whom is a representative from a land-grant college. The Administrator may specify a larger number to serve. He shall appoint one member of the committee as chairman, and the chairman shall be the spokesman of the committee for receiving and forwarding reports and other functions of the committee.

(c) The Administrator shall appoint the experts so selected and fix their compensation at not to exceed the maximum permitted by other authority per day for each day or part thereof spent in committee meetings and in traveling to and from committee meetings held outside the city of their residence, plus necessary traveling and subsistence expenses while the experts are serving away from their places of residence. Subsistence expenses shall not exceed the maximum per diem permitted by other authority.

§ 180.12 Procedure for advisory committee.

(a) The Administrator shall submit to the chairman of the committee the petition for tolerances, together with certification by the Administrator and such other relevant, reliable information as may be available. When the Administrator submits a proposal to an advisory committee, he shall inform the petitioner and furnish him with copies of material other than the petition and certification that is furnished the committee. The chairman of the committee shall acknowledge receipt of the information and readiness of the committee to act. The date of receipt of such information shall be considered the beginning of the period allowed for consideration by the committee. Copy of this acknowledgment shall be forwarded to the petitioner by the chairman of the committee.

(b) A secretariat to advisory committees will be established by the Administrator. The secretariat shall furnish members of the committee with copies of the proposal or petition, certification from the Administrator, and any data received by the chairman. If the chairman of the committee believes that a meeting of the committee is necessary before making a recommendation, he shall so advise the Administrator. Such meetings shall be held in Washington, D.C., or such other place as the Administrator may designate. The Administrator shall furnish a suitable meeting place for the committee. If a meeting is held, the secretariat shall keep the minutes and provide clerical assistance.

(c) As soon as practicable, but not later than 60 days after receipt of proposal or petition (unless the time has been extended as provided in paragraph (d) of this section), the chairman shall certify to the Administrator the report

of the committee, including any minority report, and shall return the petition for tolerances and the certification. The report will include copies of all relevant material considered by the committee, except that in the case of scientific literature readily available in scientific libraries proper reference may be made to it instead of furnishing actual copies. The report of the advisory committee shall be available for inspection by any interested person after a tolerance or exemption resulting from the petition is published.

(d) If at any time within 60 days, the chairman believes that the advisory committee needs more time, he shall so inform the Administrator in writing, in which case he shall make the certification contemplated by section 408 (d) (3) of the act within the additional 30 days.

(e) The date of receipt of the committee report will be the date for computing time for the Administrator to act for the purposes of both sections 408 (d) (3) and (e).

(f) The chairman of the committee, after consultation with the committee members, will inform the National Academy of Sciences of the committee's opinion as to the member who may best represent the committe at a hearing, if

one occurs.

(g) More than one petition or proposal may be handled by a committee concurrently.

(h) Persons authorized under section 408 (h) to discuss proposals or petitions with the committee shall notify the chairman and if practicable make appointments through him. The report of the committee shall show the names of persons other than committee members discussing proposals or petitions with the committee. Except for discussions with authorized persons the committee shall not disclose data originating with a petitioner prior to publication of a regulation.

PROCEDURE FOR FILING OBJECTIONS AND HOLDING A PUBLIC HEARING § 180.13 Objections to regulations and requests for hearings.

(a) Objections under section 408(d) (5) shall be submitted in quintuplicate to the hearing clerk of the Agency and shall be accompanied by a filing fee as specified in § 180.33 (h). Each objection to a provision of the regulation shall be separately numbered.

(b) A statement of objections shall not be accepted for filing if:

(1) It fails to establish that the objector is adversely affected by the regulation; or

(2) It does not specify with particularity the provisions of the regulation to which objection is taken; or

(3) It does not state reasonable grounds for each objection raised. Grounds which it is reasonable to conclude are capable of being established by reliable evidence at the hearing and which if proved would call for changing the provisions specified in the objections will be deemed reasonable grounds.

(c) If the statement of objections may not be filed, the Administrator shall inform the objector of the reasons.

(d) If objections to a regulation issued pursuant to a petition are filled by a person other than the petitioner, the Agency shall send a copy of the objections by certified mail, return receipt requested, to the petitioner at the address given in the petition. Petitioner shall have 2 weeks from the date of receipt of the objections to make written reply.

§ 180.14

Public hearing; notice.

If the objections and statements filed by any person, when they are considered with the record in the proceeding (including any reply to the objections that the petitioner may have filled) show that the person filing the objections is adversely affected and that the grounds stated in support of the objections are reasonable, the Administrator shall cause to be published in the FEDERAL REGISTER & notice reciting the objections and announcing a public hearing to receive evidence on them. The notice shall designate the place where the hearing will be held, specify the time within which appearances must be filed, and specify the time (not earlier than 30 days after the date of the notice) when the hearing will start. The hearing shall convene at the place and time announced in the notice but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof by the presiding officer at the hearing.

§ 180.15 Presiding officer.

The hearing shall be conducted by a presiding officer, who shall be a hearing examiner appointed as provided in the Administrative Procedure Act and desig

nated by the Administrator for conducting the hearing. Any such designation may be made or revoked by the Administrator at any time. Hearings shall be conducted in an informal but orderly manner in accordance with these regulations and the requirements of the Administrative Procedure Act. The presiding officer shall have the power to administer oaths and affirmations; to request the member of an advisory committee designated as provided by section 408 (d) (5) to testify with respect to the report and recommendations of the committee; to rule upon offers of proof and admissibility of evidence; to receive relevant evidence; to examine witnesses; to regulate the course of the hearing; to hold conferences for the simplification of the issues, and to dispose of procedural requests; but he shall not have power to decide any motion that involves final determination of the merits of the proceeding.

§ 180.16 Parties; burden of proof; ap

pearances.

At the hearing, the person whose objections raised the issues to be determined shall be, within the meaning of section 7(c) of the Administrative Procedure Act, the proponent of the order sought, and accordingly shall have the burden of proof. Any interested person shall be given an opportunity to appear at the hearing, either in person or by his authorized representative, and to be heard with respect to matters relevant to the issues raised by the objections. Any interested person who desires to be heard at the hearing in person or through a representative shall, within the time specified in the notice of hearing, file with the presiding officer a written notice of appearance setting forth his name, address, and employment. If such person desires to be heard through a representative, such person or such representative shall file with the presiding officer a written appearance setting forth the name, address, and employment of such person. Any person or representative shall state with particularity in the appearance his interest in the proceedings and shall set forth the specific provisions of the regulations concerning which objections have been made on which such person desires to be heard. The appearance shall also set forth with particularity the position to be taken concerning the objections on which he wishes to be heard. No person shall be