exempted from the requirement of a tolerance, or which are within a tolerance permitted under section 408 are used, the processed foods will not be considered unsafe within the meaning of section 406 if:

(1) The poisonous or deleterious pesticide residues have been removed to the extent possible in good manufacturing practice; and

(2) The concentration of the pesticide in the preserved or processed food when ready to eat is not greater than the tolerance permitted on the raw agricultural commodity.

§ 120.2 Pesticide chemicals considered unsafe. (a) In general, pesticide chemicals are not generally recognized as safe for use, for the purpose of section 408 (a), except sulfur, lime, and limesulfur.

(b) Upon written request, the Pesticide Branch will advise interested persons whether a pesticide chemical should be considered as poisonous or deleterious, or one not generally recognized by qualified experts as safe.

(c) The training and experience necessary to qualify experts to evaluate the safety of pesticide chemicals for the purposes of section 408 (a) are essentially the same as training and experience necessary to qualify experts to serve on advisory committees prescribed by section 408 (g). (See § 120.11.)

§ 120.3 Tolerances for related pesticide chemicals. (a) Pesticide chemicals that cause related pharmacological effects will be regarded, in the absence of evidence to the contrary, as having an additive deleterious action. (For example, pesticide chemicals within each of the following groups have related pharmacological effects: Many chlorinated hydrocarbons, arsenic-containing chemicals, metallic dithiocarbamates, many organic phosphates.)

(b) Tolerances established for such related pesticide chemicals may limit the amount of a common component (such as As,O,) that may be present, or may limit the amount of biological activity (such as cholinesterase inhibition) that may be present, or may limit the total amount of related pesticide chemicals (such as chlorinated hydrocarbons) that may be present.

§ 120.4 Certification of usefulness and residue estimate. The time period

for the Department's consideration of a petition will not begin to run until the Secretary of Agriculture certifies that the pesticide chemical involved is useful and gives an opinion whether the tolerance proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed. The tolerance thereafter established ordinarily will not exceed that figure which the Secretary of Agriculture states, in his opinion, reasonably reflects the amounts of residue likely to result.

§ 120.5 Zero tolerances. A zero tolerance means that no amount of the pesticide chemical may remain on the raw agricultural commodity when it is offered for shipment. A zero tolerance for a pesticide chemical in or on a raw agricultural commodity may be established because, among other reasons:

(a) A safe level of the pesticide chemical in the diet of two different species of warm-blooded animals has not been re

liably determined.

(b) The chemical is carcinogenic to or has other alarming physiological effects upon one or more of the species of the test animals used, when fed in the diet of such animals.

(c) The pesticide chemical is toxic, but is normally used at times when, or in such manner that, fruit, vegetables, or other raw agricultural commodities will not bear or contain it.

(d) All residue of the pesticide chemical is normally removed through good agricultural practice such as washing or brushing or through weathering or other changes in the chemical itself, prior to introduction of the raw agricultural commodity into interstate commerce.

§ 120.6 Exemptions from the requirement of a tolerance. (a) An exemption from a tolerance shall be granted when it appears that the total quantity of the pesticide chemical in or on all raw agricultural commodities for which it is useful under conditions of use currently prevailing or proposed will involve no hazard to the public health.

(b) When applied to growing crops, in accordance with good agricultural practice, the following pesticide chemicals are exempt from the requirement of a tolerance:

(1) The following copper compounds: Bordeaux mixture, copper acetate, basic

copper carbonate (malachite), copperlime mixtures, copper oxychloride, copper silicate, copper sulfate basic, copperzinc chromate, cuprous oxide.

(2) N-Octylbicyclo-(2,2,1)-5-heptene

2,3-dicarboximide).

(3) Petroleum oils.

(4) Piperonyl butoxide.

(5) Piperonyl cyclonene.

(6) N-Propyl isome.

(7) Pyrethrum and pyrethrins.

(8) Rotenone or derris or cube roots. (9) Ryania.

(10) Sabadilla.

These pesticides are not exempted from the requirement of a tolerance when applied to a crop at the time of or after harvest.

PROCEDURE FOR FILING PETITIONS

§ 120.7 Petitions proposing tolerances or exemptions for pesticide residues in or on raw agricultural commodities. (a) Petitions to be filed with the Department under the provisions of section 408 (d) shall be submitted in duplicate to the Pesticide Branch. 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 § 120.33. 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:

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. (Sufficient information should be submitted about the analytical method to permit competent investigators to apply it successfully.)

E. Practicable methods for removing residue 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 $------, payable to the Food and Drug Administration to cover clerical operations, initial administrative review, and the cost incurred in considering the petition after it has been filed. Very truly yours,

The petitioner will be notified of the date on which his petition is filed.

ALL PETITIONS SHOULD BE SUBMITTED IN DUPLICATE. A SINGLE COPY WILL NOT BE ACCEPTED FOR FILING

(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 Pesticide Branch shall notify the petitioner within 15 days after its receipt of acceptance or nonacceptance of a petition, and if not accepted the rea

sons therefor. Copy of the notice shall be sent to the Plant Pest Control Branch, Agricultural Research Service, Department of Agriculture. 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 § 120.33 (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 Commissioner 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 Pesticide Branch may request a sample of the pesticide chemical at any time while a petition is under consideration. The Pesticide Branch 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 Secretary of Agriculture 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 Commissioner shall publish in the FEDERAL REGISTER Within 90 days after receipt of the certification of usefulness, a regulation establishing a tolerance for residues of of the pesticide chemical or exempting

such residues from the necessity of a tolerance, as provided in section 408 (d) (2) of the act.

§ 120.8 Withdrawal of petitions without prejudice. In some cases the Pesticide Branch 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 refiling or the date of receipt of certification from the Secretary of Agriculture, whichever is later. A deposit for fees as specified in § 120.33 (f) shall accompany the resubmission of the petition.

§ 120.9 Substantive amendments to petitions. After a petition has been filed 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 specified in § 120.33 (g).

ADVISORY COMMITTEES

§ 120.10 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 Commissioner and forward with such request an advance deposit for fees prescribed by § 120.33 (i) (3).

(b) If further advance deposits are not made upon request of the Commissioner, as provided for in § 120.33 (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 Commissioner requested the further advance deposit.

(c) In case the Commissioner 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.

§ 120.11 Appointment of advisory committee. (a) Whenever the referral of a petition or proposal to an advisory committee is requested or the Commissioner otherwise deems such referral necessary, the Commissioner will request the National Academy of Sciences 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 Commissioner 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 Commissioner 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 Commissioner shall appoint the experts so selected and fix their compensation at not to exceed $50.00 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 $25.00 per day.

§ 120.12 Procedure for advisory committee. (a) The Commissioner shall submit to the chairman of the committee the petition for tolerances, together with certification by the Secretary of Agriculture and such other relevant, reliable information as may be available. When the Commissioner 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 Commissioner. The secretariat shall furnish members of the committee with copies of the proposal or petition, certification from the Secretary of Agriculture, 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 Commissioner. Such meetings shall be held in Washington, D. C., or such other place as the Commissioner may designate. The Commissioner 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 Commissioner the report of the committee, including any minority report, and shall return the petition for tolerances and the certification by the Secretary of Agriculture. 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 Commissioner 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 Commissioner to act for the purposes of both sections 408 (d) (3) and (e).

(5) 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 committee 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

§ 120.13 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 Department and shall be accompanied by a filing fee as specified in § 120.33 (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

does (3) It 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 Commissioner shall inform the objector of the reasons.

(d) If objections to a regulation issued pursuant to a petition are filed by a person other than the petitioner, the Food and Drug Administration shall send a copy of the objections by registered 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.

If

§ 120.14 Public hearing; notice. 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 filed) show that the person filing the objections is adversely affected and that the grounds stated in support of the objections are reasonable, the Commissioner shall cause to be published in the FEDERAL REGISTER a 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.

§ 120.15 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 designated by the Commissioner for conducting the hearing. Any such designation may be made or revoked by the Commissioner 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,