Chapter 559 - 2d Session AN ACT All 68 Stat. 511. To amend the Federal Food, Drug, and Cosmetic Act with respect to residues of pesticide chemicals in or on raw agricultural commodities. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of Pesticide chemthe Federal Food, Drug, and Cosmetic Act is amended by adding at ical residues. the end thereof the following new paragraphs: 52 Stat. 1041. "(q) The term 'pesticide chemical' means any substance which, 21 USC 321. alone, in chemical combination or in formulation with one or more Definitions. other substances, is an 'economic poison' within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U. S. C., secs. 135-135k) as now in force or as hereafter amended, and which is used 61 Stat. 163. in the production, storage, or transportation of raw agricultural commodities. “(r) The term 'raw agricultural commodity' means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing." SEC. 2. Clause (2) of section 402 (a) of the Federal Food, Drug, and Adulterated Cosmetic Act is amended to read as follows: "(2) if it bears or con- food. tains any added poisonous or added deleterious substance, except a pesticide chemical in or on a raw agricultural commodity, which is unsafe within the meaning of section 406, or if it is a raw agricultural 21 USC 346. commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 408 (a);". SEC. 3. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end thereof the following new section: "TOLERANCES FOR PESTICIDE CHEMICALS IN OR ON RAW AGRICULTURAL COMMODITIES "SEC. 408. (a) Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, added to a raw agricultural commodity, shall be deemed unsafe for the purposes of the application of clause (2) of section 402 (a) unless "(1) a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed by the Secretary of Health, Education, and Welfare under this section and the quantity of such pesticide chemical in or on the raw agricultural commodity is within the limits of the tolerance so prescribed; or "(2) with respect to use in or on such raw agricultural commodity, the pesticide chemical has been exempted from the requirement of a tolerance by the Secretary under this section. While a tolerance or exemption from tolerance is in effect for a pesticide chemical with respect to any raw agricultural commodity, such raw agricultural commodity shall not, by reason of bearing or containing any added amount of such pesticide chemical, be considered to be adulterated within the meaning of clause (1) of section 402 (a). 21 USC 342. 21 USC 342. "(b) The Secretary shall promulgate regulations establishing toler- Establishment of ances with respect to the use in or on raw agricultural commodities toleranoes. of poisonous or deleterious pesticide chemicals and of pesticide chemicals which are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, to the extent necessary to protect the public health. In establishing any such regulation, the Secretary shall give appropriate consideration, among other relevant factors, (1) to the All 68 Stat. 512, necessity for the production of an adequate, wholesome, and economical food supply; (2) to the other ways in which the consumer may be affected by the same pesticide chemical or by other related substances that are poisonous or deleterious; and (3) to the opinion of the Secretary of Agriculture as submitted with a certification of usefulness under subsection (1) of this section. Such regulations shall be promulgated in the manner prescribed in subsection (d) or (e) of this section. In carrying out the provisions of this section relating to the establishment of tolerances, the Secretary may establish the tolerance applicable with respect to the use of any pesticide chemical in or on any raw agricultural commodity at zero level if the scientific data before the Secretary does not justify the establishment of a greater tolerance. "(c) The Secretary shall promulgate regulations exempting any pesticide chemical from the necessity of a tolerance with respect to use in or on any or all raw agricultural commodities when such a tolerance is not necessary to protect the public health. Such regulations shall be promulgated in the manner prescribed in subsection (d) or (e) of this section. "(d) (1) Any 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 may file with the Secretary of Health, Education, and Welfare, a petition proposing the issuance of a regulation establishing a tolerance for a pesticide chemical which constitutes, or is an ingredient of, such economic poison, or exempting the pesticide chemical from the requirement of a tolerance. The petition shall contain data showing "(A) the name, chemical identity, and composition of the pesticide chemical; "(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; "(D) the results of tests on the amount of residue remaining, including a description of the analytical methods used; "(E) practicable methods for removing residue which exceeds any proposed tolerance; "(F) proposed tolerances for the pesticide chemical if tolerances are proposed; and "(G) reasonable grounds in support of the petition. Samples of the pesticide chemical shall be furnished to the Secretary upon request. Notice of the filing of such petition shall be published in general terms by the Secretary within thirty days after filing. Such notice shall include the analytical methods available for the determination of the residue of the pesticide chemical for which a tolerance or exemption is proposed. "(2) Within ninety days after a certification of usefulness by the Secretary of Agriculture under subsection (1) with respect to the pesticide chemical named in the petition, the Secretary of Health, Education, and Welfare shall, after giving due consideration to the data submitted in the petition or otherwise before him, by order make public a regulation "(A) establishing a tolerance for the pesticide chemical named in the petition for the purposes for which it is so certified as useful, or "(B) exempting the pesticide chemical from the necessity of a tolerance for such purposes, unless within such ninety-day period the person filing the petition requests that the petition be referred to an advisory committee or the All 68 Stat. 513. Secretary within such period otherwise deems such referral necessary, in either of which events the provisions of paragraph (3) of this subsection shall apply in lieu hereof. "(3) In the event that the person filing the petition requests, within Referral to ninety days after a certification of usefulness by the Secretary of advisory comAgriculture under subsection (1) with respect to the pesticide chemical mitte.. named in the petition, that the petition be referred to an advisory committee, or in the event the Secretary of Health, Education, and Welfare within such period otherwise deems such referral necessary, the Secretary of Health, Education, and Welfare shall forthwith submit the petition and other data before him to an advisory committee to be appointed in accordance with subsection (g) of this section. As soon as practicable after such referral, but not later than sixty days thereafter, unless extended as hereinafter provided, the committee shall, after independent study of the data submitted to it by the Secretary and other data before it, certify to the Secretary a report and recommendations on the proposal in the petition to the Secretary, together with all underlying data and a statement of the reasons or basis for the recommendations. The sixty-day period provided for herein may be extended by the advisory committee for an additional thirty days if the advisory committee deems this necessary. Within Regulation. thirty days after such certification, the Secretary shall, after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, by order make public a regulation "(A) establishing a tolerance for the pesticide chemical named in the petition for the purposes for which it is so certified as useful; or "(B) exempting the pesticide chemical from the necessity of a tolerance for such purposes. "(4) The regulations published under paragraph (2) or (3) of Effectivity. this subsection will be effective upon publication. "(5) Within thirty days after publication, any person adversely Hearings. affected by a regulation published pursuant to paragraph (2) or (3) of this subsection, or pursuant to subsection (e), may file objections thereto with the Secretary, specifying with particularity the provisions of the regulation deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. A copy of the objections filed by a person other than the petitioner shall be served on the petitioner, if the regulation was issued pursuant to a petition. The petitioner shall have two weeks to make a written reply to the objections. The Secretary shail thereupon, after due notice, hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee shall be made a part of the record of the hearing, if relevant and material, subject to the provisions of section 7 (c) of the Administrative Procedure Act (5 U. S. C., sec. 1006 (c)). The National Academy of Sciences shall designate a 60 Stat. 241. member of the advisory committee to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing: Provided, That this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing. As soon as practicable after completion of the hearing, the Secretary shall act upon such objections and by order make public a regulation. Such regulation shall be based only on substantial evidence of record at such hearing, including any report, recommendations, underlying data, and reasons certified to the Secretary by an All 68 Stat. 514. advisory committee, and shall set forth detailed findings of fact upon which the regulation is based. No such order shall take effect prior to the ninetieth day after its publication, unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions. Secretary's (e) The Secretary may at any time, upon his own initiative or upon proposals, etc. the request of any interested person, propose the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance. Thirty days after publication of such a proposal, the Secretary may by order publish a regulation based upon the proposal which shall become effective upon publication unless within such thirty-day period a person who has registered, or who has submitted an application for the registration of, an economic 7 USC 135 note. poison under the Federal Insecticide, Fungicide, and Rodenticide Act containing the pesticide chemical named in the proposal, requests that the proposal be referred to an advisory committee. In the event of such a request, the Secretary shall forthwith submit the proposal and other relevant data before him to an advisory committee to be appointed in accordance with subsection (g) of this section. As soon as practicable after such referral, but not later than sixty days thereafter, unless extended as hereinafter provided, the committee shall, after independent study of the data submitted to it by the Secretary and other data before it, certify to the Secretary a report and recommendations on the proposal together with all underlying data and a statement of the reasons or basis for the recommendations. The sixty-day period provided for herein may be extended by the advisory committee for an additional thirty days if the advisory committee deems this necessary. Within thirty days after such certification, the Secretary may, after giving due consideration to all data before him, including such report, recommendations, underlying data and statement, by order publish a regulation establishing a tolerance for the pesticide chemical named in the proposal or exempting it from the necessity of a tolerance which shall become effective upon publication. Regulations issued under this subsection shall upon publication be subject to paragraph (5) of subsection (d). Confidential data. Advisory oommittees. Members. Compensation. "(f) All data submitted to the Secretary or to an advisory committee in support of a petition under this section shall be considered confidential by the Secretary and by such advisory committee until publication of a regulation under paragraph (2) or (3) of subsection (d) of this section. Until such publication, such data shall not be revealed to any person other than those authorized by the Secretary or by an advisory committee in the carrying out of their official duties under this section. "(g) Whenever the referral of a petition or proposal to an advisory committee is requested under this section, or the Secretary otherwise deems such referral necessary the Secretary shall forthwith appoint a committee of competent experts to review the petition or proposal and to make a report and recommendations thereon. Each such advisory committee shall be composed of experts, qualified in the subject matter of the petition and of adequately diversified professional background selected by the National Academy of Sciences and shall include one or more representatives from land-grant colleges. The size of the committee shall be determined by the Secretary. Members of an advisory committee shall receive as compensation for their services a reasonable per diem, which the Secretary shall by rules and regulations prescribe, for time actually spent in the work of the committee, and shall in addition be reimbursed for their necessary traveling and subsistence expenses while so serving away from their All 68 Stat. 515. places of residence. The members shall not be subject to any other provisions of law regarding the appointment and compensation of employees of the United States. The Secretary shall furnish the Clerical assist committee with adequate clerical and other assistance, and shall by anoe, eto. rules and regulations prescribe the procedure to be followed by the committee. "(h) A person who has filed a petition or who has requested the Consultation referral of a proposal to an advisory committee in accordance with right. the provisions of this section, as well as representatives of the Department of Health, Education, and Welfare, shall have the right to consult with any advisory committee provided for in subsection (g) in connection with the petition or proposal. "(i) (1) In a case of actual controversy as to the validity of any Appeals. order under subsection (d) (5), (e), or (1) any person who will be Judicial readversely affected by such order may obtain judicial review by filing in view. the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a petition praying that the order be set aside in whole or in part. "(2) In the case of a petition with respect to an order under subsection (d) (5) or (e), a copy of the petition shall be forthwith served upon the Secretary, or upon any officer designated by him for that purpose, and thereupon the Secretary shall certify and file in the court a transcript of the proceedings and the record on which he based his order. Upon such filing, the court shall have exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The findings of the Secretary with respect to questions of fact shall be sustained if supported by substantial evidence when considered on the record as a whole, including any report and recommendation of an advisory committee. "(3) In the case of a petition with respect to an order under subsection (1), a copy of the petition shall be forthwith served upon the Secretary of Agriculture, or upon any officer designated by him for that purpose, and thereupon the Secretary shall certify and file in the court a transcript of the proceedings and the record on which he based his order. Upon such filing, the court shall have exclusive jurisdiction. to affirm or set aside the order complained of in whole or in part. The findings of the Secretary with respect to questions of fact shall be sustained if supported by substantial evidence when considered on the record as a whole. "(4) If application is made to the court for leave to adduce additional evidence, the court may order such additional evidence to be taken before the Secretary of Health, Education, and Welfare or the Secretary of Agriculture, as the case may be, and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper, if such evidence is material and there were reasonable grounds for failure to adduce such evidence in the proceedings below. The Secretary of Health, Education, and Welfare or the Secretary of Agriculture, as the case may be, may modify his findings as to the facts and order by reason of the additional evidence so taken, and shall file with the court such modified findings and order. "(5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States Code. The commencement of proceedings under this section shall not, 62 Stat. 928. unless specifically ordered by the court to the contrary, operate as a |