Sept. 6, 1958, Pub. L. 85-929, § 3(c), 72 Stat. 1785; July 12, 1960, Pub. L. 86-618, title I, § 103(a)(1), 74 Stat. 398.)

AMENDMENTS

1960-Pub. L. 86-618 repealed former subsec. (b), which required the Secretary to promulgate regulations for the listing of coal-tar colors.

1958-Subsec. (a). Pub. L. 85-929 substituted "clause (2)(A)" for “clause (2)” in first sentence.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective, subject to the provisions of section 203 of Pub. L. 86-618, on July 12, 1960, see section 202 of Pub. L. 86-618, set out as an Effective Date of 1960 Amendment note under section 376 of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND DESICCANT AMENDMENT OF 1959 Effective date of subsec. (a) of this section as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-139, Aug. 7, 1959, 73 Stat. 288.

EFFECTIVE DATE OF 1958 AMENDMENT

Effective date of 1958 amendment of subsec. (a), see section 6(b), (c) of Pub. L. 85-929, set out as an Effective Date of 1958 Amendment note under section 342 of this title.

TRANSFER OF FUNCTIONS

All functions vested in the Secretary of Health, Education, and Welfare in establishing tolerances for pesticide chemicals under this section together with the authority to monitor compliance with the tolerances and the effectiveness of surveillance and enforcement and to provide technical assistance to the States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, were transferred to the Administrator of the Environmental Protection Agency by Reorg. Plan No. 3 of 1970, § 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government Organization and Employees.

For transfer of functions of the Federal Security Administrator to the Secretary of Health, Education, and Welfare, and of the Food and Drug Administration to the Federal Security Agency, see Transfer of Functions note set out under section 41 of this title.

CROSS REFERENCES

Pesticide chemical regulations, see section 346a of this title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 342, 346a, 371 of this title.

§ 346a. Tolerances for pesticide chemicals in or on raw agricultural commodities

(a) Conditions of safety

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 342(a) of this title unless

(1) a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed by the Administrator of the Environmental Protection Agency 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 Administrator 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 342(a) of this title.

(b) Establishment of tolerances

The Administrator shall promulgate regulations establishing tolerances with respect to the use in or on raw agricultural commodities 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 Administrator shall give appropriate consideration, among other relevant factors, (1) to the 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 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 Administrator 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 Administrator does not justify the establishment of a greater tolerance.

(c) Exemptions

The Administrator 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) Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings

(1) Any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] may file with the Administrator a petition proposing the issuance of a regulation establishing a tolerance for a pesticide chemical which constitutes, or is an ingredient of, such pesticide, 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 Administrator upon request. Notice of the filing of such petition shall be published in general terms by the Administrator 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 under subsection (1) of this section with respect to the pesticide chemical named in the petition, the Administrator 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 Administrator 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 ninety days after a certification of usefulness under subsection (1) of this section with respect to the pesticide chemical named in the petition, that the petition be referred to an advisory committee, or in the event the Administrator within such period otherwise deems such referral necessary, the Administrator 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 Administrator and other data before it, certify to the Administrator a report and recommendations on the proposal in the petition to the Administrator, 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 Administrator 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 this subsection will be effective upon publication.

(5) Within thirty days after publication, any person adversely affected by a regulation published pursuant to paragraph (2) or (3) of this subsection, or pursuant to subsection (e) of this section, may file objections thereto with the Administrator, 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 Administrator shall 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 556(d) of title 5. The National Academy of Sciences shall designate a 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 Administrator, 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 Administrator 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 Administrator by an 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 Administrator finds that emergency conditions exist necessitating an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.

(e) Regulations pursuant to Administrator's proposals

The Administrator may at any time, upon his own initiative or upon 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 Administrator 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, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] 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 Administrator 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 Administrator and other data before it, certify to the Administrator 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 Administrator 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) of this section.

(f) Data submitted as confidential

All data submitted to the Administrator or to an advisory committee in support of a petition under this section shall be considered confidential by the Administrator 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 Administrator or by an advisory committee in the carrying out of their official duties under this section.

(g) Advisory committees; appointment; composition; compensation; clerical assistance

Whenever the referral of a petition or proposal to an advisory committee is requested under this section, or the Administrator otherwise deems such referral necessary the Administrator 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 Administrator. Members of an advisory committee shall receive compensation

and travel expenses in accordance with section 376(b)(5)(D) of this title. The members shall not be subject to any other provision of law regarding the appointment and compensation of employees of the United States. The Administrator shall furnish the Committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee. (h) Right of consultation

A person who has filed a petition or who has requested the referral of a proposal to an advisory committee in accordance with the provisions of this section, as well as representatives of the Environmental Protection Agency, shall have the right to consult with any advisory committee provided for in subsection (g) of this section in connection with the petition or proposal.

(i) Judicial review

(1) In a case of actual controversy as to the validity of any order under subsections (d)(5), (e), or (l) of this section any person who will be adversely affected by such order may obtain judicial review by filing in 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) of this section, a copy of the petition shall be forthwith transmitted by the clerk of the court to the Administrator, or any officer designated by him for that purpose, and thereupon the Administrator shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition, the court shall have exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The findings of the Administrator 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) of this section, a copy of the petition shall be forthwith transmitted by the clerk of the court to the Administrator, or any officer designated by him for that purpose, and thereupon the Administrator shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28. Upon the filing of such petition, the court shall have exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The findings of the Administrator 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 Administrator 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 Administrator 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. The commencement of proceedings under this section shall not, unless specifically ordered by the court to the contrary, operate as a stay of an order. The courts shall advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

(j) Temporary tolerances

The Administrator may, upon the request of any person who has obtained an experimental permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] or upon his own initiative, establish a temporary tolerance for the pesticide chemical for the uses covered by the permit whenever in his judgment such action is deemed necessary to protect the public health, or may temporarily exempt such pesticide chemical from a tolerance. In establishing such a tolerance, the Administrator shall give due regard to the necessity for experimental work in developing an adequate, wholesome, and economical food supply and to the limited hazard to the public health involved in such work when conducted in accordance with applicable regulations under the Federal Insecticide, Fungicide, and Rodenticide Act.

(k) Regulations based on public hearings before January 1, 1953

Regulations affecting pesticide chemicals in or on raw agricultural commodities which are promulgated under the authority of section 346(a) of this title upon the basis of public hearings instituted before January 1, 1953, in accordance with section 371(a) of this title, shall be deemed to be regulations under this section and shall be subject to amendment or repeal as provided in subsection (m) of this section.

(1) Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations

The Administrator, upon request of any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.), and whose request is accompanied by a copy of a petition filed by such person under subsection (d)(1) of this section with respect to a pesticide chemical which constitutes, or is an ingredient of, such pesticide, shall, within thirty days or within sixty days if upon notice prior to the termination of such thirty days the Administrator deems it necessary to postpone action for such period, on the basis of data before him, either

(1) certify that such pesticide chemical is useful for the purpose for which a tolerance or exemption is sought; or

(2) notify the person requesting the certification of his proposal to certify that the pesticide chemical does not appear to be useful for the purpose for which a tolerance or exemption is sought, or appears to be useful for only some of the purposes for which a tolerance or exemption is sought.

In the event that the Administrator takes the action described in clause (2) of the preceding sentence, the person requesting the certification, within one week after receiving the proposed certification, may either (A) request the Administrator to certify on the basis of the proposed certification; (B) request a hearing on the proposed certification or the parts thereof objected to; or (C) request both such certification and such hearing. If no such action is taken, the Administrator may by order make the certification as proposed. In the event that the action described in clause (A) or (C) is taken, the Administrator shall by order make the certification as proposed with respect to such parts thereof as are requested. It' the event a hearing is requested, the Administrator shall provide opportunity for a prompt hearing. The certification of the Administrator as the result of such hearing shall be made by order and shall be based only on substantial evidence of record at the hearing and shall set forth detailed findings of fact. In no event shall the time elapsing between the making of a request for a certification under this subsection and final certification by the Administrator exceed one hundred and sixty days. The Administrator shall submit with any certification of usefulness under this subsection an opinion, based on the data before him, whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed for the purpose for which the certification is made. The Administrator, after due notice and opportunity for public hearing, is authorized to promulgate rules and regulations for carrying out the provisions of this subsection.

(m) Amendment of regulations

The Administrator shall prescribe by regulations the procedure by which regulations under this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of regulations establishing tolerances, including the appointment of advisory committees and the procedure for referring petitions to such committees.

(n) Guaranties

The provisions of section 333(c) of this title with respect to the furnishing of guaranties shall be applicable to raw agricultural commodities covered by this section.

(0) Payment of fees; services or functions as conditioned on; waiver or refund of fees

The Administrator shall by regulation require the payment of such fees as will in the aggregate, in the judgment of the Administrator, be So in original. Probably should read "In".

sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performance of the Administrator's functions under this section. Under such regulations, the performance of the Administrator's services or other functions pursuant to this section, including any one or more of the following, may be conditioned upon the payment of such fees: (1) The acceptance of filing of a petition submitted under subsection (d) of this section; (2) the promulgation of a regulation establishing a tolerance, or an exemption from the necessity of a tolerance, under this section, or the amendment or repeal of such a regulation; (3) the referral of a petition or proposal under this section to an advisory committee; (4) the acceptance for filing of objections under subsection (d)(5) of this section; or (5) the certification and filing in court of a transcript of the proceedings and the record under subsection (i)(2) of this section. Such regulations may further provide for waiver or refund of fees in whole or in part when in the judgment of the Administrator such waiver or refund is equitable and not contrary to the purposes of this subsection. (June 25, 1938, ch. 675, § 408, as added July 22, 1954, ch. 559, §3, 68 Stat. 511, and amended Aug. 28, 1958, Pub. L. 85-791, § 20, 72 Stat. 947; Oct. 30, 1970, Pub. L. 91-515, title VI, § 601(d)(1), 84 Stat. 1311; 1970 Reorg. Plan No. 3, § 2(a)(4), (8)(ii), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086; Nov. 18, 1971, Pub. L. 92157, title III, § 303(a), 85 Stat. 464; Oct. 21, 1972, Pub. L. 92-516, § 3(3), 86 Stat. 998.)

REFERENCES IN TEXT

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsecs. (d), (e), (j), and (7), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§ 136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables volume.

CODIFICATION

"Section 556(d) of title 5" was substituted for "section 7(c) of the Administrative Procedure Act (5 U.S.C. sec. 1006(c))", in subsec. (d), on authority of section 7(b) of Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 631, section 1 of which enacted Title 5, Government Organization and Employees.

AMENDMENTS

1972-Subsecs. (d)(1), (e), (1). Pub. L. 92-516 substituted references to pesticide for references to economic poison wherever appearing therein.

1971-Subsec. (g). Pub. L. 92-157 struck out ", which the Secretary shall by rules and regulations prescribe," appearing following "as compensation for their services a reasonable per diem" prior to amendment in 1970, by Pub. L. 91-515, which overlooked such language when amending subsec. (g) as provided in 1970 Amendment note.

1970-Subsec. (g). Pub. L. 91-515 substituted provisions authorizing members of an advisory committee to receive compensation and travel expenses in accordance with section 376(b)(5)(D) of this title, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1958-Subsec. (i)(2). Pub. L. 85-791, § 20(a), in first sentence, substituted “transmitted by the clerk of the court to the Secretary, or" for "served upon the Secre

tary, or upon", substituted "file in the court the record of the proceedings" for "certify and file in the court a transcript of the proceedings and the record", and inserted "as provided in section 2112 of title 28", and which, in second sentence, substituted "the filing of such petition" for "such filing".

Subsec. (i)(3). Pub. L. 85-791, § 20(b), in first sentence, substituted "transmitted by the clerk of the court to the Secretary of Agriculture, or" for "served upon the Secretary of Agriculture, or upon”, substituted "file in the court the record of the proceedings" for "certify and file in the court a transcript of the proceedings and the record", and inserted “as provided in section 2112 of title 28", and, in second sentence, substituted "the filing of such petition" for "such filing".

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementatin of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub. L. 92-516, set out as an Effective Date note under section 136 of Title 7, Agriculture.

TRANSFER OF FUNCTIONS

"Administrator of the Environmental Protection Agency" was substituted, in subsecs. (a) to (j), (1), (m), and (o), for “Secretary of Health, Education, and Welfare" and in subsecs. (b), (d), (i), and (1), for “Secretary of Agriculture" pursuant to Reorg. Plan No. 3 of 1970, set out in the Appendix to Title 5, Government Organization and Employees, which transferred to the Administrator of the Environmental Protection Agency all functions vested in the Secretary of Health, Education, and Welfare in establishing tolerances for pesticide chemicals under this section together with the authority to monitor compliance with the tolerances and the effectiveness of surveillance and enforcement and to provide technical assistance to the States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, and which also transferred to the Administrator of the Environmental Protection Agency the functions of Agriculture Department and the Secretary of Agriculture under subsec. (1) of this section.

CROSS REFERENCES

Federal Advisory Committee Act, see Appendix to Title 5, Government Organization and Employees.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 342, 346b, 453, 601, 1033 of this title.

§ 346b. Authorization of appropriations

There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of sections 321(q), (r), 342(a)(2), and 346a of this title. (July 22, 1954, ch. 559, § 4, 68 Stat. 517.)

CODIFICATION

Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§ 347. Intrastate sales of colored oleomargarine (a) Law governing

Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the