226 



considered to be adulterated within the meaning of 

 clause (1) of section 342(a) of this title. In deter- 

 mining the quantity of such added substance to be 

 tolerated in or on different articles of food the Sec- 

 retary shall take into account the extent to which 

 the use of such substance is required or cannot be 

 avoided in the production of each such article, and 

 the other ways in which the consumer may be 

 affected by the same or other poisonous or deleteri- 

 ous substances. (June 25. 1938. ch. 675, § 406, 52 

 Stat. 1049; 1940 Reorg. Plan No. IV, § 12, eff. June 

 30. 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg. Plan 

 No. 1, I 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 

 631; 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1960 — Pub L. 86-618 repealed former subsec.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 lor 

 the listing of coal-tar colors. 



1958 — Subsec. (a). Pub. L. 85-929 substituted "claiise 

 (2) (A)" for "clause (2)" In first sentence. 



§346a. Tolerances for pesticide chemicals in or on 

 raw agricultural commodities. 



(a) Conditions of safety. 



Any poisonous or deleterious pesticide chemi- 

 cal, 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 Environ- 

 mental Protection Agency under this section and 

 the quantity of such pesticide chemical in or on 

 the raw agricultural conunodity is within the limits 

 of the tolerance so prescribed: or 



(2) with respect to use in or on such raw agri- 

 cultural commodity, the pesticide chemical has 

 been exempted from the requirement of a toler- 

 ance 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 con- 

 taining any added amount of such pesticide chemi- 

 cal, be considered to be adulterated within the mean- 

 ing of clause (1) of section 342 (a) of this title. 



(b) Establishment of tolerances. 



The Administrator shall promulgate reg\ilations 

 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 chemi- 

 cals, as safe for use, to the extent necessary to pro- 

 tect the public health. In establishing any such regu- 

 lation, the Administrator shaU give appropriate con- 

 sideration, among other relevant factors. (1) to the 

 necessity for the production of an adequate, whole- 



some, 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 (2) of this section. Such 

 regulations shall be promulgated in the manner pre- 

 scribed in subsection (d) or (e) of this section. In 

 carrying put 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 way 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. Sucb 

 regulations shall be promulgated In the manner 

 prescribed in subsection (d) or (e) of thLs 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 Rodentlclde Act 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 pesti- 

 cide, or exempting the pesticide chemical from the 

 requirement of a tolerance. The petition shall con- 

 tain data showing — 



(A) the name, chemical identity, and composi- 

 tion of the pesticide chemical ; 



(B) the amount, frequency, and time of appli- 

 cation of the pesticide chemical ; 



(C) full reports of investigations made with re- 

 spect to the safety of the pesticide chemical; 



(D) the results of tests on the amount of resi- 

 due 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 chem- 

 ical if tolerances are proposed ; and 



(O) reasonable grounds in support of the 

 petition. 

 Samples of the pesticide chemical shall be furnished 

 to the Administrator upon request. Notice of the fil- 

 ing of such petition shall be published in general 

 terms by the Administrator within thirty days after 

 filing. Such notice shall include the analytical meth- 

 ods 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 (Z) of this section with 

 respect to the pesticide chemical named in the peti- 

 tion, the Administrator shaU, after giving due con- 



