Page:United States Statutes at Large Volume 92 Part 1.djvu/879

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PUBLIC LAW 95-000—MMMM. DD, 1978

PUBLIC LAW 9 5 - 3 9 6 — S E P T. 30, 1978

92 STAT. 8 2 5

WAIVER OF DATA REQUIREMENTS PERTAINING TO EFFICACY

Sec. 5. Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof the follow- 7 USC 136a. i n g: " I n considering an application for the registration of a pesticide, the Administrator may waive d a t a requirements pertaining to efficacy, in which event the Administrator may register the pesticide without determining that the pesticide's composition is such as to w a r r a n t proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 24(c) of this Act, a presumption is Post, p. 835. established "that the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.". REGISTRATION UNDER SPECIAL CIRCUMSTANCES; I N T E R I M ADMINISTRATIVE REVIEW

SEC. 6. Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act is amended by adding at the end thereof new para- 7 USC 136a. g r a p h s (7) and (8) as follows: "(7)

REGISTRATION UNDER SPECIAL CIRCUMSTANCES.—Notwith-

standing the provisions of subsection (c)(5) of this section— " (A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determines that (i) the pesticide and proposed use are identical or substantially similar to any currently registen^d pesticide and use thereof, or differ only in ways that would not signijficantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or. amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. A n applicant seeking conditional registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under subsection (c)(5) of this section: Provided, That, if the applicant is unable to submit an item of d a t a because it has not yet been generated, the Administrator may register or amend the registration of the pesticide under such conditions as will require the submission of such d a t a not later than the time such data are required to be submitted with respect to similar pesticides already registered under this Act. " (B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, no registration of a pesticide may be amended to " permit an additional use of such pesticide if "the Administrator has issued a notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated