CFR

152.81—Applicability.

(a) Except as provided in paragraph (b) of this section, §§ 152.83 through 152.119 apply to:

(1) Each application for registration of a new product;

(2) Each application for an amendment of a registration; and

(3) Each application for reregistration under FIFRA section 3(g).

(b) This subpart E does not apply to:

(1) Applications for registration submitted to States under FIFRA section 24(c) ;

(2) Applications for experimental use permits under FIFRA section 5 ;

(3) Applications for emergency exemptions under FIFRA section 18 ;

(4) Applications to make only one or more of the following types of amendments to existing registrations, unless the Administrator or his designee finds that Agency consideration of scientific data would be necessary in order to approve the amendment under FIFRA section 3(c)(5) :

(i) An increase or decrease in the percentage in the product of one or more of its active ingredients or deliberately added inert ingredients;

(ii) A revision of the identity or amount of impurities present in the product;

(iii) The addition or deletion of one or more deliberately added inert ingredients;

(iv) The deletion of one or more active ingredients;

(v) A change in the source of supply of one or more of the active ingredients used in the product, if the new source of the active ingredient is a product which is registered under FIFRA section 3 ;

(vi) Deletion of approved uses of claims;

(vii) Redesign of the label format involving no substantive changes, express or implied, in the directions for use, claims, representations, or precautionary statements;

(viii) Change in the product name or addition of an additional brand name, if no additional claims, representations, or uses are expressed or implied by the changes;

(ix) Clarification of directions for use;

(x) Correction of typographical errors;

(xi) Changes in the registrant's name or address;

(xii) Adding or deleting supplemental registrants;

(xiii) Changes in the package or container size;

(xiv) Changes in warranty, warranty disclaimer, or liability limitation statements, or addition to or deletion of such statements;

(xv) “Splitting” a label for the sole purpose of facilitating the marketing of a product in different geographic regions with appropriate labels, where each amended label will contain previously approved use instructions (and related label statements) appropriate to a particular geographic region;

(xvi) Any other type of amendment, if the Administrator or his designee determines, by written finding, that the Agency consideration of scientific data would not be necessary in order to approve the amendment under FIFRA section 3(c)(5); and

(xvii) Compliance with Agency Regulations, adjudicatory hearing decisions, notices, or other Agency announcements that unless the registration is amended in the manner the Agency proposes, the product's registration will be suspended or cancelled, or that a hearing will be held under FIFRA section 6. (However, this paragraph does not apply to amendments designed to avoid cancellation or suspension threatened under FIFRA section 3(c)(2)(B) or because of failure to submit data.)

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