[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR152.81]

[Page 17-18]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of Contents
 
  Subpart E--Procedures To Ensure Protection of Data Submitters' Rights
 
Sec. 152.81  Applicability.

    (a) Except as provided in paragraph (b) of this section, 
Secs. 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;

[[Page 18]]

    (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.)