[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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, Sec. Sec.  

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;



[[Page 18]]



    (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.)