[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: 40CFR158.20]



[Page 78-79]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

                      Subpart A_General Provisions

 

Sec.  158.20  Overview.









                      Subpart A_General Provisions



Sec.

158.20 Overview.

158.25 Applicability of data requirements.

158.30 Timing of the imposition of data requirements.

158.32 Format of data submission.

158.33 Procedures for claims of confidentiality of data.

158.34 Flagging of studies for potential adverse effects.

158.35 Flexibility of the data requirements.

158.40 Consultation with the Agency.

158.45 Waivers.

158.50 Formulators' exemption.

158.55 Agricultural vs. non-agricultural pesticides.

158.60 Minor uses.

158.65 Biochemical and microbial pesticides.

158.70 Acceptable protocols.

158.75 Requirements for additional data.

158.80 Acceptability of data.

158.85 Revision of data requirements and guidelines.



                    Subpart B_How To Use Data Tables



158.100 How to determine registration data requirements.

158.101 Required vs. conditionally required data.

158.102 Distinguishing between what data are required and what substance 

          is to be tested.

158.108 Relationship of Pesticide Assessment Guidelines to data 

          requirements.



              Subpart C_Product Chemistry Data Requirements



158.150 General.

158.153 Definitions.

158.155 Product composition.

158.160 Description of materials used to produce the product.

158.162 Description of production process.

158.165 Description of formulation process.

158.167 Discussion of formation of impurities.

158.170 Preliminary analysis.

158.175 Certified limits.

158.180 Enforcement analytical method.

158.190 Physical and chemical characteristics.



                    Subpart D_Data Requirement Tables



158.202 Purposes of the registration data requirements.

158.240 Residue chemistry data requirements.

158.290 Environmental fate data requirements.

158.340 Toxicology data requirements.

158.390 Reentry protection data requirements.

158.440 Spray drift data requirements.

158.490 Wildlife and aquatic organisms data requirements.

158.540 Plant protection data requirements.

158.590 Nontarget insect data requirements.

158.640 Product performance data requirements.

158.690 Biochemical pesticides data requirements.

158.740 Microbial pesticides--Product analysis data requirements.



Appendix A to Part 158--Data Requirements for Registration: Use Pattern 

          Index.



    Authority: 7 U.S.C. 136-136y.



    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted.







    (a) Legal authority. These requirements are promulgated under the 

authority of sections 3, 5, 12, and 25 of the Federal Insecticide, 

Fungicide and Rodenticide Act, as amended (FIFRA) (7 U.S.C. 136-136y).

    (b) Purposes of this part. (1) The primary purpose of this part is 

to specify the types and minimum amounts of data and information the 

Agency requires in order to make regulatory judgments about the risks 

and benefits of various kinds of pesticide products under the criteria 

set forth in FIFRA sections 3(c)(5) (C) and (D) and 3(c)(7).

    (2) This part also specifies the types and minimum amounts of data 

and information the Agency requires to decide whether to approve 

applications for experimental use permits under FIFRA section 5.

    (3) Finally, this part specifies the types and minimum amounts of 

data and information that an applicant for registration, amended 

registration, or reregistration must submit or cite in support of an 

application in order to satisfy the requirements of FIFRA section 

3(c)(1)(D) and sections 3(c)(5)(B) or



[[Page 79]]



3(c)(7). Use of the term ``registration'' in this part will pertain to 

new registrations and amended registrations as well as reregistration 

accomplished under section 3(g), unless stated otherwise.

    (c) Availability of related guidelines. The data requirements for 

pesticide registration specified in this part pertain to product 

chemistry, residue chemistry, environmental fate, toxicology, reentry 

protection, aerial drift evaluation, wildlife and aquatic organisms, 

plant protection, nontarget insects, product performance, and 

biochemical and microbial pesticides. The standards for conducting 

acceptable tests, guidance on evaluation and reporting of data, further 

guidance on when data are required, definition of most terms, and 

examples of protocols are not specified in this part. This information 

is available in advisory documents (collectively referred to as 

Pesticide Assessment Guidelines) through the National Technical 

Information Service, 5285 Port Royal Road, Springfield, VA 22161 

(telephone: 703-487-4650).