[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: 40CFR158.80]



[Page 87-88]

 

                   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.  158.80  Acceptability of data.



    (a) General policy. The Agency will determine whether the data 

submitted to fulfill the data requirements specified in this part are 

acceptable. This determination will be based on the design and conduct 

of the experiment from which the data were derived, and an evaluation of 

whether the data fulfill the purpose(s) of the data requirement. In 

evaluating experimental design, the Agency will consider whether 

generally accepted methods were used, sufficient numbers of measurements 

were made to achieve statistical reliability, and sufficient controls 

were built into all phases of the experiment. The Agency will evaluate 

the conduct of each experiment in terms of whether the study was 

conducted in conformance with the design, good laboratory practices were 

observed, and results were reproducible. The Agency will not reject data 

merely because they were derived from studies which, when initiated were 

in accordance with an Agency-recommended protocol, even if the Agency 

subsequently recommends a different protocol, as long as the data 

fulfill the purposes of the requirements as described in this paragraph.

    (b) Previously developed data. The Agency will consider that data 

developed prior to the effective date of this



[[Page 88]]



part would be satisfactory to support applications provided good 

laboratory practices were followed, the data meet the purposes of this 

part, and the data permit sound scientific judgments to be made. Such 

data will not be rejected merely because they were not developed in 

accordance with suggested protocols.

    (c) Data developed in foreign countries. The Agency considers all 

applicable data developed from laboratory and field studies anywhere to 

be suitable to support pesticide registrations except for data from 

tests which involved field test sites or a test material, such as a 

native soil, plant, or animal, that is not characteristic of the United 

States. When studies at test sites or with materials of this type are 

anticipated, applicants should take steps to assure that United States 

materials are used or be prepared to supply data or information to 

demonstrate the lack of substantial or relevant differences between the 

selected material or test site and the United States material or test 

site. Once comparability has been established, the Agency will assess 

the acceptability of the data as described in paragraph (a) of this 

section.

    (d) Data from monitoring studies. Certain data are developed to meet 

the monitoring requirements of FIFRA sections 5, 8 or 20. Applicants may 

wish to determine whether some of these data may meet the requirements 

of this part. In addition, data developed independently of FIFRA 

regulations or requirements may also satisfy data requirements in this 

part. Consultation with appropriate EPA Product Managers would be 

helpful if applicants are unsure about suitability of such data.