[Code of Federal Regulations]
[Title 40, Volume 22]
[Revised as of July 1, 2004]
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

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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.