[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR177.102]

[Page 280-281]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 177--ISSUANCE OF FOOD ADDITIVE REGULATIONS--Table of Contents
 
      Subpart F--Submission of Scientific and Technical Information
 
Sec. 177.102  Data and information required to support petition to establish a food additive regulation, to increase a tolerance, or to remove a condition on 
          use.


    A petition to establish a food additive regulation, or to modify a 
food additive regulation by increasing a tolerance for a pesticide 
residue in or on a processed food or by removing any other condition of 
use of a food additive, shall include the following data and 
information:
    (a)(1) The name and composition of the food additive that is a 
subject of the petition, and the chemical composition of each component 
of the food additive.
    (2) The name, chemical identity, and composition of each pesticide 
residue that is a subject of the petition.
    (3) The identity of the processed food(s) in question.
    (b) A statement of any conditions of use proposed for the food 
additive, including all directions, recommendations, and suggestions 
proposed regarding the use of the food additive, i.e., the amount, 
frequency, method, and time of application or other use, and a copy of 
its proposed labeling.
    (c) Full reports of investigations made with respect to the toxicity 
of the food additive and of its safety for the proposed use, including 
full information as to the methods and controls used in conducting such 
investigations.
    (d) The results of tests to determine the identity and amount of 
pesticide residues in or on the processed food resulting from the 
proposed use of the food additive, including a description of the 
analytical methods used, and a description of practicable methods for 
measuring such pesticide residues.
    (e) Full reports of investigations made with respect to the toxicity 
of such pesticide residues, including full information as to the methods 
and controls used in conducting such investigations.
    (f) All relevant data bearing on the physical or other technical 
effects such food additive is intended to produce,

[[Page 281]]

and the quantity of such food additive required to produce such effect.
    (g) The terms of each food additive regulation proposed.
    (h) Any other information relevant to the approval of the petition 
known to the petitioner that is unfavorable to the petition.
    (i) A statement of why, in the petitioner's opinion, it would be 
reasonable for the Administrator to approve the petition, taking into 
account the terms of the FFDCA and FIFRA, this part, the petition, the 
data and information submitted or cited in support of the petition, and 
other information available to the Agency.
    (j) An informative summary of the petition and of the data, 
information, and arguments submitted or cited in support of the 
petition, and a statement that the petitioner agrees that such summary 
or any information it contains may be published as a part of the notice 
to be furnished to the public under Sec. 177.88 or as part of a proposal 
under Sec. 177.130. The summary need not refer to any method or process 
that is entitled to protection as a trade secret under FFDCA section 
301(j).

[55 FR 50288, Dec. 5, 1990, as amended at 58 FR 34203, June 23, 1993]