[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: 40CFR177.81]

[Page 279]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 177--ISSUANCE OF FOOD ADDITIVE REGULATIONS--Table of Contents
 
               Subpart E--Procedures for Filing Petitions
 
Sec. 177.81  Petition for establishment, modification, or revocation of a food additive regulation.


    (a) Who may submit a petition. Any person may submit a petition 
requesting the Agency to issue a regulation to establish, modify, or 
revoke a food additive regulation.
    (b) Where to submit petition. A petition shall be submitted to: 
Office of Pesticide Programs (H7504C), Document Processing Desk - PETN, 
U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    (c) Identification of petitioner. A petition must be signed by the 
petitioner or the petitioner's authorized representative, and must state 
the petitioner's mailing address and telephone number.
    (d) Material to be in English language. The petition shall be 
written in the English language. If any part of the accompanying 
material is written in a language other than English, it shall be 
accompanied by an accurate and complete English translation.
    (e) Format for data submission. Data and information submitted in 
support of a petition shall be on separate sheets or sets of sheets of 
paper, suitably identified. If an item of data has already been 
submitted to the Agency, the petitioner may cite it rather than 
resubmitting it. The data shall be submitted in the manner specified by 
Sec. 158.32 of this chapter.
    (f) Confidentiality of data and information in petition, amendment, 
or supplement--(1) Asserting confidentiality claims. A petitioner may 
assert a claim that data and information in a petition, or any amendment 
or supplement to a petition, other than the summary described in 
Sec. 177.102(j), are entitled to confidential treatment under part 2 of 
this chapter. To assert such a claim, the petitioner must mark those 
portions of the petition, amendment, or supplement, and those portions 
of any data and information submitted in support of the petition, 
amendment, or supplement, with the words ``trade secret,'' 
``proprietary,'' or other words that indicate the data or information 
are claimed to be confidential business information. If the data and 
information have also been submitted to EPA under FIFRA, the person 
shall assert the confidentiality claim in accordance with Sec. 158.33 of 
this chapter.
    (2) Effect of asserting confidentiality claim. If a petitioner 
asserts a confidentiality claim in accordance with this paragraph for 
any data or information in a petition, amendment, or supplement, the 
Agency will disclose that data or information only in accordance with 
parts 2, 158, 178, and 179, of this chapter, and FIFRA and FFDCA, as 
applicable.
    (3) Failure to assert confidentiality claim. If a petitioner does 
not assert a claim that specific data and information in a petition, or 
any amendment or supplement to a petition, are entitled to confidential 
treatment under part 2 of this chapter in accordance with paragraph 
(e)(1) of this section at the time of submission of the petition, 
amendment, or supplement, the Agency will treat that data and 
information as available for disclosure to the public without further 
notice to the petitioner.