[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: 40CFR180.29]

[Page 327-328]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 180_TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS 
IN FOOD--Table of Contents
 
                    Subpart B_Procedural Regulations
 
Sec. 180.29  Adoption of tolerance on initiative of Administrator or on 
request of an interested person.

    (a) Upon the Administrator's own initiative, or at the written 
request of any interested person furnishing reasonable grounds therefor 
and such fees or deposits as are prescribed by Sec. 180.33, the 
Administrator may propose, under sec. 408(e) of the Federal Food, Drug, 
and Cosmetic Act, the issuance of a regulation establishing a tolerance 
for a pesticide chemical or exempting it from the necessity of a 
tolerance, or a regulation modifying or revoking an existing tolerance 
or exemption. As used in the preceding sentence, ``reasonable grounds'' 
shall include a statement describing the nature of the requestor's 
interest in issuance of such a tolerance or exemption, and adequate data 
on subjects outlined in sec. 408(d)(1) (A) through (F) of the Federal 
Food, Drug, and Cosmetic Act. Any petition received by the Agency which 
requests establishment of a tolerance or

[[Page 328]]

exemption for pesticide residues in or on a raw agricultural commodity 
that result from any pesticide use not directly associated with 
producing, storing, or transporting that commodity, will be treated by 
the Agency as a request for issuance of the tolerance or exemption under 
sec. 408(e) of that Act. (As the Agency interprets that Act, the 
certification of usefulness which is a prerequisite of issuing a 
regulation under sec. 408(d) can only be made with respect to pesticides 
used to help produce, store, or transport the commodity for which the 
tolerance or exemption is sought.) Requests shall be submitted in 
duplicate to: Registration Division (TS-767), Environmental Protection 
Agency, Washington, DC 20460. If any part of the request or supporting 
data is in a language other than English, it must be accompanied by a 
complete and accurate English translation. If the Administrator decides 
that a request does not warrant a proposal for the issuance of a 
regulation, he shall so inform the requestor and state the reasons for 
his decision.
    (b) The notice of the proposal shall show whether it is made on the 
initiative of the Administrator or at the request of an interested 
person, naming such person.
    (c) If within 30 days after publication of the proposal a person who 
has registered, or who has submitted an application for registration of 
an economic poison under the Federal Insecticide, Fungicide, and 
Rodenticide Act containing the pesticide chemical named in the proposal, 
requests in writing that the proposal be referred to an advisory 
committee and makes advance deposit as provided by Sec. 180.33, the 
Administrator shall appoint a committee as provided in Sec. 180.11 and 
refer the proposal and relevant data to such committee. The Agency and 
the committee shall proceed as prescribed in section 408 and this part.
    (d) If further advance deposits are not made upon request of the 
Administrator, as provided in Sec. 180.33, the request for referral of 
the petition to an advisory committee shall be considered withdrawn, and 
a tolerance shall be established within 90 days from the date on which 
the Administrator requested the further advance deposit.
    (e) The Administrator shall provide a period of not less than 30 
days for persons to comment on the proposed regulation.
    (f) After reviewing any timely comments received, the Administrator 
may by order establish, modify, or revoke a tolerance regulation, which 
order and regulation shall be published in the Federal Register. An 
order published under this section shall state that persons may submit 
objections and requests for a hearing in the manner described in part 
178 of this chapter.
    (g) Any final regulation issued under this section shall be 
effective on the date of publication in the Federal Register unless 
otherwise provided in the regulation.
    (h) In ruling on a request under paragraph (a) of this section, the 
Administrator may publish a Federal Register notice requesting 
information and views on the request, or provide other procedures as a 
matter of discretion.
    (i) When a request is denied under this section, the administrative 
record consists of:
    (1) The request, including all data and information submitted in 
support of the request.
    (2) Any Federal Register notice requesting information and views.
    (3) Any comments submitted by members of the public in response to 
the Federal Register notice requesting information and views.
    (4) If the request resulted in any other procedures, the order of 
the Administrator providing the procedures and the administrative record 
of the procedure provided.
    (5) All other documents or information submitted to the record.
    (6) The Administrator's order and decision on the request, including 
all information identified by the Administrator as part of the record.

[36 FR 22540, Nov. 25, 1971, as amended at 46 FR 3020, Jan. 13, 1981; 55 
FR 21200, May 23, 1990; 55 FR 50300, Dec. 5, 1990]