[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR152.50]

[Page 15-17]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 
 
                    Subpart C_Registration Procedures
 
Sec. 152.50  Contents of application.

    Each application for registration or amended registration must 
include the following information, as applicable:
    (a) Application form. An application form must be completed and 
submitted to the Agency. Application forms are provided by the Agency, 
with instructions as to the number of copies required and proper 
completion.
    (b) Identity of the applicant--(1) Name. The applicant must identify 
himself. An applicant not residing in the United States must also 
designate an agent in accordance with paragraph (b)(3) of this section 
to act on behalf of the applicant on all registration matters.
    (2) Address of record. The applicant must provide an address in the 
United States for correspondence purposes. The U.S. address provided 
will be considered the applicant's address of record, and EPA will send 
all correspondence concerning the application and any subsequent 
registration to that address. It is the responsibility of the applicant 
and any registrant under Sec. 152.122 to ensure that the Agency has a 
current and accurate address.
    (3) Authorized agent. An applicant may designate a person residing 
in the United States to act as his agent. If an applicant wishes to 
designate an agent, he must send the Agency a letter stating the name 
and United States address of his agent. The applicant must notify the 
Agency if he changes his designated agent. This relationship may be 
terminated at any time by the applicant by notifying the Agency in 
writing.

[[Page 16]]

    (4) Company number. If an applicant has been assigned a company 
number by the Agency, the application must reference that number.
    (c) Summary of the application. Each application must include a list 
of the data submitted with the application, together with a brief 
description of the results of the studies. The list of data submitted 
may be the same as the list required by Sec. 158.32 of this chapter. 
The summary must state that is is releasable to the public after 
registration in accordance with Sec. 152.119.
    (d) Identity of the product. The product for which application is 
being submitted must be identified. The following information is 
required:
    (1) The product name;
    (2) The trade name(s) (if different); and
    (3) The EPA Registration Number, if currently registered.
    (e) Draft labeling. Each application for new registration must be 
accompanied by five legible copies of draft labeling (typescript or 
mock-up). Each application for amended registration that proposes to 
make any changes in the product labeling must be accompanied by five 
legible copies of draft labeling incorporating the proposed labeling 
changes. If the proposed labeling change affects only a portion of the 
labeling, such as the use directions, the applicant may submit five 
copies of that portion of the label which is the subject of the 
amendment. Upon request, an applicant for amended registration must 
submit a complete label to consolidate amendments.
    (f) Registration data requirements. (1) An applicant must submit 
materials to demonstrate that he has complied with the FIFRA sec. 
3(c)(1)(D) and subpart E of this part with respect to satisfaction of 
data requirements, to enable the Agency to make the determination 
required by FIFRA sec. 3(c)(5)(B). Required items are described in 
subpart E of this part.
    (2) An applicant must furnish any data specified in part 158 of this 
chapter which are required by the Agency to determine that the product 
meets the registration standards of FIFRA sec. 3(c) (5) or (7). Each 
study must comply with:
    (i) Section 158.30 of this chapter, with respect to times for 
submission;
    (ii) Section 158.32 of this chapter, with respect to format of 
submission;
    (iii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made;
    (iv) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects; and
    (v) Section 160.12 of this chapter, if applicable, with respect to a 
statement of whether studies were conducted in accordance with the Good 
Laboratory Practices of part 160.
    (3) An applicant shall furnish with his application any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on man or the environment, which would be required to 
be reported under FIFRA sec. 6(a)(2) if the product were registered.
    (g) Certification relating to child-resistant packaging. If the 
product meets the criteria for child-resistant packaging, the applicant 
must submit a certification that the product will be distributed or sold 
only in child-resistant packaging. Refer to part 157 of this chapter for 
the criteria and certification requirements.
    (h) Request for classification. If an applicant wishes to request a 
classification different from that established by the Agency, he must 
submit a request for such classification and information supporting the 
request.
    (i) Statement concerning tolerances. If the proposed labeling bears 
instructions for use of the pesticide on food or feed crops, or if the 
intended use of the pesticide results or may be expected to result, 
directly or indirectly, in pesticide residues in or on food or feed 
(including residues of any active ingredient, inert ingredient, 
metabolite, or degradation product), the applicant must submit a 
statement indicating whether such residues are authorized by a 
tolerance, exemption from the requirement of a tolerance, or food 
additive regulation issued under section 408 or 409 of the Federal Food, 
Drug and Cosmetic Act (FFDCA). If such residues have not been 
authorized, the application must be accompanied by a petition for 
establishment of appropriate

[[Page 17]]

tolerances, exemptions from the requirement of a tolerance, or food 
additive regulations, in accordance with part 180 of this chapter.

[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 
FR 32096, June 19, 1995]