[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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 

Contents

 

                    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]