[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: 40CFR166.20]



[Page 182-185]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 166_EXEMPTION OF FEDERAL AND STATE AGENCIES FOR USE OF PESTICIDES 

UNDER EMERGENCY CONDITIONS--Table of Contents

 

      Subpart B_Specific, Quarantine, and Public Health Exemptions

 

Sec.  166.20  Application for a specific, quarantine, or public health 

exemption.





    (a) General information required in an application for a specific, 

quarantine or public health exemption. An application must be submitted 

in writing by the head of the Federal or State agency, the Governor of 

the State involved, or their official designee. If a designee has been 

delegated authority to request exemptions, written authorization of such 

delegation must accompany the request or be on file with the Agency. In 

addition, the application must contain all applicable information 

specified in paragraphs (a) (1) through (11) of this section.

    (1) Identity of contact persons. (i) Unless otherwise specified, the 

person who



[[Page 183]]



submits the application will be considered the contact person for all 

matters relating to administration of the emergency exemption.

    (ii) Requests should identify by name and telephone number one or 

more qualified experts who may be contacted in case any questions arise 

concerning the application.

    (2) Description of the pesticide. The application shall contain a 

description of the pesticide(s) proposed for use under the exemption. 

Such information shall include:

    (i) For a federally registered pesticide product:

    (A) A copy of the label(s) if a specific product(s) is/are 

requested; or the formulation(s) requested if a specific product is not 

requested; and

    (B) A copy of any additional labeling proposed for the emergency 

exemption; or

    (ii) For any other pesticide products:

    (A) A confidential statement of formula or reference to one already 

submitted to the Agency; and

    (B) Complete labeling to be used in connection with the proposed 

exemption use.

    (3) Description of the proposed use. The application shall identify 

all of the following:

    (i) Sites to be treated, including their locations within the State;

    (ii) The method of application;

    (iii) The rate of application in terms of active ingredient and 

product;

    (iv) The maximum number of applications;

    (v) The total acreage or other appropriate unit proposed to be 

treated;

    (vi) The total amount of pesticide proposed to be used in terms of 

both active ingredient and product;

    (vii) All applicable restrictions and requirements concerning the 

proposed use which may not appear on labeling;

    (viii) The duration of the proposed use; and

    (ix) Earliest possible harvest dates.

    (4) Alternative methods of control. The application shall contain:

    (i) A detailed explanation of why the pesticide(s) currently 

registered for the particular use proposed in the application is not 

available in adequate supplies and/or effective to the degree needed to 

control the emergency. If the applicant states that an available 

registered pesticide is ineffective for the given situation, the 

statement must be supported by field data which demonstrate 

ineffectiveness of registered pesticides, or, if such data are 

unavailable, statements by qualified agricultural experts, extension 

personnel, university personnel or other persons similarly qualified in 

the field of pest control; and

    (ii) A detailed explanation of why alternative practices, if 

available, either would not provide adequate control or would not be 

economically or environmentally feasible.

    (5) Effectiveness of proposed use. The application shall contain 

data, a discussion of field trials, or other evidence which provide the 

basis for the conclusion that the proposed pesticide treatment will be 

effective in dealing with the emergency.

    (6) Discussion of residues for food uses. If the proposed use is 

expected to result in residues of the pesticide in or on food, the 

application shall list the food likely to contain such residues and 

shall contain an estimate of the maximum amount of the residue likely to 

result from the proposed use, together with the information on which 

such estimates are based.

    (7) Discussion of risk information. The application shall address 

the potential risks to human health, endangered or threatened species, 

beneficial organisms, and the environment expected to result from the 

proposed use, together with references to data and other supporting 

information.

    (8) Coordination with other affected State or Federal agencies. If 

the proposed use of the pesticide is likely to be of concern to other 

Federal or State agencies, the application shall indicate that such 

agencies have been contacted prior to submission of the application, and 

any comments received from such agencies shall be submitted to EPA.

    (9) Acknowledgment by registrant. The application shall contain a 

statement by the registrants of all pesticide products proposed for use 

acknowledging that a request has been made to the Agency for use of the 

pesticide under this section. This acknowledgment shall include a 

statement of support for



[[Page 184]]



the requested use, including the expected availability of adequate 

quantities of the requested product under the use scenario proposed by 

the applicant(s); and the status of the registration in regard to the 

requested use including appropriate petition numbers, or of the 

registrant's intentions regarding the registration of the use.

    (10) Description of proposed enforcement program. Prior to approval, 

the applicant shall provide an explanation of the authority of the 

applicant or related State or Federal agencies for ensuring that use of 

the pesticide under the proposed exemption would comply with any special 

requirements imposed by the Agency and a description of the program and 

procedures for assuring such compliance.

    (11) Repeated uses. Applications for the use of a pesticide at a 

site for which the applicant has previously been exempted under section 

18 shall contain an interim report summarizing the results of the 

specific, quarantine, or public health exemption previously issued, if 

the application is submitted prior to the time the final report for the 

previous exemption is due. The interim report shall contain that 

information specified in Sec.  166.32 to the extent available at the 

time the application is made.

    (b) Information required for a specific exemption. An application 

for a specific exemption shall provide all of the following information, 

as appropriate, concerning the nature of the emergency:

    (1) The scientific and common name of the pest or pest complex;

    (2) A discussion of the events which brought about the emergency 

condition;

    (3) A discussion of the anticipated risks to endangered or 

threatened species, beneficial organisms, or the environment that would 

be remedied by the proposed use of the pesticide; and

    (4) A discussion of the anticipated significant economic loss, 

together with data and other information supporting the discussion, that 

addresses one or more of the following, as appropriate:

    (i) Yield or utilized yield reasonably anticipated in the absence of 

the emergency and expected losses in quantity due to the emergency;

    (ii) The information in paragraph (b)(4)(i) of this section plus 

prices reasonably anticipated in the absence of the emergency and 

changes in prices and/or production costs due to the emergency;

    (iii) The information in paragraph (b)(4)(ii) of this section plus 

operating costs reasonably anticipated in the absence of the emergency;

    (iv) Any other information explaining the economic consequences of 

the emergency.

    (5) Re-certification of an emergency condition. Applicants for 

specific exemptions may submit re-certification applications relying on 

previously submitted information to satisfy the information requirements 

of paragraphs (a)(1) through (a)(10) of this section, and of paragraphs 

(b)(1) through (b)(4) of this section, where all of the following 

conditions are met:

    (i) An exemption was granted for the same pesticide at the same site 

to the same applicant the previous year;

    (ii) The emergency condition could reasonably be expected to 

continue for longer than 1 year;

    (iii) EPA has not declared the use ineligible for re-certification;

    (iv) The use is not subject to public notice pursuant to Sec.  

166.24(a)(1) through (a)(6);

    (v) The applicant certifies that all of the following are true:

    (A) The emergency condition described in the preceding year's 

application continues to exist;

    (B) Except as expressly identified, all information submitted in the 

preceding year's application is still accurate;

    (C) Except as expressly identified, the proposed conditions of use 

are identical to the conditions of use EPA approved for the preceding 

year;

    (D) Any conditions or limitations on the eligibility for re-

certification identified in the preceding year's notice of approval of 

the emergency exemption have been satisfied;

    (E) The applicant is not aware of any alternative chemical or non-

chemical practice that may offer a meaningful level of pest control, or 

has provided documentation that each such known



[[Page 185]]



practice does not provide adequate control or is not economically or 

environmentally feasible.

    (c) Information required for a quarantine exemption. An application 

for a quarantine exemption shall provide all of the following 

information concerning the nature of the emergency:

    (1) The scientific and common name of pest;

    (2) The origin of pest and the means of its introduction or spread 

if known; and

    (3) The anticipated impact of not controlling the pest.

    (d) Information required for a public health exemption. An 

application for a public health exemption shall provide all the 

following information concerning the nature of the emergency:

    (1) The scientific and common name of the pest to be controlled and, 

if the pest is a vector, a description of the disease it is expected to 

transmit;

    (2) A discussion of the magnitude of the health problems which are 

expected to occur without the pesticide use; and

    (3) Discussion of the availability of medical treatment for the 

health problem.



[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 

FR 4511, Jan. 27, 2006]