PART 166—EXEMPTION OF FEDERAL AND STATE AGENCIES FOR USE OF PESTICIDES UNDER EMERGENCY CONDITIONS Authority: 7 U.S.C. 136p, and 136w. Source: 51 FR 1902, Jan. 15, 1986, unless otherwise noted. Subpart A—General Provisions § 166.1 Purpose and organization. (a) Purpose and scope. (b) Organization. (2) Subpart B of this part establishes procedures and criteria for specific, quarantine, and public health exemptions. (3) Subpart C of this part establishes procedures and criteria for crisis exemptions. § 166.2 Types of exemptions. There are four types of emergency exemptions which may be authorized: specific, quarantine, public health, and crisis exemptions. (a) Specific exemption. A specific exemption may be authorized in an emergency condition to avert: (1) A significant economic loss; or (2) A significant risk to: (i) Endangered species, (ii) Threatened species, (iii) Beneficial organisms, or (iv) The environment. (b) Quarantine exemption. (c) Public health exemption. (d) Crisis exemption. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4510, Jan. 27, 2006] § 166.3 Definitions. Terms used in this part have the same meaning as in the Act. In addition, as used in this part, the following terms shall apply: Act Agency and EPA Beneficial organism Emergency condition (1) No effective pesticides are available under the Act that have labeled uses registered for control of the pest under the conditions of the emergency; and (2) No economically or environmentally feasible alternative practices which provide adequate control are available; and (3) The situation: (i) Involves the introduction or dissemination of an invasive species or a pesticide new to or not theretofore known to be widely prevalent or distributed within or throughout the United States and its territories; or (ii) Will present significant risks to human health; or (iii) Will present significant risks to threatened or endangered species, beneficial organisms, or the environment; or (iv) Will cause significant economic loss due to: (A) An outbreak or an expected outbreak of a pest; or (B) A change in plant growth or development caused by unusual environmental conditions where such change can be rectified by the use of a pesticide(s). First food use Food Invasive species IR-4 New chemical Significant economic loss (1) For pest activity that primarily affects the current crop or other output, one or more of the following: (i) Yield loss greater than or equal to 20%. (ii) Economic loss, including revenue losses and cost increases, greater than or equal to 20% of gross revenues. (iii) Economic loss, including revenue losses and cost increases greater than or equal to 50% of net revenues. (2) For any pest activity where EPA determines that the criteria in paragraph (1) of this definition would not adequately describe the expected loss, substantial loss or impairment of capital assets, or a loss that would affect the long-term financial viability expected from the productive activity. Special Review Unreasonable adverse effects on the environment [73 FR 75597, Dec. 12, 2008] § 166.7 User notification; advertising. (a) A State or Federal agency that obtains an exemption may notify eligible users of the availability of the exempted pesticide(s) through user groups, retail dealers, and other means. Notification may include distributing copies of the section 18 approval letter, labeling, or other information to eligible persons. (b) As set forth more fully in § 168.22 of this chapter, EPA interprets FIFRA sections 12(a)(1) (A) and (B) as making it unlawful for any person who distributes, sells, offers for sale, holds for sale, ships, delivers for shipment, or receives and (having so received) delivers or offers to deliver any pesticide, to advertise the pesticide for any use authorized by an emergency exemption, except for advertisements that are placed in media that address only persons in the geographical area to which the exemption applies, state the name and address of one or more retail dealers where users may buy the pesticide, and contain a prominent notice of the limitations on use under the emergency exemption. EPA may withdraw an exemption if the use of the pesticide covered by the exemption is advertised unlawfully. [54 FR 1125, Jan. 11, 1989] Subpart B—Specific, Quarantine, and Public Health Exemptions § 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. (1) Identity of contact persons. (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. (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. (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. (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. (6) Discussion of residues for food uses. (7) Discussion of risk information. (8) Coordination with other affected State or Federal agencies. (9) Acknowledgment by registrant. (10) Description of proposed enforcement program. (11) Repeated uses. (b) Information required for a specific exemption. (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. (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 § 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 practice does not provide adequate control or is not economically or environmentally feasible. (c) Information required for a quarantine exemption. (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. (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] § 166.22 Consultation with the Secretary of Agriculture and Governors of the States. The Agency, in determining whether or not such emergency conditions exist, shall consult with the Secretary of Agriculture and the Governor of any State concerned if they request such determination. § 166.24 Public notice of receipt of application and opportunity for public comment. (a) Publication requirement. Federal Register (1) The application proposes use of a new chemical; (2) The application proposes the first food use of an active ingredient; (3) The application proposes any use of a pesticide if the pesticide has been subject to a suspension notice under section 6(c) of the Act; (4) The application proposes use of a pesticide which: (i) Was the subject of a notice under section 6(b) of the Act and was subsequently cancelled, and (ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was the subject of the notice under section 6(b); (5) The application proposes use of a pesticide which: (i) Contains an active ingredient which is or has been the subject of a Special Review, and (ii) Is intended for a use that could pose a risk similar to the risk posed by any use of the pesticide which is or has been the subject of the Special Review; (6) The application proposes use of a pesticide which: (i) Was voluntarily canceled under section 6(f) of the Act, and (ii) Is intended for a use that poses a risk similar to the risk posed by any use of the pesticide which was voluntarily canceled under section 6(f); (7) The application proposes use of a pesticide for a specific or public health exemption, if: (i) An emergency exemption has been requested or approved for that use in any 3 previous years, or any 5 previous years if the use is supported by the IR-4 program, and (ii) A complete application for registration of that use and/or a petition for tolerance for residues in or on the commodity has not been submitted to the Agency; or (8) The Administrator determines that publication of notice is appropriate. (b) Contents. (1) The name of the applicant; (2) The name of the active ingredient requested for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number; (3) The total amount of product or active ingredient proposed for use; (4) The geographical location where treatment is proposed; (5) The proposed number of acres or other appropriate units proposed to be treated; (6) A summary of the applicant's description of the emergency conditions including the pest and the site or crop to be treated; (7) A description of the major conditions of use of the pesticide as proposed by the applicant; (8) If the pesticide proposed for use meets the criteria of paragraph (a) (3), (4), or (5) of this section, an identification of the types of risks that were the basis for EPA's regulatory action; and (9) The name, telephone number, and address of a person in the Agency who can provide further information. (c) Length of comment period. Federal Register. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006] § 166.25 Agency review. (a) General. (1) Whether an emergency condition exists or will exist; (2) The Agency's ability and intention to establish a time-limited tolerance(s) or exemption(s) from the requirement of a tolerance for any pesticide residues resulting from the authorized use, identifying the level of permissible residues in or on food or feed resulting from the proposed use; (3) The anticipated benefits to be derived from the proposed use; and (4) The potential risks to human health, endangered or threatened species, beneficial organisms, and the environment from the proposed use. (b) Criteria for approval. (1) He determines that: (i) An emergency condition exists; (ii) The use of the pesticide under the exemption will not cause unreasonable adverse effects on the environment; (iii) Registration of the pesticide use for which the exemption is requested has not been suspended under section 6(c) of the Act or cancelled following a notice under section 6(b) of the Act, unless the use is authorized in accordance with the provisions of §§ 164.130 through 164.133 of this chapter; (2) Giving due consideration to: (i) Whether the pesticide is reasonably likely to be used in compliance with the requirements imposed by the Agency under the exemption; and (ii) The progress which has been made toward registration of the proposed use, if a repeated specific or public health exemption is sought. It shall be presumed that if a complete application for registration of a use, which has been under a specific or public health exemption for any 3 previous years, or any 5 previous years if the use is supported for registration by the IR-4 program, has not been submitted, reasonable progress towards registration has not been made. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006] § 166.28 Duration of exemption. (a) Specific or public health exemptions. (b) Quarantine exemption. § 166.30 Notice of Agency decision. (a) Notification of applicants. (1) Incomplete applications. (2) Complete applications Denials. (ii) Approvals. shall (b) Federal Register publication. Federal Register (i) The name of the applicant; (ii) The pesticide authorized for use; (iii) The crop or site to be treated; and (iv) The name, address, and telephone number of a person in the Agency who can provide further information. (2) In addition, if EPA has issued a Notice of Receipt of an application for an exemption, it will issue a notice of its final decision and the reasons for that decision. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006] § 166.32 Reporting and recordkeeping requirements for specific, quarantine, and public health exemptions. (a) Unexpected adverse effects information. (b) Interim and final reports. (1) Total acreage, amount of commodity or other unit treated and the total quantity of the pesticide used; (2) A discussion of the effectiveness of the pesticide in dealing with the emergency condition; (3) A description of any unexpected adverse effects which resulted from use of the pesticide under the exemption; (4) The results of any monitoring required and/or carried out under the exemption; (5) A discussion of any enforcement actions taken in connection with the exemption; (6) Method(s) of disposition of a food crop, if required to be destroyed under an exemption; and (7) Any other information requested by the Administrator. (c) Records. (1) Locations where the pesticide was applied; (2) Dates of application (range); and (3) Total quantity of the pesticide used. [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 FR 4512, Jan. 27, 2006] § 166.34 EPA review of information obtained in connection with emergency exemptions. EPA shall review information submitted in connection with emergency exemptions and, when applicable, use it in connection with other regulatory decisions under the Act. § 166.35 Revocation or modification of exemptions. (a) Grounds. (1) An emergency no longer exists; (2) Use of the pesticide under the exemption may cause unreasonable adverse effects on the environment; (3) The pesticide authorized under the exemption is not effective at controlling the pest or conditions causing the emergency; or (4) The terms and conditions established by the exemption and these regulations are not being complied with. (b) Implementation. Subpart C—Crisis Exemptions § 166.40 Authorization. The head of a Federal or State agency, the Governor of a State, or their official designee, may issue a crisis exemption in situations involving an unpredictable emergency situation when: (a) An unpredictable emergency condition exists; (b) The time element with respect to the application of the pesticide is critical, and there is not sufficient time either to request a specific, quarantine, or public health exemption or, if such a request has been submitted, for EPA to complete review of the request; and (c) EPA has provided verbal confirmation that, for food uses, a tolerance or exemption from the requirement of a tolerance can be established in a timely manner, responsive to the projected timeframe of use of the chemical and harvest of the commodity, and that, for any use, the Agency has no other objection. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006] § 166.41 Limitations. The crisis provisions may not be utilized to authorize a pesticide use if any of the following has occurred: (a) EPA has informed the head of the Federal or State agency, the Governor, or their official designee, not to issue such an exemption; (b) The pesticide use has been suspended under section 6(c) of the Act; (c) The pesticide use has been cancelled following a notice issued under section 6(b) of the Act; (d) The pesticide contains a new chemical; or (e) The application proposes the first food use of a pesticide. § 166.43 Notice to EPA and registrants or basic manufacturers. (a) Timing of notice. (2) The State or Federal agency issuing the crisis exemption shall notify the registrant(s) or, if appropriate, the basic manufacturer(s) of the pesticide(s) being used under the crisis exemption at the same time notice is given to EPA or as soon thereafter as possible. (b) Contents of notice. (1) The name of the product and active ingredient authorized for use, along with the common name and CAS number if available, including a copy of the EPA registered label and use directions appropriate to the authorized use; (2) The site on which the pesticide is to be used or is being used; (3) The use pattern; (4) The date on which the pesticide use is to begin and the date when the use will end; (5) An estimate of the level of residues of the pesticide expected to result from use under the crisis exemption; (6) Earliest anticipated harvest date of the treated commodity; (7) Description of the emergency situation; and (8) Any other pertinent information available at the time. [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 FR 4512, Jan. 27, 2006] § 166.45 Duration of crisis exemption. A crisis exemption may be authorized for: (a) Only as long as is necessary to control the pest or conditions causing the emergency; and (b) No longer than 15 days, unless an application requesting a specific, quarantine, or public health exemption for this use has been submitted to the Agency. § 166.49 Public notice of crisis exemptions. (a) Periodic notices. Federal Register (1) The name of the applicant; (2) The pesticide authorized for use; (3) The crop or site to be treated; and (4) The name, address, and telephone number of a person in the Agency who can provide further information. (b) Annual reports. Federal Register (1) The number of crisis exemptions declared; and (2) The number of crisis exemptions revoked. [51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006] § 166.50 Reporting and recordkeeping requirements for crisis exemption. (a) Adverse effects information. (b) Final reports. (2) Information to be included in the crisis exemption report includes the same information as required in § 166.32(b) and an explanation as to why there was a need to utilize the crisis provisions. (c) Records. (1) Location where the pesticide was applied; (2) Dates of application (range); and (3) Total quantity of the pesticide used. [51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993] § 166.53 EPA review of crisis exemption and revocation of authority. (a) Review. (b) Revocation Individual crisis exemptions. (i) There are insufficient data to determine the risks posed from the use; (ii) Such action is necessary to protect man or the environment; or (iii) The State or Federal agency is not complying with the requirements of this subpart C. (2) State or Federal agency authority. (i) Such action is necessary to protect man or the environment; or (ii) The State or Federal agency is not complying with the requirements of this subpart C. (c) Reason for revocation.