215 

Environmental Protection Agency § 166.2 

(d) How must a State inform EPA of revisions to its containment regulations? 

Any state that has received authorization to continue implementing its 

state containment regulations must inform EPA by letter signed by the designated State Lead Agency within 6 

months of any revision to the State’s 

containment regulations. EPA will inform the state by letter if it determines that the State’s containment 

regulations are no longer adequate 

based on the revisions. The State’s containment regulations will remain in effect, unless and until EPA sends the 

state a letter making this determination. 

PART 166—EXEMPTION OF FEDERAL 

AND STATE AGENCIES FOR USE 

OF PESTICIDES UNDER EMERGENCY CONDITIONS 

Subpart A—General Provisions 

Sec. 

166.1 Purpose and organization. 

166.2 Types of exemptions. 

166.3 Definitions. 

166.7 User notification; advertising. 

Subpart B—Specific, Quarantine, and 

Public Health Exemptions 

166.20 Application for a specific, quarantine, 

or public health exemption. 

166.22 Consultation with the Secretary of 

Agriculture and Governors of the States. 

166.24 Public notice of receipt of application 

and opportunity for public comment. 

166.25 Agency review. 

166.28 Duration of exemption. 

166.30 Notice of Agency decision. 

166.32 Reporting and recordkeeping requirements for specific, quarantine, and public 

health exemptions. 

166.34 EPA review of information obtained 

in connection with emergency exemptions. 

166.35 Revocation or modification of exemptions. 

Subpart C—Crisis Exemptions 

166.40 Authorization. 

166.41 Limitations. 

166.43 Notice to EPA and registrants or 

basic manufacturers. 

166.45 Duration of crisis exemption. 

166.49 Public notice of crisis exemptions. 

166.50 Reporting and recordkeeping requirements for crisis exemption. 

166.53 EPA review of crisis exemption and 

revocation of authority. 

AUTHORITY: 7 U.S.C. 136–136y. 

SOURCE: 51 FR 1902, Jan. 15, 1986, unless 

otherwise noted. 

Subpart A—General Provisions 

§ 166.1 Purpose and organization. 

(a) Purpose and scope. Section 18 of 

the Act authorizes the Administrator 

to exempt State and Federal agencies 

from any provision of the Act, if he determines that emergency conditions 

exist which require an exemption. The 

regulations in this part establish procedures whereby the Administrator 

may exempt a Federal or State agency 

from the provisions of the Act which 

regulate the manner in which a pesticide is made available for use or is 

used. 

(b) Organization. (1) The provisions in 

subpart A of this part describe the four 

types of emergency exemptions authorized by the Agency and define terms 

used in this part. 

(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. A quarantine exemption may be authorized in 

an emergency condition to control the 

introduction or spread of any pest that 

is an invasive species, or is otherwise 

new to or not theretofore known to be 

widely prevalent or distributed within 

and throughout the United States and 

its territories. 

(c) Public health exemption. A public 

health exemption may be authorized in 

an emergency condition to control a 


ICR ATTACHMENT B-1

40 CFR part 166
216 

§ 166.3 40 CFR Ch. I (7–1–07 Edition) 

pest that will cause a significant risk 

to human health. 

(d) Crisis exemption. A crisis exemption may be utilized in an emergency 

condition when the time from discovery of the emergency to the time 

when the pesticide use is needed is insufficient to allow for the authorization of a specific, quarantine, or public 

health exemption. 

[51 FR 1902, Jan. 15, 1986, as amended at 71 

FR 4510, Jan. 27, 2006] 

§ 166.3 Definitions. 

Terms used in this part shall have 

the meanings established by the Federal Insecticide, Fungicide, and 

Rodenticide Act. In addition, as used in 

this part, the following terms shall 

also apply: 

(a) The term the Act means the Federal Insecticide, Fungicide, and 

Rodenticide Act, as amended, 7 U.S.C. 

136 et seq. 

(b) The terms the Agency and EPA 

mean the U.S. Environmental Protection Agency. 

(c) The term beneficial organism 

means any pollinating insect, or any 

pest predator, parasite, pathogen or 

other biological control agent which 

functions naturally or as part of an integrated pest management program to 

control another pest. 

(d) The term emergency condition 

means an urgent, non-routine situation 

that requires the use of a pesticide(s) 

and shall be deemed to exist when: 

(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 

pest 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). 

(e) The term first food use refers to 

the use of a pesticide on a food or in a 

manner which otherwise would be expected to result in residues in a food, if 

no tolerance or exemption from the requirement of a tolerance for residues of 

the pesticide on any food has been established for the pesticide under section 408(b)(2) and (c)(2) of the Federal 

Food, Drug, and Cosmetic Act. 

(f) The term food means any article 

used for food or drink for man or animals. 

(g) The term new chemical means an 

active ingredient not contained in any 

currently registered pesticide. 

(h) The term significant economic loss 

means that, compared to the situation 

without the pest emergency and despite the best efforts of the affected 

persons, the emergency conditions at 

the specific use site identified in the 

application are reasonably expected to 

cause losses meeting any of the following criteria: 

(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 (h)(1) 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. 

(i) The term Special Review refers to 

any interim administrative review of 

the risks and benefits of the use of a 

pesticide conducted pursuant to the 

217 

Environmental Protection Agency § 166.20 

provisions of EPA’s Rebuttable Presumption Against Registration rules, 

40 CFR 162.11(a), or any subsequent 

version of those rules. 

(j) The term unreasonable adverse effects on the environment means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs 

and benefits of the use of any pesticide. 

(k) The term invasive species means, 

with respect to a particular ecosystem, 

any species that is not native to that 

ecosystem, and whose introduction 

does or is likely to cause economic or 

environmental harm or harm to human 

health. 

(l) The term IR-4 program means the 

Interregional Research Project No. 4, a 

cooperative effort of the state land 

grant universities, the U.S. Department of Agriculture and EPA, to address the chronic shortage of pest control options for minor crops, which are 

generally of too small an acreage to 

provide economic incentive for registration by the crop protection industry. 

[51 FR 1902, Jan. 15, 1986, as amended at 71 

FR 4510, Jan. 27, 2006] 

§ 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. 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 

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. 

218 

§ 166.20 40 CFR Ch. I (7–1–07 Edition) 

(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 

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 

219 

Environmental Protection Agency § 166.20 

the previous exemption is due. The interim report shall contain that information specified in §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 §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. 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 

220 

§ 166.22 40 CFR Ch. I (7–1–07 Edition) 

(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. The Administrator shall issue a notice of receipt in the FEDERAL REGISTER for a 

specific, quarantine, or public health 

exemption and request public comment 

when any one of the following criteria 

is met: 

(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 IR4 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. The notice of receipt of 

an application for an emergency exemption shall contain the following information: 

(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. Normally, a notice of receipt shall give the 

public 15 days in which to file comments on the application. The Administrator may shorten or eliminate the 

comment period if he determines that 

the time available for a decision on the 

application requires it and shall state 

reasons for such action in a notice in 

221 

Environmental Protection Agency § 166.30 

the FEDERAL REGISTER. The Administrator may extend the comment period 

if additional time for comment is requested and such an extension would 

not interfere with a timely decision on 

the application. 

[51 FR 1902, Jan. 15, 1986, as amended at 71 

FR 4511, Jan. 27, 2006] 

§ 166.25 Agency review. 

(a) General. The Agency will review 

all requests as expeditiously as possible, making every attempt to respond 

to requests prior to the time when the 

proposed use is needed. The Agency 

will review the application and other 

available data necessary to make a determination with respect to all of the 

following: 

(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. The Administrator may authorize a specific, public 

health, or quarantine exemption, based 

on the information available to the 

Agency, after: 

(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. 

EPA shall allow use of a pesticide 

under a specific or public health exemption for as long a period as is reasonably expected to be necessary but in 

no case for longer than 1 year. 

(b) Quarantine exemption. EPA shall 

allow use of a pesticide under a quarantine exemption for as long a period 

as is deemed necessary but in no case 

for longer than 3 years. Quarantine exemptions may be renewed. Interim reports containing the information specified in §166.32(b) to the extent available 

shall be filed annually. 

§ 166.30 Notice of Agency decision. 

(a) Notification of applicants. The 

Agency shall notify an applicant of its 

decision to approve or deny an application request for an emergency exemption in a timely manner. 

(1) Incomplete applications. The Agency may discontinue the processing of 

any application that does not address 

all of the requirements of §166.20 until 

such time the additional information is 

submitted by the applicant. 

(2) Complete applications—(i) Denials. 

The Agency shall provide the specific 

reasons and rationale for denying the 

exemption request. If the denial is 

based on a specific information gap, 

the decision shall be reconsidered in a 

timely manner when the information 

gap is filled. 

(ii) Approvals. The Agency shall provide the specific terms and conditions 

under which the exempted pesticide 

may be used. 

(b) Federal Register publication. (1) At 

least quarterly, the Administrator 

222 

§ 166.32 40 CFR Ch. I (7–1–07 Edition) 

shall issue a notice in the FEDERAL

REGISTER announcing all approvals of 

specific, quarantine, and public health 

exemptions. The notice shall contain 

all of the following: 

(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. Any unexpected adverse effects resulting from the use of a pesticide 

under a specific, quarantine, or public 

health exemption must be immediately 

reported to the Agency. 

(b) Interim and final reports. A final 

report summarizing the results of pesticide use under any specific, quarantine, or public health exemption 

must be submitted to the Agency within 6 months from the expiration of the 

exemption unless otherwise specified 

by the Agency. For quarantine exemptions granted for longer than 1 year, 

interim reports must be submitted annually. When an application for renewal of the exemption is submitted 

before the expiration of the exemption 

or before submission of the final report, an interim report must be submitted with the application. The information in interim and final reports 

shall include all of the following: 

(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. Records for all treatments involving the first food use of a 

pesticide will be maintained by the 

agency to which the emergency exemption was granted for a minimum of 2 

years following the date of expiration 

of the exemption. On request by the 

Agency these records shall be made 

available to the Administrator. 

Records will include all of the following: 

(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. The Administrator may 

revoke or modify the terms or conditions of a specific, quarantine, or public health exemption if he determines 

one of the following: 

(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. 

223 

Environmental Protection Agency § 166.45 

(b) Implementation. The revocation or 

modification becomes effective as soon 

as the Administrator notifies the State 

or Federal agency which submitted the 

application. Upon notification, the applicant is required immediately to take 

all necessary steps to assure that further use complies with the terms and 

conditions of any modification or, if 

the exemption has been revoked, to 

stop further use. 

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. (1) The State or 

Federal Agency issuing the crisis exemption must notify the Administrator 

in advance of utilization of the crisis 

provisions. 

(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. Information required to be provided in notices shall 

include all of the following: 

(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. 

224 

§ 166.49 40 CFR Ch. I (7–1–07 Edition) 

§ 166.49 Public notice of crisis exemptions. 

(a) Periodic notices. At least quarterly, the Administrator shall issue a 

notice in the FEDERAL REGISTER announcing issuance of crisis exemptions. 

The notice shall contain all of the following: 

(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. Annually, the 

Agency shall issue a notice in the FEDERAL REGISTER that shall summarize: 

(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. Any adverse effects resulting from the use of a 

pesticide under a crisis exemption 

must be immediately reported to the 

Agency. 

(b) Final reports. (1) A report summarizing the results of treatment under a 

crisis exemption will be required to be 

submitted to the Agency within 3 

months following the last date of treatment. If a specific, quarantine, or public health exemption has been approved 

while the crisis exemption is in effect, 

however, the crisis exemption report 

may be incorporated into the specific, 

quarantine, or public health exemption 

final report required under §166.32(b) 

and submitted at the time it is due. 

(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. Records will be maintained for a minimum of 2 years following the date of expiration of the exemption. On request by the Agency, 

these records shall be made available 

to the Administrator. Records will include all of the following: 

(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. When a crisis exemption 

is about to be or has already been declared by a State or Federal agency, 

EPA will undertake an expedited review of the pesticide to determine if 

use of the pesticide may result in such 

unreasonable health or environmental 

risks that the crisis authority should 

not be exercised or the crisis exemption should be revoked. 

(b) Revocation—(1) Individual crisis exemptions. A crisis exemption for the use 

of a specific pesticide may be revoked 

if the Administrator determines that: 

(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. 

The Administrator may revoke the authority of a State or Federal agency to 

issue crisis exemptions for any pesticide if he determines that: 

(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. The Agency 

shall provide the specific reasons for 

revoking an agency’s authority to 

issue a crisis exemption and for revoking an issued crisis exemption. 

PART 167—REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT 

PRODUCING ESTABLISHMENTS, 

SUBMISSION OF PESTICIDE REPORTS 

Subpart A—General Provisions 

Sec. 

167.3 Definitions. 

Subpart B—Registration Requirements 

167.20 Establishments requiring registration.