2311ss03_Attachment B-1_40 CFR part 166_FIFRA-EmergencyExemptions

Environmental Protection Agency

§ 164.133

by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is warranted,
he will then publish notice in the FEDERAL REGISTER setting forth his determination and briefly describing the
basis for the determination. Such notice shall announce that a formal public hearing will be held in accordance
with 5 U.S.C. section 554. The notice
shall specify: (1) The date on which the
hearing will begin and end, (2) the issues of fact and law to be adjudicated
at the hearing, (3) the date on which
the presiding officer shall submit his
recommendations, including findings of
fact and conclusions, to the Administrator, and (4) the date on which a
decision by the Administrator is
anticipated.
§ 164.132 Procedures governing hearing.
(a) The burden of proof in the hearing
convened pursuant to § 164.131 shall be
on the applicant and he shall proceed
first. The issues in the hearing shall be
whether: (1) Substantial new evidence
exists and (2) such substantial new evidence requires reversal or modification
of the existing cancellation or suspension order. The determination of these
issues shall be made taking into account the human and environmental
risks found by the Administrator in his
cancellation or suspension determination and the cumulative effect of all
past and present uses, including the requested use, and uses which may reasonably be anticipated to occur in the
future as a result of granting the requested reversal or modification. The
granting of a particular petition for
use may not in itself pose a significant
risk to man or the environment, but
the cumulative impact of each additional use of the cancelled or suspended
pesticide may re-establish, or serve to
maintain, the significant risks previously found by the Administrator.
(b) The presiding officer shall make
recommendations, including findings of
fact and conclusions and to the extent
feasible, as determined by the presiding officer, the procedures at the hearing shall follow the Rules of Practice,
set forth in subparts A and B of this
part 164.

§ 164.133 Emergency waiver of hearing.
(a) In the case of an application subject to this subpart D which is filed
under section 18 of FIFRA, and regulations thereunder, and for which a hearing is required pursuant to § 164.131, the
Administrator may dispense with the
requirement of convening such a hearing in any case in which he determines:
(1) That the application presents a
situation involving need to use the pesticide to prevent an unacceptable risk:
(i) To human health, or (ii) to fish or
wildlife populations when such use
would not pose a human health hazard;
and
(2) That there is no other feasible solution to such risk; and
(3) That the time available to avert
the risk to human health or fish and
wildlife is insufficient to permit convening a hearing as required by
§ 164.131; and
(4) That the public interest requires
the granting of the requested use as
soon as possible.
(b) Notice of any determination made
by the Administrator pursuant to paragraph (a) of this section shall be published in the FEDERAL REGISTER as
soon as practicable after granting the
requested use and shall set forth the
basis for the Administrator’s determination.

PART 166—EXEMPTION OF FEDERAL
AND STATE AGENCIES FOR USE
OF PESTICIDES UNDER EMERGENCY CONDITIONS
Subpart A—General Provisions
Sec.
166.1
166.2
166.3
166.7

Purpose and organization.
Types of exemptions.
Definitions.
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.

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§ 166.1

40 CFR Ch. I (7–1–96 Edition)

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.
166.47 Notification of FDA, USDA, and
State health officials.
166.49 Public notice of crisis exemptions.
166.50 Reporting and recordkeeping requirements for crisis exemptions.
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 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
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.
§ 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

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§ 166.7

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 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 permanent tolerance, exemption
from the requirement of a tolerance, or
food additive regulation for residues of
the pesticide on any food has been established for the pesticide under section 408 (d) or (e) or 409 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, under the emergency conditions: for a productive activity, the
profitability would be substantially
below the expected profitability for
that activity; or, for other types of activities, where profits cannot be calculated, the value of public or private
fixed assets would be substantially
below the expected value for those assets. Only losses caused by the emergency conditions, specific to the impacted site, and specific to the geographic area affected by the emergency

conditions are included. The contribution of obvious mismanagement to the
loss will not be considered in determining loss. In evaluating the significant
of an economic loss for productive activities, the Agency will consider
whether the expected reduction in profitability exceeds what would be expected as a result of normal fluctuations over a number of years, and
whether the loss would affect the longterm financial viability expected from
the productive activity. In evaluating
the significance of an economic loss for
situations other than productive activities, the Agency will consider reasonable measures of expected loss.
(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
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.
§ 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

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§ 166.20

40 CFR Ch. I (7–1–96 Edition)

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) The registration number and the
name of the pesticide product if a specific product is requested; or the formulation(s) requested if a specific
product is not desired; 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 total acreage or other appropriate unit proposed to be treated;
(v) The total amount of pesticide proposed to be used in terms of both active
ingredient and product; and
(vi) All applicable restrictions and
requirements concerning the proposed
use and the qualifications of applicators using the pesticide.
(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

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§ 166.20

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) Notification of registrant or basic
manufacturer. The application shall
contain a statement that the registrants of all pesticide products proposed for use or, if appropriate, the
basic manufacturer have been notified
that a request has been made to the
Agency for use of the pesticide under a
specific, quarantine, or public health
exemption.
(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 § 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, which addresses
all of the following:
(i) Historical net and gross revenues
for the site;
(ii) The estimated net and gross revenues for the site without the use of the
proposed pesticide; and
(iii) The estimated net and gross revenues for the site with use of the proposed pesticide.
(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]

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§ 166.22

40 CFR Ch. I (7–1–96 Edition)

§ 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 for a specific or public health
exemption, if:
(i) An emergency exemption has been
requested or granted for that use in
any 3 previous years, 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

(7) 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
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.
§ 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

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§ 166.30

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 level of residues in or on all
food resulting from the proposed use;
(3) The anticipated benefits to be derived from the proposed use; and
(4) The potential risks to the 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, has
not
been
submitted,
reasonable
progress towards registration has not
been made.
§ 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 which does not contain
all of the information required by
§ 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) Notification of FDA, USDA, and
State health officials. If a use authorized
under a specific, quarantine, or public
health exemption will result in residues of the pesticide chemical in or on
food, the Agency shall notify the Food
and Drug Administration, U.S. Department of Health and Human Services,
and the Food Safety and Inspection
Service, U.S. Department of Agriculture, as appropriate, of the level of
residues expected to result. Additionally, the Agency shall ensure that
State health and food officials, as appropriate, are also provided with the
information specified in this paragraph.
(c) FEDERAL REGISTER publication. (1)
At least quarterly, the Administrator
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

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40 CFR Ch. I (7–1–96 Edition)

(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.

(1) Locations where the pesticide was
applied;
(2) Dates of application (range); and
(3) Total quantity of the pesticide
used.

§ 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.

(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) Final reports. A report summarizing the results of pesticide use under a
specific, quarantine, and public health
exemption must be submitted to the
Agency within 6 months from the expiration of the exemption unless otherwise specified by the Agency. The information in this report 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:

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

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.
(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 emergency condition exists;
and

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§ 166.49

(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.
§ 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) When feasible,
the State or Federal Agency issuing
the crisis exemption must notify the
Administrator at least 36 hours in advance of utilization of the crisis provisions. In no case shall notice be given
to the Agency later than 24 hours after
the decision to avail itself of a crisis
exemption.
(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 active ingredient
authorized for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
(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 or the date on which use
of the pesticide began;

(5) An estimate of the level of residues of the pesticide expected to result
from use under the crisis exemption;
and
(6) Any other pertinent information
available at the time.
[51 FR 1902, Jan. 15, 1986, as amended at 58
FR 34203, June 23, 1993]

§ 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.
§ 166.47 Notification of FDA, USDA,
and State health officials.
If a use authorized under a crisis exemption will result in residues of the
pesticide chemical in or on food, the
Agency will notify the authorizing
agency, the Food and Drug Administration, U.S. Department of Health and
Human Services and the Food Safety
and Inspection Service, U.S. Department of Agriculture, as appropriate, of
the level of residues expected to result
and whether such residues pose an unacceptable risk to public health. This
notice shall be provided as soon as the
Agency makes its determination. Additionally, the Agency will ensure that
State health and food officials, as appropriate, are also provided with this
information.
§ 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 State or Federal
agency using a crisis exemption;
(2) The name of the active ingredient
authorized for use, including, if available, the common name and the Chemical Abstracts Service (CAS) number;
(3) The site to be treated;

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§ 166.50

40 CFR Ch. I (7–1–96 Edition)

(4) The name, telephone number, and
address of a person in the Agency who
can provide further information; and
(5) Whether a specific, quarantine, or
public health exemption has been requested.
(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.
§ 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.

clared 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

Subpart B—Registration Requirements
167.20 Establishments
tion.

requiring

registra-

Subparts C and D—[Reserved]
Subpart E—Recordkeeping and Reporting
Requirements

[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 de-

Definitions.

167.85 Reporting requirements.
167.90 Where to obtain and submit forms.
AUTHORITY: 7 U.S.C. 136 (e) and (w).
SOURCE: 53 FR 35058, Sept. 8, 1988; 54 FR
32638, Aug. 9, 1989, unless otherwise noted.

176