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EMERGENCY EXEMPTIONS UNDER SECTION 18 OF
THE FEDERAL INSECTICIDE FUNGICIDE AND RODENT1CIDE ACT
II. INSTRUCTIONS FOR SUBMISSION OF
EMERGENCY EXEMPTION APPLICATIONS
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REGISTRATION DIVISION
OFFICE OF PESTICIDE PROGRAMS
06/22/92
§ HEADQUARTERS
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TABLE OF CONTENTS
Page
Continued....
Page
I. General Instructions
1
A. Repeat Applications 1
B. Submission Instructions 1
- U.S. Mail 2
- Overnight Express Mail 2
- FAX and E-Mail 2
Itemized Instructions 3
A. General Information Required 3
/. Type of Exemption 3
2. Identity of Contact Persons 3
3. Description of Pesticide 3
4. Description of Proposed Use 4
5. Alternative Methods of Control 5
6. Efficacy of Use Proposed 5
7. Residues in Food 5
& Discussion of Risk Information .... 6
9. Coordination with Other Agencies . . 6
10. Notification of Registrant 7
11, Enforcement Program 7
12. Repeat Uses 7
13, Progress Toward Registration 7
B. Requirement! for Specific Exemptions Baaed
on Significant Economic Loss 8
1. Name of Pest 8
2. Emergency Condition 8
3. Additional Benefits Information 9
4. Discussion of Economic Loss 9
C. Requirements for Specific Exemptions Based
on Significant Risks to Threatened or
Endangered Species, Beneficial Organisms,
or the Environment 11
1. Name of Pest 11
2. Emergency Condition 12
3, Anticipated Risks to Endangered or
Threatened Species, Beneficial
Organisms or the Environment .... 12
D. Requirements for Quarantine
Exemptions
12
7. Name of Pest 12
2. Origin of Introduced Pest 12
3. Impact of the Pest 12
E. Requirements for Public Health
Exemptions
13
/. Name of Pest 13
2. Health / Pest Problem 13
3. Medical Treatment 13
F. Requirements for Crisis Exemptions ... 13
1. Limitations 13
2. Notification 14
3. Contents of the Notification 14
G. Submission of Final Reports
Emergency Response and Minor Us*
Section Contacts
E-Mail EPA Regional C
14
16
17
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INSTRUCTIONS FOR COMPLETING SECTION 18
EMERGENCY EXEMPTION APPLICATIONS
(SPECIFIC, PUBLIC HEALTH, AND QUARANTINE EXEMPTIONS)
I. GENERAL INSTRUCTIONS
Please follow the itemized instructions carefully and provide all the information
requested in the appropriate spaces. If additional space is needed to complete a
particular item attach additional pages as necessary. If any of the information required
(as specified in the itemized instructions) is not available or you are only able to furnish
partial data, please provide a detailed explanation of the reason for the omission. In
order to reduce the possibility that EPA will halt review of an incomplete application,
the submitting agency should explain why information is missing. Do not leave an item
blank as this will delay processing of the application.
The attached sample application format is provided for convenience. Although
submission of your application according to this format is not required, following the
same organizational format may help expedite processing of your application. If you
choose to use a comparable application format be sure that all the information specified
in the itemized instructions is provided in your application.
A. REPEAT APPLICATIONS
Please note that applicants should submit fully completed applications for every
emergency exemption request, including repeat requests. The Agency will not refer to
previously submitted applications in consideration of a repeat section 18 request.
Although the Agency realizes some of the information in an application for a repeat use
may remain the same, it is improbable that emergency conditions, economic loss, and
other elements of the emergency situation are static. The repeat application should
provide updated information in the appropriate sections to address the changes in the
nature of the emergency. Supporting data (such as residue data, copies of published
articles, etc.) which has been included as attachments in any exemption request
submitted within the last three fiscal years may be referenced.
B. SUBMISSION INSTRUCTIONS
To submit a section 18 emergency exemption application, send the original and one copy
' of the application (and any accompanying data or attachments) to the Emergency
Response and Minor Use Section (ERMUS) using one of the methods shown below.
Please do not submit applications to any other address. Applications which are
submitted to the Division Director, the Director of Pesticide Programs, the Assistant
Administrator, the Administrator, or a similar office will result in further delays and
will not expedite the processing of your application.
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For U.S. Mail, send completed application to:
Section Head (H7505C)
Emergency Response and Minor Use Section
Registration Support Branch
Registration Division/OPP
U.S. E.P.A.
401 M Street, S.W.
Washington, D.C. 20460
For overnight delivery (first ensure delivery will occur between 9:00 AM and 3:00 PM
weekdays, excluding Federal holidays), send completed application to:
Section Head (H7505C)
Emergency Response and Minor Use Section
Registration Support Branch
Registration Division/OPP
U.S. E.P.A.
Room 716, Crystal Mall D
1921 Jefferson Davis Highway
Arlington, Virginia 22202
An application will not be processed until the complete application, including all
attachments and accompanying data, has been received. The FAX or electronic
messaging (E-mail) is suggested when submitting supplemental information to follow-up
on a previously submitted application, or notification of a crisis exemption. However, it
is generally not recommended to use either of these when sending documents with
numerous pages.
Send FAXes to:
Section Head (H750SC)
Emergency Response and Minor Use Section
Registration Support Branch
FAX No. (703) 308-1848
Send E-mail Applications to:
ERMUS
(If further information is required regarding use of, or access to, the "All-
in-One" E-mail system, you should contact your appropriate EPA regional
contact from the list, attached at the end of these instructions.)
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All applications received by the ERMUS will be acknowledged by phone or in writing.
If you do not receive acknowledgement, you should verify that your application has been
received by phoning the section head. The attached personnel resource listing at the end
of these instructions contains the current names and phone numbers of the ERMUS
staff.
II. ITEMIZED INSTRUCTIONS
The sections which follow coincide with the sections of the sample application format
provided. Each section contains a detailed description of the information that should be
provided in the corresponding sections of the application. The 40 CFR references for
the different sections of the application requirements are listed where applicable.
In addition to the information required in the application as specified in the following
instructions, the emergency exemption application must include a written request for the
exemption from the head of the Federal or State Lead Pesticide agency, the Governor of
the State involved, or their official designee. In the case where a designee has been
delegated the authority to request exemptions, written authorization of such delegation
must be on file with the Agency. The cover letter requesting the emergency exemption
must accompany the application at the time of submission.
A. GENERAL INFORMATION REQUIRED
1. TYPE OF EXEMPTION. Indicate type of exemption - specific, public health, or
quarantine.
2. IDENTITY OF CONTACT PERSONS (166.20(a)(l)). Identify contact person for
administrative purposes. The contact person will be assumed to be the person who
signed the application unless otherwise specified. Be sure to include phone and fax
numbers, and the correct address to which all correspondence should be mailed.
Additionally, identify one or more qualified experts and their areas of expertise who may
be contacted regarding the various aspects of the emergency situation. The qualified
expert should not have a financial interest in the decision. Be sure to include phone and
fax numbers.
3. DESCRIPTION OF PESTICIDE (16620(a)(2)). Identify the active ingredient using
the accepted American National Standards Institute (ANSI) name or the most accurate
. common chemical name.
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For federally registered pesticides, the application should specify the EPA Registration
Number, registrant, and the trade name of the product. If a specific product is not
requested, specify the formulation(s) requested and the percent active ingredient.
Provide a copy of the federally registered label and any additional labeling proposed for
the emergency exemption use which will be distributed. Any supplemental directions for
use will be listed in the authorizing mailgram which may be distributed to individuals
involved with use under the emergency exemption.
For all other pesticide products, the application should include a confidential statement
of formula or a reference to one already submitted to the Agency as part of a previous
or pending action for this active ingredient (give EPA File Symbol, EUP number, or
SLN number), and complete labeling which will be used in connection with the proposed
exemption use. Also include a description of how unused material will be disposed of
upon expiration of this exemption.
4. DESCRIPTION OF PROPOSED USE (166.20(a)(3)). The application shall specify
all of the following:
a. The sites to be treated, including specific locations within the state. Specify the
names of counties where applications will occur if not statewide. (As much detail
as possible, e.g., proximity to water bodies, residences, etc. will particularly aid
EPA review.);
b. The method of application. Be as specific as possible with respect to method,
particularly if an innovative method which may reduce exposure will be used;
c. The rate of application in terms of both active ingredient and product;
d. The maximum number of applications;
e. The total acreage (or other appropriate units) to be treated under the exemption;
f. The total amount of pesticide to be used in terms of both active ingredient and
product;
g. The use season or that period of time for which use of the chemical is requested.
If production and distribution of the pesticide product will be a concern, please
explain (while this information is not required in the regulations, it is very useful);
and
h. All applicable restrictions, user precautions and requirements concerning the
proposed use and the qualifications of applicators.
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5. ALTERNATIVE METHODS OF CONTROL (166.20(a)(4)). The application shall
state whether there are any registered pesticides for the proposed use. In the case of
existing registered alternatives, the application shall contain a detailed explanation of
why each of these products are not sufficient to control the emergency. If the applicant
is claiming a lack of efficacy for the registered alternatives, field data demonstrating the
ineffectiveness of the registered alternatives must be included with the application.
Under extenuating circumstances or in the absence of such field data, written statements
from qualified agricultural experts, extension or university personnel, or other persons
similarly qualified in the field of pest control verifying the lack of efficacy will be
acceptable. If a pesticide is available but not recommended by the appropriate State
officials, an explanation of why it is not recommended must be provided. If a pesticide is
included in the State recommendations but determined to be ineffective for this
particular emergency situation, this discrepancy must also be explained.
If the necessary application equipment to use a registered pesticide is not available, an
explanation of what attempts were made to obtain use of the necessary equipment and
the results of those attempts must be provided.
If the applicant is claiming the registered alternatives are not available in sufficient
quantities, the application should contain a detailed explanation of what attempts were
made to obtain an adequate supply and results of these attempts.
The application shall also contain a detailed explanation, supported by field data, of why
it is not economically and/or environmentally feasible to employ alternative control
practices to resolve the emergency. For repeat uses, the use of an alternative control
practice (if available) is expected to be used in subsequent years to address an
anticipated emergency instead of use of a pesticide under section 18 (e.g. rotating crops,
using tolerant/resistant crop strains, preplan! treatment, etc.). An application for a
repeat use should indicate why such a practice was not employed.
6. EFFICACY OF USE PROPOSED UNDER SECTION 18 (16620(a)(5)). The
application must contain data, a discussion of field trials, or other evidence (e.g.
experimental testing, small plot trials, laboratory trials, or corroborating evidence from
similar uses) which provided the basis for the conclusion that the proposed pesticide
treatment will be effective in alleviating the emergency.
7. RESIDUES IN FOOD (16620(a)(6)). For purposes of section 18, food commodities
.will include raw agricultural commodities, processed food, and potable water. Residue
levels must be estimated for all the food commodities even if residues in a processed
food are expected to be lower than those in the treated commodity. The application
shall address whether residues are expected in or on food, a list of food item(s) likely to
contain residues, and an estimate of the maximum amount of residues likely to result
from the proposed use.
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If residue levels are expected to be nondetectable, the application should so state and
specify the limit of detection.
The residue data from which the above residue estimate is derived must be provided if
not already on file with the EPA. If data are on file with the EPA please provide the
appropriate reference number (tolerance petition or MRID number) for locating the file.
If certain potential food/feed items will not be allowed into the marketplace, cite
method for controlling distribution in the marketplace (e.g. fresh market only).
8. DISCUSSION OF RISK INFORMATION (166.20(a)(7)). This section is intended to
provide the Agency with the applicant's perception of potential risks from a proposed
use. Assessing the potential impact the proposed use will have on the environment is
ultimately the responsibility of the Agency. The Agency hopes that this requirement will
heighten the requesting agency's awareness of the risks involved with the proposed use of
a pesticide and thus enable it to weigh more fully the benefits and the risks in
determining whether or not to request a particular use.
The application shall address the potential risks to human health, endangered or
threatened species, beneficial organisms, and the environment from the proposed use. A
description of the application sites including proximity to aquatic systems, endangered
species habitats, residences, etc., as well as soil type should be provided (as much detail
as possible will expedite the Agency's review), along with references to data or other
supporting information. Proposals to mitigate risks (protective clothing, setback
restrictions, soil-type restrictions, etc.) should be listed here.
9. COORDINATION WITH OTHER AFFECTED STATE/FEDERAL AGENCIES
(166.20(a)(8)). The application should indicate whether the proposed use of the
pesticide is Likely to be of concern to other Federal or State agencies, and list those
agencies that have been contacted. Any comments received from the affected agencies
must be submitted with the application or forwarded as they are received to the EPA
Prior to submitting the emergency exemption application to EPA, the applicant should
request the Endangered Species Specialist in the Regional Office, U.S. Fish and Wildlife
Service to provide the applicant with a "species list" of the endangered or threatened
species that are present in the areas to be treated (applicant must provide USFWS with
the locations of pesticide applications under the proposed exemption). The species list
provided by the Fish and Wildlife Service must be included in the application for the
emergency exemption.
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10. NOTIFICATION OF REGISTRANT (166,20(a)(9)). The application shall contain a
statement or evidence that registrants or basic manufacturers of all products proposed
for use under the emergency exemption have been notified of the exemption request. A
copy of a letter from the registrant is preferred. This letter might also include
information on the progress towards registration of the proposed use (See REPEAT
USES, below).
11. ENFORCEMENT PROGRAM (166.20
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Once a complete application for registration has been submitted, progress toward
registration will be evaluated on a case-by-case basis. In general, the Agency is not
inclined to grant repeat exemptions unless reasonable progress toward registration has
been made.
Prior to making an application for a repeat specific or public health exemption, the state
or federal agency should contact the registrant regarding the progress being made toward
registration of the proposed use. The section 18 application should contain a discussion
of progress toward registration, including a summary of deficiencies and data gaps and
the registrant's timetable for rectifying registration deficiencies.
B. REQUIREMENTS FOR SPECIFIC EXEMPTIONS BASED ON SIGNIFICANT
ECONOMIC LOSS
The majority of specific exemptions requested are based on a potential significant
economic loss as a result of a pest outbreak or unusual environmental conditions. An
application for this type of specific exemption should include the information specified
below.
1. SCIENTIFIC AND COMMON NAME OF PEST (166.20(b)(l)). The application shall
specify the scientific and common name of the pest or pest complex for which use of the
chemical is sought.
2. DISCUSSION OF THE EMERGENCY CONDITION (166.20(b)(2)). The application
shall include a discussion of the events which brought about the emergency (weather
conditions, severe pest pressure, resistance development, pesticide cancellations, etc.).
Claims of severe pest or disease pressure must be documented with data or written
testimony of qualified experts. When an exemption application is submitted prior to the
existence of an emergency condition, a detailed explanation of why such emergency
condition is expected must be submitted. This type of exemption application would be
authorized based on a "threshold level." A threshold level would be the level at which
the Agency had determined that an emergency condition would exist. The Applicant
should propose a threshold level for the Agency's consideration. Examples of threshold
levels include a specified number of plant pests per plant, some level of rainfall
occurring within a specific timeframe, the presence of weeds at a given crop stage, or
some percentage of crop defoliation due to a pest. Once a pest population or a situation
progressed to this threshold level, use under the exemption would be allowed.
If resistance development, phytotoricity, or similar claims are the basis for the
emergency exemption, the applicant must include evidence (in the form of field or
laboratory data) to support his claim. Written testimony from qualified experts may be
acceptable when data are not available.
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In addition to efficacy data for the proposed pesticide, registered alternative pesticide,
and alternative practices, discussed previously in section II.A.5 and 6, yield data from
studies comparing the proposed pesticide to the next best alternative(s) should be
provided by the applicant, if available, to substantiate yield loss claims.
3. ADDITIONAL BENEFITS INFORMATION
In those instances where the Agency determines that a significant risk exists from a
proposed use, an in-depth benefit analysis will be conducted. Economic impacts of the
following types will be considered whenever they are fully addressed in the application:
a. Impacts at the pesticide user level.
b. Measurable change in price and availability of the commodity to consumers.
c. Measurable reduction in sales and/or employment of organizations supplying the
affected producers.
d. Measurable reduction in business volume and/or employment of organizations
marketing the output of the affected producers.
e. Measurable reduction in the economic base, including employment of
communities affected by the supplier and marketing organizations.
Any of the above information or any non-economic or qualitative information which
describes the benefits from using the pesticide will also be taken into consideration by
the Agency.
4. DISCUSSION OF ECONOMIC LOSS (166.20(b)(4)). The application shall discuss
anticipated significant economic loss associated with the emergency condition. The
discussion must include data and other information which will allow the Agency to
perform an economic analysis of the emergency situation.
The Agency requires five years of yield and price data along with cost of production data
(either five years of production cost data or a crop budget) to complete an economic
analysis (40 CFR 16&2(b)(4)(i). This information should include the cost of pesticides
or other pest control practices used over the last 5 years and the cost of the pesticide
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requested under the exemption. Whenever possible these costs should include both
materials and application. The sample table below should be used as a guide for
providing suitable data for the Agency's analysis. Failure to provide the necessary
economic information will result in delays in the processing of application.
YEAR
Yean
Year 2
Year3
Year 4
Years
Average
YIELD PER
ACRE (flats,
bushels,
Ibs., etc.)
xxxxx
xxxxx
xxxxx
xxxxx
xxxxx
xxxxx
PRICE
PER
UNIT
$ xx.xx
XX.XX
XX.XX
XX.XX
XX.XX
XX.XX
GROSS
Revenue
Per acre
$XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
COST
PER
ACRE
$XXX
XXX
XXX
XXX
XXX
XXX
NET
Revenue
Per acre
$xxxx
XXXX
XXXX
XXXX
XXXX
XXXX
If the five years of requested data includes data from abnormal year(s), either favorable
(ideal growing conditions) or unfavorable (drought), this should be explained in the
discussion and an alternative estimate of the normal range in profitability provided. The
application should fully explain how the alternative estimate of the normal range in
profitability was derived.
If production cost data are not available, a best estimate of the cost of production should
be provided. The data submitted should pertain to the area within the state impacted by
the emergency. Applicants should be cautious about submitting statewide data.
Statewide data are generally inadequate for demonstrating the nature and extent of a
problem unless the problem exists on the vast majority of the crop acreage within the
State.
In addition to the above data, 40 CFR Sections 16&20(b)(4)(ii) and 16&20(b)(4)(iii)
require the applicant to provide the estimated net and gross revenues for the site with
and without the use of the proposed pesticide. The estimated revenues for the site
without the proposed use should be calculated based on the next best registered
alternative pesticide or cultural practice being utilized. The revenue estimates should
also be based on average expected yield reductions, not the maximum potential yield
loss. If a reduction in quality is the nature of the emergency, provide information on
the proportion of yield falling Into each grade over the past 5 years and the effect of the
emergency on quality of production (provide prices for each grade over the last 5 years).
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In evaluating the signficance of an economic loss for productive activities, the Agency
will also consider whether the loss would affect the long-term financial viability expected
for the activity. For example, an enterprise may face a situation where, due to
circumstances beyond its control (e.g. bad weather), it must have a remarkably good
upcoming crop year to remain financially viable. Even though profits, without an
exemption, are expected to be within the historical range, this will not be sufficient to
make up for the previous crop failures. The enterprise will only realize the above-
average profits needed to assure its long-term financial viability if an emergency
exemption is granted to control an emergency pest problem. In such a situation, an
emergency exemption could be granted even though profits without the exemption are
expected to be within the historical range.
When the above information is not applicable because the exemption is requested for
purposes unrelated to agricultural production, such as for protection of structures,
museum pieces, or park land, an applicant should explain the inapplicability, discuss the
expected economic losses in other reasonable terms, and provide the best available
supporting data.
C. REQUIREMENTS FOR SPECIFIC EXEMPTIONS BASED ON
SIGNIFICANT RISKS TO THREATENED OR ENDANGERED SPECIES.
BENEFICIAL ORGANISMS. OR THE ENVIRONMENT
Applications for this type of specific exemption must be based on the determination that
there is an urgent, non-routine situation which, if not addressed, could pose significant
risk to threatened or endangered species, beneficial organisms, or the environment.
Applications for this type of exemption must include documentation that all three criteria
for an emergency condition are met:
(1) no effective registered pesticides are available,
(2) no feasible alternative control practices are available, and
(3) (in this particular case) the situation will present significant risks to the
environment.
1. SCIENTIFIC AND COMMON NAME OF PEST (166.20(b)(l). The application shall
specify the scientific and common name of the pest or pest complex for which use of the
chemical is sought.
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2. DISCUSSION OF THE EMERGENCY CONDITION
The application shall include a discussion of the events which brought about the
emergency situation. There may be instances when a pest must be controlled in order to
protect threatened and endangered species. It is possible that the pesticide(s) registered
to control a particular predator species has lost its effectiveness, thereby jeopardizing the
continued existence of a particular threatened or endangered species. The use of
another pesticide to effectively control the predator species could be requested under
this type of exemption. There may also be instances when a pest population should be
controlled in order to protect beneficial organisms which are used as pest predators in an
integrated pest management program. It is possible that the use of a registered pesticide
would reduce or eliminate a pest predator and thus require the use of additional
pesticides to control the pest the predator would have controlled. The use of another
pesticide, which is less toxic to the predator, could be requested under this type of
exemption.
3. DISCUSSION OF THE ANTICIPATED RISKS TO ENDANGERED OR
THREATENED SPECIES, BENEFICIAL ORGANISMS, OR THE ENVIRONMENT
The application shall discuss the anticipated risks to endangered or threatened species,
beneficial organisms, or the environment that would be remedied by the proposed use of
the pesticide.
D. QUARANTINE EXEMPTION REQUIREMENTS
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. The
application for the quarantine exemption should include the information specified below.
1. SCIENTIFIC AND COMMON NAME OF PEST (166.20(c)(l)). The application
shall specify the scientific and common name of the pest or pest complex for which use
of the chemical is sought.
2. ORIGIN OF INTRODUCED PEST (166.20(c)(2)). The application shall provide the
origin of the pest and the means of its introduction and spread into the area if known.
3. IMPACT OF THE PEST (166.20(c)(3)). The application shall indicate the
anticipated impact of not controlling pest and any other information pertinent to the
economic importance of this pest.
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E. PUBLIC HEALTH EXEMPTION REQUIREMENTS
A public health exemption may be authorized in an emergency condition to control a
pest that will cause a significant risk to human health. In instances involving a significant
risk to human health due either to the pest itself or a disease for which the pest is a
vector, there does not necessarily have to be an outbreak of a pest population but rather
an increase in the disease incidence within a pest population. The application for the
public health exemption should include the information specified below.
1. SCIENTIFIC AND COMMON NAME OF PEST (166.20(d)(l)). The application
shall specify the scientific and common name of the pest or pest complex to be
controlled and, if the pest is a vector, a description of the disease it is expected to
transmit.
2. HEALTH/PEST PROBLEM (166.20(d)(2)). The application shall provide a
discussion of the magnitude of the health problems which are expected to occur without
the use of the pesticide and resultant spread of the pest.
3. MEDICAL TREATMENT (166.20(d)(3)). The application shall provide a discussion
of the availability of medical treatments available to remedy any resultant health
problem associated with the spread of the pest.
F. CRISIS EXEMPTION REQUIREMENTS
A crisis exemption may be issued by the head of a Federal or State agency, the
Governor of a State, or their official designee in situations involving an unpredictable
emergency situation when an emergency situation exists and the time element with
respect to the pesticide application is critical and there is not sufficient time to request a
specific, quarantine, or public health exemption, or if such a request has been submitted,
for the EPA to complete its review of the application.
The issuing agency must comply with the provisions specified below once a decision to
avail itself of a crisis exemption has been reached.
1. LIMITATIONS (166.41). The crisis provisions may not be utilized if any of the
following apply:
. a. The EPA has instructed the head of the Federal or State agency, Governor, or
official designee not to issue such a crisis exemption;
b. The pesticide use has been suspended under section 6(c) of FIFRA;
c. The pesticide use has been canceled under section 6(b) of FIFRA;
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d. The pesticide contains a new chemical (active ingredient not contained in a
currently registered pesticide); or
e. The application proposes the first food use of a pesticide (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 tolerance, or food additive
regulation for residues of the pesticide on any food has been established for the
pesticide under §408 or §409 FFDCA).
2. NOTIFICATION (166.43(a)). The State or Federal agency issuing the crisis
exemption must provide notification to the EPA at least 36 hrs in advance of utilization
of the crisis provisions when feasible. In no case shall notice be given to the EPA later
than 24 hours after utilization of the crisis provisions. Please note any notification by
phone must be followed by written notification. This notification must contain the the
information listed below:
3. CONTENTS OF THE NOTICE (166.43(b)). The above notice shall include all of the
following:
a. The name of active ingredient authorized for the crisis use, including the common
name and the Chemical Abstracts Service (CAS) number;
b. The crop or site on which the pesticide is to be used;
c. The use pattern (method, number, and rate of applications);
d. The dates that applications started or will begin and end;
e. An estimate of the level of residues of the pesticide expected to result from use
under the crisis exemption (for food crops); and
f. A discussion of the emergency situation and any other pertinent information
available at the time, including an explanation why time was insufficient to
request a specific or quarantine exemption, and intentions with respect to
requesting a specific exemption for this use.
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 the EPA.
G. SUBMISSION OF FINAL REPORTS
40 CFR 166.32 states that a report summarizing the results of the pesticide use under an
emergency exemption must be submitted to the Agency no later than six months from
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the expiration of the exemption unless otherwise specified by the Agency. Please note
the final report for crisis exemptions is due no later than three months following the
date of the last application unless followed with a specific, quarantine, or public health
exemption for the same use. In this case the final report for the crisis exemption may be
incorporated into the final report for the specific, quarantine, or public health exemption,
but the report should clearly indicate that it covers both exemptions.
Please be sure to reference the EPA assigned emergency exemption number (92-TX-01,
etc.) when submitting final reports to the Agency. Final reports should be submitted
under separate cover and not included in subsequent emergency exemption requests for
the same use. A copy of the final report sent to EPA headquarters should also be sent
to your EPA Regional Office.
The final report for an emergency exemption shall include the following information:
1. The total acreage, amount of commodity, or other unit treated under the
exemption, and the total quantity of pesticide used;
2. A discussion of the effectiveness of the pesticide used in dealing with the
emergency condition;
3. A description of any unexpected adverse effects which may have resulted from the
use of the pesticide under the emergency exemption;
4. The results of any compliance monitoring required and/or carried out under the
exemption;
5. A discussion of any enforcement actions taken in connection with the exemption;
6. The method(s) of disposition of a food crop, if required to be destroyed, under an
exemption;
7. Any other information requested by the Administrator in connection with the
granting of an exemption; and
8. In the cases where a crisis exemption was declared, an explanation as to why
there was a need to utilize the crisis provisions.
RD/OPP 06/22/92
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-16-
EMERGENCY RESPONSE AND MINOR USE SECTION CONTACTS
REBECCA COOL
SECTION HEAD
(703) 305-7717
ALICE HARRIS
MANAGEMENT ASSISTANT
(703) 305-6077
ANDREA BEARD
EMERGENCY EXEMPTION SPECIALIST
(703) 305-7890
LARRY FRIED
EMERGENCY EXEMPTION SPECIALIST
(703) 305-7889
LIBBY PEMBERTON
EMERGENCY EXEMPTION SPECIALIST
(703) 305-5309
SUSAN STANTON
EMERGENCY EXEMPTION SPECIALIST
(703) 305-6359
HOYT JAMERSON
MINOR USE OFFICER
(703)305-5310
RD/OPP 06/22/92
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-17-
ALL-IN-ONE E-MAIL EPA REGIONAL CONTACTS
REGION I:
Nancy Atkinson
(617) 565-3377
FTS 835-3377
REGION II:
Carol Equo .
(212) 264-1414
FTS 264-1414
REGION III:
Andrea Parker
(215) 597-7853
FTS 597-7853
REGION IV:
Carolyn White
(404) 347-0509
FTS 257-0509
REGION V:
Patricia Thompson
(312) 886-6015
FTS 886-6015
REGION VI:
Dave White .
(214) 655-6540
FTS 255-6540
REGION VII:
Patricia Jones
(913) 551-7238
FTS 276-7238
REGION IX:
Doris Yee
(415) 744-1762
FTS 484-1762
REGION X:
Laura Cook .
(206) 553-1580
FTS 399-1580
ALL-IN-ONE CUSTOMER SUPPORT
1-800-334-2405
FTS 629-7862
RD/OPP 06/22/92
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
TYPE OF EXEMPTION BEING REQUESTED (check one) [p.3]
D SPECIFIC
D QUARANTINE
D PUBLIC HEALTH
CONTACT PERSQN(S) AND QUALIFIED EXPERT(S) (166.20(a)(l)) [p.3]
CONTACT PERSON:
Name:
QUALIFIED EXPERT:
Name:
Title:
Title:
Organization:
Address:
Organization:
Address:
Phone:
Phone:
DESCRIPTION
Common Chemical Name
(Active Ingredient):
Trade Name(s)
and EPA Reg. Nos.:
Formulation:
OF PESTICIDE REQUESTED (166.20(a)(2)) [p.3]
% Active Ingredient:
Manufacturer(s): 1
J
RD/OPP 06/22/92
PAGE:
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
DESCRIPTION OF PROPOSED USE (16620(a)(3)) [p.4]
Sites to be Treated:
Method of .Application:
Rate of Application (in terms of a.i. and product):
Maximum Number of Applications:
Total Acreage (or other units^ to be Treated:
Total Amount of Pesticide to be Used fin terms of a.i. and product1):
Use Season (period of time for which use of chemical is requested^:
Additional Restrictions. User Precautions and Requirements. Qualifications of Applicators, etc.:
ALTERNATIVE METHODS OF CONTROL (166.20(a)(4)) [p5]
(Efficacy data and/or other information included as a separate attachment)
Registered Alternative Pesticides:
Alternative Control Practices:
RD/OPP 06/22/92 PAGE 2
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
EFFICACY OF USE PROPOSED UNDER SECTION 18 (166.20(a)(5)) [p.5]
(Efficacy data and/or other information included as a separate attachment)
EXPECTED RESIDUE LEVELS IN FOOD (166.20(a)(6)) [p.5]
(Residue data included as separate attachment)
RD/OPP 06/22/92
PAGE:
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
DISCUSSION OF RISK INFORMATION (166.20(a)(7)) [p.6]
(Potential risks to human health, endangered or threatened species,
beneficial organisms, and the environment)
Description of application sites, including proximity to residential areas, aquatic systems.
endangered or threatened species habitats, soil types, etc.
Possible risks posed bv use:
Proposals to mitigate risks:
RD/OPP 06/22/92 PAGE: 4
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
COORDINATION WITH OTHER AFFECTED FEDERAL, STATE, AND LOCAL AGENCIE;
<166.20(a)(8)) [p.6]
(List of species of endangered or threatened species from USFWS included
as separate attachment)
NOTIFICATION OF REGISTRANT (166.20(a)(9)) [p.7]
(Letter from registrant included as separate attachment)
ENFORCEMENT PROGRAM (166.20(a)(10)) {p.7]
(Explanation of legal authority and program resources for enforcement)
If the requested use involves:
~o A pesticide containing an active ingredient which has not been federally registered
for use on a food commodity (a "first food use")
o A canceled or suspended pesticide use
o A potential hazard to human health or the environment if the provisions of the
exemption are not strictly enforced
Include Description of the Enforcement Program, and Procedures for Assuring Compliance:
RD/OPP 06/22/92
PAGE 5
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
REPEAT USES (166.20(a)(ll)) [p.7]
(If use being requested is a repeat use, and final report has not been filed,
interim final report included as a separate attachment)
PROGRESS TOWARD REGISTRATION (166.25(b)(2)(ii)) [p.7]
(Information from registrant concerning the current status)
(Not Required for Request for a Quarantine Exemption)
RD/OPP 06/22/92
PAGE:
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Specific Exemption Request Based on Significant Economic Loss
NAME OF PEST (166.20(b)(l)) [p.8]
Scientific Name:
Common Name:
DISCUSSION OF EVENTS OR CIRCUMSTANCES WHICH BROUGHT ABOUT
THE EMERGENCY CONDITION (166.20(b)(2) [p.8]
RD/OPP 06/22/92
PAGE: 7
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Specific Exemption Request Based on Significant Economic Loss (cont.)
DISCUSSION OF ECONOMIC LOSS (166.20(b)(4)) [p.9J
Economic Data From the Past Five Years (166.20(b)(4)(i)) [p. 10]
YEAR
Average
YIELD PER
ACRE (flats,
bushels,
Ibs., etc.)
PRICE
PER
UNIT
$
GROSS
Revenue
Per acre
$
COST
PER
ACRE
$
NET
Revenue
Per acre
$
ESTIMATED REVENUES FOR THE SITE TO BE TREATED (166.20(b)(4)(ii)&(iii)) [p.10]
Estimated net and gross revenues without the use of proposed pesticide (but with next best
alternative^:
Estimated net and gross revenues with the use of the proposed pesticide:
RD/OPP 06/22/92
PAGE: 8
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Specific Exemption Request Based on Significant Risks to
Endangered or Threatened Species, Beneficial Organisms, or the Environment
NAME OF PEST (166.20(b)(l)) [p.ll] 1
Scientific Na^ne:
Common Name:
DISCUSSION OF EVENTS OR CIRCUMSTANCES WHICH BROUGHT ABOUT
THE EMERGENCY CONDITION (166.20(b)(2) [p.12]
RD/OPP 06/22/92
PAGE 9
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1
SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Specific Exemption Request Based on Significant Risks to
Endangered or Threatened Species, Beneficial Organisms, or the Environment (cont.)
DISCUSSION OF ANTICIPATED RISKS TO ENDANGERED OR THREATENED SPECIES,
BENEFICIAL ORGANISMS, OR THE ENVIRONMENT (166.20(b)(3)) [p. 12]
RD/OPP 06/22/92 PAGE: 10
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Quarantine Exemption Request
NAME OF PEST (166.20(c)(l)) [p.12]
Scientific Name:
Common Name:
ORIGIN OF INTRODUCED PEST (166.20(c)(2)) [p.12]
Origin of pest, means of its introduction, and spread into the area (if known):
IMPACT OF THE PEST (166.20(c)(3)) [p.12]
Anticipated Impact of not controlling pest, and other information pertinent to economic
importance of this nest:
RD/OPP 06/22/92
PAGE: 11
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SAMPLE SECTION 18 EMERGENCY EXEMPTION APPLICATION FORMAT
Information for a Public Health Exemption Request
NAME OF PEST (166.20(d)(l)) [p. 13]
Scientific Name:
Common Name:
Disease Transmitted:
HEALTH / PEST PROBLEM (166.20(d)(2)) [p.13}
Magnitude of expected health problems expected to occur without the proposed use, and resultant
spread of the pest:
MEDICAL TREATMENT (166.20(d)<3)) [p.13]
Availability of medical treatment to remedy any resultant health problem associated with the
spread of the pest:
RD/OPP 06/22/92 PAG& 12
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SAMPLE SECTION 18 CRISIS EXEMPTION NOTIFICATION FORMAT
(40 CFR 166.43(b)) [p.14]
Name of Chemical:
Active Ingredient:
Common Name:
Product Namefs) and EPA Ree. No.fs):
Chemical Abstract Service (CAS) Number:
Site or Crop on Which the Chemical is to be Used, or is Being Used;
Use Pattern:
Method of Application:
Rate of Application:
Maximum Number of Applications:
Other Pertinent Information, such as PHI:
Dates That Applications Started or Will Begin, and End;
o
Estimate of the Level of Residues of the Chemical Expected to Result from Use Under the Crisis
Exemption (for Food Croos) (Other data or information included as an attachment);
Discussion of the Emergency Situation, and Any Other Pertinent Information Currently Available.
Including an Explanation of Why There Was Insufficient Time to Request a Specific or
Quarantine Exemption, and Whether a Specific or Quarantine Exemption Will be Requested
(Other information included as an attachment):
RD/OPP 06/22/92
PAGE.
; 13
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SAMPLE SECTION 18 EMERGENCY EXEMPTION FINAL REPORT FORMAT
(40 CFR 166.32) [p. 14]
Total Acreage. Amount of Commodity or other Unitsr Treated Under Exemption:
Total Quantity of Pesticide Used:
Total Amount of A.I.:
Total Amount of Product:
Discussion of the Effectiveness of the Pesticide Used in Dealing With the Emergency Situation
(Other information included as an attachment):
Description of Anv Unexpected Adverse Effects Which Resulted from This Use (Other information
included as an attachment):
Results of Anv Compliance Monitoring Required and/or Carried Out Under this Exemption
(Other Information included as an attachment):
RD/OPP 06/22/92
PAGE 14
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SAMPLE SECTION 18 EMERGENCY EXEMPTION FINAL REPORT FORMAT (continued)
(40 CFR 166.32) [p. 14]
Discussion of Any Enforcement Actons Taken in Connection With the Exemption (Other
information included as an attachment):
Method of Disposition of Food Crop, if Required to be Destroyed Under Exemption (Other
information included as an attachment):
ic EPA in Connc
?tion (Other information
included as an attachment);
o
Was a Crisis Exemption Also Declared?
Does this Renort Cover Both a Snecific or Quarantine, and a Crisis Exemption?
Explanation Whev there Was a Need to Utilize Crisis Provisions, if Crisis Declared (Other
information included as an attachment);
RD/OPP 06/22/92
PAGE
15
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