SEQ CHAPTER \h \r 1 	SUPPORTING STATEMENT FOR

	AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title of the Information Collection

	Application and Summary Report for an Emergency Exemption for
Pesticides

	OMB No.:  2070-0032 		EPA No.:  0596.09

	1(b)	Short Characterization/Abstract

	This Information Collection Request (ICR) is a renewal of an existing
ICR that is currently approved by OMB and is due to expire February 28,
2008.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes the Environmental Protection Agency (EPA) to
grant emergency exemptions to states and Federal agencies to allow an
unregistered use of a pesticide for a limited time if EPA determines
that emergency conditions exist.  A Section 18 action arises when
growers and others encounter a pest problem on a site for which there is
either no registered pesticide available, or for which there is a
registered pesticide that would be effective but is not yet approved for
use on that particular site.  Section 18 also allows EPA to grant
unregistered pesticide use exemptions for public health and quarantine
reasons.

Most requests for emergency exemptions are made by state lead
agricultural agencies, although agencies such as the United States
Departments of Agriculture (USDA), Defense (DOD) and Interior (USDI)
also request exemptions.  This process is generally initiated when
growers in particular regions identify an urgent, non-routine situation
which registered pesticides will not alleviate.  The growers contact
their state lead agency (usually a state’s department of agriculture)
and request that the state agency apply to EPA for a Section 18
emergency exemption for a particular use.  The state agency evaluates
the requests and submits requests to EPA for emergency exemptions they
believe are warranted.  The uses are requested for a limited period of
time to address the emergency situation only.

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

Unexpected changes in climatic conditions, development of pest
resistance and/or importation of pests are some of the unpredictable
situations that could give rise to a section 18 emergency exemption
request.  In these situations there is an immediate need for a pesticide
for a use for which it is not registered and for which there is
insufficient time to obtain registration.

Requests for Section 18 emergency exemptions, i.e., the submission of
applications, are at the discretion of a state, U.S. territory, or
federal agency.  Should one of these entities apply for an emergency
exemption, EPA requests the information and data identified under
Section 4(b) “Information Requested” of this supporting statement.
If EPA determines that conditions exist which require an exemption and
the risks are acceptable, EPA typically approves the emergency exemption
request.  EPA will deny an exemption request if the pesticide use may
cause unreasonable adverse effects to human health or the environment,
or if emergency criteria are not met.  As a matter of course, a state
may withdraw an exemption request at any point in the process.

	In unpredictable emergency situations when insufficient time for a
formal section 18 application and review process is available to address
the problem, a state agency may issue a crisis exemption which allows
for the immediate use of an unregistered pesticide for no longer than 15
days, unless an application for the specific exemption request has been
submitted to EPA.

	The state issuing the crisis exemption must coordinate the declaration
with EPA prior to releasing it to the users.  EPA performs a cursory
review of the use to ensure there are no concerns.  If any concerns are
noted, EPA confers with the state and under extreme cases may not allow
a crisis to be declared.  If the state follows up the crisis with, or
has already submitted, an emergency exemption request, the use may
continue under the crisis until EPA has made a decision on the request.
EPA must establish the appropriate time-limited tolerance(s) required by
the Federal Food, Drug and Cosmetic Act (FFDCA,) for any pesticide uses
to commercial agricultural items under emergency exemptions, including
crisis exemptions.

	Over the past three years 2004, 2005, 2006, EPA has received an average
of approximately 494 section 18 requests.  Producers of minor crops are
especially reliant on the emergency exemption program.  Less frequently,
emergency exemption applications are submitted in order to combat pests
which pose a threat to public health.  The section 18 emergency
exemption program is also supporting certain agricultural homeland
security initiatives.

New Streamlined Regulations:

	On January 27, 2006, EPA published a final rule (71 FR 4495) revising
the regulations governing emergency exemptions.  EPA received
considerable stakeholder involvement and identified several
opportunities to streamline and improve the pesticide emergency
exemption process without compromising protection for human health and
the environment  The new section 18 rule became effective on March 28,
2006.  The final rule, 40 CFR part 166, contains two primary revisions
to the application, review and approval process for specific exemptions.

The first major revision was to create a streamlined recertification
application for eligible repeat emergency exemption requests.  Second,
major revision was to clarify the definition of significant economic
loss and revision of data requirements for documenting loss.
Specifically, the revised regulations allow states to submit an
abbreviated recertification request in certain instances. This
recertification request cites previously submitted and reviewed data to
support their response to an on-going emergency pest problem. The Agency
anticipates that the new streamlined recertification process will reduce
the burden on states and expedite the processing of emergency exemption
requests.  The new economic approach is a tiered method which allows an
applicant to easily classify the emergency situation while minimizing
data requirements.  The thresholds in the tiered approach provide clear,
uniform standards to determine the significance of anticipated economic
losses, rather than the previous approach of comparing revenues under
the emergency to historical variations in revenues for the particular
crop and region.  Since the new process has only been in place for just
over a year, it is too early to tabulate the anticipated reduction in
burden for this renewal request.

(see http://www.epa.gov/opprd001/section18/section18rule_fs.htm).

	Section 18 of FIFRA (see Attachment A) states in part that, "The
Administrator may, at [his/her] discretion, exempt any federal or state
agency from any provision of this Act if [s]he determines that emergency
conditions exist that require such exemption".  Under this provision,
EPA may temporarily authorize federal or state agencies to allow use of
pesticide products under emergency conditions.  Detailed regulations
regarding the procedures for emergency exemptions are contained in 40
CFR Part 166.  Attachment B provides a specific section-by-section
listing of each of the requirements under 40 CFR 166 that are related to
this ICR.

	The provisions of Federal Food, Drug, and Cosmetic Act requires that
EPA establish tolerances, or maximum legal limits for all pesticide
residues in food, including those resulting from Section 18 emergency
uses.  Tolerances established for emergency exemptions are time-limited
to correspond to the use season or multiple use seasons.  Thus, data
collected under this collection also allows the Agency establish
tolerances or tolerance exemptions for section 18 emergency actions.
When the Agency establishes a tolerance, there must be a finding that
there is “reasonable certainty that no harm” will result to human
health from aggregate and cumulative exposure to the pesticide, as
required by the health-based standard. For section 18 actions, these
Agency tolerance setting activities decisions must be conducted in a
timely manner, and their expiration dates, are established by a final
rulemaking published in the Federal Register.  The procedural regulation
for establishing tolerances is codified at  21 U.S.C. 346(a). (see
Attachment C) and the Time-limited tolerances for pesticide emergency
exemptions are codified at  40 CFR 176, see Attachment D.

	2(b)	Practical Utility/Users of the Data

	EPA uses the information collected to carry out its statutory
responsibilities under FIFRA section 18.  This data collected allows EPA
to evaluate an application for a permit for the temporary use of a
pesticide product for an unregistered use and whether such use will
mitigate an emergency situation.  Generally, the data submitted must
support the Agency’s evaluation of whether: 1) an emergency exists; 2)
use of the pesticide under the exemption will be protective of human
health and the environments; and 3) the requested product’s
effectiveness in allaying the emergency. The application and follow-up
reporting is essential to weighing the emergency nature of the situation
as well as the effectiveness, risks of the treatment program, and
comparing the cost impacts based on the new tiered thresholds for
significant economic loss determination.

	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Non duplication.

	This information collection activity is unique and is administered by
EPA pursuant to FIFRA.  The possibility of duplication does not exist by
any other federal agency.

	3(b)	Public Notice and Opportunity to Comment

	In preparing to renew this ICR, EPA is publishing a notice in the
Federal Register, which will provide a 60-day public notice and comment
period on the draft ICR.

	3(c)	Consultations.

	Consultation and/or dialogue between states and the Agency during the
submission and review of an application are frequent and ongoing.
Questions or consultations pertaining to a particular submission are
addressed in meetings or telephone conversations with the applicant and
do not necessarily occur at specified intervals.  In addition to
communications regarding specific exemption requests, Agency staff
participates in stakeholder training workshops with state pesticide
regulatory representatives.  These communications permit an exchange of
problems and questions on the program in general and other relevant
issues.  For example, OPP staff members conducted a series of training
workshops at headquarters and several regional locations for
stakeholders.  (Attachment E - reserved for Public Comment)

	For this renewal, EPA consulted with three state entities that are
active in this regulatory process in order to seek feedback on the
burden estimates in the ICR, the clarity of instructions provided, the
feasibility of reporting the data by electronic means, and other
questions pertaining to the requirements of the program.  EPA staff
contacted the representatives by telephone and e-mail and asked them for
feedback on the burden and cost estimates in the ICR.  The solicitation
for consultation included state representatives from the Department of
Environmental Conservation, Bureau of Pesticides Management from New
York, the Colorado Department of Agriculture, and the Pesticide and
Plant Pest Management Division in the State of Michigan. The
consultation comments are part of this document in Attachment F.

	3(d)	Effects of Less Frequent Collection.

	As discussed above, there is no collection schedule for this
information collection activity, per se.  State and federal agencies
initiate the information collection activity when they prepare an
emergency exemption application for submission to EPA.  State and
federal agencies determine the frequency in which to pursue an emergency
exemption request with EPA.  EPA does not solicit or request the
exemption application.

3(e) General Guidelines.

	EPA requires the states to maintain records of the first food use of a
pesticide under an emergency exemption for two years following the date
of expiration.  Generally, an applicant for an emergency exemption is
not required to maintain data beyond the date that the summary report
has been received by the Agency.  Therefore, the OMB guidelines codified
in 5 CFR 1320.6 indicate that data, other than health, medical, or tax
records, need not be retained for more than three years and will not be
exceeded in this program.

	3(f) Confidentiality

	Although the EPA urges the submitter to minimize the amount of claimed
Confidential Business Information (CBI), certain limited all data and/or
information brought to the Agency in conjunction with this rule may be
claimed as trade secret, or commercial or financial information and will
be protected from disclosure by the EPA under FIFRA section 10 and the
associated regulation as contained in 40 CFR Part 2, Subpart B.  In
general, EPA works to make information relative to section 18 decisions
and supporting data easily available to the public (e.g. web site
postings of program information, and public distribution of decision
documents).  Growers and industry stakeholders need to be made aware of
section 18 exemptions.  Thus, as a rule, claims of confidentiality are
not made on emergency exemption applications.  On certain rare
occasions, the manufacturer of the requested producer may have product
formulation information that is necessary to protect CBI.

When trade secret information or Confidential Business Information is
provided to the Agency, such information is protected from disclosure
under FIFRA Section 10, as amended and EPA's confidentiality regulation,
Title 40 CFR, Subpart B.  Data submitted to the Agency are handled
strictly in accordance with the FIFRA CBI Security Manual.  This manual
contains instructions relative to all contact with confidential
documents, including responsibility of EPA employees; physical security
measures; CBI materials within EPA, such as CBI typing procedures
(documents typed internally or on contract); and division internal
procedures.  The manual dictates that: (1) all CBI must be marked or
flagged as such , (2) all CBI must be kept in secure, double-locked
areas, and (3) all CBI for destruction must be cleared by a document
control officer and placed in the Office of Prevention, Pesticides and
Toxic Substances paper shredder.

3(g) Sensitive Questions

	No information of a sensitive or private nature is requested in
conjunction with this collection activity.  Further, this information
collection activity complies with the provisions of the Privacy Act of
1974 and OMB circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents/NAICS Codes

	Respondents affected by the collection activities under this ICR are
federal and state agencies which regulate pesticides or pesticide
products.  The North American Industrial Classification System (NAICS)
code assigned to the states and federal government agencies responding
to this information is 9241, The Administration of Environmental Quality
Programs subsector groups of government establishments primarily engaged
in the administration of environmental quality.

4(b)	Information Requested

	To apply for an exemption, an application must be submitted in writing
by the head of a 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 EPA.

	Applications for specific, quarantine, or public health exemptions must
contain the following information:

Identity of contact person(s)	Name and telephone number of one or more
qualified experts who may be contacted if questions arise concerning the
application.

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

For a federally registered pesticide:

registration number and name of pesticide product (if a specific product
is requested), or formulation(s) requested (if a specific product is not
desired), and

 copy of any additional labeling proposed for the emergency exemption.

For an unregistered pesticide product, copy of:

EPA Form No. 8570-4 Confidential Statement of Formula (or reference to
one already submitted to the Agency), and

Complete labeling to be used in connection with proposed use.

Description of the proposed use	Application must identify all of the
following:

sites to be treated, including locations within the state,

method of application,

rate of application of active ingredient and product,

total acreage or other appropriate unit proposed to be treated,

total amount of pesticide proposed to be used (active ingredient and
product), and

all applicable restrictions and requirements concerning proposed use and
qualifications of applicators using the pesticide.

Alternative methods of control	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 that
demonstrate this, 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.  In addition, a detailed explanation must be provided of why
alternative practices, if available, either would not provide adequate
control or would not be economically or environmentally feasible.

Effectiveness of proposed use	Application must contain data, discussion
of field trials, and other evidence that provide the basis for the
conclusion that the proposed pesticide treatment will be effective in
dealing with the emergency.

Discussion of residues for food uses	If proposed use is expected to
result in residues of the pesticide in or on food or feed, application
must list the food likely to contain such residues and must 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.

Discussion of risk information	Potential risks to human health,
endangered species, beneficial organisms, and the environment expected
to result from the proposed use, together with references to data and
other supporting information.

Coordination with other affected state or federal agencies.	If the
proposed pesticide use is likely to be of concern to other federal or
state agencies, application must indicate that such agencies have been
contacted prior to submission of the application, and any comments
received from such agencies must be submitted to EPA.

Notification of registrant or basic manufacturer.	Statement that the
registrants of all pesticide products proposed for use or, if
appropriate, the basic manufacturer, support the request for a specific,
quarantine, or public health exemption.

Description of proposed enforcement program.	Explanation of the
authority of the applicant or related state or federal agency for
ensuring that use of the pesticide under the proposed exemption would
comply with any special requirements imposed by EPA and a description of
the program and procedures for assuring such compliance.

Progress toward registration.

	Prior to submitting an application for a repeat specific or public
health exemption, the federal or state agency must contact the
registrant regarding the progress being made toward registration of the
proposed use and include this information in the section 18 application.
 This information must also include a summary of study deficiencies and
data gaps, and registrant's timetable for completing requirements for
registration.

In addition, the following information must be provided:

For a specific exemption	All of the following, as appropriate, must be
provided concerning the nature of the emergency:

scientific and common name of the pest or pest complex;

events that brought about the emergency condition;

anticipated risks to endangered or threatened species, beneficial
organisms, or the environment that would be remediated by the proposed
use of the pesticide; and

anticipated significant economic loss that would occur without the use
of the requested registered pesticide, together with data and other
supporting information, that addresses the historical net and gross
revenues for the site, the estimated net and gross revenues for the site
without use of the proposed pesticide, and the estimated net and gross
revenues for the site with use of the proposed pesticide.

For a quarantine exemption	A quarantine exemption may be authorized in
an emergency condition to control the introduction or spread of any pest
new to and therefore known to be widely prevalent or distributed within
and throughout the United States and its territories.  The application
for the quarantine exemption must include the following information:

scientific and common name of the pest or pest complex;

origin of the introduced pest and the means of its introduction and
spread into the area, if known.

economic impact of controlling versus not controlling the pest via the
proposed pesticide treatment.

For a public health exemption	Scientific and common name of pest or pest
complex; if the pest is a vector, a description of the disease it is
expected to transmit; and

magnitude of the health problems that are expected to occur without the
pesticide use; and availability of medical treatment for the health
problem.

For a crisis exemption, only the following information must be provided:
The state or federal agency issuing the crisis exemption must coordinate
any crisis declaration in advance with EPA prior to initiating the use.
  The notice must include:

name of active ingredient authorized for the crisis use, including the
common name and the Chemical Abstracts Service (CAS) number;

crop or site on which the pesticide is to be used;

use pattern (method, number, and rate of applications);

dates that applications started or will begin and end;

an estimate of the level or residues of the pesticide expected to result
from use under the crisis exemption (for food crops); and

discussion of the emergency situation and any other pertinent
information available at the time, including why time was insufficient
to request a specific or quarantine exemption, and intentions with
respect to requesting a specific exemption for this use.

4(c)	Data Items, Including Record keeping requirements

	EPA Form No. 8570-4, Confidential Statement of Formula, (Attachment H)
is the single form associated with either the application for, or
summary reports on, an emergency exemption. To comply with the reporting
and record keeping requirements for specific, quarantine, and public
health exemptions, the exemption holder must provide the following data
items to EPA:

Unexpected adverse effects information		Any unexpected adverse effects
resulting from the use of a pesticide under a  crisis, specific,
quarantine, or public health exemption must be reported immediately to
the Agency.

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

total acreage, amount of commodity or other unit treated and the total
quantity of the pesticide used;

discussion of the effectiveness of the pesticide in dealing with the
emergency condition;

description of any unexpected adverse effects that resulted from the use
of the pesticide under the exemption;

results of any monitoring required and/or carried out under the
exemption;

any enforcement actions taken in connection with the exemption;

method(s) of disposition of food crops, if required to be destroyed; and

any other information requested by the Administrator.

Records	Records for all treatments involving the first food use of a
pesticide will be maintained by the state or federal agency for which an
emergency exemption was granted for a minimum of two years following the
date of expiration of the exemption.  On request by EPA, these records
must be made available to the Administrator.  Records must include the
following;

locations where the pesticide was applied;

dates of application (range); and

total quantity of the pesticide used.

	4(d)	Applicant Activities

	To obtain a permit to use an unregistered pesticide product under
emergency conditions, an applicant must petition EPA in writing and
provide information addressing the data items listed above and commit to
the submission of the summary report on the action taken to meet the
emergency Section 18 Emergency Exemption applications are submitted to
the Risk Integration Minor Use, and Emergency Response Branch (Mail Code
7505P), Registration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue., N.W.,
Washington, D.C., 20460.

	In order to participate in the program, the applicant must:

Read germane FIFRA requirements and CFR regulations.

Process, compile, and review the requested data for accuracy and
appropriateness.

Generate application correspondence and follow-up summary report.

Store, file or maintain the information.

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	On October 25, 2000, EPA published a Final Rule in the Federal Register
(65 FR 64125) entitled “Time-Limited Tolerances for Pesticide
Emergency Exemptions.”  This rule, which became effective on November
24, 2000, set into place a process to ensure timely decisions on any
tolerance-related issue in response to a request for an emergency
exemption for a pesticide to be used on food or feed.  Under this rule,
time-limited tolerance petitions related to FIFRA Section 18 are
evaluated on a case-by-case basis to determine if adequate reliable data
are available to make the required safety finding mandated under FFDCA
Section 408 and FQPA.

	Applications for emergency exemptions are submitted by U.S. states and
territories, and federal agencies at their discretion.  These
applications are received by the Office of Pesticide Programs (OPP),
Registration Division, Risk Integration, Minor Use, and Emergency
Response Branch, where they are reviewed for completeness.  The
application package is routed to scientists and economists within OPP to
determine whether the proposed emergency exemption is warranted, that
there is “reasonable certainty of no harm” to human health resulting
from aggregate and cumulative exposure, and that it presents no undue
hazard to humans or the environment.  Once the determinations are made,
the applicant is notified in writing.  The tolerance is published in the
Federal Register.

	The Agency conducts the following activities when responding to an
emergency exemption application under FIFRA section 18:

Route the application/report to appropriate scientists and economists
for review.

Review information submitted for scientific accuracy.

Perform a biological, ecological, and economic analysis and a
multi-disciplinary risk assessment of the requested use and then forward
a regulatory recommendation on the proposed exemption along with a draft
notification to EPA management.

Make the FQPA finding of “reasonable certainty of no harm” to human
health resulting from aggregate and cumulative exposure. Establish a
time-limited tolerance if required.

Conduct an assessment of the progress toward registration for the
requested use.

OPP Director (or designee) makes final decision.

Notify applicant of decision.

Prepare and publish Federal Register Notice (for applicable food use
requests).

Record electronic data in Agency's data system and internet cite.

	5(b) Collection Methodology and Management

	When applications for emergency exemptions are received by EPA, they
are jacketed and filed by the name of the state, territory or federal
agency, by the date, and by the number of the submission for that
entity.  The application is tracked in EPA’s data system as an active
pending request through the determination process, and subsequent
receipt of the summary report, after which the exemption becomes a
historical file and the regulatory action is closed.

	5(c) Small Entity Flexibility

	No flexibility for small entities exists under this information
collection activity.  Section 18 of FIFRA applies directly only to
State, territorial, and federal government agencies; it does not apply
to other entities.  States are not “small entities” as defined by
the Regulatory Flexibility Act.

	5(d)	Collection Schedule

	There is no collection schedule associated with this information
collection activity, per se.  This information collection activity is
initiated by the States or by certain federal agencies when they
determine that they are confronted with an emergency situation and
subsequently submit an emergency exemption application to EPA under
FIFRA Section 18.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a)	Estimating Respondent Burden

	The total annual response burden associated with submitting an
application for Emergency Exemption (Section 18s) is estimated to be
49,500 burden hours per year at a cost of  $2,472,770 indexed to 2006
dollars for the next three years.  The number of applications received
by EPA has decreased from an average of 500 per year for the years 2001
- 2003 to an average of about 494 per year for the years ranging from
2004 - 2006.  The important trends seen in the applications received in
the past three years are:

the successful transition of a high number of minor crop section 18
programs to full registrations and tolerances under section 3 labels;

in spite of the focus on eliminating long-running section 18
applications there are continuing pest management challenges that are
national in scope that trigger emergency exemption requests (e.g. the
use of coumaphos and thymol in bee hives to control varroa mite;
expanding reliance on section 18 programs to plan for and respond to
public health and agricultural homeland security threats - such as
anthrax decontamination, foot and mouth disease, and soybean rust;

States have started requesting Section 18 emergency exemptions for more
than one chemical to deal with some pest problems;

The Agency expects that some of these factors will persist and
subsequently expects to receive an average of 500 applications annually
for the next three years.

	6(b)	Estimating Respondent Costs

For a period of some years when estimating labor rates for most OPP
program ICR renewals, the Agency adjusted the ICR renewal labor rates by
using the NASA Gross Domestic Product (GDP) Deflator Inflation
Calculator to index the labor cost for a particular year.  However, in
July 2006, Agency economists completely re-estimated wages, benefits,
and overhead for all labor categories for the pesticide industry, state
government and Agency employees.  The Agency analysis uses currently
available information on labor rates and other benefits from publicly
available websites.  A copy of the methodology used to re-estimate the
labor rates and formulas used to derive the fully loaded rates and
overhead costs are listed in Attachment J.

The total respondent burden in terms of hours is estimated to be 49,500
hours annually.    The total respondent cost for is this ICR renewal
estimated to be $2,472,770 annually.  To derive the labor rates for all
respondents associated with submitting an application for Section 18
Emergency Exemptions, Agency economists estimated the wages for the
management, technical, and clerical labor categories using the
methodology cited above.  The state respondent costs for this renewal
for managerial, technical and clerical rates are estimated at $74.41,
$49.38, $33.78 hour, respectively and $93.07, $66.34, and $47.17 for
management, technical, and clerical labor, respectively for federal
agencies.  These labor rates are fully loaded and include benefits and
overhead costs.  Using the Agency’s burden estimate and the
fully-loaded labor rates, the Agency estimates the applicant labor costs
to be approximately $4945.54 per response.

State Government “Applicant” Burden/Cost Estimates

COLLECTION ACTIVITY	Burden Hours

(per application)	Total

	Mgmt.

$71.41/hr	Tech.

$49.38/hr	Cler.

$33.78/hr	Hours	Costs ($)

Read FIFRA and FQPA requirements and CFR regulations.	4	4	0	8	483.16

Process, compile, and review the requested data for accuracy and
appropriateness.	0	74	0	74	3,654.12

Generate application correspondence and follow-up summary report.	0	15	0
15	740.70

Store/maintain/submit information	0	0	2	2	67.56

Totals	4	93	2	99	4945.54

ANNUAL BURDEN:  99 Total Hours  x  500 applications = 49,500 Hours

ANNUAL COSTS:	(a) Management: 4 hours	x	$	71.41 500 applicants = 		$
142,820

			(b) Technical:	   93 hours	x	$49.38x	500 applicants = 		$2,296,170

			(c) Clerical:	     2 hours x	$33.78x	500 applicants = 		$     33,780

  													       Total=		$2,472,770

	6(c)	Estimating Agency Burden and Cost

	 The estimated cost to the Federal government of the Emergency
Exemption program consists of two components.  The first is the number
of hours and costs incurred by the Agency to complete a standard
application.  The second component is the costs for other elements that
do not fall under the category of collection activities, but are
required as part of the program.

	The total Agency burden in terms of hours is estimated to be 54,000
hours annually.    The total annual Agency cost for processing Emergency
Exemption Requests is estimated to be

$3,637,575

Annual Agency Burden/Cost Estimates

COLLECTION ACTIVITY	Burden Hours

(per application)	Total

	Mgmt.

$93.07/hr	Tech.

$66.34/hr	Cler.

$47.17/hr	Hours	Costs

Read and review the applications or reports for completeness.	0	8	1	9
577.89

Route the application/report to appropriate scientists and economists
for review.	0	4	0	4	265.36

Review information submitted for scientific accuracy.	0	16	0	16	1,061.44

Perform:

- a biological, ecological, and economic analysis

- a multi-disciplinary risk assessment

- make FFDCA section 408(b)(2)(A)(ii) safety findings

-  forward a regulatory recommendation on the proposed exemption along
with a draft notification to the requestor.	2	40	1	43	2,886.91

Reach final decision, prepare Final Rule Notice and notify applicant.	5
28	1	34	2,370.04

Record electronic data in Agency's Pesticide Regulatory Action Tracking
System (PRATS), record receipt in branch tracking system and file hard
copy in Branch files.	0	1	1	2	113.51

Totals	7	97	4	108	7,275.15

ANNUAL BURDEN: 108 Total Hours  x  500 applications = 54,000 Hours

ANNUAL COSTS:	(a) Management: 7 hours	x	$93.07 x 500 applicants = 		$
325,745

			(b) Technical:	   97 hours	x	$66.34 x	500 applicants = 	   $
3,217,490

			(c) Clerical:	     4 hours x	$47.17 x	500 applicants = 		$    94,340

  												           Total=		     $3,637,575

OTHER ANNUAL AGENCY COSTS:

Average annual frequency of related Federal Register publications (avg.
cost = $2000):

Type of Federal Register Document	Number per Year	Cost

Notice: Receipt of Application for Emergency Exemption; Solicitation of
Public Comment 	5	$10,000

Final Rule: Pesticide Tolerance for Emergency Exemptions	25	$50,000

Final Rule: Extension of Tolerance(s) for Emergency Exemptions 	3	$6,000

Notice: Pesticide Emergency Exemptions; Agency Decisions and State and
Federal Agency Crisis Declarations	2	$4,000

Total	35	$70,000

OVERALL TOTAL ANNUAL AGENCY COST BURDEN:

$3,635,500 + $70,000 = $3,705,500

		6(d)	Bottom Line Burden Hours and Cost Tables

Total Burden and Cost Estimates

	TOTAL ESTIMATES

	Hours	Costs

State Government Applicants - Annual	49,500	$2,472,770

Agency - Annual	54,000	     $3,637,575

		6(e)	Reasons for Change in Burden.

	There is no change in the respondent or agency burden hours associated
with this ICR from the last ICR renewal.  While the average number of
section 18 emergency exemption applications filed annually, has
decreased slightly from 500 for the period 2001- 2003 to just under 500
(494) for the period 2004 - 2006.  For this ICR renewal the Agency will
again project the number of annual section 18 applications to be 500 for
the next three years.  However, the Agency anticipates a reduction in
respondent burden hours over the next three years due to the streamlined
recertification process for section 18 applications discussed in section
2 of this document.  For example, during the 2006 use season, EPA
identified 188 exemptions eligible for the less data-intensive
application process through the recertification program.  Further, in
2006 the Agency made registration decisions for 146 use determinations
which negated the need for additional applications to be submitted with
regard to those same uses.  Since the new process has only been in place
for just over a year, it is too early to tabulate the anticipated
reduction in burden for this renewal request.

		6(f)	Burden Statement

	The annual respondent burden for collection of information associated
with the rule is estimated to average 99 hours per application.
According to the Paperwork Reduction Act, “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency.  For this collection, it is the time reading the regulations,
planning the necessary data collection activities, conducting tests,
analyzing data, generating reports and completing other required
paperwork, and storing, filing, and maintaining the data.  The agency
may not conduct or sponsor, and a  person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.  The OMB control number for this information collection
appear at the beginning and the end of this document.  In addition OMB
control numbers for EPA’s regulations, after initial display in the
final rule, are listed in 40 CFR part 9.

	 The Agency has established a public docket for this ICR under Docket
ID No. EPA-HQ-OPP-2007-0320, which is available for online viewing at
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.
This docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.  The docket telephone number is (703)
305-5805.  You may submit comments regarding the Agency's need for this
information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques.

Comments may be submitted to EPA electronically through
http://www.regulations.gov or by mail addressed to Director, Collection
Strategies Division, U.S. Environmental Protection Agency (2822T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460.  You can also send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA.  Include docket ID No.
EPA-HQ-OPP-2007-0320 and OMB control number 2070-0032 in any
correspondence but do not submit Section 18 requests and any related
information (e.g., forms, reports, etc.) to these addresses.  The
information described in this ICR is to be submitted to the address
identified in section 4(b) of this supporting statement.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2007-0320.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_"
www.regulations.gov  or otherwise accessed as described in section 6(f)
of the supporting statement.

ATTACHMENT A:	FIFRA Section 18 - 7 U.S.C. 136p This attachment is
available as part of the electronic copy of the ICR’s Supporting
Statement and can also be accessed in PDF via the Internet at
HYPERLINK http://www.epa.gov/opp00001/regulating/fifra.pdf
http://www.epa.gov/opp00001/regulating/fifra.pdf .

ATTACHMENT B:	40 CFR Part 166 - Exemption of Federal and State Agencies
for Use of Pesticides under Emergency Conditions -  This attachment is
available as part of the electronic copy of the ICR’s Supporting
Statement and can also be accessed via the Internet at   HYPERLINK
http://www.epa.gov/epacfr40/chapt-I.info/chi-toc.htm
http://www.epa.gov/epacfr40/chapt-I.info/chi-toc.htm

ATTACHMENT C: 21 U.S.C 346a - Tolerances and exemptions for pesticide
chemical residues, FFDCA section 408 - This attachment is available as
part of the electronic copy of the ICR’s Supporting Statement and can
also be accessed via the Internet at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&do
cid=Cite:+21USC346a"
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&doc
id=Cite:+21USC346a

ATTACHMENT D:	65 FR 64125 (40 CFR Part 176) - Final Rule; Time-Limited
Tolerances for Pesticide Emergency Exemptions - This attachment is
available as part of the electronic copy of the ICR’s Supporting
Statement and can also be accessed via the Internet at   HYPERLINK
http://www.epa.gov/fedrgstr/EPA-PEST/2000/October/Day-25/p27405.pdf
http://www.epa.gov/fedrgstr/EPA-PEST/2000/October/Day-25/p27405.pdf

ATTACHMENT E:	Public Comment Received Regarding the Proposed Renewal ICR
and EPA Response to Comment – reserved. This attachment, if any, is
available as part of the electronic docket EPA-HQ-OPP-2007-0320 to the
ICR’s Supporting Statement.

ATTACHMENT F:	Consultant Contacts for Application and Summary Report for
an Emergency Exemption for Pesticides & Questions Asked EPA During
Consultations - This attachment is available as part of the electronic
copy of the ICR’s Supporting Statement.

ATTACHMENT G:	EPA Form No. 8570-4 - Confidential Statement of Formula -
This attachment is available as part of the electronic docket
EPA-HQ-OPP-2007-0320 2007-0320 to the ICR’s Supporting Statement.  The
form is also available electronically via the Internet at   HYPERLINK
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf

ATTACHMENT H: 	Methodology for Estimating OPP ICR Wage Rates for
Industry, State and EPA Labor Costs; Memo From Richard Keigwin, Director
Biological and Economic Analysis Division, to OPP Division Directors,
July 2006.  This attachment is only available as part of the electronic
docket EPA-HQ-OPP-2007-0320 2007-0320 to the ICR’s Supporting
Statement.

ATTACHMENT I:	Display Related to OMB Control #2070-0032 - Listings of
Related Regulations in 40 CFR 9.1 - This attachment is available as part
of the electronic copy of the ICR’s Supporting Statement.

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment A

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18

7 U.S.C. 136p

ATTACHMENT A

SEC. 18. [7 U.S.C. 136p] EXEMPTION OF FEDERAL AND STATE AGENCIES.

	The Administrator may, at the Administrator’s discretion, exempt any
Federal or State agency from any provision of this Act if the
Administrator determines that emergency conditions exist which require
such exemption. The Administrator, 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.

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment B

40 CFR Part 166

ATTACHMENT B

Code of Federal Regulations

Title 40 – Protection of the Environment

Part 166 – Exemption of Federal and State Agencies for

Use of Pesticides under Emergency Conditions

Section	Contents

Subpart A—General Provisions

§ 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.

§ 166.47 	Notification of FDA, USDA, and State health officials.

§ 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
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 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 long-term 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 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 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]

§ 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 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

(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.

§ 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) 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:

(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]

§ 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.

(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

(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;

(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.

[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.

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment C

FFDCA Section 408

ATTACHMENT C

SEC. 346a.—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES

	(a) REQUIREMENT FOR TOLERANCE OR EXEMPTION

		(1) GENERAL RULE.—

	Except as provided in paragraph (2) or (3), any pesticide chemical
residue in or on a food shall be deemed unsafe for the purpose of
section 342(a)(2)(B) of this title unless—

		(A) a tolerance for such pesticide chemical residue in or on such food
is in effect under this section and the quantity of the residue is
within the limits of the tolerance; or

		(B)an exemption from the requirement of a tolerance is in effect under
this section for the pesticide chemical residue.

For the purposes of this section, the term “food”, when used as a
noun without modification, shall mean a raw agricultural commodity or
processed food.

		(2) PROCESSED FOOD.—Notwithstanding paragraph (1)—

		(A) if a tolerance is in effect under this section for a pesticide
chemical residue in or on a raw agricultural commodity, a pesticide
chemical residue that is present in or on a processed food because the
food is made from that raw agricultural commodity shall not be
considered unsafe within the meaning of section 342(a)(2)(B) of this
title despite the lack of a tolerance for the pesticide chemical residue
in or on the processed food if the pesticide chemical has been used in
or on the raw agricultural commodity in conformity with a tolerance
under this section, such residue in or on the raw agricultural commodity
has been removed to the extent possible in good manufacturing practice,
and the concentration of the pesticide chemical residue in the processed
food is not greater than the tolerance prescribed for the pesticide
chemical residue in the raw agricultural commodity; or

		(B) if an exemption for the requirement for a tolerance is in effect
under this section for a pesticide chemical residue in or on a raw
agricultural commodity, a pesticide chemical residue that is present in
or on a processed food because the food is made from that raw
agricultural commodity shall not be considered unsafe within the meaning
of section 342(a)(2)(B) of this title.

(3) RESIDUES OF DEGRADATION PRODUCTS.—If a pesticide chemical residue
is present in or on a food because it is a metabolite or other
degradation product of a precursor substance that itself is a pesticide
chemical or pesticide chemical residue, such a residue shall not be
considered to be unsafe within the meaning of section 342(a)(2)(B) of
this title despite the lack of a tolerance or exemption from the need
for a tolerance for such residue in or on such food if—

		(A)  the Administrator has not determined that the degradation product
is likely to pose any potential health risk from dietary exposure that
is of a different type than, or of a greater significance than, any risk
posed by dietary exposure to the precursor substance;

				(B) either—

		(i) a tolerance is in effect under this section for residues of the
precursor substance in or on the food, and the combined level of
residues of the degradation product and the precursor substance in or on
the food is at or below the stoichiometrically equivalent level that
would be permitted by the tolerance if the residue consisted only of the
precursor substance rather than the degradation product; or

		(ii) an exemption from the need for a tolerance is in effect under
this section for residues of the precursor substance in or on the food;
and

		(C) the tolerance or exemption for residues of the precursor substance
does not state that it applies only to particular named substances and
does not state that it does not apply to residues of the degradation
product.

	(4) EFFECT OF TOLERANCE OR EXEMPTION.—While a tolerance or exemption
from the requirement for a tolerance is in effect under this section for
a pesticide chemical residue with respect to any food, the food shall
not by reason of bearing or containing any amount of such a residue be
considered to be adulterated within the meaning of section 342(a)(1) of
this title.

	(b) AUTHORITY AND STANDARD FOR TOLERANCE.—

	(1) AUTHORITY.—The Administrator may issue regulations establishing,
modifying, or revoking a tolerance for a pesticide chemical residue in
or on a food—

				(A) in response to a petition filed under subsection (d) of this
section; or

				(B) on the Administrator's own initiative under subsection (e) of
this section.

As used in this section, the term “modify” shall not mean expanding
the tolerance to cover additional foods.

		(2) STANDARD.—

				(A) GENERAL RULE.—

		(i) STANDARD.—The Administrator may establish or leave in effect a
tolerance for a pesticide chemical residue in or on a food only if the
Administrator determines that the tolerance is safe. The Administrator
shall modify or revoke a tolerance if the Administrator determines it is
not safe.

		(ii) DETERMINATION OF SAFETY.—As used in this section, the term
“safe”, with respect to a tolerance for a pesticide chemical
residue, means that the Administrator has determined that there is a
reasonable certainty that no harm will result from aggregate exposure to
the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.

		(iii) RULE OF CONSTRUCTION.—With respect to a tolerance, a pesticide
chemical residue meeting the standard under clause (i) is not an
eligible pesticide chemical residue for purposes of subparagraph (B).

				(B) TOLERANCES FOR ELIGIBLE PESTICIDE CHEMICAL RESIDUES.—

		(i) DEFINITION.—As used in this subparagraph, the term “eligible
pesticide chemical residue” means a pesticide chemical residue as to
which—

		(I) the Administrator is not able to identify a level of exposure to
the residue at which the residue will not cause or contribute to a known
or anticipated  harm to human health (referred to in this section as a
“nonthreshold effect”);

		(II) the lifetime risk of experiencing the nonthreshold effect is
appropriately assessed by quantitative risk assessment; and

		(III) with regard to any known or anticipated harm to human health for
which the Administrator is able to identify a level at which the residue
will not cause such harm (referred to in this section as a
“nonthreshold effect”), the Administrator determines that the level
of aggregate exposure is safe.

		(ii) DETERMINATION OF TOLERANCE.—Notwithstanding subparagraph
(A)(i), a tolerance for an eligible pesticide chemical residue may be
left in effect or modified under this subparagraph if—

								(I) at least one of the conditions described in clause (iii) is
met; and

								(II) both of the conditions described in clause (iv) are met.

		(iii) CONDITIONS REGARDING USE.—For purposes of clause (ii), the
conditions described in this clause with respect to a tolerance for an
eligible pesticide chemical residue are the following:

		(I) Use of the pesticide chemical that produces the residue protects
consumers from adverse effects on health that would pose a greater risk
than the dietary risk from the residue.

		(II) Use of the pesticide chemical that produces the residue is
necessary to avoid a significant disruption in domestic production of an
adequate, wholesome, and economical food supply.

		(iv) CONDITIONS REGARDING RISK.—For purposes of clause (ii), the
conditions described in this clause with respect to a tolerance for an
eligible pesticide chemical residue are the following:

		(I) The yearly risk associated with the nonthreshold effect from
aggregate exposure to the residue does not exceed 10 times the yearly
risk that would be allowed under subparagraph (A) for such effect.

		(II) The tolerance is limited so as to ensure that the risk over a
lifetime associated with the nonthreshold effect from aggregate exposure
to the residue is not greater than twice the lifetime risk that would be
allowed under subparagraph (A) for such effect.

		(v) REVIEW.—Five years after the date on which the Administrator
makes a determination to leave in effect or modify a tolerance under
this subparagraph, and thereafter as the Administrator deems
appropriate, the Administrator shall determine, after notice and
opportunity for comment, whether it has been demonstrated to the
Administrator that a condition described in clause (iii)(I) or clause
(iii)(II) continues to exist with respect to the tolerance and that the
yearly and lifetime risks from aggregate exposure to such residue
continue to comply with the limits specified in clause (iv). If the
Administrator determines by such date that such demonstration has not
been made, the Administrator shall, not later than 180 days after the
date of such determination, issue a regulation under subsection (e)(1)
of this section to modify or revoke the tolerance.

		(vi) INFANTS AND CHILDREN.—Any tolerance under this subparagraph
shall meet the requirements of subparagraph (C).

		(C) EXPOSURE OF INFANTS AND CHILDREN.—In establishing, modifying,
leaving in effect, or revoking a tolerance or exemption for a pesticide
chemical residue, the Administrator—

						(i) shall assess the risk of the pesticide chemical residue based
on—

		(I) available information about consumption patterns among infants and
children that are likely to result in disproportionately high
consumption of foods containing or bearing such residue among infants
and children in comparison to the general population;

		(II) available information concerning the special susceptibility of
infants and children to the pesticide chemical residues, including
neurological differences between infants and children and adults, and
effects of in utero exposure to pesticide chemicals; and

		(III) available information concerning the cumulative effects on
infants and children of such residues and other substances that have a
common mechanism of toxicity; and

						(ii) shall—

		(I) ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue; and

		(II) publish a specific determination regarding the safety of the
pesticide chemical residue for infants and children.

The Secretary of Health and Human Services and the Secretary of
Agriculture, in consultation with the Administrator, shall conduct
surveys to document dietary exposure to pesticides among infants and
children. In the case of threshold effects, for purposes of clause
(ii)(I) an additional tenfold margin of safety for the pesticide
chemical residue and other sources of exposure shall be applied for
infants and children to take into account potential pre- and post-natal
toxicity and completeness of the data with respect to exposure and
toxicity to infants and children. Notwithstanding such requirement for
an additional margin of safety, the Administrator may use a different
margin of safety for the pesticide chemical residue only if, on the
basis of reliable data, such margin will be safe for infants and
children.

		(D) FACTORS.—In establishing, modifying, leaving in effect, or
revoking a tolerance or exemption for a pesticide chemical residue, the
Administrator shall consider, among other relevant factors—

		(i) the validity, completeness, and reliability of the available data
from studies of the pesticide chemical and pesticide chemical residue;

		(ii) the nature of any toxic effect shown to be caused by the
pesticide chemical or pesticide chemical residue in such studies;

		(iii) available information concerning the relationship of the results
of such studies to human risk;

		(iv) available information concerning the dietary consumption patterns
of consumers (and major identifiable subgroups of consumers);

		(v) available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity;

		(vi) available information concerning the aggregate exposure levels of
consumers (and major identifiable subgroups of consumers) to the
pesticide chemical residue and to other related substances, including
dietary exposure under the tolerance and all other tolerances in effect
for the pesticide chemical residue, and exposure from other
non-occupational sources;

		(vii) available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers;

		(viii) such information as the Administrator may require on whether
the pesticide chemical may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen or other endocrine
effects; and

		(ix) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data.

		(E) DATA AND INFORMATION REGARDING ANTICIPATED AND ACTUAL RESIDUE
LEVELS.—

		(i) AUTHORITY.— In establishing, modifying, leaving in effect, or
revoking a tolerance for a pesticide chemical residue, the Administrator
may consider available data and information on the anticipated residue
levels of the pesticide chemical in or on food and the actual residue
levels of the pesticide chemical that have been measured in food,
including residue data collected by the Food and Drug Administration.

		(ii) REQUIREMENT.—If the Administrator relies on anticipated or
actual residue levels in establishing, modifying, or leaving in effect a
tolerance, the Administrator shall pursuant to subsection (f)(1) of this
section require that data be provided five years after the date on which
the tolerance is established, modified, or left in effect, and
thereafter as the Administrator deems appropriate, demonstrating that
such residue levels are not above the levels so relied on. If such data
are not so provided, or if the data do not demonstrate that the residue
levels are not above the levels so relied on, the Administrator shall,
not later than 180 days after the date on which the data were required
to be provided, issue a regulation under subsection (e)(1) of this
section, or an order under subsection (f)(2) of this section, as
appropriate, to modify or revoke the tolerance.

		(F) PERCENT OF FOOD ACTUALLY TREATED.—In establishing, modifying,
leaving in effect, or revoking a tolerance for a pesticide chemical
residue, the Administrator may, when assessing chronic dietary risk,
consider available data and information on the percent of food actually
treated with the pesticide chemical (including aggregate pesticide use
data collected by the Department of Agriculture) only if the
Administrator—

		(i) finds that the data are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide chemical residue;

		(ii) finds that the exposure estimate does not understate exposure for
any significant subpopulation group;

		(iii) finds that, if data are available on pesticide use and
consumption of food in a particular area, the population in such area is
not dietarily exposed to residues above those estimated by the
Administrator; and

		(iv) provides for the periodic reevaluation of the estimate of
anticipated dietary exposure.

		(3) DETECTION METHODS.—

		(A) GENERAL RULE.—A tolerance for a pesticide chemical residue in or
on a food shall not be established or modified by the Administrator
unless the Administrator determines, after consultation with the
Secretary, that there is a practical method for detecting and measuring
the levels of the pesticide chemical residue in or on the food.

		(B) DETECTION LIMIT.—A tolerance for a pesticide chemical residue in
or on a food shall not be established at or modified to a level lower
than the limit of detection of the method for detecting and measuring
the pesticide chemical residue specified by the Administrator under
subparagraph (A).

	(4) INTERNATIONAL STANDARDS.—In establishing a tolerance for a
pesticide chemical residue in or on a food, the Administrator shall
determine whether a maximum residue level for the pesticide chemical has
been established by the Codex Alimentarius Commission. If a Codex
maximum residue level has been established for the pesticide chemical
and the Administrator does not propose to adopt the Codex level, the
Administrator shall publish for public comment a notice explaining the
reasons for departing from the Codex level.

	(c) AUTHORITY AND STANDARD FOR EXEMPTIONS.—

	(1) AUTHORITY.—The Administrator may issue a regulation establishing,
modifying, or revoking an exemption from the requirement for a tolerance
for a pesticide chemical residue in or on food—

				(A) in response to a petition filed under subsection (d) of this
section; or

				(B) on the Administrator's initiative under subsection (e) of this
section.

		(2) STANDARD.—

				(A) GENERAL RULE.—

		(i) STANDARD.—The Administrator may establish or leave in effect an
exemption from the requirement for a tolerance for a pesticide chemical
residue in or on food only if the Administrator determines that the
exemption is safe. The Administrator shall modify or revoke an exemption
if the Administrator determines it is not safe.

		(ii) DETERMINATION OF SAFETY.—The term”safe'', with respect to an
exemption for a pesticide chemical residue, means that the Administrator
has determined that there is a reasonable certainty that no harm will
result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.

		(B) FACTORS.—In making a determination under this paragraph, the
Administrator shall take into account, among other relevant
considerations, the considerations set forth in subparagraphs (C) and
(D) of subsection (b)(2) of this section.

	(3) LIMITATION.—An exemption from the requirement for a tolerance for
a pesticide chemical residue in or on food shall not be established or
modified by the Administrator unless the Administrator determines, after
consultation with the Secretary—

		(A) that there is a practical method for detecting and measuring the
levels of such pesticide chemical residue in or on food; or

		(B) that there is no need for such a method, and states the reasons
for such determination in issuing the regulation establishing or
modifying the exemption.

	(d) PETITION FOR TOLERANCE OR EXEMPTION.—

	(1) PETITIONS AND PETITIONERS.—Any person may file with the
Administrator a petition proposing the issuance of a regulation—

		(A) establishing, modifying, or revoking a tolerance for a pesticide
chemical residue in or on a food; or

		(B) establishing, modifying, or revoking an exemption from the
requirement of a tolerance for such a residue.

		(2) PETITION CONTENTS.—

		(A) ESTABLISHMENT.—A petition under paragraph (1) to establish a
tolerance or exemption for a pesticide chemical residue shall be
supported by such data and information as are specified in regulations
issued by the Administrator, including—

		(i)(I) an informative summary of the petition and of the data,
information, and arguments submitted or cited in support of the
petition; and

		(II) a statement that the petitioner agrees that such summary or any
information it contains may be published as a part of the notice of
filing of the petition to be published under this subsection and as part
of a proposed or final regulation issued under this section;

		(ii) the name, chemical identity, and composition of the pesticide
chemical residue and of the pesticide chemical that produces the
residue;

		(iii) data showing the recommended amount, frequency, method, and time
of application of that pesticide chemical;

		(iv) full reports of tests and investigations made with respect to the
safety of the pesticide chemical, including full information as to the
methods and controls used in conducting those tests and investigations;

		(v) full reports of tests and investigations made with respect to the
nature and amount of the pesticide chemical residue that is likely to
remain in or on the food, including a description of the analytical
methods used;

		(vi) a practical method for detecting and measuring the levels of the
pesticide chemical residue in or on the food, or for exemptions, a
statement why such a method is not needed;

		(vii) a proposed tolerance for the pesticide chemical residue, if a
tolerance is proposed;

		(viii) if the petition relates to a tolerance for a processed food,
reports of investigations conducted using the processing method(s) used
to produce that food;

		(ix) such information as the Administrator may require to make the
determination under subsection (b)(2)(C) of this section;

		(x) such information as the Administrator may require on whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen or other endocrine
effects;

		(xi) information regarding exposure to the pesticide chemical residue
due to any tolerance or exemption already granted for such residue;

		(xii) practical methods for removing any amount of the residue that
would exceed any proposed tolerance; and

		(xiii) such other data and information as the Administrator requires
by regulation to support the petition.

If information or data required by this subparagraph is available to the
Administrator, the person submitting the petition may cite the
availability of the information or data in lieu of submitting it. The
Administrator may require a petition to be accompanied by samples of the
pesticide chemical with respect to which the petition is filed.

		(B) MODIFICATION OR REVOCATION.—The Administrator may by regulation
establish the requirements for information and data to support a
petition to modify or revoke a tolerance or to modify or revoke an
exemption from the requirement for a tolerance.

	(3) NOTICE.—A notice of the filing of a petition that the
Administrator determines has met the requirements of paragraph (2) shall
be published by the Administrator within 30 days after such
determination. The notice shall announce the availability of a
description of the analytical methods available to the Administrator for
the detection and measurement of the pesticide chemical residue with
respect to which the petition is filed or shall set forth the
petitioner's statement of why such a method is not needed. The notice
shall include the summary required by paragraph (2)(A)(i)(I).

		(4) ACTIONS BY THE ADMINISTRATOR.—

		(A) IN GENERAL.—The Administrator shall, after giving due
consideration to a petition filed under paragraph (1) and any other
information available to the Administrator—

		(i) issue a final regulation (which may vary from that sought by the
petition) establishing, modifying, or revoking a tolerance for the
pesticide chemical residue or an exemption of the pesticide chemical
residue from the requirement of a tolerance (which final regulation
shall be issued without further notice and without further period for
public comment);

		(ii) issue a proposed regulation under subsection (e) of this section,
and thereafter issue a final regulation under such subsection; or

						(iii) issue an order denying the petition.

		(B) PRIORITIES.—The Administrator shall give priority to petitions
for the establishment or modification of a tolerance or exemption for a
pesticide chemical residue that appears to pose a significantly lower
risk to human health from dietary exposure than pesticide chemical
residues that have tolerances in effect for the same or similar uses.

				(C) EXPEDITED REVIEW OF CERTAIN PETITIONS.—

		(i) DATE CERTAIN FOR REVIEW.—If a person files a complete petition
with the Administrator proposing the issuance of a regulation
establishing a tolerance or exemption for a pesticide chemical residue
that presents a lower risk to human health than a pesticide chemical
residue for which a tolerance has been left in effect or modified under
subsection (b)(2)(B) of this section, the Administrator shall complete
action on such petition under this paragraph within 1 year.

		(ii) REQUIRED DETERMINATIONS.—If the Administrator issues a final
regulation establishing a tolerance or exemption for a safer pesticide
chemical residue under clause (i), the Administrator shall, not later
than 180 days after the date on which the regulation is issued,
determine whether a condition described in subclause (I) or (II) of
subsection (b)(2)(B)(iii) of this section continues to exist with
respect to a tolerance that has been left in effect or modified under
subsection (b)(2)(B) of this section. If such condition does not
continue to exist, the Administrator shall, not later than 180 days
after the date on which the determination under the preceding sentence
is made, issue a regulation under subsection (e)(1) of this section to
modify or revoke the tolerance.

	(e) ACTION ON ADMINISTRATOR'S OWN INITIATIVE.—

		(1) GENERAL RULE.—The Administrator may issue a regulation—

		(A) establishing, modifying, suspending under subsection (l)(3) of
this section, or revoking a tolerance for a pesticide chemical or a
pesticide chemical residue;

		(B) establishing, modifying, suspending under subsection (l)(3) of
this section, or revoking an exemption of a pesticide chemical residue
from the requirement of a tolerance; or

				(C) establishing general procedures and requirements to implement
this section.

	(2) NOTICE.—Before issuing a final regulation under paragraph (1),
the Administrator shall issue a notice of proposed rulemaking and
provide a period of not less than 60 days for public comment on the
proposed regulation, except that a shorter period for comment may be
provided if the Administrator for good cause finds that it would be in
the public interest to do so and states the reasons for the finding in
the notice of proposed rulemaking.

	(f) SPECIAL DATA REQUIREMENTS.—

	(1) REQUIRING SUBMISSION OF ADDITIONAL DATA.—If the Administrator
determines that additional data or information are reasonably required
to support the continuation of a tolerance or exemption that is in
effect under this section for a pesticide chemical residue on a food,
the Administrator shall—

		(A) issue a notice requiring the person holding the pesticide
registrations associated with such tolerance or exemption to submit the
data or information under section 3(c)(2)(B) of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a(c)(2)(B));

		(B) issue a rule requiring that testing be conducted on a substance or
mixture under section 4 of the Toxic Substances Control Act (15 U.S.C.
2603); or

		(C) publish in the Federal Register, after first providing notice and
an opportunity for comment of not less than 60 days' duration, an
order—

		(i) requiring the submission to the Administrator by one or more
interested persons of a notice identifying the person or persons who
will submit the required data and information;

		(ii) describing the type of data and information required to be
submitted to the Administrator and stating why the data and information
could not be obtained under the authority of section 3(c)(2)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136a(c)(2)(B)) or section 4 of the Toxic Substances Control Act (15
U.S.C. 2603);

		(iii) describing the reports of the Administrator required to be
prepared during and after the collection of the data and information;

		(iv) requiring the submission to the Administrator of the data,
information, and reports referred to in clauses (ii) and (iii); and

(v) establishing dates by which the submissions described in clauses (i)
and

		(iv) must be made.  The Administrator may under subparagraph (C)
revise any such order to correct an error.  The Administrator may under
this paragraph require data or information pertaining to whether the
pesticide chemical may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen or other endocrine
effects.

		(2) NONCOMPLIANCE.—If a submission required by a notice issued in
accordance with paragraph (1)(A), a rule issued under paragraph (1)(B),
or an order issued under paragraph (1)(C) is not made by the time
specified in such notice, rule, or order, the Administrator may by order
published in the Federal Register modify or revoke the tolerance or
exemption in question.  In any review of such an order under subsection
(g)(2) of this section, the only material issue shall be whether a
submission required under paragraph (1) was not made by the time
specified.

	(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS, AND ADMINISTRATIVE REVIEW.—

	(1) EFFECTIVE DATE.—A regulation or order issued under subsection
(d)(4), (e)(1), or (f)(2) of this section shall take effect upon
publication unless the regulation or order specifies otherwise. The
Administrator may stay the effectiveness of the regulation or order if,
after issuance of such regulation or order, objections are filed with
respect to such regulation or order pursuant to paragraph (2).

		(2) FURTHER PROCEEDINGS.—

		(A) OBJECTIONS.—Within 60 days after a regulation or order is issued
under subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
(n)(5)(C) of this section, any person may file objections thereto with
the Administrator, specifying with particularity the provisions of the
regulation or order deemed objectionable and stating reasonable grounds
therefor. If the regulation or order was issued in response to a
petition under subsection (d)(1) of this section, a copy of each
objection filed by a person other than the petitioner shall be served by
the Administrator on the petitioner.

		(B) HEARING.—An objection may include a request for a public
evidentiary hearing upon the objection. The Administrator shall, upon
the initiative of the Administrator or upon the request of an interested
person and after due notice, hold a public evidentiary hearing if and to
the extent the Administrator determines that such a public hearing is
necessary to receive factual evidence relevant to material issues of
fact raised by the objections. The presiding officer in such a hearing
may authorize a party to obtain discovery from other persons and may
upon a showing of good cause made by a party issue a subpoena to compel
testimony or production of documents from any person. The presiding
officer shall be governed by the Federal Rules of Civil Procedure in
making any order for the protection of the witness or the content of
documents produced and shall order the payment of reasonable fees and
expenses as a condition to requiring testimony of the witness. On
contest, such a subpoena may be enforced by a Federal district court.

		(C) FINAL DECISION.—As soon as practicable after receiving the
arguments of the parties, the Administrator shall issue an order stating
the action taken upon each such objection and setting forth any revision
to the regulation or prior order that the Administrator has found to be
warranted. If a hearing was held under subparagraph (B), such order and
any revision to the regulation or prior order shall, with respect to
questions of fact at issue in the hearing, be based only on substantial
evidence of record at such hearing, and shall set forth in detail the
findings of facts and the conclusions of law or policy upon which the
order or regulation is based.

	(h) JUDICIAL REVIEW.—

	(1) PETITION.—In a case of actual controversy as to the validity of
any regulation issued under subsection (e)(1)(C) of this section, or any
order issued under subsection (f)(1)(C) or (g)(2)(C) of this section, or
any regulation that is the subject of such an order, any person who will
be adversely affected by such order or regulation may obtain judicial
review by filing in the United States Court of Appeals for the circuit
wherein that person resides or has its principal place of business, or
in the United States Court of Appeals for the District of Columbia
Circuit, within 60 days after publication of such order or regulation, a
petition praying that the order or regulation be set aside in whole or
in part.

	(2) RECORD AND JURISDICTION.—A copy of the petition under paragraph
(1) shall be forthwith transmitted by the clerk of the court to the
Administrator, or any officer designated by the Administrator for that
purpose, and thereupon the Administrator shall file in the court the
record of the proceedings on which the Administrator based the order or
regulation, as provided in section 2112 of title 28. Upon the filing of
such a petition, the court shall have exclusive jurisdiction to affirm
or set aside the order or regulation complained of in whole or in part.
As to orders issued following a public evidentiary hearing, the findings
of the Administrator with respect to questions of fact shall be
sustained only if supported by substantial evidence when considered on
the record as a whole.

	(3) ADDITIONAL EVIDENCE.—If a party applies to the court for leave to
adduce additional evidence and shows to the satisfaction of the court
that the additional evidence is material and that there were reasonable
grounds for the failure to adduce the evidence in the proceeding before
the Administrator, the court may order that the additional evidence (and
evidence in rebuttal thereof) shall be taken before the Administrator in
the manner and upon the terms and conditions the court deems proper. The
Administrator may modify prior findings as to the facts by reason of the
additional evidence so taken and may modify the order or regulation
accordingly. The Administrator shall file with the court any such
modified finding, order, or regulation.

	(4) FINAL JUDGMENT; SUPREME COURT REVIEW.—The judgment of the court
affirming or setting aside, in whole or in part, any regulation or any
order and any regulation which is the subject of such an order shall be
final, subject to review by the Supreme Court of the United States as
provided in section 1254 of title 28. The commencement of proceedings
under this subsection shall not, unless specifically ordered by the
court to the contrary, operate as a stay of a regulation or order.

	(5) APPLICATION.—Any issue as to which review is or was obtainable
under this subsection shall not be the subject of judicial review under
any other provision of law.

	(i) CONFIDENTIALITY AND USE OF DATA.—

	(1) GENERAL RULE.—Data and information that are or have been
submitted to the Administrator under this section or section 348 of this
title in support of a tolerance or an exemption from a tolerance shall
be entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the same
extent provided by sections 3 and 10 of the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136a, 136h).

		(2) EXCEPTIONS.—

		(A) IN GENERAL.—Data and information that are entitled to
confidential treatment under paragraph (1) may be disclosed, under such
security requirements as the Administrator may provide by regulation,
to—

		(i) employees of the United States authorized by the Administrator to
examine such data and information in the carrying out of their official
duties under this chapter or other Federal statutes intended to protect
the public health; or

		(ii) contractors with the United States authorized by the
Administrator to examine such data and information in the carrying out
of contracts under this chapter or such statutes.

		(B) CONGRESS.—This subsection does not authorize the withholding of
data or information from either House of Congress or from, to the extent
of matter within its jurisdiction, any committee or subcommittee of such
committee or any joint committee of Congress or any subcommittee of such
joint committee.

	(3) SUMMARIES.—Notwithstanding any provision of this subsection or
other law, the Administrator may publish the informative summary
required by subsection (d)(2)(A)(i) of this section and may, in issuing
a proposed or final regulation or order under this section, publish an
informative summary of the data relating to the regulation or order.

	(j) STATUS OF PREVIOUSLY ISSUED REGULATIONS.—

	(1) REGULATIONS UNDER SECTION 346.—Regulations affecting pesticide
chemical residues in or on raw agricultural commodities promulgated, in
accordance with section 371(e) of this title, under the authority of
section 346(a) of this title upon the basis of public hearings
instituted before January 1, 1953, shall be deemed to be regulations
issued under this section and shall be subject to modification or
revocation under subsections (d) and (e) of this section, and shall be
subject to review under subsection (q) of this section.

	(2) REGULATIONS UNDER SECTION 348.—Regulations that established
tolerances for substances that are pesticide chemical residues in or on
processed food, or that otherwise stated the conditions under which such
pesticide chemicals could be safely used, and that were issued under
section 348 of this title on or before August 3, 1996, shall be deemed
to be regulations issued under this section and shall be subject to
modification or revocation under subsection (d) or (e) of this section,
and shall be subject to review under subsection (q) of this section.

	(3) REGULATIONS UNDER SECTION 346a.—Regulations that established
tolerances or exemptions under this section that were issued on or
before August 3, 1996, shall remain in effect unless modified or revoked
under subsection (d) or (e) of this section, and shall be subject to
review under subsection (q) of this section.

	(4) CERTAIN SUBSTANCES.—With respect to a substance that is not
included in the definition of the term “pesticide chemical'' under
section 321(q)(1) of this title but was so included on the day before
October 30, 1998, the following applies as of October 30, 1998:

		(A) Notwithstanding paragraph (2), any regulation applying to the use
of the substance that was in effect on the day before October 30, 1998,
and was on such day deemed in such paragraph to have been issued under
this section, shall be considered to have been issued under section 348
of this title.

		(B) Notwithstanding paragraph (3), any regulation applying to the use
of the substance that was in effect on such day and was issued under
this section (including any such regulation issued before August 3,
1996) is deemed to have been issued under section 348 of this title.

	(k) TRANSITIONAL PROVISION.—If, on the day before August 3, 1996, a
substance that is a pesticide chemical was, with respect to a particular
pesticidal use of the substance and any resulting pesticide chemical
residue in or on a particular food—

	(1) regarded by the Administrator or the Secretary as generally
recognized as safe for use within the meaning of the provisions of
subsection (a) of this section or section 321(s) of this title as then
in effect; or

	(2) regarded by the Secretary as a substance described by section
321(s)(4) of this title; such a pesticide chemical residue shall be
regarded as exempt from the requirement for a tolerance, as of August 3,
1996. The Administrator shall by regulation indicate which substances
are described by this subsection. Any exemption under this subsection
may be modified or revoked as if it had been issued under subsection (c)
of this section.

	(l) HARMONIZATION WITH ACTION UNDER OTHER LAWS.—

	(1) COORDINATION WITH FIFRA.—To the extent practicable and consistent
with the review deadlines in subsection (q) of this section, in issuing
a final rule under this subsection that suspends or revokes a tolerance
or exemption for a pesticide chemical residue in or on food, the
Administrator shall coordinate such action with any related necessary
action under the Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq.).

	(2) REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING CANCELLATION OF
ASSOCIATED REGISTRATIONS.—If the Administrator, acting under the
Federal Insecticide, Fungicide, and Rodenticide Act, cancels the
registration of each pesticide that contains a particular pesticide
chemical and that is labeled for use on a particular food, or requires
that the registration of each such pesticide be modified to prohibit its
use in connection with the production, storage, or transportation of
such food, due in whole or in part to dietary risks to humans posed by
residues of that pesticide chemical on that food, the Administrator
shall revoke any tolerance or exemption that allows the presence of the
pesticide chemical, or any pesticide chemical residue that results from
its use, in or on that food. Subsection (e) of this section shall apply
to actions taken under this paragraph. A revocation under this paragraph
shall become effective not later than 180 days after—

				(A) the date by which each such cancellation of a registration has
become

		effective; or

		(B) the date on which the use of the canceled pesticide becomes
unlawful under the terms of the cancellation, whichever is later.

	(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING SUSPENSION OF
ASSOCIATED REGISTRATIONS.—

		(A) SUSPENSION.—If the Administrator, acting under the Federal
Insecticide, Fungicide, and Rodenticide Act, suspends the use of each
registered pesticide that contains a particular pesticide chemical and
that is labeled for use on a particular food, due in whole or in part to
dietary risks to humans posed by residues of that pesticide chemical on
that food, the Administrator shall suspend any tolerance or exemption
that allows the presence of the pesticide chemical, or any pesticide
chemical residue that results from its use, in or on that food.
Subsection (e) of this section shall apply to actions taken under this
paragraph. A suspension under this paragraph shall become effective not
later than 60 days after the date by which each such suspension of use
has become effective.

		(B) EFFECT OF SUSPENSION.—The suspension of a tolerance or exemption
under subparagraph (A) shall be effective as long as the use of each
associated registration of a pesticide is suspended under the Federal
Insecticide, Fungicide, and Rodenticide Act. While a suspension of a
tolerance or exemption is effective the tolerance or exemption shall not
be considered to be in effect. If the suspension of use of the pesticide
under that Act is terminated, leaving the registration of the pesticide
for such use in effect under that Act, the Administrator shall rescind
any associated suspension of tolerance or exemption.

	(4) TOLERANCES FOR UNAVOIDABLE RESIDUES.—In connection with action
taken under paragraph (2) or (3), or with respect to pesticides whose
registrations were suspended or canceled prior to August 3, 1996, under
the Federal Insecticide, Fungicide, and Rodenticide Act, if the
Administrator determines that a residue of the canceled or suspended
pesticide chemical will unavoidably persist in the environment and
thereby be present in or on a food, the Administrator may establish a
tolerance for the pesticide chemical residue. In establishing such a
tolerance, the Administrator shall take into account both the factors
set forth in subsection (b)(2) of this section and the unavoidability of
the residue. Subsection (e) of this section shall apply to the
establishment of such tolerance. The Administrator shall review any such
tolerance periodically and modify it as necessary so that it allows no
greater level of the pesticide chemical residue than is unavoidable.

	(5) PESTICIDE RESIDUES RESULTING FROM LAWFUL APPLICATION OF
PESTICIDE.—Notwithstanding any other provision of this chapter, if a
tolerance or exemption for a pesticide chemical residue in or on a food
has been revoked, suspended, or modified under this section, an article
of that food shall not be deemed unsafe solely because of the presence
of such pesticide chemical residue in or on such food if it is shown to
the satisfaction of the Secretary that—

		(A) the residue is present as the result of an application or use of a
pesticide at a time and in a manner that was lawful under the Federal
Insecticide, Fungicide, and Rodenticide Act; and

		(B) the residue does not exceed a level that was authorized at the
time of that application or use to be present on the food under a
tolerance, exemption, food additive regulation, or other sanction then
in effect under this chapter; unless, in the case of any tolerance or
exemption revoked, suspended, or modified under this subsection or
subsection (d) or (e) of this section, the Administrator has issued a
determination that consumption of the legally treated food during the
period of its likely availability in commerce will pose an unreasonable
dietary risk.

	(6) TOLERANCE FOR USE OF PESTICIDES UNDER AN EMERGENCY EXEMPTION.—If
the Administrator grants an exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136p) for a
pesticide chemical, the Administrator shall establish a tolerance or
exemption from the requirement for a tolerance for the pesticide
chemical residue. Such a tolerance or exemption from a tolerance shall
have an expiration date. The Administrator may establish such a
tolerance or exemption without providing notice or a period for comment
on the tolerance or exemption. The Administrator shall promulgate
regulations within 365 days after August 3, 1996, governing the
establishment of tolerances and exemptions under this paragraph. Such
regulations shall be consistent with the safety standard under
subsections (b)(2) and (c)(2) of this section and with section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act.

	(m) FEES.—

	(1) AMOUNT.—The Administrator shall by regulation require the payment
of such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide, equip,
and maintain an adequate service for the performance of the
Administrator's functions under this section. Under the regulations, the
performance of the Administrator's services or other functions under
this section, including—

				(A) the acceptance for filing of a petition submitted under
subsection (d) of this

		section;

		(B) establishing, modifying, leaving in effect, or revoking a
tolerance or establishing, modifying, leaving in effect, or revoking an
exemption from the requirement for a tolerance under this section;

				(C) the acceptance for filing of objections under subsection (g) of
this section; or

		(D) the certification and filing in court of a transcript of the
proceedings and the record under subsection (h) of this section;

may be conditioned upon the payment of such fees. The regulations may
further provide for waiver or refund of fees in whole or in part when in
the judgment of the Administrator such a waiver or refund is equitable
and not contrary to the purposes of this subsection.

	(2) DEPOSIT.—All fees collected under paragraph (1) shall be
deposited in the Reregistration and Expedited Processing Fund created by
section 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. 136a-1(k)). Such fees shall be available to the Administrator,
without fiscal year limitation, for the performance of the
Administrator's services or functions as specified in paragraph (1).

	(n) NATIONAL UNIFORMITY OF TOLERANCES.—

	(1) “QUALIFYING PESTICIDE CHEMICAL RESIDUE” DEFINED.—For purposes
of this subsection, the term means a pesticide chemical residue
resulting from the use, in production, processing, or storage of a food,
of a pesticide chemical that is an active ingredient and that—

		(A) was first approved for such use in a registration of a pesticide
issued under section 3(c)(5) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136a(c)(5)) on or after April 25, 1985, on the
basis of data determined by the Administrator to meet all applicable
requirements for data prescribed by regulations in effect under that Act
(7 U.S.C. 136 et seq.) on April 25, 1985; or

		(B) was approved for such use in a reregistration eligibility
determination issued under section 4(g) of that Act (7 U.S.C. 136a-1(g))
on or after August 3, 1996.

	(2) “QUALIFYING FEDERAL DETERMINATION” DEFINED.—For purposes of
this subsection, the term “qualifying Federal determination” means a
tolerance or exemption from the requirement for a tolerance for a