  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
qualifying pesticide chemical residue that—

		(A) is issued under this section after August 3, 1996, and determined
by the Administrator to meet the standard under subsection (b)(2)(A) (in
the case of a tolerance) or (c)(2) (in the case of an exemption) of this
section; or 

		(B)(i) pursuant to subsection (j) of this section is remaining in
effect or is deemed to have been issued under this section, or is
regarded under subsection (k) of this section as exempt from the
requirement for a tolerance; and 

		(ii) is determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case
of an exemption) of this section. 

	(3) LIMITATION.—The Administrator may make the determination
described in paragraph (2)(B)(ii) only by issuing a rule in accordance
with the procedure set forth in subsection (d) or (e) of this section
and only if the Administrator issues a proposed rule and allows a period
of not less than 30 days for comment on the proposed rule. Any such rule
shall be reviewable in accordance with subsections (g) and (h) of this
section. 

	(4) STATE AUTHORITY.—Except as provided in paragraphs (5), (6), and
(8) no State or political subdivision may establish or enforce any
regulatory limit on a qualifying pesticide chemical residue in or on any
food if a qualifying Federal determination applies to the presence of
such pesticide chemical residue in or on such food, unless such State
regulatory limit is  identical to such qualifying Federal determination.
A State or political subdivision shall be deemed to establish or enforce
a regulatory limit on a pesticide chemical residue in or on a food if it
purports to prohibit or penalize the production, processing, shipping,
or other handling of a food because it contains a pesticide residue (in
excess of a prescribed limit). 

		(5) PETITION PROCEDURE.— 

		(A) IN GENERAL.—Any State may petition the Administrator for
authorization to establish in such State a regulatory limit on a  in or
on any food that is not identical to the qualifying Federal
determination applicable to such qualifying pesticide chemical residue. 

				(B) PETITION REQUIREMENTS.—Any petition under subparagraph (A) 

		shall—

						(i) satisfy any requirements prescribed, by rule, by the
Administrator; and 

		(ii) be supported by scientific data about the pesticide chemical
residue that is the subject of the petition or about chemically related
pesticide chemical residues, data on the consumption within such State
of food bearing the pesticide chemical residue, and data on exposure of
humans within such State to the pesticide chemical residue. 

		(C) AUTHORIZATION.—The Administrator may, by order, grant the
authorization described in subparagraph (A) if the Administrator
determines that the proposed State regulatory limit—

						(i) is justified by compelling local conditions; and 

						(ii) would not cause any food to be a violation of Federal law. 

		(D) TREATMENT.—In lieu of any action authorized under subparagraph
(C), the Administrator may treat a petition under this paragraph as a
petition under subsection (d) of this section to modify or revoke a
tolerance or an exemption. If the Administrator determines to treat a
petition under this paragraph as a petition under subsection (d) of this
section, the Administrator shall thereafter act on the petition pursuant
to subsection (d) of this section. 

		(E) REVIEW.—Any order of the Administrator granting or denying the
authorization described in subparagraph (A) shall be subject to review
in the manner described in subsections (g) and (h) of this section. 

	(6) URGENT PETITION PROCEDURE.—Any State petition to the
Administrator pursuant to paragraph (5) that demonstrates that
consumption of a food containing such pesticide residue level during the
period of the food's likely availability in the State will pose a
significant public health threat from acute exposure shall be considered
an urgent petition. If an order by the Administrator to grant or deny
the requested authorization in an urgent petition is not made within 30
days of receipt of the petition, the petitioning State may establish and
enforce a temporary regulatory limit on a  in or on the food. The
temporary regulatory limit shall be validated or terminated by the
Administrator's final order on the petition. 

	(7) RESIDUES FROM LAWFUL APPLICATION.—No State or political
subdivision may enforce any regulatory limit on the level of a pesticide
chemical residue that may appear in or on any food if, at the time of
the application of the pesticide that resulted in such residue, the sale
of such food with such residue level was lawful under this section and
under the law of such State, unless the State demonstrates that
consumption of the food containing such pesticide residue level during
the period of the food's likely availability in the State will pose an
unreasonable dietary risk to the health of persons within such State. 

	(8) SAVINGS.—Nothing in this chapter preempts the authority of any
State or political subdivision to require that a food containing a
pesticide chemical residue bear or be the subject of a warning or other
statement relating to the presence of the pesticide chemical residue in
or on such food. 

	(o) CONSUMER RIGHT TO KNOW.—Not later than 2 years after August 3,
1996, and annually thereafter, the Administrator shall, in consultation
with the Secretary of Agriculture and the Secretary of Health and Human
Services, publish in a format understandable to a lay person, and
distribute to large retail grocers for public display (in a manner
determined by the grocer), the following information, at a minimum: 

	(1) A discussion of the risks and benefits of pesticide chemical
residues in or on food purchased by consumers. 

	(2) A listing of actions taken under subparagraph (B) of subsection
(b)(2) of this section that may result in pesticide chemical residues in
or on food that present a yearly or lifetime risk above the risk allowed
under subparagraph (A) of such subsection, and the food on which the
pesticide chemicals producing the residues are used. 

	(3) Recommendations to consumers for reducing dietary exposure to
pesticide chemical residues in a manner consistent with maintaining a
healthy diet, including a list of food that may reasonably substitute
for food listed under paragraph (2). 

Nothing in this subsection shall prevent retail grocers from providing
additional information. 

	(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.—

	(1) DEVELOPMENT.—Not later than 2 years after August 3, 1996, the
Administrator shall in consultation with the Secretary of Health and
Human Services develop a screening program, using appropriate validated
test systems and other scientifically relevant information, to determine
whether certain substances may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or such other
endocrine effect as the Administrator may designate. 

	(2) IMPLEMENTATION.—Not later than 3 years after August 3, 1996,
after obtaining public comment and review of the screening program
described in paragraph (1) by the scientific advisory panel established
under section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136w(d)) or the science advisory board
established by section 4365 of title 42, the Administrator shall
implement the program. 

	(3) SUBSTANCES.—In carrying out the screening program described in
paragraph (1), the Administrator —

				(A) shall provide for the testing of all pesticide chemicals; and 

		(B) may provide for the testing of any other substance that may have
an effect that is cumulative to an effect of a pesticide chemical if the
Administrator determines that a substantial population may be exposed to
such substance. 

	(4) EXEMPTION.—Notwithstanding paragraph (3), the Administrator may,
by order, exempt from the requirements of this section a biologic
substance or other substance if the Administrator determines that the
substance is anticipated not to produce any effect in humans similar to
an effect produced by a naturally occurring estrogen. 

		(5) COLLECTION OF INFORMATION.— 

		(A) IN GENERAL.—The Administrator shall issue an order to a
registrant of a substance for which testing is required under this
subsection, or to a person who manufactures or imports a substance for
which testing is required under this subsection, to conduct testing in
accordance with the screening program described in paragraph (1), and
submit information obtained from the testing to the Administrator,
within a reasonable time period that the Administrator determines is
sufficient for the generation of the information. 

		(B) PROCEDURES.—To the extent practicable the Administrator shall
minimize duplicative testing of the same substance for the same
endocrine effect, develop, as appropriate, procedures for fair and
equitable sharing of test costs, and develop, as necessary, procedures
for handling of confidential business information. 

				(C) FAILURE OF REGISTRANTS TO SUBMIT INFORMATION.—

		(i) SUSPENSION.—If a registrant of a substance referred to in
paragraph (3)(A) fails to comply with an order under subparagraph (A) of
this paragraph, the Administrator shall issue a notice of intent to
suspend the sale or distribution of the substance by the registrant. Any
suspension proposed under this paragraph shall become final at the end
of the 30-day period beginning on the date that the registrant receives
the notice of intent to suspend, unless during that period a person
adversely affected by the notice requests a hearing or the Administrator
determines that the registrant has complied fully with this paragraph. 

		(ii) HEARING.—If a person requests a hearing under clause (i), the
hearing shall be conducted in accordance with section 554 of title 5.
The only matter for resolution at the hearing shall be whether the
registrant has failed to comply with an order under subparagraph (A) of
this paragraph. A decision by the Administrator after completion of a
hearing shall be considered to be a final agency action. 

		(iii) TERMINATION OF SUSPENSIONS.—The Administrator shall terminate
a suspension under this subparagraph issued with respect to a registrant
if the Administrator determines that the registrant has complied fully
with this paragraph. 

		(D) NONCOMPLIANCE BY OTHER PERSONS.—Any person (other than a
registrant) who fails to comply with an order under subparagraph (A)
shall be liable for the same penalties and sanctions as are provided
under section 16 of the Toxic Substances Control Act (15 U.S.C. 2615) in
the case of a violation referred to in that section. Such penalties and
sanctions shall be assessed and imposed in the same manner as provided
in such section 16. 

	(6) AGENCY ACTION.—In the case of any substance that is found, as a
result of testing and evaluation under this section, to have an
endocrine effect on humans, the Administrator shall, as appropriate,
take action under such statutory authority as is available to the
Administrator, including consideration under other sections of this
chapter, as is necessary to ensure the protection of public health. 

	(7) REPORT TO CONGRESS.—Not later than 4 years after August 3, 1996,
the Administrator shall prepare and submit to Congress a report
containing— 

		(A) the findings of the Administrator resulting from the screening
program described in paragraph (1); 

		(B) recommendations for further testing needed to evaluate the impact
on human health of the substances tested under the screening program;
and 

		(C) recommendations for any further actions (including any action
described in paragraph (6)) that the Administrator determines are
appropriate based on the findings. 

	(q) SCHEDULE FOR REVIEW.— 

	(1) IN GENERAL.—The Administrator shall review tolerances and
exemptions for pesticide chemical residues in effect on the day before
August 3, 1996, as expeditiously as practicable, assuring that— 

		(A) 33 percent of such tolerances and exemptions are reviewed within 3
years of August 3, 1996; 

		(B) 66 percent of such tolerances and exemptions are reviewed within 6
years of August 3, 1996; and 

		(C) 100 percent of such tolerances and exemptions are reviewed within
10 years of August 3, 1996. 

In conducting a review of a tolerance or exemption, the Administrator
shall determine whether the tolerance or exemption meets the
requirements of subsections (b)(2) or (c)(2) of this section and shall,
by the deadline for the review of the tolerance or exemption, issue a
regulation under subsection (d)(4) or (e)(1) of this section to modify
or revoke the tolerance or exemption if the tolerance or exemption does
not meet such requirements. 

	(2) PRIORITIES.—In determining priorities for reviewing tolerances
and exemptions under paragraph (1), the Administrator shall give
priority to the review of the tolerances or exemptions that appear to
pose the greatest risk to public health. 

	(3) PUBLICATION OF SCHEDULE.—Not later than 12 months after August 3,
1996, the Administrator shall publish a schedule for review of
tolerances and exemptions established prior to August 3, 1996. The
determination of priorities for the review of tolerances and exemptions
pursuant to this subsection is not a rulemaking and shall not be subject
to judicial review, except that failure to take final action pursuant to
the schedule established by this paragraph shall be subject to judicial
review. 

	(r) TEMPORARY TOLERANCE OR EXEMPTION.—The Administrator may, upon the
request of any person who has obtained an experimental permit for a
pesticide chemical under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.) or upon the Administrator's own
initiative, establish a temporary tolerance or exemption for the
pesticide chemical residue for the uses covered by the permit.
Subsections (b)(2), (c)(2), (d), and (e) of this section shall apply to
actions taken under this subsection. 

	(s) SAVINGS CLAUSE.—Nothing in this section shall be construed to
amend or modify the provisions of the Toxic Substances Control Act (15
U.S.C. 2601 et seq.) or the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.)

																

Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment D

Final Rule; Time-Limited Tolerances for Pesticide Emergency Exemptions
(65 FR 65125)



ATTACHMENT D

[Federal Register: October 25, 2000 (Volume 65, Number 207)]

[Rules and Regulations]

[Page 64125-64132]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr25oc00-23]

[[Page 64125]]

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Part III

Environmental Protection Agency

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40 CFR Part 176

Time-Limited Tolerances for Pesticide Emergency Exemptions; Final Rule

[[Page 64126]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 176

[OPP-181051A; FRL-6749-7]

RIN 2070-AD15

Time-Limited Tolerances for Pesticide Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY:  This final rule governs the establishment of time-limited
tolerances and exemptions for residues of a pesticide chemical resulting
from its emergency use as authorized under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The

purpose of this rule is to set into place a process that will ensure
timely decisions on any tolerance related issue in response to a request
for an emergency use of a pesticide chemical to be used in or on food or
feed. Under this rule, EPA will implement the provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA) related to FIFRA section 18
time-limited tolerances by evaluating each petition 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. This rule
pertains only to regulatory changes resulting from the 1996 enactment of
the Food Quality Protection Act (FQPA) which amended FFDCA.

DATES:  This rule is effective November 24, 2000.

FOR FURTHER INFORMATION CONTACT:  For general information contact:
Joseph E. Hogue, Office of Pesticide Programs (7506C), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9072; e-mail address: hogue.joe@epa.gov. For
applicability questions contact: Robert Forrest, Chief, Minor

Use, Inerts and Emergency Response Branch (7505C), Registration
Division, Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 308-9376; e-mail address: forrest.robert@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this final rule if you are the
Federal government or a State or Territorial government agency charged
with pesticide authority. Regulated categories and entities may include,
but are not limited to:

------------------------------------------------------------------------

Category	NAICS codes	Examples of 

potentially affected 

entities

------------------------------------------------------------------------

Federal government	9241	Federal agencies that petition EPA for FIFRA
section 18 use authorization

State or Territorial governments                                		

States or territories charged with pesticide authority that petition EPA
for FIFRA section 18 use authorization

------------------------------------------------------------------------

     This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this table could also be
affected. The North American Industrial Classification System (NAICS)
codes are provided to assist you and others in determining whether or
not this action might apply to certain entities. If you have questions
regarding the applicability of this action to a particular entity,

consult Sec. 176.1 or the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

 

     1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select “Laws and

Regulations,” “Regulations and Proposed Rules,” and then look up
the entry for this document under the “Federal Register--Environmental
Documents.” You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.

     2. In person. The Agency has established an official record for
this action under docket control number OPP-181051A. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed as
Confidential Business Information (CBI). This official record includes
the documents that are physically located in the docket, as well as the
documents that are referenced in those documents. The public version of
the official record does not include any information claimed as CBI. The
public version of the official record, which includes printed, paper
versions of any electronic comments submitted during an applicable
comment period, is available for inspection in the Public Information
and Records Integrity Branch (PIRIB), Room 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding Federal holidays. The PIRIB telephone number
is (703) 305-5805.

II. Background

A. What Action is the Agency Taking?

     The amendments to FFDCA, as prescribed by FQPA, went into effect
immediately upon enactment on August 3, 1996. Under these amendments,
EPA is required to conduct all pesticide tolerance-setting activities,
including those approved for section 18 emergency exemptions, under an
amended FFDCA section 408 with a new safety standard and new regulatory
procedures. In the Federal Register of June 3, 1999 (64 FR 29823) (FRL-
5750-1), EPA published, and opened for public comment, proposed
regulations for setting time-limited tolerances for section 18 emergency
exemptions. In its proposal, EPA described its current emergency
exemption program and the interim practices taken to evaluate requests
for section 18 tolerances or tolerance exemptions, and to establish
section 18 tolerances, prior to the issuance of this final rule.

     In the time period spanning from August 1996 to the present, EPA
has been evaluating section 18 exemption requests and issuing associated
tolerances or tolerance exemptions on a case-by-case basis. These
evaluations have been determined based on materials submitted by

Federal and State agencies in accordance with EPA guidance and interim
procedures sent to them in September 1996 and further elaborated in
Pesticide Registration Notice 97-1, dated January 1997, which

[[Page 64127]]

is available in the OPP Docket (see Unit I.B.2). This non-binding
interim approach to current section 18 tolerance decisions has remained
in place while the Agency has developed this FFDCA section 408(l)(6)
procedural regulation.

     The June 3, 1999 proposal was strictly a procedural scheme and did
not modify any regulatory policies associated with the approval of the
emergency exemption itself under FIFRA. EPA proposed to establish a new
part 176 in the CFR to house exclusively regulations governing the
setting of time-limited tolerances for emergency exemptions. In summary,
EPA proposed to:

     1. Review data for establishing a time-limited tolerance only after
a section 18 request has been submitted;

     2. Evaluate each submission individually on a case-by-case basis to
determine if adequate reliable information is available to make the
required safety finding;

     3. Not routinely require additional data to be generated and
instead rely on submitted data already reviewed and evaluated; and

     4. Strive to make a regulatory decision in a timely manner.

     If a tolerance could not be established then the emergency
exemption would not be granted. Time-limited tolerances would typically
be set for a period of 24 months to allow the treated crop from the
previous year’s emergency application to clear the channels of trade.

     In addition to the above proposed procedure, EPA solicited comments
on several other options for addressing time-limited tolerances. One
approach was to require a full data set to support section 18 tolerances
in the same manner as is required for the establishment of 

permanent tolerances. EPA also considered requiring a minimum data set
in which the applicant would need to provide a specific subset of the
data normally required to establish a permanent tolerance. Under this
approach, the Agency would evaluate only those defined studies in making
its safety finding. EPA did not include either approach as its primary
option because they did not allow for timely decisions. Another approach
for setting time-limited tolerances was suggested by the National Food
Processors’ Association. If this approach were adopted, EPA would not
conduct a full-risk assessment for a section 18 tolerance, but would
instead assess the incremental risk of the proposed emergency pesticide
use, that is, the amount that the proposed

use would increase dietary risk above the risk from existing uses. 

B. What is the Agency’s Authority for Taking this Action?

     Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that “emergency
conditions exist which require such exemption.” Regulations regarding
EPA’s implementation of FIFRA section 18 are codified in 40 CFR part
166.

     FQPA amended the FFDCA by directing EPA to establish time-limited
tolerances or tolerance exemptions for pesticide use authorized by EPA
under section 18 of FIFRA that may result in residues in or on food or
feed. Specifically the FFDCA section 408(l)(6) requires EPA to establish
a tolerance or exemption from the requirement of a tolerance for
pesticide chemical residues in or on food that will result from the use
of a pesticide under an emergency exemption. Section 408(l)(6) also
requires EPA to promulgate regulations governing the establishment of

tolerances and tolerance exemptions for pesticide uses approved for
emergency situations under FIFRA section 18. Section 408(e)(1)
authorizes the Administrator to establish, modify, suspend, or revoke
any tolerance or exemption from the requirement of a tolerance on her
own initiative, and to establish general procedures and requirements to
implement section 408. This final rule is issued under the authority of
sections 408(e)(1)(c) and 408(l)(6) of FFDCA, as amended by FQPA.

III. Public Comment and EPA Response

     EPA received a total of 10 comments in response to its proposed
rule. Five States, two growers groups, two pesticide manufacturing
companies, and one public interest group submitted comments. In
addition, the National Food Processors’ Association attached its
previously submitted petition requesting that EPA use an incremented
risk approach to its comments. This petition, entitled “Petition To
Issue A Regulation Governing Establishment Of Section 18 Tolerances,”
was co-sponsored by 19 associated grower groups. Everyone expressed
support of EPA’s premise that timeliness and rapid review of section
18 requests is the essence of the program. In this regard, all parties
agreed that the Agency should only utilize “available data in its
section 18 tolerance reviews.”

     EPA, in addition to considering changes based on public comments,
also made minor changes to Sec. Sec. 176.5 and 176.11(a) in the final
rule to clarify the provisions and to conform to other regulations
(particularly 40 CFR part 166). EPA has also changed the text of Sec.
176.3 slightly by changing “a State, U.S. Territory, or Federal
agency” to “any entity, authorized under section 18 of FIFRA to
request an emergency exemption,” and by changing “declares”a
crisis exemption to “issues.” A similar change has been made to Sec.
176.15. These changes will eliminate any future need to amend these
rules in the event that EPA’s regulations or FIFRA are ever changed so
that an entity other than a State, U.S. Territory, or Federal agency
would be allowed to request an emergency exemption. Other changes to the
final rule were made as discussed in this unit. Following is a summary
of the significant comments received by EPA and its response to these

comments.

A. EPA Should Adopt an Incremental Risk Approach to Setting Tolerances
for Emergency Exemptions

     Eight submitters commented on the approach EPA should take to
establish time-limited tolerances for emergencies. Two commenters agreed
with EPA’s proposed scheme to set tolerances on a case-by-case basis
using available, reliable information to make the required safety
finding. Six commenters, while not critical of EPA’s proposed
approach, urged the Agency to instead implement an accelerated review
process based on the incremental risk of the emergency use. One
commenter thought that the minimum data set approach was
“intriguing” and could deserve further consideration. This approach,
it was stated, had the potential to lend clarity and objectivity to the
section 18 process and eliminate the need for the Agency to use “best
judgement.”

     The proponents of the incremental-risk approach argued that since
emergency exemptions are by their very nature extreme situations, the
process for addressing them should take this into account and they
should be given special treatment. Pesticide use in an emergency is for
a short term and generally is limited to a single-geographic area,
therefore there is less exposure to the pesticide and minimal associated
risk. One commenter noted that the Agency’s policy of

conducting a full-risk assessment for section 18 tolerances does not
consider the limited scope and duration of the use. The commenter stated
that performing full risk assessments each time a section 18 tolerance
is requested not only slows down the entire section 18 review process,
but also diverts Agency resources. According to the commenter

[[Page 64128]]

an incremental-risk approach would eliminate the time pressures and
would avoid the disruption to EPA’s base pesticide regulatory
programs.

     In spite of the thoughtful comments on the fourth option, EPA
believes that the case-by-case approach outlined in its proposal is the
most practical approach that does not significantly sacrifice timeliness
or efficiency and is in compliance with the law. It allows the Agency to
make appropriate decisions quickly while fully protecting human health,
especially infants and children, and safeguarding the environment.
Moreover, this approach, coupled with the Agency’s newly established
Threshold of Regulation Policy for pesticide tolerances (see Unit IV.)
may resolve many concerns expressed by those who favor the
incremental-risk approach.

     EPA is not prepared at this time to adopt the approach suggested by
the commenters. In addition to presenting difficult legal issues, the
incremental-risk approach may not be needed to address the commenters’
concerns regarding purported EPA denial of section 18 emergency

exemption petitions or a lack of timely review by the Agency of such
petitions. EPA’s initial implementation of the new tolerance
requirement necessitated adjusting Agency procedures and involved some
deviation from past EPA review times in handling section 18 emergency
exemption requests. Now that EPA has had 4 years experience in setting
section 18 emergency exemption tolerances, it believes that it has
adequately adapted the emergency exemption process to deal with the
longer lead-time inherent in the requirement for establishment of these
tolerances. Further, as noted in this unit, the Agency’s newly
established Threshold of Regulation Policy for pesticide tolerances (see
Unit IV.) may address many of the commenters’ concerns.

B. The Timely Establishment of a Tolerance After Granting an Emergency
Exemption is Crucial

     Several commenters said that EPA should establish a tolerance at
the time of the section 18 approval. The underlying concern was that the
Agency would not be able to establish a tolerance before the crop is
harvested or the commodity enters into interstate commerce. One person
remarked that in addition to the presence of an emergency condition,
growers are subject to increased uncertainty and anxiety the longer it
takes the Agency to establish a tolerance. The commenters were concerned
that crops treated in the course of an emergency would be considered
adulterated and seized for the lack of an established tolerance.

     As a general matter, the Agency agrees with the submitter. For new
pesticides, the Agency grants a registration and establishes the
required tolerances simultaneously. However, due to the urgent nature of
pest emergencies, growers need to be able to lawfully apply a pesticide
as soon as possible or face significant economic loss for that year. If
the Agency concludes that it is unable to establish a time-limited
tolerance for that use, it will notify the applicant immediately so that
some other method of control for the emergency pest situation can be
sought. EPA often has to balance its workload between establishing
tolerances and processing section 18 requests. During peak periods for
emergency exemption requests, resources used to set a tolerance could
result in the delay of another State’s section 18 application.
Nonetheless, EPA is committed to working toward the goal of being able
to set a tolerance at the same time as granting the

emergency exemption. For example, in Fiscal Year (FY) 1999, EPA’s
average time to establish a tolerance once the exemption was granted was
66 days. This is significantly faster than the average of 87 days it
took the Agency in FY 1998.

     FFDCA section 408(l)(5) explains the conditions upon which foods
and feeds may be subject to enforcement action due to pesticide
residues. Under this subsection, if a tolerance is no longer in effect,
i.e., it has been revoked or has expired, the crop may continue to be
marketed if:

     1. The crop was treated with an approved use of the pesticide at
the time of treatment, and

     2. The level of the residues do not exceed the tolerance in effect
at the time the pesticide was applied.

  In the second instance, it is important to note that the tolerance
must be in place at the time the pesticide is used. This is why many
States often submit section 18 emergency exemption requests several
months prior to the onset of the emergency in anticipation of the 2-3
month time between issuing the exemption and establishing the tolerance.
They acknowledge that for residues resulting from the use to be
considered lawful once the tolerance has expired, the tolerance must 

be in place at the time of application, not the time of harvest.
Nonetheless, EPA’s policy of setting tolerances for longer duration
than the exemption ensures that crops treated during an emergency
situation should lawfully clear trade channels while the tolerance is
still in effect.

C. All Emergency Exemptions Issued Under Section 18 Should Be Covered
Under the “Pipeline” Provision

     Many of those who submitted comments thought that the
“pipeline” provision of 408(l)(5) should apply to exemptions
declared under crisis situations. The “pipeline” can be described as
those crops that have been treated legally with a pesticide that are
still in the channels of

trade when the tolerance is either revoked or, as in the case of an
emergency exemption, has expired. Those who commented on this felt that
although a tolerance is not in place at the time the unregistered
pesticide is used, since the pesticide use was legal under FIFRA section
18, any resulting pesticide residues should also be considered legal and
not subject to enforcement actions.

     Crisis exemptions are by definition unpredictable. In instances
where an emergency condition occurs suddenly and there is no time to
formally request a specific emergency exemption, a State or Federal
agency may issue a crisis exemption and permit the use of an
unregistered pesticide (40 CFR 166.40). Under a crisis exemption a
pesticide is almost always used in the field prior to the establishment
of a tolerance. However, this situation can occur for specific
exemptions as well. In many instances, a specific exemption request
(especially with first-time tolerance requests) is granted and the
pesticide may be used in the field prior to the establishment of the

time-limited tolerance, where appropriate. EPA later conducts a full
review and establishes the time-limited tolerance. If the time-limited
tolerance is not set at a length of time to allow for crops to clear
trade channels, or is not extended and therefore expires, commodities
treated under these circumstances could be adulterated and subject to
seizure.

     In both of these instances the “pipeline” provision does not
apply because a tolerance was not set at the time the pesticide is
applied. The statutory requirement of FFDCA section 408(l)(5)(B) is not
met. EPA cannot alter the requirements in the FFDCA through regulations.
Nonetheless, as noted in this unit, EPA’s policy of setting tolerances
for longer duration than the section 18 exemption generally ensures that
crops treated during an emergency situation should clear trade channels
while the tolerance is still in effect.

     Some commenters expressed concern that even though they legally
applied a pesticide under a crisis emergency exemption, if after EPA
review the 

[[Page 64129]]

necessary tolerance level would exceed the safety standard and by law
could not be set, their entire crop could be subject to Federal
enforcement measures. To avoid this potentially dire situation, States
and Federal agencies are urged to consult with the Agency to determine
whether the pesticide in question has particular safety issues or
concerns before declaring a crisis.

D. Time-Limited Tolerances Should Be Set for Longer Than 24 Months

     A few commenters thought EPA should consider establishing
time-limited tolerances for longer than 2 years. One commenter remarked
that certain exemptions will likely be needed for 3 or more years
because issues such as new pest pressures or the development of
resistance are

not likely to go away once they have appeared. The commenter suggested
EPA set tolerances for 3 years upon initially granting the section 18
request based on circumstances which are likely to persist over several
years. The commenter added that an exemption such as one based on
unusual weather patterns probably will not reoccur in succeeding years
and a 2-year tolerance is adequate in this situation. 

     Under EPA’s regulations, specific exemptions and public health
exemptions can be authorized for periods of up to 1 year (40 CFR
166.28(a)). Since actions taken under this section are intended to
address an emergency need for temporary pest relief, most section 18
exemptions are granted for one growing season. In the preamble to the
proposed rule, EPA stated that it will typically set a time-limited
tolerance for a 2-year period. This is expected to allow treated crops

from the previous year to clear the channels of trade. The Agency is
flexible on this point and may set time-limited tolerances for longer
time periods if warranted. In addition, EPA may modify or extend a
time-limited tolerance at any time on its own initiative or at the
applicant’s request. EPA has changed Sec. 176.13 in the final rule to
clarify that it may extend the duration of a tolerance for various
reasons. EPA strongly recommends that if an applicant believes that 24

months is insufficient for a time-limited tolerance, the applicant
should request a more appropriate length of time in the initial section
18 request. This will permit the Agency to judge whether a longer period
would be appropriate.

     One commenter noted that in the proposed regulatory text, the words
“unless extended” should be added to Sec. 176.11(b) to be consistent
with the language in Sec. 176.13. Section 176.11(b) states that “(b)
Tolerances will automatically expire and be revoked, without further

action by EPA, at the time set out in the Federal Register notice
establishing the tolerance.” EPA agrees with this suggestion and has
added the phrase to this section.

E. This Rulemaking Should Be Considered a “Significant Action” that
Requires OMB Review

     Two commenters disagreed with the determination that the proposed
rule was not a “significant regulatory action” as defined under
section 3(f) of Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), and stated it should have

therefore undergone review by the Office of Management and Budget (OMB),
and that the final rule should be reviewed by OMB. One commenter stated
that emergency exemptions are by definition “of economic
importance.” In addition, crop losses associated with emergency

exemptions are routinely multi-million dollar situations and that
individual States and individual growers are “significantly”
impacted by a cumbersome tolerance setting process. It was suggested
that OMB review the potential impacts associated with delays in
establishing tolerances.

     E.O. 12866 defines as “significant” a regulatory action that is
likely to:

     1. Have an annual effect on the economy of $100 million or more, or
adversely and materially affect a sector of the economy; productivity;
competition; jobs; the environment; public health or safety; or State,
local, or tribal governments or communities;

     2. Create serious inconsistency or otherwise interfere with an
action taken or planned by another agency;

     3. Materially alter the budgetary impacts of entitlements, grants,
user fees, or loan programs; or

     4. Raise novel legal or policy issues.

     The determination of whether or not a regulatory action should be
reviewed by OMB under E.O. 12866 is made in consultation with OMB. Since
this rule is a procedural rule that codifies the internal process by
which EPA will set emergency tolerances, OMB determined that it was

not a significant regulatory action that required OMB review under E.O.
12866. As stated in the proposal’s preamble, EPA estimates that the
direct cost of this rule will be minimal because only EPA and applicants
are directly affected, and this action does not require applicants to
submit new or additional information. 

     The Agency determined that this rule, once promulgated, is not
expected to significantly change applicant activities, such that it
would increase the current burden to applicants and therefore is
unlikely to have a major economic impact on the States or Federal
agencies that apply for section 18 exemptions. In addition, EPA affirms
that promulgation of this rule will have no direct impact on any other
sector of the economy, or on any other government entities, programs, or
policies. A copy of the economic analysis is available in the public
version of the official record for this rule (see Unit I.B.2.).

IV. Is a Tolerance Needed?

     On October 27, 1999, EPA published in the Federal Register a notice
of availability of a policy entitled, “Threshold of Regulation
Policy--Deciding Whether a Pesticide With a Food Use Pattern Requires a
Tolerance” (64 FR 57881) (FRL-6388-2). This policy pertains to the use

of a pesticide (including an emergency use) on, in, or near food which
does not result in residues that are detectable in food. EPA is adopting
this policy which sets forth criteria to consider in

evaluating whether there is no “need” to establish a tolerance,
i.e., there is no reasonable expectation of finite residues of the
pesticide in the food. If the criteria are met, there is no requirement
for a tolerance or tolerance exemption. The Threshold of Regulation
policy

will be applicable for pesticide uses that result in no detected
residues in food and for which the degree of potential risk posed by any
theoretically possible residues is so minimal that tolerance

setting serves no purpose. 

     The Threshold of Regulation Policy can apply to time-limited
tolerances for section 18 emergency exemptions. In these instances, the
Agency will consider surrogate data in the case of emergency exemption
requests where all the data needed on the performance of the analytical

method or the magnitude of the residue as determined by field trial
studies on the subject commodity are unavailable. Given the emergency
circumstances, EPA may consider accepting data from a different crop to
establish eligibility for the threshold of regulation. Persons wishing

a Threshold of Regulation policy decision should make the request in
writing and submit materials and information that are ordinarily
required to support time-limited tolerances or tolerance exemptions.

V. Regulatory Assessment Requirements

A. Executive Order 12866

     Pursuant to Executive Order 12866, entitled Regulatory Planning and

[[Page 64130]]

Review (58 FR 51735, October 4, 1993), it has been determined that this
action is not a “significant regulatory action” and is therefore not
subject to review by OMB. OMB has made this determination because this
final rule is a procedural rule that codifies the internal process by

which EPA will set emergency tolerances. Applicants for section 18
emergency exemptions (i.e., Federal and State agencies) are the only
parties, other than EPA, directly affected by this action. According to
the economic assessment conducted by the Agency, the applicants of
section 18 emergency exemptions are not expected to experience any
adverse impacts as a result of this rule because the rule does not
require any new or additional data from applicants.

     A copy of the economic assessment is available in the public
version of the official record for this rule (see Unit I.B.2.). 

B. Regulatory Flexibility Act

     Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that this regulatory
action does not have a significant economic impact on a substantial
number of small entities. Applicants for section 18 emergency exemptions
are U.S. States, territories, or Federal agencies which, by definition,
are not small entities under the RFA. Applicants for section 18
emergency exemptions are the only parties, other than EPA, directly
affected by this action. 

     Information regarding this determination will be provided to the
Chief Counsel for Advocacy of the Small Business Administration (SBA)
upon request.

C. Paperwork Reduction Act

     Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid OMB control number. The OMB control numbers for EPA’s
regulations, after appearing in the preamble of the final rule, are
listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the
related collection instrument. This regulatory action does not contain
any new information collection requirements that would require
additional OMB review and approval.

     The information collection activities related to the procedures for
emergency exemptions under section 18 of FIFRA, which are contained in
40 CFR part 166, are already approved by OMB under OMB control number
2070-0032 (EPA ICR No. 596), and the process and informational needs for
requesting that the Agency establish or provide an exemption from the
establishment of a tolerance or maximum-residue level for the use of a
pesticide on food or feed crops, which are contained in 40 CFR part 180,
are already approved by OMB under OMB control number 2070-0024 (EPA ICR
No.597). As described in the information collection instruments, the
annual respondent burden for the information collection activities in 40
CFR part 166 is estimated to average 103 hours per application,
including time for reading the regulations, processing, compiling and
reviewing the requested data, generating application correspondence or
summary reports, and storing, filing, and maintaining the data. The
annual respondent burden for the information collection activities in 40
CFR part 180 is estimated to average 1,726 hours per petition, including
time for reading the regulations, processing, compiling and reviewing
the requested data, generating the request, storing, filing, and
maintaining the data.

     As defined by the PRA and 5 CFR 1320.3(b), “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. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.

D. Environmental Justice Considerations

     This final rule does not involve special considerations of
environmental-justice issues pursuant to Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority Populations
and Low-Income Populations (59 FR 7629, February 16, 1994). The Agency
has determined that this final rule does not affect the environmental
and health conditions in low-income and minority communities because
this rule codifies the internal process by which EPA will set emergency
tolerances, and only applies to applicants for section 18 emergency
exemptions (i.e., Federal and State agencies). In general, low-income
and minority communities are more likely to benefit from the risk
assessment process needed for the establishment of tolerances for
section 18 actions that might impact their community.

E. Unfunded Mandates Reform Act

     Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not contain
a Federal mandate that may result in expenditures of $100 million or
more for State, local, and tribal governments, in the aggregate, or the
private sector in any 1 year. As applicants for section 18 emergency
exemptions, Federal and State agencies are the only parties, other than
EPA, directly affected by this action. The potential impact on State
agencies, however, is expected to be minimal because this action does
not require applicants to submit new or additional information. In
addition, EPA has determined that this rule does not significantly or
uniquely affect small governments. Accordingly, this action is not
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

F. Federalism

     Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), requires EPA to develop an accountable process to ensure
“meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.”
“Policies that have federalism implications” is defined in the
Executive Order to include regulations that have “substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.” This final
rule will not have substantial direct effects on the States, on the

relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132. Since this rule
codifies an internal process for the Agency, and does not impose
requirements on others, the Agency determined that this rule will not
adversely impact the entities that apply for section 18 exemptions. The
process established by this final rule will more likely benefit
applicants and others by establishing an effective and efficient process
for the Agency to take the necessary tolerance actions in a timely
manner. Thus, the requirements of

[[Page 64131]]

section 6 of the Executive Order do not apply to this rule.
Nevertheless, the Agency provided an opportunity for Federal and State
agencies to review and provide comments on the proposed process. A
discussion of the comments EPA received, which includes comments from
several State and local officials, and how those comments are addressed
in the final rule, is provided in Unit III. 

G. Consultation and Coordination with Indian Tribal Governments

     Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. This final
rule implements requirements specifically set forth by the Congress in

FFDCA section 408(l)(6) without the exercise of any discretion by EPA.
The final rule does not significantly or uniquely affect the communities
of Indian tribal governments. Accordingly, the requirements of section
3(b) of Executive Order 13084 do not apply to this final rule.

H. Children’s Health Protection

     This final rule is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866 (see
Unit V.A.). In addition, this final rule is procedural in nature and
does not involve decisions on environmental health or safety risks that
may disproportionately affect children.

I. National Technology Transfer and Advancement Act

     This regulatory action does not involve any technical standards
that would require Agency consideration of voluntary consensus standards
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus standards
bodies. The NTTAA requires EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and applicable
voluntary consensus standards.

J. Civil Justice Reform

     In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR
4729, February 7, 1996).

K. Constitutionally Protected Property Rights

     EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property Rights
 (53 FR 8859, March 15, 1988), by examining the takings implications of
this rule in accordance with the ``Attorney General’s Supplemental
Guidelines for the Evaluation of Risk and Avoidance of Unanticipated
Takings'' issued under the Executive Order. 

VI. Submission to Congress and the General Accounting Office

     The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States. EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of the
rule in the Federal Register. This action is not a “major rule” as
defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 176

     Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

     Dated: October 16, 2000.

Carol M. Browner,

Administrator.

     Therefore, 40 CFR chapter I is amended by adding new part 176 to
read as follows:

PART 176--Time-Limited Tolerances for Emergency Exemptions

Sec.

176.1   Scope and applicability.

176.3   Definitions.

176.5   Establishment of a time-limited tolerance or exemption.

176.7   Information needed to establish a tolerance.

176.9   Publication of a tolerance.

176.11   Duration of a tolerance.

176.13   Modification of a time-limited tolerance.

176.15   Effect of a tolerance.

     Authority:  21 U.S.C. 346a and 371.

Sec. 176.1  Scope and applicability.

     This part describes the procedures and criteria under which EPA
will establish time-limited tolerances and exemptions from the
requirement of a tolerance for pesticide chemical residues associated
with use of pesticides under emergency or crisis exemptions under FIFRA

section 18. This part applies only to tolerances issued on the
initiative of EPA as the result of the issuance of an emergency
exemption or the declaration of a crisis exemption. This part does not

cover time-limited tolerances in any other circumstances.

Sec. 176.3  Definitions.

     The terms have the same meaning as in the Federal Insecticide,
Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug,
and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In
addition, the following terms are defined for the purposes of this part.

     Agency means the U.S. Environmental Protection Agency.

     Applicant means any entity authorized under section 18 of FIFRA to
request an emergency exemption that requests such an exemption under
Sec. 166.20 of this chapter, or issues a crisis exemption under Sec.
166.40 of this chapter.

     Crisis exemption means an exemption authorized under FIFRA section
18, in accordance with Sec. Sec. 166.40 through 166.53 of this chapter. 

     Emergency exemption means a specific, quarantine, or public health
exemption authorized under FIFRA section 18 and the regulations at Sec.
Sec. 166.20 through 166.35 of this chapter.

     EPA means the U.S. Environmental Protection Agency.

[[Page 64132]]

     FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et seq.).

     FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C 136 et seq.).

     Tolerance means the maximum amount of a pesticide chemical residue
that may lawfully be present in or on a raw agricultural commodity, or
processed food, or animal feed, expressed as parts per million by weight
of the pesticide chemical residue in the food or feed.

     Tolerance exemption means a formal determination by the Agency
pursuant to FFDCA section 408(c), 21 U.S.C 346a(c), that no tolerance is
needed for a given pesticide chemical residue in or on a particular food
commodity. For purposes of this part, the term “tolerance” shall

include an exemption from the requirement of a tolerance.

Sec. 176.5   Establishment of a time-limited tolerance or exemption.

     EPA will establish a time-limited tolerance for pesticide chemical
residues in or on raw or processed food or feed resulting from the use
of a pesticide chemical, if EPA authorizes an emergency exemption or a
crisis exemption. EPA will consider establishing such a tolerance only

if an applicant acting under authority of FIFRA section 18 either has
requested an emergency exemption, has stated its intention to issue a
crisis exemption, or has issued a crisis exemption for a use that may
result, directly or indirectly, in pesticide chemical residues in food
or feed.

Sec. 176.7   Information needed to establish a tolerance.

     (a) EPA will establish a time-limited tolerance only if EPA can
determine that the tolerance is safe, that is, there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue. EPA will base its determination upon data
submitted by the applicant and other readily available data. If, taking
into account the limited duration and emergency nature of a section 18
application, and based on the available data the Agency cannot conclude
that there is a reasonable certainty that no harm will result from the
use proposed by the applicant or granted pursuant to a crisis exemption,
EPA will not establish a tolerance.

     (b) Data and other relevant information to support the
establishment of a time-limited tolerance may be submitted by the
applicant, or by any other person, in support of the time-limited
tolerance. The applicant may also cite relevant data previously
submitted to the Agency.

Sec. 176.9  Publication of a tolerance.

     (a) If EPA issues an emergency exemption or crisis exemption under
FIFRA section 18, and EPA concludes that the tolerance for residues
resulting from use of the pesticide under the exemption will be safe,
then EPA will establish the tolerance by publishing an amendment to 40

CFR part 180 in the Federal Register.

     (b) A tolerance under this part may be established without prior
publication of a proposed tolerance or comment period. 

Sec. 176.11  Duration of a tolerance.

     (a) Tolerances issued under this part will become effective upon
publication in the Federal Register, unless otherwise specified by the
Administrator.

     (b) Unless extended, tolerances will automatically expire and be
revoked, without further action by EPA, at the time set out in the final
rule published in Federal Register.

     (c) The Administrator may revoke a tolerance at any time if the
Administrator determines that the tolerance is no longer safe. 

Sec. 176.13  Modification of a time-limited tolerance.

     If additional emergency or crisis exemptions are authorized that
would extend use beyond the date originally authorized, or if EPA
determines that the duration of a time-limited tolerance is

insufficient to allow treated commodities to clear the channels of
trade, EPA may modify the time-limited tolerance by publication of a
final rule in the Federal Register. EPA will use the same criteria and
procedures for modification as for establishing tolerances under this
part.

Sec. 176.15  Effect of a tolerance.

     The establishment of a tolerance under this part does not alter the
requirement that any applicant comply with procedures established in
part 166 of this chapter for emergency exemptions of FIFRA.

[FR Doc. 00-27405 Filed 10-24-00; 8:45 am]

BILLING CODE 6560-50-S



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment E

Public Comment Received Regarding 

the Proposed Renewal ICR and EPA Response to Comment



ATTACHMENT E – reserved for public comment – see docket entries, if
any, at EPA-HQ-OPP-2007-0320

		



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment F

Consultant Contacts and Comments Received in the Consultation Process



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment F

Consultant Contacts and Comments Received in the Consultation Process



ATTACHMENT F

Application and Summary Report for an Emergency Exemption for Pesticides


(OMB 2070-0032)		

Consultant Contacts and Comments Received in the Consultation Process

Dr. Brian J. Hughes

Toxicologist/Pesticide Registration Manager

Pesticide and Plant Pest Management Division 5th Floor, Constitution
Hall North

Lansing, Michigan 48933

(517) 241-3267

Cynthia Crowley, Environmental Chemist l

New York State Department of Environmental Conservation

Bureau of Pesticides Management

Division of Solid & Hazardous Materials

625 Broadway

Albany, New York 12233

(518) 402-8768

Dr. Laura Quakenbush

Colorado Department of Agriculture

Division of Plant Industry

700 Kipling Street, Suite 4000

Lakewood, Colorado 80215

(303) 239-4147

EPA Questions asked in Consultation 

(1)	Publicly Available Data

Is the data that the Agency seeks available from any public source, or
already collected by another office at EPA or by another agency?  The
states agreed that all of the necessary data the Agency seeks is not
available anywhere else and that each application is unique.  However,
parts of the section 18 package can be pulled from other sources, such
as reference to a previously submitted application from another state
for the same use pattern.

CO	No

MI	No.  The specifics of pest problems, range, and economic impacts vary
from state to state.  There are agencies that make parts of the
information public.  For example, the USDA Michigan Agricultural
Statistic Service has amounts of acreage for a particular commodity by
county, but the extent and magnitude of the economic impacts are
different.  Only partial data can be obtained through alternate
resources.  It is usually the technical expertise to evaluate the data
in the context of pest management that gives meaning to it.

NY	No. While other resources are available for parts of the submission
(Our state and national ag databases, extension agents), we still need
to collate the information into a single submission

	

If yes, where can you find the data?  (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are
available, but that they do not meet our data needs very well?)  	

NY	Crop statistics are available publicly from the New York State
Agriculture & Markets and the National Agriculture Statistical Service
websites; this would include acreage planted and harvested as well as
value of the crop.  These sites also give the historical information for
previous years.  Cornell also uses data that are not publicly available.
 Many times we have to rely on grower information relative to crop
inputs such as cost of materials, chemicals/fertilizers, harvesting, to
determine the cost of producing a commodity on a per acre basis.  Also,
grower spray records are collected to evaluate resistance and the number
of sprays being made

(2)	Frequency of Collection 

Can the Agency collect the information less frequently and still produce
the same outcome? 

CO	Not without a federal rule change.  Frequency is mandated by rule
(CFR).  We would support more regional and national submissions.  For
example, a national submission from USDA for soybean rust.

MI	Yes, particularly when the section 18s are repeated from year to
year.

NY	We are probably constrained by the CFR, but could specific exemptions
be for more than one use season?  The streamlined re-certification
process makes this less of an issue.  Can more regional or national
submissions be made?  The states would certainly support a national
submission (from USDA) for soybean rust quarantine exemptions

(3)	Clarity of Instructions   

The ICR is intended to require that respondents provide certain data so
that the Agency can utilize them.  

Based on the instructions (regulations, PR Notices, etc.), is it clear
what you are       required to do and how to submit such data? If not,
what suggestions do you have to clarify the instructions?

CO	Clarity of instructions is relatively good.  I have built my own
template for initial section 18 requests using the November 8, 2001
Instructions document from EPA.

MI	 The instructions are sufficient.

NY	Instructions are detailed and clear.  Cornell has an outline and
instructions on their PMEP website that provides	assistance to those
wanting to create an emergency exemption.

Do you understand that you are required to maintain records?   

CO	Yes.

MI	Yes, we maintain the records for 3 years in our files.

	 

NY	Yes

Considering that there is no required submission format, is it difficult
to submit information in ways that are clear, logical and easy to
complete?   

CO	I understand what is required for submission, but the learning
process was not that easy.  Editing an example from another state or a
previous submission is easier than using the EPA guidance.  It would be
useful if the 2001 “Instructions” were updated to reflect the recent
changes.

MI	There is an outline in 40 CFR 166.20 that provides adequate guidance
on the information that must be in the section 18 applications. 	

 

NY	No

Are there forms associated with this process?  Do you use them?  Are
they clear, logical, and easy to complete?

CO	There are no EPA-provided forms associated with this process.  

MI	There are no forms associated with this process from EPA.  AAPCO has
a created a format for the letters of recertification.  However, states
can choose to create their own format.  In this case, I prefer my own
submission format.   	

 

NY	No

(4)	Electronic Reporting and Record keeping 

The Government Paperwork Elimination Act requires agencies make
available to the public electronic reporting alternatives to paper-based
submissions by 2003, unless there is a strong reason for not doing so. 
One such reason is that, at the present time, the Agency is unable to
ensure the security of CBI that might be transmitted over the Internet.

What do you think about electronic alternatives to paper-based records
and data submissions?  Current electronic reporting alternatives include
the use of web forms/XML based submissions via the Agency’s Internet
site and magnetic media-based submissions, e.g., diskette, CD-ROM, etc. 
Would you be interested in pursuing electronic reporting?  

CO	It would be useful to be able to submit initial requests, repeat
requests, and use reports electronically.  We would be interested in
submitting via email, but with any information that might be considered
CBI (under Colorado definitions) submitted has hardcopy and/or on CD. 
We would be less interested using any web-based systems.

MI	The Michigan Department of Agriculture is in favor of electronic
submission and would like to explore this opportunity.  However, I think
there should be some security measure if submissions are sent over the
internet (encryption).

NY	The New York Department of Environmental Conservation submitted
re-certifications only electronically this year.  We are moving towards
having all of our information in electronic format and would support
electronic submissions (email, FTP, or through an Agency web site).

			

Are you keeping your records electronically?  If yes, in what format?

CO	The request is a word file (which we could easily submit as a .pdf
file if preferred).  However, some of the additional documents may not
be provide to us in electronic format.  We have increasingly been asking
for electronic versions of section 3 labels, section 18 use directions,
supporting efficacy data, residue study data, and other supporting
documents.  

We currently keep as many of the documents as possible needed for or
related to a particular section 18 submission in electronic form.  Each
year has a folder with each candidate section 18 request having a
sub-folder on a network drive.  It is easier to find the documents on
the network drive than digging out the hard file.  Formats vary,
including .doc (word), .xls (excel), .pdf and an occasional PowerPoint
file of efficacy data.  

Our section 18 responsibilities are considered a critical function under
our emergency planning, and much of our planning resolves around access
to information on the networked drives (not my hard files).  I need to
be able to continue on with section 18 activities within 12 hours of
losing access to our building.

MI	The submissions are kept on the Department of Agriculture’s server
on the hard drive.  The files are Word 2002 and in .pdf format. Yes, we
maintain the records for 3 years in our files.

NY	WordPerfect, Word, PDF, Excel.  Emergency exemptions are posted on
the Cornell website for the current and previous year(s).

Although the Agency does not offer an electronic reporting option
because of CBI-related security concerns at this time,  

Would you be more inclined to submit CBI on diskette (CD or DVD) than on
paper?  

CO	Most section 18 submissions do not involve submission of CBI.  In a
few rare cases, detailed economic data may be provided by a business. 
This is kept as a separate attachment instead of including it as part of
the section 18 request document.  We would be more inclined to submit
CBI as a hard-copy than electronic.  Papers are shredded and it is less
clear how to destroy information on electronic media.  We currently send
back CD’s when submitted by our state pesticide registration
registrants for this reason (they may stick the CSF on a CD along with
labels and MSDS’s.)

MI	We would more than likely transmit CBI via CD.

NY 	New York State does not have any CBI concerns for Sec 18
submissions.

What benefits would electronic submission bring you in terms of burden
reduction or greater efficiency in compiling the information?  

CO	The major benefit for an electronic submission to EPA would be the
assurance that the submission reached the correct person more quickly
and more dependably.  There would also be a cost savings.  We wouldn’t
need to pay for shipment via federal express, wouldn’t have
photocopying costs, and would require less staff time for copying and
mailing.  Electronic submissions would not provide a benefit in terms of
compiling the information.

MI	There is no overall burden reduction or efficiency in compiling the
data.

NY 	Reduction of duplication and shipping costs (both time and $).  Also
no postage is necessary as there is no “snail” mail along with easy
storage and access.  It is also easier to post to a website since there
is no need for xeroxing and duplicating.  Email has made the turnaround
time much quicker relative to getting information from the registrant.

(5)	Burden and Costs

Are the labor rates accurate? 

CO	The labor rates for Mgmt. and Tech are reasonable, but the clerical
rate is high.     We would estimate only $24/hour for clerical, not $42.

 

MI	EPA labor rates may reflect national average.  However, costs to the
state in Michigan may be less. 	

 

NY	Yes

The Agency assumes there is no capital cost associated with this
activity.  Is that correct?  

CO	Yes, there are no capital costs associated with this activity.

MI	Yes, there are no capital costs associated with this activity.   	

NY	Yes, there are no capital costs associated with this activity.

Bearing in mind that the burden and cost estimates include only burden
hours and costs associated with the paperwork involved with this ICR,
e.g., the ICR does not include estimated burden hours and costs for
conducting studies, are the estimated burden hours and labor rates
accurate? If you provide burden and cost estimates that are
substantially different from EPA’s, please provide an explanation of
how you arrived at your estimates.

CO	The burden hours for Clerical should be higher.  

The amount of time required from clerical will depend on how many
applicators use the section 18 product.  For many of our section 18
requests, we require each applicator to be a licensed applicator, obtain
a special permit from us, and submit a final use report providing the
information we need to supply to EPA in our use report.  Clerical staff
talks to each applicator on the phone, issues a permit number, sends
them an application package, makes sure each permittee returns there
permit application and the final the use report, and compiles a summary
of the total amount and area of use.  This is the source of the
information we send to EPA in our final use report.

The burden hours for “technical” is too high, we estimate 40 hours
for CDA staff; not 93.  We also consult with University extension people
and also grower groups and industries that want a section 18.  If we
include their time as well (not including effort to conduct efficacy
studies or summarize studies that they would be doing regardless of use
in a section 18 request) it might add an additional 15 hours.  (= 55
hours total for technical).

How this was determined:  In a typical year, the pesticide registration
coordinator prepares about 10 section 18 requests.  During previous
years, this would occupy 50% of her time for one month and 25% for an
additional 2 months on section 18’s during the winter months.  That
works out to 40 hours.

MI	Cost burdens are not vastly different.   

New York State Burden/Cost Estimates	

COLLECTION ACTIVITY	

Burden Hours 

(per application)	

Total



	

Mgmt.

$65/hr	

Tech.

$54/hr	

Cler.

$42/hr	

Hours	

Costs ($)



Read FIFRA and FQPA requirements and CFR regulations.	

2	

4	

0	

6	

346



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

4	

15.6	

0	

15.6	

1,102



Generate application correspondence and follow-up summary report.	

0	

4	

0	

4	

216



Store/maintain/submit information	

0	

0	

3.5	

3.5	

147



Totals	

6	

23.6	

3.5	

33.1	

1,811



Are there other costs that should be accounted for that may have been
missed?

CO	There have been training costs incurred as we learned the new
streamlined submission process, and participated in various meetings and
discussions prior to the final rule change.

MI	Are you including the costs of only issuing the Section 18 without
any enforcement or follow-up costs?  If so, these are costs with the
section 18 that are potentially missed. Also if there is any special
conditions in the granting document (eg monitoring).

NY	No costs have been missed.

(6)  	Miscellaneous – Response to Emergency Exemption Process
Revisions

	How has the streamlined application process impacted your Division? 

As it pertains to recertification of certain repeat emergency exemptions

CO	The streamlined process has greatly reduced the effort required to
prepare repeat requests.  This year we put together four of these in one
day (2 hours each).  Under the old system repeat requests would take
less time and effort than the initial application, perhaps 24 hours
instead of the 40 hour average.

MI	The streamlined process has actually lessened the time of the
technical expert in responding to section 18 requests.

NY	The streamlined process has been a significant savings in time and
money.

As it pertains to the criteria used to determine when a potential
emergency condition is expected to cause a significant economic loss and
the data requirements used to document the loss

Has the application and review process for submitting repeat emergency
exemptions improved since the regulation went into effect March 28,
2006?

CO	This has also made preparation of section 18 requests substantially
easier.  It also makes it easy to know when a situation will not qualify
and clarifies for extension specialists what type of information is
needed.  This may reduce EPA’s workload in ways that they may not be
directly aware of, since we will not submit a request if it doesn’t
meet the very clear criteria that have now been spelled out for us.

The application process for submitting repeat exemptions has improved
since the regulations took effect in March of 2006.  It is still too
early to see if the turn-around time on EPA’s side has been reduced.  

MI 	In a few instances, we have needed to seed the help of an
agricultural economist to deal with a tier 3 economic analysis.   Since
the new the regulation went into effect we have been able to turn around
section 18 submissions faster and receive approval quicker from EPA.

NY 	As it pertains to the criteria used to determine when a potential
emergency condition is expected to cause a significant economic loss and
the data requirements used to document the loss.  The information and
time required for this is similar to what was required previously. Yes,
the application and review process for submitting repeat emergency
exemptions have improved since the regulation went into effect March 28,
2006.

 



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment G

EPA Form No. 8570-4

Confidential Statement of Formula

This attachment is available as part of the electronic in the docket 
EPA-HQ-OPP-2007-0320.  he 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 



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

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 available only as part of the electronic in the docket 
EPA-HQ-OPP-2007-0320.  



Application and Summary Report for an Emergency Exemption for Pesticides

OMB No. 2070-0032 EPA No. 0596.08

Attachment I

Display Related to OMB Control No. 2070-0032 

Listings of Related Regulations in 40 CFR 9.1

ATTACHMENT I

Display Related to OMB Control #2070-0032 - Listings of 

Related Regulations in 40 CFR 9.1

	As of May 10, 1993, the OMB approval numbers for EPA regulations in
Chapter I of Title 40 of the Code of Federal Regulations (CFR) appear in
a listing in 40 CFR 9.1 (58 FR 27472).  This listing fulfills the
display requirements in section 3507(f) of the Paperwork Reduction Act
(PRA) for EPA regulations.  The listing at 40 CFR 9.1 displays this OMB
Control number for the following regulations:

Program
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