Document ID: EPA-HQ-OPP-2008-0473-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-05T05:00Z

SUPPORTING STATEMENT FOR AN 

INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a).	Title of the Information Collection  

Pesticide Program Public Sector Collections

OMB Nos.:  2070-new 

 		

EPA Nos.:  2311.01

1(b).	Short Characterization/Abstract 

	In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), this document announces that Environmental Protection Agency’s
(EPA), Office of Pesticide Programs (OPP) is planning to submit a
request to consolidate several existing approved Information Collection
Requests (ICRs) to the Office of Management and Budget (OMB). Before
submitting the consolidated ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of this information collection. 
The new consolidated ICR, entitled: “Pesticide Program Public Sector
Collections” and identified by EPA ICR No. 2311.01 and OMB Control No.
2070-[new] will consolidate the following currently approved ICRs:
"Applications and Summary Report for Emergency Exemption," (EPA No.
0596.08, OMB No. 2070-0032) is currently at OMB for approval of the
renewal document; and “Notice of Pesticide Registration by States to
meet a Special Local Need" (EPA No.0595.08, OMB No. 2070-0055,)
scheduled to expire August 31, 2009. 

Collectively, these ICRs enable the EPA to process and 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 including granting unregistered pesticide use
exemptions for public health and quarantine reasons.  This collection
also enables EPA to process information to allow States to register
additional uses of federally registered pesticides for distribution and
use within the State to meet a special local need.  EPA is specifically
looking for comments about the clarity and ease of public review this
consolidated document creates.     

1(c).	The Consolidated Document

These ICRs are being consolidated in to one document because the
programs they represent share similar respondent populations, state
governments and other federal agencies seeking exemptions or other
modifications to the federal pesticide registration program defined in
FIFRA.  The Agency believes consolidating these ICRs into one document
will increase the clarity of review for the public and will streamline
Agency review for such programs.  

	The document is divided into two separate individual parts, Part A and
Part B.  No changes to the currently approved ICRs have been made.  The
respective PRA burden hours and costs for each part were calculated in
different years and thus have different labor costs.  Notably the labor
costs for Part 1, the section 18 program are lower because the Agency
economists developed completely new estimates of wages, benefits and
overhead for all labor categories for affected industries, state
government, and EPA employees in 2006. The labor costs are higher for
Part B, the section 24(c) program because the Agency used an older
methodology (pre-2006) which  generally adjusted the labor rate
estimates used in the previous renewal by using methods such as the NASA
Gross Domestic Product (GDP) Deflator Inflation Calculator to index the
labor cost for a particular year.  During the next ICR renewal cycle the
burden hours and costs for both parts A and B will be indexed to the
same year.                  

Part A 

Part A describes the Section 18 of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) program which authorizes 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.  

In compliance with the PRA, EPA reported changes to the burden and costs
in the electronic docket EPA-HQ-OPP-2007-0320 (72 FRN 30794, June 4,
2007).  At that time, no public comments were received related to any
changes to the burden hours and costs for this program.  This
consolidated document does not change any substantive parts of thise
original document and is currently at OMB for approval of the renewal
document.  This document is being re-submitted to OMB for: 1)
re-assignment of OMB document tracking number and 2) public comment on
the consolidated document.

Part B

Section 24(c) of FIFRA authorizes the States to register additional uses
of federally registered pesticides for distribution and use within the
State to meet a special local need (SLN).   A State-issued registration
under FIFRA section 24(c) is deemed a federal registration for the
purposes of the pesticide's use within the State's boundaries.  A State
must notify EPA, in writing, of any action it takes, i.e., when it
issues, amends, or revokes a State registration.  The Agency has 90 days
to disapprove the registration.  In such cases, the State is responsible
for notifying the affected registrant.

In compliance with the PRA, EPA reported changes to the burden and costs
in the electronic docket EPA-HQ-OPP-2005-0086 (70 FRN 20538, April 20,
2005).  At that time, one public comment was received however the
comment was not related to the no public comments were received related
to any changes to the burden hours and costs for this program.  Thise
consolidated document does not change any substantive parts of theis
original document.  This document is being re-submitted to OMB for: 1)
re-assignment of OMB document tracking number and 2) public comment on
the consolidated document.



Part A 

Applications and Summary Report for Emergency Exemption;

 OMB Number 2070-0032 and EPA Number 0596.08 

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 SUPPORTING STATEMENT FOR

	AN INFORMATION COLLECTION REQUEST (ICR)

	(EPA-HQ-OPP-2007-0320, 72 FRN 30794, June 4, 2007) 

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 was due to expire February
28, 2008 but is currently at OMB for approval of the renewal document. 
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

This information collection allows the Agency to access needed data to
expeditiously make statutory determinations to grant or deny a section
18 request. 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 situationssituations, 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.  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 (see Attachment B).

	Section 408 of the Federal Food, Drug, and Cosmetic Act (see Attachment
C) 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 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 the renewal for this ICR, EPA published a notice in the
Federal Register (72 FR 30794) on June 4, 2007 which provided a 60-day
public notice and comment period on the draft ICR.  The Agency did not
receive any public comments on the draft renewal 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.  

	For this renewal, EPA consulted by telephone and e-mail with
representatives of three state agencies 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.  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. 

	

	While only briefly summarized here, generally, each of the states
consulted agreed that the new streamlined process for re-certified
section 18 applications has produced savings in both the amount of time
and money.  Two of the three states, MI and NY stated that the
Agency’s burdens and cost estimates were accurate, while CO disagreed.
 EPA notes that there will always be some variance of burden hours and
costs between state programs because of the differences of how the
programs are administered in each state.  At this time the Agency does
not believe the variance between the states burden hours and costs and
the Agency’s estimated burden hours and costs warrants readjustment. 
Thus, no changes to the burden hours and costs have been made for this
ICR renewal request to OMB.  Two states, CO and MI expressed some degree
of concern about web based submissions and/or electronically submitted
data to the Agency because of security concerns.  However, NY noted that
it submitted re-certifications only electronically in the past year. 
The details of consultant contacts and the comments received in the
consultation process are part of this document in Attachment E.  

	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 F)
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 

Agency economists revised the estimated wages, benefits and overhead for
all labor categories for affected industries, state government, and EPA
employees based on publicly available data from the US Bureau of Labor
Statistics. The formulas used to estimate the labor rates and formulas
used to derive the fully loaded rates and overhead costs for this ICR
renewal are listed in Attachment G. 

	Methodology:	The methodology uses data on each sector and labor type
for an Unloaded wage rate (hourly wage rate), and calculates the Loaded
wage rate (unloaded wage rate + benefits), and the Fully loaded wage
rate (loaded wage rate + overhead).  Fully loaded wage rates are used to
calculate respondent costs.  This renewal uses 2003 base data.

	Unloaded Wage Rate:  Wages are estimated for labor types (management,
technical, and clerical) within applicable sectors. The Agency uses
average wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm" 
http://www.bls.gov/oes/current/oes_nat.htm .  

	Sectors: The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table.  Within each sector, the wage data are provided by
Standard Occupational Classification (SOC).  The SOC system is used by
Federal statistical agencies to classify workers into occupational
categories for the purpose of collecting, calculating, or disseminating
data (see   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm" 
http://www.bls.gov/oes/current/oes_stru.htm  ).  

	Loaded Wage Rate: Unless stated otherwise, all benefits represent 43%
of unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable; the applicable
percentage will be stated.

	Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.

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 estimated annual respondent burden for this
renewal ICR over the previous ICR.  The Agency expects to receive 500
section 18 applications annually over the next three years.  The Agency
believes that respondents will experience some measure of  burden
reduction 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.  During the consultation period for this
renewal, all three states, CO, MI, and NY noted that there was a cost
savings as a result of the stream lining process.  Although EPA expects
that this process change will result in some burden reduction, there is
insufficient information available to the Agency at this time to fully
assess the impact of these changes.    

		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
appears 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
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.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2007-0320 and
OMB Control No. 2070-0032, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

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:	7 U.S.C. 136p  - Section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act. Also available at online at the US House
of Representatives’  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+17
57+0++%28%29%20%20AND%20%28%287%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28136p%29%29%3ACITE%20%20%20%20%20%20%20%20%20" US Code
website 

Attachment B:	40 CFR Part 166 - Exemption of Federal and State Agencies
for Use of Pesticides under Emergency Conditions. Also available online
at the National Archives and Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=fa8e6a03533d54
0884422a4c93e3ff11&rgn=div5&view=text&node=40:23.0.1.1.16&idno=40"
Electronic CFR Website 

Attachment C:	21 U.S.C 346a - Tolerances and exemptions for pesticide
chemical residues, FFDCA section 408. Also available at online at the US
House of Representatives’  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t21t25+14
9+1++%28%29%20%20AND%20%28%2821%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28346a%29%29%3ACITE%20%20%20%20%20%20%20%20%20" US Code
website 

Attachment D:	40 CFR Part 176 - Time-Limited Tolerances for Pesticide
Emergency Exemptions. Also available online at the National Archives and
Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=fa8e6a03533d54
0884422a4c93e3ff11&rgn=div5&view=text&node=40:23.0.1.1.25&idno=40"
Electronic CFR Website 

Attachment E:	Consultant Contacts for Application and Summary Report for
an Emergency Exemption for Pesticides & Questions Asked EPA During
Consultations

Attachment F:	EPA Form No. 8570-4 - Confidential Statement of Formula.
Also available online at   HYPERLINK
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf 	 

Attachment G:	State Government and EPA Labor Wage Formulas

Attachment H:	Display Related to OMB Control #2070-0032 -Listings of
Related Regulations in 40 CFR 9.1

   

ATTACHMENT H

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 Title 	40 CFR citation

Exemption of Federal and State Agencies for 

Use of Pesticides Under Emergency Conditions	166.20

						     	166.32

						     	166.43

						     	166.50

Part B

Notice of Pesticide Registration by States to Meet a Special Local Need
(SLN) under FIFRA Section 24(c), OMB Number 2070-0055 and EPA NO.
0595.09

 

SUPPORTING STATEMENT FOR AN

INFORMATION COLLECTION REQUEST (ICR)

(EPA-HQ-OPP-2005-0086, 70 FRN 20538, April 20,2005)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

Notice of Pesticide Registration by States to Meet a Special Local Need
(SLN) under FIFRA Section 24(c)

OMB NO. 2070-0055 				EPA NO. 0595.09

1(b)	Short Characterization/Abstract

This data collection program is designed to provide the Environmental
Protection Agency (EPA, the Agency) with the necessary data to review
approval of State-issued pesticide registrations.  The Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), Section 24(c)
authorizes the States to register additional uses of federally
registered pesticides for distribution and use within the State to meet
a special local need (SLN) (Attachment A).  A State-issued registration
under FIFRA section 24(c) is deemed a federal registration for the
purposes of the pesticide's use within the State's boundaries.  A State
must notify EPA, in writing, of any action it takes, i.e., when it
issues, amends, or revokes a State registration.  The Agency has 90 days
to disapprove the registration.  In such cases, the State is responsible
for notifying the affected registrant.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The EPA requires this information to ensure that the States do not issue
any registrations that might conflict with other requirements in FIFRA,
or with section 408 of the Federal Food Drug, and Cosmetic Act (FFDCA)
which require that a tolerance exist for any pesticide used on a food or
feed commodity (Attachment B).  FIFRA section 24(c)(3) mandates that if
the Administrator determines that a registration issued by a State is
inconsistent with the FFDCA or if the use of a pesticide registered by
the State constitutes an imminent hazard, the Administrator may
disapprove the registration.

2(b)	Practical Utility/Users of the Data

	The potential respondents to this information collection activity are
the States, which FIFRA section 2(aa) defines to include Washington,
D.C., Puerto Rico, the U.S. Virgin Islands, Guam and the islands of the
Pacific Territory, and American Samoa.  The information "users" are the
Agency decision makers within the Office of Pesticide Programs (OPP) and
is used to ensure conformity with FIFRA and FFDCA.  The States are
required to collect from the manufacturer or grower groups adequate
information to support the section 24(c) application for registration or
amendment.  Both the State and the manufacturer or grower group are
required to keep records.

3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 	CRITERIA

3(a)	Non duplication

Not applicable.  This is the only information collection activity of its
kind and information collected in this data collection program is
collected only once per receipt of an application for a FIFRA section
24(c) registration.  Consequently, the possibility for duplication does
not exist.

3(b)	Public Notice Required Prior to ICR Submission to OMB

	In proposing to renew this ICR, EPA published a Federal Register Notice
on April 20, 2005 (70 FR 20538) and provided a 60-day public notice and
comment period.  The Agency received one public comment expressing
concern about the use of pesticides (Attachment C). Since the public
comment did not provide information related to the burden estimates, nor
did it address the series of questions posed in the Federal Register
Notice which accompanied the proposed ICR, no adjustments were made to
the ICR based on these comments.  

EPA also consulted with a stakeholder who actively interacts with the
Agency through the use of this collection instrument, their comments are
set forth below.

3(c)	Consultations

In addition to informal consultation between States and the EPA during
the submission and review of SLN registration applications, which occurs
on an ongoing basis, EPA consulted with one respondent and sought
comment on the proposed burden for this ICR renewal.  One commenter,
from Dupont Company, agreed with the burden hours in the supporting
statement.  No other comments were received.

Mr. Jack Cain

DuPont

  HYPERLINK "mailto:Jack.Cain@USA.dupont.com"  Jack.Cain@USA.dupont.com 

3(d)	Effects of Less Frequent Collection

Not applicable.  This activity is conducted only once per receipt of an
application for a FIFRA section 24(c) registration.  Consequently, there
is no way that the EPA can reduce the frequency of the collection.  

	3(e)	General Guidelines

The recordkeeping activities briefly described in this ICR exceed OMB('s
guideline that agencies not require that records be retained for more
than 3 years (5 CFR 1320.5(d)(2)(iv)).  As authorized under FIFRA
section 8, EPA regulations require that registrants retain records
containing research data relating to registered pesticides (including
all data submitted to EPA in support of a registration - see 40 CFR
169.2(k)) for as long as the registration is valid and the producer is
in business.  However, the burden related to the recordkeeping
requirements is 

covered under another ICR (see OMB Control No. 2070-0028, Recordkeeping
Requirements for Producers of Pesticides under Section 8 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)).

In addition, this ICR does not include any estimated burden or costs
related to the third party activities associated with pesticide product
labeling.  In 1995, OMB determined, in the context of OMB Control No.
2070-0060, Application for New and Amended Pesticide Registration, that
the Agency does not need to estimate burden or costs for the third party
disclosure requirement involving the registrant('s disclosure of product
specific information to potential users and the general public through
the pesticide labeling.  This activity is not considered to be a
collection of information subject to approval under the PRA because the
information that must be included as the product labeling has been
approved and provided by EPA. (5 CFR 1320.3(c)(2)).

3(f).  Confidentiality

The Agency estimates that fewer than 0.1% of the 24(c) registrations it
receives are for new products and would thus require submission of a
Confidential Statement of Formula, which contains Confidential Business
Information (CBI).  However, as many as 5% to 10% of 24(c) registrations
may include residue data, which also contains CBI, in support of an
unregistered use.  In addition, any data and/or information brought to
the Agency in conjunction the submission of 24(c) registrations may be
claimed as trade secret, commercial or financial information and must be
protected from disclosure by EPA under FIFRA section 10 and the
associated regulation as contained in 40 CFR Part 2, Subpart B.  All CBI
data submitted to the EPA under FIFRA is handled strictly in accordance
with the provisions of the FIFRA Confidential Business Information
Security Manual.

3(g)	Sensitive Questions

Not applicable.  No information of a sensitive or private nature is
requested in conjunction with this collection activity.  In addition,
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 Code

Section 2(aa) of FIFRA defines (State( s to include any of the 50
States, the District of Columbia, the Commonwealth of Puerto Rico, the
United States Virgin Islands, Guam, the Trust  Territory of the Pacific
Islands, and American Samoa.  The North American Industrial
Classification System (NAICS) code for the State government agencies
participating in this data collection is 9241.

1.

4(b)	Information Requested

    4(b)(i)	Information Requested by States to support SLN
registrations.

        4(b)(i)(A)	Application for a 24(c) registration.  

Applicants for State registrations under FIFRA section 24(c) to meet a
special local need (typically pesticides manufacturers and grower
groups) must submit the following information directly the State using
EPA Form 8570-25, Application for/Notification of State Registration of
a Pesticide to Meet a Special Local Need (Attachment D) and EPA Form
8570-4, Confidential Statement of Formula, (Attachment E) when
applicable:

   (1)	Name and address of the applicant and any other person whose name
will appear on the labeling or in the directions for use.

   (2)	The name of the pesticide product, and, if the application is for
an amendment to a federally registered product the EPA registration
number of that product,

   (3)	A copy of the proposed labeling, including all claims made for
the product as well as directions for its use to meet the special local
need, consisting of:

   (a) 	For a new product, a copy of the complete proposed labeling; or,

   (b)	For an additional use of a federally registered product, a copy
of proposed supplemental labeling and a copy of the labeling for the
federally registered product.

   (c)	If a State classifies for restricted use a product or use, which
is not required to be so classified under FIFRA, supplemental labeling
for the product or use containing additional appropriate precautions,
and a statement that the product or use is for restricted use within the
State may be required.

   (4)	The complete formula of the product, if the application is for a
new product registration.

   (5)	Any other information that is required to be reviewed prior to
registration. 

        4(b)(i)(B)	Information following the issuance of a 24(c)
registration.

A copy of the final printed labeling as soon as practical after a
registration is issued. New product labeling must contain:

   (1)	A statement identifying the State where registration is to be
valid.

   (2)	The special local need registration number assigned by the State.

   (3)	For an additional use of a federally registered product, the
State must require that at the time of sale, labeling from the federally
registered product be accompanied by supplemental labeling. 



        	4(b)(i)(C) 	Information Requested by EPA to verify an SLN
registration.

Within ten working days from the date a State issues, amends or revokes
a registration, the State is required to notify the EPA, in writing, of
the action.

   (1)	Using EPA Form 8570-25 where applicable, notification of State
registrations, or amendments thereto, shall include:

   (a)	Effective date of the registration or amendment, 

   (b)	Confidential statement of the formula of any new product, and 

   (c)	A copy of the draft labeling reviewed and approved by the State,
provided that labeling previously approved by the Administrator as part
of a federal registration need not be submitted.

   (2)	Notification of State registrations or amendments shall be
supplemented by the State sending to the EPA a copy of the final printed
labeling approved by the State within 60 days after the effective date
of the registration or amendment.

   (3)	Notification of revocation of a registration by a State shall
indicate the effective date of revocation, and shall state the reasons
for revocation.

   (4)	The Agency may request, when appropriate, that a State submit any
data used by the State to determine that unreasonable adverse effects
will not be caused.

    4(b)(ii) 	Respondent Activities

The following are the activities in which an applicant must engage in
order to obtain a State registration under FIFRA section 24(c).

Gather data	

Proposed label, product formulation (if applicable), name of applicant,
name of product, federal registration number (if applicable), and any
other information required by the State.

Submit materials to the State	

Compile necessary data and materials. Complete application for State
registration (EPA Form 8570-25) and submit to State

Store, file, and maintain the information	

Applicant must maintain records of information submitted to the State
for as long as the State registration is active.



A State must engage in the following activities in order to comply under
this data collection program:

Compile information	

Organize data submitted by registrant (or grower group) to develop the
SLN justification.  Registrant must maintain records of information
submitted to the State.

Review information	

Evaluate the data:

1. Determine whether there is a special local need for the registration;

2. Determine that use of the product for which registration is sought
will not cause unreasonable adverse effects on humans or the
environment;

3. For use of a product with public health claims, determine that the
product warrants the claims made, i.e., efficacy determination;

4. Review the proposed labeling submitted with the application to
determine State and federal compliance;

5. Issue or amend State registration.

Notify Federal Government	

Complete and submit EPA Form 8570-25 and all accompanying data and
materials.  Respond to any Agency questions or concerns.

Store, file, and maintain the data	

Maintain copies of the information and data submitted to EPA.

Respond to Registrant 

(if necessary)	

Notify registrant if Federal Government disapproves the State's
registration.

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

5(a)	Agency Activities

EPA must conduct the following activities under this data collection
activity:



Read and record State-submitted information	

EPA Form 8570-25 and the application is screened, jacket created, and
information is recorded in electronically for tracking purposes.

Review data submissions	

Review materials for adherence to federal requirements of label
integrity, lack of imminent risk, and the existence of appropriate
tolerances.

Publish summary of 24(c)s	

Publish, on a regular basis, in the Federal Register, a summary of all
State registrations received and those disapproved. 

Notify State (if necessary)	

Notify the State if the registration is disapproved.

Store/file/maintain the data	

Maintains an electronic reference file on all FIFRA section 24(c)
applications received and approved.

5(b)	Collection Methodology and Management

The section 24(c) application form and any supporting materials are
received and date-marked to start the 90-day clock.  They are screened
for completeness, a master file jacket is created for the incoming
application, and the case is assigned a unique identifier.  Identifying
information then is extracted for the required FR Notice of receipt, for
the Pesticide Product Information System (PPIS) inventory of all 24(c)
actions, and for tracking records.

The file then is reviewed for substantive acceptability, and any
scientific data is routed for review by appropriate specialists.  When
all reviews are completed a decision is made to accept or disapprove the
application.

If the decision is to disapprove the application, the State is notified,
and a notice of disapproval is published in the FR.  The disapproval is
recorded in the PPIS data base.  If the decision is to accept the
application, this is recorded in the master file, and no further action
is required.

5(c)	Small Entity Flexibility

Not applicable. As identified in section 4(a) of this supporting
statement, Section 24 of FIFRA applies directly only to the government
agencies of the 50 states, Washington D.C., and the territorial
governments of the United States; it does not apply to other entities. 
States are not small entities as defined under the Regulatory
Flexibility Act and the Unfunded Mandates Reform Act.  Small entity
flexibility does not exist under this information collection activity
because the respondent community does not consist of any small entities.
 While pesticide manufacturers and grower groups may be affected by
EPA-State activities under this ICR, any activities they undertake are
in response to FIFRA Section 24, which expressly delegates certain
pesticide registration authority to States.  These entities must comply
with State procedures to obtain a special local need registration under
FIFRA section 24(c).  Consequently, the Agency cannot offer them any
flexibility without intruding on State processes.

5(d)	Collection Schedule

Not applicable.  This activity is conducted only once per receipt of an
application for a FIFRA section 24(c) registration.  Consequently, there
is no set schedule for collection of this information.

6.	ESTIMATING BURDEN AND COST OF THE COLLECTION

6(a)	Estimating Respondent Burden

    6(a)(1)	Applicant Burden

As discussed in further detail under section 6(e) of this supporting
statement, the Agency estimates the average burden for applicants for
State registrations under FIFRA section 24(c) to equal approximately 39
hours per response.  This includes 14 hours of management labor, 19
hours of technical labor and 6 hours of clerical labor per response. 
The Agency expects that nearly 450 applications will be submitted
annually during the next 3 years and therefore estimates that the annual
applicant burden will equal 17.550 hours.

    6(a)(2)	State Agency Burden

As discussed in further detail in sections 3(c) and 6(e) of this
supporting statement, EPA estimates the State Agency burden to average
13 hours per response.  This includes an estimated 12.3 hours of
technical labor and 0.7 hours of clerical labor per State agency
response.  The Agency anticipates that nearly 450 SLN applications will
be submitted each year for an estimated annual burden of 5,850 hours. 
From that, EPA estimates that each State will receive, on average, 8 or
9 SLN applications per year.

    6(a)(3)	Overall Burden

The overall respondent burden associated with this collection is
estimated to be 23,4000 hours per year.  Respondents include both the
State governments and the companies filing for State registrations.  No
changes have been made in the requirements for Section 24(c)
applications, and no changes have been made to the provisions of this
information collection activity.

6(b)	Estimating Respondent Cost

 EPA has increased its estimated labor rates for applicants and State
government personnel factoring in an inflation cost index of 1.056 based
on the Gross Domestic Product Deflator inflation index.   These labor
rates are fully loaded and included benefits and overhead costs and
expressed in 2005 dollars.  For applicants, EPA estimates labor costs of
$135, $92 and $42 per hour for management, technical and clerical
burden, respectively.  For State agency personnel, EPA estimates labor
costs of $88, $66, and $34 per hour for management, technical and
clerical burden, respectively.  Using the Agency('s burden estimates and
the fully loaded labor rates, the Agency estimates the applicant costs
to be approximately $3,851.00 per response and State agency costs to be
approximately $835 per response for a total of $4,686 per response. The
overall annual cost associated with this information collection, based
on an estimate 450 responses per year, is estimated to be $2,108,700 -
error in document original document total should be $2,126,520).



RESPONDENT BURDEN/COST ESTIMATES PER 24(c) REGISTRATION

REGISTRANT	

HOURS, RATES	

TOTAL

Collection Activities

	

Mgmt.

$135/hr	

Tech.

$92/hr.

	

Cler.

$42hr.

	

Hours	

Costs

 ($)

Gather data	

5.00	

12.50 	

0.00	

17.50	

1825.

Submit materials to State	

9.00	

 5.50	

1.00	

15.50	

1763

Store/file/maintain the data 	

 0.00	

 1.00	

5.00	

  6.00	

302

TOTAL	

14.00	

19.00	

6.00	

39.00	

$3,890

STATE GOVERNMENT	

HOURS, RATES	

TOTAL

Collection Activities	

Mgmt.

$88/hr

	

Tech.

$66/hr.

	

Cler.

$34/hr.

	

Hours	

Costs

Compile information	

0.0	

1.0	

0.0	

1.0	

66.00

Review submission information	

0.0	

5.5	

0.0	

5.5	

363.00

Complete and transmit paperwork to EPA (including label revisions, SLN
registration cancellations, and other follow-up actions)	

0.0	

5.4	

0.4	

5.8	

370.00

Store/file/maintain the data 	

0.0	

0.0	

0.1	

0.1	

3.40

Respond to Registrant (if necessary)	

0.0	

0.4	

0.2	

0.6	

33.20

TOTAL	

0.0	

12.3	

0.7	

13	

$835.60

ANNUAL BURDEN: 52 Total Hours x 450 Applications = 23,400 hours

ANNUAL COSTS: $4,686 x 450 Applications = $2,126,520.00

6(c)	Estimating Agency Burden and Cost

The Agency technical employee burden associated with the 24(c)
registration program has been estimated from the Time Accounting
Information System (TAIS) and OPP's regulatory action resource tracking
systems, although neither management nor clerical burden is captured by
these systems.  The estimate for management burden is based on the
assumption that only a small portion of 24(c) registrations requires
management decisions, usually only those the technical staff recommends
for denial.  The hours associated with reviewing the data submissions
and publishing summaries have been revised to reflect that it is
actually the data review portion of the collection activity that takes
the most time.  The estimate for notifying the State is small because of
the small number of application denials.

The Agency cost associated with this program is estimated to be $424,035
per year.  The labor rates are based on Office of Personnel Management
salary tables for federal employees for the years 2000 through 2003 and
include benefits and overhead costs, as well as locality pay for the
Washington, DC-Baltimore area. 

ANNUAL AGENCY BURDEN/COST ESTIMATES PER 24(c) SUBMISSION

COLLECTION ACTIVITIES	

	HOURS, RATES	

	TOTAL

	

Mgmt.

$99/hr.	

Tech. 

$72/hr	

Cler.

$34/hr.	

Hours	

Costs

Read and  record State-submitted information	

0.0	

0.1	

0.1	

0.2	

10.50

Review data submissions	

0.6	

11.0  	

0.0	

11.6 	

 851.40

Publish summary of 24(c)s	

0.1	

0.5	

0.1	

0.7	

49.30

Store/file/maintain the data	

0.0	

0.0	

0.1	

0.1	

 3.40

Notify the State (if necessary)	

0.1	

0.2	

0.1	

0.4	

 27.70

TOTAL	

0.8	

11.8  	

0.4	

13.0  	

$942.30

ANNUAL AGENCY BURDEN:       13 Total Hours x 450 Applications = 5850 hrs

ANNUAL AGENCY COSTS:	$942.30 x 450 Applications= $424,035

6(d).  Bottom Line Hours And Costs

MASTER TABLE

	

	TOTAL

	

	Hours	

	Costs 

Respondents (applicants & states) 	

	23,400	

	$2,126,520   

Agency	

	  5,850	

	$424,035

6(e)	Reasons For Changes in Burden

The Agency has revised the estimated applicant burden upwards to reflect
the average number of petitions that have been received in the last
three years is 450 annually.  In the last renewal for this ICR the
annual petition rate was only 350 per year.  This trend, coupled with
updated 2005 labor figures accounts for the slightly higher burden and
cost figures for this ICR renewal.  No other burden changes have
occurred.  This proposal represents a burden increase of 5,200 (from
18,200 to 23,400) burden hours and $541,370 (from $1,585,130 to
2,126,520) in increased burden hour costs over the last ICR renewal. 

6(f)	Burden Statement

     The annual respondent burden for this ICR is estimated to average
52 hours per response (39 hours per applicant and 13 hours per State),
including time for compiling the information/data submitted by the
registrant, reviewing the information for special local needs
determination, completing paperwork to notify the federal government,
storing/filing/maintaining the data, and responding back to the
registrant if the registration is disapproved by EPA.  The burden
estimate includes hours spent by the registrant in preparing the
application for submission to EPA.

To comment on 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,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OPP-2005-0086, which is available for public viewing at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 South Bell Street, Arlington, VA.  The Docket
Public Reading Room is open from 8:30 a.m. to 4:00 p.m., Monday through
Friday, excluding legal holidays.  The telephone number for the Docket
is (703) 305-5805.  An electronic version of the public docket is
available through the Federal eRegulations Portal at
www.regulations.gov.  Use www.regulations.gov to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically.  Once in the system, select Environmental Protection
Agency” in the “Agency” drop-down menu and then key in the Docket
ID number identified above.  Also, you can send comments to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for
EPA.  Please include Docket ID No. EPA-HQ-OPP-2005-0086 and OMB Control
No. 2070-0055 in any correspondence. 

ATTACHMENTS TO THE SUPPORTING STATEMENT

*NOTE: Each of the attachments to this supporting statement are
available electronically only through the Federal eRegulations Portal
(www.regulations.gov), under the docket identification number
EPA-HQ-OPP-2005-0086except for Attachment F (which is included with the
electronic file for this supporting statement)..   You can easily access
the attachments electronically www.regulations.gov.  Once in the system,
select Environmental Protection Agency” in the “Agency” drop-down
menu and then key in the docket ID number identified above.  Then,
search the docket index for these documents by the titles provided in
this list of attachments.  If you have any difficulties, please contact
the technical person listed in the Federal Register notice announcing
the submission of this ICR to OMB for review and approval.

ATTACHMENT A:	FIFRA Section 24(c) (7 U.S.C. 136v)

ATTACHMENT B:	FFDCA Section 408 (21 U.S.C. 346a) 

ATTACHMENT C:	Public Comment – Comment submitted in response to
Federal Register notice published on April 20, 2005 (70 FR 20538).

ATTACHMENT D:	EPA Form 8570-25 - Application for/Notification of State
Registration of a Pesticide to Meet a Special Local Need

ATTACHMENT E:	EPA Form 8570-4 - Confidential Statement of Formula

ATTACHMENT F:	Display Related to OMB Control #2070-0055 - Listings of
Related Regulations in 40 CFR 9.1 - An electronic copy of this
attachment follows in the electronic file for this ICR.

ATTACHMENT G:	40 CFR 162, Subpart D - STATE REGISTRATION OF PESTICIDE
PRODUCTS: Regulations Pertaining to State Registration of Pesticides To
Meet Special Local Needs

          

	

OMB CONTROL NO. 2070-0055

ATTACHMENT F

Display Related to OMB Control #2070-0055 - 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 Title 	40 CFR citation

Good Laboratory Practice Standards	160

State Registration of Pesticide Products	162.153

      The NASA inflation calculator for adjusting costs form one year to
the another was based on using the Gross Domestic Product (GDP) Deflator
inflation index.  This calculator is based on the inflation rate during
the US Government Fiscal Year, which begins on October 1 and ends on
September 30.  This inflation calculator will compute inflation from
1940 to 2009.  

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