Document ID: EPA-HQ-OPP-2007-0923-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-09-24T04:00Z

SUPPORTING STATEMENT FOR AN 

INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a).	Title of the Information Collection  

Pesticide Data Call-In Program 

OMB Nos.:  2070-new 

 		

EPA Nos.:  2288.01

1(b).	Short Characterization/Abstract 

This is a proposal to consolidate and renew several currently approved
information collection requests (ICR).  The Environmental Protection
Agency’s (EPA), Office of Pesticide Programs (OPP) is proposing
consolidation into one document the ICRs for Data Call-Ins for the
Special Review and Registration Review Programs OMB Control No.:
2070-0057; EPA ICR No. 0922.07; the Data Generation for Pesticide
Reregistration OMB #.:2070-0107 EPA #.:1504.05 and the Data Acquisition
for Anticipated Residue and Percent of Crop Treated OMB No.:2070-0164;
EPA No.: 1911.02 ICRs.  These ICRs are currently due to expire on the
same day, June 30, 2008. 

Collectively, these ICRs enable the EPA to acquire the necessary data to
assess whether the continued registration of an existing pesticide
causes an unreasonable adverse effect on human health or the
environment.  For the four programs represented by these collections,
the Agency issues a Data Call-in (DCI) to collect the required
information to support the statutorily mandated pesticide reviews. These
ICRs are being consolidated because the programs they represent share
similar respondent populations, and the methodology the Agency uses to
calculate the Paperwork Reduction Act (PRA) burden hours and costs are
the same. The Agency is consolidating the ICRs into one document to
increase the clarity of review for the public, to streamline Agency
review and to meet the terms of clearance for renewal as required by
OMB.  The proposed consolidated ICR document will be titled the
“Pesticide Data Call-in Program.”  

2.	NEED FOR AND USE OF THE COLLECTION

2(a).  Need/Authority for the Collection

EPA's Office of Pesticide Programs (OPP), under the Assistant
Administrator for Prevention, Pesticides and Toxic Substances, uses the
information collected under this ICR to obtain the data needed by OPP
scientists to assess and characterize pesticide risks, and to determine
whether the pesticide continues to meet the standards established by
law.  Before the Agency determines that specific data are needed, the
Agency will first search for available information (i.e., EPA databases
for information that may have been submitted to EPA under another ICR,
voluntarily, or submitted by another respondent; information that has
otherwise published in the literature; or information that is otherwise
publicly available).  Only if the needed data is not found will EPA
require the submission or generation of the specific data needed.  Such
data may include toxicology studies, fish and wildlife studies,
environmental fate studies, chemistry studies and/or other data needed
to analyze the potential risks and benefits associated with pesticide
chemicals.

Sections §3(a) and §12(a)(1) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) require a person to register a pesticide product
with the EPA before the pesticide product may be lawfully sold or
distributed in the United States.  A pesticide registration is a license
that allows a pesticide product to be sold and distributed for specific
uses under specified terms and conditions such as use instructions and
precautions.  The proponent of initial or continued registration always
bears the burden of demonstrating that a pesticide product meets the
statutory standard for registration.  A pesticide product may be
registered or remain registered only if it meets the statutory standard
for registration given in section §3(c) (5) of FIFRA, which is as
follows:

Its composition is such as to warrant the proposed claims for it.

Its labeling and other material required to be submitted comply with the
	requirements of this Act.

It will perform its intended function without unreasonable adverse
effects on the 	environment.

When used in accordance with widespread and commonly recognized practice
it 	will not generally cause unreasonable adverse effects on the
environment.

FIFRA §2(bb) defines “unreasonable adverse effects on the
environment'' as (1) “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, or (2) a human dietary risk from
residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the Federal Food
Drug and Cosmetic Act.''

	The programs and DCI activities represented in this proposed renewal
and consolidation share a common statutory authority, Section 3(c) (2)
(B) of FIFRA, which authorizes EPA to require pesticide registrants to
generate and submit data to the Agency, when such data are needed to
maintain an existing registration of a pesticide. EPA’s determination
that additional data are needed can occur for various reasons, with the
following four reasons being the most common:  

The Re-registration Program: Section 4 of FIFRA requires EPA to
re-assess the health and safety data for all pesticide active
ingredients registered before November 1, 1984, to determine whether
these “older” pesticides meet the criteria for registration that
would be expected of a pesticide being registered today for the first
time. Section 4 directs EPA to use Section 3(c) (2) (B) authority to
obtain the required data. While, Reregistration Eligibility Decisions
are expected to be completed by 2006 for food-use pesticide ingredients
and 2008 for non-food use pesticide ingredients, the Agency may still
need to issue DCIs after FY 2008 to close out the program. (Attachment
A) 

   

The Registration Review Program: Section 3(g) of FIFRA contains
provisions to help achieve the goal of reviewing each pesticide every 15
years to assure that the pesticide continues to pose no risk of
unreasonable adverse effects on human health or the environment. 
Section 3(g) instructs EPA to use the section 3(c)(2)(B) authority to
obtain the required data. (Attachments B and C)   

The Special Review Program: Though rare, EPA may conduct a Special
Review if EPA believes that a pesticide poses risks of unreasonable
adverse effects on human health or the environment.  Section 3(c) (2)
(B) of FIFRA provides a means of obtaining any needed data. (Attachment
B)   

Anticipated Residue/Percent Crop Treated Information: Under section 408
of the Federal Food, Drug and Cosmetic Act (FFDCA), before a pesticide
may be used on food or feed crops, the Agency must establish a tolerance
for the pesticide residues on that crop or established an exemption from
the requirement to have a tolerance.  Section 408(b)(2)(E) and (F) of
FFDCA authorize the use of anticipated or actual residue (ARs) data and
percent crop treated (PCT) data to establish, modify, maintain, or
revoke a tolerance for a pesticide. (Attachment D)  The FFDCA requires
that if AR data are used, data must be reviewed five years after a
tolerance is initially established.  If PCT data are used, the FFDCA
affords EPA the discretion to obtain additional data if any or all of
several conditions, including but not limited to the following, are met:

the existing data have been found unreliable; 

exposure estimates underestimate exposures for any significant
population group; and 

dietary exposure must be re-evaluated periodically.

Enforcement and Unanticipated Incidents:  In extremely rare instances, a
need for a data call-in may arise from changes in the discovery of
deficiencies in previously submitted data, or from the discovery of
specific attributes of the pesticide or its ingredients.  This may give
rise to concerns such as observed or suspected adverse human health or
environmental effects attributed to the use of a pesticide.  Or such
data is needed in support of Agency enforcement cases resulting from
consumer complaints about the product, its storage stability, the
integrity of its container, or exaggerated advertising claims.  This
type of DCI is needed because the concern and therefore the need for
data arise not from a mandated review program like the programs
described above, but from unanticipated circumstances.  Section 3(c) (2)
(B) of FIFRA provides a means of obtaining any needed data.  

	In order to conduct the required re-evaluation, a Pesticide Registrant
may be required to submit specific data necessary to demonstrate that
residues do not exceed the residue levels used to establish the
tolerance. Under the authority of section 3(c) (2) (B) of FIFRA, the
Agency will issue a DCI to obtain any additional data. 

2(b).  Practical Utility/Users of the Data   

EPA uses the information collected to carry out its statutory
responsibilities under sections section 4 of FIFRA,  section 3(g) of
FIFRA, section 6 (b) of FIFRA, and section 408 of FFDCA.  The data
collected allows EPA to assess whether the continued registration of an
existing pesticide causes an unreasonable adverse effect on human health
or the environment.  

The Agency issues DCIs as part of one or more statutorily mandated
review processes and has determined that more information is needed. 
Agency decisions requiring additional data are usually “triggered”
by the data requirements set forth in 40 CFR parts 150 through 180, with
the majority of the data requirements regarding studies captured in 40
CFR part 158.  

The Agency uses data requirements to ensure that the statutory standards
are met.  Some of these standards include, but are not limited to,
determining if a pesticide can remain registered because it does not
causes an unreasonable adverse effect on human health or the
environment, section §3(c) (5) and section 2(bb) of FIFRA, the safety
standard of section 408 of FFDCA, as amended, directs the Agency to
consider aggregate exposures from dietary and other non-occupational
sources when assessing the risks of a pesticide.  In addition to dietary
exposure, such sources as drinking water and residential use must be
considered.  Thus, EPA must make the statutory determination that
pesticide residues in food or feed will result in a reasonable certainty
of no harm to human health from aggregate exposure through dietary,
non-occupational, and drinking water routes of exposure.  FQPA also
directs EPA to consider the cumulative effects of pesticides that share
a “common mechanism of toxicity,” consider special sensitivities of
infants and children, and consider possible endocrine disruptor effects.
 EPA must also evaluate the data obtained from registrants to ensure
that residues in or on food are not above the residue levels relied on
for establishing the tolerance.  If the submitted residue data
demonstrates that the residue levels are above the levels relied on for
establishing the tolerance, EPA will take appropriate action to modify
or revoke the tolerance.

2(b)(1) Types of DCIs:  

 The data that EPA collects and reviews fall into three general
categories:  confirmatory data, voluntary data, and product-specific
data. 

Confirmatory Data.  In making a regulatory decision, additional generic
studies sometimes are required to confirm the Agency’s risk
assessments, findings, or conclusions about a pesticide, and to help
determine whether further use modifications will be necessary to reduce
risks of concern.  

Voluntary Data.  While EPA has always received voluntarily submitted
data, the advent of FQPA enactment on August 3, 1996, required EPA to
specifically consider a number of new factors when making pesticide
reregistration and other types of regulatory decisions.  On January 31,
1997, EPA issued Pesticide Registration (PR) Notice 97-1 identifying
areas in which the Agency may need additional data to fully assess risks
under FQPA.  The notice encouraged registrants to supplement their
original reregistration submissions with additional information that may
permit more accurate estimates of exposure and/or risk.  As a result of
PR Notice 97-1, EPA received large numbers of voluntarily submitted
studies for pesticides in reregistration, particularly for large volume,
controversial chemicals.  While the reregistration program is near
completion, the Agency still anticipates receiving a small number of
voluntarily submitted studies from registrants to fulfill other
statutory requirements.  

	Product-Specific Data.  After the existing data supporting a pesticide
are evaluated and a regulatory determination is made, EPA’s focus
turns to the information and data required to make regulatory decisions
at the product-specific level.  For every end-use product (that is,
every product that contains an active ingredient), certain data specific
to the product as formulated and sold (including acute toxicity and
product chemistry studies), revised labeling, and in certain instances,
the Agency requires the submission of a Confidential Statement of
Formula.  For example: Registrants are required to submit a Confidential
Statement of Formula (EPA Form 8570-4) to comply with
registration-related requirements under FIFRA section 3, such as when a
registrant seeks to add uses for a currently-registered pesticide, or
when the registrant changes a registered pesticide’s formulation.  The
requirement is mentioned here since registrants have not always
submitted the required information immediately to EPA and the deficiency
may remain at the time of the regulatory review.  The paperwork burden
for the submission of Form 8570-4 is covered under OMB Control No.
2070-0060 (Application for New/Amended Pesticide Registration; EPA ICR.
No. 0277.  Additional information and data are essential to making the
final regulatory decision regarding the particulars of a specific
product.   

3(a).  Non duplication

The information collected under these programs is specific to the needs
of the federal pesticide law negating the need for similar data by other
federal agencies or any other office within EPA.  Prior to requesting
any information the Agency must review existing records for the
availability of the information that it is considering requesting.  The
Agency maintains files on all pesticide chemicals, which includes all
correspondence and information/data submitted. Before any DCI is issued,
these files are referenced to determine whether the necessary data are
already on hand, thereby eliminating duplicative data requests.  For
example: At this time, a majority of the percent-crop-treated
information can be obtained internally, thus DCIs will only be issued
when more data is necessary.  The data for anticipated residues, on the
other hand, is unique to the requirements of FIFRA, and, therefore, must
be submitted to the Agency.   EPA also provides for public comment
periods for all the review programs which may modify the DCI
requirements if warranted by information provided by registrants or the
public.  

 

OPP publishes a list of data submitters and encourages the registrants
to act cooperatively in the development of data or in its use.  OPP
encourages cost-sharing agreements among manufacturers of specific
pesticide chemicals in order to minimize the duplication of laboratory
tests and reduce the costs for developing the data. All DCI notices
explain the statutory provisions for cost-sharing agreements under
FIFRA.

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

Pursuant to 5 CFR 1320.8(d), EPA is publishinged a Federal Register (FR)
notice (See 73 FR 2907; January 16, 2008) notice soliciting comment on
this information collection activity and the Agency’s intent to renew,
consolidate and request OMB approval of this ICR.  The Agency received
only one public comment on this consolidated renewal ICR from William M.
Mahlburg, Director Government Affairs, Nufarm Americas, Inc.  Mr.
Mahlburg suggested that the Agency re-evaluate the timing set for
registrant response to DCIs to provide more time for registrants to
respond because technical registrants for numerous active ingredients
will be affected by multiple DCIs that are simultaneous or overlapping. 
Mr. Mahlburg stated that due to a multitude of end-use product
registrations that Nufarm submits large volumes of studies termed “low
burden” and that companies with more than 25 end-use product
registrations with the same active ingredient were constrained by the
Agency’s set DCI response time line and needed additional DCI response
time to help eliminate the response process burdens associated with high
volume registration companies.  

The Agency does not expect that a given technical registrant will
typically receive simultaneous DCIs for multiple active ingredients. 
However, in situations where a large number of studies are required, the
Agency has responded to requests for time extensions by staggering when
responses are due.  In its comment, Nufarm did not submit any new burden
data for the Agency to consider.  Therefore, there are no new data for
the Agency to evaluate.    In addition, submissions to the Agency from
1996-2004 of voluntary data not required by the Agency but which are
submitted by registrants to supplement an active ingredient database
show that most are considered by the Agency to be “low burden.”  At
this time, the Agency does not anticipate changing the low burden hour
study projections documented in this ICR.  Overall, in developing
paperwork burden estimates, EPA assumed that responses (including ones
to end-use product-specific data) from registrants would not include the
following:  data already generated at registration, submitted under a
previous DCI, resubmissions because the original data were not complete
or did not meet submission requirements, or preexisting data that can be
found in published, peer reviewed literature.  Since the commenter did
not offer any new burden numbers for the Agency to consider, the Agency
did not change the burden numbers in the final document.     

The FR notice and the proposed renewal ICR as well as the any public
comment received are located in the docket for this action, which can be
accessed at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2007-0923 

3(c).  Consultations

Consultation and/or dialogue between registrants and the Agency
concerning data requirements, need for particular information and the
protocol to be used to conduct the study are frequent and ongoing.    

	Generally, all programs discussed in this DCI Program ICR are
intrinsically woven with the Agency's public participation review
process. This integrated public participation framework provides
consistent, predictable opportunities for public and stakeholder
involvement through public comment periods at regular intervals to help
inform EPA’s regulatory decision making.  EPA’s formalized public
participation process (See 69 FR 26819, May 14, 2004; also   HYPERLINK
"http://www.epa.gov/oppsrrd1/public.htm" 
http://www.epa.gov/oppsrrd1/public.htm ) recognizes that all pesticides
do not present the same degree of risk or complexity of issues, the
Agency has included options for conducting a full six-phase process, a
modified four-phase process, or a streamlined low-risk process, as
appropriate. These options give EPA the flexibility to tailor its public
participation process to the uses and risks of each pesticide and to
obtain public input as needed while still making timely decisions and
meeting statutory deadlines and program goals.  If appropriate to
resolve scientific questions, the Agency may also seek peer review
and/or advice from the FIFRA Science Advisory Panel SAP.  The FIFRA SAP
is a Federal advisory committee established in 1975 under FIFRA that
operates in accordance with requirements of the Federal Advisory
Committee Act. The FIFRA SAP is composed of a permanent panel consisting
of seven members who are appointed by the EPA Administrator from
nominees provided by the National Institutes of Health and the National
Science Foundation.  FIFRA, as amended by the FQPA of 1996, established
a Science Review Board consisting of at least 60 scientists who are
available to the FIFRA SAP on an ad hoc basis to assist in reviews
conducted by the Panel.

	Until the DCI is issued, the registrant is not required to submit the
data.  Many manufacturers wait to generate and/or submit new or existing
data until EPA issues the DCI primarily because EPA’s issuance of a
DCI also triggers the data compensation provisions of section 3(g) (1)
(B) of FIFRA and the DCI provides tangible documentation of data
compensation rights.

EPA will consulted with  with aa variety of regispondents strants
regarding the information collection activities in for this ICR during
during the renewal and consolidation process.  A list of the respondents
contacted is below: 

Ray McAlister, Vice President

Science and Regulatory Affairs

CropLife America

  HYPERLINK "mailto:ray@croplife.us_"  ray@croplife.us 

Susan Little, Executive Director

Consumer Specialty Products Association

900 17th Street N. W..

Washington, DC  20005

  HYPERLINK "mailto:slittle@cspa.org"  slittle@cspa.org 

Daniel Botts, Director

FFDA's Environmental & 

Pest Management Division

Minor Crop Farmer Alliance 

Technical Committee (Chairman)

Florida Fruit & Vegetable Assoc.

  HYPERLINK "mailto:daniel.botts@ffva.com"  daniel.botts@ffva.com 

Rebeckah Freeman Adcock,

Director, Congressional Relations

American Farm Bureau

600 Maryland, Ave., S.W.

Suite 1000W

Washington, DC  20024

rebeckah@fb.org

The consolidation questions and any responses received are included in
the docket as attachments E-1 through E-4 for this action.  Generally,
the questions and Ddiscussions with respondents will included whether
the labor rate estimates in the ICR are accurate and whether the
estimates of burden and methodology for arriving at the estimate are
correct, and whether respondents would consider submitting the
information electronically, such as through web forms and whether the
consolidation document was easy to read.   To date, one respondent,
Rebeckah F. Adcock, American Farm Bureau Federation noted that the
document was clearly written and concisely laid out.  The Agency has not
received any comments regarding the burden.   Any public comment
received will be located in the docket for this action, which can be
accessed at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2007-0923 

3(d).	Effects of Less Frequent Collection 

    

Information is collected under this ICR only when the Agency has
identified a need for the specific data, and only on a one-time basis. 
AR or PCT information is collected one time within the five years
preceding the reliance on such data.  The AR or PCT information
collection is required by sections 408(b)(2)(E)(I) and 408(b)(2)(F) of
the FFDCA and cannot be collected less frequently.

3(e).	General Guidelines

The only guideline established under the Paperwork Reduction Act (PRA)
that is exceeded in this collection is the time period for retaining
records.  Pursuant to FIFRA §8, EPA recordkeeping requirements in 40
CFR 169.2(k) state that records containing research data relating to
registered pesticides be retained as long as the registration is valid
and the producer remains in business.  Registrations are valid until
they are either voluntarily canceled or withdrawn by the registrant or
until EPA has cause to suspend or cancel the registration.  Since the
average period of marketability of a pesticide ranges from 15 to 30
years, the PRA guidelines specifying that data other than health,
medical or tax records not be required to be retained for more than
three years will be exceeded in this collection activity.

	3(e)(1). Forms

The forms associated with this ICR may also be used for other
information collection activities that are approved under separate OMB
Control numbers, e.g., and 2070-0060.  Specifically:

Confidential Statement of Formula, (EPA Form 8570-4)

Formulator's Exemption Statement, (EPA Form 8570-27)

 

Certification of Compliance with Data Gap Procedures, (EPA Form 8570-28)
  

Certification of Attempt to Enter into an Agreement with Registrants for
Development of Data (EPA Form 8570-32) 

Certification with Respect to Citation of Data (in Pesticide
Registration (PR) Notice 98-5) (EPA Form 8570-34) 

Data Matrix (also in PR Notice 98-5) (EPA Form 8570-35)

Summary of the Physical/Chemical Properties (EPA Form 8570-36) 

Self-Certification Statement for the Physical/Chemical Properties (EPA
Form 8570-37) 

The Data Call-In Response Form and the Requirements Status and
Registrant’s Response Form have been approved with the DCI related
ICRs by OMB for several years, although no official EPA Form number had
been assigned in the past.  These two forms are automatically generated
by EPA’s computer databases and are pre-populated with information
that is specific to each individual registrant that receives a Data
Call-In notice for a given pesticide.  These forms are not widely
accessible to general public.  Instead, EPA will continue to generate
the pre-populated, registrant-specific forms through the Agency’s
computer system when preparing to issue Data Call-In notices. 

In the past, under the separate renewals for these ICRs and in
accordance with 5 CFR 1320.5(a)(1)(iii)(C), EPA discontinued the display
of expiration dates on these forms  because the forms had not changed
after many years of use and were not expected to change in the future. 
The OMB approved prior ICR requests, and EPA will continue to omit the
expiration dates on these forms.  See Attachment F for accessibility to
forms.  

	3(e)(2). DCI Justification Process

When OMB last approved these ICRs in 2005, OMB mandated in the terms of
clearance that EPA only issue DCIs that have prior approval by OMB. 
Thus, in a separate DCI approval request, EPA must provide OMB with
detailed information regarding the specifics about the DCI including,
all of the studies to be required for a particular chemical, need for
the data, total study costs, number of respondents impacted, PRA burden
hour and cost estimates, and impacts on small business.

3(f).	Confidentiality

Except as provided in FIFRA section 10(d)(1)(A), (B) or (C), health and
safety data submitted by registrants under FIFRA must be made available
by the Agency upon request from anyone not affiliated with a
multi-national pesticide firm. These exceptions, however, specifically
prohibit disclosure of the inert ingredients in a pesticide or of its
manufacturing, quality control processes, sales and production data, or
trade secrets. 

Registrants may claim at the time of submission that specific data are
subject to treatment as confidential for reasons other than falling
within the exclusions for mandatory release. All data subject to such
claims, or falling within FIFRA section 10(d)(1)(A), (B), or (C) are
handled strictly in accordance with the provisions of the FIFRA
Confidential Business Information Security Manual. The manual requires
that all CBI must be marked or flagged as such, all CBI must be kept in
secure (double-locked) areas, and all CBI intended to be destroyed must
be cleared by a Document Control Officer and shredded.

3(g).	Sensitive questions

No information of a sensitive or private nature is requested in
conjunction with this information collection activity, and 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 to the information collection activities related to this ICR
consist of pesticide Registrants identified by the North American
Industrial Classification System (NAICS) code 325320 (Pesticide and
Other Agricultural Chemical Manufacturing). 

4(b).  Information Requested

      (i)  Data Items, Including Record Keeping Requirements

Considering the potential variation in the specific need identified for
the individual pesticide under review, the specific data items that may
be collected for the individual pesticides under this ICR are also
likely to vary from pesticide to pesticide.  However, based on the
specific need identified for the pesticide, the Agency may request, or
the registrant may voluntarily submit several types of data, including,
but not limited to: 

Product Chemistry

Residue Chemistry

Environmental Fate

Toxicology

Reentry Protection

Spray Drift

Wildlife and Aquatic Organisms

Plant Protection

Nontarget Insect

Product Performance

		Biochemical Pesticides

Microbial Pesticides

	Exposure Studies

	Dermal Absorption/Penetration Studies

	Acute and Subchronic Neurotoxicity Studies

	Cholinesterase Determination

	Biomonitoring Studies (in Children)

	Monte Carlo Probabilistic Assessments/Acute and Chronic Dietary
Exposure 			Analyses

	Historical Water Monitoring Data 

	Field Monitoring Studies and Evaluations

	Runoff and Drift Monitoring Studies

	Pesticide Removal Studies using Vegetative Filter Strips

	Retrospective Analyses of Surface Water Contamination

	Analyses of Use Patterns

	Research Studies of Applications and Use in Professional Markets

	Comparative Formulations/Application Methods/Resulting Crop Residue
Studies

	Mechanistic Studies for Carcinogenicity 

	Studies on Potential to React with DNA

	Monitoring data (States, special monitoring, market basket, single
serving, etc.)

	Field trials, 

	Processing studies,  

	Reduction in residue data (washing, peeling, cooking, etc.), 

	Livestock feeding studies  

	Metabolism studies

	Percent crop treated data

These categories, which are defined in greater detail in 40 CFR Part
158, basically consist of the criteria for information and/or data that
are necessary to make a regulatory finding.  (See guidelines and
policies to assist registrants with responding to DCIs; see science
policy at   HYPERLINK
"http://www.epa.gov/pesticides/science/policies.htm" 
http://www.epa.gov/pesticides/science/policies.htm  and test guidelines
at   HYPERLINK "http://www.epa.gov/opptsfrs/home/guidelin.htm" 
http://www.epa.gov/opptsfrs/home/guidelin.htm .)   In addition to the
categories identified above, the Agency may also require that a special
study be conducted to provide critical information about the risks and
benefits of the pesticide in support of continued registration.  Agency
requests for special studies would be based on the particular
characteristics of the chemical, and the Agency’s need for such
information to make the required statutory finding. 

(ii) Respondent Activities

A pesticide registrant who receives a DCI will generally engage in the
following activities under this ICR. 

read instructions	

read the DCI letter to understand what data are to be submitted

plan activities	

plan the activities necessary to comply with the DCI, or develop options
to avoid having to submit data (e.g., exemption/waiver), submit 90-day
response to EPA 

create information	

conduct research, administer tests, analyze data to develop studies,
perform laboratory analysis, write study documents 

gather information	

search for existing data that will satisfy the DCI

compile and review	

assemble and evaluate data for accuracy and appropriateness for
compliance with the DCI

complete paperwork	

prepare necessary correspondence, documents and packages for submitting
data to EPA

maintain and file	

maintain the data and other information submitted to the Agency 

Registrants who receive a DCI notice from EPA must notify the Agency how
they intend to comply with the terms of the DCI notice within 90 days of
receipt of the notice.  Registrant options for complying with the DCI
notice vary greatly and thus the per respondent burden can also vary
greatly.  A summary of the registrant compliance options are listed
below:

	(iii) Reducing the PRA Burden: Variation of Response to A DCI

 

Voluntary Cancellation - Registrants opting to voluntarily cancel their
products containing the active ingredient that is subject to the DCI
must submit a completed Data Call-In Response Form.  If a product is
voluntarily cancelled, further sale and distribution of that product
after the effective date of cancellation must be in accordance with the
existing stocks provision of the individual DCI notice.

Deletion of Uses - Registrants choosing to amend their registration to
delete the uses of their product to which the requirements apply must
submit the Requirements Status and Registrant's Response Form, a
completed application for amendment, a copy of their proposed amended
labeling, and all other information required for processing the
application.  They must also complete a Data Call-In Response Form.  If
registrants choose to delete the use(s) subject to the DCI notice or
uses subject to specific data requirements, further sale, distribution,
or use of their product after one year from the due date of their 90-day
response must bear an amended label.

Generic Data Exemption - Registrants are entitled to apply for a generic
data exemption from the requirement to submit or cite generic data
concerning an active ingredient if the active ingredient in the product
is derived exclusively from purchased, registered pesticide products
containing the active ingredient.  To qualify for a generic data
exemption, a product must meet all of the following requirements:

a. The active ingredient(s) in the registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and be purchased from a source
not connected with the registrant; and,

b. Every registrant who is the ultimate source of the active
ingredient(s) in the product subject to the DCI notice must be in
compliance with the requirements of the notice and must remain in
compliance; and

c. The registrant of the product that is the subject of the DCI notice
must have provided to EPA an accurate and current "Confidential
Statement of Formula" for each of the products to which the Notice
applies.  

Registrants applying for the Generic Data Exemption complete and submit
a Data Call-In Response Form along with all supporting documentation. If
a generic data exemption is claimed, the registrant is not required to
complete the Requirements Status and Registrant's Response Form. Generic
data exemption cannot be selected as an option for product specific
data.

	Registrants who are granted a Generic Data Exemption rely on the
efforts of other persons to provide the Agency with the required data. 
If the registrant(s) who have committed to generate and submit the
required data fail to take appropriate steps to meet the requirements,
the Agency will consider that both the submitting and exempted
registrants are not in compliance and will normally initiate proceedings
to suspend the registrations of both registrants’ products unless the
registrant who was granted the generic data exemption commits to submit
and does submit the required data within the specified time.  In such
cases the Agency generally will not grant a time extension for
submitting the data.

Submission of Required Data - Registrants choosing this option must
agree to either:  submit the data required by the notice within the
specified time frame; enter into an agreement with one or more other
registrants to develop data jointly; make offers to cost-share; submit
an existing study that has not been submitted previously to the Agency
by anyone; submit or cite data to upgrade a study classified by EPA as
partially acceptable and upgradeable; or cite an existing study that EPA
has classified as acceptable or an existing study that has been
submitted but not reviewed by the Agency.

Submission of Data Waiver Request - A registrant may request either a
low volume/minor use waiver or a waiver based on the registrant’s
belief that the data requirement(s) do not apply to their product.  In
addition to the Requirements Status and Registrant's Response Form,
registrants requesting low volume/minor use waivers must submit the
following information:

a.  Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the
active ingredient(s), include foreign sales for those products that are
not registered in this country but are applied to sugar (cane or beet),
coffee, bananas, cocoa, and other such crops, by year for each of the
past five years.

b.  An estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site, by year for each of the past five
years.

c.  Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years, including information on
raw material cost, direct labor cost, advertising, sales and marketing,
and any other significant costs, listed separately.

d.  Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that
were directly related to the active ingredient(s), such as costs of
initial registration and any data development.

e.  A list of each data requirement for which the registrant is
requesting a waiver.

f.  The type of waiver sought and the estimated cost to the registrant
(listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data
requirements.

g.  A list of each data requirement for which the registrant is not
seeking any waiver and the estimated cost (listed separately for each
data requirement and associated test) of conducting the testing needed
to fulfill each of these data requirements.

h.  For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct
production costs of product(s) containing the active ingredient(s)
(following the parameters in item c above), indirect production costs of
product(s) containing the active ingredient(s) (following the parameters
in item d above), and costs of data development pertaining to the active
ingredient(s).   In addition, the registrant must provide a description
of the importance and unique benefits of the active ingredient(s) to
users and discuss the use patterns and the effectiveness of the active
ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies.  Registrants should provide information
on any of the following factors in order to assist EPA in making a
determination about the importance of an Active ingredient's benefits:

documentation of the usefulness of the active ingredient(s) in
Integrated Pest Management;

description of the beneficial impacts on the environment of use of the
active ingredient(s), as opposed to its registered alternatives;

information on the breakdown of the active ingredient(s) after use and
on its persistence in the environment, and description of the
product’s usefulness against pest(s) of public health significance.

Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume minor use waiver will
result in denial of the request for a waiver.

	Request for Waiver of Data - A registrant may also request a waiver if
they believe that a particular data requirement should not apply because
the corresponding use is no longer registered or the requirement is
inappropriate.  In addition to the Requirements Status and Registrant's
Response Form, registrants requesting a waiver of data requirements must
submit a rationale explaining why the registrant believes the data
requirements should not apply, as well as copies of current product
labels and a current copy of the Confidential Statement of Formula for
each product.  If the Agency determines that a registrant does not
qualify for a waiver and that the data are required for the product(s),
the registrant must choose a method of meeting the requirements of the
notice within the 90-day time frame provided by the notice. Within 30
days of the registrant’s receipt of the Agency's written decision, the
registrant must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.



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

5(a).  Agency Activities

The following Agency activities are necessary to conduct a DCI under
this ICR:

develop DCI correspondence 	

prepare the DCI letter  identifying all the data needed

answer registrants' questions	

respond to any questions the registrant may have regarding the DCI

review data submissions 	

review data submissions for completeness and appropriateness

record DCI submissions 	

record submissions in tracking system for internal review

analyze data   	

conduct scientific reviews of data

store data 	

index data and store it in Agency files

5(b).  Collection Methodology and Management 

After initiating a statutorily mandated pesticide review whether a
Special Review, closeout of a Reregistration Review, a Registration
Review or a AR or PCT Review and determining that additional data is
needed, the Agency will issue a DCI when the need for additional data
has been identified.  

OPP tracks DCIs and all registrant responses through the Office of
Pesticide Programs Information Network (OPPIN), OPP's general purpose
action tracking system.  Additionally, the Reference Files System (REFS)
is used if the registrant voluntarily cancels a product in response to a
DCI.  The Pesticide Data Management System (PDMS) lists the bibliography
of data submitters for the DCI and OPPIN tracks the submissions.  All
correspondence associated with the issuance and response to the DCI is
filed in the master registration file or ‘registration jacket’ of
affected products.  Data submitted in response to a DCI is processed,
catalogued and archived in the PDMS.  Failures to comply with DCI
requirements are referred to EPA's Office of Enforcement and Compliance
Assurance for appropriate follow-up actions.

Although the Agency does not publish the submitted information, and
public access to the PDMS bibliography is made through the National
Pesticides Information Retrieval System (NPIRS).  NPIRS supports
searches of the PDMS database by chemical, subject, submission date,
laboratory, guideline number, and document type.  The public may request
copies of non-confidential studies through FOIA.

OPP continues to investigate the possibility of providing optional
electronic data transfer services to the industry as a means of
minimizing the burden of registration activities.  The Agency's
pesticide program, along with the pesticide industry, recognizes the
advantages in terms of accuracy, speed, cost and personnel from
electronic data transfer technologies.  In addition, OPP continues to
consult with industry associations and other federal agencies, and is
participating in an Agency-wide workgroup to develop electronic
reporting standards intended to facilitate the submission and use of
information about pesticides. 

5(c).  Small Entity Flexibility

Currently, pesticide registrants may be divided into two groups. 
Approximately 10 percent of the total: manufacture or import chemical
active ingredients intended for use as pesticides, sell these active
ingredients to other firms for formulation into pesticide products,
and/or make the end-products themselves.  The second, and by far the
larger, group of registrants purchase the active ingredients in their
pesticide products from members of the first group, and combine them
with pesticide inert ingredients or sometimes simply repackage them to
make their end-use products.

This second group is primarily comprised of small businesses.  When
small businesses use a registered source of the active ingredient to
formulate their products, they generally are exempt from generating
health and safety data for pesticide active ingredients ("generic
data").  Consequently, they usually need only respond to a DCI for
active ingredient data by claiming the "generic data exemption" (for
more detail, see section 4(b)(iii) “Reducing the PRA Burden”
Variation of Response to a DCI” of this document).  They do not incur
any other information burden associated with the data call-in.

5(d).  Collection Schedule

There is not a collection schedule per se.  DCIs are issued when the
need is identified.  The time frame in which the respondents must then
submit the requested material is specifically established for each DCI
based on the individual circumstances surrounding the particular DCI and
applicable review.  As part of the consolation and public participation
process, EPA works with respondents to ensure that sufficient time is
built into the individual DCIs to allow for respondents to gather and
submit the requested information. However, DCIs will generally be issued
whenever ARs data is relied upon, either to establish new tolerances or
reassess existing tolerances.  Registrants have five years before data
must generally be submitted in support of the ARs used.  Data must also
be periodically reviewed when PCT estimates are relied upon, but in most
cases the Agency will be able to internally collect or generate this
data.  In cases where the Agency is unable to get the information
itself, the registrant must submit data within five years of the use of
PCT estimates.  Additional time is provided for development of new
studies appropriate to the nature of the studies required.

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	Methodology Used To Estimate the Burden for DCIs 

To estimate the burden and costs for the paperwork related activities
for respondents to comply with DCIs notices issued under any of the
review programs, EPA estimates PRA activities to be 35% of the cost to
generate new data.  This methodology is based on using the average cost
estimates for the specific studies requests in each DCI and is only
applicable to DCI related data generation.  This approach was adopted
because it allows the Agency to consider the potential for there to be
greater burden related to a more complex study.  The premise is that a
more expensive study probably causes the respondent to incur more burden
hours and costs than generating a less expensive study.  The public,
registrants, key stakeholders, and OMB developed this percentage from
numerous sources of information including agency expertise, consultation
with industry, and repeated review on the Agency’s information
collection activities.  

To help calculate the PRA costs, the Agency maintains an archive of the
basic FIFRA study cost estimates that were developed through surveys of
independent testing laboratories, Agency economic analyses, and
registrant comments during ICR renewal periods.  To the extent possible,
EPA uses multiple sources to provide test cost estimates, which are
updated as needed.   

This methodology assumes all recipients of a DCI generate all of the
data as specified in the DCI notice.  Using this assumption however, the
Agency has chosen to overestimate the burden because not all DCI
recipients engage in all of the DCI activities.  The Agency is aware
that DCI recipients who engage in a taskforce for data generation,
voluntarily cancel the product or affected uses, submit or cite existing
data, or are granted a waiver incur fewer burden hours and cost.  T  SEQ
CHAPTER \h \r 1 he Agency actively encourages cost-sharing agreements
among manufacturers of specific pesticide chemicals to minimize the
duplication of laboratory tests conducted and to minimize costs for DCI
recipients.  

Common to developing the burden estimates for all DCIs, EPA uses the
following general assumptions:

Studies were submitted by registrants (not grower groups, or other
agencies, etc.);

studies had not been requested under a previous DCI;

studies were not a request to resubmit because the original study
submitted was not

complete or did not meet the data submission requirements; and

studies submitted that are based on preexisting data and can be found in
published, peer reviewed literature were not included.

A detailed discussion of the Agency’s “Methodology Used to Estimate
Paperwork Burden Hours and Costs by the Office of Pesticide Programs for
Submission of Required Data/Information for Responding to a Data Call-In
Notice” is available at Attachment G to this document.

Updating Labor Rates 

	When estimating labor rates for OPP ICR renewals in recent years, the
Agency generally adjusted the labor rate estimates used in the previous
renewals by using methods such as the NASA Gross Domestic Product (GDP)
Deflator Inflation Calculator to index the labor cost for a particular
year.  However, for this ICR renewal, Agency economists developed
completely new estimates of wages, benefits and overhead for all labor
categories for affected industries, state government, and EPA employees.
 The goal is to use a transparent, consistent methodology and current,
publicly-available data, to provide more accurate estimates and allow
easy replication of the estimates.

	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.

A copy of the formula work sheets used to re-estimate the labor rates
and to derive the fully loaded rates and overhead costs for this all of
the respondents (registrants) and the Agency for this ICR renewal are
listed in Attachment H.  

	Format 

	For reader clarity this consolidation document contains tfohreeur
separate parts which discuss “Section 6 - Estimating The Burden And
Cost Of The Collection.”   For this section only, discussions
regarding PRA burden and costs for each of the review programs have been
restructured into separate parts which allow the reader/reviewer to
readily identify the burden activities associated with a particular
review program.  The parts are labeled as follows:

Part 1 – Section 6: Estimating the Burden and Cost of the Collection
for the Reregistration Review program (including reassessing import
tolerances).

Part 2 – Section 6: Estimating the Burden and Cost of the Collection
for the Special Review and Registration Review Programs 

Part 3 – Section 6: Estimating the Burden and Cost of the Collection
for the Anticipated Residue and Percent Crop Treated Review Programs

   

Part 4 – Section 6: Estimating the Burden and Cost of the Collection
for Enforcement and Unanticipated Incidents 

Part 1-  Section 6:

Estimating the Burden and Cost of the Collection for the Reregistration
Review program (including reassessing import tolerances).

 

Part 1 describes the burden activities associated with the
Reregistration review program, which also includes the burden activities
associated with import tolerance reassessment.  While the final
regulatory decisions for the Reregistration program are scheduled for
completion in 2008, the Agency will still issue Reregistration DCIs for
the life of this ICR. 

	6(a)   Estimating Respondent Burden – Reregistration 

The total estimated annual burden hours for respondents to comply with
the information collection activity for the Reregistration Program to be
165,351 hours, with the total annual respondent burden cost estimated to
be $5,789,404.  

The burden estimate is dependent upon the type or class of chemical
under review and whether there is a high, medium or low burden that are
directly related to the complexity of studies, and the cost of such
studies   required for a particular chemical.  Reregistration review
burden estimates are based only on Phase 5 (completion) activities and
for reassessing existing import tolerances.  EPA examined the historical
data for confirmatory, product specific and voluntary data that have
been submitted for representative pesticides in this program.  This
information was used to project the estimates in this ICR. As a result
of the review, EPA will not  adjust the estimated hourly burden per
response for any of the respondents for the renewal of this ICR.  

Over the next three years, EPA expects to issue 137 DCIs for active
ingredients and the pesticide products that contain them.  The breakdown
of the regulatory decisions for the Reregistration Program that EPA
expects to make over the next 3 years is as follows:

Type of Decision	

No. of Pesticide Ingredients

Reregistration Eligibility Decisions (REDs) and efficacy data 	

107

Import tolerances (ingredients with no U.S. registrations)	

30

Total	

137

6(a)(1). Paperwork Burden Related to the Submission of Confirmatory Data
– Reregistration 

Confirmatory data are required of registrants to complete registrant
databases and to assist in the evaluation of risk findings.  For DCIs
involving confirmatory studies, EPA also assumed that only one
respondent – the manufacturer of the active ingredient – will
provide the data requested (i.e, one registrant will submit an average
of 9.8 “confirmatory” studies per DCI, and therefore, there will be
only one response submitted to EPA per DCI involving confirmatory data. 
EPA expects to issue 137 confirmatory DCIs over the next 3 years, which
equals an average of 45.66 confirmatory DCIs annually.  See Table 1
below for burden activity details.   

Table 1.  Annual Respondent Burden for DCIs Involving Confirmatory
Studies

             

                 Collection Activities	

Burden Hours	

Total

	

 Mgmt.

$103.62/hr	

   Tech.

  $67.05/hr	

   Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

12	

0	

0	

12	

$1,243.44

2. Discuss test and protocol with Agency	

6	

6	

0	

12	

$1,024.02

3. Plan activities	

24	

6	

0	

30	

$2,889.18

4. Create information	

18	

299	

36	

353	

$23.131.79

5. Gather information	

0	

30	

0	

30	

$2,011.50

6. Process, compile, review information for accuracy	

35	

48	

0	

83	

$6,845.10

7. Complete written forms	

0	

0	

12	

12	

$406.20

8. Record, disclose, display information	

11	

0	

24	

35	

$1,952.22

9. Store, file, or maintain information	

11	

0	

18	

29	

$1,749.12

Total Annual Burden	

117	

389	

90	

596	

$41,252.57

Estimated Total Annual Respondent Burden & Costs for DCIs Involving
Confirmatory Studies:

Burden: 596 hours per response x 1 response per DCI x 45.66 DCIs  =
27,213.36 burden hours.

Costs: $41,253 per response x 1 response per DCI x 45.66 DCIs =
$1,883,611.90

6(a) (2).  Paperwork Burden Related to Voluntarily Submitted Data -
Reregistration

Voluntary data consist of studies not required by the Agency but are
submitted by registrants to supplement a pesticide database.  To account
for the burden attributed to voluntarily submitted data, the Agency
inventoried the types of voluntarily submitted data for a range of
chemicals.  Based on a sampling of Reregistration Eligibility Decisions
(REDs) affected by FQPA tolerance reassessment submitted over an eight
year period (1996- 2004), the Agency received 67 voluntary data
submissions.  This averages to 8.375 submissions annually.          

In the past, many of voluntarily submitted studies have been existing
studies, e.g., studies found in existing literature, or studies that
were slightly modified and resubmitted, or studies of lower cost.  Some
may be special studies such as a Monte Carlo, or limited market basket
survey, or other studies to provide the Agency with actual exposure
data.  Regardless of the voluntarily submitted status, the Agency has
categorized these data as high, medium or low burden and averaged the
burden for these studies as if they represented a cross section of
typical data requirements.      

           

For the next ICR renewal period, EPA recognizes that some registrants
will continue to submit voluntary data to support the activities for the
completion of the reregistration review program as well as and the other
review programs.  EPA expects to receive 25 voluntary such submissions
over the next three years; 16 of which are expected to be “low
burden” submissions and 9 of which are expected to be “high
burden” submissions.  Thus, EPA expects to receive about 8 voluntary
submissions annually; 5.3 of which are expected to be “low burden”
submissions and 3 of which are expected to be “high burden”
submissions.  For the details of the burden hours and costs see Table
2.A and Table 2. B. 

Table 2. A.  Annual Respondent Burden for Submissions of Voluntary Low
Burden Studies

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

12	

0	

0	

12	

$1,243.44

2. Discuss test and protocol with Agency	

6	

6	

0	

12	

$1,024.02

3. Plan activities	

24	

6	

0	

30	

$2,889.18

4. Create information	

18	

299	

36	

353	

$23,131.11

5. Gather information	

0	

30	

0	

30	

$2,011.50

6. Process, compile, review information for accuracy	

35	

48	

0	

83	

$6,845.10

7. Complete written forms	

0	

0	

12	

12	

$ 406.20

8. Record, disclose, display information	

11	

0	

24	

35	

$1,952.22

9. Store, file, or maintain information	

11	

0	

18	

29	

$1,749.12

Total Annual Burden	

117	

389	

90	

596	

$41,252.57

Estimated Total Annual Respondent Burden & Costs for DCIs Involving
Voluntary Low Burden:

Burden: 596 hours x 5.3 responses  = 3,159 hours

Costs: $41,253 x 5.3 responses  = $218,640.90



Table 2. B.  Annual Respondent Burden for Submission of Voluntary High
Burden Studies

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

72	

0	

0	

72	

$7,460.64

2. Discuss test and protocol with Agency	

36	

36	

0	

72	

$6,144.12

3. Plan activities	

144	

36	

0	

180	

$17,339.40

4. Create information	

108	

1,791	

215	

2,114	

$145,833.03

5. Gather information	

0	

179	

0	

179	

$12,001.95

6. Process, compile, review information for accuracy	

215	

287	

0	

502	

$41,521.65

7. Complete written forms	

0	

0	

72	

72	

$2,437.20

8. Record, disclose, display information	

72	

0	

144	

216	

$12,335.04

9. Store, file, or maintain information	

72	

0	

108	

180	

$11,116.44

Total Annual Burden	

719	

2,329	

539	

3,587	

$256,189.43

Estimated Total Annual Respondent Burden for DCIs Involving Voluntary
High Burden:

Burden: 3,587 hours x 3 responses = 9,565 hours

Costs: $256,189 x 3 responses = $768,567

6(a)(3).  Paperwork Burden Related to the Submission of Product-Specific
Data – Reregistration 

	Product-specific data is generally comprised of toxicity and product
chemistry data. In the past for DCIs involving product-specific data
(sometimes referred to as PDCIs), EPA examined several typical
reregistration cases with a typical number of batches and EPA’s
estimate of the number and type of PDCI studies required.  EPA noted
that while the number pesticide products captured by a RED for an active
ingredient (and, therefore, the number of responses per PDCI associated
with a RED) vary greatly from 1 to more than 100, the average number of
responses per PDCI was three (3). It is a common industry practice where
the manufacturer of the active ingredient and the companies that use
that active ingredient in their products share their financial and
scientific resources in order to provide EPA with a complete DCI
response.  This helps industry avoid a duplication of effort and thereby
minimize the burden and cost impacts on each individual company.   

	The industry practice regarding the citation of data on similar
products and the citation of existing data previously submitted to the
Agency could also be the reason that the number of studies called in
under the PDCI typically differs significantly from the number of new
studies actually generated in response to the PDCI.  For example, in
2004 the Agency evaluated a sampling of 95 pesticide product reviews
(PDCIs) related to 5 randomly selected pesticide chemicals to determine
the number of new Acute Toxicity and Product Chemistry studies generated
in response to a DCI.  Based on this evaluation, it was determined that
approximately 18% of the Acute Toxicity data requirements and
approximately 10% of the Product Chemistry data requirements were newly
generated data.  Among the six Acute Toxicity requirements surveyed,
(acute oral, acute dermal, acute inhalation, acute eye irritation, acute
dermal irritation and dermal sensitization), the Acute eye irritation
(870.2400), and Acute dermal irritation (870.2500) studies accounted for
as much as 50% of the new data produced (in equal proportions).  The
other 50% of the new data is equally distributed between the remaining
four study requirements.   Among the ten Product Chemistry requirements
surveyed, (Storage Stability (830.6317), Corrosion Characteristics
(830.6320), Viscosity (830.7100) and the Analytical Methods (830.1800)
guidelines accounted for approximately 90% of the new data produced (in
equal proportions).  The remaining 10% of the new data was equally
distributed between the Flammability (830.6315), pH (830.7000), Density
(830.7300), and various requirements for technical/pure active
ingredients including Preliminary analysis (830.1700), Water solubility
(830.7840 or 830.7860), and Vapor pressure (830.7950).  

	The Agency projects 49 PDCIs (16.33 annually) will be called-in over
the next three years.  This equates to about 28% of the 137 DCIs to be
issued for this ICR renewal.  The Agency will again predict each PDCI
will generate about three (3) responses.  Table 3 provides the detail
for these burden activities.      

Table 3.   Annual Respondent Burden Estimates for Product Specific DCI
Activities

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

Hours	

Costs

1. Read and discuss test requirements	

51	

0	

0	

51	

$5,284.62

2. Discuss test and protocol with Agency	

26	

26	

0	

52	

$4,437.42

3. Plan activities	

102	

26	

0	

128	

$12,312.54

4. Create information	

77	

1,280	

154	

1,511	

$99,015.64

5. Gather information	

0	

128	

0	

128	

$8,582.40

6. Process, compile, review information for accuracy	

154	

204	

0	

358	

$29,635.68

7. Complete written forms	

0	

0	

51	

51	

$1,726.35

8. Record, disclose, display information	

51	

0	

102	

153	

$8,737.32

9. Store, file, or maintain information	

51	

0	

77	

128	

$7,891.07

Total Annual Burden	

512	

1,664	

384	

2,560	

$177,623.04

Estimated Total Annual Respondent Burden for Product Specific DCI
Activities:

Burden: 2,560 hours x 3 responses per DCI x 16.33 DCIs = 125,414.40
hours.

Costs: $177,623 x 3 responses per DCI x 16.33 DCIs = $2,900,583.50

6(b).  Estimating Respondent Costs - Reregistration 

The total annual cost for all respondents is estimated to be $5,789,404.
 Respondent costs are based on managerial, technical and clerical burden
hours estimated at $103.62, $67.05, and $33.85 per hour, respectively.  

	6(c).  Estimating Agency Burden and Cost - Reregistration 

The Agency’s annual burden hours and costs for developing DCI
correspondence, communication with registrants, developing documents,
tracking and storing the evaluation of the data submissions, and other
DCI processing activities is detailed in Table 4 below.  For this
renewal, EPA projects a slight decrease in the burden hours and costs
associated with the performance of the duties issuing and processing
DCIs.  The decrease is attributable to the reduction of the number of
DCIs, from 142 to 137, the Agency plans to issue over the next three
years. 

Table 4. Annual Agency Burden Estimates

Collection Activities	

Burden Hours	

Total

	

Mgmt.

$101.16/hr	

Tech.

$66.88/hr	

Cler.

$39.23/hr	

Hours	

Costs

a. Develop DCI correspondence	

948	

9,480	

948	

11,376	

$766,915.97

b. Answer DCI questions from registrants	

119	

4,740	

0	

4,859	

$329,049.24

c. Review, evaluate data submission	

238	

138,029	

0	

138,267	

$9,231,379.52

d. Record DCI submissions	

0	

0	

1,896	

1,896	

$74,380.08

e. Store data	

0	

0	

238	

238	

$9,336.74

Total Annual Agency Burden	

1,305	

152,249	

3,082	

156,636	

$10,411,061.55

 6(d).	Bottom Line Hours and Cost Tables – Reregistration 

The total annual estimated burden hours and costs for the
Rereregistration review program for the next three years is represented
in Table 5 below.

Table 5.  Annual Bottom Line Hours And Costs / Master Table

Collection Activity	

Burden Hours	

         Costs

DCI Involving Confirmatory Studies	

27,213	

$1,883,612

Voluntary Low Burden Studies	

3,159	

$218,641

Voluntary High Burden Studies	

9,565 	

$786,567

Product Specific DCIs 	

125,414	

$2,900,584

Total Annual Respondent Burden and Costs 	

165,351 	

$5,789,404 

Total Annual Agency Burden 	

156,636	

$10,411,061.55

6(e).	Reasons for Change in Burden - Reregistration 

In the ICR renewal, EPA projects a slight decrease in the estimated
number of DCIs the Agency will issue annually, from 47.33 to 45.66,
compared to the last ICR. Consequently, EPA expects that the associated
burden will decrease because less DCI responses will be submitted to the
Agency each year.  Part of this reduction is also attributable to the
reduction of DCI responses for product specific data, 16.33 instead of
30.33, as reported in the last ICR.  However, EPA is projecting it will
receive about the same number of voluntarily submitted data of 8
responses (5.3 low burden and 3 high burden) annually.  EPA’s estimate
of the burden breakdown for each individual respondent for each labor
category (management, technical and clerical) remains unchanged from the
previous ICR.  The overall adjustments in the burden for this ICR result
in a net decrease hours annually from 275,063 to 165,351 which is
directly related to the decrease in the number of DCIs to be issued. 
Part of the reduction in the estimated costs, for respondents and Agency
personnel is attributable to EPA’s methodology which re-estimated 
labor rates for industry and the Agency.  The decrease is a program
adjustment. 

6(f).  Burden Statement - Reregistration 

The total estimated respondent burden hours are 496,053 hours for the
next three years at an estimated burden cost of $17,314,212. 

Part 2 – Section 6:

Estimating the Burden and Cost of the Collection 

for the Special Review and Registration Review Programs 



Part 2 describes the burden activities associated with the Special
Review and Registration Review programs.  

6(a)   Estimating Respondent Burden – Special Review 

	 Special Review Program 

Special Reviews, though rare, are conducted when the Agency determines
such a review is warranted.  In the Special Review Program, EPA focuses
on specific hazards or uses of a pesticide.   Special Reviews are not
intended to be comprehensive evaluations of the pesticide, instead the
DCIs are to address the specific hazard or exposure concerns are that
are at issue.   

The total estimated annual respondent burden hours and costs for Special
Review is estimated at 919 burden hours with the total annual respondent
cost estimated at $56,202. 

 The potential number of Special Review DCIs required, the type of data,
and the number of respondents affected is quite variable.  Thus, a
Special Review DCI may request data on more than one pesticide, and may
involve two or more respondents who are encouraged to join together to
provide the needed data.  The annual burden estimate is based on the
following assumptions: (a) that the Agency would issue one DCI under the
Special Review program in any given 12-month period, and (b) for each
Special Review DCI issued there would be one response.  The Agency has
also assumed an average total test cost of $500,000 per Special Review
DCI.  

Over a three-year ICR approval period, three responses would be expected
and the total respondent burden for Special Review related activities is
estimated to be 2,757 hours. This estimate remains unchanged from the
previous ICR.  Because of the variability inherent in each Special
Review DCI, the estimates serve as a proxy for what the actual burdens
are likely to be.  Although the Agency estimated that an average of 1
respondent per Special Review DCI is expected because historically, a
majority of the Special Review DCIs has only affected 1 or 2
respondents, on rare occasions, some previous Special Review DCIs have,
exceeded this.  In recent years, the Agency has not issued one Special
Review DCI each year over a three-year period.  Table 1A details the
estimated annual respondent burden hours and costs for Special Review
DCIs



Table 1A:  	Estimated Annual Burden hours and Cost Estimates for Special
Review DCIs per Respondent

	

	BURDEN HOURS (per year) 	

TOTALS

COLLECTION ACTIVITIES	

Mgmt.  $103.62/hr	

Tech.

$67.05/hr	

Cler.

$33.85/hr	

	Hrs	

	Cost

1) Read and discuss test requirements	

18	

0	

0	

18	

$1,865.16

2) Discuss test and protocol with Agency	

9	

9	

0	

18	

$1,536.03

3) Plan activities	

0	

0	

0	

0	

$0

4) Create information	

37	

9	

0	

46	

$4,437.39

5) Gather information	

28	

460	

0	

488	

$29,617.74

6) Process, compile, review  information for accuracy	

0	

46	

0	

46	

$3,084.30

7) Complete written forms	

55	

74	

55	

184	

$12,522.55

8) Record, disclose, display information	

0	

0	

18	

18	

$609.30

9) Store, file, or maintain information	

36	

0	

65	

166	

$5,930.57

TOTAL	

183

	

598

	

138

	

919	              $56,201.85

Special Review Estimated Annual  Respondent Burden hours and Cost 

Hours: 919 hours per response X 1 response X 1 DCI= 919 hours

Costs: $56,202 per response X 1 response X 1 DCI= $56,202

6(a)(1) Estimating the Respondent Burden – Registration Review 

	Registration Review

While the agency projected burden hours and cost of issuing DCI for the
Registration Review program in the last ICR, no DCI could be issued
until the final procedural rules for the registration review program
were issued.  The final rules were published August 9, 2006 (71 FR
45719) and became effective October 10, 2006.   The first dockets for
registration review cases were opened in February 2007 and a majority of
dockets opened to date have identified the need for additional data in
order to complete the preliminary risk assessment. The Agency is
actively developing the internal protocols necessary to issue DCIs under
this program.  Estimates include additional activities anticipated by
the reauthorization of the Pesticide Registration Improvement Act
amendments of October 9, 2007. 

The total estimated annual burden hours for respondents to comply with
this information collection activity is 65,374 hours with the total
annual respondent cost estimated to be $4,595,587.  

During Registration Review, EPA will, among other things, update the
databases of pesticides to obtain data that were not required when the
pesticide was registered or reregistered, but which are now required and
determined necessary.  Like the Special Review program, the potential
number of Registration review DCIs that will be issued, the type of
data, and the number of respondents affected will be quite variable.

 Over the next 3 years EPA expects to issue 121 DCIs (41 annually) for
the Registration Review Program.  The Agency assumes that one respondent
“registrant” will provide the data requested.  The Agency estimates
one registrant will submit an average of 1.5 studies per DCI.   A
detailed illustration of the estimated annual respondent burden hours
and costs is listed in Table 1B.  



Table 1B:  Estimated Annual Respondent Burden Hours and Costs for
Registration Review DCIs 

	

	BURDEN HOURS (per year) 	

TOTALS

COLLECTION ACTIVITIES	

Mgmt.  $103.62/hr	

Tech. 67.05/hr	

Cler.

$33.85/hr	

	Hrs	

Cost

1) Read and discuss test requirements	

22	

0	

0	

22	

$2,279.64

2) Discuss test and protocol with Agency	

11	

11	

0	

22	

$1,877.37

3) Plan activities	

44	

11	

0	

55	

$5,296.83

4) Create information	

33	

544	

33	

610	

$41,011.71

5) Gather information	

0	

54	

0	

54	

$3,620.70

6) Process, compile, review  information for accuracy	

65	

87	

0	

152	

$12,568.65

7) Complete written forms	

0	

0	

22	

22	

$744.70

8) Record, disclose, display information	

22	

0	

44	

66	

$3,769.04

9) Store, file, or maintain information	

22	

0	

38	

60	

$3,565.94

TOTAL	

219	

707	

137	

1,063	

$74,724.58

Registration Review Estimated Annual Respondent Burden Hours and Cost 

Hours: 1063 hours per response X 1.5 responses X 41 DCIs = 65,374.5
hours

Costs: $74,725 per response X 1.5 responses X 41 DCIs = $4,595,587.5 



6(b).	Estimating Respondent Costs - Special Review and Registration 
Review

The estimated annual cost for all respondents for Special Review and
Registration review is estimated to be $3,418,827.   Respondent costs
are based on managerial, technical and clerical burden hours estimated
at $103.62, $67.05, and $33.85 per hour, respectively.         

6(c).  	Estimating Agency Burden and Cost - Special Review Registration
Review

Special Review – Agency Burden 

In this ICR, the estimated average number of Agency burden hours per
response for Special Review is the same as in the previous ICR; i.e.,
1,348 hours.  Over a three-year ICR approval period, 3 responses are
expected and the total Agency burden hour and cost is estimated at 4,044
(1,348 x 3) hours.  See Table 2A for the detail of the Agency burden
hours and costs for processing Special Reviews.  

Table 2A: Estimated Annual Agency Burden and hours Cost for Special
Review DCIs 

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

32	

	160	

	60	

252	

$16,291.72

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

$11,105.44

Review and analyze data submissions	

	4	

	880	

	0	

884	

$59,259.04

Record DCI submissions	

	0	

	0	

	40	

40	

$1,569.20

Store Data	

	0	

	0	

      8	

8	

$313.40

TOTAL	

	40	

 1,200	

	108	

1,348	

$88,539.24

Hours: 1348 per response X 1.5 responses X 1 DCIs =   2,022 Hours 

Costs: $88,539 per response X 1.5 responses X 1 DCIs = $132,808.5 

Registration Review – Agency Burden

The annual estimated Agency burden hours and costs for Registration
Review are illustrated in Table 2B below.   

Table 2B:Estimated Annual Agency Burden Hours and Costs for Registration
Review DCIs

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

64	

	320	

	120	

504	

$32,583.94

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

$11,105.44

Review and analyze data submissions	

	4	

	0	

	0	

4	

$404.64

Record DCI submissions	

	0	

	0	

	80	

80	

$3,138.40

Store Data	

	0	

	0	

      8	

8	

$265.84

TOTAL	

	72	

 480	

	208	

760	

$47,497.76

Registration Review Estimated Agency Annual Burden Hours and Costs

Hours: 760 per response x 1.5 responses x 41 DCIs = 46,740 hours

Costs: $47,498 per response x 1.5 responses x 41 DCIs = $2,921,127

6(d). 	Bottom Line Burden Hours and Cost Tables/ Master Table for
Special Review and Registration Review

The estimated total and annual Respondent burden hours and costs are
illustrated in Table 3, while the estimated total and annual Agency
burden hours and costs are illustrated in Table 4.

Table 3: Bottom Line Respondent Burden Hours and Costs/ Master Table  

	

	

Per Response	

Number of Responses	

Totals

	

Hours	

 Cost 

Hours	

Cost

Special Review	

919	

$56,202  	

1      	

    919	

$56, 202

Registration Review	

1,063	

$74,735 	

41	

 43,583	

$3,064,135 

TOTAL ANNUAL BURDEN	

1,982	

$130,937 	

42	

  44,502	

$3,120,337

TOTAL 3 YEAR BURDEN	

5,946	

 $392,811  	

126	

  133,506	

$9,361,011 

 Table 4: Bottom Line Agency Burden Hours and Costs/Master Table  

	

	

Per Response	

Number of Responses	

Totals

	

Hours	

 Costs 

Hours	

Cost

Special Review	

1,348	

$88,539	

1          	

1,348	

$88,539

Registration Review	

760	

$47,498	

41	

31,160	

$1,947,418

TOTAL ANNUAL BURDEN	

2,108	

$136,037	

42	

32,508	

$2,035,957

TOTAL 3 YEAR BURDEN	

6,324	

 $416,340	

126	

140,844	

$6,107,871

6(e). 	Reasons for Change in Burden - Special Review and Registration
Review

This ICR renewal request will result in a slight increase in the annual
respondent burden of 675 hours, i.e., from 64,699 to 65,374 hours, when
compared with the previous ICR.  Most of the burden increase can be
attributed to the increase in the number of DCIs (41 DCIs verses 40
DCIs) to be issued under the Registration review program that is now
underway.  This is a program adjustment.     

6(f).  Burden Statement - Special Review and Registration Review

The annual respondent burden for the information collection activities
under this ICR is estimated to average 919 hours for Special Review DCIs
and 65,374 hours for Registration Review DCIs.  



Part 3 – Section 6

Estimating the Burden and Cost of the Collection for 

the Anticipated Residue and Percent Crop Treated Review Programs

   



Part 3 describes the burden activities associated with the Anticipated
Residue and Percent Crop Treated (AR/PCT) review programs.  The AR/PCT
review program requires the Agency to re-evaluate of previous Agency
decisions regarding the establishment of a tolerance (maximum residue
limit) for pesticide residues on food or feed crops.  The law also
requires that tolerance decisions based on ARs or PCT data be verified
to ensure that residues in or on food are not above the residue levels
relied on for establishing the tolerance.

	6(a)   Estimating Respondent Burden - AR/PCT

The annual respondent range between 59 and 13,636 burden hours per DCI,
depending upon the type of DCI response requested.  The total estimated
burden for this ICR of XXXX burden hours is based on the Agency’s
estimate of the potential burden and number of responses for each of the
following four types of potential DCIs:

Type 1- DCI for anticipated residues requiring a base set of data
(13,636 hrs.); 

Type 2- DCI for anticipated residues requiring minimum data (69 hrs.); 

Type 3- DCI for anticipated residues collected from publicly available
sources (137 hrs.);

 and 

Type 4- DCI for percent crop treated using existing information (59
hrs.).  

After re-evaluation the burden hours from the last ICR, the Agency is
not changing the burden hour estimates from the last ICR renewal period.
 The following information presents the Agency’s burden estimates for
each type of DCI.  

AR DCI Type 1 - DCI for anticipated residues requiring a base set of
data:

Respondent burden hours for generating and submitting data in response
to a DCI for anticipated residues requiring a base set of data to be
submitted are estimated at 13,636 burden hours per response.  And one
response equals one DCI.  EPA also considered the typical burden for
reading instructions, planning activities, compiling and reviewing the
submission, submitting the data to EPA, and related record keeping in
estimating the total per response burden and costs.  Using the USDA’s
Pesticide Data Program (PDP) which generates publicly available
monitoring data as the basis, EPA estimated the burden for conducting a
monitoring study to gather the necessary data.  Portions of the annual
respondent burden hours and cost are related to generation of new data
for meeting 40 CFR part 158 data requirements for anticipated residues. 

In most cases, registrants will be able to get the information from
federal and state monitoring programs, thus EPA estimates that no more
than two registrants might generate their own monitoring data in
response to the DCI.  The total annual burden hours for a Type -1 AR DCI
is estimated to be 27,272 hours,  The Agency projects only two (2) Type
1 AR DCIs will be issued generating one response per DCI.



TABLE 1 

Type 1 AR DCI- Annual Respondent Burden/Cost Estimates for Anticipated
Residues 

Generating Anticipated Residue Data

	

BURDEN HOURS (per year)	

TOTAL

ACTIVITIES	

Mgmt. $103.62	

Tech. 

$67.05	

Cler. 

$33.85	

Hours	

Costs

1) Read instructions	

2	

0	

0	

2	

207.24

2) Plan activities	

4	

0	

0	

4	

414.48

3) Create information	

0	

13,600	

0	

13,600	

911,880.00

4) Gather information	

0	

16	

0	

16	

1,072.80

5) Compile and review	

1	

8	

0	

9	

 640.02

6) Complete paperwork	

2	

0	

2	

4	

275.01

7) Maintain and file	

0	

0	

1	

1	

33.85

TOTAL	

9	

13,624	

3	

13,636	

$914,443.40

Type I AR DCI	Burden: 13,636 per response x 1 response x 2 DCIs = 27,272
hours

			Costs: $914,443 per response x 1 response x 2 DCIs = $1,828,886

Type 2 AR DCI - DCI for anticipated residues verification use
information data:

Minimum data captures the burden for cases in which the respondent
verifies that nothing has changed; i.e., the formulation, use rate,
geographic distribution of use, etc. have not changed since the ARs
where used to establish or reassess the tolerance.  The EPA estimates
that this verification for updating use information is estimated at 69
burden hours per response.  EPA estimates that no more than 10
respondents each year will comply with a DCI by submitting a base set of
data for updating use information.  As such, the total respondent burden
hours per year are estimated at 690 hours.  See Table 2.

TABLE 2

Type 2 AR DCI - Annual Respondent Burden/Cost Estimates for Anticipated
Residues Requiring Minimum Data for Verifying Use Information 

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $103.62	

Tech. 

$67.05	

Cler. $

33.85	

Hours	

Costs

1) Read Instructions	

8	

0	

0	

8	

828.96

2) Plan Activities	

16	

0	

0	

16	

1657.92

3) Create Information	

0	

0	

0	

0	

0

4) Gather Information	

0	

16	

0	

16	

1072.80

5) Compile and Review	

2	

16	

0	

18	

1280.04

6) Complete Paperwork	

2	

0	

8	

10	

470.04

7) Submit and File	

0	

0	

1	

1	

33.85

Total	

28	

32	

9	

69	

$5,293.61

Type 2 AR DCI 	Burden: 69 per response x 10 responses x 1 DCI = 690
hours

			Cost: $5,294 per response x 10 responses x 1 DCI = $52,940.    

Type 3 AR DCI  - DCI for anticipated residues collected from publicly
available sources:

The average respondent burden for submitting a base set of data for
updating monitoring information is estimated at 137 burden hours per
year.  EPA estimates that an average of 4 respondents each year is
likely to be able to comply with a DCI by submitting data from publicly
available sources.  As such, the total annual respondent burden for this
type of DCI is estimated to be 548 burden hours.  See Table 3.

TABLE 3  

Type 3 AR DCI: Annual Respondent Burden/Cost Estimates for Anticipated
Residues Collected from Publicly Available Sources

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $103.62	

Tech.

$67.05	

Cler. 

$33.85	

Hours	

Costs

1) Read Instructions	

8	

0	

0	

8	

828.96

2) Plan Activities	

16	

0	

0	

16	

1,657.96

3) Create Information	

0	

0	

0	

0	

0

4) Gather Information	

0	

60	

0	

60	

4,023.00

5) Compile and Review	

2	

40	

0	

42	

2889.24

6) Complete Paperwork	

2	

0	

8	

10	

478.04

7) Submit and File	

0	

0	

1	

1	

33.85

Total	

28	

100	

9	

137	

9,911.05

Type 3 AR DCI  	Burden: 137 per response x 4 responses x 1 DCI = 548
hours.

		Cost:  $9,911 per response x 4 responses x 1 DCI = $39,644

Type 4 PCT DCI - DCI for percent crop treated using existing
information:  

The annual per respondent burden for generating percent crop treated
estimates using existing information is estimated to be 59 burden hours.
 Percent crop treated estimates are generally conducted within the
Agency, and only in rare instances would a registrant need to gather the
information; one DCI  per year impacting one respondent is probably an
overestimation.  The estimated costs assume that cost of purchasing or
obtaining percent crop treated information derived from existing,
contracted data sources.  See Table 4.

TABLE 4 

Type 4 PCT DCI - Annual Respondent Burden/Cost Estimates for Percent
Crop Treated Using Existing Information

	

Burden Hours (per year)	

Total

 Activities	

Mgmt. $103.62	

Tech. 

$67.05	

Cler.

$33.85	

Hours	

Costs

1) Read Instructions	

  1	

  1	

  0	

  2	

170.67

2) Plan Activities	

  0	

  2	

  0	

  2	

134.1

3) Create  Information	

  0	

  8	

  0	

  8	

536.4

4) Gather Information	

  0	

 22	

  0	

 22	

1475.1

5) Compile and Review	

  1	

 20	

  0	

 21	

1444.62

6) Complete Paperwork	

  1	

  0	

  2	

  3	

171.32

7) Submit and File	

  0	

  0	

  1	

  1	

33.85

Total	

  3	

 53	

  3	

 59	

$3,966.06

Type 4 PCT DCI -	Burden: 59 hours per response x 1 response x 1 DCI= 59
hours 

			Cost: $3,966 per response x 1 response x 1 DCI = $3,966  

6(b)	Estimating Respondent Costs - AR/PCT DCIs

The total annual cost for all respondents of AR and PCT DCIs is
estimated to be $1,925,436.  Respondent costs are based on managerial,
technical and clerical burden hours estimated at $103.62, $67.05, and
$33.85 per hour, respectively.  

6(c)	Estimating Agency Burden and Costs – AR/PCT

The Agency’s annual burden hours and costs for developing DCI
correspondence, communication with registrants, developing documents,
tracking and storing the evaluation of the data submissions, and other
DCI processing activities is detailed in Table 5 and Table 6 below.  For
this renewal, EPA projects the same number of burden hours associated
with the performance of the duties issuing and processing AR DCIs as was
projected in the last ICR.  Thus, like the last ICR, this renewal will
project the Agency will process 4 AR DCIs and 1 PCT DCI annually.  

TABLE 5  

Annual Estimated Agency Burden Hour and Cost 

For Processing AR DCIs Types 1-3

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $101.16	

Tech. 

$66.88	

Cler. 

$39.23	

Hours	

Costs

Develop DCI notice	

  1	

  0	

  2	

  3	

179.62

Answer Registrants' questions	

  0	

  4	

  5	

  9	

463.67

IN-process data submissions	

  0	

  0	

  4	

  4	

156.92

Analyze data	

  1	

 80	

  0	

 81	

5451.56

Record and store DCI data	

  0	

  0	

  2	

  2	

78.46

Total	

  2	

 84	

 13	

 99	

$6,330.23

AR DCIs Types 1-3  	

Annual Estimated Agency Burden: 99 hours x 16 responses = 1,584 hrs

Annual Estimated Agency Cost: $6,330 x 16 responses = $101,280. 

TABLE 6 

Annual Estimated Agency Burden Hours and Costs for 

Processing Type 4 - PCT DCIs 

	

Burden Hours (per year)	

Total

Collection Activities	

Mgmt. $101.16	

Tech. 

$66.88	

Cler. 

$39.23	

Hours	

Costs

Develop DCI notice	

  1	

  0	

  2	

  3	

140.39

Answer Registrants' questions	

  0	

  4	

  5	

  9	

463.67

IN-process data submissions	

  0	

  0	

  4	

  4	

156.92

Analyze data	

  1	

 40	

  0	

 41	

2776.36

Record and store DCI data	

  0	

  0	

  2	

  2	

78.46

Total	

  2	

 44	

 13	

 59	

$3615.80

Type 4 PCT DCIs  - Estimated Annual Agency Burden Activities  

Hours: 59 hours x 1 response = 59 hours

Costs: $3,616 x 1 response = $3,616

6(d)	Bottom Line Burden Hours and Cost Table

The total estimated annual respondent burden is 28,569 burden hours
(28,509 burden hours for all AR DCI submissions + 59 burden hours for
PCT DCI submissions), with an associated cost of $1,925,436 ($1,921,471
or all AR DCI submissions + $3,965 for PCT DCI submissions) see table
below.  

The total estimated annual Agency burden is 1,643 burden hours (1,584
burden hours for all AR DCI submissions + 59 burden hours for PCT DCI
submissions), with an associated cost of $104,896 ($101,280 for all AR
DCI submissions + $3,616 for PCT DCI submissions). See Table 7 below.   

		Table 7 

Annual Bottom Line Hours and Costs/Master Table  

	

Key Activities	

Hours	

Costs

Respondents	

Type 1- DCI: generating anticipated residue data.	

27,272	

$1,828,886

	

Type 2- DCI for submitting minimal verification of use information  	

690	

$52,940

	

Type 3- submitting anticipated residue data from publicly available
sources	

548	

$39,644

	

Type 4- submitting percent crop treated data using existing information.

59	

$3,966

Total estimated respondent burden/costs.	

28,569	

$1,926,436

Agency 	

Type 1-3 AR DCIs for managing anticipated residue DCI’s	

1,584	101,280

	

Type -4 PCT DCIs for managing percent crop treated DCI’s.	

59	

$3,616

Total Agency burden/costs.	

1,643	

$104,896

6(e)	Reasons for Change in Burden - AR/PCT

For this ICR renewal the annual estimated respondent burden hours are
28,569 hours at a cost of $1,925,436.  There is no increase in the
burden hours over the last ICR renewal.  However, the costs have
decreased slightly due to the adjustment attributable to EPA’s
re-estimation of labor rates for industry and the Agency.  This is a
program adjustment. 

6(f)	Burden Statement - AR/PCT

The estimated total respondent burden for this ICR over the next three
years is 85,707 hours with the annual burden hours ranging from 59 hours
to 13,636 hours per response, depending on the type of DCI. 

Part 4 -  Section 6:

Estimating the Burden and Cost of the Collection for the Enforcement and
Unanticipated Incidents   



Part 4 describes the burden activities associated with the Enforcement
and Unanticipated Incident DCI activities.  

6(a)   Estimating Respondent Burden – Enforcement and Unanticipated
Incident 

The total estimated annual respondent burden hours and costs for
Enforcement and Unanticipated Incident DCI is estimated at 6,266 burden
hours for the life of the ICR.   

 The potential number of DCIs required, the type of data, and the number
of respondents potentially affected is quite variable.  Thus, a this
type of DCI may request data on more than one pesticide, and may involve
two or more respondents who are encouraged to join together to provide
the needed data.  The variability inherent in this type of  DCI means
the estimates serve only as a proxy for what the actual burdens are
likely to be. The annual burden estimate is based on the following
assumptions: (a) that the Agency would issue only one DCI for this type
of activity and only once during the life cycle of the ICR and (b) for
the DCI issued there would be one response.  The Agency has also assumed
an average total test cost of $500,000 per Enforcement and Unanticipated
Incident DCI.  

 Historically, there is very little information documenting the need for
this type of DCI but such events have occurred.  For example one of the
worst cases occurred in 1976 when the  Food an Drug Administration (FDA)
conducting a routine inspection uncovered deficiencies in the manner in
which studies were being conducted at Industrial Biotest Laboratories,
Inc., (IBT) one of the largest independent laboratories in the U.S. at
the time.  By 1978 EPA and FDA were conducting joint audits of two other
IBT facilities and uncovered similar problems and the case had been
referred to the Department of Justice. This turned out to be a massive
undertaking.  Of  the 1205 IBT studies identified by EPA, 801 studies,
or  approximately 66%, were considered significant to regulatory
decisions such as the induction of tumors, birth defects, genetic
mutations, neurotoxicity and other chronic reproductive effects.  Of the
801 studies considered significant to regulatory decisions, 594  were
found to be invalid by EPA and Canada.  By 1983, EPA warned pesticide
product registrants that products supported by invalid health effects
studies conducted by IBT faced suspension action unless replaced by
other tests or a commitment to further testing. (EPA Releases Report on
IBT Lab Studies; Warns of Suspension Action, Environmental News EPA
Press Release, Monday July 11, 1983) (see also House of Representatives,
Committee on Agriculture, Washington, DC, Improving Data- Pesticide
Decisions, July 27 1983; Statement of Edwin Johnson, Director, Office of
Pesticide Programs, Environmental Protection Agency)        

The estimate of respondent burden hours per response for Enforcement and
Unanticipated Incident Activities is 6,266 hours and is based on the
same burden hour break down projected in the 2001 ICR OMB 2070-0122; EPA
nNo. 1503.04 which the Agency allowed to expire 12/31/04.  The estimated
Agency burden hours is based on Agency estimates similar to the burdens
projected for the special review program, 1348 burden hours.  While the
Agency does not anticipate using any of these burden hours, the Agency
will project a one time burden estimate for the three year life cycle of
ICR. Table 1 lists the potential respondent burden hours and costs and
Table 2 lists the potential Agency burden hours and costs and Table 3,
lists the potential  three year bottom line totals for Enforcement and
Unanticipated Incident Activities.   



6(b).	Estimating Respondent Costs - Enforcement Unanticipated Incident
Activities 

The estimated three year cost for all respondents for Enforcement
Unanticipated Incident Activities is estimated to be $420,291.  
Respondent costs are based on managerial, technical and clerical burden
hours estimated at $103.62, $67.05, and $33.85 per hour, respectively.  
      

TABLE 1.   TOTAL RESPONDENT BURDEN/COST ESTIMATES

Enforcement and Unanticipated Incident DCI 

	Burden Hours (per year)	

Totals

Collection Activities	

Mgmt. $103.62	

Tech. $67.05	

Cler.

 $33.85	

Hours	

Costs

1)Read Instructions	

2	

0	

0	

2	

207.24

2)Plan Activities	

2	

0	

0	

2	

207.24

3)Create  Information	

0	

6,249	

0	

6,249	

418,6995.45

4)Gather Information	

0	

3	

0	

3	

201.15

5)Compile and Review	

1	

4	

0	

5	

371.82

6)Complete Paperwork	

2	

0	

2	

4	

274.94

7)Submit and File	

0	

0	

1	

1	

33.85

Total	

7	

6,256	

3	

6,266	

420,291.69

TOTAL BURDEN HOURS: 6,266 hours x 1 response = 6,266 hours 

TOTAL BURDEN COSTS: $420,291 x 1 response = $420,291 

6(c).  	Estimating Agency Burden and Cost - Enforcement Unanticipated
Incident Activities 

TABLE 2:  TOTAL AGENCY BURDEN AND HOURS COST 

Enforcement And Unanticipated Incident  DCI 

	Collection 

Activities	

	Burden Hours 	

Total

	

	Mgmt.

	$101.16/hr	

	Tech.

	$66.88/hr	

	Cler.

	$39.23/hr	

Hours	

Cost

Develop DCI correspondence needed	

32	

	160	

	60	

252	

16,291.72

Answer registrants' questions regarding the DCI	

	4	

	160	

	0	

164	

11,105.44

Review and analyze data submissions	

	4	

	880	

	0	

884	

59,259.04

Record DCI submissions	

	0	

	0	

	40	

40	

1569.20

Store Data	

	0	

	0	

      8	

8	

313.84

TOTAL	

	40	

 1,200	

	108	

1,348	

88,539.24

Hours: 1348 per response X 1 responses X 1 DCI =   1348 Hours 

Costs: $88,539 per response X 1 responses X 1 DCI = $88,539 

6(d). 	Bottom Line Burden Hours and Cost Tables/ Master Table for
Enforcement and Unanticipated Incident DCI 

 

Table 3: Bottom Line Burden Hours and Costs/ Master Table  

Enforcement and Unanticipated Incidents	

	

Number of Responses

	

Hours	

 Cost 

	Respondents	6,266	$420,291	1

Agency 	1348	$88,539	1

6(e). 	Reasons for Change in Burden - Enforcement and Unanticipated
Incident DCIs 

This new ICR burden will result in a increase in the total estimated
respondent burden of 6,266 hours for the three year life cycle of this
ICR (or 2067 burden hours annually).  This is a new program activity.   
 

6(f).  Burden Statement - Enforcement and Unanticipated Incident DCIs 

The total respondent burden for the information collection activities
for the three year life cycle of this ICR is estimated to average 6,266
burden hours for Enforcement and Unanticipated Incident activities.

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-2007-0923, 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-2007-0923 and OMB control numbers 2070-0057; 2070-0107; and
2070-0164 in any correspondence but do not submit any DCI or other
related information (e.g., forms, reports, etc.) to these addresses.  

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-2007-0923.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_" 
www.regulations.gov  or otherwise accessed as described in this section
6(f) of the supporting statement.

ATTACHMENT A:	Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 4 - Reregistration of Registered Pesticides; (7 U.S.C.
136a-1) - this attachment is part of the docket for this action and is
also only available via the internet at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&do
cid=Cite:+7USC136a-1" 
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&doc
id=Cite:+7USC136a-1 

ATTACHMENT B: Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) - Sec. 136a.

			(7 U.S.C. 136a) Registration of pesticides (includes section 3(g) –
Registration Review; and section 3(c) (2)(B) for Data Call-Ins).  This
attachment is only available as part of the docket for this action and
is also available via the internet at   HYPERLINK
"http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&do
cid=Cite:+7USC136a" 
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&doc
id=Cite:+7USC136a 

  			  

ATTACHMENT C: 40 CFR Parts 9 and 155,   HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr9_07.html"  OMB
approvals under the Paperwork Reduction Act  at:    HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfrv1_07.html" 
http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfrv1_07.html   and
Registration Standards And Registration Review at:  HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfrv1_07.html"     
HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr155_07.html" 
http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr155_07.html  . ). 
These attachments are available as part of the docket for this action
and also available  only available electronically via the internet. 

  

 ATTACHMENT D:	Federal Food, Drug, and Cosmetic Act (FFDCA); Section 408
- Tolerances and Exemptions for Pesticide Chemical Residues (21 U.S.C.
346a).  This attachment is part of the docket for this action and is
also only available electronically 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 E:	Public comment received from William M. Mahlburg, Director
Government Affairs, Nufarm, Americas, Inc.).  This attachment is as part
of the electronic docket at EPA-HQ-OPP-2007-0923- 0006.1.    

ATTACHMENT E-1

Consolation questions and comment received from Rebeckah Freeman Adcock,
Director, Congressional Relations American Farm Bureau is part of this
docket at docket at EPA-HQ-OPP-2007-0923 

ATTACHMENT E-2

Consolation questions for Ray McAlister, Vice President Science and
Regulatory Affairs, CropLife America is part of this docket at docket at
EPA-HQ-OPP-2007-0923 

ATTACHMENT E-3

Consolation questions for Susan Little, Executive Director, Consumer
Specialty Products Association is part of this docket at docket at
EPA-HQ-OPP-2007-0923 

ATTACHMENT E-4

Consolation questions for Daniel Botts, Director, FFDA's Environmental &
Pest Management Division Minor Crop Farmer Alliance Technical Committee
Chairman) Florida Fruit & Vegetable Assoc. is part of this docket at
docket at EPA-HQ-OPP-2007-0923 

ATTACHMENT F:	Forms that are commonly associated with Data Call-ins are
listed below and are only available electronically as a PDF file on the
internet cite at   HYPERLINK "http://www.epa.gov/opprd001/forms/" 
http://www.epa.gov/opprd001/forms/ 

	

			EPA Form No. 8570-4 - Confidential Statement of Formula.   This
attachment is only electronically via the Internet.  

			

			EPA Form 8570-27 - Formulator's Exemption Statement. This attachment
is only electronically via the Internet.  

 

 		EPA Form 8570-28 - Certification of Compliance with Data Gap
Procedures, 			This attachment is only electronically via the Internet. 

 

			EPA Form 8570-32 - Certification of Attempt to Enter into an
Agreement with 				Registrants for Development of Data Form.  This
attachment is only available 				electronically via the Internet. 

			EPA Form 8570-34 - Certification with Respect to Citation of Data
Form 

			This attachment is only available electronically via the Internet. 

			EPA Form 8570-35 - Data Matrix Form.  This attachment is only
available 				electronically via the Internet. 

			EPA Form 8570-36 - Summary of the Physical/Chemical Properties Form 

			This attachment is only available electronically via the Internet. 

			EPA Form 8570-37 - Self-Certification Statement for the
Physical/Chemical Properties.   This attachment is only available
electronically via the Internet.

			The These two forms below are automatically generated by EPA’s
computer databases and are pre-populated with information that is
specific to each individual registrant that receives a Data Call-In
notice for a given pesticide.  These forms are not widely accessible to
general public.  

			EPA Form 6300.4  - Data Call-In Response Form – This form is a part
of Attachment F and is only available as an electronic attachment to the
supporting statement.  This form can only be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007-0923-0002. 

			EPA Form 6300.3 - Requirements Status and Registrant’s Response -
This form is a part of Attachment F and is only available as an
electronic attachment to the supporting statement.  This form can only
be accessed at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2007-0923-0003. 

ATTACHMENT G:  General Methodology Used to Estimate Paperwork Burden
Hours and Costs by the Office of Pesticide Programs for Submission of
Required Data/Information for Responding to a Data Call-In Notice.  This
document can only be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2007- 0923-0005.

 

ATTACHMENT H: 	Work Sheets to Calculate Industry and EPA Labor Costs -
this attachment is part of the supporting statement available as part of
the electronic docket EPA-HQ-OPP-2007-0923-000.



03/4/214/08

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