August 10, 2007

SUPPORTING STATEMENT

FOR AN INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 

1(a) Title of the Information Collection: Plant-Incorporated
Protectants; CBI Substantiation and Adverse Effects Reporting

OMB No.: 2070-0142              EPA ICR No.: 1693.04

1(b) Short Characterization/Abstract 

The Environmental Protection Agency (EPA) is responsible for the
regulation of pesticides as authorized by the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). Prior to EPA granting a
registration, the manufacturer of the pesticide must demonstrate to the
Agency that the use of the pesticide product will not result in any
unreasonable adverse effects to humans or the environment. EPA is also
responsible under the Federal Food, Drug, and Cosmetic Act (FFDCA) for
establishing a tolerance or exemption from the requirement of a
tolerance for pesticide residues on food or feed. 

On January 16, 2001, the Agency promulgated a final rule that addresses
the regulatory status of pesticidal substances that are produced by
plants (plant-incorporated protectants). The final rule (Attachment A)
clarifies regulatory responsibilities at different stages of field
testing through registration, and ultimate sale and distribution,
regardless of whether the pesticidal capabilities evolved in the plants,
were introduced by plant breeding or through the techniques of modern
biotechnology. It is now possible to introduce into plants, e.g.,
through genetic engineering, mechanisms of pest and disease control
strategies. Therefore, pesticidal substances that are produced by plants
can be diverse and can potentially originate from any taxonomic 

kingdom. A plant-incorporated protectant is defined in the final rule as
"the pesticidal substance that is intended to be produced and used in a
living plant and the genetic material necessary for the production of
such a substance." 

The final rule accomplishes two things: it exempts a wide range of
plant-incorporated protectants from registration requirements under
FIFRA, and it imposes two new requirements on manufacturers of some
plant-incorporated protectants. 

This Information Collection Request (ICR) covers the two information
collection related provisions contained in the final rule, i.e., the
provision that requires registrants that make Confidential Business
Information (CBI) claims to substantiate such claims when they are made,
and the provision that requires manufacturers of plant-incorporated
protectants exempted from 

 

requirements of registration under the final rule to report adverse
effects to the Agency. It is important to note that current CBI
regulations at 40 CFR part 2 require that claimants substantiate their
CBI claims for their own records when the claim is made, and
subsequently provide the substantiation to EPA only if requested. The
substantiation, however, is not required to be included with the
submission to EPA in which the CBI claims are made. The burden
associated with the existing requirement is already approved by OMB.
Although the final rule now requires the claimant to include the CBI
substantiation in the plant-incorporated protectant related submissions
to EPA, it is difficult to identify any additional burden that such a
requirement might actually impose. Nevertheless, the Agency has chosen
the conservative approach of including potential burden and costs for
preparing and submitting the CBI substantiation at the time of
submission of the information containing the CBI claim as required by
the final rule. 

The clarifications contained in the final rule that are related to
information collection activities that are part of registration
activities, e.g., data requirements for pesticide registrations, are
already approved by OMB under the PRA, and that approval is not impacted
by the clarification provided in the final rule. Information collection
activities related to pesticide registration are approved under OMB
Control Nos. 2070-0060 (Application for New or Amended Pesticide
Registration), 2070-0024 (Tolerance Petitions for Pesticides on
Food/Feed Crops and New Inert Ingredients), and 2070-0040 (Application
for Experimental Use Permit (EUP) to Ship and Use a Pesticide for
Experimental Purposes Only). 

This ICR, therefore, discusses the paperwork burdens associated with the
requirement for registrants to substantiate CBI claims when they are
made, and the requirement for manufacturers of plant-incorporated
protectants exempted from registration requirements under the final rule
to report adverse effects to the Agency within 30 days. 

2. 	NEED FOR AND USE OF THE COLLECTION 

2(a) Need/Authority for the Collection 

	Although FIFRA requires the registration of most pesticides, it also
authorizes the Agency’s regulation of unregistered pesticides. FIFRA
section 3(a) provides that, to the extent necessary to prevent
unreasonable adverse effects on the environment, the Administrator may
limit the distribution, sale, or use of any pesticide that is not
registered under section 3 of FIFRA, or subject to an experimental use
permit under section 5 of FIFRA, or subject to an emergency exemption
under section 18 of FIFRA. Pesticides that are "not registered" include
pesticides that are exempt from FIFRA requirements under section 25(b)
(Attachment B). 

FIFRA section 2(bb) defines the term "unreasonable adverse effects on
the environment" to mean: “(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” (7 U.S.C. 136(bb)). 

Section 25(b)(2) of FIFRA allows EPA to exempt, by regulation, any
pesticide from some or all of the requirements of FIFRA, if the
pesticide is of a character which is unnecessary to be subject to FIFRA
in order to carry out the purposes of that Act (7 U.S.C. 136w(b)(2)).
EPA interprets FIFRA section 25(b)(2) to authorize EPA to exempt a
pesticide or category of pesticides that EPA determines poses a low
probability of risk to the environment, and that is not likely to cause
unreasonable adverse effects to the environment even in the absence of
regulatory oversight under FIFRA. 

To determine whether a pesticide qualifies for an exemption under
section 25(b)(2), EPA evaluates both the potential risks and benefits of
the use of the pesticide. In evaluating a pesticide under the first
exemption criterion, whether use of the pesticide poses a low
probability of risk to the environment, EPA considers the extent of the
potential risks caused by use of the pesticide to the environment,
including humans and other animals, plants, water, air and land.
Potential risks to humans include dietary risks as well as non-dietary
risks such as those resulting from occupational or residential exposure
to the pesticide. EPA uses the FFDCA section 408 standard in evaluating
dietary risks. EPA will not exempt pesticides under section 25(b)(2)
that fail the low probability of risk criterion. 

In evaluating a pesticide under the second exemption criterion, whether
the use of the pesticide is likely to cause unreasonable adverse effects
on the environment even in the absence of regulatory oversight under
FIFRA, EPA balances all the potential risks to human health, including
any dietary risks, and risks to the remainder of the environment from
use of the pesticide against the potential benefits associated with its
use. In balancing risks and benefits, EPA considers the economic,
social, and environmental costs and benefits of the use of the
pesticide. If the pesticide meets both exemption criteria, EPA may
exempt the pesticide from regulation under FIFRA section 25(b)(2). 

Under FFDCA section 408(a) (Attachment C), a pesticide chemical residue
in or on food is not safe unless EPA has issued either: a tolerance for
the residue and the residue is within the tolerance limits, or an
exemption from the requirement of a tolerance for the residue (21 U.S.C.
346a(a)(1)). FFDCA section 408 authorizes EPA to determine a residue is
safe and exempt from the requirement of a tolerance if the Administrator
“. . . has determined that there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information” (21 U.S.C.
346a(c)(2)(A)). Section 408 of the FFDCA also directs EPA to
specifically consider harm that may result to infants and children as a
result of pesticide chemical residues. 

 	A determination that a pesticide chemical meets the safety standard of
section 408(a) of the FFDCA may also be relevant to whether a pesticide
qualifies for a FIFRA section 25(b)(2) exemption with respect to human
health risks arising from other routes of exposure. However, FIFRA does
not provide for exemption of a pesticide in food based solely upon
consistency with the FFDCA section 408 exemption standard. At a minimum,
EPA also must evaluate risks arising from occupational exposure to
humans and determine that such risks meet both exemption criteria. In
addition, EPA must evaluate the risks to the environment from the
pesticide and determine both that the pesticide poses only a low
probability of environmental risks, and that use of the pesticide is not
likely to cause any unreasonable adverse effects on the remainder of the
environment in the absence of regulation under FIFRA. 

2(b) Practical Utility/Users of the Data 

EPA believes that requiring the substantiation of CBI claims for
plant-incorporated protectants at the time of submission to the Agency
will help ensure a timely EPA response to submissions for
plant-incorporated protectants, protect the public’s right to access
information consistent with FIFRA, and ensure that information
qualifying as CBI is properly protected from unauthorized disclosures.
Since registrants are already required to ensure that CBI claims are
proper prior to asserting the CBI protection for information submitted
to EPA, this requirement simply affects the time at which the
substantiation is submitted to the Agency, i.e., it requires the
inclusion of this substantiation with the submission. 

While the Agency’s analysis of the potential risks and benefits of
plant-incorporated protectants has led it to conclude that the
categories of plant-incorporated protectants described in 40 CFR part
174, subpart B warrant exemption, it is possible that there may be
unforeseeable adverse effects to human health or the environment from
the testing and use of otherwise 

exempted plant-incorporated protectants, as the exemptions at subpart B
are broad and cover literally thousands of potential substances, some of
which under certain use conditions have the potential to be toxic. The
Agency thus includes as a condition of exemption, a requirement to
report to EPA within 30 days any factual adverse effects associated with
these otherwise exempt plant-incorporated protectants. These reporting
requirements are similar to reporting requirements imposed on
registrants under FIFRA section 6(a)(2) for registered pesticides.
However, since the 6(a)(2) reporting requirement applies to registered
pesticides and many plant-incorporated protectants are exempted from
registration by the final FIFRA rule, the Agency imposed, under FIFRA
section 3 and 25(b) authorities, a separate reporting requirement to
obtain any information on unforeseen adverse effects from the exempted
plant-incorporated protectants. 

The information supplied to substantiate claims of confidentiality will
be used by the Agency to determine whether CBI claims comply with the
confidentiality provisions of FIFRA. Early substantiation of CBI claims
will enable the Agency to promptly release information supporting
plant-incorporated protectants registration decisions, without delaying
registrations in order to obtain CBI substantiation once a decision has
been made to register a plant-incorporated protectant, while still
protecting legitimate CBI. 

The adverse effects reports on exempted plant-incorporated protectants
will be utilized by the Agency to evaluate adverse effects to determine
if any additional regulatory actions are warranted. These reports will
also enable the Agency to report to appropriate oversight bodies and the
public its evaluation of such adverse effects and will help support any
additional decision on regulatory oversight. 

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

   CRITERIA

   3(a) Non duplication 

In fulfilling its mission as the Federal agency primarily responsible
for the regulation of pesticides, EPA works closely with the U.S.
Department of Agriculture (USDA) which has responsibilities under the
Federal Plant Protection Act (FPPA), and the U.S. Food and Drug
Administration (FDA) which has responsibilities under the FFDCA. EPA,
USDA and FDA consult and exchange information when such consultation is
helpful in resolving safety questions. The three agencies also strive
for consistency between programs, adopting consistent approaches, to the
extent permitted by the respective statutory authorities. A consistent
approach between agencies is easier for the regulated community to
understand. It is also more likely to conserve resources, as submitters
would more likely be able to use data developed for one agency to meet
requirements posed by another agency for the same or similar products. 

Generally, respondents are not required to submit applications or any
other related data or information regarding testing to any other federal
agency or to any other EPA program office. However, there may be
requirements under the FPPA for plants that produce plant-incorporated
protectants. Under the FPPA, the USDA's Animal and Plant Health
Inspection Service (APHIS) regulates field testing of genetically
altered plants, while EPA will have regulatory oversight of the
pesticide substances produced by those plants. In instances where review
under the FPPA may be triggered, the respondent will need to contact
APHIS for a determination of whether the plant containing a
plant-incorporated protectant is a plant pest that will need a permit. 

In any case, there is no known duplication related to the requirements
covered in this ICR, i.e., the up-front CBI substantiation or the
submission of adverse effects reports for exempted plant-incorporated
protectants. Each respondent must submit information unique to his/her
product application, or allegation received, and will do so only once on
occasion. 

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

	In preparing to renew this ICR, EPA published a notice in the Federal
Register which provided a 60-day public notice and comment period on the
draft ICR (see 72 FR 11862; March 14, 2007).  EPA did not receive
comment in response to this notice. 

3(c) Consultations 

In developing its approach to plant-incorporated protectants, EPA
requested advice from two scientific advisory groups at three meetings.
In 1992, a subpanel of the FIFRA Scientific Advisory Panel (SAP)
reviewed a draft proposed policy statement and answered a series of
scientific questions concerned primarily with EPA’s proposed
exemptions under FIFRA. The following year, a Subcommittee of the EPA
Biotechnology Science Advisory Committee (BSAC) met to address a series
of scientific questions concerned primarily with EPA’s proposed
exemptions under the FFDCA. In 1994, a joint meeting of these two groups
met to address a series of scientific questions on approaches to
plant-incorporated protectants under both FIFRA and FFDCA. Advice from
these scientific advisory groups was considered in finalizing this rule.


In addition to the public consultation described above, consultation
and/or dialogue between industry and managers in the Biopesticides and
Pollution Prevention Division (BPPD) of the Office of Pesticide Programs
(OPP) occurs on an informal, on-going, as-needed basis, during the
submission and review of an application for EUP or registration.
Experience has shown that if any sort of problem arises, be it
technical, administrative, or otherwise, or, if there are suggestions
for improvements in the program, the applicants will not hesitate to
inform BPPD. Any questions or consultations connected with a particular
submission are addressed in a meeting or telephone conversation with the
applicant, and do not necessarily occur at specified intervals. 

During the preparation of this ICR renewal, EPA staff contacted the
following representatives of pesticide registrants by e-mail and asked
them for their responses to questions concerning the information
collection and assessment of the burden estimates in the ICR (see
Attachment D): 

• Myrna Q. Sevilla, BHN Research, email:    HYPERLINK
"mailto:mqs@BHNseed.com"  mqs@BHNseed.com 

• Penny Hunst, Dow Agrosciences, email:   HYPERLINK
"mailto:felusrg@dow.com"  felusrg@dow.com 

• Russell Schneider, Monsanto Co., 202-383-2866, e-mail:   HYPERLINK
"mailto:russell.p.schneider@monsanto.com" 
russell.p.schneider@monsanto.com 

The registrants were asked only about up-front substantiation of
confidential business information claims. There have been no adverse
effects reporting for exempted PIPs. 

	The three respondents consulted generally agreed that the information
EPA asks for is not available from another source, and that the
instructions for submission are clear, although one suggested a standard
form for substantiation of CBI claims.  They also expressed interest in
electronic reporting, “but only if EPA can guarantee absolute secure
transmission and data storage,” as one respondent put it.  All three
stated that the burden estimates used by EPA in this ICR renewal request
are realistic.

3(d) Effects of Less Frequent Collection 

Not applicable. The information is submitted either in conjunction with
the application or when an adverse effect occurs for an exempted
plant-incorporated protectant. This activity is conducted only once per
"event," and therefore, there are no available means by which the Agency
can reduce the frequency. 

3(e) General Guidelines 

The collection activities covered by this ICR comply with the PRA
guidelines established by OMB. 

3(f) Confidentiality 

Although the EPA urges submitters to minimize the amount of information
that is claimed as CBI, any data and/or information submitted to the
Agency may be claimed as trade secret, or commercial or financial
information and will be protected from disclosure by the EPA under FIFRA
section 10 and the associated regulations as contained in 40 CFR Part 2,
Subpart B. When information that is claimed as trade secret or CBI is
provided to the Agency, such information is subject to the protections
and procedures set forth in FIFRA Section 10. Nothing in this rule
affects those protections. 

Even if a registrant fails to include the required substantiation for
any CBI claims made in the plant-incorporated protection application
when that application is submitted to EPA, the Agency intends to still
handle such claims in accordance with the FIFRA Confidential Business
Information Security Manual. This manual contains instructions relative
to all contact with confidential documents, including responsibility of
EPA employees, physical security measures, CBI materials within EPA, CBI
typing procedures (documents typed internally or by contract), and
interdivisional routing procedures. The manual dictates all CBI must be
marked or flagged as such, that it must be kept in secure, i.e.,
double-locked areas, and that all CBI to be destroyed must be cleared by
a document control officer and placed in EPA's paper shredder. 

3(g) Sensitive Questions 

Not applicable. No information of a sensitive or private nature is
requested in conjunction with this collection activity. Further, this
information collection activity complies with the provisions of the
Privacy Act of 1974 and OMB circular A-108. 

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 

4(a) Respondents/NAICS Codes 

The respondents for the information collection activities contained in
this ICR include producers and importers of plant-incorporated
protectants. These entities may be classified under the following North
American Industrial Classification System (NAICS) codes: 

32532	Pesticides and Other Agricultural Chemical Manufacturing



54171	Research and Development in the Physical, Engineering, and Life 

Sciences

325414	Biological Products (except Diagnostic) Manufacturing



611310	Colleges, Universities, and Professional Schools



422910	Farm Supplies Wholesalers 



422930	Flower, Nursery Stock, and Florists’ Supplies (Wholesalers) 





4(b) Information Requested 

(i) Data items, including record keeping requirements 

Registrants must continue to review the regulations regarding CBI,
review the materials in their submission for which claims are being
made; and ensure that CBI claims are properly made. Pursuant to the
final rule, registrants must submit a substantiation for any CBI claim
made for information for plant-incorporated protectants submitted to
EPA. The Agency is not imposing any new requirements regarding the basis
for making a CBI claim, or the points that must be addressed to
substantiate any CBI claim that is made. These requirements already
exist in 40 CFR part 2. In addition, EPA is not imposing any specific
form or format for these substantiations. (See 40 CFR 174.9) 

Manufacturers of plant-incorporated protectants exempted from
registration requirements (i.e., those exempted under FIFRA section
25(b) in the final rule), must submit to EPA any information they
subsequently obtain regarding adverse effects on human health or the
environment alleged to have been caused by the exempted
plant-incorporated protectant. The Agency anticipates that the entities
will obtain adverse effects information during the normal course of
business, and then will make a report to the Agency with adequate
background information for the Agency to be able to make a decision to
either ask for additional information or to act on the information
presented. The Agency does not foresee any extra data collection effort
to find adverse effects beyond the normal course of business but rather
envisions these effects being discovered from ongoing studies of various
plant-incorporated protectants or customer complaints. Although EPA
specifies the content of any adverse effects report submitted to EPA,
EPA is not imposing any specific form or format for these reports. (See
40 CFR 174.71) 

In addition, entities may also be asked to respond to Agency questions
that arise based on the submission, whether it be the CBI
substantiation, or the adverse effects report. Such follow-up activities
are assumed as part of the initial burden estimates. Should further
information be necessary, e.g., should the adverse effect information
reported to EPA indicate the need for a study or other additional
information, any additional Agency requirement would come in the form of
a data call-in covered under the existing regulations and ICR (Data
Call-Ins: Special Review and Registration Review;  OMB# 2070-0057;  EPA#
922.07). This ICR is not intended to address such activities. 

(ii) Respondent Activities 

 

The requirements for up-front CBI substantiation and adverse effects
reporting are separate requirements that only occur on occasion. The CBI
substantiation occurs when an entity is submitting plant-incorporated
protectant related information to EPA that contains CBI claims pursuant
to 40 CFR part 2. The adverse effects reporting occurs when an entity
obtains information regarding adverse effects on human health or the
environment alleged to have been caused by the exempted
plant-incorporated protectant. 

Although each activity is distinct, a typical respondent for each
activity is expected to engage in the following activities: 

Read Regulations	The respondent needs to become familiar with the
regulations governing CBI substantiation or adverse effects reporting as
they pertain to plant-incorporated protectants. 



Plan Activities	The respondent must develop/amend and implement a plan
to ensure compliance with these requirements. The registrant is also
encouraged to consult with the Agency. 



Gather Information	The information necessary to provide the required
substantiation or any information obtained on adverse effects must be
assembled.

Review Information	The respondent must check the CBI substantiation for
accuracy and completeness, or verify that the adverse effects report
accurately reflects the information they have obtained. 



Complete Paperwork	The information must be compiled into a document(s)
or report(s) and prepared for submission to EPA. 



Submit Information	The respondent must submit the information to the
Office of Pesticide Programs as required.

Store, Maintain, and File Information	The final rule does not contain
any new recordkeeping requirements. Please note however that FIFRA
section 8, and the related regulations in 40 CFR part 169, require
registrants to store and maintain certain information related to their
pesticide products. Since no new recordkeeping requirements were imposed
by this rule, EPA did not include any related burden in this ICR. 





5. 	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGIES, AND INFORMATION MANAGEMENT 

5(a) Agency Activities 

The Agency must evaluate the CBI substantiations when submitted, and
process any adverse effect reports for exempted plant-incorporated
protectants when received. Although these activities are distinct and
separate, the Agency is expected to engage in the following activities: 

Consult with the registrant	The Agency will respond to any questions
either in writing, or verbally via meetings or by telephone, and provide
any other assistance or guidance requested. 



Record submissions	Whether the submission involves an application
package for the registration of a plant-incorporated protectant, or an
adverse effects report for allegations related to an exempted
plant-incorporated protectant, the submission is recorded or logged in
by the Agency to document its receipt. The Agency will create an
electronic record of the necessary information for routing and tracking
purposes. 



Review submissions	The Agency will review the incoming materials with
CBI claims to evaluate the CBI substantiations for completeness and
appropriateness, and will review the incoming adverse effects reports to
determine what, if any, substantive review or action might be necessary
as follow-up to the alleged adverse effects. 



Store the information	The Agency will maintain the information contained
in the submitted application package, including the CBI substantiation
that was submitted, and will maintain any adverse effects report(s)
submitted. 





5(b) Collection Methodology and Management 

	Respondents to this ICR providing substantiation of CBI claims at the
time the claims are made must necessarily submit the information as part
of their larger package for registration of a pesticide product, since
it is parts of that package that are claimed as CBI.  Although EPA is
working to allow electronic submission of registration packages, they
are currently submitted by mail.

All information received by the Agency pertaining to CBI substantiation
or adverse effects for exempted plant-incorporated protectants will be
routed to the Biopesticides and Pollution Prevention Division (BPPD) of
the Office of Pesticide Programs (OPP). It will be pin-punched by date,
screened, and entered into the Office of Pesticide Programs Information
Network (OPPIN). 

For registration packages involving plant-incorporated protectants, a
file will be created and the application package will be forwarded to
the appropriate Manager within BPPD. The Manager assures that the
initial OPPIN entry is correct, reviews the information, and if
necessary, routes the submitted data through scientific and/or
administrative review. If the scientific information indicates that the
submission is deficient in any manner, the submitter has the option of
attempting to correct the deficiency. If the submission indicates that
information claimed as CBI warrants said claim, the applicant is
notified and the information is marked as such. The Agency will continue
current practice of treating information claimed as CBI as such, until a
CBI determination is made. If a determination is made that a CBI claim
is not warranted or the claim is not substantiated, the registrant will
be notified that the information claimed as CBI, does not qualify as CBI
because it does not meet the regulatory requirements. They will be given
an opportunity to respond as provided in the existing regulations. The
package will then be processed accordingly. 

For adverse effects reports related to exempted plant-incorporated
protectants, a file will be created and the report will be forwarded to
the appropriate product Manager within BPPD. The Manager assures that
the initial OPPIN entry is correct, reviews the information, and
determines the appropriate review and next steps based on the contents
of the report, routing the report through scientific and/or
administrative review, as appropriate. If an adverse effect report
indicates that additional action is warranted or necessary, the Agency
will take appropriate action. 

5(c) Small Entity Flexibility 

In promulgating the final rule, the Agency considered potential small
entity impacts, and has taken steps to minimize potential impacts to the
extent permitted. EPA believes that the CBI substantiation is fairly
easy to provide for information which warrants CBI claims. The entity,
regardless of size, is already required to make the CBI determination
prior to submitting its registration application to EPA. The final rule
simply requires that the information be provided with the submission to
substantiate the CBI claim. This is reflected in the relatively low cost
estimate for CBI substantiation for a plant-incorporated protectant
submission. This relatively small cost represents a reasonable step to
ensure the public has access to all non-confidential information on
plant-incorporated protectants once they are registered. 

In addition, the Agency has taken steps to ensure that only the person
who produces the exempted plant-incorporated protectant for sale and
distribution is responsible for adverse effects reporting, and only if
they obtain the adverse effects information. The Agency has designed
such reporting to be minimal and has placed the burden on the Agency to
take additional action beyond the entity making the report. 

5(d) Collection Schedule 

The CBI substantiation occurs only upon submission of claims of
confidentiality and the adverse effects reporting only occurs on
occasion. There is no collection schedule per se associated with these
collection activities. These activities are conducted once per
submission. 

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

6(a) Estimating Respondent Burden 

Burdens for this analysis consist primarily of the administrative burden
associated with the drafting and submission of the CBI substantiation
and the adverse effects reports. The burden estimates are based on the
Agency’s experience regarding existing burden estimates related to CBI
substantiation and adverse effects reporting for conventional
pesticides, and provide reasonable estimates for the average time
necessary to perform each activity for each submission. 

For purposes of this ICR, EPA is assuming that no more than 42
PIP-related registration applications with associated CBI
substantiations will be submitted over the three-year approval period
for this ICR, or 14 per year. The Agency has not received the numbers of
submissions projected during the period since this rule was promulgated.
This is due to the longer than expected time to develop new
plant-incorporated protectants and the continued lack of acceptance in a
number of foreign countries. The Agency is continuing to assume 14
applications, and therefore 14 associated CBI substantiations, per year
based on the fact that the number of PIPs-related registration
applications has been increasing.

Table 1 – Average Respondent Burden and Cost Estimates per Submission
for Substantiation of CBI Claims Made in a Plant-Incorporated Protectant
Registration Application

	Burden and Cost Estimates	Totals

Activities	Mgmt.

($100.86/hr)	Tech.

($64.80/hr)

	Clerical

($33.05/hr)

	Burden

(hrs)

	Costs

($)



Read Regulations	1($100.86)	2($129.60)	0	3	$230.46



Plan Activities	2 ($201.72)	4($259.20)	0	6	$460.92



Gather Information	0	4($259.20)	0	4	$259.20

Review Information	2 ($201.72)	1($64.80)	1($33.05)	4	$299.57



Complete Paperwork	0	1($64.80)	2($66.10)	3	$130.90



Submit Information	0.5($50.43)	0.5($32.40)	0.5($16.53)	1.5	$99.36



Totals	5.5($554.73)	12.5($810)	3.5($115.68)	21.5	$1,480.41





Estimated Total Annual Respondent Burden: 14 events x 21.5 hours = 301
hours

Estimated Total Annual Respondent Cost: 14 events x $1,480.41 =
$20,725.74

Although the Agency does not anticipate any adverse effect reports to be
submitted for exempted plant-incorporated protectants, this ICR includes
an estimate of one such report being submitted over the three-year
approval period for this ICR. The per-submission estimate is therefore
divided by 3 to provide an average annual burden and cost to include in
the total annual estimates for this ICR. The total annual average burden
and costs for the adverse effects report is calculated as follows: 

Table 2 - Average Respondent Burden and Cost Estimates per Submission
for Submitting an Adverse Effects Report for an Exempt
Plant-Incorporated Protectant



	Burden and Cost Estimates	Totals 



Activities	Mgmt.

($100.86/hr)

	Tech.

($64.80/hr)

	Clerical

($33.05/hr)

	Burden (hrs)	Costs ($)



Read Regulations	0.5 ($50.43)	1 ($64.80)	0	1.5	$115.23



Plan 

Activities 	0.5 ($50.43)	0.5 ($32.40)	0	1

	$82.83

Gather 

Information	0

	1 ($64.80)	0	1	$64.80

Review 

Information	0.5 ($50.43)	0.5 ($32.40)	0	1	$82.83

Complete 

Paperwork	0	0.5 ($32.40)	1 ($33.05)	1.5	$65.45

Submit 

Information 	0	0.5 ($32.40)	0.5 ($16.53)	1.0	$48.93

Cost for 

Mailing 	0	0	0	0	$0.39

Totals	1.5 ($151.29)	4 ($259.20)	1.5 ($49.58)	7	$460.46



Assuming a single adverse effects report submitted over three year
period:

Estimated Total Annual Respondent Burden: (1 event x 7 hours) ÷ 3 = 2.3
hours

Estimated Total Annual Respondent Cost: (1 event x $460.46) ÷ 3 =
$153.49

6(b) Estimating Respondent Costs 

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

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology cited above.  The respondent costs for this renewal for
managerial, technical and clerical rates are estimated at $100.86,
$64.80, and $33.05 per hour, respectively.  These labor rates are fully
loaded and include benefits and overhead costs. 

Since CBI substantiations are simply added to the registration
application package and are not submitted separately, there are no
additional costs related to the transmittal of this information to the
Agency. The costs for submitting the registration application package
are already included under the existing ICRs. 

These respondent burden and cost estimates may also represent an upper
bound because the analysis assumes that all plant-incorporated
protectant related registration applications will include information
that the registrants will claim as CBI which will need to substantiated.
It is likely that registrants will recognize, over time, that it is in
their interest to make all information on plant-incorporated protectants
publicly available to reduce, if not eliminate, the negative impressions
of genetically modified foods. 

6(c). Estimating Agency Burden and Costs 

The Agency will incur burden and costs while performing the various
activities necessary to review CBI substantiation submissions and any
adverse effects reports submitted for exempted plant-incorporated
protectants. These activities are described in Section 5 of this ICR and
may include the tracking and review of submissions, requests for
additional information, or consultations with applicants. 

Tables 3 and 4 provide the average EPA burden and cost estimates for
performing these activities.

Table 3 - Average Burden and Cost Estimates per Submission for EPA
Activities related to  CBI Substantiation 

	Burden and Cost Estimates 	Totals

Activities	Mgmt. 

($93.07/hr) 

	Tech. 

($66.34/hr) 

	Clerical 

($47.17/hr) 

	Burden (hrs) 

	Costs 

($) 



Consult With the 

Registrant 

	1 ($93.07) 	 3($199.02)	0.5($23.59)	4.5	$315.68

Record Submissions	0 

	0.5($33.17) 	1($47.17) 	1.5	$80.34

Review Submissions	1($93.07) 	2($132.68)	 0 	3 	$225.75

Store the Information	0 	0.5($33.17)	1 ($47.17)	1.5 	$80.34

Totals	2($186.14) 

	6($398.04) 	2.5($117.93) 	10.5 	$702.11



Assuming that each of the 14 registration applications expected annually
over the next 3 years involves CBI claims for which substantiation must
be reviewed by EPA, the total annual average burden and costs for the
Agency to process the CBI substantiations under this ICR is as follows: 

Estimated Total Annual Agency Burden: 14 events x 10.5 hours = 147 hours

Estimated Total Annual Agency Cost: 14 events x $702.11 = $9,829.54



Table 4 - Average Burden and Cost Estimates per Submission for EPA
Activities related to an Adverse Effects Report Submitted for an Exempt
Plant-Incorporated Protectant

	Burden and Cost Estimates 	Totals

Activities	Mgmt. 

($93.07/hr) 

	Tech. 

($66.34/hr) 

	Clerical 

($47.17/hr) 

	Burden (hrs)	Costs 

($) 



Consult With the 

Registrant 	0.5($46.54)  	 1 ($66.34)	0.5($23.59)	2	$136.46

Record Submissions	0 

	0.5($33.17)	1 ($47.17)	1.5	$80.34

Review Submissions	1 ($93.07) 	1 ($66.34)	0	2	$159.41

Store the Information	0 	0.5($33.17)	0.5($23.59)	1 	$56.76

Totals	1.5($139.61) 	3 ($199.02)	2 ($94.34)	6.5	$432.97

 

 	Assuming a single adverse effects report might be submitted over the 3
year approval period for the ICR, the total annual average burden and
costs for EPA activities related to the adverse effects report is
calculated as follows: 

Estimated Total Annual Agency Burden: (1 event x 6.5 hours) ÷ 3 = 2.2
hours

Estimated Total Annual Agency Cost: (1 event x $432.97) ÷ 3 = $144.32

In addition, the Agency may determine that additional follow-up action
is necessary for either type of submission and will be providing
necessary guidance for these requirements. 

6(d) Bottom Line Burden and Cost Table

The following table presents the total estimated annual burden and costs
for this ICR: 

Table 5 – Total Annual Burden and Cost Estimates

	Respondent	Agency	Totals

Activities	Burden 

(hrs) 	Costs 

($)	Burden 

(hrs) 

	Costs 

($) 

	Burden 

(hrs) 

	Costs 

($)

CBI Substantiations	301	20,725.74	147	9,829.54	448	30,555.28

Adverse Effects Reports	2.3	153.49	2.2	144.32	4.5	297.81

Totals	303	20,879	149	9,974	452	30,853.09

Columns and Rows may not add due to rounding



6(e) Reasons for Change in Burden 

The Agency does not anticipate a change in the burden.  The number of
actual submissions is not expected to change and the Agency finds no
basis to change the burden estimates per submission.  Therefore, the
burden hour estimates remain unchanged from the last renewal period.  

6(f) Burden Statement 

The total annual respondent burden for the collection of information
contained in this ICR is estimated to be 303 hours. The annual
respondent burden for the collection of information associated with the
substantiation at the time of submission for CBI claims related to a
plant-incorporated protectant registration application is estimated to
average 21.5 hours per submission, and the annual respondent burden for
the collection of information associated with the reporting of adverse
effects for exempted plant-incorporated protectants is estimated to
average 7 hours per submission. 

As defined by the PRA and 5 CFR 1320.3(b), “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency. This includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purpose of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing 

and providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information. 

An 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 numbers for EPA’s
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. 

To facilitate public comment on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, EPA has established a public docket for this ICR
under Docket ID No. EPA-HQ-OPP-2006-0860.  All documents in the docket
are listed in the docket index. Although listed in the index, some
information may not be publicly available, e.g., CBI or other
information whose disclosure is restricted by statute.  Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form.  Publicly
available docket materials are available either in the electronic docket
at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
, or, if only available in hard copy, at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is (703) 305-5805.

Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID No. EPA-HQ-OPP-2006-0860 and OMB Control No. 2070-0142
in any correspondence.



 

ATTACHMENTS TO THE SUPPORTING STATEMENT

ATTACHMENT A:  Regulations Under the Federal Insecticide, Fungicide, and
Rodenticide Act for Plant-Incorporated Protectants (Formerly
Plant-Pesticides); Final Rule (66 FR 37771)  is available at   HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2001/July/Day-19/p17981.htm" 
http://www.epa.gov/fedrgstr/EPA-PEST/2001/July/Day-19/p17981.htm  or as
part of the docket EPA-HQ-2006-0860 

ATTACHMENT B:  FIFRA Section 25(b) is available at    HYPERLINK
"http://www4.law.cornell.edu/uscode/7/ch6.html" 
http://www4.law.cornell.edu/uscode/7/ch6.html  or as part of the docket
EPA-HQ-2006-0860

ATTACHMENT C:  FFDCA Section 408(a) is available at   HYPERLINK
"http://www4.law.cornell.edu/uscode/21/ch9.html" 
http://www4.law.cornell.edu/uscode/21/ch9.html  or as part of the docket
EPA-HQ-2006-0860

ATTACHMENT D:  Record of Consultations Between the U.S. Environmental
Protection Agency and Respondents to the Information Collection Request
is only available as part of the docket EPA-HQ-2006-0860

ATTACHMENT E:  Methodology for Estimating OPP ICR Wage Rates for
Industry, State and EPA Labor Costs; Memo From Richard Keigwin, Director
Biological and Economic Analysis Division, to Bill Diamond, Arnold
Layne, Lois Rossi and Elizabeth Leovey July 25, 2006.   This document is
only available as part of the docket EPA-HQ-2006-0860

ATTACHMENT F:  Display Related to OMB Control #2070-0142 -Listings of
Related Regulations in 40 CFR 9.1 is available as part of the docket
EPA-HQ-2006-0860

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