Document ID: EPA-HQ-OPP-2010-0281-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2011-01-26T05:00Z

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.: 1693.07

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. 

The Agency promulgated a final rule, codified at 40 CFR part 174, that
addresses the regulatory status of pesticidal substances that are
produced by plants (plant-incorporated protectants). A
plant-incorporated protectant (PIP) 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 rule (Attachment A) exempts a wide range of
PIPs from registration requirements under FIFRA, and it imposes two new
requirements on manufacturers of some PIPs.

This Information Collection Request (ICR) covers the two information
collection related provisions contained in the 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 PIPs exempted from requirements
of registration under the final rule to report adverse effects to the
Agency.  The 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 40 CFR 174 requires the claimant to include the CBI
substantiation in the PIP- 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 rule. 

The provisions of 40 CFR 174 that are related to information collection
activities which 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 PIPs 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 PIPs at
the time of submission to the Agency will help ensure a timely EPA
response to submissions for PIPs, 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. 

The Agency’s analysis of the potential risks and benefits of PIPs has
led it to conclude that the categories of PIPs described in 40 CFR part
174, subpart B warrant exemption.  However, it is possible that there
may be unforeseeable adverse effects to human health or the environment
from the testing and use of otherwise exempted PIPs, 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 therefore included, as a condition of
exemption, a requirement to report to EPA within 30 days any factual
adverse effects associated with these otherwise exempt PIPs. 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 PIPs are exempted from registration requirements,
the separate reporting requirement is necessary in order to obtain any
information on unforeseen adverse effects from the exempted PIPs. 

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 PIPs
registration decisions, without delaying registrations in order to
obtain CBI substantiation once a decision has been made to register a
PIP, while still protecting legitimate CBI. 

The adverse effects reports on exempted PIPs 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 PIPs. 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 PIP is a plant pest that will need a permit.  In
addition, registrants may be required to obtain an experimental use
permit (EUP) for PIPs-related field trials.  In such cases, registrants
would be expected to comply with the applicable EUP requirements.  As
described in section 1(b) of this supporting statement, the paperwork
activities associated with EUPs are addressed in a separate ICR.  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 PIPs. 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 75 FR 24690; May 5, 2010).  EPA received one comment
during this period. According to the commenter, the current reporting
requirements are appropriate and do not constitute an undue burden on
the industry, including small businesses. The comment is available in
the public docket and can be viewed online at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov , referencing Docket
ID No. EPA–HQ–OPP–2010-0281.

3(c)  Consultations 

In developing its approach to PIPs, 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 PIPs under both FIFRA and FFDCA. Advice from
these scientific advisory groups was considered in developing the
provisions codified at 40 CFR 174. 

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 phone or e-mail
and asked them for their assessment of the burden and cost estimates in
the ICR:

Dr. Russell P. Schneider, Senior Director, Regulatory Affair and Policy,
Monsanto 		Company, russell.p.schneider@monsanto.com

Mr. Nick Storer, Dow AgroSciences, nstorer@dow.com

Tracy Rood, Senior Regulatory Manager, Pioneer Hi Bred, INC., A Dupont
Company, tracy.rood@pioneer.com

One representative provided comments on the ICR. The representative
agreed that EPA’s estimates for the burden associated CBI
substantiation are realistic, but noted that their company does not have
a good estimate for this burden. According to the same representative,
EPA underestimated the burden for adverse affects reporting.  The
representative did not, however, provide the Agency with alternative
burden and cost estimates for either CBI substantiation or adverse
affects reporting. Thus, the consultations did not provide the Agency
with sufficient basis to amend the burden or cost estimates.

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 PIP.
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 guidelines
provided under the PRA and the implementing regulations issued 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 PIP 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 PIPs. 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 40 CFR
174, registrants must submit a substantiation for any CBI claim made for
information for PIPs 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 PIPs exempted from registration requirements 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 PIP. 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 PIPs 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 Control No.
2070-0057; EPA ICR No. 922). 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 PIP 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 PIP. 

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 PIPs. 

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 PIPs 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 PIP, or an adverse effects report for
allegations related to an exempted PIP, 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 PIPs 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 PIPs, 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 PIPs, 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 requirements codified at 40 CFR 174, 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 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 PIP submission. This relatively small cost represents a reasonable
step to ensure the public has access to all non-confidential information
on PIPs once they are registered. 

In addition, the Agency has taken steps to ensure that only the person
who produces the exempted PIP 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 54
PIP-related registration applications with associated CBI
substantiations will be submitted over the three-year approval period
for this ICR, or 18 per year. This estimate is based on the average
number of submissions with CBI per year over the last two years.  Based
on the number of EUP applications over the last two years, EPA estimates
6 EUP applications per year, each of which requires a CBI list of EUP
cooperators.  Based on the number of PIP applications over the last two
years, EPA estimates that there may be up to 12 new PIP applications
each year, each of which may contain CBI.    

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.

($109.82/hr)	Tech.

($60.39/hr)	Clerical

($35.89/hr)	Burden

(hrs)	Costs

($)

Read Regulations	1	2	0	3	 230.60 

Plan Activities	2 	4	0	6	 461.19 

Gather Information	0	4	0	4	 241.56 

Review Information	2 	1	1	4	 315.92 

Complete Paperwork	0	1	2	3	 132.17 

Submit Information	0.5	0.5	0.5	1.5	 103.05 

Totals	5.5	12.5	3.5	21.5	1,484.48 

Estimated Total Annual Respondent Burden: 18 events x 21.5 hours = 387
hours

Estimated Total Annual Respondent Cost: 18 events x $1,484.48 = $26,721 

Although the Agency does not anticipate any adverse effect reports to be
submitted for exempted PIPs, 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.

($109.82/hr)	Tech.

($60.39/hr)	Clerical

($35.89/hr)	Burden (hrs)	Costs

($)

Read Regulations	0.5	1	0	1.5	115.30 

Plan Activities 	0.5	0.5	0	1	 85.10 

Gather Information	0	1 	0	1	 60.39 

Review Information	0.5 	0.5	0	1	 85.10 

Complete Paperwork	0	0.5	1 	1.5	 66.08 

Submit Information 	0	0.5 	0.5	1.0	 48.14 

Cost for Mailing 	0	0	0	0	 0.44 

Totals	1.5	4 	1.5	7	 460.56 

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 $460.56) ÷ 3 = $154

6(b)  Estimating Respondent Costs 

	Consistent with recent ICR renewals, OPP is using labor cost estimates
from Agency economists with respect to wages, benefits and overhead for
all labor categories for affected industries, state government, and EPA
employees.  This approach uses a transparent and consistent methodology
employing publicly-available data to provide more accurate estimates and
allow easy replication of the calculations.

	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 the Agency’s staffing costs.  

	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.  Attachments F and F.1 contain
worksheets providing the breakout of these costs.  Costs are indexed to
2008 data.  

To derive the labor rates for this ICR, Agency economists estimated the
wages for the management, technical, and clerical labor categories using
the methodology described in Attachment E.  The respondent costs for
this renewal for managerial, technical and clerical rates are estimated
at $109.82, $60.39, and $35.89 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 PIP-related registration applications may
include information that the registrants will claim as CBI which will
need to be substantiated. It is likely that registrants will recognize,
over time, that it is in their interest to make all information on PIPs
publicly available to improve the transparency of the regulatory
process.

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.

($107.56/hr)	Tech.

($71.58/hr)	Clerical

($41.21/hr)	Burden (hrs)	Costs

($)

Consult With Registrant 	1	3	0.5	4.5	342.91

Record Submissions	0	0.5	1	1.5	77.00

Review Submissions	1	2	0	3	250.73

Store the Information	0	0.5	1	1.5	77.00

Totals	2	6	2.5	10.5	747.64

Estimated Total Annual Agency Burden: 18 events x 10.5 hours = 189 hours

Estimated Total Annual Agency Cost: 18 events x $747.64 = $13,457. 

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

Activities	Burden and Cost Estimates	Totals

	Mgmt.

($107.56/hr)	Tech.

($71.58/hr)	Clerical

($41.21/hr)	Burden

(hrs)	Costs

($)

Consult With Registrant 	0.5 	 1 	0.5	2	 145.97 

Record Submissions	0	0.5	1	1.5	 77.00 

Review Submissions	1 	1	0	2	 179.14 

Store the Information	0 	0.5	0.5	1 	 56.40 

Totals	1.5 	3	2	6.5	 458.50 

 

 	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 $458.50) ÷ 3 = $153

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

Activities	Burden (hrs) 	Costs ($)	Burden (hrs) 	Costs ($)

CBI Substantiations	387 	 26,721 	 189 	 13,457 

Adverse Effects Reports	2 	 154 	 2 	 153 

Totals	389 	 26,875 	 191 	 13,610 

Columns and Rows may not add due to rounding

6(e)  Reasons for Change in Burden 

	The expected number of responses requiring CBI substantiation has
increased from 14 in the last ICR approval to 18 for this ICR renewal.
The number of adverse effect reporting submissions remains the same. 
The increase in the expected number of responses is primarily driven by
an expected increase in the number of applications for experimental use
permits requiring CBI substantiation. 

	The total burden hours per respondent has not changed for this ICR
renewal. However, because of the increase in CBI substantiations, the
total annual burden estimate has increased from 303 to 389 hours. The
annual respondent costs have also increased from $20,879 to $26,875. The
increase in CBI substantiations is the primary reason for the increase
in costs, although part of the cost increase is due to the rise in labor
cost when indexed to 2008 dollars. The annual burden increase represents
an adjustment.

6(f)  Burden Statement 

The total annual respondent burden for the collection of information
contained in this ICR is estimated to be 389 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 PIP
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 PIPs 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. 

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2010-0281, which is available for online viewing at
www.regulations.gov, or in person viewing at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays.  The docket
telephone number is (703) 305-5805.  You may submit comments regarding
the Agency's need for this information, the accuracy of the provided
burden estimates and any suggested methods for minimizing respondent
burden, including the use of automated collection techniques.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2010-0281 and
OMB Control No. 2070-0142, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2010-0281.  These attachments are available for online
viewing at www.regulations.gov or otherwise accessed as described in
section 6(f) of the supporting statement.

Attachment A:	40 CFR part 174 - Procedures And Requirements For Plant-
Incorporated Protectants. Also available online at the National Archives
and Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=73df279ae16b89
53054fc6a0436550e5;rgn=div5;view=text;node=40%3A23.0.1.1.24;idno=40;cc=e
cfr" Electronic CFR Webpage 

Attachment B	7 USC 136w(b) - FIFRA Section 25(b). Also available online
at the US House of Representatives’ Office of the Law Revision
Counsel’s   HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+20
31+7++%287%20USC%20136w%28b%29%20%29%20%20%20%20%20%20%20%20%20%20"  US
Code website 

Attachment C:	7 USC 346a(a) - FFDCA Section 408(a).  Also available
online at the US House of Representatives’ Office of the Law Revision
Counsel’s   HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t21t25+14
9+0++%28%29%20%20AND%20%28%2821%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28346a%29%29%3ACITE%20%20%20%20%20%20%20%20%20"  US Code
website 

Attachment D:	Record of Consultations

Attachment E:	Worksheet for Estimating OPP ICR Wage Rates for Industry,
State and EPA Labor Costs

Attachment F:

Attachment G:	Public Comment 

Display Related to OMB Control #2070-0142

July 26, 2010

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