SUPPORTING STATEMENT FOR 

AN INFORMATION COLLECTION REQUEST (ICR) 

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

a)	Title:	Submission of Unreasonable Adverse Effects Information under
FIFRA Section 6(a)(2)

             	ICR Nos.:  OMB No. 2070-0039; EPA No. 1204.11

b)	Abstract

This Information Collection Request (ICR) is a renewal of an existing
ICR that is currently approved by OMB and is due to expire October 31,
2010.  Section 6(a)(2) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), see Attachment A, requires pesticide
registrants to submit information to the Agency which may be relevant to
the balancing of the risks and benefits of a pesticide product.  The
statute requires the registrant to submit any factual information that
it acquires regarding adverse effects associated with its pesticidal
products, and it is up to the Agency to determine whether or not that
factual information constitutes an unreasonable adverse effect.  In
order to limit the amount of less meaningful information that might be
submitted to the Agency, the EPA has limited the scope of factual
information that the registrant must submit.  The agency’s regulations
at 40 CFR 159 provide a detailed description of the reporting
obligations of registrants under FIFRA section 6(a)(2). 

2.	NEED FOR AND USE OF THE COLLECTION

a)	Need/Authority for the Collection

This information collection stems from a non-discretionary statutory
requirement.  Submission of information about unreasonable adverse
effects is specifically required under section 6(a)(2) of the Federal
Insecticide Fungicide and Rodenticide Act (FIFRA) (7 USC 136d(a)(2)):  

"If at any time after the registration of a pesticide the registrant has
additional factual information regarding unreasonable adverse effects on
the environment of the pesticide, he shall submit such information to
the Administrator."  

The Agency’s FIFRA section 6(a)(2) regulations are codified in the
Code of Federal Regulations (CFR) at 40 CFR part 159, Attachment B, and
Agency guidance is available in Pesticide Registration Notice 98-3, see
Attachment C.   

In terms of scope, please note that in CSMA and NACA v. EPA, 484 F.
Supp. 513 (1980), the U.S. District Court for the District of Columbia
agreed with EPA that FIFRA Section 6(a)(2) covers all information
relevant to EPA's determination of whether a pesticide may cause
unreasonable adverse effects.  The Court agreed that submissible
information includes the same type of information as that provided by a
registrant as part of an application for registration.  The Court
specifically rejected the argument that the responsibility for
determining what constitutes an unreasonable adverse effect shifts to
industry once EPA has granted a registration.

b)	Practical Utility/Users of the Data

The Office of Pesticide Programs (OPP) is the primary user of the
information that registrants submit to the Agency under FIFRA section
6(a)(2).  The information submitted is an essential component of the
Agency’s pesticide registration and registration review programs which
also require the submission of important information regarding a
pesticide’s adverse effects -- information which may not have been
available at the time of the Agency’s initial review of a registration
application.  Because this information has possible significant
consequences for human health or the environment, had the information
been available earlier, the Agency’s determination with regard to the
registration of the pesticide may well have been different.  If
warranted by the information provided, EPA may seek to amend the
registration in order to address the concerns raised by the information.

In essence, this information provides an important means of focusing EPA
attention on key problem areas regarding the use of the pesticide in
question.  The adverse effects information submitted under section
6(a)(2) is considered by EPA in conjunction with other information to
determine whether pesticides containing a specific active ingredient
should be reregistered, or whether the terms and conditions of
registration should be changed.  This type of information may also be
pertinent to granting emergency exemptions under section 18 of FIFRA. 

Registrants perform studies in support of registration applications, in
response to data call-ins issued by EPA, or voluntarily for their own
purposes.  The authority to call-in data (a.k.a. DCI “data call-in”)
is found in section 3(c)(2)(B) of FIFRA, and the accounting for the
burden hours and costs for all OPP program DCIs is documented in the ICR
entitled the Pesticide Data Call-In Program ICR, OMB #2070-0174; EPA #
2288.01.  The outcome of studies, whether they demonstrate known effects
or new adverse effects, are carefully analyzed by registrants and
presented to the Agency.  The 6(a)(2) rule does not impose the
requirement to perform studies but merely to identify and promptly
submit adverse effects information to the Agency when they are
identified.

A number of registrants have indicated that adverse effects information
is valuable to them as well.  Registrants who actively seek 6(a)(2)
information justify their actions as part of product stewardship,
customer relations, minimizing liability, and protecting or expanding
market share.  According to feedback that EPA has received, registrants
acquire and use this information as a way of determining whether actual
product use circumstances reveal new risk issues that did not emerge
when the data were developed for the original registration application. 
These registrants believe that it is an integral part of their product
stewardship program and that collecting, analyzing and reacting to
adverse effects information is essential to the way in which they
conduct business as a routine matter.  For example, Consumer Specialty
Products Association, the trade association for registrants of
antimicrobial pesticide products, has a voluntary program for their
members called Product Care.  Among their principles is the need for
members to provide information to their customers and the need to have a
system in place to minimize adverse effects when product related
incidents occur.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

a)	Non-Duplication

The information required to be submitted under this ICR is generally
available only from registrants who have opted to secure registration of
their pesticide product(s).  The only feasible means of collecting the
required information is from pesticide registrants because it is either
health and safety data generated, owned or used by the registrants, or
is submitted to registrants by consumers and other interested parties. 
This information collection avoids duplication by limiting the
submission requirements under FIFRA section 6(a)(2) to information which
has not been submitted to the OPP previously.  Further, it exempts
information submitted under section 8(e) of the Toxic Substances Control
Act (TSCA).  Information in published articles is generally also exempt
from submission.

b)	Consultations

	As part of preparation of this ICR renewal, EPA contacted
representatives of a cross-section of pesticide registrants seeking
feedback on the adverse effect information reporting requirements and
processes as well as an assessment of the burden estimates associated
with this effort. The following companies were asked to participate in
the consultation process:

Syngenta CropProtection, Inc. (Dennis Hackett, 336-632-2535)

Clorox Services Company (Myranda Hanstedt, 925-425-6860)

Sysco Corporation (Richard Cottrell, 281-584-1793

Sunburst Chemicals, Inc. (Bill Scepanski, 952-886-3684)

Bayer CropScience (S. Gerret Van Duyn, 919-549-2914)

Canberra Corporation (John Wiegand, 419-841-6616)

	All companies provided comments except for Sunburst Chemical.
Individual responses are listed in Attachment G.  

	Regarding the availability for this information from another source,
all but one company agreed that there was no other source other than
what they learned themselves.  Bayer commented that some incident data
from universities is available to the EPA upon request.  EPA would
respond that universities have no responsibility to report under
6(a)(2), since they are not normally registrants.  But, EPA would need
to know which university department was holding the information in order
to direct a request to gather it.  EPA would not normally have this
information.

	Bayer also added that state poison control centers and administrative
departments also stored incident data.  Some of the state data is
available publicly, and EPA does gather some of this data for its
incident collections.  States often only summarize the details and
sometimes do not even report the exact products involved, which limits
the usefulness of some of this data.

	Regarding frequency of reporting there was mixed response.  Some
companies, such as Bayer, felt that those incidents required to be
reported on a monthly basis could be as effectively reported quarterly. 
Syngenta and Clorox felt that reporting could be done less frequently
and still be effective.  Sysco commented that the reporting could
perhaps be done less frequently but that the current reporting frequency
was not particularly burdensome to them.  Canberra felt that the current
schedule was acceptable.  EPA will certainly take these comments under
consideration.

	Most respondents indicated that the instructions for reporting adverse
effects information are normally clear, however some noted that
additional consultation with lawyers, outside consultants  and EPA
experts was also useful.  Canberra and Clorox felt the instructions were
clear.  Syngenta recommended improved content on EPA’s Adverse Effects
web page including FIFRA 6(a)(2) submissions and a Frequently Asked
Questions section.  EPA will certainly consider those suggestions.

	Bayer raised three issues regarding the clarity of the instructions,
which relate more to interpretation of the regulations than discussion
directly pertinent to the Paperwork Reduction Act (PRA) burden of the
Information Collection Request.  EPA has responded to Bayer directly on
these issues and a copy of the agency response has been placed in docket
# EPA-HQ-OPP-2009-0886 for this action.

	All respondents were clear that they needed to retain records. 
Canberra and Clorox felt the instructions were clear.  All respondents
except for Clorox made use of the Voluntary Incident Reporting Forms. 
Sysco Corporation commented that they used the forms “developed by
PROSAR Corporation,” a private company providing  poison control
center services and adverse event reporting for 6(a)(2) registrants. 
EPA would like to clarify this to say that a representative of PROSAR
did work with the industry work group that developed the Voluntary
Incident Reporting forms, and it makes use of them today.   (See a copy
of the Voluntary Incident Reporting Form in Attachment H.

	The response to questions regarding e-submission of adverse effects
information was decidedly mixed.  Syngenta and Bayer are currently using
the electronic submission process for major active ingredient
registration submissions and are willing to work with EPA towards
developing new processes for handling adverse effects information. 
Correspondence about adverse effects information within Syngenta is
usually handled through email, and they are moving towards a Documentum
based document management system as a supplement to their paper records
storage system.  At present they are more inclined to submit CBI on
paper rather than on diskette, CD, DVD, or via the web.  Clorox thinks
electronic reporting options should be pursued, and they are handling
their documents in both .pdf and .doc formats.  They are interested in
real time instantaneous submission of documents including CBI over
“secure web based transmission.”  Sysco is inclined to submit .pdf
documents via web based email.  Canberra Corporation indicates that they
keep their information in Word document format, and they have not been
successful using XML schema on other EPA e-submissions for labeling. 
They would prefer to submit CBI data on CD to the Agency as opposed to
sending it via the web.  Sysco Corporation also mentioned the cost of
sending information to the Agency via certified mail.

	Bayer commented that they understand that EPA’s ePRISM program for
electronic study submission is not meant for 6(a)(2) study submission,
and they have consequently not been using it for that reason.  Bayer is
correct in stating that EPA’s web site has not yet encouraged using
electronic submission methods for 6(a)(2) submissions, however the
Agency is working towards this goal.  The Agency does encourage
electronic reporting for other types of registration-oriented
submissions, see Electronic Submissions for Registering Pesticide
Products (  HYPERLINK
"http://www.epa.gov/pesticides/regulating/registering/submissions/" 
http://www.epa.gov/pesticides/regulating/registering/submissions/ ). 
Bayer adds that they support the use of electronic submission in terms
of direct data stream in order to avoid formatting and data entry errors
due to rekeying of data.  They also commented that providing incident
reports in an electronic format such as .pdf files would save
considerable time and allow for electronic archiving of data as opposed
to both electronic and hard copy archiving.

	The Agency agrees with many in industry that believe electronic
submission, particularly for respondents with large volumes of reporting
data, would greatly reduce a number of reporting errors related to
formatting and help reduce reporting and archival burdens.  However, as
noted by industry response, consensus on the type and method of
electronic reporting preferences vary greatly.  As EPA continues to
develop new electronic submission protocols to accommodate a broader
spectrum of pesticide activities, the Agency will continue to plan for
the development of infrastructure to accommodate electronic reporting to
support the needs of industry respondents both large and small.

	Regarding burden hours and costs, Canberra and Clorox felt the rates
were accurate.  Sysco did not comment on the labor rates.  Syngenta felt
the labor rates were fairly accurately reflected.  Syngenta felt the
burden hours were low, especially for training, and that is a priority
for such a large multinational corporation with many employees at
several foreign offices.  Syngenta also felt that flagging studies for
6(a)(2) submission required a committee of six to eight scientific and
technical experts meeting twice a month.  It should be noted that this
is a large company which tends to have higher expenditures for 6(a)(2)
work given the increased numbers of registrations and the global nature
of its research activities.  EPA’s regulations do require registrant
companies to decide which studies to submit to EPA with 6(a)(2)
flagging, but we believe the companies still have to review their
studies to decide which ones to submit anyway.  EPA believes the costs
of performing the studies are not significantly different depending on
whether they are submitted or not.  EPA’s estimates are averages
covering many, very small companies as well as a relatively small number
of very large companies.  The Agency also believes that it accounts for
all activities in estimating burden hours including record keeping,
staff training, and legal expertise.

Bayer Corporation, a large multinational company with many offices
worldwide, felt that the EPA cost burden estimate was considerably low. 
The burden information Bayer submitted as part of the company’s burden
analysis included, “scientific review of studies; contract services to
handle and report incidents on a timely basis; computerized reporting
systems; trending and analysis infrastructure and efforts; costs
associated with investigation of alleged field incidents; sample and
tissue analysis of affected plants and animals; legal fees and guidance;
archiving costs and systems, and employee time and efforts (as a
percentage of average salary and benefits).”  Since Bayer is a very
large global company, EPA believes Bayer probably has higher per hour
costs for 6(a)(2) reporting than most of the other 1,732 registrants
currently subject to 6(a)(2) reporting requirements.  However, some of
the burden activities Bayer has submitted to EPA are not Paperwork
Reduction Act (PRA) burdens.  The non-PRA burden activities include cost
associated with investigation of alleged field incidents, trending and
analysis infrastructure and efforts, and sample and tissue analysis of
affected plants and animals.  These activities are not required by the
regulation.  EPA also suspects that some of the other burden categories
Bayer described such as legal fees and guidance and contract services of
quality to handle and report incidents on a timely basis might also
contain an aggregation of 6(a)(2) PRA and non-PRA burden activities. 
Bayer did not provide enough of a detailed breakdown of these burden
activities for EPA to determine which activities were solely PRA burden
related.  Bayer also submitted a case for the inclusion of
“opportunity costs generated from delays in conducting business and
productivity costs associated with the time allocated for compliance
with 6a2.”   These are not PRA activity costs.  EPA calculates PRA
activity burdens as the minimum activities required by section 6(a)(2)
of FIFRA (40 CFR 159).  When the non-PRA burdens are deleted from the
Bayer burden activities, the Agency expects Bayer’s cost to be closer
to the industry sector averages for Pesticide, Fertilizer, and Other
Chemical Manufacturing (NAICS 325300) as calculated by the U.S. Bureau
of Labor Statistics (BLS) and used in the ICR.

Bayer also felt they had a capital investment due to the expenses of
their computerized reporting systems.  For small to midsize companies
the capital costs of data system investments to support 6(a)(2)
activities is aggregated within the cost of tracking a number of
business activities.  EPA assumes these companies do not have data
servers or departments dedicated solely to 6(a)(2) reporting.  EPA
calculations include overhead costs which accounts for a percentage of
the capital investment that uses a portion of the computerized
infrastructure to address 6(a)(2) reporting.  However, global companies,
like Bayer, have dedicated staff to track 6(a)(2), animal studies, and
pharmaceutical and other compliance tracking.  EPA understands global
companies have developed software and data systems to help fulfill their
compliance reporting requirements, but also notes these dedicated
department costs probably do not disaggregate the PRA and non-PRA
6(a)(2) reporting burdens.  EPA’s overhead cost formulas may or may
not sufficiently account for global companies with dedicated 6(a)(2)
reporting departments,  however, based on limitations of the data
submitted and a lack of information on the applicability of Bayer data
to the broader industry, EPA does not have sufficient information to
change the estimated per hour industry wage rates in the ICR.

Canberra also notes the costs of communicating to and training
distributors is an extra cost that can be substantial but did not submit
any data to allow the EPA to reconsider calculations.

EPA provides frequent consultation to assist in the understanding of the
6(a)(2) regulations. These activities have included dialogue between
industry and the Agency on adverse effects information reporting
requirements, content, definitions, format, and timing.  In addition to
phone conversations and preparing e-mails and letters, Agency staff
members have participated in meetings with individual registrants as
well as gatherings of large groups such as the Pesticide Program
Dialogue Committee.  These communications permit an exchange of issues,
problems and solutions on many issues.

c)	Public Notice Required Prior to ICR submission to OMB

Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR)
Notice on February 24, 2010 (75 FR 8336) announcing the proposed renewal
of this information collection activity and provided a 60-day public
comment period. No public comments were received. 

d)	Effect of Less Frequent Collection

Under FIFRA section 6(a)(2), the information collection activity is a
one time, non-repetitive submission of information.  As such, there is
no set interval for multiple collections.   The information is
submitted one time, according to the timeframes described in the rule
for various categories of information. 

e)	General Guidelines

Section 6(a)(2) regulations do not prescribe specific recordkeeping
requirements, the EPA requirements in 40 CFR Section 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 typical 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 for those studies which are required to support registration or
registration review under FIFRA section 3, and which show adverse
effects that make them reportable under section 6(a)(2).  The burdens
associated with this recordkeeping requirement have already been
approved by OMB under another ICR and are therefore excluded from this
ICR.

f)	Confidentiality 

Much of the information submitted pursuant to section 6(a)(2)
constitutes FIFRA section 10(d)(1) safety and efficacy information.  On
September 28, 1999, the Agency issued a class determination that safety
and efficacy information submitted under section 6(a)(2) of FIFRA is not
entitled to confidential treatment, Attachment E.  The determination
enables the Agency to respond more quickly and efficiently to requests
for information submitted under section 6(a)(2).  

Data submitted to the Agency are handled in accordance with the
provisions of the FIFRA Confidential Business Information (CBI) Security
Manual which provides procedures for protecting information claimed as
confidential in accordance with FIFRA section 10.  If the information is
not protected under FIFRA section 10, and it is not otherwise protected
from release under the Freedom of Information Act (FOIA), EPA is
obligated to make it available to members of the public upon request
under FOIA.

g)	Sensitive Questions 

No questions of a sensitive or private nature are included in this
information collection.  If information of a sensitive nature is
submitted, the Agency will protect it appropriately, as provided by the
Privacy Act or other relevant statutes.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

a)	Respondents/NAICS Codes

Potential respondents affected by the collection activities under this
ICR include anyone who holds or ever held a registration for a pesticide
product issued under FIFRA section 3 or 24(c). The North American
Industrial Classification System (NAICS) code is 325320 (Pesticide and
Other Agricultural Chemical Manufacturing).

b)	Information Requested

i)	Data Items

As further defined by the final rule implementing the FIFRA section
6(a)(2) requirements, registrants are required to report on: 

(1)  studies showing new or more severe toxicological responses than
previously reported of any type in any strain of test organism; 

(2)  epidemiological or exposure studies of human population groups
indicating greater exposure than previously reported; 

(3)  studies or incidents tending to show lack of efficacy of certain
pesticide products with public-health related uses;  

(4)  incidents involving toxic or adverse effects to human or other
non-target organisms; 

(5)  information on excess residues on food or feed, or residues in
surface water, ground water or drinking water; 

(6)  information on metabolites, degradates, contaminants or impurities
which may be of toxicological concern; 

(7)  information showing that certain health-related products fail to
perform as claimed or that pests have developed resistance to a product;
and 

(8) other information which may be relevant to risk/benefit
determinations of any type. 

ii)	Respondent Activities

Respondents must:

(1) read the final rule or instructions, 

(2) plan activities to ensure required information is identified and
submitted, 

(3) process, compile and review information for accuracy and
appropriateness, 

(4) complete written instruments to effectuate a submission, and 

(5) submit the information to EPA.

Under FIFRA section 6(a)(2), as implemented by the regulation in 40 CFR
part 159, pesticide registrants have no obligation to create or seek out
adverse effects information.  Such activities may be conducted by the
registrant in support of pesticide registration under FIFRA section 3
and registration review under section 3 (g), the burden account for
these activities are approved by OMB under separate ICRs.  Registrants
also may collect adverse information in the normal course of business,
such as following up on consumer complaints to gather more information. 
Regardless of how the information comes into the possession of the
registrant, once the registrant acquires information subject to
submission under section 6(a)(2), as defined by the regulations, the
registrant must submit it to EPA.  

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

a)	Agency Activities

The Agency will continue the following current activities with regard to
the FIFRA section 6(a)(2) program: 1) answering questions and providing
guidance to respondents; 2) receiving and recording data submissions; 3)
analyzing claims of confidentiality and providing appropriate
protection; 4) storing the data submitted; and 5) screening and
analyzing the information for significance.	 

b)	Collection Methodology and Management

The regulation allows flexibility in the method or format for the
required submission.  In essence, the regulationspecifies the types of
data that should be reported to the extent the information is available
and the reporting time-frames.   For incident information (but not
studies), these vary according to the significance of the information.

Scientific studies containing 6(a)(2) information are assigned a Master
Record Identifier Number as are all other pesticide studies.  Adverse
effects incident reports are entered into a computerized data base which
can track incidents by chemical, submitter, type of incident, date of
submission, and other parameters.  All 6(a)(2) submissions are screened
by subject matter experts throughout the pesticide program.  Data are
forwarded to and reviewed by pesticide product managers and science
reviewers for relevance to the regulatory status of the pesticide
product(s) to which the submitted information pertains.  The public may
access the data by making a request under FOIA.  

OPP has established criteria for voluntary submission of study reports
in electronic form (Adobe PDF on CD-ROM).  A 6(a)(2) study could be
submitted electronically just as easily as a non-6(a)(2) study. 
Regarding incidents, electronic submission is possible, but would
require a number of activities to be completed as prerequisites.  First,
OPP would work with registrants to develop a standard form for
submitting incident reports.  The resulting form would have to be
approved by OMB.  This standard form would be an essential precursor to
electronic submission of incident data.  The submission technique would
comply with the Agency’s electronic submission standards.  Finally,
OPP has been working on conversion of many of its existing databases to
a single integrated system.  The current incident data base is expected
to become part of an integrated system and this is an essential
precursor to electronic submission of incident data.

It should be noted that at the time the final regulations went into
effect and at the request of the regulated community, OPP staff worked
with industry representatives and trade associations on voluntary forms
for incident reporting.  This was done by the trade associations as a
service for their members.  The agency accepts incident reports using
the voluntary forms as well as incidents formatted in other ways.  The
voluntary forms may well serve as the foundation for standardized forms,
see Attachment H.  

c)	Small Entity Flexibility

Regardless of the size of the registrant, the 6(a)(2) regulations
provide simplified reporting and extended reporting time-frames for most
incident reports.  The Agency does not mandate a specific format for the
required submission, but, as noted above, has worked with industry to
provide one to facilitate submissions.  It is interesting to note that
of the 1733 registrants with active registrations in November 2008, 718
hold only one product registration and 762 hold from two to ten
registrations.  The median number of registrations per company is two.  

The requirements of FIFRA section 6(a)(2) related to studies fall
largely on basic producers, i.e., a producer who produces the active
ingredient from raw materials, because they are the registrants most
likely to generate and possess data subject to the information
collection.  Formulators (companies that do not manufacture active
ingredients) are exempt from generating most health effects data
required to support registration except for product-specific acute
toxicity studies. 

Both basic producers and formulators, however, may register and market
end use products and receive incident reports from distributors and
users of their products as well as other sources such as state
regulatory agencies.  The number of incident reports associated with a
pesticide product depends on such variables as the volume of sales of
that product, and whether it is sold to the general public or is
restricted to experienced and trained applicators.  Some registrants put
toll free telephone numbers on their labels making it easy for consumers
to contact them with incident reports.  Other registrants, however, do
not.  Thus, it is difficult to generalize about the relative burden of
incident reporting in terms of small versus large companies.  

To further simplify compliance, EPA has issued detailed guidance, see
Attachments C and D.  Because at the present time there is no standard
reporting format prescribed in the regulations, the submitters can use a
format of their choosing.  

d)	Collection Schedule

The information required to be submitted under FIFRA section 6(a)(2) is
not based on any schedule because the information is non-repetitive in
nature.  As such, the information required to be submitted by
respondents is generally on an "as received basis."  The regulations
establish time-frames within which reportable information received by
registrants must be submitted to EPA.  The reporting time-frames vary
according to the organism exposed and the relative severity or rarity of
the alleged effects.  Allegations of human deaths must be reported
individually by registrants within 15 days of acquiring the information.
 Other serious and rare incidents are reported individually.  Generally,
they may be accumulated for one month and submitted by the end of the
month following the accumulation period.  Minor or common incidents are
reported as aggregate counts of incidents and effects for each product
registration number or active ingredient.  They may be accumulated for
three months and submitted by the end of the second month following the
accumulation period. 

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

a)  Estimating Respondent Burden       

To estimate the respondent burden, the Agency used current statistics on
the number of registrants of active products.  For burden estimates
related to study and incident data submissions, actual statistics for FY
2006-2008 were used.

As of November 2008, for purposes of this analysis, the Agency assumes
1,733 registrants with active registrations.  The number of
registrations held by each registrant ranges from 1 to 705 and the
median is two.  Seven hundred and eighteen (718) registrants hold only
one product registration and 1,480 hold ten or fewer registrations. 
Thirty-three (33) registrants hold 51 - 100 product registrations.  Only
37 companies hold more than 100 registrations. 

Former registrants have an obligation to report adverse effects
information for one year after the cancellation or transfer of their
product so long as the former registrant holds no active registrations. 
Since stocks of the formerly registered products diminish, it is
unlikely these former registrants would acquire or submit much adverse
effects information to the Agency.  Former registrants, therefore, are
not included in the estimated 1,733 registrants assumed for this
analysis. 

 	The Agency received an average of 183 study-related submissions
annually from FY2006 through FY2008.  For purposes of this analysis, the
Agency assumes 183 study-related submissions will be received each year
in the future. 

From FY2006 through FY 2008, the Agency received an average of 956
submissions per year from registrants containing an average of 70,622
incidents per year.  Of these, 5,866 incidents were individually
reported and 64,756 were reported as aggregate statistics on the yearly
average. A small number of incidents, an average of 455 per year, were
reported by parties other than registrants.  These include states, EPA
regional offices, and private groups and individuals.  These parties are
not required to report adverse effects information to the Agency, but
their reports are received and processed in the same way as
registrant-submitted information. 

The level of registrant reporting could have been substantially higher
had it not been for action taken by the Agency to eliminate certain
types of incident reports.  The final regulations included the following
as a condition for reporting incidents:

40 CFR 159.184(a)(2) - The registrant is aware or has been informed that
the person or non-target organism suffered a toxic or adverse effect or
may suffer a delayed or chronic adverse effect in the future.  (Emphasis
added)

A literal interpretation of the italicized language above could have
resulted in registrants reporting all asymptomatic exposures.  Those are
cases in which someone alleges exposure to a pesticide, but is
experiencing no symptoms.  Or someone may call a registrant to ask if
they may get sick after an exposure or to express concern that they may
get sick in the future as a result of an exposure.  (These were referred
to as ‘may suffer’ incidents.)  OPP consulted with a major 

poison control center to determine the volume of asymptomatic exposure
calls they receive.  According to the poison control center’s
statistics for a major pesticide company, nearly half the calls they
handled were asymptomatic exposures.  In order to focus resources - both
the Agency’s and registrants’ - on a manageable volume of useful
incident reports, the Agency eliminated the requirement to report ‘may
suffer’ incidents.  This was accomplished in PR Notice 98-4
(Attachment D), which referenced the Agency’s authority under Part
159.155 of the FIFRA 6(a)(2) regulations to eliminate specified
requirements by written notice to registrants. Elimination of the
requirement is still in effect.

From FY2006 through FY2008 a total of 187 registrants submitted incident
reports.  Registrants may report for themselves alone or they may report
for themselves and related entities such as their divisions or
subsidiaries.  Registrant task forces such as the Acetochlor
Registration Partnership may report for their member registrants for
specific types of incidents. 

 

For purposes of this ICR renewal, the Agency estimates that it will
continue to receive 71,000 (rounded-up to two significant digits)
incident reports from the regulated community each year.  It is the
estimated number of incidents - not the total number of registrants or
number of registrants represented by current incident reporting - that
drives the burden estimates in this analysis. 

Another aspect of the respondents’ burden is ongoing employee training
on compliance with 6(a)(2) reporting requirements.  New employees would
require training and experienced employees are likely to receive
refresher training.  Each company would plan training and track the
status of training efforts.  For purposes of determining the number of
employees that need to be trained on adverse effects information
reporting, EPA assumed an average of 10 employees per registrant or
17,330 individuals requiring training each year.  Please note that this
estimate is strictly an average.  The actual number would range from one
person in a small company to several dozen in a large company.   The
Agency does not believe that a high proportion of people in any company
need detailed training in 6(a)(2) requirements.  Most employees who are
likely to receive information concerning the effects of pesticide
products are simply made aware of the need to pass information along to
an appropriate individual or unit within the company that evaluates
reports and prepares submissions to the Agency.

b)	Estimating Respondent Costs

i)	Estimating Labor 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 cited above.  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.

Tables 1 - 6 summarize the annual burden hours and costs to registrants
for compliance with the section 6(a)(2) requirements, including the PRA
calculations for employee 6(a)(2) training. 

Table 1: Annual Respondent Burden/Cost Estimates per Submission -
STUDIES

	BURDEN HOURS (PER STUDY)	TOTAL



COLLECTION ACTIVITIES	Management $109.82/hr	Technical $60.39/hr	Clerical
$35.89/hr	Hours	Costs ($)

Read Instructions	0.10	0.20	0.00	0.30	23.06

Create Information	0.00	1.00	0.00	1.00	 60.39

Compile and Review	0.10	0.50	0.00	0.60	41.18

Complete Paperwork	0.00	0.10	0.50	0.60	 23.98

Store and Maintain Data	0.00	0.20	0.50	0.70	 30.02

TOTAL	0.20	2.00	1.00	3.20	178.63

ANNUAL BURDEN: 3.2 Total Hours x 183 Studies =586 Hours

ANNUAL COSTS:  (a) Management: 0.20 hours/study x $109.82/hour x 183
Studies   = 	$   4,019 

    (b) Technical: 2.00 hours/study x $60.39/hour x 183 Studies 	=	$
22,103

   (c) Clerical:   1.00 hour/study x $35.89/hour x 183 Studies 	=	$  
6,568

  			                                       		TOTAL		=	$ 32,690

Table 2: Annual Respondent Burden/Cost Estimates per Submission -
INCIDENTS

	BURDEN HOURS (PER YEAR)	TOTAL



COLLECTION ACTIVITIES	Management $109.82/hr	Technical $60.39/hr	Clerical
$35.89/hr	

Hours	

Costs ($)

Read Instructions	0.00	0.10	0.00	0.10	6.04

Create Information	0.00	0.50	0.00	0.50	30.20

Compile and Review	0.20	0.50	0.00	0.70	52.16

Complete Paperwork	0.00	0.00	0.50	0.50	17.95

Store and Maintain Data	0.00	0.10	0.20	0.30	13.22

TOTAL	0.20	1.20	0.70	2.10	119.57

ANNUAL BURDEN:  2.10 Total Hours x 71,000 Incidents 	= 	149,100 Hours

ANNUAL COSTS: (a) Management:   0.20 hours x   $109.82 x 71,000
Incidents	=	$  1,559,444

   (b) Technical:       1.20 hours x   $60.39 x 71,000 Incidents	=	$ 
5,145,228

   (c) Clerical:          0.70 hours x   $35.89 x 71,000 Incidents 	=	$ 
1,783,733

  			                                       	TOTAL			=	$  8,488,405



Table 3: Total Annual Respondent Burden/Cost for Required Submissions

	Per Submission Estimates	Total Submissions Expected each Year	Totals

	Burden Hours	Costs ($)

Burden Hours	Costs ($)

Studies	3.2	178.63	    183	     586*	     32,690* 

Incident	2.1	119.56	

71,000	 149,100**	8,488,405**

TOTAL	5.3	298.19	71,183	149,686	 8,521,095

*taken from Table 1 calculations

**taken from Table 2 calculations

 Table 4: Registrant Burden/Cost Estimates for Additional Activities -
TRAINING 



Activities/registrants	Burden Hour per Respondent 	Totals

	Management $109.82/hr	Technical $60.39/hr	Clerical $35.89/hr	

Hours	

Costs ($)

Plan training	0.50	0.10	0.00	0.60	60.95

Conduct employee training 	0.50	1.50	1.00	3.00	181.39

Follow-up, tracking	0.00	0.10	0.20	0.30	13.22

 Total 	1.00	1.70	1.20	3.90	255.55



Table 5: Total Registrant Burden/Cost Estimates for Additional
Activities -TRAINING



Activity	Per Registrant - Total	# Expected	Totals

	Hours	Costs ($)

Hours	Costs ($)

Plan training 	

0.6*	60.95	1,733	1,040	105,625

Conduct employee training 	

3.0*	181.39	17,330	51,990	3,143,402

Follow-up, tracking	

0.3*	13.22	1,733	520	22,905

Total 	3.9*	255.55	20,796	53,550	3,271,932

 	* taken from Table 4

Table 6: Total Annual Burden/Cost for Registrants

	Per Activity Total Estimates	

Total Activities 	Totals

	Burden Hours	Costs ($)

Burden Hours	Costs ($)

Studies	3.2	255.60	     183	        586*	     32,690* 

Incidents	2.1	168.60	  71,000	  149,100**	

8,488,405**

Training	3.9	346.50 	       20,796***	53,550***	3,271,932***

TOTAL



203,236	

11,793,027

*taken from Table 1 calculations

**taken from Table 2 calculations

	***taken from Table 5

ii)	Estimating Capital, and Operations and Maintenance Costs

There are no capital expenditures, or operation and maintenance costs
associated with this information collection activity.

c)	Estimating Agency Burden and Cost

Agency activities include: screening 6(a)(2) submissions by subject
matter experts to determine the significance of the information;
information management activities to record, file, and track the
submissions; communicating with registrants, providing guidance on the
requirements; and management and oversight of the process. 

Screening and managing submitted information involves a mixture of
technical and clerical skills.  Agency economists estimated the labor
rates for EPA employees conducting these tasks.   The EPA fully loaded
employee costs for this renewal for technical and clerical rates are
estimated at $71.58 and $41.21 per hour, respectively, a detailed work
sheet of these formulas are in Attachment F.  These labor rates are
fully loaded and include benefits and overhead costs.  

The Agency burden estimate does not include the effort to fully review a
6(a)(2) study or to prepare the resulting documents.  Nor does the
burden estimate include the effort to take regulatory action that may
result from 6(a)(2) adverse effects information.  The burden associated
with those activities is covered under other ICR’s. This ICR does
include the costs of subject matter experts reviewing incident
reporting.  The following tables illustrate the estimated Agency burden
and costs:	

Table 7: Annual Agency Burden/Cost Estimates per Submission - STUDIES



	BURDEN HOURS (per year)	TOTAL

COLLECTION ACTIVITIES	Technical

 $71.58/hr 	Clerical

 $41.21/hr 	Hours	Costs ($)

Screen submitted information	2.00	0.00	2.00	143.16

Record, file and track submissions	3.60	0.90	4.50	294.78

TOTAL	5.60	0.90	6.50	437.94

ANNUAL BURDEN: 	6.5 Total Hours x 183 studies		=	1,190  Hours

ANNUAL COSTS: 	(a) Technical: 5.6 hours x $71.58 x 183 studies		=	$  
$73,355  

(b) Clerical: 0.9 hours x $41.21 x 183 studies 		=	$       6,787

                                				         TOTAL		=	$     80,142

Table 8: Annual Agency Burden/Cost Estimates per Submission - INCIDENTS

	BURDEN HOURS (per year)	TOTAL

COLLECTION ACTIVITIES	Technical

 $71.58/hr 	Clerical

 $41.21/hr 	Hours	

Costs ($)

Screen submitted information	0.132	0.00	0.132	9.43

Record, file and track submissions	0.0205	0.029	0.050	2.66

Communications, Guidance	0.025	0.00	0.025	1.79

TOTAL	0.177	0.029	0.207	13.88

ANNUAL BURDEN: 0.207 Total Hours x 71,000 submissions		=	14,697 Hours

ANNUAL COSTS: (a) Technical: 0.177 hours x $71.58 x 71,000 submissions  
 =$    899,546  

  (b) Clerical: 0.029 hours x 41.21 x 71,000 submissions       = $      
84,845

                                           	TOTAL					         =$  
984,391

Table 9: Total Annual Burden/Cost for Agency

	Per Submission Estimates	Total Submissions Expected each Year	Totals

	Burden Hours	Costs ($)

Burden Hours	Costs ($)

Studies	6.50	437.94	    183	    1,190*	80,142*

Incidents	0.207	   13.88 	71,000	     14,697**	984,391**

TOTAL



  15,887	  1,064,533

	*taken from Table 7 calculations

	**taken from Table 8 calculations			

d)  Bottom Line Hours and Costs Tables

The total burden hours and costs for respondents and the Agency have
been calculated and are presented in Table 10:

Table 10: MASTER TABLE	TOTAL    



	Hours	Cost

Annual Respondent Burden/Cost Estimates	203,236*	 $11,793,027* 

Annual Agency Burden/Cost Estimates	     15,887**  	     $1,064,533**

TOTAL	219,123	 $12,857,560  

*taken from Table 6

**taken from Table 9

The average per respondent burden is 117.27 hours (203,236 total hours
( 1,733 total potential respondents), and the average cost is $6,805 per
respondent ($11,793,027 total cost ( 1,733 total potential respondents).
 Not all of the potential respondents are likely to submit information
each year. This calculation is a simple average of the burden and does
not reflect the more likely potential respondent burden which is
characterized by the type of submission, the number of registrations
held, and the number of incidents that need to be reported. 

Reasons for Change in Burden

For the respondent burden, in the previous ICR OMB approved 167,316
burden hours for submission of information from pesticide registrants
under FIFRA 6(a)(2) with a cost of $9,809,591.  This ICR renewal request
reflects an increase of approximately 35,920 burden hours to an annual
respondent burden of 203,236 hours at a cost of $11,793,027.  This
reflects an adjustment in the number of registrants of active products
(1,733 versus 1,720) and an increase in burden to account for additional
employees being trained, per commenters suggestion.  The change in
burden is an adjustment. 

The Agency burden has increased, which reflects an increase in the
number of incident submissions and more communications relating to
incident data.  Total burden hour estimates associated with studies are
reduced because the estimated number of study submissions is reduced
from 240 studies to 183.  Burden estimates associated with the number of
incident reports, however, are increased because of the increased volume
of incident reporting (31%).  Overall, considering both the decrease in
studies and the increase in incidents, the total respondent burden hours
increased from 167,316 to 203,236.  The change in burden is an
adjustment.   

Calculations of labor rates and related burden costs have changed for
both EPA and respondents. In previous renewals cycles, the Agency merely
adjusted the labor rates to account for inflation.  However, for this
renewal, Agency economists have completely re-estimated wages, benefits,
and overhead for all labor categories for both Agency employees and
respondents.  Therefore, total burden costs have increased, but may not
be directly comparable to the previous ICR.

f)	Burden Statement

The total annual "respondent" (applicant) is estimated to be 203,236
hours, with an average potential per respondent burden of 117.27 hours. 
According to the PRA, “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 numbers for EPA’s regulations, after initial display in the
final rule, are listed in 40 CFR part 9, and appear on the information
collection instrument as applicable, i.e., form or instructions.       

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OPP-2009-0886.  An electronic version of the public docket is
available at   HYPERLINK "http://www.regulations.gov/" 
http://www.regulations.gov/ which may be used to obtain a copy of the
draft collection of information, submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search,” then key in the docket ID number
identified in this document.  The documents are also available for
public viewing at the OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Room S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington VA.  The Docket is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
 The telephone number for the Docket is (703) 305-5806.  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 Number EPA-HQ-OPP-2009-0886, the EPA ICR Number 1204.11 and OMB
Control Number 2070-0039 in any correspondence, but do not submit
6(a)(2) information to this address.  The 6(a)(2) information should be
submitted to USEPA, Office of Pesticide Programs as specified in 40 CFR
150.17 and 40 CFR 159.156.

7.	LIST OF ATTACHMENTS

	All of the attachments listed below can be found in the docket for this
ICR, or as part of the supporting statement or are available via a link
(unless otherwise noted); accessible electronically through   HYPERLINK
"http://www.regulations.gov/"  www.Regulations.gov  . On the main page,
select Advanced Search from the menu bar at the top and select Docket
Search. Enter the Docket ID Number, EPA-HQ-OPP-2009-0886 in the Docket
ID field. Click on the Submit button. From the results page, you will be
able to link to the docket view or directly open select documents found
in the docket.

ATTACHMENT A:	

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) – Section
6(a)(2) (7 USC 136d),   HYPERLINK
"http://www.law.cornell.edu/uscode/7/usc_sec_07_00000136---d000-.html" 
http://www.law.cornell.edu/uscode/7/usc_sec_07_00000136---d000-.html 

 

ATTACHMENT B:	

FIFRA Section 6(a)(2) Reporting Requirements - Codified as 40 CFR part
159.

ATTACHMENT C:	

PR Notice 98-3 - Guidance on Final FIFRA 6(a)(2) Regulations for
Pesticide Product Registrants see   HYPERLINK
"http://www.epa.gov/PR_Notices/"  http://www.epa.gov/PR_Notices/  

ATTACHMENT D:	

PR Notice 98-4 - Additional Guidance on Final FIFRA Section 6(a)(2)
Regulations for Pesticide Product Registrants (w/Attachment) see  
HYPERLINK "http://www.epa.gov/PR_Notices/" 
http://www.epa.gov/PR_Notices/ 

ATTACHMENT E:	

Class Determination Regarding Confidentiality of 6(a)(2) Information

  HYPERLINK
"http://www.epa.gov/EPA-PEST/1999/December/Day-15/p32185.htm" 
http://www.epa.gov/EPA-PEST/1999/December/Day-15/p32185.htm 

ATTACHMENT F:	

Worksheet for Estimating OPP ICR Wages Rates for Industry, State, and
EPA Labor Costs

ATTACHMENT G: 	

List of Consultation Questions and Responses for 6(a)(2)

	

ATTACHMENT H: 	

Industry’s Voluntary 6(a)(2) Incident Reporting Forms & Guidance
Documents see  

  HYPERLINK "http://www.epa.gov/pesticides/fifra6a2/" 
http://www.epa.gov/pesticides/fifra6a2/ .

		August 10, 2010

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