Icr-ss-2249.01-2009-04-15

April 15, 2009

SUPPORTING STATEMENT FOR AN
INFORMATION COLLECTION REQUEST (ICR)

1.

IDENTIFICATION OF THE INFORMATION COLLECTION
1(a) Title of the Information Collection:
Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor
Screening Program (EDSP)
EPA ICR No.: 2249.01; OMB Control No.: 2070-(tbd)
Docket ID No.: EPA-HQ-OPPT-2007-1081

1(b) Short Characterization/Abstract
This is a new information collection request (ICR) under the Paperwork
Reduction Act (PRA), 44 USC 3501 et seq., covering the information collection activities
associated with Tier 1 screening of the first group of chemicals under the Endocrine
Disruptor Screening Program (EDSP). The EDSP is established under §408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires endocrine screening of
all pesticide chemicals. To view the statutory language, see Attachment A.
The Agency first proposed the basic components of the EDSP on August 11,
1998 (Ref. 1). After public comments, external consultations and peer review, EPA
provided additional details about the EDSP on December 28, 1998 (Ref. 2). The EDSP
consists of a two-tiered approach to screen all pesticide chemicals for potential
endocrine disrupting effects. The purpose of Tier 1 screening (referred to as
“screening”) is to identify substances that have the potential to interact with the
estrogen, androgen, or thyroid hormone systems using a battery of assays. The
purpose of Tier 2 testing (referred to as “testing”), is to identify and establish a doseresponse relationship for any adverse effects that might result from the interactions
identified through the Tier 1 assays. Additional information about the EDSP is available
through the Agency’s Web site at http://www.epa.gov/scipoly/oscpendo/index.htm.
The focus of this ICR is on the information collection activities associated with the
Tier 1 screening of the first group of chemicals identified for initial screening under the
EDSP. The list of chemicals was produced using the approach described in a Federal
Register notice issued on September 27, 2005, and includes chemicals that the
Agency, in its discretion, has decided should be tested first based upon exposure
potential (Ref. 3). Nothing in the approach for generating the initial list provides a basis
to infer that by simply being on this list these chemicals are suspected to interfere with
the endocrine systems of humans or other species, and it would be inappropriate to do
so. As such, the list of chemicals resulting from the application of this approach should
not be construed as a list of known or likely endocrine disruptors.
After considering comments on the draft list of chemicals issued on June 18,
2007 for public review and comment (Ref. 4), EPA finalized the list of chemicals to be
the first to undergo Tier 1 screening on April 3, 2009 (Ref. 5). The first group of
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chemicals identified for testing includes pesticide active ingredients and High Production
Volume (HPV) chemicals used as pesticide inerts. For purposes of the public review
draft of this ICR, the Agency used the draft list of chemicals to calculate the burden and
cost estimates. Since the final list is now available, this ICR uses the final list of
chemicals (see Attachment G). More information on the EPA’s priority setting approach
and the list of chemicals is available at
http://www.epa.gov/scipoly/oscpendo/prioritysetting.
On April 3, 2009, after considering comments on a draft Policy and Procedures
Document that was issued on December 13, 2007 (Ref. 6), EPA signed a document
describing the specific details of the policies and procedures that EPA generally intends
to adopt for initial screening under the EDSP, including the statutory requirements
associated with and format of the Orders that will be used to request the Tier 1 data, as
well as EPA's procedures for fair and equitable sharing of test costs and handling
confidential data (Ref. 7). The Policy and Procedures Document (see Attachment B)
describes the administrative policies and procedures that EPA generally intends to use
in implementing the EDSP for initial screening, and serves as the general source for the
information collection activities associated with the issuance of Orders for Tier 1
screening under the EDSP, which are covered by this ICR.
While the requirements in the statutes and the individual Tier 1 Orders are
binding on EPA and the Order recipients, the Policy and Procedures Document does
not impose any binding requirements. The policies and procedures described in the
Policy and Procedures Document are not intended to be binding on either EPA or any
outside parties, and EPA may depart from them where circumstances warrant and
without prior notice. The Tier 1 Order, however, is binding on the Order recipient and
non-compliance with the provisions in the Order will result in penalties as described in
the Order.
This ICR only covers the information collection activities related to Tier 1
screening of the chemicals on the final list in Attachment G. It does NOT cover the
information collection activities related to Tier 2 testing. EPA will prepare a separate
ICR to address the information collection activities associated with Tier 2 testing. In
addition, subsequent Tier 1 screening of additional chemicals not identified in
Attachment G will be addressed separately, either in a separate ICR or in an
amendment to this ICR. In either case, EPA will follow the notice and comment process
prescribed by the PRA to first seek public comment on the new or revised ICR before
submitting it to OMB for review and approval under the PRA.

2.

NEED FOR AND USE OF THE COLLECTION
2(a) Need/Authority for the Collection
2(a)(i) Authority

The EDSP was established in 1998 to carry out the mandate in §408(p) of the
FFDCA (see Attachment A), which directs EPA “to develop a screening program . . . to

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determine whether certain substances may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen, or such other endocrine effect as
the Administrator may designate.” If a substance is found to have an effect, section
408(p)(6) directs the administrator to take action under available statutory authority to
ensure protection of public health. That is, the ultimate purpose of the EDSP is to
provide information to the Agency that will allow the Agency to evaluate the risks
associated with the use of a chemical and take appropriate steps to mitigate any risks.
The necessary information includes identifying any adverse effects that might result
from the interaction of a substance with the endocrine system and establishing a doseresponse curve.
FFDCA section 408(p)(1) requires EPA “to develop a screening program, using
appropriate validated test systems and other scientifically relevant information to
determine whether certain substances may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen, or such other effects as [EPA]
may designate.” [21 U.S.C. 346a(p)].
FFDCA section 408(p)(3) expressly requires that EPA “shall provide for the
testing of all pesticide chemicals.” FFDCA section 201 defines “pesticide chemical” as
“any substance that is a pesticide within the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), including all active and pesticide inert
ingredients of such pesticide.” [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)]. The
statute also provides EPA with discretionary authority to “provide for the testing of any
other substance that may have an effect that is cumulative to an effect of a pesticide
chemical if the Administrator determines that a substantial population may be exposed
to such a substance.” [21 U.S.C. 346a(p)(3)].
FFDCA section 408(p)(5)(A) provides that the Administrator “shall issue an order
to a registrant of a substance for which testing is required [under FFDCA section
408(p)], or to a person who manufactures or imports a substance for which testing is
required [under FFDCA section 408(p)], to conduct testing in accordance with the
screening program, and submit information obtained from the testing to the
Administrator within a reasonable time period” that the Agency determines is sufficient
for the generation of the information.”
FFDCA section 408(p)(5)(B) requires that, “to the extent practicable, the
Administrator shall minimize duplicative testing of the same substance for the same
endocrine effect, develop, as appropriate, procedures for fair and equitable sharing of
test costs, and develop, as necessary, procedures for handling of confidential business
information. . . .” [21 U.S.C. 346a (p)(5)(B)].
If a registrant fails to comply with an Order issued under FFDCA section
408(p)(5), the Administrator is required to issue “a notice of intent to suspend the sale or
distribution of the substance by the registrant. Any suspension proposed under this
paragraph shall become final at the end of the 30–day period beginning on the date that
the registrant receives the notice of intent to suspend, unless during that period, a
person adversely affected by the notice requests a hearing or the Administrator
determines that the registrant has complied fully with this paragraph.” [21 U.S.C. 346a
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(p)(5)(C)]. Any hearing is required to be conducted in accordance with section 554 of
the Administrative Procedures Act (APA). [5 U.S.C. 554]. FFDCA section 408(p)
explicitly provides that “the only matter for resolution at the hearing shall be whether the
registrant has failed to comply with a test order under subparagraph (A) of this
paragraph.” [21 U.S.C. 346a (p)(5)(C)(ii)]. A decision by the Administrator after
completion of a hearing is considered to be a final Agency action. [21 U.S.C. 346a
(p)(5)(C)(ii)]. The Administrator shall terminate a suspension issued with respect to a
registrant if the Administrator determines that the registrant has complied fully with
FFDCA section 408(p)(5). [21 U.S.C. 346a (p)(5)(C)(iii)].
FFDCA section 408(p)(5)(D) provides that any person (other than a registrant)
who fails to comply with an order issued under FFDCA section 408(p)(5) shall be liable
for the same penalties and sanctions as are provided for under section 16 of the Toxic
Substances Control Act (TSCA). [21 U.S.C. 346a (p)(5)(D)]. Such penalties and
sanctions shall be assessed and imposed in the same manner as provided in TSCA
section 16. Under section 16 of TSCA, civil penalties of up to $25,000 per day may be
assessed, after notice and an administrative hearing held on the record in accordance
with section 554 of the APA. [15 U.S.C. 2615(a)(1)–(2)(A)].
FFDCA section 408(f) establishes procedures that the Agency “shall use” to
require data to support the continuation of a tolerance or exemption that is in effect.
The provision identifies three options:
•
•
•

Issuance of a notice to the person holding a pesticide registration under FIFRA
section 3(c)(2)(B) [FFDCA section 408(f)(1)(A)].
Issuance of a rule under section 4 of TSCA [FFDCA section 408(f)(1)(B)].
Publication of a notice in the Federal Register requiring submission, by certain
dates, of a commitment to generate the data “by one or more interested
persons.” [FFDCA section 408(f)(1)(C)].

Before using the third option, however, EPA must demonstrate why the data
“could not be obtained” using either of the first two options. FFDCA section 408(f)(1)
expressly provides that EPA may use these procedures to “require data or information
pertaining to whether the pesticide chemical may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen or other endocrine
effects.” Finally, FFDCA section 408(f)(1)(B) provides that, in the event of failure to
comply with a rule under TSCA section 4 or an order under FFDCA section
408(f)(1)(C), EPA may, after notice and opportunity for public comment, modify or
revoke any tolerance or exemption to which the data are relevant.
In addition, FFDCA section 408(i) provides that “[d]ata that are or have been
submitted to the Administrator under this section or FFDCA section 409 in support of a
tolerance or an exemption from a tolerance shall be entitled to confidential treatment for
reasons of business confidentiality and to exclusive use and data compensation to the
same extent provided by section 3 and section 10 of [FIFRA].”
A number of other statutory provisions are discussed in this document and,
consequently, are also described in this section.
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FIFRA section 3(c)(1)(F) provides certain protections for people who submit data
to EPA in connection with decisions under EPA's pesticide regulatory program.
Specifically, FIFRA section 3(c)(1)(F) confers “exclusive use” or “data compensation”
rights on certain persons (“original data submitters”) who submit data (in which they
have an ownership interest), in support of an application for registration, reregistration,
or experimental use permit, or to maintain an existing registration.
Applicants who cite qualifying data previously submitted to the Agency by the
original data submitter must certify that the original data submitter has granted
permission to the applicant to cite data or that the applicant has made an offer of
compensation to the original data submitter. In the case of “exclusive use” data, the
applicant must obtain the permission of the original data submitter and certify to the
Agency that the applicant has obtained written authorization from the original data
submitter. (Data are generally entitled to “exclusive use” for 10 years after the date of
the initial registration of a pesticide product containing a new active ingredient.) If data
are not subject to exclusive use but are compensable, an applicant may cite the data
without the permission of the original data submitter, so long as the applicant offers to
pay compensation for the right to rely on the data. (Data are “compensable” for 15
years after the date on which the data were originally submitted.) If an applicant and an
original data submitter cannot agree on the appropriate amount of compensation, either
may initiate binding arbitration to reach a determination. If an applicant fails to comply
with either the statutory requirements or the provisions of a compensation agreement or
an arbitration decision, the application or registration is subject to denial or cancellation.
[See also 7 U.S.C. 136a (c)(1)(F)(ii)–(iii)].
FIFRA section 3(c)(2)(B) provides that “. . .[i]f the Administrator determines that
additional data are required to maintain in effect an existing registration of a pesticide,
the Administrator shall notify all existing registrants of the pesticide to which the
determination relates and provide a list of such registrants to any interested person.” [7
U.S.C. 136a(c)(2)(B)]. Continued registration of a pesticide requires that its use not
result in “unreasonable adverse effects on the environment” (defined as “(1) any
unreasonable risk to man or the environment, taking into account the economic, social,
and environmental cost and benefits of the use of any pesticide, or (2) a human dietary
risk from residues that results from a use of a pesticide in or on any food inconsistent
with the standard under section 408 of the [FFDCA].” [7 U.S.C. 136(bb)].
FIFRA section 3(c)(2)(B) contains a mechanism by which recipients of notices of
data requirements (referred to as “Data Call-In notices” or “DCI notices”) may jointly
develop data and provides that “[a]ny registrant who offers to share in the cost of
producing the data shall be entitled to examine and rely upon such data in support of
maintenance of such registration.” The section establishes procedures to allow
registrants who received DCI notices to use binding arbitration to resolve disputes about
each person's fair share of the testing costs.
Further, FIFRA section 3(c)(1)(F) makes clear that data submitted under FIFRA
section 3(c)(2)(B) are also “compensable” when cited in support of an application for a
registration. In other words, a pesticide company that chooses to rely on such data
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rather than develop its own data must offer compensation to the original data submitter
– usually the data generator. Lastly, the Agency may suspend the registration of a
pesticide if the registrant fails to take appropriate steps to provide data required under a
DCI notice in a timely manner.
Finally, FIFRA section 3(c)(2)(D) contains a provision, referred to as the
“formulator's exemption” that is intended to simplify and promote equity in the
implementation of the data compensation program under FIFRA section 3(c)(1)(F). This
exemption relieves an applicant of the obligation to submit a study, or to cite and obtain
permission or offer to pay data compensation to cite the results of a study if the study is
relevant to the safety assessment of a registered product that the applicant buys from
another person and uses to make the applicant's product. Congress' rationale for this
exemption is that the seller will recover any data generation costs through the purchase
price of its product. Thus, if a pesticide formulator applies to register a product
containing an active ingredient that the formulator purchased from the basic
manufacturer of the active ingredient, the formulator does not need to submit or cite and
offer to pay compensation for any data specifically relevant to the purchased product.
The Agency has extended the principles of the formulator’s exemption to data
requirements under FIFRA section 3(c)(2)(B). Consequently, if the formulator received
a DCI notice requiring data on the active ingredient, the formulator could comply by
providing documentation that it bought the active ingredient from another registrant.
In addition, section 1457 of the Safe Drinking Water Act (SDWA) provides EPA
with discretionary authority to require testing, under the FFDCA section 408(p)
screening program, “of any other substances that may be found in sources of drinking
water if the Administrator determines that a substantial population may be exposed to
such substance.” [42 U.S.C. 300j–17].
2(a)(ii) Need
In addition to fulfilling a direct statutory mandate, the collection of information
under this ICR is needed in order to provide information to the Agency that will allow the
Agency to identify substances that have the potential to interact with the estrogen,
androgen, or thyroid hormone systems using a battery of assays. The fact that a
substance may interact with a hormone system, however, does not mean that when the
substance is used, it will cause adverse effects in humans or ecological systems.
In the last two decades there has been a growing awareness of the possible
adverse effects in humans and wildlife from exposure to chemicals that can interfere
with the endocrine system. These effects can include developmental malformations,
interference with reproduction, increased cancer risk, and disturbances in the immune
and nervous system function. Clear evidence exists that some chemicals cause these
effects in wildlife, but limited evidence exists for the potential of chemicals to cause
these effects in humans at environmental exposure levels. Very few chemicals have
been tested as to their potential to interfere with the endocrine system, and it has been
recognized that current standard test methods do not provide adequate data to identify
potential endocrine disruptors (EDs) or to assess their risks to humans and wildlife. In
light of these concerns, the 1996 Food Quality Protection Act (FQPA) amended FFDCA
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to include a mandate for EPA to set up the EDSP using validated methods to test all
pesticide chemicals (and other substances that may have cumulative effect of a
pesticide or a substantial population is exposed) for their potential to interact with the
endocrine system. To access an overview of the endocrine system and information on
endocrine disruptors go to
http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/primer.htm.

2(b) Use/Users of the Data
In general, EPA intends to use the data collected under the EDSP, along with
other information, to determine if the chemical may pose a risk to human health or the
environment due to disruption of the endocrine system. The determination that a
chemical does or is not likely to have the potential to interact with the endocrine system
(i.e., disruption of the estrogen, androgen, or thyroid hormone systems) will be made on
a weight-of-evidence basis taking into account data from the Tier 1 assays and/or other
scientifically relevant information.
The data collected under Tier 1 will allow the Agency to evaluate the potential
interaction of a chemical with the endocrine system. EPA has extensive experience in
using data from multiple sources to develop integrated assessments of hazard, modes
of action / mechanisms of toxicity, and overall potential for risk. EPA scientists will
continue to use such experience, together with insights from the validation process for
Tier 1 assays, to address the potential of chemicals to cause adverse effects as a
consequence of interaction with the endocrine system. In fact, EPA has considered the
potential interaction of a chemical with the endocrine system in making certain pesticide
registration decisions. For example, EPA considered data from prototypes of the
assays included in the current EDSP Tier 1 screen, along with other existing data, in
preparing the risk assessments of procymidone1 and vinclozolin2.
The Agency intends to take a weight-of-evidence approach to evaluate the
available data for a particular chemical to determine whether the potential endocrine
disrupting effects associated with the use of the chemical can be ascertained with the
data available, or whether additional data is needed. Chemicals that go through Tier 1
screening and are found to have the potential to interact with the estrogen, androgen, or
thyroid hormone systems will proceed to the next stage of the EDSP where EPA will
determine which, if any, of the Tier 2 tests are necessary based on the available data.
Tier 2 testing is designed to identify any adverse endocrine-related effects caused by
the substance, and establish a quantitative relationship between the dose and that
endocrine effect.
In addition to helping determine whether or not Tier 2 testing is necessary for a
particular substance, the Tier 1 screening data may also be used to determine what
kind of Tier 2 data is appropriate, and whether or not similar substances might share
common mechanisms. Subsequently, when used with the Tier 2 testing data, the Tier 1
1 To access the procymidone decision, go to http://www.epa.gov/pesticides/reregistration/procymidone/.
2 To access the vinclozolin decision, go to http://www.epa.gov/pesticides/reregistration/vinclozolin/.
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screening data will become a part of the risk characterization of a pesticide that is
intrinsic to FIFRA and FFDCA decisions.
The tiered approach for screening (Tier 1) and testing (Tier 2) that EPA is using
under the EDSP is the most cost-effective and least burdensome approach for
complying with the statutory mandate to screen all pesticides for endocrine disruptor
effects. Instead of requiring that all pesticides undergo the testing that would be
necessary to determine (a) whether the substance causes adverse endocrine-related
effects, (b) identify the adverse endocrine-related effects caused by the substance, and
(c) establish a quantitative relationship between the dose and the adverse endocrinerelated effect, EPA determined that it would be more efficient (and would use fewer
animals) to conduct the less expensive and less complex Tier 1 screening to identify
those substances that have the potential to interact with the estrogen, androgen and
thyroid hormone systems.
The paperwork related requirements imposed on the respondents as part of Tier
1 screening under the EDSP allow EPA to ensure that the identified screening data will
be developed, that the results will meet basic scientific standards, that unforeseen
complications or issues can be promptly addressed, and that the screening is
progressing on schedule so that the data will be available for consideration in time for
anticipated regulatory decisions as required under FIFRA and FFDCA.
Within the Office of Prevention, Pesticides and Toxic Substances (OPPTS), the
Office of Pesticide Programs (OPP) and the Office of Science Coordination and Policy
(OSCP) will be responsible for issuance of the Orders, receiving, processing and
maintaining records of responses to the Orders, as well as other administrative
functions related to the Orders. OSCP and OPP will coordinate the review of Tier 1
screening data received and resulting determinations related to the subject chemical.
As indicated previously, this ICR only applies to Tier 1 screening. A subsequent
ICR will address Tier 2 testing. Tier 2 is discussed here only in the context of the use of
Tier 1 data.

3.

NON-DUPLICATION, CONSULTATION, & OTHER COLLECTION
CRITERIA
3(a) Non-duplication

The information collected under this program is collected by no other federal
agency or any other office within EPA. FFDCA specifically assigns this task to EPA. As
described above, this information is required for EPA’s evaluation of endocrine
disrupting effects and of the health and environmental effects and economic benefits
associated with the use of chemicals and pesticides that are shown to have ED effects.
The EDSP is the only program in the United States mandated to validate assays and
require testing of chemicals for their potential to disrupt the endocrine system. Prior to
the passage of the FQPA and initiation of EDSP, there were no validated methods to
screen or test chemicals for their potential to affect the endocrine system.
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The Agency has a strong commitment to avoiding potential duplication in all of its
testing programs, and actively promotes efficiency through its harmonized test
guidelines and active participation in the rigorous scientific effort to identify data needs
for risk assessments, develop testing protocols, and develop new methods for testing
chemicals that minimize potential duplication, create greater efficiencies in testing, and
minimize the use of animals in testing.
As a charter member of the Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM), EPA is working in a manner consistent
with the interagency validation framework in the development and refinement of assays
to reduce animal use, refine procedures involving animals to make them less stressful,
and replace the use of animals in tests where scientifically appropriate. When complete,
EPA will use these validated methods or assays to identify and characterize the
endocrine activity of pesticides, commercial chemicals, and environmental
contaminants, specifically in relation to estrogen, androgen, and thyroid hormones.
The Agency considered these goals in developing the procedures for the EDSP,
both those procedures used within EPA and those that might be used by the
respondents. For example, when a chemical is manufactured by several companies,
the procedures encourage the companies to join together to develop and submit the
requested data to EPA. In addition, Order recipients and other interested stakeholders
will be able to cite existing or submit other scientifically relevant data that they believe
meet the screening requirements defined in the Order. This is described in more detail
in the Policy and Procedures Document (Attachment B).

3(b) Public Notice Required Prior to ICR Submission to OMB
On December 13, 2007, EPA published a notice in the Federal Register to
provide a 60-day public notice and comment period on the draft ICR (Ref. 8). EPA
received comments from 11 entities, and has prepared a Response to Comment
document that can be found in Attachment H. Several changes were made to the ICR
in response to public comments, ranging from language changes to increase overall
understanding to specific changes in the burden activities and estimates. The
substantive changes are highlighted in this section.
Several commenters felt that the ICR needed to include the cost and burden for
the potential need to conduct analytical chemistry tests on the substance to be tested.
Recognizing that this test is a standard prerequisite to conducting any tests on a
particular substance because it is used to define the substance being tested, EPA has
added this element and the related cost and burden to this ICR.
Several commenters asserted that the estimated test costs used to calculate
data generation burden appeared to be low because it is not clear whether the
estimates considered the final protocols. Since the Tier 1 screens are still new and are
not yet provided by the commercial laboratories, more refined cost estimates are simply
not available at this time. Nevertheless, EPA has increased the estimated test costs
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used to calculate data generation burden, and intends to conduct a thorough evaluation
of the test costs as part of its evaluation of the Tier 1 process established for the initial
screening of chemicals under the EDSP.
To facilitate completion of the initial response within the 90 days, EPA revised the
Initial Response Form to more clearly identify the response options for the two different
kinds of entities that might receive an Order, and created a new Initial Response Form
for the Consortium. There are now two Forms (see Attachment D) - One form is for use
by the Individual Order recipient and the other is for use when a Consortium provides
their group’s response. EPA intends to include both of the Initial Response Forms in
the EDSP Order Packet that is sent to the recipients.
Other changes are identified within the Agency’s responses to the comments
(see Attachment H).

3(c) Consultations
Since the establishment of EDSP in 1998, EPA has consulted with various
stakeholders throughout its development and implementation efforts, including:
agrichemical and commodity chemical industries, environmental organizations, public
health organizations, academia, animal welfare organizations, state governments, and
federal agencies, including consultation with the Department of Health and Human
Services. A historical overview of the external consultations and public comment
opportunities provided since 1996 is available at
http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/index.htm.
In addition to the solicitation of public comment on the Agency’s draft policy and
procedures for implementing the EDSP (Ref. 6), the draft List (Ref. 4), and the draft ICR
(Ref. 8), EPA held two public workshops with interested parties. The workshops
provided an opportunity for the Agency and stakeholders to discuss comments and
questions about the draft policy, procedures and this ICR, as well as share ideas and
information about potential improvements. These workshops contributed to
improvements in this ICR.

3(d) Effects of Less Frequent Collection
Once per chemical substance is the statutory minimum, because FFDCA section
408(p)(3) specifically requires that EPA “shall provide for the testing of all pesticide
chemicals,” unless the Agency can determine that the chemical qualifies for the
statutory exemption—i.e., that it is not anticipated to interact with the endocrine system.
In addition, a recipient of an Order for Tier 1 screening may provide an initial
response that could justify delaying Tier 1 screening or, although expected to be rare for
the initial group of chemicals, allowing the company to go directly to Tier 2. The Agency
will consider any such requests on a case-by-case or chemical-by-chemical basis and
will provide a written response that will be made publicly available. In some cases, the
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Agency’s response to an individual requester may be applicable to all Order recipients
for that chemical or could otherwise provide insight to recipients of Orders for other
chemicals.
For purposes of this ICR, the Agency assumes that all recipients of an Order for
Tier 1 screening will provide an initial response and either generate the data or join a
consortium to generate the data, while the submission of a progress report and the data
will occur only once per chemical.

3(e) General PRA Guidelines
The one general PRA guideline that is exceeded by this collection is the time
period for retaining records. When data are generated to support a pesticide
registration under FIFRA, EPA requirements in 40 CFR 169.2(k) apply, which state that
records containing research data relating to registered pesticides be retained for as long
as the registration is valid and the producer remains in business. Registrations are valid
until they are either voluntarily cancelled or withdrawn by the registrant or until EPA has
cause to suspend or cancel the registration. Since the average period of marketability
of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other
than health, medical or tax records not be required to be retained for more than three
years will be exceeded in this ICR.
In those regulatory cases where the Agency’s action may be challenged, it is
imperative that all records, raw data, and specimens be available. Recognizing this, the
recordkeeping requirements in 40 CFR part 169 were authorized to exceed the PRA
general guidelines when they were established. Those requirements are being adopted
unchanged under the EDSP for these chemicals because the data submitted would be
used to support pesticide registration related decisions under FIFRA and FFDCA.

3(f)

Confidentiality

In general, most health and safety data submitted by registrants, manufacturers,
and importers under FFDCA are considered to contain no Confidential Business
Information (CBI). Although FFDCA §408(p)(5)(B) requires that EPA develop, to the
extent practicable and as necessary, procedures for the handling of confidential
business information, it does not provide the authority for the Agency to either create
new rights or to modify existing rights to confidentiality. Rather, EPA believes that this
provision directs the Agency to create procedures that operate within the existing
confines of FIFRA §10, the Freedom of Information Act (FOIA), and the Trade Secrets
Act.
As discussed in more detail in the Policy and Procedures Document (Attachment
B), because the data would support a tolerance or exemption from the requirement of a
tolerance, FFDCA §408(i) provides that much of the data submitted in response to an
Order issued under FFDCA §408(p) would be subject to the protections in FIFRA §10.
In addition, CBI submitted by pesticide registrants in response to an Order issued under
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FFDCA §408(p) would be considered as part of the registration process, and would
therefore be considered to be data submitted in support of a registration. However
covered, data subject to FIFRA §10 would be provided certain protections that go
beyond those authorized by FOIA. For example, FIFRA §10(g) generally prohibits EPA
from releasing information submitted by a registrant under FIFRA to a foreign or
multinational pesticide producer, and requires the Agency to obtain an affirmation from
all persons seeking access to such information that they will not disclose the information
to a foreign or multinational producer. FFDCA §408(i) extends the protection available
under FIFRA §10 for data submitted in support of a tolerance or tolerance exemption.
All other confidential business information submitted in response to an Order
issued under FFDCA §408(p) (i.e., data not in support of a registration or
tolerance/tolerance exemption) is only protected by the provisions of FOIA and the
Trade Secret Act. FOIA requires agencies to make information available to the public
upon request, except for information that is “specifically made confidential by other
statutes” or data that are “trade secrets and commercial or financial information
obtained from a person and is privileged or confidential.” [5 U.S.C. §552]. Note that
substantive criteria must be met to claim confidentiality of business information, as
specified in 40 CFR §2.208.
EPA would consider that data submitted jointly with a registrant, or as part of a
consortium in which pesticide registrants participate, to be data submitted in support of
a tolerance/tolerance exemption or registration, and therefore entitled to protection
under FIFRA §10. However, if a non-registrant chooses not to partner with a registrant,
such data would only be subject to the protections available under FOIA and the Trade
Secrets Act.

3(g) Sensitive Questions
No information of a sensitive or private nature is requested in conjunction with
this information 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

Respondents to this ICR consist of those individuals and companies that receive
an Order issued under FFDCA §408(p) by the Agency to collect Tier 1 screening data
under the EDSP. Under FFDCA §408(p)(5)(A), EPA “shall issue” Orders “to a
registrant of a substance for which testing is required . . . or to a person who
manufactures or imports a substance for which testing is required.” EPA has
generally identified the following categories of potential recipients of the Tier 1 Orders:

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• Registrants - Entities who manufacture or import a pesticide active ingredient or
inert ingredient and hold an active EPA registration for that substance. In the
pesticide universe, there are Technical Registrants (basic manufacturers) and
End-Use Registrants (customers). A Technical Registrant manufactures or
imports the active ingredient or inert ingredient that is, in most cases, used in the
formulation of other pesticide products. An End-Use Registrant manufactures or
imports the end-use product that contains an active ingredient or an inert
ingredient that they obtain from a technical registrant. Although the Technical
Registrant can also be an End-Use Registrant, the Agency’s focus for purposes
of the Tier 1 Orders is on the Technical Registrant.
• Manufacturers/Importer – Persons who manufacture or import a chemical
substance but do NOT hold an EPA registration for that substance. For the most
part, the chemical substances may be used as an inert ingredient in a pesticide,
but also have other non-pesticidal uses.
The Agency used the following North American Industrial Classification System
(NAICS) codes to obtain publicly available information about potential respondents that
informed the estimates presented in this ICR:
• Chemical Manufacturers and Processors (NAICS code 325), e.g., persons who
manufacture, import or process chemical substances.
• Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing (NAICS code
3253), e.g., persons who manufacture, import or process pesticide, fertilizer and
agricultural chemicals. This includes Producers & Formulators of Pesticide
Products (NAICS code 32532); Producers of Antifouling Paints (NAICS code
32551); Producers of Antimicrobial Pesticides (NAICS code 32561); and
Producers of Nitrogen Stabilizers (NAICS code 32531).
• Scientific research and development services (NAICS code 5417), e.g., persons
who conduct testing of chemical substances for endocrine effects. These entities
will not receive Orders, but their potential involvement in responding to
paperwork activities did inform the estimates presented in this ICR.
Although final identification of all the specific individual recipients for the Tier 1
Order for each of the initial chemicals will not be finalized until the Orders are being
prepared for final issuance, the Agency has updated the preliminary searches
completed for the draft ICR in 2007. Specifically, the Agency searched internal data
sources to identify potential recipients, or respondents for the purposes of estimating
the burden in this ICR. For example, the Agency used internal OPP data sources to
identify the technical registrants and the end-use product registrants for pesticide active
ingredients on the initial list, and used the data from the TSCA Inventory Update Rule
(IUR) database to identify manufacturers and importers of the HPV chemicals identified
as inert ingredients on the initial list. It is important to note that the IUR data are based
on reports from companies that domestically manufacture or import the chemical in
quantities greater than 10,000 lbs/yr at a single site in 1998 and 2002 and in quantities
greater than 25,000 lbs/yr at a single site in 2006. Since such thresholds do not exist
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for EDSP, the use of IUR data may not have identified everyone that should receive a
Tier 1 Order. As such, when the Agency identifies the final recipients of the Tier 1
Order, it intends to also search a few external public sources of information in an
attempt to identify other manufacturers and importers of the listed chemicals. For this
same reason, the Agency has increased the number of potential respondents used for
calculating the burden and cost in this ICR, as discussed later in this section.
For purposes of calculating the number of potential respondents for this ICR, the
Agency divided the respondents into three categories: 1) Order Recipients; 2) Data
Generators/Submitters; and 3) Consortium Participants. The Order Recipients category
includes everyone that could receive an Order issued under FFDCA §408(p) for these
chemicals; the Data Generators/ Submitters category includes one company for each
chemical; and the Consortium Participants category includes the Order recipients that
are not in the Data Generators/Submitters category. Table 1 presents the estimated
number of respondents based on the Agency’s efforts to date to identify potential Order
recipients.
In addition to the Order recipients identified by the Agency, EPA may issue an
Order under FFDCA §408(p)(5) to a manufacturer or importer who enters the
marketplace after the issuance of the initial Orders and when they begin to sell an inert
ingredient following the submission of required EDSP data on the ingredient by
manufacturers or importers who were in the marketplace when the initial Orders were
issued. The Agency refers to these as “catch-up” Orders. As with the initial Order
issued under FFDCA §408(p), recipients of a “catch-up” Order could fulfill the testing
requirement either by submitting the results of a new study or by citing the data
submitted by another person. In furtherance of the goal of “fair and equitable sharing of
test costs,” the Agency would accept citation of existing data only if the recipient either
had the original data submitter’s permission or the recipient had made an appropriate
offer to pay compensation to the original data submitter that also determined how
disputes would be resolved.
At this time the Agency has no way to predict or estimate the number of potential
recipients for these “catch-up” Orders. For purposes of estimating the burden in this
ICR, the Agency is estimating that up to 20 entities might receive such “catch-up”
Orders in any one year. Since such Orders will be issued after the original Orders have
been issued, the recipients of such Orders will probably either join an existing
consortium or provide data compensation to the data generator, rather than generate
and submit the data on their own. EPA will monitor the issuance of such “catch-up”
Orders and the corresponding responses during the approval of this ICR. If it appears
necessary to increase this estimate during that period, EPA will submit an Information
Correction Worksheet to OMB to adjust the total approved burden accordingly.
Table 1 - Estimated Number of Potential Order Recipients (Respondents)
Potential Respondent
Category
Order Recipients
Data Generators/Submitters
Consortium Participants

Pesticide
Registrants
207
58
149

Estimated Number of Respondents
Manufacturers/
Catch-Up Orders
Importers
163
20
9
0
154
20

Page 14 of 48

Total
390
67
323

April 15, 2009

The estimated total number of potential respondents is 390.

4(b) Respondent Activities
Each respondent, or recipient of an Order issued under FFDCA §408(p), is
expected to engage in the following activities:
(1) Read instructions – Each recipient of an Order issued under FFDCA §408(p)
will need to read the Order to understand what they must do to comply with the Order,
what deadlines are associated with those activities and the details of how and who to
respond to. Depending on the recipients familiarity with the EDSP, the respondent may
also want to read other information about the EDSP, such as the Policy and Procedures
Document that formed the basis for the requirements in the Order and describes the
specific details of the policies and procedures that EPA generally intends to adopt for
initial screening under the EDSP, including the statutory requirements associated with
and format of the Orders issued under FFDCA §408(p), as well as EPA's procedures for
fair and equitable sharing of test costs and handling confidential data.
To illustrate what an Order recipient might expect to receive in terms of
instructions that they must follow to comply with the Order, the Agency provided draft
templates for the two different kinds of Orders that the Agency intended to use. After
considering public comment on the related procedures and the changes made to it to
address comments, EPA revised the two templates. (See Attachment C). The two
templates, one for Pesticide Registrants, and the other for Manufacturers/Importers, are
similar in most respects, differing only to the extent necessary to reflect the necessary
differences as articulated in the Policy and Procedures Document. Although the
Agency intends to use these templates as presented in Attachment C, the individual
Orders will contain the necessary requirements for the subject chemical. As such, the
final individual chemical Orders may vary.
(2) Plan activities – After reading the Tier 1 Order they received, the recipient will
need to plan the activities necessary to comply with the Order based on their
determination regarding their intended response and whether they are interested in
forming a consortia with other manufacturers of the chemical or conducting the tests
themselves.
(3) Submit an initial response to EPA – The Tier 1 Order will direct each recipient
to provide an initial response to EPA within 90 days of the issuance of the Order that
indicates how they intend to comply with the Order. To simplify completion of this initial
response within the 90 days, EPA has created an Initial Response Form for
Individual Order Recipients (See Attachment D – (1)). EPA intends to include this
form in the Order packet, pre-populated with the basic information about the recipient,
the chemical covered, and the applicable test data sought. The recipient of the Order
packet would complete the form by checking the appropriate boxes to indicate their
intentions with regard to each assay listed in the Order, and, if applicable, attach
appropriate documentation to provide a rationale and/or supporting documentation for

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their response. The response is assay specific to provide maximum flexibility to the
recipients who may wish to choose different response options for the individual assays
identified in the Order. An Order recipient may elect any of these options for one or
more of the assays in the Order, and is not limited to electing a single response for all
assays, nor are they required to elect different options for each assay. For simplicity,
however, the Response Form is structured so that recipients indicate their responses on
an assay-by-assay basis – even if the response is the same for more than one of the
assays. For example, the recipient may submit or cite existing data to address one or
more assay, indicate that they will generate the data for one or more assay, and/or
indicate that the intend to form or join a consortia to provide the data for one or more of
the other assays identified in the Order.
If the recipient intends to form or join a consortium (or task force) with other
manufacturers of the chemical to provide the data for one or more of the assays
identified in the Order, each consortium participant or potential participant is expected to
submit an Initial Response Form for Individual Order Recipients within 90 calendar
days. Within 150 calendar days of issuance of the Order, or as part of their initial
response, the designated lead for the consortium is expected to submit the Initial
Response Form for Consortium /Task Force (Attachment D – (2)) to provide the
primary contact for the task force or consortium, the list of participants, and an indication
of the task force or consortium’s planned response for each assay, along with
documentation of its formation (such as a copy of the joint agreement or a written
statement by all the parties that an agreement exists). The joint agreement to produce
the data need not specify all of the terms of the final arrangement between the parties
or the mechanism to resolve the terms.
The various response options available to a recipient, along with related activities
they may engage in that are specific to that response option are described in section
4(c)(i) of this ICR.
(4) Read and discuss the protocol – The Order recipients will need to read the
protocols for the assays identified in the Order and may have questions or may need to
modify one or more of the protocols for the subject chemical. An Order recipient
wishing to deviate from any of the protocols identified in the Order, may do so only after
consultation with EPA. Such requests should be submitted to EPA with a clear rationale
and explanation of the deviation. All protocol variations will be reviewed by EPA and a
response will be sent to the specific Order recipient in a timely fashion. These
procedures are consistent with current EPA practices regarding pesticide test guidelines
and the data requirements in 40 CFR parts 158 and 161. Although this activity is
expected to be primarily performed by the data generating entity, other participants in a
consortium may also participate in these discussions.
If the Order recipient chooses to submit or cite existing data, including other
scientifically relevant information, this discussion would be focused on whether the data
provided or cited follows an accepted scientific methodology or protocol, including but
not limited to those presented in EPA’s harmonized test guideline compendium (see
http://www.epa.gov/oppts and select “Test Methods & Guidelines” on the left). Such
recipients will be expected to provide a cogent and complete rationale for why they
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believe the information is sufficient to satisfy part or all of the Order. EPA’s decisions
about whether the information satisfies part or all of the Tier 1 Order will be based on
the weight-of-evidence from all relevant information available to the Agency.
In addition, the Order recipient is expected to comply with the Agency’s good
laboratory practice (GLP) standards described in 40 CFR part 160, which require
entities to follow certain practices when conducting studies, and, with the submission of
data to EPA, to provide a GLP compliance statement indicating: a) that the data were
generated using GLPs; or b) describe in detail “all differences” between the GLPs and
the practices used; or c) confirm that you did not sponsor or conduct the study and do
not therefore know whether the study was conducted in accordance with the GLPs.
(5) Generate the data – As indicated by the initial response, some recipients will
conduct the research or administer the tests to generate the data requested in the
Order.
For the purposes of calculating paperwork burden hours and costs in this ICR,
EPA assumed that the data generation will not be directly performed by the Order
recipient. Instead, EPA assumes that data generation will be performed by a contract
laboratory at the request of the Order recipient or a consortium. The Agency has no
information to estimate how many recipients might use a contract laboratory and how
many might generate the data in house. Assuming that data will always be generated
by a contract laboratory is consistent with the assumption used in other ICRs that
involve data generation. In addition, as indicated by one of the commenters on the ICR,
many companies now outsource toxicology testing because it is less expensive than
maintaining that function in-house (Ref. 9, p.5). Nevertheless, only those activities
imposed by the information collection request are attributable to this ICR. For example,
the travel time and costs for the contract laboratory staff to travel to meet with the
contracting company is not an activity imposed by the information collection request and
is therefore not attributable to the ICR. Nor are any costs or burden related to mistakes
made by the contract laboratory, such as failure to properly follow an applicable
protocol, which then requires the contract laboratory to redo the screening assay.
(6) Report progress, compile and review the data – Unless EPA has notified a
recipient in writing that the requirements of the Order have been satisfied, the Order
recipient will be expected to submit a progress report to EPA within 12 months after the
issuance of the Order. The progress report should provide a brief description of the
status of the planned activities for each assay, and, if applicable, a description of any
problems encountered or expected difficulties in meeting the schedule for complying
with the Order.
(7) Complete paperwork to assemble the submission package - Those Order
recipients that generate the data or serve as the consortium lead will be expected to
compile the data results from performing the assay(s), review the data for completeness
and compliance with GLPs, and assemble the submission package in accordance with
the instructions provided in the Order. In general, these are the same submission
procedures as those that are currently used for submitting other data in support of a
pesticide registration, with only a few modifications – such as the mailing address.
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(8) Submit final data to EPA – The final data package is then submitted to EPA
following the specific instructions provided in the Order, which will also specify the due
date for final compliance with the Order’s request for data. Although the Order specifies
a final due date for submission of all of the data specified in the Order, an Order
recipient may either submit the data for each individual assay as it is completed, or
submit the data from all of the assays at one time. The Order recipient may also submit
the data before the due date specified in the Order.
(9) Maintain records - Recipients will be asked to maintain a record of their initial
response for three (3) years, and recipients who submit data will be asked to maintain
records pursuant to 40 CFR 169.2(k), i.e., containing research data relating to a
registered pesticides for as long as the registration is valid and the producer remains in
business.
For purposes of estimating the potential respondent paperwork burden and costs
associated with these activities, the Agency identified three separate categories of
duties: 1) managerial; 2) technical; and 3) clerical. Each activity identified above may
involve one or more duty category. In Table 2, the Agency identifies the assumed
recipient activities divided between the three duty categories.
Table 2 – Expected Order Recipient Activities by Burden Categories
(assumes initial response is to generate the data)
Activity Managerial Duties
Technical Duties
Read EPA’s Policy and
Read EPA’s Policy and
Procedures Document
Procedures Document
(1)
Review the EDSP Order
Review the EDSP Order
Identify timeframe for response
Identify & evaluate response
Evaluate response options
options
(2)
Plan activities
Negotiate/establish consortium/ Participate in consortium/ task
task force agreements
force discussions
Determine response
Recommend a response
(3)
Oversee employee activities
Sign initial response forms
Communicate with EPA
Review of protocol (deviations)
Review GLPs (deviations)
Identify & discuss other
(4)
scientifically relevant
information & related protocol
&/or GLP deviations
Plan/oversee employee and
Plan the data collection
contract activities
activities using the approved
protocols
Secure contract lab services
Conduct the tests, using
and approve statement of work
protocols & GLPs
(5)
(SOW)
Communicate with EPA, as
Maintain records and
appropriate
procedures during testing
period in accordance with the
GLPs
(6)
Review final report(s)
Compile & review data
Page 18 of 48

Clerical Duties

Complete response form
Send to EPA
Arrange logistics for calls
or meetings with EPA

Assist in preparing files

April 15, 2009
Activity

(7)
(8)

Managerial Duties
Approve final submission
package

Technical Duties
Prepare final data reports
Draft summary of the data for
cover letter
Review final submission
package

Prepare final submission
package

Prepare data for files

Send submission to EPA
Prepare final file folders
Maintain records

Approve/sign submission

(9)

Clerical Duties

4(c) Information Requested
This section of the ICR describes the information that an Order recipient is
expected to provide the Agency. In general, all Order recipients are expected to provide
an initial response (with information associated with that response when applicable),
and those recipients that generate data, either individually or as part of a consortium,
are expected to provide a 1 year progress report and submit data to EPA.
The Order will identify the specific Tier 1 data being requested and will provide
the specific instructions for complying with the Order. All Order recipients are expected
to provide an initial response that identifies how the recipient intends to respond to the
Order. The specific information requested with the initial response from each Order
recipient will vary based on the respondent’s initial response – the options for which are
described in section 4(c)(i) of this ICR. For purposes of this ICR, however, it is
important to clarify that many of the initial response options already exist within the
pesticide program, e.g., for Data-Call-Ins under FIFRA 3(c)(2)(B). In providing the
option as described in more detail in the Policy and Procedures Document (Attachment
B), the Agency is adopting those existing procedures unchanged for use under the
EDSP. Under those existing procedures, a registrant may engage in additional
activities associated with that response option. For example, a respondent/registrant
could choose to reformulate the product or seek a formulator’s exemption. Both of
these initial response options involve established procedures, and additional activities
that are already approved by OMB under separate existing ICRs. The Agency believes
that any additional use of those existing procedures related to the EDSP do not impact
the estimated burden covered by the existing ICRs. As such, this ICR does not
duplicate the burden associated with the response options that involve existing
procedures that are already covered by another ICR.
4(c)(i) Order Recipient’s Response Options
As described in more detail in the Policy and Procedures Document (Attachment
B), the recipient of an Order will have several potential response options, as specified
within the Order itself. The recipient uses the Initial Response Form for Individual
Order Recipients (see Attachment D – (1)) to indicate which option they intend to use
to respond to the data request for each assay. The response is assay specific to
provide maximum flexibility to the recipients who may wish to choose different response
options for the individual assays identified in the Order. An Order recipient may elect
any of these options for one or more of the assays in the Order, and is not limited to
electing a single response for all assays, nor are they required to elect different options
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for each assay.
The recipient of the Order packet would complete the form by checking the
appropriate boxes to indicate their intentions with regard to each assay listed in the
Order, and, if applicable, attach appropriate documentation to provide a rationale and/or
supporting documentation for their response.
The following is a description of each of the available response options (see also
Attachment E, which provides an overview of the response options in a workflow
format):
(1) I Will Generate New Data. The recipient would choose this option to indicate
that they agree to individually generate new data for each test specified to meet the
requirements of the Order. In the case of data pertaining to an inert ingredient for which
there is no tolerance or exemption, the recipient may identify a “cooperating
registrant/agent” for EPA (e.g., to whom EPA could send a DCI notice under FIFRA
§3(c)(2)(B) or identify on the recipient list). The cooperating registrant/agent would then
become jointly responsible for generating and submitting the data. This is different from
a consortium, which is discussed later.
(2) I Am Citing or Submitting Existing Data. The recipient would choose this
option to submit or cite existing data (including other relevant scientific information) that
they believe can be used to satisfy part or all of the Tier 1 Order. Existing data may be
of several types. An example may be an in vitro assay for transcriptional activation that
is conducted with a different cell line and by a different protocol. But more generally,
existing data may be “other scientifically relevant information.” Other scientifically
relevant information can include data from studies other than the EDSP Tier 1 assays,
e.g., studies conducted to satisfy a 40 CFR part 158 or part 161 data requirement, data
from other studies conducted to address an identified issue, or data from studies found
in the scientific literature. In addition to the Tier 1 Order recipient, anyone can submit
other scientifically relevant information. To allow EPA to review the submission of other
scientifically relevant information in a timely fashion, the submitter of the information
should consider providing a scientifically sound rationale that explains how the
submitted or cited data provides the information needed to satisfy part or all of the Tier 1
Order and/or otherwise inform the Agency's Tier 1 determination.
The submitted or cited study should have been conducted in accordance with
accepted scientific methodology or protocol, including but not limited to those presented
in EPA’s harmonized test guideline compendium (see http://www.epa.gov/oppts and
select “Test Methods & Guidelines” on the left). Deviations from the protocols validated
for the Tier 1 assays, will need to be identified, along with an explanation for the
deviations, including an explanation as to why, notwithstanding the deviations, the
protocol used should still be considered as providing an accepted scientific methodology
or protocol, and any other information the submitter thinks the Agency should consider
in deciding whether to accept the data in satisfaction of the Order.
If EPA has previously reviewed a protocol for a study that is being submitted or
cited, the submitter needs to identify any action taken by the Agency on the protocol
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and must indicate the manner in which all Agency comments, concerns or issues were
addressed in the final protocol and study.
If a study that has been previously submitted to EPA is cited, that study must
have been classified by EPA as acceptable (i.e., the study was not rejected by the
Agency for any reason related to completeness or quality) or it must be a study which
has not yet been reviewed by the Agency. When citing something that was previously
submitted, the Agency needs a copy of the title page along with the identification
number of the study cited (MRID number), and, if the study has been reviewed by the
Agency, the Agency's classification of the study. The Agency specifically asks that a
study that has previously been submitted to EPA NOT be resubmitted for another
purpose.
EPA will review any existing study submitted or cited in response to the Order to
determine whether the study is of sufficient quality and can be used to satisfy the Order.
The Agency intends to notify submitters in writing of its determination, as well as make
the determination publicly available.
If the individual citing a study is not the original data submitter, that individual
may need to submit an offer to pay compensation to the original data submitter.
Consequently, such individuals are encouraged to simultaneously include an offer to
pay [in accordance with 40 CFR § 152.93] [which includes an offer to resolve any
dispute over the recipients’ shares of the test costs by submitting the dispute to a
neutral third party with authority to bind the parties (e.g., through binding arbitration or
through a state or federal court action)], unless the individual has received confirmation
from EPA that no such compensation is necessary.
(3) I Will Enter (or Offer to Enter) Into an Agreement to Form a Consortium to
Generate the Data. The recipient would choose this option to indicate that they are
forming a task force or consortium to comply with the Order. In such cases, each
participant or potential participant is expected to submit an Initial Response Form for
Individual Order Recipients within 90 calendar days. Within 150 calendar days of
issuance of the Order, or as part of their initial response, the designated lead for the
consortium is expected to submit the Initial Response Form for Consortium /Task
Force (Attachment D – (2)) to provide the primary contact for the task force or
consortium, the list of participants, and an indication of the task force or consortium’s
planned response for each assay, along with documentation of its formation (such as a
copy of the joint agreement or a written statement by all the parties that an agreement
exists). The joint agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms.
Alternatively, an Order recipient may provide EPA with documentation that they
made a judicially enforceable offer to enter into an agreement to develop data jointly
with one or more recipients of the Order and that they offered to pay a reasonable share
of the test costs (or developed a process for resolving disputes with regard to the
appropriate share of test costs). If the required data are not generated by the person(s)
to whom the offer is made, all parties, including those that have made offers to pay or

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otherwise joined the consortium, would be responsible for generating and submitting the
data.
(4) Claim Not to be Subject to the Test Order. The recipient would choose this
option to indicate that they are not subject to the Order because:
(i) In the case of a Tier 1 Order involving a pesticide active ingredient, the
recipient is not a pesticide registrant, or
(ii) In the case of an initial Tier 1 Order that involves a pesticide inert ingredient,
the recipient does not currently manufacture or import the chemical, or
(iii) In the case of a “catch-up” Order, the recipient obtains the chemical solely
from persons who are either (1) the original data submitter; (2) a person who has
complied with a Tier 1 Order by offering compensation; or (3) a person who is
otherwise an approved source for the pesticide inert ingredient.
The recipient's initial response would include an explanation and documentation
supporting their claim to allow EPA to evaluate the claim. If EPA can not verify the
claim, the recipient is still subject to the Order and the deadline(s) for responding
remain.
(5) I Intend to Voluntarily Cancel or Reformulate the Product Registration. This
option is only available for pesticide registrants. Registrants may request voluntary
cancellation of their product’s pesticide registration pursuant to FIFRA section 6(f).
Doing so would initiate the existing procedures for a voluntary cancellation. Under
those procedures, the registrant may either adopt the standard procedures for sale or
use of existing stocks of their pesticide, or may propose an alternative procedure.
Alternatively, in the case of an inert ingredient, a registrant of an end-use product may
submit an application to amend the formulation of its product by removing the ingredient
that is the subject of the Tier 1 Order. This is all accomplished through the submission
of an application to amend the registration following the established procedures. In
general, EPA’s policy does not include the issuance of orders under FFDCA §408(p) to
registrants of end-use products.
(6) I Claim a Formulators’ Exemption. A product registrant who receives an
Order to test a chemical who purchases the chemical from another recipient who has
agreed to generate the data may be eligible for a formulators’ exemption, but exercise
of this option may depend on the authority under which the Order is issued. If EPA
were to rely solely on FIFRA 3(c)(2)(B), the option would not be available for Orders to
test an inert ingredient since manufacturers and importers would not be subject to a
FIFRA order. Such a claim would initiate the existing procedures for formulators’
exemption. EPA will confirm claims of eligibility. A formulators’ exemption would
become invalid if the supplier of the chemical were not to submit the data either
individually or jointly with other recipients.
(7) I Have or Am in the Process of Discontinuing the Manufacture/Importation of
the Inert Ingredient. This option is only available for pesticide inert ingredients. The
recipient of an Order for a pesticide inert ingredient (i.e., manufacturer/importer) would
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choose this option to indicate that they have already or are in the process of
discontinuing the manufacture or import of the chemical. The recipient's initial response
would include an explanation and documentation supporting their claim. EPA intends to
verify such a claim. If EPA confirms the claim, the Initial Response Form is the only
response required to satisfy the Order. If, however, EPA determines that the claim is
false, the recipient must comply with the Order.
(8) I Will Not Sell the Chemical for Use in Pesticide Products. This option is only
available for pesticide inert ingredients. The recipient of an Order for a pesticide inert
ingredient (i.e., manufacturer/importer) would choose this option to indicate that they do
not currently or agree to no longer sell their chemical for use in the pesticide market. To
elect this option, the Order recipient would indicate, as part of its initial response, that
they commit to discontinue, on or before a date six months after the issuance of the Tier
1 Order, all sale and distribution of the chemical to any person who the recipient knows,
or reasonably should know, intends to use the chemical in the formulation of a pesticide
product. The Order recipient would also indicate that it will include in all contracts for
sale or distribution of the material a provision that contractually prohibits the purchaser
from using the substance in the formulation of a pesticide product. As part of its initial
response, the Order recipient would be asked to provide a copy of the contract provision
and a certification to include this contractual provision in any contracts entered into on
or after a date six months after the issuance of the Tier 1 Order.
(9) Request an exemption under FFDCA section 408(p)(4). FFDCA section
408(p)(4) provides that “the Administrator may, by order, exempt from the requirements
of this section a biologic substance or other substance if the Administrator determines
that the substance is anticipated not to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen.” For the initial screening, EPA is not aware
of sufficient data that would allow the Agency to confidently determine that a chemical
meets the statutory standard for an exemption--i.e., that it is not anticipated to interact
with the endocrine system. Although a relatively broad range of toxicity data are
available for pesticide active ingredients regulated under FIFRA, in most cases EPA has
not yet established how the available data might be confidently used to predict the
endocrine disruption potentials of these chemicals. This may be due to the non-specific
nature of an effect or effects observed, questions related to whether the mode of action
in producing a given effect or effects is or are endocrine system-mediated in whole or in
part, or the lack of relevant data to make a judgment altogether.
However, if an Order recipient believes that this showing can be made for its
chemical, the Agency would consider requests to issue such an exemption order on a
case-by-case or chemical-by-chemical basis in response to individual submissions. In
order for the Agency to make the necessary statutory finding to issue the exemption, the
request would need to provide any hazard-related information that you believe would
allow EPA to determine that your chemical is anticipated to not be an endocrine
disruptor, i.e., is not anticipated “to produce any effect in humans similar to an effect
produced by a naturally occurring estrogen.”
(10) Other initial responses. a). Pre-enforcement challenges to a Tier 1 Order.
A recipient may wish to challenge the Tier 1 Order. The Order will describe the informal
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process by which a recipient may raise, and EPA may review, objections to the
issuance of an Order or to specific provisions in the Order. For EPA to be able to
respond to the objections in a timely manner, the recipient would need to state with
particularity the scope and basis of the objection, providing sufficient detail to allow the
Agency to evaluate the objection.
b). Additional EDSP screening is unnecessary because the chemical is an
endocrine disruptor or was used as a “positive control” in the EDSP validation effort. If
an Order recipient chooses to ask EPA to reconsider some or all of the testing specified
in the Tier 1 Order, EPA would review the request, along with the appropriate
information supporting the claim that additional EDSP screening of the chemical is
unnecessary because the chemical is an endocrine disruptor or was used as a “positive
control” in the EDSP validation effort, on a case-by-case basis. Based on the
information currently available, EPA generally expects that if the chemical was used by
EPA as a ‘‘positive control’’ to validate one or more of the screening assays, only the
data submitted related to those assays for which the chemical was used to complete the
testing as part of the validation effort would be sufficient to satisfy the Tier 1 Order.
4(c)(ii) Progress Report
Unless EPA has notified the Order recipient in writing that the requirements of
the Order have been satisfied, the Order recipient must submit a progress report to EPA
within 12 months of the issuance of the Order (the specific due date will be identified in
the Order). The progress report should provide a brief description of the status of the
respondent’s planned activities for each assay, and, if applicable, a description of any
problems encountered or expected difficulties in meeting the schedule for complying
with the Order.
4(c)(iii) Extension Requests
If a recipient cannot comply with the time frame established in the Order (see
section 5(d) of this ICR), they may seek additional time by submitting a written request
to the Agency before the applicable deadline. The written request must include: (1) a
detailed description of the expected difficulty and (2) a proposed schedule including
alternative dates for meeting the requirements of the Order. If the delay is based on
technical or laboratory difficulties, recipients are expected to explain any technical or
laboratory difficulties and provide documentation from the laboratory performing the
testing.
While EPA is considering any such request, the original deadlines in the Order
remain unchanged. The Agency will respond to such requests in writing because
extensions can only be granted in writing. If EPA does not grant the request, the
original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant,
manufacturer, or importer. Extensions will not be considered if the request for extension
is not made in a timely fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.

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4(c)(iv) Data Generation
The Tier 1 Order will request specific data on how the chemical substance
interacts with the estrogen, androgen, or thyroid hormone systems using a battery of
assays. The Tier 1 screening battery is intended to identify chemicals affecting the
estrogen, androgen, or thyroid hormone systems through any of several recognized
modes of action. The proposed Tier 1 screening battery underwent peer review by the
FIFRA Scientific Advisory Panel (SAP) in March 2008. The SAP concluded that the
proposed battery of assays was adequate to begin screening chemicals to detect the
potential for interaction with the estrogen, androgen or thyroid (EAT) hormonal systems.
For more information about the FIFRA SAP review of the Tier 1 screening battery, go to
http://www.epa.gov/scipoly/sap/meetings/2008/032508_mtg.htm.
The availability of the final Tier 1 screening battery will be announced in the
Federal Register before any Tier 1 Orders will be issued. Until that is done, this ICR
and the Order Templates in Attachment C only provide the list of assays that are
expected to be in the battery. In doing so, the Agency has identified the universe of
assays that might be included in the final Tier 1 battery. The Agency may, however, not
include all of these assays in the final Tier 1 battery, or may otherwise decide to only
include a subset of these assays in an individual Tier 1 Order that is issued under the
EDSP for a particular chemical and respondent. For example, the Agency may
determine that only a subset of the assays are necessary to inform the Agency's Tier 1
determination for a particular chemical. In the event that the Order does not include all
of these assays, it will always include a subset of these assays. In other words, the Tier
1 Order would not include assays that are not identified on this list.
In addition, recipients of the Tier 1 Order will generate the data using the test
protocols identified in the Order or provided by EPA, unless the recipient discusses and
EPA approves an alternative test protocol. This is already discussed previously in this
ICR.
The following is a list and brief description of each of the assays that are
expected to be part of the final Tier 1 battery:
1. Amphibian Metamorphosis (Frog) - The Amphibian Metamorphosis assay
involves the use of tadpoles to determine if chemicals affect the hypothalamicpituitary-thyroid (HPT) axis during metamorphosis and consequently result in
developmental effects.
2. Androgen Receptor Binding (Rat Prostate) - The androgen receptor (AR) is
involved in the development of male sexual characteristics. The AR Binding
assay identifies chemicals that affect the endocrine system by binding to
hormone receptors to either mimic the action of the natural hormone or block
access of the hormone to the site and thus block hormone controlled activity.
3. Aromatase (Human Recombinant) - Aromatase is an enzyme complex
responsible for estrogen biosynthesis that converts androgens into estrogens,
estradiol, and estrone. The Aromatase in vitro assay focuses on this portion of
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the steroidogenic pathway to detect substances that inhibit aromatase activity.
4. Estrogen Receptor Binding - The estrogen receptor (ER) is involved in female
maturation and reproductive function. The ER Binding assay measures the
ability of a chemical to bind to the estrogen receptor.
5. Estrogen Receptor Transcriptional Activation (Human Cell Line (HeLa-9903)) The estrogen receptor (ER) is involved in female maturation and reproductive
function. The ER Transcriptional Activation is a cell-based assay that measures
the ability of a chemical to bind to the ER and activate transcription resulting in
the synthesis of the enzyme luciferase.
6. Fish Short-term Reproduction - The Fish Short-term Reproduction assay screens
for disturbances in the hypothalamic-pituitary-gonadal (HPG) axis including (anti)estrogenic, (anti-)androgenic, aromatase inhibition, and steroid modulating
effects. The assay examines abnormalities associated with survival,
reproductive behavior, secondary sex characteristics, histopathology, and
fecundity (i.e., number of spawns, number of eggs/spawn, fertility, and
development of offspring) of fish exposed to test chemicals.
7. Hershberger (Rat) - The Hershberger assay is designed to detect androgenic
and anti-androgenic effects. In this in vivo assay, the weight of several
androgen-dependent tissues, including accessory sex glands, are measured in
castrated or immature male rats.
8. Female Pubertal (Rat) - The Pubertal Female assay involves the use of rats to
screen for estrogenic and thyroid activity in females during sexual maturation.
This assay examines abnormalities associated with sex organs and puberty
markers, as well as thyroid tissue.
9. Male Pubertal (Rat) - The Pubertal Male assay involves the use of rats to screen
for androgenic, anti-androgenic, and thyroid activity in males during sexual
maturation. This assay examines abnormalities associated with sex organs and
puberty markers, as well as thyroid tissue.
10. Steroidogenesis (Human Cell Line – H295R) - The Steroidogenesis in vitro
assay detects interference with the body's production of male and female
steroid sex hormones. This assay is a cell-based assay using the H295R
human adrenocortical carcinoma cell line which can detect inducers of
enzymes responsible for steroid synthesis as well as chemicals that inhibit it.
11. Uterotrophic (Rat) - The Uterotrophic assay involves the use of female rats to
screen for estrogenic effects. In this in vivo assay, uterine weight changes are
measured in ovariectomised or immature female rats.
For purposes of estimating the potential burden for the Tier 1 screening
information collection activities covered by the ICR, the Agency is assuming that each
Tier 1 Order will include all of the above listed assays. By assuming that each Order
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will include all of these assays, the ICR provides coverage for those cases where the
Order may not include all of the assays.
4(c)(v) Data Submission
As described in more detail in the Policy and Procedures Document (Attachment
B), the data submission content and format under the EDSP is based on that used
currently for other pesticide data submissions. Since the initial chemicals involve
pesticides and pesticide inerts, EPA believes that doing this helps to minimize the
potential burden because the Order recipients are likely to be familiar with the existing
requirements. As such, the content and format of the data submission package for
transmittal to EPA should be consistent with the following existing standards, which are
expected to be incorporated into the individual Orders:
1. Format for Data Submission. As part of a cooperative NAFTA project, EPA
and the Canadian Pest Management Regulatory Agency (PMRA) developed standard
data evaluation formats, or templates. The templates have been in use by these
agencies since 2002 for writing their data evaluation records (DERs) of studies
submitted under FIFRA and FFDCA to EPA and the Canadian data codes (DACOs).
The DER that the agencies prepare contains a study profile documenting basic study
information such as materials, methods, results, applicant’s conclusions and the
evaluator's conclusions. The templates provide pesticide registrants and the public an
opportunity to gain a better understanding of the regulatory science review and
decision-making process. The agencies encourage registrants to include study profiles
based on these templates in their study documents for all pesticide types. These
templates describe the layout and scope of information that should be contained within
a study profile and can serve as guides for preparation of study documents. Use of the
templates improves the likelihood of a successful submission, since the information
necessary for an efficient agency review is outlined. Additional details about these
templates are available at:
http://www.epa.gov/pesticides/regulating/studyprofile_templates/.
In addition, Pesticide Registration (PR) Notice 86-5, entitled "Standard Format for
Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA),”
describes the requirements for organizing and formatting submittals of data supporting a
pesticide registration (http://www.epa.gov/PR_Notices/pr86-5.html). The Agency has
begun the process of updating the guidance in PR Notice 86-5 to further clarify the data
submission process for pesticide related submissions and will provide the public with an
opportunity to comment on the proposed revisions to PR Notice 86-5 consistent with the
procedures described in PR Notice 2003-3, entitled “Procedural Guidance for EPA's
Office of Pesticide Programs Procedures Concerning the Development, Modification,
and Implementation of Policy Guidance Documents”
(http://www.epa.gov/PR_Notices/pr2003-3.pdf).
The Agency also encourages Order recipients to submit completed study profiles
and supporting data in an electronic format (PDF) whether submitting one or several

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studies. For more information about electronic submissions, go to
http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm.
2. Transmittal Document. Each submission in satisfaction of a Tier 1 Order must
be accompanied by a transmittal document that includes the following information:
(1) Identity of the submitter.
(2) The date on which the submission package was prepared for transmittal to
EPA.
(3) Identification of the Tier 1 Order associated with the submission (e.g., the
number assigned to the Order).
(4) A list of the individual documents included in the submission.
3. Individual Study or Test Result Documents. Unless otherwise specified by
the Agency, each submission must be in the form of individual documents or studies.
Previously submitted documents should not be resubmitted unless specifically
requested by the Agency. Instead previously submitted documents should be cited with
adequate information to identify the previously submitted document. Each study or
document should include the following:
(1) A title page including the following information:
(i) The title of the study, including identification of the substance(s) tested
and the test name or data requirement addressed.
(ii) The author(s) of the study.
(iii) The date the study was completed.
(iv) If the study was performed in a laboratory, the name and address of the
laboratory, project numbers or other identifying codes.
(v) If the study is a commentary on or supplement to another previously
submitted study, full identification of the other study with which it should be
associated in review.
(vi) If the study is a reprint of a published document, all relevant facts of
publication, such as the journal title, volume, issue, inclusive page
numbers, and date of publication.
(2) Upon submission to EPA, each document must be accompanied by a signed
and dated document containing the appropriate statement(s) regarding any
data confidentiality claims as described in the Tier 1 Order.
(3) A statement of compliance or non-compliance with respect to GLP standards
as required by 40 CFR 160.12, if applicable.
(4) A complete and accurate English translation must be included for any
information that is not in English.

5.

AGENCY ACTIVITIES, COLLECTION METHODOLOGY, &
INFORMATION MANAGEMENT
5(a) Agency Activities

The functions and responsibilities associated with the EDSP under FFDCA
section 408(p) have been assigned to OPPTS. Within OPPTS, OPP will be primarily
responsible for the administrative functions related to the issuance of the Orders,
receiving, processing and maintaining records of responses to the Orders, as well as
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other administrative functions related to the Orders. OSCP and OPP will coordinate the
review of Tier 1 screening data received and resulting determinations related to the
subject chemical.
In addition to preparing and issuing the Orders, the data collected under FFDCA
section 408(p) will be received by OPP, where the data will first be reviewed for
completeness and then routed to the appropriate Agency team of scientists and
analysts for technical review. Although the technical review teams will consist mostly of
staff from OPP and OSCP, it will also include staff from other EPA offices, e.g., Office of
Pollution Prevention and Toxics (OPPT), Office of Water (OW), Office or Research and
Development (ORD), and other EPA offices as appropriate.
In general, the Agency is expected to engage in the following general activities
under this ICR:
(1) Prepare instructions. Prepare procedural steps, guidance & instructions for
Order recipients so that they understand what data are to be submitted, when & how.
The Policy and Procedures Document (Attachment B) describes the policies and
procedures that EPA intends to use to implement the data collection component of the
EDSP. Although that document is non-binding, the Agency will incorporate specific
instructions into each Order, so that each Order recipient receives detailed instructions
on what they must do to comply with the Order.
(2) Identify chemicals to be screened. EPA has implemented the September
2005 selection approach to identify the chemicals for which Tier 1 screening under the
EDSP will be required (Ref. 3). After considering public comments on the draft list (Ref.
4), EPA recently issued a final list (Ref. 5). This ICR assumes that all of the chemicals
on the final list will be the subject of a Tier 1 Order issued under FFDCA §408(p).
(3) Identify Recipients. EPA has identified the potential recipients of the Tier 1
Orders for the chemicals identified on the final list of initial chemicals to be screened
under the EDSP. See the discussion on respondents in section 4(a) of this ICR.
For Tier 1 Orders involving pesticide active ingredients, the Agency used the
Office of Pesticide Programs Information Network (OPPIN). OPPIN is an internal OPP
database for query, input and tracking of pesticide products, ingredients, studies,
regulatory decisions and other information about registered products.
For Tier 1 Orders involving inerts, the Agency used OPPIN (where applicable)
and other databases like the TSCA Inventory Update Reporting (IUR) database and
other public information sources to identify appropriate manufacturers/importers. These
other databases may include other internal EPA databases and publicly available
sources like Dun and Bradstreet, online marketing material, etc.
In addition, to facilitate the formation of consortia to develop the data requested
in an Order, and to the extent that the information is not protected as confidential
business information, EPA will provide each Order recipient with a list of the other
recipients of the Order for the subject chemical. The list of Order recipients will also be
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published in the Federal Register and posted on the Agency's EDSP Web site, along
with the status of the Order (including recipients’ responses). EPA intends to update
the list with subsequent publication(s) and posting(s) as appropriate.
This ICR also assumes that other entities that should receive an Order might be
identified after the first set of Orders are issued, either by EPA or by someone else. In
those cases, EPA intends to issue “catch-up” Orders as appropriate.
(4) Prepare the EDSP Tier 1 Orders. EPA intends to use the appropriate Order
template (see Attachment C) to prepare individual Orders for each chemical and Order
recipient. The Order will identify all of the non-CBI protected recipients so that the
recipients may more easily identify the potential participants to include in a consortium,
and it will indicate how many recipients could not be listed. Those companies protected
as CBI will not be listed in that Order, but will still receive an Order and will have an
opportunity to designate an agent for purposes of the List of Order Recipients. As
indicated previously, EPA intends to publish the List of Order Recipients for chemical
specific Orders in the Federal Register, and will maintain an up to date list on the
Agency’s EDSP Web site.
Along with preparation of the Orders, EPA will prepare the pre-populated Initial
Response Form for each Order recipient. The Agency intends to accomplish this
through a semi-automated process using the same database that will track the Orders,
initial responses, and data submissions. This system is discussed in more detail in
section 5(b) of this ICR. In using this approach, EPA is maximizing the available
resources and efficiencies related to the administrative components of Tier 1 screening
under the EDSP.
(5) Review & Approve Orders. The EDSP Tier 1 Orders will be reviewed and
approved by a senior Agency official(s) for completeness before they are issued.
(6) Issue the Orders. The appropriate authorized OPPTS senior official will sign
each Order, which will then be processed for issuance as appropriate. Orders will then
be mailed to each recipient using certified and return receipt mailing options offered by
the U.S. Postal Service (Ref. 10).
(7) Process Initial Responses. OPP will receive the Initial Response Form,
document the response, track responses & determine next steps based on the
responses. In general, the Agency will review the response to determine if it is
complete and whether it satisfies the request in the Tier 1 Order, if so, the response will
be documented accordingly. Depending on the response, the Agency may also need to
complete other tasks, e.g., document lead for a consortia, process a voluntary
cancellation request or request for reformulation, etc. The Agency will also need to
verify claims and review data cited or submitted and provide a written response to the
Order recipient that accepts or rejects their claim(s).
(8) Provide Assistance & Complete Follow-up, as needed. The Agency will
respond to any questions the recipient may have regarding the Tier 1 Order in a timely
manner, as well as process any requests for extensions or protocol variations.
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(9) Address Non-responders. Once identified, the Agency will determine
appropriate action (i.e., whether to initiate cancellation procedures, refer the case to the
Office of Enforcement and Compliance Assurance (OECA) for enforcement, etc.).
(10) Issue “Catch-up” Orders. EPA may issue a so called “catch-up” Tier 1
Order to a manufacturer or importer who begins to sell an inert ingredient following the
submission of required EDSP data on the ingredient by manufacturers or importers who
were in the marketplace when the initial Tier 1 Orders were issued.
(11) Process Data Submissions. The Agency will process submissions of data
generated under the Tier 1 Order, including initial review of the data submission for
completeness, initial log-in to document receipt, and determining the close out of the
Order. As indicated previously, this will be coordinated by OPP and OSCP. Although
each Order will need to be addressed individually, the Agency may determine that the
satisfaction of the Order for a particular chemical by one Order recipient can be used to
determine that all of the Orders for that chemical are also satisfied. However,
satisfaction of an Order by one Order recipient, may not affect the need for the other
Order recipients to comply at all. For more information, see the Policy and Procedures
Document (Attachment B).
(12) Analyze Data. OPP will implement the Agency’s internal standard review
procedures to review the data. For example, what does the data tell us about the
chemical’s potential to interact with E, A, and/or T?
In general, the Agency intends to take a weight-of-evidence approach to evaluate
the available data for a particular chemical to determine whether the potential endocrine
disrupting effects associated with the use of the chemical can be ascertained with the
data available, or whether additional data is needed.
(13) Incorporate/ Use the Data. The Agency will incorporate the data into a risk
assessment and make a regulatory decision as necessary and appropriate. EPA has
extensive experience in using data from multiple sources to develop integrated
assessments of hazard, modes of action / mechanisms of toxicity, and overall potential
for risk. EPA scientists will continue to use such experience, together with insights from
the validation process for Tier 1 assays, to address the potential of chemicals to cause
adverse effects as a consequence of interaction with the endocrine system. For
example, do we know enough to determine whether or not we should take any
regulatory action to prevent or mitigate the exposures that might lead to the interaction
identified? Should the chemical be considered for Tier 2 testing?
In addition, chemicals that go through Tier 1 screening and are found to have the
potential to interact with the estrogen, androgen, or thyroid hormone systems will
proceed to the next stage of the EDSP where EPA will determine which, if any, of the
Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to
identify any adverse endocrine-related effects caused by the substance, and establish a
quantitative relationship between the dose and that endocrine effect.

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(14) Store Data in Retrievable System. The Agency will index and store the data
in the Agency’s files. Primarily the data will be stored in OPPIN, because the initial
group of chemicals to be screened are pesticides or chemicals used as inerts in
pesticide products. This system is discussed in more detail in section 5(b) of this ICR.

5(b) Collection Methodology and Management
For each of the chemicals identified for Tier 1 screening as part of the EDSP, the
specific data requested, the testing necessary to generate that data, along with the
validated protocols to conduct the tests, the time frame for completing the testing, and
the date by which the requested data must be submitted to the Agency will be
established in the Tier 1 Order. As indicated previously, the Agency intends to utilize
the systems and procedures already established and in use for Data-Call-In activities
under FIFRA to collect and manage the data submitted in response to the Tier 1 Order.
For example, as with other pesticide data related submissions, EPA will maintain a
record of each study submitted in the Agency’s Pesticide Document Management
System (PDMS), and public access to the PDMS bibliography may be made through the
National Pesticides Information Retrieval System (NPIRS). NPIRS supports searches
of the PDMS database by chemical, subject, submission date, laboratory, guideline
number, and document type. The public, after satisfying any applicable requirements
(e.g., FIFRA §10) may request copies of non-confidential studies through FOIA.
In addition, OPP’s Information Technology & Resource Management Division
(ITRMD) is enhancing the Agency’s tracking database (PRISM) to provide the
necessary information to accomplish the Tier 1 goal; specifically capturing information
regarding a chemical’s active and inert ingredients. Currently, the system has the
capability to handle active ingredient information. The complete management of active
ingredients can be accomplished with the DCI (Data Call-In) module within PRISM;
however, the management of inert ingredients had to be developed.
To meet the goals of the EDSP, the system will allow for the creation of Orders
for each active ingredient and inert ingredient. For the active ingredients, the system
will manage associated company, product, and requirement information. For inert
ingredients, the system will manage the associated companies only, since these
companies may not have any registered products. In addition, the system needs to
allow for the submission of studies through registrant consortiums. It needs to be able
to give the member companies (who received Orders) credit for the submissions when
the consortium is identified as the study owner. For every inert there shall be a
subsection for its Battery, results and comments. The system will track the milestones
associated with the drafting, concurrence, mail-out, 90-day response, submission
receipts, and reviews. Also, the system shall manage response extensions and identify
and manage all non-responsive companies.
In addition to tracking the previously mentioned elements related to each specific
Order, the Agency will track the following: submission type, submission date,
submission comment, review sent and completed dates, requirement status and
requirement status comment. These elements are needed in order to track the

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responses submitted by each company, the submitted studies, study reviews, study
status and requirement status. The Agency will produce several reports to facilitate
tracking, etc. For example, a 90-day company response status report is needed to
determine whether companies have responded, and to identify their intentions. An
option to display only overdue responses will be included. It should include all
chemicals and be sorted by company (and product if applicable). A requirement status
report by requirement across all chemicals, sorted by company is needed in order to
present overall progress and allow management to directly identify delays.

5(c) Small Entity Flexibility
In developing the Policy and Procedures Document (Attachment B), the Agency
considered alternatives for small businesses to the extent practical within the mandate
in FFDCA. For example, as described in more detail in EPA’s policy statement, EPA
does not intend to issue Tier 1 Orders to registrants of end-use products or formulators,
primarily because most small entities potentially impacted under the EDSP are end-use
product registrants or formulators and are not basic manufacturers or registrants. As
such, small businesses are not expected to be responsible for supplying endocrine data
on a chemical they use in their end-use product or formulation.
In addition, the procedures are intended to minimize potential duplicative testing,
and emphasize collaborative efforts to generate the requested data. If there is a small
business that does happen to manufacture one of the chemicals and therefore receives
a Tier 1 Order, the small business may minimize potential burden by joining a
consortium or task force, which may relieve the small business of direct responsibility
for generating or submitting the data. EPA has further facilitated this collaborative
approach by including the list of Order recipients for a particular chemical in the original
Order package that the entity will receive. Participants in a consortium are free to
negotiate the terms of the agreement, including the level of participation expected from
each member. Typically, that level of participation, which may be based on time or
money, is based on the entity’s market share for that chemical.
EPA can accommodate requests for extensions of time from small businesses,
and provide other assistance, as needed. In fact, OPP has established small business
liaisons that are available to provide a broad range of assistance to small businesses.
An extension in time may help a small business because other manufacturers who
received an Order for that same chemical may submit the data sooner. Since an entity
may demonstrate that they made a reasonable offer to contribute towards the costs for
generating that data, a small entity in this case would only be responsible for their fair
share of the costs, and the time an effort involved in making a reasonable offer.

5(d) Collection Schedule
There is no periodic schedule for the collections under this ICR. This information
collection activity only involves a one-time, three step collection activity per chemical.
The Order will identify the applicable due dates for the collections under the Order. In

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general, the basic schedule EPA intends to use in the Order is based on the timeframes
identified in Table 3:
Table 3 – General Basis for Establishing the Due Dates in the Order
Timeframes for Due Dates:
Within 90 calendar days of the Order’s issuance
(+ 10 calendar days for processing)
Within 150 calendar days of the Order’s
issuance (+ 10 calendar days for processing)
Within 12 months from Order’s issuance
24 months from Order’s issuance

What is Due:
Individual Recipient’s Initial Response
Consortia’s Documentation & Initial Response
A Progress Report describing the status of an Order
Recipient’s compliance with the Order.
Final Study Report and submission of the data to
EPA

In calculating the due date for the Initial Response, the Agency has included an
additional 10 calendar days to build in extra time for the Agency to process the final
Order package after signature, i.e., to add all the due dates that will be calculated from
the signature date, and for physical delivery of the package to the Post Office for
mailing. In general, the Agency does not expect to consider requests for extending the
deadlines for the Initial Response. However, the Agency will consider extending the
final report due date when the circumstances warrant it. The Agency’s policy regarding
time extensions is presented in the Policy and Procedures document (Attachment B).
The time period for Tier 1 screening is expected to take longer than one year
from commencement based on the anticipated composition of the screening battery, but
respondents will not be expected to commence screening as soon as they receive the
Orders, or complete the individual assays in any particular sequence. Although the
activities are expected to occur over the three year approval period for the ICR, the
timing of these activities within that three year period is not specific enough to
accurately divide them by year. For purposes of estimating the potential paperwork
burden in this ICR, EPA assumed that the data would be submitted within 2 or 3 years
of receiving the Tier 1 Order, i.e., within the 3 year approval period for this ICR. To
calculate an annual burden, the Agency assumed a 3 year duration of equal annual
effort.

6.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

The PRA requires EPA to estimate the “paperwork burden” i.e., 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. OMB will not approve a
“collection” until EPA provides an ICR that describes the information collection activities
in detail and provides an estimate of the paperwork burden hours and costs.
Under the PRA, “burden” means the “time, effort, or financial resources
expended by persons to generate, maintain, or provide information to or for a Federal
Agency.” This can include the resources to: review instructions; develop, acquire,
install, and use technology and systems; search data sources; collect, review, validate,
and verify information/data; process and maintain information/data; disclose and
transmit/submit information/data; change/adjust the existing ways of complying with
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any previously applicable instructions and requirements to now comply with new
requirements; and, train personnel. The Agency is also required to estimate the
paperwork costs, which include both the costs associated with the paperwork burden
hours, and any additional costs not tied to a burden hour, but incurred under the PRA
nonetheless (e.g., the cost for mailing the forms to EPA).
In this section of the ICR, the Agency discusses the methodology and
assumptions used to calculate the potential paperwork burden and costs for both
respondents and EPA.

6(a) Methodology for Estimating Respondent Burden and Cost
6(a)(i) Method Used to Calculate the Loaded Labor Rates
Average wage data for the relevant sectors of respondents are available in the
National Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.
We used the NAICS codes to obtain the estimated loaded labor rates used in this ICR,
i.e., NAICS 325300, Pesticide, Fertilizer, & Other Agricultural Chemical Manufacturing
http://www.bls.gov/oes/current/naics4_325300.htm. Within that 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. Each broad occupation
includes detailed occupation(s) based on similar job duties, skills, education, or
experience. For more information on SOC and what is included in each SOC, see
http://www.bls.gov/oes/current/oes_stru.htm. The SOCs used for the following labor
types are listed below in Table 4 and apply to all of the sectors identified above.
Table 4 - Respondent SOCs Used in this ICR
Labor Category

SOC #

Standard Occupational Classification

Management

11-0000

Management Occupations

Technical

19-0000

Life, Physical, and Social Science Occupations

Clerical

43-0000

Office and Administrative Support Occupations

For purposes of calculating a loaded labor rate, we used the mean average
hourly wage rate and assumed that benefits are 43% of wage rates, based on benefits
for all civilian non-farm workers from http://www.bls.gov/news.release/ecec.t01.htm. We
then multiply the loaded wage by 50% to get overhead costs. Overhead costs are
added to the loaded wage rate to get the fully loaded wage rate.

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Table 5 – Respondent Loaded Labor Rates Used in this ICR
Labor Category
Unloaded Hourly Rate1
Benefits Percentage2
Benefits per hour
Loaded Hourly Rate

Formula Used
Managerial
Technical
Clerical
W
$ 48.31
$ 35.86
$ 15.78
Lb = B/W
43%
43%
43%
B = W*Lb
$ 20.77
$ 15.42
$ 6.62
Wb = W+B
$ 69.08
$ 51.28
$ 22.40
(= W(1+Lb))
Overhead Percentage3
Lo = OH/Wb
50%
50%
50%
Overhead per hour
OH = Wb*Lo
$ 34.54
$ 25.64
$ 11.20
Fully Loaded Hourly Rate
Wf = Wb+OH
$ 103.62
$ 76.92
$ 33.60
(= W+B+OH)
1. Data Source: http://www.bls.gov/oes/current/naics4_325300.htm.
2. Fringe benefits/wage per hour.
3. U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-45202-001, January 2002, pg. 2-34. The loading for indirect costs used in this ICR (i.e., 50%) is within the
range of 20-70% of the load labor rate (wage + benefits) suggested in this EPA guidance.

For this ICR, the Agency therefore uses the following labor rates for the
respondents: Managerial = $103.62; Technical = $76.92; and Clerical = $33.60.
6(a)(ii) Method Used to Calculate the Burden and Costs
The specific activities used for estimating the potential burden and costs are
identified in section 4(b) of this ICR. Paperwork burden hours and costs are subdivided
into the managerial, technical, and clerical duty labor categories, which are also
described in more detail in section 4(b) of this ICR.
The Agency then used two basic approaches to calculate the potential burden
and costs for this ICR: 1) For the data generation activities, EPA calculated the
paperwork burden as a percentage of the testing costs; and 2) For the rest of the
paperwork activities, EPA estimated the average amount of time required to complete
the specific activity, considering estimates provided in other approved ICRs involving
the same activity, feedback from stakeholders, and EPA’s overall experience with such
activities.
1. Method Used to Calculate the Burden and Costs for Data Generation. EPA
calculated the paperwork burden for the data generation activities as a percentage of
the testing costs. This percent-based estimate of paperwork associated with conducting
a test was initially established in consultation with OMB in the 1980’s in an effort to
provide a reasonable estimate of the burden associated with the paperwork component
of data generation, which may vary based on the complexity of the test performed. This
appears to be a reasonable and fair alternative to simply setting a single estimate for
data generation burden or perhaps using some set criteria like high, medium or low
burden, neither of which may fairly reflect potential differences in burden. For purposes
of this ICR, the Agency has adopted this established methodology for estimating the
paperwork burden for data generation, which is explained further in this section of the
ICR.
To calculate the burden associated with the paperwork activities involved in
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conducting the tests, the Agency starts with the cost of the test, typically the market
price for the test as identified by laboratories that offer testing services. Since the tests
that will be used in the EDSP are not yet offered by the laboratories, market costs for
these tests are not available. The Agency therefore used estimated costs for 2 assays
that were based on estimates provided by the EPA scientist overseeing the validation
effort for those 2 assays. Since EPA is funding the assay validation effort, we believe
that these estimates are reasonable surrogates for actual market prices at this time and
for the purposes of this ICR. For the other assays, the Agency used the Cost Estimate
Survey of commercial laboratories and other information provided by industry
representatives (Ref. 9 & 10). Once these tests are available on the market, these
costs will be adjusted as appropriate.
Based on the existing methodologies, EPA used 35% of the estimated total test
cost to calculate the total potential cost for the paperwork activities related to data
generation. The 35% of test cost is disaggregated by labor category, and then burden
hours are extrapolated by using the loaded labor rates. To disaggregate by labor
category, the Agency considered the estimated distribution of paperwork activity across
the labor category represented and the existing methodology assumption that
paperwork activities for data generation mostly involve the technical staff to perform the
tests, with a few activities related to management and clerical.
See Figure 1 for an illustrated outline of the Agency burden calculation process
for data generation. The results from using this method are presented in section 6(b) of
this ICR.
Figure 1: Method for Calculating Paperwork Burden from Test Costs
Identify
35% of the
Test Cost

Divide 35% cost into:
20% for Managerial
65% for Technical
15% for Clerical

Divide each by
Loaded Labor
rate for that
Category

Burden
Hours by
Category

This approach assumes and incorporates the following:
1) Recipients generate all of the data as specified in the Tier 1 Order.
2) All data generation is performed by an independent laboratory.
3) Paperwork burden is disaggregated by labor category as follows:
a. Managerial (20%)
b. Technical (65%)
c. Clerical (15%)
4) Labor rates are fully loaded, meaning that they include the estimated costs of
wages, overhead, and benefits paid to an employee. See section 6(a)(i) of
this ICR.
2. Method Used to Calculate the Burden and Costs for Other Activities. For the
other activities, EPA estimated the burden hours by considering the activities
themselves and the expected amount of time that the activity involves on average.
These estimates consider the Agency’s experience with similar data collection activities
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and direct experience in conducting the assays for validation. The costs are calculated
using the loaded labor rates for the labor categories that are identified in section 6(a)(i)
of this ICR.
As indicated previously, almost all of the response options provided to recipients
of Tier 1 Orders are the same as those afforded to pesticide registrants in response to
DCIs. Although other ICRs already address the paperwork burden associated with the
activities involved in those options, the Agency has provided a general estimate for the
burden associated with providing the supporting materials related to the various options
based on its general experience with the pesticide program. At this time, it is not
possible to estimate how many respondents may choose which option.
Regardless of the response option that recipients of Tier 1 Orders choose, the
Agency has assumed that the data will be generated for each chemical with all
manufacturers participating in a consortium or task force, and with only one Order
recipient engaged in actually generating and submitting the data. This means that all of
the potential recipients of Orders will experience a base set of burden associated with
the initial receipt, response activities and subsequent burden related to consortium
participation, and that one recipient for each of the chemicals will experience the burden
associated with generating the data, submitting a one-time progress report and
eventually submitting the data. The results of this method are presented in section 6(b)
of this ICR.
Until the Agency has some experience with this new collection activity, it is
impossible to provide a more refined estimate. At this time, it is important to note that
the estimated total burden for this ICR is based on several assumptions that are
intended to be biased towards providing conservative estimates. These estimates
should not, however, be interpreted as providing an accounting for all of the paperwork
activities associated with the EDSP Tier 1 screening for the initial chemicals. Once all
of the protocols for the Tier 1 assays are finalized and the Orders are issued for the first
group of chemicals to be screened under the EDSP, the Agency intends to conduct a
more thorough evaluation of the screening costs and related activities.

6(b) Calculating Respondent Burden and Costs
This section explains how the Agency calculated the estimated respondent
burden and costs for this ICR.
6(b)(i) Respondent Burden Estimates
The estimated respondent burden for each of the paperwork activities described
in Table 2 in section 4(b) of this ICR, disaggregated by the labor category listed in
Table 4, are presented in Table 6 below.

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Table 6 – Estimated Per Chemical Burden Hours for the Activities
Activity (a)
1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
Total burden:

Managerial
12
48
24
36
24
273
5
36
5

Technical
12
42
21
145
145
1196
20
191
20

Clerical
0
0
2
0
2
632
7
12
7

Total
24
90
47
181
171
2101
32
239
32

3
0
466

0
24
1816

2
62
726

5
86
3008

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) This estimate includes an estimated burden to provide additional material with the response.
(c) Burden estimate is a percentage of the total test cost, which is calculated in Attachment F (rounded).

As discussed earlier, all respondents are not expected to engage in the same
basic activities. Using the respondent categories and numbers presented in Table 1,
Tables 7-9 present the estimated respondent burden for each category of respondent.
Sorting the potential burden this way will facilitate the Agency’s completion of separate
information collection (IC) forms for each category of respondent, which is now required
in the ICR submission and tracking electronic system that is being used.
Table 7 – Estimated Burden Hours by Activity for Pesticide Registrant
Activity (a)

Estimated
Burden
(b)

Estimated #
Respondents
(c)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission package
10) Submit final data to EPA
11) Maintain records
Total burden:

24
90
47
181
171
2101
32
239
32
5
86
3008

207
207
207
58
149
58
58
58
58
58
207

Total
Burden
Hours
(d)
4,968
18,630
9,729
10,498
25,479
121,858
1,856
13,862
1,856
290
17,802
226,828

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1, pesticide registrant column.
(d) Total = (b) x (c)

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Table 8 – Estimated Burden Hours by Activity for Manufacturers/Importers
Activity (a)

Estimated
Burden
(b)

Estimated #
Respondents
(c)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission package
10) Submit final data to EPA
11) Maintain records
Total burden:

24
90
47
181
171
2101
32
239
32
5
86
3008

163
163
163
9
154
9
9
9
9
9
163

Total
Burden
Hours
(d)
3,912
14,670
7,661
1,629
26,334
18,909
288
2,151
288
45
14,018
89,905

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1, manufacturer/importer column.
(d) Total = (b) x (c)

As indicated previously, EPA intends to issue “catch-up” Orders to those
companies that enter the market place after the initial Order recipients have responded.
These respondents will not be expected to generate data. Instead, the respondents will
need to join an existing consortia (or offer to join), or otherwise compensate (or make an
offer to compensate) those who have already done so.
Table 9 – Estimated Burden Hours by Activity for “Catch-up” Orders
Activity (a)

Estimated
Burden
(b)

Estimated #
Respondents
(c)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission package
10) Submit final data to EPA
11) Maintain records
Total burden:

24
90
47
181
171
2101
32
239
32
5
86
3008

20
0
20
0
20
0
0
0
0
0
20

Total
Burden
Hours
(d)
480
0
940
0
3,420
0
0
0
0
0
1,720
6,560

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1, Catch-up Orders column.
(d) Total = (b) x (c)

Table 10 presents the total estimated respondent burden.

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Table 10 – Estimated Total Respondent Burden Hours by Activity
Activity (a)

Estimated
Burden
(b)

Estimated #
Respondents
(c)

1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission package
10) Submit final data to EPA
11) Maintain records
Total burden:

24
90
47
181
171
2,101
32
239
32
5
86
3,008

390
390
390
67
323
67
67
67
67
67
390

Total
Burden
Hours
(d)
9,360
35,100
18,330
12,127
55,233
140,767
2,144
16,013
2,144
335
33,540
325,093

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) Per chemical burden taken from the total column in Table 6.
(c) Number of potential respondents from Table 1.
(d) Total = (a) x (b)

Since there is expected to be some overlap between the potential recipient
categories, the number of potential respondents used for this estimate may be reduced
once the final list of Order recipients is complete. The Agency also expects that a single
potential respondent might receive more than one Tier 1 Order if they manufacture or
import more than one of the listed chemicals, and that there are multiple potential
respondents for each chemical. For example, the Agency estimates that an Order
recipient might receive as many as 4 Orders (i.e., covering 4 chemicals), with the
average company receiving 2 Orders (i.e., covering 2 chemicals). There may be as
many as 56 recipients for an individual Order, with an average of less than 5 recipients
for most of the Orders. As indicated previously, these estimates cannot be further
refined until the Agency identifies all of the specific Order recipients for the final list of
chemicals that will undergo Tier 1 screening under this ICR, which will cannot occur until
the Orders are ready to be issued. As such, the number of potential individual Order
recipients in Table 1 represents the best available estimate of potential respondents at
this time.
6(b)(ii) Respondent Cost Estimates
The estimated respondent cost for each of the paperwork activities is presented
in Table 11. The burden costs are calculated by multiplying the burden hours in Table 6
by the loaded labor rate for the different labor categories, with the costs for generating
the data coming from Attachment F.
In addition to the burden costs, the costs of delivering the data to the Agency are
added to arrive at the total estimated per respondent cost. Delivery costs were
calculated using the Agency’s experience with data submissions for pesticide deliveries,
which assumes the delivery of a paper copy and a CD-Rom using special delivery.
Although not required, nor used by everyone, the Agency is using special delivery for
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the calculation to provide a conservative estimate that would account for expected
variations in delivery costs. Based on the 2-day delivery rate for a large envelope up to
2 lbs. in weight, the US Postal Service rate is $10.55 from the west coast to the east
cost (Ref. 11). Total delivery costs ($10.55 x 67 submissions = $706.85) was then
added to the estimated cost in Tables 11 & 12.
Table 11 – Estimated per Chemical Costs by Activity
Activity (a)
1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for
submission
9) Complete paperwork to assemble the
submission package
10) Submit final data to EPA
11) Maintain records
12) Delivery Costs
Total costs:

Managerial
$103.62/hr.
1243.44
4973.76
2486.88
3730.32
2486.88
28302
518.10
3730.32

Technical
$76.92/hr.
923.04
3230.64
1615.32
11153.40
11153.40
91982
1538.40
14691.72

Clerical
$33.60/hr.
0
0
67.20
0
67.20
21227
235.20
403.20

Total
$
2,166.48
8,204.40
4,169.40
14,883.72
13,707.48
141,511.00
2,291.70
18,825.24

518.10

1538.40

235.20

2,291.70

310.86
0
0
$48,300.66

0
1846.08
0
$139,672.40

67.20
2083.20
0
$24,385.40

378.06
3,929.28
10.55
$212,369.01

(a) Activities described in more detail in section 4(b) of this ICR, which are disaggregated based on labor category.
(b) This estimate includes an estimated burden to provide any additional burden requested for an option.
(c) Burden cost estimate is a percentage of the total test cost, which is calculated in Attachment F (rounded).

Table 12 presents the estimated total respondent costs for the initial group of
chemicals expected to undergo Tier 1 screening under the EDSP.
Table 12 – Estimated Total Respondent Costs by Activity
Activity
1) Read instructions
2) Plan activities
3) Submit an initial response to EPA (b)
4) Read and discuss the protocol
5) Participate in Consortium
6) Generate the data (c)
7) Submit Progress Report
8) Compile and review the final data for submission
9) Complete paperwork to assemble the submission
package
10) Submit final data to EPA
11) Maintain records
12) Delivery Costs
Total costs:

Estimated
Costs ($)
2,166.48
8,204.40
4,169.40
14,883.72
13,707.48
141,511.00
2,291.70
18,825.24
2,291.70

Estimated
Respondents
390
390
390
67
323
67
67
67
67

Total $
(rounded)
844,927
3,199,716
1,626,066
997,209
4,427,516
9,481,237
153,544
1,261,291
153,544

378.06
3,929.28
10.55
$212,369.01

67
67
67

25,330
263,262
707
$22,434,349

As discussed previously, the total respondent burden hours and costs calculated
for this ICR involves activities that are expected to occur over the 3 year approval period
for the ICR, as opposed to annually for each of the 3 years. Since the timing of these
activities is not specific enough to accurately divide them by year, the Agency has
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assumed a 3 year duration of equal annual effort. As such, the total annual
respondent burden and costs for this ICR is simply divided by 3 to get an
estimated annual burden of approximately 108,364 hours (325,093 hours ÷ 3) and a
cost of approximately $7,478,116 ($22,434,349 ÷ 3).

6(c) Methodology for Estimating Agency Burden and Cost
6(c)(i) Method Used to Calculate the Loaded Labor Rates
To calculate the Agency’s loaded labor rate, we used the average wage data
available in the National Industry-Specific Occupational Employment and Wage
Estimates from the Bureau of Labor Statistics (BLS) at
http://www.bls.gov/oes/current/oes_nat.htm. Specifically, we used the NAICS code
999100 to obtain the estimated loaded labor rates used in this ICR for the Federal
Executive Branch (http://www.bls.gov/oes/current/naics4_999100.htm). As was done
for the respondents, we used the wage data provided by SOC (see Table 13). For
purposes of calculating a loaded labor rate, we used the mean average hourly wage
rate and assumed that benefits are 43% of wage rates, based on benefits for all civilian
non-farm workers from http://www.bls.gov/news.release/ecec.t01.htm. We then multiply
the loaded wage by 50% to get overhead costs. Overhead costs are added to the
loaded wage rate to get the fully loaded wage rate.
Table 13 - Agency Loaded Labor Rates Used in this ICR
Labor Category
Unloaded Hourly Rate1
Benefits Percentage2
Benefits per hour
Loaded Hourly Rate

Formula Used
Managerial
Technical
Clerical
W
$ 47.16
$ 31.18
$ 18.29
Lb = B/W
43 %
43 %
43 %
B = W*Lb
$ 20.28
$ 13.41
$ 7.86
Wb = W+B
$ 67.44
$ 44.59
$ 26.15
(= W(1+Lb))
Overhead Percentage3
Lo = OH/Wb
50 %
50 %
50 %
Overhead per hour
OH = Wb*Lo
$ 33.72
$ 22.30
$ 13.08
Fully Loaded Hourly Rate
Wf = Wb+OH
$ 101.16
$ 66.89
$ 39.23
(= W+B+OH)
1. Data Source: http://www.bls.gov/oes/current/naics4_999100.htm
2. Fringe benefits/wage per hour.
3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-45202-001, January 2002, pg. 2-34. The loading for indirect costs used in this ICR (i.e., 50%) is within the
range of 20-70% of the load labor rate (wage + benefits) suggested in this EPA guidance.

For this ICR, the Agency therefore uses the following labor rates for the Agency:
Managerial = $101.16; Technical = $66.89; and Clerical = $39.23.
6(c)(ii) Estimated Agency Burden and Costs
For the Agency activities, EPA estimated the burden hours by considering the
activities themselves and the expected amount of time that the activity may involve on
average. These estimates consider the Agency’s experience with similar data collection
activities. The estimated per chemical/respondent burden hours for the Agency are
presented in Table 14. To calculate the total potential Agency burden over the three

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years, EPA has multiplied this burden by the total number of chemicals (809.5 hours x
67 chemicals = 54,236.5 hours).
Table 14 – Estimated Agency per Chemical Burden Hours
Activity (a)
1) Prepare instructions
2) Identify chemicals to be screened
3) Identify recipients
4) Prepare the 408(p) Order Packages
5) Review & approve the Orders
6) Issue the Orders
7) Process initial responses (b)
8) Publish & Post List of Recipients
9) Verify claims & Send Written Responses
10) Provide assistance & follow-up, as needed
11) Identify non-responders
12) Process Data Submissions
13) Analyze data (c)
14) Incorporate data into risk assessments
15) Store data in retrievable system
16) Identify recipients of Catch-Up Orders
17) Prepare and Issue Catch-up Orders
18) Amend Recipient List, Publish & Post
19) Process responses to Catch-up Orders
20) Process Consortia Documentation
21) Close out Order
Total burden:

Managerial
2
2
2
0
2
0
1
0.5
1
0
0
0
0
0
0
0
1
0.5
0
0
0.5
12.5

Technical
12
21
16
4
4
0
4
0.5
6
36
0
8
520
104
4
1
6
0.5
2
0
2
751

Clerical
2
2
0
10
0
6
1
2
1
0
2
1
0
0
8
1
3
2
1
2
2
46

Total
16
25
18
14
6
6
6
3
8
36
2
9
520
104
12
2
10
3
3
2
4.5
809.5

(a) Activities described in more detail in section 5(a) of this ICR.
(b) This estimate includes an estimated burden to for physically processing the response.
(c) Assumes 40 hrs per assay (40 x 13).
(d) Assumes 8 hrs per assay (8 x 13).

The costs are then calculated using the loaded labor rates for the labor
categories that are identified in section 6(c)(i) of this ICR. The estimated burden hour
costs for the Agency are presented in Table 15. To calculate the total potential Agency
costs over the three years, EPA has multiplied the per chemical cost in Table 15 by the
total number of chemicals ($50,921 x 67 chemicals = $3,411,707). The total annual
costs to the Agency are estimated to be $1,137,235.60 ($3,411,707 ÷ 3).

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Table 15 – Estimated Agency Per Chemical Burden Hour Costs
Activity (a)
1) Prepare instructions
2) Identify chemicals to be screened
3) Identify recipients
4) Prepare the 408(p) Order Packages
5) Review & approve the Orders
6) Issue the Orders
7) Process initial responses (b)
8) Provide assistance & follow-up, as needed
9) Identify non-responders
10) Process Data Submissions
11) Analyze data
12) Incorporate data into risk assessments
13) Store data in retrievable system
Total costs:

Managerial
$101.16/hr.
202.32
202.32
202.32
0
202.32
0
101.16
0
0
0
0
0
0
$910.44

Technical
$66.89/hr.
802.68
1404.69
1070.24
267.56
267.56
0
267.56
2408.04
0
535.12
34782.80
6956.56
267.56
$49,030.37

Clerical
$39.23/hr.
78.46
78.46
0
156.20
0
235.38
39.23
0
39.23
39.23
0
0
313.84
$980.03

Total
$
1,083.46
1,685.47
1,272.56
423.76
469.88
235.38
407.95
2,408.04
39.23
574.35
34,782.8
6,956.56
581.4
$50,920.84

(a) Activities described in more detail in section 5(a) of this ICR.
(b) This estimate includes an estimated burden to provide any additional burden requested for an option.

6(d) Total Burden Hours and Costs for ICR (Bottomline)
As discussed earlier, the total burden hours for respondents calculated for this
ICR involves activities that are expected to occur over the next 3 years. Since the
timing of these activities is not specific enough to accurately divide them by year, the
Agency has assumed a 3 year duration of equal effort to calculate the annual burden
and costs for this ICR.
The total annual respondent burden and costs for this ICR is simply divided by 3
to get an estimated annual burden of approximately 108,364 hours (325,093 hours ÷ 3)
and a cost of approximately $7,478,116 ($22,434,349 ÷ 3). Table 16 provides a
breakdown of the total annualized burden and cost estimate in terms of the grouping
required by OMB, i.e., distinct information collections (ICs).
Table 16 – Annualized Information Collections (ICs) for this ICR (a)
IC
Reporting
Recordkeeping
Totals:

Per Chemical (b)
Burden Hrs.
Costs $
974
$69,480
29
$1,310
1003
$70,790

Totals (c)
Burden Hrs.
Costs $
97,184
$7,390,362
11,180
$87,754
108,364
$7,478,116

(a) Burden hours and costs are annualized by dividing them by 3.
(b) For per chemical burden see Table 6, i.e., total burden minus line item 11 (3,008-86) ÷ 3, and for costs see Table
11, i.e., total cost minus line item 11 (212369 – 3929) ÷ 3. Line item 11 in both tables represents recordkeeping.
(c) For total respondent burden see Table 10, i.e., total burden minus line item 11 (325093-33540) ÷ 3, and for
costs see Table 12, i.e., total cost minus line item 11 (22,434,349-263,262) ÷ 3. Line item 11 in both tables
represents recordkeeping.

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April 15, 2009

6(e) Reasons for Change in Burden Estimates
This new information collection request is necessary to fully implement the
mandate in FFDCA 408(p). The burden estimates presented here are not currently
listed in the OMB Inventory. As such, the total estimated respondent burden in this ICR
is considered a program change related to the implementation of a statutory mandate.

6(f) Burden Statement for this ICR
The estimated per chemical/per respondent paperwork burden to comply with
this information collection activity is 3,008 hours, with an estimated cost of $212,369.
Annualized over three years, the per respondent burden is 1003 hours, and the cost is
$70,790. The total annualized estimated paperwork burden for this ICR is 108,364
hours, with an estimated total annual cost of $7,478,116.
According to the Paperwork Reduction Act (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 instructions in the Order, providing an initial response to EPA, planning
the necessary data collection activities, conducting tests, analyzing data, generating
reports and submitting data, as well as storing, filing, and maintaining the data. 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. As a
new ICR, the Agency does not yet have an OMB control number for this information
collection activity at this time. Once assigned, EPA will announce the OMB control
number for this information collection in the Federal Register, and will add it to any
related collection instruments or forms used.
Upon submission to OMB for approval, the PRA requires the Agency to provide a
30 day public review and comment opportunity, which is announced in the Federal
Register. To comment on the Agency's need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing respondent
burden, including the use of automated collection techniques, EPA has established a
public docket for this ICR under docket ID No. EPA-HQ-OPPT-2007-1081, which is
available electronically at http://www.regulations.gov. A hard copy of the docket
materials are also available for public viewing at the OPPT Docket. The OPPT Docket is
located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–
1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket
visitors are required to show photographic identification, pass through a metal detector,
and sign the EPA visitor log. All visitor bags are processed through an X-ray machine
and subject to search. Visitors will be provided an EPA/DC badge that must be visible at
all times in the building and returned upon departure.

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April 15, 2009

Submit any comments online at http://www.regulations.gov, following the online
instructions for viewing documents and submitting comments. You can also send
comments to the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for
EPA. Please include the Docket ID No. EPA-HQ-OPPT-2007-1081, and the EPA ICR
number (2249.01) in any correspondence.

7.

LIST OF REFERENCES

The following is a list of the documents that are specifically referenced in this
document, along with information about where to access the documents:
1. Endocrine Disruptor Screening Program; Notice (63 FR 42852, August 11, 1998)
http://www.epa.gov/scipoly/oscpendo/pubs/081198frnotice.pdf.
2. Endocrine Disruptor Screening Program; Proposed Statement of Policy; Notice (63 FR
71541, December 28, 1998)
http://www.epa.gov/scipoly/oscpendo/pubs/122898frnotice.pdf.
3. Endocrine Disruptor Screening Program; Chemical Selection Approach for Initial Round
of Screening; Notice (70 FR 56449, September 27, 2005)
http://www.epa.gov/fedrgstr/EPA-TOX/2005/September/Day-27/t19260.pdf.
4. Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for
Screening under the Federal Food, Drug, and Cosmetic Act; Notice (72 FR 33486, June
18, 2007) http://www.epa.gov/scipoly/oscpendo/pubs/draft_list_frn_061807.pdf.
5. Final List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for
Screening under the Federal Food, Drug, and Cosmetic Act; Notice (74 FR 17579, April
15, 2009).
6. Endocrine Disruptor Screening Program (EDSP); Draft Policy and Procedures
Document; Request for Comment; Notice (72 FR 70842, December 13, 2007)
http://www.epa.gov/scipoly/oscpendo/pubs/draft_policies_frn.pdf.
7. Endocrine Disruptor Screening Program (EDSP); Policies and Procedures for Initial
Screening; Notice (74 FR 17560, April 15, 2009) (See Attachment B to this ICR).
8. Agency Information Collection Activities; Proposed Collection; Comment Request; Tier 1
Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program
(EDSP); EPA ICR No. 2249.01, OMB Control No. 2070-new; Notice (72 FR 70839,
December 13, 2007) http://www.epa.gov/fedrgstr/EPA-TOX/2007/December/Day13/t24163.htm.
9. Cost Estimate Survey: Endocrine Screening Assays, Applied Pharmacology and
Toxicology, Inc., (May 23, 2003)
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=EPAHQ-OPPT-2007-1081-0003.
10. Comments (attachment), Applied Pharmacology and Toxicology, Inc., (March 12, 2008),
Document ID No.: EPA-HQ-OPPT-2007-1081-0013.1.
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April 15, 2009

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=EPAHQ-OPPT-2007-1081-0008.
11. U.S. Postal Service, Online Rate Calculator, as of July 20, 2007.
http://postcalc.usps.gov/.

8.

ATTACHMENTS TO THIS SUPPORTING STATEMENT

All of the attachments listed below can be found in the docket for this ICR (unless
otherwise noted); and are accessible electronically through www.Regulations.gov ,
under Docket ID Number: EPA-HQ-OPPT-2007-1081.
Attachment
A
B
C
D
E
F
G
H

Description
FFDCA sections 408(p), 408(i). Available at http://www.epa.gov/oppfead1/fqpa/ and click
on “LAWS” then click on the available PDF file for FFDCA.
Endocrine Disruptor Screening Program (EDSP); Policies and Procedures for Initial
Screening; Notice (74 FR 17560, April 15, 2009)
(1) FFDCA 408(p) Order Template for Pesticide Inert Ingredients (As of April 10, 2009).
(2) FFDCA 408(p) Order Template for Pesticide Registrants (As of April 10, 2009).
(1) Initial Response Form for Individual Order Recipients (As of April 3, 2009).
(2) Initial Response Form for Consortium/ Task Force (As of April 3, 2009).
Overall Process for EDSP Orders (April 3, 2009).
Calculations for Paperwork Burden and Costs for Data Generation Activities (April 3,
2009).
Final List of Chemicals for Initial Tier 1 Screening in the EDSP (April 3, 2009).
Response to Comments on the Public Review Draft of the Information Collection Request
(ICR) entitled: “Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor
Screening Program (EDSP)” (April 10, 2009).

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