[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54422-54428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25352]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0634; FRL-8434-8]
Endocrine Disruptor Screening Program; Tier 1 Screening Order
Issuing Announcement
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This action announces the Agency's initiation of the Endocrine
Disruptor Screening Program (EDSP) Tier 1 screening for the first group
of 67 chemicals by issuing orders between October 29, 2009, and
February 26, 2010, pursuant to the authority provided to EPA under
section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA).
The EDSP Tier 1 screening data required to satisfy an order are due
within 2 years of the date of issuance of the order. This action also
provides information for pesticide registrants, manufacturers and
importers of inert chemicals used in pesticide products, and the public
on how to obtain details about the orders (such as the date of issuance
and the recipients), the ``Pesticide Inert Ingredients Data Submitters
and Suppliers List'' (PIIDSSL), and how interested persons other than
recipients of test orders may submit other scientifically relevant
information on the chemicals subject to the orders.
DATES: Order recipients must respond according to the schedules
contained in the order they receive. Persons other than order
recipients who wish to submit other scientifically relevant information
related to one of the chemical-specific orders should submit
[[Page 54423]]
that information within 90 days of the order issuance date.
ADDRESSES: Persons other than order recipients should submit their
information identified by docket identification (ID) number EPA-HQ-OPP-
2009-0634, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0634. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Jane Scott Smith, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; fax
number: (703) 308-8090; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
use, or import pesticide/agricultural chemicals and other chemical
substances; or if you are or may otherwise be involved in the testing
of chemical substances for potential endocrine effects. Potentially
affected entities may include, but are not limited to:
Chemical manufacturers, importers 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.
Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket ID number EPA-HQ-OPP-2009-0634. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Introduction
A. What Action is the Agency Taking?
The Agency is initiating the EDSP Tier 1 screening for the first
group of 67 chemicals by issuing test orders from October 29, 2009,
through February 26, 2010. Details on the status of the orders will be
provided on EPA's website at http://www.epa.gov/endo with information,
including the order issuance date, the recipient(s) of the order, each
order recipient's response and the order due date. EPA intends to
update the list with subsequent publications and postings as
appropriate. This public listing is provided to invite the public to
identify additional entities who should receive the FFDCA section
408(p) test order. The commenters could either identify themselves or
another person as additional candidates (with proper substantiation)
for receipt of a FFDCA section 408(p) test order by contacting the
person listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's Authority for Taking this Action?
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
[[Page 54424]]
similar to an effect produced by a naturally occurring estrogen, or
such other effects as [EPA] may designate.'' (21 U.S.C. 346a(p)).
Section 408(p)(3) specifically requires that the Administrator ``shall
provide for the testing of all pesticide chemicals.'' (21 U.S.C.
346a(p)(3)).
Section 201 of FFDCA defines ``pesticide chemical'' as ``any
substance that is a pesticide within the meaning of [FIFRA], including
all active and inert ingredients of such pesticide.'' (21 U.S.C.
231(q)(1)).
Section 408(p)(5) of FFDCA provides that the Administrator shall
issue an order to a registrant of a substance for which testing is
required under this subsection, or to a person who manufactures or
imports a substance for which testing is required under this
subsection. The order shall require the recipient to conduct testing in
accordance with the screening program, and to submit information
obtained from the testing to the Administrator, within a reasonable
time period that the Administrator determines is sufficient for the
generation of the information.
Section 3(c)(2)(B) of FIFRA provides that registrants must submit
additional data, upon notification that the Administrator has
determined that additional data are required to maintain an existing
pesticide registration. (7 U.S.C. 136a(c)(2)(B)). In light of the
directive in section 408(p)(3) of FFDCA that EPA is to provide for the
endocrine screening of all pesticide chemicals, EPA considers that such
data have been statutorily determined to be necessary to maintain an
existing pesticide registration.
III. Background
EPA developed the EDSP in response to the Congressional mandate in
section 408(p) of FFDCA to ``develop a screening program. . .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 endocrine effects as [EPA] may designate'' (21 U.S.C.
346a(p)). When carrying out the program, the statute requires EPA to
``provide for the testing of all pesticide chemicals.'' 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.'' In addition, section 1457 of the Safe Drinking Water Act
(SDWA) provides EPA with discretionary authority to provide for
testing, under the FFDCA 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.''
EPA initially set forth the EDSP in the August 11, 1998 Federal
Register notice (63 FR 42852) (FRL-6021-3), and solicited public
comment on the program in the December 28, 1998 Federal Register notice
(63 FR 71542) (FRL-6052-9). The program initiated in these notices was
based on the recommendations of the Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), which was chartered under the
Federal Advisory Committee Act (FACA), 5 U.S.C. App.2, section 9(c).
The EDSTAC was comprised of members representing the commercial
chemical and pesticides industries, Federal and State agencies, worker
protection and labor organizations, environmental and public health
groups, and research scientists.
EDSTAC recommended that EPA's program address both potential human
and ecological effects; examine effects on estrogen, androgen, and
thyroid hormone-related processes; and include non-pesticide chemicals,
contaminants, and mixtures in addition to pesticides. Based on these
recommendations, EPA developed a two-tiered assessment approach for
these chemicals, referred to as the EDSP. 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
dose-response relationship for any adverse effects that might result
from the interactions identified through the Tier 1 assays. EDSTAC also
recommended that EPA establish a priority-setting approach for choosing
chemicals to undergo Tier 1 screening.
EPA implemented its EDSP in three major parts.
1. Assay validation. Under FFDCA section 408(p), EPA is required to
use ``appropriate validated test systems and other scientifically
relevant information'' to determine whether substances may have
estrogenic effects in humans or other endocrine effects as EPA may
designate. Validation is defined as the process by which the
reliability and relevance of test methods are evaluated for the purpose
of supporting a specific use. The EDSP Tier 1 screening assays were
peer reviewed by independent experts and by the FIFRA Scientific
Advisory Panel (SAP) during a public meeting on March 25-27, 2008.
Details on the validation and peer review process for the assays as
well as the peer review reports can be found on EPA's website at http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/index.htm. The FIFRA
SAP report is available at http://www.epa.gov/scipoly/sap/meetings/2008/march/minutes2008-03-25.pdf. Elsewhere in this issue of the
Federal Register, EPA is issuing the final Tier 1 battery composed of
the validated assays. The Tier 1 battery protocols can be found in the
corresponding docket EPA-HQ-OPPT-2009-0634 or the website at http://www.epa.gov/oppts (select ``Test Methods & Guidelines''). EPA is also
in the process of developing and validating Tier 2 tests. The status of
each assay can be viewed on the EDSP website in the Assay Status table:
http://www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.
2. Priority setting. EPA described its priority setting approach
for the first group of pesticide chemicals to be tested under the EDSP
in the Federal Register of September 27, 2005 (70 FR 56449) (FRL-7716-
9), and proposed the draft list of initial chemicals for review and
public comment in the Federal Register notice of June 18, 2007 (72 FR
33486) (FRL-8129-3). The public comments and Agency responses can be
found in the associated docket EPA-HQ-OPPT-2004-0109. In April 2009,
EPA published in the Federal Register its final list of the first group
of chemicals to be screened under EDSP. The first group of 67 chemicals
identified for screening includes pesticide active ingredients and high
production volume (HPV) chemicals used as pesticide inert ingredients
(also known as other ingredients). This list should not be construed as
a list of known or likely endocrine disruptors. More information on
EPA's priority setting approach for selection of the first group of
chemicals for the EDSP is available at http://www.epa.gov/scipoly/oscpendo/prioritysetting.
The first group of chemicals to be screened consists of chemicals
that section 408(p) of FFDCA requires be screened, i.e., pesticide
active ingredients and chemicals used as pesticide inert ingredients
(also known as other ingredients). EPA anticipates that it may, in the
future, modify its approach to selecting chemicals for screening.
Information and factors that EPA may consider in selecting chemicals
could include: Public input; the results of testing chemicals on the
initial list; management considerations to increase the integration of
screening with other regulatory activities within the Agency;
implementation considerations flowing from a decision
[[Page 54425]]
to extend screening to additional categories of chemicals (e.g., non-
pesticide chemical substances); and the availability of new priority
setting tools (e.g., High Throughput Pre-screening or Quantitative
Structure Activity Relationships models). More information on EPA's
priority setting approach is available at http://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
3. Procedures. EPA published a document in the Federal Register of
December 13, 2007 (72 FR 70842) (FRL-8340-3), that describes the
proposed procedures that EPA would use to issue orders, the proposed
procedures that order recipients would use to respond to the order, how
data protection and compensation would be addressed in the test orders,
and other related proposed procedures or policies. In addition, EPA
developed a draft template for the test order and a draft information
collection request (ICR) to obtain the necessary clearances under the
Paperwork Reduction Act (PRA). On April 15, 2009, the Agency published
the final policies and procedures and related documents in the Federal
Register ((74 FR 17560) (FRL-8399-9), (74 FR 17579) (FRL-8399-7), and
(74 FR 17477) (FRL-8412-2)). EPA generally intends to adopt these
procedures for initial screening of chemicals under the EDSP, including
the statutory requirements associated with and format of the test
orders, as well as EPA's procedures for fair and equitable sharing of
test costs and handling of confidential data (docket number EPA-HQ-
OPPT-2007-1080).
IV. Order Issuance Schedule
The Agency intends to initiate the EDSP Tier 1 screening for the
first group of 67 chemicals by issuing test orders listed in the
following table.
Table 1-List of Chemicals and Order Issuance Dates for Tier 1 Screening in the EDSP
----------------------------------------------------------------------------------------------------------------
Pesticide Active
Chemical Name CAS Number Ingredient (x) or as Order Issuance Time Frame
Noted
----------------------------------------------------------------------------------------------------------------
Abamectin 71751-41-2 x January 2010
----------------------------------------------------------------------------------------------------------------
Acephate 30560-19-1 x November 2009
----------------------------------------------------------------------------------------------------------------
Acetone 67-64-1 HPV/Inert February 2010
----------------------------------------------------------------------------------------------------------------
Atrazine 1912-24-9 x October 2009
----------------------------------------------------------------------------------------------------------------
Benfluralin 1861-40-1 x October 2009
----------------------------------------------------------------------------------------------------------------
Bifenthrin 82657-04-3 x November 2009
----------------------------------------------------------------------------------------------------------------
Butyl benzyl phthalate 85-68-7 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Captan 133-06-2 x January 2010
----------------------------------------------------------------------------------------------------------------
Carbamothioic acid, dipropyl-, S-ethyl 759-94-4 x November 2009
ester
----------------------------------------------------------------------------------------------------------------
Carbaryl 63-25-2 x November 2009
----------------------------------------------------------------------------------------------------------------
Carbofuran 1563-66-2 x November 2009
----------------------------------------------------------------------------------------------------------------
Chlorothalonil 1897-45-6 x December 2009
----------------------------------------------------------------------------------------------------------------
Chlorpyrifos 2921-88-2 x November 2009
----------------------------------------------------------------------------------------------------------------
Cyfluthrin 68359-37-5 x November 2009
----------------------------------------------------------------------------------------------------------------
Cypermethrin 52315-07-8 x November 2009
----------------------------------------------------------------------------------------------------------------
2,4-D 94-75-7 x October 2009
----------------------------------------------------------------------------------------------------------------
DCPA (or chlorthal-dimethyl) 1861-32-1 x October 2009
----------------------------------------------------------------------------------------------------------------
Diazinon 333-41-5 x November 2009
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate 84-74-2 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Dichlobenil 1194-65-6 x December 2009
----------------------------------------------------------------------------------------------------------------
Dicofol 115-32-2 x December 2009
----------------------------------------------------------------------------------------------------------------
Diethyl phthalate 84-66-2 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Dimethoate 60-51-5 x November 2009
----------------------------------------------------------------------------------------------------------------
Dimethyl phthalate 131-11-3 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Di-sec-octyl phthalate 117-81-7 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Disulfoton 298-04-4 x November 2009
----------------------------------------------------------------------------------------------------------------
[[Page 54426]]
Endosulfan 115-29-7 x December 2009
----------------------------------------------------------------------------------------------------------------
Esfenvalerate 66230-04-4 x November 2009
----------------------------------------------------------------------------------------------------------------
Ethoprop 13194-48-4 x November 2009
----------------------------------------------------------------------------------------------------------------
Fenbutatin oxide 13356-08-6 x October 2009
----------------------------------------------------------------------------------------------------------------
Flutolanil 66332-96-5 x December 2009
----------------------------------------------------------------------------------------------------------------
Folpet 133-07-3 x January 2010
----------------------------------------------------------------------------------------------------------------
Gardona (cis-isomer) 22248-79-9 x November 2009
----------------------------------------------------------------------------------------------------------------
Glyphosate 1071-83-6 x January 2010
----------------------------------------------------------------------------------------------------------------
Imidacloprid 138261-41-3 x January 2010
----------------------------------------------------------------------------------------------------------------
Iprodione 36734-19-7 x January 2010
----------------------------------------------------------------------------------------------------------------
Isophorone 78-59-1 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Linuron 330-55-2 x December 2009
----------------------------------------------------------------------------------------------------------------
Malathion 121-75-5 x November 2009
----------------------------------------------------------------------------------------------------------------
Metalaxyl 57837-19-1 X December 2009
----------------------------------------------------------------------------------------------------------------
Methamidophos 10265-92-6 X November 2009
----------------------------------------------------------------------------------------------------------------
4,7-Methano-1H-isoindole-1,3(2H)-dione, 113-48-4 x January 2010
2-(2-ethylhexyl)-3a,4,7,7a-tetrahydro-
----------------------------------------------------------------------------------------------------------------
Methidathion 950-37-8 x November 2009
----------------------------------------------------------------------------------------------------------------
Methomyl 16752-77-5 x November 2009
----------------------------------------------------------------------------------------------------------------
Methyl ethyl ketone 78-93-3 HPV/Inert January 2010
----------------------------------------------------------------------------------------------------------------
Methyl parathion 298-00-0 x November 2009
----------------------------------------------------------------------------------------------------------------
Metolachlor 51218-45-2 x December 2009
----------------------------------------------------------------------------------------------------------------
Metribuzin 21087-64-9 x December 2009
----------------------------------------------------------------------------------------------------------------
Myclobutanil 88671-89-0 X December 2009
----------------------------------------------------------------------------------------------------------------
Norflurazon 27314-13-2 X October 2009
----------------------------------------------------------------------------------------------------------------
o-Phenylphenol 90-43-7 x January 2010
----------------------------------------------------------------------------------------------------------------
Oxamyl 23135-22-0 x November 2009
----------------------------------------------------------------------------------------------------------------
Permethrin 52645-53-1 x November 2009
----------------------------------------------------------------------------------------------------------------
Phosmet 732-11-6 x November 2009
----------------------------------------------------------------------------------------------------------------
Piperonyl butoxide 51-03-6 x November 2009
----------------------------------------------------------------------------------------------------------------
Propachlor 1918-16-7 x December 2009
----------------------------------------------------------------------------------------------------------------
Propargite 2312-35-8 x October 2009
----------------------------------------------------------------------------------------------------------------
Propiconazole 60207-90-1 x December 2009
----------------------------------------------------------------------------------------------------------------
Propyzamide 23950-58-5 x January 2010
----------------------------------------------------------------------------------------------------------------
Pyridine, 2-(1-methyl-2-(4- 95737-68-1 x January 2010
phenoxyphenoxy)ethoxy)-
----------------------------------------------------------------------------------------------------------------
Quintozene 82-68-8 x December 2009
----------------------------------------------------------------------------------------------------------------
[[Page 54427]]
Resmethrin 10453-86-8 x November 2009
----------------------------------------------------------------------------------------------------------------
Simazine 122-34-9 x December 2009
----------------------------------------------------------------------------------------------------------------
Tebuconazole 107534-96-3 x December 2009
----------------------------------------------------------------------------------------------------------------
Toluene 108-88-3 HPV/Inert February 2010
----------------------------------------------------------------------------------------------------------------
Triadimefon 43121-43-3 x December 2009
----------------------------------------------------------------------------------------------------------------
Trifluralin 1582-09-8 x January 2010
----------------------------------------------------------------------------------------------------------------
Details on the status of the orders will be provided on EPA's
website at http://www.epa.gov/endo with information, including the
order issuance date, the recipient(s) of the order, the order
recipient's response to the order, and the order due date.
V. Submission of Other Scientifically Relevant Information by
Interested Parties
The Agency published the final policies and procedures and related
documents in the Federal Register of April 15, 2009 ((74 FR 17560), (74
FR 17579), and (74 FR 17477)); as part of those documents, EPA
discussed its policies relating to the submission of other
scientifically relevant information in satisfaction of a test order. As
explained at greater length in those documents, if recipients of the
FFDCA section 408(p) test orders choose to cite or submit existing
data, (i.e., other scientifically relevant information (OSRI)), along
with a rationale that explains how the cited or submitted study
satisfies the Tier 1 test order in lieu of developing new data, EPA
will determine whether the information can be used to satisfy part or
all of the Tier 1 order and/or otherwise inform the Tier 1
determination. Existing data may include data that has already been
generated using the assay(s) specified in the order, or other
scientifically relevant information. Other scientifically relevant
information is information that informs the determination as to whether
the substance may have an effect that is similar to an effect produced
by a substance that interacts with the estrogen, androgen, and/or
thyroid hormonal systems (e.g., information that identifies substances
as having the potential to interact with the estrogen, androgen, and/or
thyroid system(s); information demonstrating whether substances have an
effect on the functioning of the endocrine system). Other
scientifically relevant information may either be functionally
equivalent to information obtained from the Tier 1 assays--that is,
data from assays that perform the same function as EDSP Tier 1 assays--
or may include data that provide information on a potential consequence
or effect that could be due to effects on the estrogen, androgen or
thyroid systems. Some other scientifically relevant information may be
sufficient to satisfy part or all of the Tier 1 order and/or otherwise
inform the Tier 1 determination.
The Agency has written a paper entitled ``EPA's Approach for
Considering Other Scientifically Relevant Information (OSRI) under the
EDSP'' (see www.regulations.gov and search for docket number EPA-HQ-
OPPT-2007-1080-0032). This paper was developed to provide guidance to
EPA staff and managers who will review the responses to Tier 1 test
orders issued under the EDSP, and may also be of interest to parties
considering whether to submit OSRI to EPA. This paper is intended only
to provide general guidance and is not binding on either EPA or any
outside parties. Anyone, including members of the general public, may
provide OSRI, and the Agency will assess the information for
appropriateness on a case-by-case basis to determine whether the
information can be used to satisfy part or all of the Tier 1 order and/
or otherwise inform the Tier 1 determination.
Persons other than those receiving testing orders who would like to
submit OSRI on chemicals subject to test orders should include the
following information:
The submitter's contact information.
The name of the program (i.e., Endocrine Disruptor
Screening Program (EDSP).
The name of the chemical to which the information applies.
The citation of the study and/or a copy of the study, if
possible.
The order number(s) to which the information applies.
A rationale that explains how the cited or submitted
study(ies) satisfies all or some portion of the Tier 1 order.
In order for this information to be given timely consideration, the
information should be submitted on the same time frame as the response
to orders, i.e. this information should be submitted as a comment to
the docket for this action (EPA-HQ-OPP-2009-0634) within 90 days of the
issuance date of the orders for a given chemical. The details about the
dates of issuance of the orders can be found at www.epa.gov/endo.
VI. Pesticide Inert Ingredients Data Submitters and Suppliers List
Currently, EPA maintains a list of all data on pesticide active
ingredients that supports registration of products containing the
active ingredient, along with contact information for the submitters
(i.e., owners) of the data, known as the ``Data Submitters List.'' The
Agency published the final policies and procedures and related
documents in the Federal Register on April 15, 2009 ((74 FR 17560), (74
FR 17579), and (74 FR 17477)) describing EPA's intention to establish a
Pesticide Inert Ingredients Data Submitters & Suppliers List (PIIDSSL)
which is similar to the ``Data Submitters List.'' The purpose of the
PIIDSSL is to identify any entity who has submitted compensable data on
a pesticide inert ingredient in response to a test order issued under
section 408(p) of FFDCA. Pursuant to FIFRA section 3(c)(1)(F), when a
applicant's product contains a pesticide inert ingredient on the
PIIDSSL, EPA intends to require the applicant to identify the source of
the pesticide inert ingredient. If the applicant's source does not
appear on the PIIDSSL, EPA intends to require the applicant either to
switch to a source on the PIIDSSL; offer to pay compensation to the
original data submitter(s) on the PIIDSSL; or generate
[[Page 54428]]
their own data to support their application.
The PIIDSSL can be found on EPA's website at www.EPA.gov/DataSubmittersList or a link to it can be found at www.epa.gov/endo.
List of Subjects
Environmental protection, Chemicals, Endocrine disruptors,
Pesticides.
Dated: October 14, 2009.
Stephen A. Owens,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E9-25352 Filed 10-20-09; 8:45 am]
BILLING CODE 6560-50-S