Endocrine Disruptor Screening Program; Second List of Chemicals for Tier 1 Screening, 70248-70254 [2010-28818]
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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
restrictions on the use of lead tackle in
the state. Other states have outreach and
education and tackle exchange
programs.
The comments that EPA has received
from states and a state organization
highlight the geographic focus of state
controls on lead fishing tackle.
According to the Association of Fish
and Wildlife Agencies, ‘‘the exposure to
certain migratory birds (primarily loons,
and to a lesser extent, swans) and
related impacts to populations of those
birds is localized, and where impacts
have been substantiated to be
significant, state fish and wildlife
agencies have acted to regulate the use
of lead sinkers and jigs. In the northeast,
five states have enacted restrictions
(e.g., ban in certain bodies of water; ban
on certain weights and sizes) on the use
of lead fishing tackle where studies have
identified lead toxicosis as a
contributing factor to declining loon
populations. Some states are also
offering a fishing tackle exchange
program (non-lead for lead products).
States have thus demonstrated a
responsible exercise of their authority to
regulate or restrict lead fishing tackle
under circumstances of exposure where
it contributes to decline in loon
populations’’ (Ref. 2).
Several state fish and game agencies
submitted comments (Refs. 3–5). All
support denial of the petition and
provide several reasons why they do not
support the actions requested in the
petition. These comments assert that
mortality from ingestion of lead fishing
tackle is rare and is primarily limited to
some areas of the country, that states are
already working closely with the Fish
and Wildlife Service on education and
exchange programs, and that where
there have been impacts on loons and
trumpeter swans, states have already
taken action. These states contend that
these impacts are best addressed by
geographically targeted actions that the
states are undertaking. As noted by
these commenters, states in the northern
part of the country, where the majority
of the impacts on loons has been
observed, have taken action to limit or
ban the use of lead sinkers or have
implemented tackle exchange programs.
While it is the case, as petitioners
noted, that 16 years ago, in 1994, EPA
proposed a ban of lead for use in certain
smaller-sized fishing sinkers under
TSCA section 6(a)(2)(A), the sweeping
alternative requested by petitioners was
not one the Agency, as reflected in its
proposal, found to be appropriate even
then. (59 FR 11122, March 9, 1994). The
steps that have been taken at the Federal
and State levels since that time make a
nationwide ban on all lead fishing gear
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such as that sought by petitioners even
less appropriate today.
Moreover, the market for fishing gear
is changing. While lead tackle may still
constitute the largest percentage of the
fishing sinker market, over the last
decade the availability of fishing sinkers
made from other materials has
expanded. New non-lead products have
entered the market, and the market
share of lead sinkers has decreased.
With improvements in technology,
changes in consumer preferences, statelevel restrictions, and increased market
competition, the market for lead fishing
sinkers is expected to continue to
decrease while the market for
substitutes such as limestone, steel, and
tungsten fishing sinkers is expected to
continue to increase (Ref. 6).
In sum, EPA is not persuaded that the
action requested by the petitioners—a
sweeping national uniform rule on lead
in all fishing gear—is necessary. The
petitioners also have failed to
demonstrate that a national ban on lead
fishing gear is the least burdensome
approach to adequately address the risk
to the environment addressed in the
petition, as required by TSCA section 6,
given the mix of actions that state
agencies and the Federal Government
already are taking to address the impact
of lead fishing sinkers on local
environments. The risk described by the
petitioners does appear to be more
prevalent in some geographic areas than
others, and the trend over the past
decade has been for increasing state and
localized activity regarding lead in
fishing gear. For these reasons, EPA
denied the petitioners’ request for a
national ban on lead in all fishing gear.
V. References
1. American Bird Conservancy, Petition to
the Environmental Protection Agency to Ban
Lead Shot, Bullets and Fishing Sinkers under
the Toxic Substances Control Act. August 3,
2010.
2. Association of Fish and Wildlife
Agencies. Letter to Honorable Lisa Jackson,
Administrator, United States Environmental
Protection Agency. September 2, 2010.
3. The State of Arizona Game and Fish
Department. Letter to Lisa P. Jackson,
Administrator, United States Environmental
Protection Agency. September 14, 2010.
4. Kentucky Department of Fish & Wildlife
Resources Tourism, Art and Heritage Cabinet.
Letter to Honorable Lisa Jackson,
Administrator, United States Environmental
Protection Agency. September 15, 2010.
5. Commonwealth of Virginia Department
of Game and Inland Fisheries. Letter to
Honorable Lisa Jackson, Administrator,
United States Environmental Protection
Agency. September 15, 2010.
6. Background Document—TSCA § 21
Petition; Pb in Fishing Sinkers and Other
Components. October 2010.
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List of Subjects
Environmental protection, Bird, Lead,
Lead bullets, Lead fishing sinkers, Lead
shot.
Dated: November 4, 2010.
Steve A. Owens,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2010–28972 Filed 11–16–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2009–0477; FRL–8848–7]
Endocrine Disruptor Screening
Program; Second List of Chemicals for
Tier 1 Screening
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
This document announces the
second list of chemicals and substances
for which EPA intends to issue test
orders under the Endocrine Disruptor
Screening Program (EDSP). EPA
established the EDSP in response to
section 408(p) of the Federal Food,
Drug, and Cosmetic Act (FFDCA). This
second list of chemicals expands the
EDSP in an effort to include all
pesticides, required by FFDCA, and
adds priority drinking water chemicals
into the program for screening as
authorized by SDWA section 1457.
Today’s publication provides public
notice of EPA’s tentative decisionmaking in advance of the actual
issuance of EDSP testing orders.
DATES: In order for the Agency to
consider information and/or comments
that may be relevant to the inclusion or
exclusion of chemicals contained on the
second EDSP list, this information and/
or comments should be received by EPA
on or before December 17, 2010.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2009–0477, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2009–0477.
The DCO is open from 8 a.m. to 4 p.m.,
SUMMARY:
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Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2009–0477. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
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 Web site 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 https://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 https://
www.regulations.gov, or, if only
available in hard copy, 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 legal holidays. The telephone
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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.
For
technical information contact: William
Wooge, Office of Science Coordination
and Policy, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8476; e-mail address:
wooge.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you produce, manufacture,
use, consume, work with, or import
substances included on the second
EDSP list. 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 manufacturers
(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 technical person listed under FOR
FURTHER INFORMATION CONTACT.
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B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Introduction
A. What action is the agency taking?
Today’s document announces the
second list of chemicals that the Agency
intends to include in its EDSP. Through
the issuance of orders, the Agency
intends to require the submission of
Tier 1 Screening data for these
chemicals. Elsewhere in today’s issue of
the Federal Register, EPA also is
announcing the policies and procedures
expected to be followed for certain
chemicals on this list. Information on
EDSP and Tier 1 Screening data is
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25 orders per year for the testing of
these chemicals.’’
B. What is the agency’s authority for
taking this action?
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available on the Agency’s Web site at
https://www.epa.gov/endo.
III. Background
EPA’s authority for taking this action
is based on several different
Congressional actions, including
FFDCA, the Safe Drinking Water Act
(SDWA), and the House Appropriations
Committee report for EPA’s FY 2010
appropriations.
EPA developed the EDSP in 1998 to
implement FFDCA section 408(p),
which 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 endocrine effect as [EPA] may
designate.’’ (21 U.S.C. 346a(p)). The
statute generally requires EPA to
‘‘provide for the testing of all pesticide
chemicals’’ and gives EPA 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)). The statute also authorizes
EPA to exempt a chemical upon a
determination that ‘‘the substance is
anticipated not to produce any effect in
humans similar to an effect produced by
a naturally occurring estrogen.’’ (21
U.S.C. 346a(p)(4)).
Section 1457 of SDWA provides that
‘‘in addition to the substances’’ referred
to in FFDCA section 408(p)(3)(B), ‘‘the
Administrator may provide for testing
under the screening program authorized
by section 408(p) of such Act, in
accordance with the provisions of
section 408(p) of such Act, of any other
substance 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). EPA used its authority
under SDWA to identify a portion of the
chemicals on the second EDSP list.
In addition, in Congress’s House
Appropriations Committee report for
EPA’s FY 2010 appropriations (H.R.
2996, H. Rept. 111–180) (Ref. 1), it
directed EPA ‘‘to publish within 1 year
of enactment a second list of no less
than 100 chemicals for screening that
includes drinking water contaminants,
such as halogenated organic chemicals,
dioxins, flame retardants (PBDEs, PCBs,
PFCs), plastics (BPA), pharmaceuticals
and personal care products, and issue
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EPA developed EDSP in response to
a Congressional mandate in FFDCA ‘‘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 effect as [EPA] may
designate’’ (21 U.S.C. 346a(p)). As part
of EDSP, EPA issues orders to collect
certain test data on listed chemical
substances. Unit II.B. describes the
authority for listing a chemical. Test
data requirements are derived from
specific test assays, which are divided
into two tiers. Tier I test assays are used
to screen the chemicals for interaction
with the estrogen (E), androgen (A) or
thyroid (T) hormonal systems. Tier II
test assays are intended to test for more
specific chemical effects on the
endocrine system, and are currently in
the process of being developed and
validated. Further information regarding
EDSP and requirements for Tier I and
Tier II can be found on the Agency’s
EDSP Web site, at https://www.epa.gov/
endo/.
IV. Development of the Second EDSP
List
In developing the second EDSP list,
EPA focused on a subset of chemicals
and substances that have been listed as
priorities within EPA’s drinking water
and pesticides programs. While the
Agency has not included some
chemicals or substances on the second
EDSP list as explained in Unit IV.A.,
non-inclusion does not mean that these
other chemicals or substances may not
be subject to testing in the near term nor
in the future. In addition, based on
current information, the public should
not presume that the listing of a
chemical or substance indicates in any
way that EPA currently suspects that
such chemical or substance interferes
with the endocrine systems of humans
or other species simply because it has
been listed for screening under the
EDSP. At the present time, EPA believes
that these chemicals or substances
should be candidates, at least for
screening purposes, under EDSP testing
based only on their pesticide
registration status and/or because such
substances may occur in sources of
drinking water to which a substantial
population may be exposed.
A. Basis for Chemical Selection
The Agency considered chemicals
contained on the Office of Water (OW)
and Office of Pesticide Programs (OPP)
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priority lists for inclusion on the second
EDSP list.
1. Initial compilation of OW
candidate chemicals. The Agency
identified candidate chemicals that are
either contaminants regulated with a
national primary drinking water
regulation (NPDWR) (40 CFR part 141)
(Ref. 2) or are unregulated contaminants
that are listed on the third Contaminant
Candidate List (CCL 3) (USEPA, 2009)
(Ref. 3). EPA began with the 85
regulated drinking water contaminants
with existing NPDWRs and the 116
unregulated contaminants listed on CCL
3 because these represent many of the
priority contaminants for the drinking
water program. Most of the regulated
drinking water contaminants with
NPDWRs were designated by Congress
under the 1986 or the1996 SDWA
amendments. Because Congress
designated these contaminants for
regulation due to concerns about
occurrence in drinking water and
adverse impacts on human health, EPA
believes that each such substance meets
the statutory testing criteria from SDWA
section 1457. SDWA section 1412(b)(9)
requires the Agency to periodically
review the existing NPDWRs and revise
them, if appropriate. Information about
the potential for endocrine disruption
will assist the Agency in updating
human health assessments, which the
Agency considers in its periodic review
of NPDWRs to ensure that they are
protective of human health.
SDWA section 1412(b)(1) requires the
Agency to develop a list of unregulated
contaminants that are known or
anticipated to occur in public water
systems (PWSs) and may require
regulation under SDWA. The Agency is
required to develop the CCL list every
5 years. In determining whether a
substance may occur in drinking water,
EPA considers not only public water
system monitoring data, but also data on
ambient concentrations in surface water
and ground water, and releases to the
environment (e.g., reporting data from
the Toxics Release Inventory). The
Agency believes that such data are
sufficient to anticipate contaminants
that may occur in public water systems
and furthermore, also represent those
substances that may be found in sources
of drinking water and to which a
substantial population may be exposed.
In selecting contaminants for the CCL,
SDWA section 1412(b)(1)(C) requires
that the Agency ‘‘take into
consideration, among other factors of
public health concern, the effect of such
contaminants upon subgroups that
comprise a meaningful portion of the
general population (such as infants,
children, pregnant women, the elderly,
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individuals with a history of serious
illness, or other subpopulations) that are
identifiable as being at greater risk of
adverse health effects due to exposure to
contaminants in drinking water than the
general population.’’ The protocol that
EPA used to develop CCL 3 was
reviewed by internal experts, as well as
external experts such as the National
Drinking Water Advisory Council and
the Science Advisory Board (Ref. 3). The
CCL 3 has undergone a rigorous listing
and expert review process, including a
public nomination and comment period,
and therefore, represent an excellent
source of potential drinking water
candidates to consider for EDSP
screening. The information about the
potential for endocrine disruption will
assist the Agency in evaluating the
human health impacts of unregulated
drinking water contaminants. In the
CCL listing, EPA already has made the
component of the SDWA section 1457
determination that such substances may
occur in sources of drinking water. The
final CCL 3 listing also represents EPA’s
determination that a substantial
population may be exposed to such
substance for the purposes of SDWA
1457.
In listing drinking water contaminants
on the CCL 3, EPA closely evaluated the
nature of the occurrence and prevalence
information supporting each such CCL 3
listing. Evaluating occurrence, EPA
considered and evaluated data based on
occurrence in finished drinking water
and ambient water, as well as based on
total releases to the environment,
pesticide application rates, and
production volumes (73 FR 9628,
February 21, 2008) (FRL–8529–7). In
deciding whether to move a possible
drinking water contaminant from the
preliminary CCL 3 to the proposed CCL
3, EPA scored each such contaminant
based on, among other attributes, its
occurrence attributes (at 73 FR 9640–41,
February 21, 2008). The occurrence
attributes were weighted more heavily
based on a hierarchy representing
prevalence of the contaminant in the
water environment or likely release to
the water environment. The results of
that scoring are described at 73 FR 9644,
February 21, 2008. The administrative
record supporting the CCL 3 ultimately
published in 2009 includes
contaminant-by-contaminant
information sheets that document the
occurrence data upon which EPA relied
for the listing of CCL 3 contaminants.
The basis for EPA’s inclusion of the CCL
3 contaminants on its tentative testing
list, therefore, also provides the basis for
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EPA’s determination that a substantial
population may be exposed to each such
substance for the purposes of SDWA
section 1457.
2. Initial compilation of OPP
candidate chemicals. The Agency
identified candidate chemicals from
OPP based on pesticides that were
scheduled for Registration Review
during fiscal years 2007 and 2008. This
selection is part of the Agency’s intent
to efficiently expedite the testing of
pesticides by conducting the testing in
parallel or as part of the OPP
Registration Review program.
3. Streamlining the second EDSP list.
Consolidating the lists of OW and OPP
chemicals resulted in over 200
chemicals. A listing of these chemicals
is available in the docket for this notice
(Ref. 4). The Agency streamlined this
initial second EDSP list by excluding
any chemical that fell into one or more
of the following categories:
i. Biological agent and naturally
occurring chemicals (e.g., microbials,
microbial toxins, inorganics,
radionuclides).
ii. Chemicals for which the
manufacturer, importer or registrant
cannot be clearly identified (e.g.,
disinfection byproducts or DBPs,
microbes, microbial toxins, degradate
compounds with more than one
possible source).
iii. Chemicals already included on the
first EDSP list because these chemicals
have already received an EDSP order.
Note however that if no one agreed to
provide data in response to that order,
additional orders may be issued under
a SDWA determination.
iv. Chemicals that are hormones with
confirmed endocrine effects.
v. Chemicals not likely to be
biologically active or which are
incompatible with testing assays for
various reasons due to one or more of
their physiochemical properties (e.g.,
gases, strongly acidic or basic,
solubility, vapor pressure molecular
weight).
vi. Pesticides that are scheduled for
registration review after FY 2008.
Although these chemicals have been
excluded from the second EDSP list for
one or more of these reasons, it is
important to note that these exclusions
do not imply that the Agency has no
interest in the potential for endocrine
disruption activity for these chemicals.
In some instances, the Agency
recognizes that information on
endocrine effects is already available
(e.g., for the hormones) or the Agency is
currently collecting information (e.g.,
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through the first EDSP list). In other
cases, the Agency simply realizes that at
this time there is some difficulty with
collecting the information about
endocrine effects through the EDSP (i.e.,
because of the Agency’s inability to
identify a manufacturer, importer, or
registrant or because the contaminant is
incompatible with the testing assays). In
addition, EPA recognizes that some of
the naturally occurring chemicals also
have anthropogenic sources and should
be considered for the EDSP. In no way
should it be inferred that removal from
this initial second EDSP list signifies
that a chemical does not have the
potential to be placed on a future EDSP
chemical list. The Agency intends to
reexamine currently excluded chemicals
for future EDSP chemical lists.
EPA is interested in receiving
information from the public that may
help the Agency resolve the difficulties
with the currently excluded chemicals
so that the Agency will be able to
consider adding them to future EDSP
chemical lists.
B. Second EDSP List of Chemicals
There are approximately 134
chemicals on the second ESDP list (see
Table 1). This list includes a large
number of pesticides, two
perfluorocarbon compounds (PFCs), and
three pharmaceuticals (erythromycin,
nitroglycerin, and quinoline). This list
also consists of an array of other
chemicals, ranging from those used for
industrial manufacturing processes, as
plasticizers, or in the production of
pharmaceutical and personal care
products (PPCPs).
EPA is interested in receiving
information and/or comment that may
inform the exclusion or inclusion of
chemicals on the second EDSP list. The
Agency does not plan to respond
formally to information or comments
that may be submitted on this
document, but will add such
information to the notice docket as
public record. EPA will consider such
information and/or comment before
finalizing the second EDSP list and
publishing the Schedule for Issuance of
Orders along with the second EDSP list.
In addition, please note that by relying
on the CCL 3 as part of this effort, the
Agency does not intend to re-open CCL
3 for public comment or any of the
individual lists used to create the
second list of EDSP chemicals and does
not intend to respond to any such
comments so submitted.
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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
TABLE 1—SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING
mstockstill on DSKH9S0YB1PROD with NOTICES
Chemical name
CAS number
1,1,1,2-Tetrachloroethane ..........................................................................................
1,1,1-Trichloroethane .................................................................................................
1,1,2-Trichloroethane .................................................................................................
1,1-Dichloroethane .....................................................................................................
1,1-Dichloroethylene ..................................................................................................
1,2,3-Trichloropropane ...............................................................................................
1,2,4-Trichlorobenzene ..............................................................................................
1,2-Dibromo-3-chloropropane (DBCP) ......................................................................
1,2-Dichloroethane .....................................................................................................
1,2-Dichloropropane ..................................................................................................
1,3-Dinitrobenzene .....................................................................................................
1,4-Dioxane ................................................................................................................
1-Butanol ....................................................................................................................
2,4,5-TP (Silvex) ........................................................................................................
2-Methoxyethanol ......................................................................................................
2-Propen-1-ol .............................................................................................................
4,4′-Methylenedianiline ..............................................................................................
Acetaldehyde .............................................................................................................
Acetamide ..................................................................................................................
Acetochlor ..................................................................................................................
Acetochlor ethanesulfonic acid (ESA) .......................................................................
Acetochlor oxanilic acid (OA) ....................................................................................
Acrolein ......................................................................................................................
Acrylamide .................................................................................................................
Alachlor ......................................................................................................................
Alachlor ethanesulfonic acid (ESA) ...........................................................................
Alachlor oxanilic acid (OA) ........................................................................................
alpha-Hexachlorocyclohexane ...................................................................................
Aniline ........................................................................................................................
Bensulide ...................................................................................................................
Benzene .....................................................................................................................
Benzo(a)pyrene (PAHs) .............................................................................................
Benzyl chloride ..........................................................................................................
Butylated hydroxyanisole ...........................................................................................
Carbon tetrachloride ..................................................................................................
Chlordane ..................................................................................................................
Chlorobenzene ...........................................................................................................
cis-1,2-Dichloroethylene ............................................................................................
Clethodim ...................................................................................................................
Clofentezine ...............................................................................................................
Clomazone .................................................................................................................
Coumaphos ................................................................................................................
Cumene hydroperoxide .............................................................................................
Cyanamide .................................................................................................................
Cyromazine ................................................................................................................
Dalapon ......................................................................................................................
Denatonium saccharide .............................................................................................
Di(2-ethylhexyl) adipate .............................................................................................
Dichloromethane ........................................................................................................
Dicrotophos ................................................................................................................
Dimethipin ..................................................................................................................
Dinoseb ......................................................................................................................
Diuron ........................................................................................................................
Endothall ....................................................................................................................
Endrin .........................................................................................................................
Epichlorohydrin ..........................................................................................................
Erythromycin ..............................................................................................................
Ethylbenzene .............................................................................................................
Ethylene dibromide ....................................................................................................
Ethylene glycol ...........................................................................................................
Ethylene thiourea .......................................................................................................
Ethylurethane .............................................................................................................
Etofenprox ..................................................................................................................
Fenamiphos ...............................................................................................................
Fenarimol ...................................................................................................................
Fenoxaprop-P-ethyl ...................................................................................................
Fenoxycarb ................................................................................................................
Flumetsulam ..............................................................................................................
Fomesafen sodium ....................................................................................................
Fosetyl-Al (Aliette) .....................................................................................................
Glufosinate ammonium ..............................................................................................
HCFC-22 ....................................................................................................................
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630–20–6
71–55–6
79–00–5
75–34–3
75–35–4
96–18–4
120–82–1
96–12–8
107–06–2
78–87–5
99–65–0
123–91–1
71–36–3
93–72–1
109–86–4
107–18–6
101–77–9
75–07–0
60–35–5
34256–82–1
187022–11–3
194992–44–4
107–02–8
79–06–1
15972–60–8
142363–53–9
171262–17–2
319–84–6
62–53–3
741–58–2
71–43–2
50–32–8
100–44–7
25013–16–5
56–23–5
57–74–9
108–90–7
156–59–2
99129–21–2
74115–24–5
81777–89–1
56–72–4
80–15–9
420–04–2
66215–27–8
75–99–0
90823–38–4
103–23–1
75–09–2
141–66–2
55290–64–7
88–85–7
330–54–1
145–73–3
72–20–8
106–89–8
114–07–8
100–41–4
106–93–4
107–21–1
96–45–7
51–79–6
80844–07–1
22224–92–6
60168–88–9
71283–80–2
72490–01–8
98967–40–9
108731–70–0
39148–24–8
77182–82–2
75–45–6
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TABLE 1—SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING—Continued
Chemical name
CAS number
mstockstill on DSKH9S0YB1PROD with NOTICES
Heptachlor ..................................................................................................................
Heptachlor epoxide ....................................................................................................
Hexachlorobenzene ...................................................................................................
Hexachlorocyclopentadiene .......................................................................................
Hexane .......................................................................................................................
Hexythiazox ...............................................................................................................
Hydrazine ...................................................................................................................
Isoxaben ....................................................................................................................
Lactofen .....................................................................................................................
Lindane ......................................................................................................................
Methanol ....................................................................................................................
Methoxychlor ..............................................................................................................
Methyl tert-butyl ether ................................................................................................
Metolachlor ethanesulfonic acid (ESA) .....................................................................
Metolachlor oxanilic acid (OA) ...................................................................................
Molinate .....................................................................................................................
Nitrobenzene ..............................................................................................................
Nitroglycerin ...............................................................................................................
N-Methyl-2-pyrrolidone ..............................................................................................
N-Nitrosodimethylamine (NDMA) ..............................................................................
n-Propylbenzene ........................................................................................................
o-Dichlorobenzene .....................................................................................................
o-Toluidine .................................................................................................................
Oxirane, methyl- ........................................................................................................
Oxydemeton-methyl ...................................................................................................
Oxyfluorfen .................................................................................................................
Paclobutrazol .............................................................................................................
p-Dichlorobenzene .....................................................................................................
Pentachlorophenol .....................................................................................................
Perchlorate .................................................................................................................
Perfluorooctane sulfonic acid (PFOS) .......................................................................
Perfluorooctanoic acid (PFOA) ..................................................................................
Picloram .....................................................................................................................
Polychlorinated biphenyls ..........................................................................................
Profenofos ..................................................................................................................
Propetamphos ............................................................................................................
Propionic acid ............................................................................................................
Pyridate ......................................................................................................................
Quinclorac ..................................................................................................................
Quinoline ....................................................................................................................
Quizalofop-P-ethyl .....................................................................................................
RDX ...........................................................................................................................
sec-Butylbenzene ......................................................................................................
Sodium tetrathiocarbonate .........................................................................................
Styrene .......................................................................................................................
Sulfosate ....................................................................................................................
Temephos ..................................................................................................................
Terbufos .....................................................................................................................
Terbufos sulfone ........................................................................................................
Tetrachloroethylene ...................................................................................................
Thiophanate-methyl ...................................................................................................
Toluene diisocyanate .................................................................................................
Toxaphene .................................................................................................................
trans-1,2-Dichloroethylene .........................................................................................
Trichloroethylene .......................................................................................................
Triethylamine .............................................................................................................
Triflumizole .................................................................................................................
Trinexapac-ethyl ........................................................................................................
Triphenyltin hydroxide (TPTH) ...................................................................................
Vinclozolin ..................................................................................................................
Xylenes (total) ............................................................................................................
Ziram ..........................................................................................................................
76–44–8
1024–57–3
118–74–1
77–47–4
110–54–3
78587–05–0
302–01–2
82558–50–7
77501–63–4
58–89–9
67–56–1
72–43–5
1634–04–4
171118–09–5
152019–73–3
2212–67–1
98–95–3
55–63–0
872–50–4
62–75–9
103–65–1
95–50–1
95–53–4
75–56–9
301–12–2
42874–03–3
76738–62–0
106–46–7
87–86–5
14797–73–0
1763–23–1
335–67–1
1918–02–1
1336–36–3
41198–08–7
31218–83–4
79–09–4
55512–33–9
84087–01–4
91–22–5
100646–51–3
121–82–4
135–98–8
7345–69–9
100–42–5
81591–81–3
3383–96–8
13071–79–9
56070–16–7
127–18–4
23564–05–8
26471–62–5
8001–35–2
156–60–5
79–01–6
121–44–8
68694–11–1
95266–40–3
76–87–9
50471–44–8
1330–20–7
137–30–4
SDWA
PAI
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CAS Number = Chemical Abstract Services Registry Number.
SDWA = Drinking water chemical based on CCL 3 List or chemicals with National Primary Drinking Water Regulations.
PAI = Pesticide active ingredient (Current pesticide registration exists).
RR = OPP Registration Review date.
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70254
Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (703) 603–0851; e-mail address:
sunderland.deirdre@epa.gov.
SUPPLEMENTARY INFORMATION:
V. References
The following is a list of the
documents that are specifically
referenced in this document. These
references are available in the docket
number identified under General
Information (Section I.B).
1. U.S. Congress. House Report 111–180.
Available at: https://frwebgate.access.gpo.gov/
cgi-bin/getdoc.cgi?dbname=111congreports
&docid=f:hr180.111.pdf.
2. USEPA. 2009. National Primary
Drinking Water Regulations. May 2009. EPA
816–F–09–004. Available at: https://
www.epa.gov/safewater/consumer/pdf/
mcl.pdf.
3. USEPA. 2009. Drinking Water
Contaminant Candidate List 3—Final Notice.
Federal Register. Vol, 74. No 194. p. 51850.
October 8, 2009.
4. Initial Compilation of Chemicals and
Substances Considered for the Second
Endocrine Disruptor Screening Program List.
List of Subjects
Environmental protection, Chemicals,
Drinking water, Endocrine disruptors,
Pesticides.
Dated: September 28, 2010.
Steve A. Owens,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2010–28818 Filed 11–16–10; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2010–0275; FRL–8853–6]
Typographical Error in Summary
Notice of Filing in Docket for
Polymerized Fatty Acid Esters With
Aminoalcohol Alkoxylates; Correction
Environmental Protection
Agency (EPA).
ACTION: Notice; correction.
AGENCY:
EPA issued a notice in the
Federal Register of June 8, 2010 (75 FR
32463) (FRL–8827–5), concerning the
Notice of Filing (NOF) for Pesticide
Petition (PP) 0E7699 for polymerized
fatty acid esters with aminoalcohol
alkoxylates submitted by Exponent, on
behalf of Croda. Although the NOF that
appeared in the Federal Register was
correct, there was a typographical error
in the summary NOF that was placed in
docket ID number: EPA–HQ–OPP–
2010–0275. This document is being
issued to announce that the Agency has
placed a corrected summary NOF in the
docket. Please see docket ID number
EPA–HQ–OPP–2010–0275 for the
corrected version.
FOR FURTHER INFORMATION CONTACT:
Deirdre Sunderland, Registration
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:21 Nov 16, 2010
Jkt 223001
Dated: November 4, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
A. Does this action apply to me?
The Agency included in the notice a
list of those who may be potentially
affected by this action. If you have
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
[FR Doc. 2010–28804 Filed 11–16–10; 8:45 am]
BILLING CODE 6560–50–P
[EPA–HQ–OAR–2010–0841; FRL–9228–2]
PSD and Title V Permitting Guidance
for Greenhouse Gases
Environmental Protection
Agency (EPA).
ACTION: Notice of availability and public
B. How can I get copies of this document comment period.
and other related information?
SUMMARY: Notice is hereby given that
EPA has established a docket for this
the EPA has posted its guidance titled,
action under docket identification (ID)
‘‘PSD and Title V Permitting Guidance
number EPA–HQ–OPP–2010–0275.
for Greenhouse Gases’’ on its significant
Publicly available docket materials are
guidance Internet Web site. EPA invites
available either in the electronic docket
public comments on this guidance
at https://www.regulations.gov, or, if only document during the comment period
available in hard copy, at the Office of
specified below.
Pesticide Programs (OPP) Regulatory
DATES: Comments should be submitted
Public Docket in Rm. S–4400, One
on or before December 1, 2010. Please
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of refer to SUPPLEMENTARY INFORMATION for
additional information on the comment
operation of this Docket Facility are
period.
from 8:30 a.m. to 4 p.m., Monday
ADDRESSES: Submit your comments,
through Friday, excluding legal
holidays. The Docket Facility telephone identified by Docket ID No. EPA–HQ–
OAR–2010–0841, by one of the
number is (703) 305–5805.
following methods:
II. What Does This Correction Do?
• https://www.regulations.gov. Follow
the on-line instructions for submitting
The Notice of Filing (NOF) for
comments.
Pesticide Petition (PP) 0E7699 for
• E-mail: a-and-r-docket@epa.gov.
polymerized fatty acid esters with
Attention Docket ID No. EPA–HQ–
aminoalcohol alkoxylates submitted by
Exponent, on behalf of Croda, published OAR–2010–0841.
• Fax: 202–566–9744. Attention
in the Federal Register (FR Doc. 2010–
Docket ID No. EPA–HQ–OAR–2010–
13689) of June 8, 2010 (75 FR 32463)
0841.
(FRL–8827–5) is corrected as follows:
• Mail: Air Docket, Attention Docket
Although the NOF that appeared in the
ID No. EPA–HQ–OAR–2010–0841,
Federal Register was correct, there was
Environmental Protection Agency, Mail
a typographical error in the summary
Code: 6102T, 1200 Pennsylvania Ave.,
NOF that was placed in docket ID
number: EPA–HQ–OPP–2010–0275. The NW., Washington, DC 20460.
• Hand Delivery: EPA Docket Center,
summary referenced an incorrect CAS
1301 Constitution Avenue, NW., Room
No. 1173188–71–2 as the test chemical
3334, Washington, DC. Such deliveries
for the studies provided in support of
are only accepted during the Docket
the petition, but should have read CAS
Center’s normal hours of operation, and
No. 1173188–81–2. This document is
special arrangements should be made
being issued to announce that the
for deliveries of boxed information.
Agency has placed the corrected
Instructions: Direct your comments to
summary NOF in the docket. Please see
docket ID number EPA–HQ–OPP–2010– Docket ID No. EPA–HQ–OAR–2010–
0841. The EPA’s policy is that all
0275 for the corrected version.
comments received will be included in
List of Subjects
the public docket without change and
Environmental protection,
may be made available online at https://
Agricultural commodities, Feed
www.regulations.gov, including any
additives, Food additives, Pesticides
personal information provided, unless
and pests, Reporting and recordkeeping the comment includes information
requirements.
claimed to be Confidential Business
PO 00000
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AGENCY:
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70248-70254]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28818]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2009-0477; FRL-8848-7]
Endocrine Disruptor Screening Program; Second List of Chemicals
for Tier 1 Screening
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This document announces the second list of chemicals and
substances for which EPA intends to issue test orders under the
Endocrine Disruptor Screening Program (EDSP). EPA established the EDSP
in response to section 408(p) of the Federal Food, Drug, and Cosmetic
Act (FFDCA). This second list of chemicals expands the EDSP in an
effort to include all pesticides, required by FFDCA, and adds priority
drinking water chemicals into the program for screening as authorized
by SDWA section 1457. Today's publication provides public notice of
EPA's tentative decision-making in advance of the actual issuance of
EDSP testing orders.
DATES: In order for the Agency to consider information and/or comments
that may be relevant to the inclusion or exclusion of chemicals
contained on the second EDSP list, this information and/or comments
should be received by EPA on or before December 17, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0477, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2009-0477. The DCO is open from
8 a.m. to 4 p.m.,
[[Page 70249]]
Monday through Friday, excluding legal holidays. The telephone number
for the DCO is (202) 564-8930. Such deliveries are only accepted during
the DCO's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0477. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://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 Web site 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 https://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 https://www.regulations.gov, or, if only available in hard
copy, 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 legal
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.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wooge, Office of Science Coordination and Policy, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8476; e-mail address:
wooge.william@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you produce,
manufacture, use, consume, work with, or import substances included on
the second EDSP list. 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
manufacturers (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 technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Introduction
A. What action is the agency taking?
Today's document announces the second list of chemicals that the
Agency intends to include in its EDSP. Through the issuance of orders,
the Agency intends to require the submission of Tier 1 Screening data
for these chemicals. Elsewhere in today's issue of the Federal
Register, EPA also is announcing the policies and procedures expected
to be followed for certain chemicals on this list. Information on EDSP
and Tier 1 Screening data is
[[Page 70250]]
available on the Agency's Web site at https://www.epa.gov/endo.
B. What is the agency's authority for taking this action?
EPA's authority for taking this action is based on several
different Congressional actions, including FFDCA, the Safe Drinking
Water Act (SDWA), and the House Appropriations Committee report for
EPA's FY 2010 appropriations.
EPA developed the EDSP in 1998 to implement FFDCA section 408(p),
which 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 endocrine effect as [EPA] may designate.'' (21
U.S.C. 346a(p)). The statute generally requires EPA to ``provide for
the testing of all pesticide chemicals'' and gives EPA 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)). The statute also
authorizes EPA to exempt a chemical upon a determination that ``the
substance is anticipated not to produce any effect in humans similar to
an effect produced by a naturally occurring estrogen.'' (21 U.S.C.
346a(p)(4)).
Section 1457 of SDWA provides that ``in addition to the
substances'' referred to in FFDCA section 408(p)(3)(B), ``the
Administrator may provide for testing under the screening program
authorized by section 408(p) of such Act, in accordance with the
provisions of section 408(p) of such Act, of any other substance 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). EPA used its authority under SDWA to
identify a portion of the chemicals on the second EDSP list.
In addition, in Congress's House Appropriations Committee report
for EPA's FY 2010 appropriations (H.R. 2996, H. Rept. 111-180) (Ref.
1), it directed EPA ``to publish within 1 year of enactment a second
list of no less than 100 chemicals for screening that includes drinking
water contaminants, such as halogenated organic chemicals, dioxins,
flame retardants (PBDEs, PCBs, PFCs), plastics (BPA), pharmaceuticals
and personal care products, and issue 25 orders per year for the
testing of these chemicals.''
III. Background
EPA developed EDSP in response to a Congressional mandate in FFDCA
``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 effect as [EPA] may designate'' (21
U.S.C. 346a(p)). As part of EDSP, EPA issues orders to collect certain
test data on listed chemical substances. Unit II.B. describes the
authority for listing a chemical. Test data requirements are derived
from specific test assays, which are divided into two tiers. Tier I
test assays are used to screen the chemicals for interaction with the
estrogen (E), androgen (A) or thyroid (T) hormonal systems. Tier II
test assays are intended to test for more specific chemical effects on
the endocrine system, and are currently in the process of being
developed and validated. Further information regarding EDSP and
requirements for Tier I and Tier II can be found on the Agency's EDSP
Web site, at https://www.epa.gov/endo/.
IV. Development of the Second EDSP List
In developing the second EDSP list, EPA focused on a subset of
chemicals and substances that have been listed as priorities within
EPA's drinking water and pesticides programs. While the Agency has not
included some chemicals or substances on the second EDSP list as
explained in Unit IV.A., non-inclusion does not mean that these other
chemicals or substances may not be subject to testing in the near term
nor in the future. In addition, based on current information, the
public should not presume that the listing of a chemical or substance
indicates in any way that EPA currently suspects that such chemical or
substance interferes with the endocrine systems of humans or other
species simply because it has been listed for screening under the EDSP.
At the present time, EPA believes that these chemicals or substances
should be candidates, at least for screening purposes, under EDSP
testing based only on their pesticide registration status and/or
because such substances may occur in sources of drinking water to which
a substantial population may be exposed.
A. Basis for Chemical Selection
The Agency considered chemicals contained on the Office of Water
(OW) and Office of Pesticide Programs (OPP) priority lists for
inclusion on the second EDSP list.
1. Initial compilation of OW candidate chemicals. The Agency
identified candidate chemicals that are either contaminants regulated
with a national primary drinking water regulation (NPDWR) (40 CFR part
141) (Ref. 2) or are unregulated contaminants that are listed on the
third Contaminant Candidate List (CCL 3) (USEPA, 2009) (Ref. 3). EPA
began with the 85 regulated drinking water contaminants with existing
NPDWRs and the 116 unregulated contaminants listed on CCL 3 because
these represent many of the priority contaminants for the drinking
water program. Most of the regulated drinking water contaminants with
NPDWRs were designated by Congress under the 1986 or the1996 SDWA
amendments. Because Congress designated these contaminants for
regulation due to concerns about occurrence in drinking water and
adverse impacts on human health, EPA believes that each such substance
meets the statutory testing criteria from SDWA section 1457. SDWA
section 1412(b)(9) requires the Agency to periodically review the
existing NPDWRs and revise them, if appropriate. Information about the
potential for endocrine disruption will assist the Agency in updating
human health assessments, which the Agency considers in its periodic
review of NPDWRs to ensure that they are protective of human health.
SDWA section 1412(b)(1) requires the Agency to develop a list of
unregulated contaminants that are known or anticipated to occur in
public water systems (PWSs) and may require regulation under SDWA. The
Agency is required to develop the CCL list every 5 years. In
determining whether a substance may occur in drinking water, EPA
considers not only public water system monitoring data, but also data
on ambient concentrations in surface water and ground water, and
releases to the environment (e.g., reporting data from the Toxics
Release Inventory). The Agency believes that such data are sufficient
to anticipate contaminants that may occur in public water systems and
furthermore, also represent those substances that may be found in
sources of drinking water and to which a substantial population may be
exposed. In selecting contaminants for the CCL, SDWA section
1412(b)(1)(C) requires that the Agency ``take into consideration, among
other factors of public health concern, the effect of such contaminants
upon subgroups that comprise a meaningful portion of the general
population (such as infants, children, pregnant women, the elderly,
[[Page 70251]]
individuals with a history of serious illness, or other subpopulations)
that are identifiable as being at greater risk of adverse health
effects due to exposure to contaminants in drinking water than the
general population.'' The protocol that EPA used to develop CCL 3 was
reviewed by internal experts, as well as external experts such as the
National Drinking Water Advisory Council and the Science Advisory Board
(Ref. 3). The CCL 3 has undergone a rigorous listing and expert review
process, including a public nomination and comment period, and
therefore, represent an excellent source of potential drinking water
candidates to consider for EDSP screening. The information about the
potential for endocrine disruption will assist the Agency in evaluating
the human health impacts of unregulated drinking water contaminants. In
the CCL listing, EPA already has made the component of the SDWA section
1457 determination that such substances may occur in sources of
drinking water. The final CCL 3 listing also represents EPA's
determination that a substantial population may be exposed to such
substance for the purposes of SDWA 1457.
In listing drinking water contaminants on the CCL 3, EPA closely
evaluated the nature of the occurrence and prevalence information
supporting each such CCL 3 listing. Evaluating occurrence, EPA
considered and evaluated data based on occurrence in finished drinking
water and ambient water, as well as based on total releases to the
environment, pesticide application rates, and production volumes (73 FR
9628, February 21, 2008) (FRL-8529-7). In deciding whether to move a
possible drinking water contaminant from the preliminary CCL 3 to the
proposed CCL 3, EPA scored each such contaminant based on, among other
attributes, its occurrence attributes (at 73 FR 9640-41, February 21,
2008). The occurrence attributes were weighted more heavily based on a
hierarchy representing prevalence of the contaminant in the water
environment or likely release to the water environment. The results of
that scoring are described at 73 FR 9644, February 21, 2008. The
administrative record supporting the CCL 3 ultimately published in 2009
includes contaminant-by-contaminant information sheets that document
the occurrence data upon which EPA relied for the listing of CCL 3
contaminants. The basis for EPA's inclusion of the CCL 3 contaminants
on its tentative testing list, therefore, also provides the basis for
EPA's determination that a substantial population may be exposed to
each such substance for the purposes of SDWA section 1457.
2. Initial compilation of OPP candidate chemicals. The Agency
identified candidate chemicals from OPP based on pesticides that were
scheduled for Registration Review during fiscal years 2007 and 2008.
This selection is part of the Agency's intent to efficiently expedite
the testing of pesticides by conducting the testing in parallel or as
part of the OPP Registration Review program.
3. Streamlining the second EDSP list. Consolidating the lists of OW
and OPP chemicals resulted in over 200 chemicals. A listing of these
chemicals is available in the docket for this notice (Ref. 4). The
Agency streamlined this initial second EDSP list by excluding any
chemical that fell into one or more of the following categories:
i. Biological agent and naturally occurring chemicals (e.g.,
microbials, microbial toxins, inorganics, radionuclides).
ii. Chemicals for which the manufacturer, importer or registrant
cannot be clearly identified (e.g., disinfection byproducts or DBPs,
microbes, microbial toxins, degradate compounds with more than one
possible source).
iii. Chemicals already included on the first EDSP list because
these chemicals have already received an EDSP order. Note however that
if no one agreed to provide data in response to that order, additional
orders may be issued under a SDWA determination.
iv. Chemicals that are hormones with confirmed endocrine effects.
v. Chemicals not likely to be biologically active or which are
incompatible with testing assays for various reasons due to one or more
of their physiochemical properties (e.g., gases, strongly acidic or
basic, solubility, vapor pressure molecular weight).
vi. Pesticides that are scheduled for registration review after FY
2008.
Although these chemicals have been excluded from the second EDSP
list for one or more of these reasons, it is important to note that
these exclusions do not imply that the Agency has no interest in the
potential for endocrine disruption activity for these chemicals. In
some instances, the Agency recognizes that information on endocrine
effects is already available (e.g., for the hormones) or the Agency is
currently collecting information (e.g., through the first EDSP list).
In other cases, the Agency simply realizes that at this time there is
some difficulty with collecting the information about endocrine effects
through the EDSP (i.e., because of the Agency's inability to identify a
manufacturer, importer, or registrant or because the contaminant is
incompatible with the testing assays). In addition, EPA recognizes that
some of the naturally occurring chemicals also have anthropogenic
sources and should be considered for the EDSP. In no way should it be
inferred that removal from this initial second EDSP list signifies that
a chemical does not have the potential to be placed on a future EDSP
chemical list. The Agency intends to reexamine currently excluded
chemicals for future EDSP chemical lists.
EPA is interested in receiving information from the public that may
help the Agency resolve the difficulties with the currently excluded
chemicals so that the Agency will be able to consider adding them to
future EDSP chemical lists.
B. Second EDSP List of Chemicals
There are approximately 134 chemicals on the second ESDP list (see
Table 1). This list includes a large number of pesticides, two
perfluorocarbon compounds (PFCs), and three pharmaceuticals
(erythromycin, nitroglycerin, and quinoline). This list also consists
of an array of other chemicals, ranging from those used for industrial
manufacturing processes, as plasticizers, or in the production of
pharmaceutical and personal care products (PPCPs).
EPA is interested in receiving information and/or comment that may
inform the exclusion or inclusion of chemicals on the second EDSP list.
The Agency does not plan to respond formally to information or comments
that may be submitted on this document, but will add such information
to the notice docket as public record. EPA will consider such
information and/or comment before finalizing the second EDSP list and
publishing the Schedule for Issuance of Orders along with the second
EDSP list. In addition, please note that by relying on the CCL 3 as
part of this effort, the Agency does not intend to re-open CCL 3 for
public comment or any of the individual lists used to create the second
list of EDSP chemicals and does not intend to respond to any such
comments so submitted.
[[Page 70252]]
Table 1--Second EDSP List of Chemicals for Tier 1 Screening
----------------------------------------------------------------------------------------------------------------
Chemical name CAS number SDWA PAI RR schedule
----------------------------------------------------------------------------------------------------------------
1,1,1,2-Tetrachloroethane............................ 630-20-6 X .......... ..............
1,1,1-Trichloroethane................................ 71-55-6 X .......... ..............
1,1,2-Trichloroethane................................ 79-00-5 X .......... ..............
1,1-Dichloroethane................................... 75-34-3 X .......... ..............
1,1-Dichloroethylene................................. 75-35-4 X .......... ..............
1,2,3-Trichloropropane............................... 96-18-4 X .......... ..............
1,2,4-Trichlorobenzene............................... 120-82-1 X .......... ..............
1,2-Dibromo-3-chloropropane (DBCP)................... 96-12-8 X .......... ..............
1,2-Dichloroethane................................... 107-06-2 X .......... ..............
1,2-Dichloropropane.................................. 78-87-5 X .......... ..............
1,3-Dinitrobenzene................................... 99-65-0 X .......... ..............
1,4-Dioxane.......................................... 123-91-1 X .......... ..............
1-Butanol............................................ 71-36-3 X .......... ..............
2,4,5-TP (Silvex).................................... 93-72-1 X .......... ..............
2-Methoxyethanol..................................... 109-86-4 X .......... ..............
2-Propen-1-ol........................................ 107-18-6 X .......... ..............
4,4'-Methylenedianiline.............................. 101-77-9 X .......... ..............
Acetaldehyde......................................... 75-07-0 X .......... ..............
Acetamide............................................ 60-35-5 X .......... ..............
Acetochlor........................................... 34256-82-1 X X ..............
Acetochlor ethanesulfonic acid (ESA)................. 187022-11-3 X .......... ..............
Acetochlor oxanilic acid (OA)........................ 194992-44-4 X .......... ..............
Acrolein............................................. 107-02-8 X X ..............
Acrylamide........................................... 79-06-1 X .......... ..............
Alachlor............................................. 15972-60-8 X X ..............
Alachlor ethanesulfonic acid (ESA)................... 142363-53-9 X .......... ..............
Alachlor oxanilic acid (OA).......................... 171262-17-2 X .......... ..............
alpha-Hexachlorocyclohexane.......................... 319-84-6 X .......... ..............
Aniline.............................................. 62-53-3 X .......... ..............
Bensulide............................................ 741-58-2 X X FY 2008
Benzene.............................................. 71-43-2 X .......... ..............
Benzo(a)pyrene (PAHs)................................ 50-32-8 X .......... ..............
Benzyl chloride...................................... 100-44-7 X .......... ..............
Butylated hydroxyanisole............................. 25013-16-5 X .......... ..............
Carbon tetrachloride................................. 56-23-5 X .......... ..............
Chlordane............................................ 57-74-9 X .......... ..............
Chlorobenzene........................................ 108-90-7 X .......... ..............
cis-1,2-Dichloroethylene............................. 156-59-2 X .......... ..............
Clethodim............................................ 99129-21-2 X X FY 2008
Clofentezine......................................... 74115-24-5 .......... X FY 2007
Clomazone............................................ 81777-89-1 .......... X FY 2007
Coumaphos............................................ 56-72-4 .......... X FY 2008
Cumene hydroperoxide................................. 80-15-9 X .......... ..............
Cyanamide............................................ 420-04-2 .......... X FY 2008
Cyromazine........................................... 66215-27-8 .......... X FY 2007
Dalapon.............................................. 75-99-0 X .......... ..............
Denatonium saccharide................................ 90823-38-4 .......... X FY 2008
Di(2-ethylhexyl) adipate............................. 103-23-1 X .......... ..............
Dichloromethane...................................... 75-09-2 X .......... ..............
Dicrotophos.......................................... 141-66-2 X X FY 2008
Dimethipin........................................... 55290-64-7 X X ..............
Dinoseb.............................................. 88-85-7 X .......... ..............
Diuron............................................... 330-54-1 X X ..............
Endothall............................................ 145-73-3 X X ..............
Endrin............................................... 72-20-8 X .......... ..............
Epichlorohydrin...................................... 106-89-8 X .......... ..............
Erythromycin......................................... 114-07-8 X .......... ..............
Ethylbenzene......................................... 100-41-4 X .......... ..............
Ethylene dibromide................................... 106-93-4 X .......... ..............
Ethylene glycol...................................... 107-21-1 X .......... ..............
Ethylene thiourea.................................... 96-45-7 X .......... ..............
Ethylurethane........................................ 51-79-6 X .......... ..............
Etofenprox........................................... 80844-07-1 .......... X FY 2007
Fenamiphos........................................... 22224-92-6 X X FY 2008
Fenarimol............................................ 60168-88-9 .......... X FY 2007
Fenoxaprop-P-ethyl................................... 71283-80-2 .......... X FY 2007
Fenoxycarb........................................... 72490-01-8 .......... X FY 2007
Flumetsulam.......................................... 98967-40-9 .......... X FY 2008
Fomesafen sodium..................................... 108731-70-0 .......... X FY 2007
Fosetyl-Al (Aliette)................................. 39148-24-8 .......... X FY 2008
Glufosinate ammonium................................. 77182-82-2 .......... X FY 2008
HCFC-22.............................................. 75-45-6 X .......... ..............
[[Page 70253]]
Heptachlor........................................... 76-44-8 X .......... ..............
Heptachlor epoxide................................... 1024-57-3 X .......... ..............
Hexachlorobenzene.................................... 118-74-1 X .......... ..............
Hexachlorocyclopentadiene............................ 77-47-4 X .......... ..............
Hexane............................................... 110-54-3 X .......... ..............
Hexythiazox.......................................... 78587-05-0 .......... X FY 2007
Hydrazine............................................ 302-01-2 X .......... ..............
Isoxaben............................................. 82558-50-7 .......... X FY 2008
Lactofen............................................. 77501-63-4 .......... X FY 2007
Lindane.............................................. 58-89-9 X .......... ..............
Methanol............................................. 67-56-1 X .......... ..............
Methoxychlor......................................... 72-43-5 X .......... ..............
Methyl tert-butyl ether.............................. 1634-04-4 X .......... ..............
Metolachlor ethanesulfonic acid (ESA)................ 171118-09-5 X .......... ..............
Metolachlor oxanilic acid (OA)....................... 152019-73-3 X .......... ..............
Molinate............................................. 2212-67-1 X .......... ..............
Nitrobenzene......................................... 98-95-3 X .......... ..............
Nitroglycerin........................................ 55-63-0 X .......... ..............
N-Methyl-2-pyrrolidone............................... 872-50-4 X .......... ..............
N-Nitrosodimethylamine (NDMA)........................ 62-75-9 X .......... ..............
n-Propylbenzene...................................... 103-65-1 X .......... ..............
o-Dichlorobenzene.................................... 95-50-1 X .......... ..............
o-Toluidine.......................................... 95-53-4 X .......... ..............
Oxirane, methyl-..................................... 75-56-9 X .......... ..............
Oxydemeton-methyl.................................... 301-12-2 X X FY 2008
Oxyfluorfen.......................................... 42874-03-3 X X ..............
Paclobutrazol........................................ 76738-62-0 .......... X FY 2007
p-Dichlorobenzene.................................... 106-46-7 X X ..............
Pentachlorophenol.................................... 87-86-5 X X ..............
Perchlorate.......................................... 14797-73-0 X .......... ..............
Perfluorooctane sulfonic acid (PFOS)................. 1763-23-1 X .......... ..............
Perfluorooctanoic acid (PFOA)........................ 335-67-1 X .......... ..............
Picloram............................................. 1918-02-1 X X ..............
Polychlorinated biphenyls............................ 1336-36-3 X .......... ..............
Profenofos........................................... 41198-08-7 X X FY 2008
Propetamphos......................................... 31218-83-4 .......... X FY 2008
Propionic acid....................................... 79-09-4 .......... X FY 2008
Pyridate............................................. 55512-33-9 .......... X FY 2007
Quinclorac........................................... 84087-01-4 .......... X FY 2008
Quinoline............................................ 91-22-5 X .......... ..............
Quizalofop-P-ethyl................................... 100646-51-3 .......... X FY 2008
RDX.................................................. 121-82-4 X .......... ..............
sec-Butylbenzene..................................... 135-98-8 X .......... ..............
Sodium tetrathiocarbonate............................ 7345-69-9 .......... X FY 2008
Styrene.............................................. 100-42-5 X .......... ..............
Sulfosate............................................ 81591-81-3 .......... X FY 2007
Temephos............................................. 3383-96-8 .......... X FY 2008
Terbufos............................................. 13071-79-9 X X FY 2008
Terbufos sulfone..................................... 56070-16-7 X .......... ..............
Tetrachloroethylene.................................. 127-18-4 X .......... ..............
Thiophanate-methyl................................... 23564-05-8 X X ..............
Toluene diisocyanate................................. 26471-62-5 X .......... ..............
Toxaphene............................................ 8001-35-2 X .......... ..............
trans-1,2-Dichloroethylene........................... 156-60-5 X .......... ..............
Trichloroethylene.................................... 79-01-6 X .......... ..............
Triethylamine........................................ 121-44-8 X .......... ..............
Triflumizole......................................... 68694-11-1 .......... X FY 2007
Trinexapac-ethyl..................................... 95266-40-3 .......... X FY 2008
Triphenyltin hydroxide (TPTH)........................ 76-87-9 X X ..............
Vinclozolin.......................................... 50471-44-8 X X ..............
Xylenes (total)...................................... 1330-20-7 X X ..............
Ziram................................................ 137-30-4 X X ..............
----------------------------------------------------------------------------------------------------------------
CAS Number = Chemical Abstract Services Registry Number.
SDWA = Drinking water chemical based on CCL 3 List or chemicals with National Primary Drinking Water
Regulations.
PAI = Pesticide active ingredient (Current pesticide registration exists).
RR = OPP Registration Review date.
[[Page 70254]]
V. References
The following is a list of the documents that are specifically
referenced in this document. These references are available in the
docket number identified under General Information (Section I.B).
1. U.S. Congress. House Report 111-180. Available at: https://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111congreports&docid=f:hr180.111.pdf.
2. USEPA. 2009. National Primary Drinking Water Regulations. May
2009. EPA 816-F-09-004. Available at: https://www.epa.gov/safewater/consumer/pdf/mcl.pdf.
3. USEPA. 2009. Drinking Water Contaminant Candidate List 3--
Final Notice. Federal Register. Vol, 74. No 194. p. 51850. October
8, 2009.
4. Initial Compilation of Chemicals and Substances Considered
for the Second Endocrine Disruptor Screening Program List.
List of Subjects
Environmental protection, Chemicals, Drinking water, Endocrine
disruptors, Pesticides.
Dated: September 28, 2010.
Steve A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2010-28818 Filed 11-16-10; 8:45 am]
BILLING CODE 6560-50-P
