Endocrine Disruptor Screening Program; Final Second List of Chemicals and Substances for Tier 1 Screening, 35922-35928 [2013-14232]
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Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices
Environmental Endocrine Disruptor
Screening Program; Review of the
Endocrine Disruptor Screening Program
by a Joint Subcommittee of the Science
Advisory Board and Scientific Advisory
Panel. July 1999. EPA publication
number EPA–SAB–EC–99–013.
Available at https://www.epa.gov/endo/
pubs/sab_sap_report.pdf.
15. EPA. U.S. Environmental Protection
Agency Endocrine Disruptor Screening
Program Comprehensive Management
Plan. June 2012. Available at https://
www.epa.gov/endo/pubs/EDSPcomprehensive-management-plan.pdf.
16. EPA. At a Glance: Issuing EDSP Second
List Orders. (March 28, 2013).
17. EPA. Chemical Data Reporting Web site
at https://www.epa.gov/oppt/cdr.
18. EPA. Status of EDSP Orders/DCIs as of
Wednesday, January 2, 2013.
19. EPA. Sample Form: ‘‘FFDCA § 408(p)
Order for SDWA § 1457 Chemicals—
Initial Response Form for Individual
Order Recipients’’ (EPA Form No. 6300–
06). March 27, 2013. Available in
Attachment D(3) to the ICR in Docket ID
Number EPA–HQ–OPPT–2013–0275.
20. EPA. OCSPP Harmonized Test Guidelines
Web site at https://www.epa.gov/ocspp/
pubs/frs/home/testmeth.htm.
21. EPA. Sample Form: ‘‘FFDCA § 408(p)
Order for SDWA § 1457 Chemicals—
Initial Response Form for Consortium’’
(EPA Form No. 6300–06–C). March 27,
2013. Available in Attachment D(4) to
the ICR in Docket ID Number EPA–HQ–
OPPT–2013–0275.
22. EPA. Central Data Exchange Web site at
https://www.epa.gov/cdx.
23. EPA. Claims of Confidentiality of Certain
Chemical Identities Submitted under
Section 8(e) of the Toxic Substances
Control Act; Notice. Federal Register (75
FR 3462, January 21, 2010) (FRL–8807–
9).
List of Subjects
Environmental protection, Chemicals,
Endocrine disruptors, Pesticides and
pests, Safe drinking water, Reporting
and recordkeeping.
Dated: May 29, 2013.
James Jones,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
[FR Doc. 2013–14228 Filed 6–13–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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[EPA–HQ–OPPT–2009–0477; FRL–9375–8]
Endocrine Disruptor Screening
Program; Final Second List of
Chemicals and Substances for Tier 1
Screening
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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SUMMARY: This document announces the
final second list of 109 chemicals
identified for Tier 1 screening under the
Endocrine Disruptor Screening Program
(EDSP). The EDSP is established under
section 408(p) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), which
requires EPA to develop a chemical
screening program using appropriate
validated test systems and other
scientifically relevant information to
determine whether certain substances
may have hormonal effects.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Hannah
Holsinger, Office of Water, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001 (MC–4607M); telephone
number: (202) 564–0403, email address:
holsinger.hannah@epa.gov, or Pat West,
Office of Science Coordination and
Policy, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001 (MC–
7201M); telephone number: (202) 564–
1656, email address: west.pat@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCAHotline@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, or import chemicals (including
pesticide chemicals) that may be found
in sources of drinking water; if you
manufacture or import chemicals that
degrade to chemicals found in sources
of drinking water; or if you are, or may
otherwise be, involved in the testing of
chemicals for potential endocrine
effects. The following list of North
American Industrial Classification
System (NAICS) codes is not intended
to be exhaustive, but rather provides a
guide to help readers determine whether
this document applies to them.
Potentially affected entities may
include:
• 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
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of chemical substances for endocrine
effects.
B. How can I get copies of this document
and other related information?
The docket for this action, identified
by docket identification (ID) number
EPA–HQ–OPPT–2009–0477, is available
at https://www.regulations.gov or at the
Office of Pollution Prevention and
Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Please review the visitor
instructions and additional information
about the docket available at https://
www.epa.gov/dockets.
II. Background
A. What action is the agency taking?
This document announces the final
second list of 109 chemicals identified
for Tier 1 screening under the Endocrine
Disruptor Screening Program (EDSP).
The EDSP is established under section
408(p) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), which requires
EPA to develop a chemical screening
program using appropriate validated test
systems and other scientifically relevant
information to determine whether
certain substances may have hormonal
effects. After considering comments
received on the draft second list of
chemicals and substances published in
the Federal Register notice of November
17, 2010 (75 FR 70248) (FRL–8848–7)
(Ref. 1), EPA is announcing the final list
of the second group of chemicals that
will be subject to screening based on the
approach described in the notice—
‘‘Endocrine Disruptor Screening
Program; Final Policies and Procedures
for Screening Safe Drinking Water Act
(SDWA) Chemicals,’’ published
elsewhere in today’s Federal Register.
The EDSP consists of a two-tiered
approach to screen and test chemicals
for potential endocrine disrupting
effects. The purpose of Tier 1 screening
is to identify substances that have the
potential to interact with the endocrine
system (specifically the estrogen,
androgen, or thyroid hormone systems)
using a battery of assays. Substances
that have the potential to interact with
estrogen, androgen or thyroid systems
may proceed to Tier 2, which is
designed to identify any adverse
endocrine-related effects caused by the
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substance, and establish a quantitative
relationship between the dose and that
endocrine effect. This second list should
not be construed as a list of known or
likely endocrine disruptors. Nothing in
the approach for generating the second
list provides a basis to infer that by
simply being on this list these chemicals
are suspected to interfere with the
endocrine systems of humans or other
species, and it would be inappropriate
to do so. In a separate notice published
elsewhere in today’s Federal Register,
EPA describes other aspects of EDSP
such as the administrative procedures
that EPA will use to require testing.
The second group of chemicals to be
tested consists of chemicals that section
408(p) of the FFDCA (Ref. 2) requires be
screened, i.e., pesticide active
ingredients and chemicals used as
pesticide inert ingredients (also known
as other ingredients) and section 1457 of
the 1996 amendment to the SDWA (Ref.
3). EPA developed this final list using
the approach outlined in the Federal
Register notice announcing the draft
second list of chemicals and substances
(Ref. 1). More information on EPA’s
priority setting approach is available at
https://www.epa.gov/scipoly/oscpendo/
pubs/prioritysetting.
This document does not describe
other aspects of EDSP such as the
administrative procedures EPA
generally intends to use to require
testing, the validated tests and battery
that will be included in EDSP, or the
timeframe for requiring the testing or
receiving the data. The administrative
procedures that EPA generally intends
to use are described in a separate notice
published elsewhere in today’s Federal
Register. The remaining topics will be
addressed in separate notices that will
be subsequently published in the
Federal Register.
B. What is the agency’s authority for
taking this action?
FFDCA section 408(p) 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)). Section
408(p)(3) 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
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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 states 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.
III. History
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)). Unit II.B.
describes the authority for listing a
chemical. As part of EDSP, EPA issues
orders to collect certain test data on
selected chemical substances. In
general, EPA intends to use the data
collected under EDSP, along with other
information, to determine if a pesticide
chemical or other substances may pose
a risk to human health or the
environment due to disruption of the
endocrine system. The determination
that a chemical does or is not likely to
have the potential to interact with the
endocrine system will be made on a
weight-of-evidence basis taking into
account data from the Tier 1 assays and/
or other scientifically relevant
information. Chemicals that go through
Tier 1 screening and are found to have
the potential to interact with the
estrogen, androgen, or thyroid hormone
systems will proceed to the next state of
EDSP where EPA will determine which,
if any, of the Tier 2 tests are necessary
based on available data. Tier 2 testing is
designed to identify any adverse
endocrine-related effects caused by the
substance, and establish a quantitative
relationship between the dose and that
endocrine effect. Further information
regarding EDSP and requirements for
Tier 1 and Tier 2 testing can be found
on the Agency’s EDSP Web site, at
https://www.epa.gov/endo/.
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IV. Development of the Second EDSP
List
The House Appropriations Committee
report for EPA’s FY 2010 appropriations
(H.R. 2996, H. Rept. 111–180) (Ref. 4),
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
polybrominated diphenyl ethers,
polychlorinated biphenyls,
perfluorocarbons (PFCs), plastics,
bisphenol A, pharmaceuticals and
personal care products, and issue 25
orders per year for the testing of these
chemicals. This process also should
allow for public input. In response, EPA
published a draft second list of
chemicals for Tier 1 screening on
November 17, 2010 and solicited public
comments on the list of chemicals. The
development of the draft second list is
described at length in that Federal
Register notice (Ref. 1).
EPA received comment letters from
approximately 60 organizations or
individuals on the November 17, 2010
draft second EDSP list. These
organizations/individuals included a
water-related association,
environmental advocacy groups,
chemical industry, consumer and pet
advocacy groups, and consultants
writing on behalf of the industry. This
notice summarizes major comments
EPA received, along with the Agency’s
response. A complete listing of public
comments and EPA’s responses related
to the draft second list of chemicals for
Tier 1 screening are included in the
document entitled ‘‘Final Comment
Response Document for the Second
Endocrine Disruptor Screening Program
List (Categorized Public Comments).’’
The document is available in the docket
for this action under docket ID number
EPA–HQ–OPPT–2009–0477.
A. SDWA 1457
Some commenters stated that EPA
had not met the requirements of SDWA
1457 when listing the draft second
EDSP list. They stated that a chemical’s
inclusion on the third Contaminant
Candidate List (CCL3) does not mean
that the chemical meets SDWA 1457
requirements. SDWA 1457 states that
‘‘the Administrator may provide for
testing under the screening program
authorized by 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.’’ SDWA
section 1457 sets forth the criteria for
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the selection of substances for EDSP.
Section 1457 does not require the
Agency to promulgate regulations
further defining these criteria.
For the EDSP, EPA selected
contaminants from the CCL3, for which
EPA had evaluated the nature of the
occurrence and prevalence information
(Ref. 5), and selected contaminants from
National Primary Drinking Water
Regulations (NPDWRs), which were
designated by Congress for regulation
due to concerns about occurrence in
drinking water and adverse impacts on
human health. The scientific basis for
EPA’s selection of contaminants on the
CCL3 also provides the basis for EPA’s
determination that a chemical may be
found in sources of drinking water to
which a substantial population may be
exposed for the purposes of SDWA
section 1457.
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B. Support for Contaminants Listed in
the Draft Second List
The Agency received comments
supporting the contaminants included
on the draft second EDSP list. One
commenter stated that the draft second
EDSP list was an appropriate starting
point since it was developed from
existing NPDWRs and the CCL3.
Another commenter acknowledged that
many of the chemicals included on the
draft second EDSP list have already
undergone a rigorous review within the
Agency for exposure potential in
vulnerable populations and noted there
is incomplete toxicity data for the
general population. The commenter
stated that EDSP will contribute
important information about endocrine
disrupting potential of chemicals which
have never been tested for sensitive
endpoints in estrogen, androgen, and
thyroid hormone disruption.
C. Exclusion or Inclusion of
Contaminants
EPA received comments concerning
contaminants that are no longer
manufactured or that have been
cancelled (banned), indicating these
should be removed from the list. EPA
also received comments related to
chemicals with physiochemical
properties that would likely result in
test assay incompatibility issues. EPA
agrees that contaminants derived from
chemicals that have been banned or are
no longer manufactured should be
removed from the list. EPA has
generally determined that it would be
reasonable to prioritize testing for those
compounds which a manufacturer,
importer, or registrant is clearly
identifiable and the Agency could order
these entities to conduct the testing.
Chemicals that have been banned or are
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no longer manufactured (or imported)
do not fit within this category. EPA also
agrees that it would be reasonable to
exclude chemicals from the second list
based on the highly reactive
physiochemical properties of the
chemicals and test assay incompatibility
issues. The exclusion rationales for
streamlining the second EDSP list are
discussed in the Federal Register notice
for the draft second list (Ref. 1).
Table 1 of this notice contains a list
of chemicals that EPA believes should
be removed from the final second list
because they are no longer
manufactured, are banned chemicals, or
the chemicals have physiological
properties that make them highly
reactive and incompatible with the
testing assays. Other chemicals remain
on the list as they are still in use and
may be found in sources of drinking
water (see Unit IV.A. of this notice).
Other comments EPA received stated
those chemicals with a maximum
contaminant level goal of zero should be
removed. EPA recognizes that it may not
be possible to set more stringent levels
for some of these chemicals at this time.
However, it is important to note that
most of the chemicals with maximum
contaminant level goals of zero are
based on chronic health endpoints and
compounds with endocrine disrupting
effects that can be subchronic. Also, it
would be important to understand
whether a chemical might be an
endocrine disruptor with subchronic
impacts since this may inform the
Agency’s risk assessment and how best
to address this contaminant from a
regulatory standpoint. In addition, if
endocrine effects occur at a level lower
than the current maximum contaminant
level, the Agency might consider
whether improvements in analytical
feasibility, which would allow
measurements at the level of endocrine
effects, have been developed since the
promulgation of the existing MCLs.
EPA also received comments stating
that the Agency should have included
some chemicals (e.g., triclosan,
alkylphenols and alkylphenol
polyethoxylates, bisphenol A, musk
fragrances, and pharmaceutical
estrogens) with known or suspected
endocrine disrupting effects on the
second list. When compiling the second
EDSP list, EPA focused on priority
drinking water contaminants and
pesticides previously identified by EPA.
These priority chemicals included the
CCL3 chemicals, chemicals with
NPDWRs, and registration review
pesticides. The basis for chemical
selection is described in the Federal
Register notice for the draft second list
(Ref. 1). While the chemicals mentioned
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in the comments were not included on
the current EDSP list, they may be
included on future EDSP lists. Several
of the chemicals suggested by
commenters were evaluated as part of
the CCL3 process but did not make the
final CCL3 for reasons that are outlined
in EPA supporting documents ‘‘Final
Contaminant Candidate List 3
Chemicals: Identifying the Universe,
Final Contaminant Candidate List 3
Chemicals: Screening to a PCCL,’’ and
‘‘Final Contaminant Candidate List 3
Chemicals: PCCL to CCL’’ (Refs. 6, 7,
and 8).
As for the current approach for
selecting chemicals for the second EDSP
list, EPA excluded chemicals that are
hormones with confirmed effects as
stated in the Federal Register notice for
the draft second list (Ref. 1). EPA did
not give weight to information on the
potential for a chemical to cause
endocrine effects as criteria for listing as
the purpose of the second EDSP list is
to identify substances that have the
potential to interact with the endocrine
system using appropriate validated test
systems and other scientifically relevant
information. The final second EDSP list
should neither be construed as a list of
known or likely endocrine disruptors
nor characterized as such.
Some commenters also stated that
naturally occurring contaminants
should be excluded from the draft
second EDSP list. EPA sought and used
the best available information regarding
all substances on the draft second EDSP
list, including those that have the
potential to naturally occur. Although
EPA acknowledges that some substances
on the list (e.g., acetaldehyde,
acrylamide, methanol, and perchlorate)
can occur naturally in the environment,
this is not the only known pathway of
occurrence for these chemicals to enter
into the environment. A basis for
chemical selection includes selecting
substances that are known or
anticipated to occur in public drinking
water. Anthropogenic pathways for
these chemicals to enter the
environment are shown through data
from the Toxic Release Inventory (TRI),
Chemical Update System/Inventory
Update Rule (CUS/IUR), and chemical
manufacturing information.
Consequently, EPA does not believe that
the fact that these chemicals can occur
naturally is sufficient reason to exclude
the manufacturers and importers of
these chemicals from conducting the
necessary testing.
D. Pesticide Registration Review Issues
EPA received comments stating that
pesticide active ingredients should not
be included on EDSP list and suggesting
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that issuance of test orders should align
with pesticide registration review
schedules.
The Agency is working toward
integrating EDSP and the Registration
Review Program, such that the data
gathering may be completed in a
coordinated manner under these two
programs to permit a timely registration
review decision inclusive of EDSP and
not rely on the fixed chemical list
approach for active ingredients.
Ultimately, EPA intends that chemicals
scheduled for registration review may
receive EDSP test orders and the data
submitted in response to those orders
are coordinated with the submission of
data required under registration review.
The Agency may then review and
evaluate the data submitted for both
programs in the same time frame,
complete the risk assessment with EDSP
outcomes as appropriate, and likely
conclude registration review for a given
chemical within the schedule,
enhancing efficiency. Currently,
however, EPA does not have an
information collection request (ICR)
clearance to issue orders to require
EDSP testing generally for registration
review chemicals. While the ICR
clearance process continues, EPA
continues to rely on the chemical list
approach for the fiscal year 2007/2008
registration review chemicals in an
attempt to begin to address EDSP testing
for the early registration review
chemicals.
V. The Final Second List of Chemicals
and Substances for Tier 1 Screening
A. Chemicals and Substances Removed
From the Draft Second List for Tier 1
Screening
EPA removed 25 chemicals and
substances from the draft second list
based on two of the criteria published
in the November 17, 2010 issue of the
Federal Register, (Ref. 1):
1. Chemicals for which the
manufacturer, importer or registrant
cannot be clearly identified (criterion
two).
2. 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
(criterion five).
EPA reevaluated the draft second list of
chemicals and substances based on
public comments and determined that
sufficient data exist to remove a total of
25 additional contaminants based on
criterion two (n=21) and criterion five
(n=4). Table 1 presents an alphabetized
list of 25 chemicals and substances EPA
removed from the original list of 134
proposed for Tier 1 screening and
provides the rationale for removal.
Although these chemicals have been
removed from the second group of
chemicals and substances that EPA will
screen, it is important to note that the
removal of these chemicals and
substances does not imply that the
Agency has no interest in the potential
for endocrine disruption activity for
these contaminants. At this time the
Agency realizes that there is some
difficulty with collecting the
information about endocrine effects
through EDSP because of the Agency’s
inability to identify a manufacturer,
importer, or registrant or because the
contaminant is incompatible with the
testing assays.
TABLE 1—CHEMICALS REMOVED FROM DRAFT SECOND EDSP LIST
Chemical name
CAS Reg No.
SDWA
PAI
Rationale
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Physiochemical properties—highly reactive;
incompatible with the testing assays.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Physiochemical properties—highly reactive;
incompatible with the testing assays.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
96–12–8
X
........................
2. 2, 4, 5–TP (Silvex) ...................................
93–72–1
X
........................
3. Benzyl chloride ........................................
100–44–7
X
........................
4. Chlordane ................................................
57–74–9
X
........................
5. Cumene hydroperoxide ...........................
80–15–9
X
........................
6. Dalapon ...................................................
75–99–0
X
........................
7. Dimethipin ................................................
55290–64–7
X
........................
8. Dinoseb ....................................................
88–85–7
X
........................
9. Endrin ......................................................
72–20–8
X
........................
10. Ethylene dibromide (EDB) .....................
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1. 1, 2-Dibormo-3-chlorproprane (DBCP) ....
106–93–4
X
........................
11. Fenamiphos ...........................................
22224–92–6
X
X
12. Fenarimol ...............................................
60168–88–9
........................
X
13. Fenoxycarb ............................................
72490–01–8
........................
X
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TABLE 1—CHEMICALS REMOVED FROM DRAFT SECOND EDSP LIST—Continued
Chemical name
CAS Reg No.
SDWA
PAI
Rationale
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Physiochemical properties—highly reactive;
incompatible with the testing assays.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Pesticide not in use; TRI and/or IUR indicates importers or manufacturers are unlikely.
Physiochemical properties—highly reactive;
incompatible with the testing assays.
14. Heptachlor .............................................
76–44–8
X
........................
15. Heptachlor epoxide ................................
1024–57–3
X
........................
16. Methoxychlor .........................................
72–43–5
X
........................
17. Molinate .................................................
2212–67–1
X
........................
18. Oxirane, methyl- ....................................
75–56–9
X
........................
19. Propetamphos .......................................
31218–83–4
........................
X
20. Pyridate ..................................................
55512–33–9
........................
X
21. Sodium tetrathiocarbonate ....................
7345–69–9
........................
X
22. Sulfosate ................................................
81591–81–3
........................
X
23. Temephos ..............................................
3383–96–8
........................
X
24. Toxaphene .............................................
8001–35–2
X
........................
25. Triethylamine .........................................
121–44–8
X
........................
Endnotes—Table 1:
• TRI contains information on toxic chemical releases from facilities that meet reporting criteria (for most chemicals the thresholds are 25,000
pounds for manufacturing and processing and 10,000 pounds for use).
• IUR contains site and manufacturing information for chemicals manufactured (including imported) in amounts of 25,000 pounds or greater at
a single site.
B. The Final Second List of Chemical
and Substances for EDSP Tier 1
Screening
Table 2 presents an alphabetized list
of the 109 chemicals and substances
included in the final second EDSP list
of chemicals for Tier 1 screening. As in
the draft second list, the final list
includes pesticides, two PFCs, and three
pharmaceuticals (erythromycin,
nitroglycerin, and quinoline). The 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, personal care products,
and toxic substances. Because this list of
chemicals was selected on the basis of
exposure potential only, it should
neither be construed as a list of known
or likely endocrine disruptors nor
characterized as such.
TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING
mstockstill on DSK4VPTVN1PROD with NOTICES
Chemical name
CAS Reg No.
1. 1,1,1,2-Tetrachloroethane .................................................................................................
2. 1,1,1-Trichloroethane .........................................................................................................
3. 1,1,2-Trichloroethane .........................................................................................................
4. 1,1-Dichloroethane ............................................................................................................
5. 1,1-Dichloroethylene ..........................................................................................................
6. 1,2,3-Trichloropropane ......................................................................................................
7. 1,2,4-Trichlorobenzene ......................................................................................................
8. 1,2-Dichloroethane ............................................................................................................
9. 1,2-Dichloropropane ..........................................................................................................
10. 1,3-Dinitrobenzene ..........................................................................................................
11. 1,4-Dioxane .....................................................................................................................
12. 1-Butanol .........................................................................................................................
13. 2-Methoxyethanol ............................................................................................................
14. 2-Propen-1-ol ...................................................................................................................
15. 4,4’-Methylenedianiline ....................................................................................................
16. Acetaldehyde ...................................................................................................................
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75–35–4
96–18–4
120–82–1
107–06–2
78–87–5
99–65–0
123–91–1
71–36–3
109–86–4
107–18–6
101–77–9
75–07–0
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TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING—Continued
mstockstill on DSK4VPTVN1PROD with NOTICES
Chemical name
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
CAS Reg No.
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) ..................................................................................................
Butylated hydroxyanisole .................................................................................................
Carbon tetrachloride ........................................................................................................
Chlorobenzene ................................................................................................................
cis-1,2-Dichloroethylene ..................................................................................................
Clethodim .........................................................................................................................
Clofentezine .....................................................................................................................
Clomazone .......................................................................................................................
Coumaphos .....................................................................................................................
Cyanamide .......................................................................................................................
Cyromazine ......................................................................................................................
Denatonium saccharide ...................................................................................................
Di(2-ethylhexyl) adipate ...................................................................................................
Dichloromethane ..............................................................................................................
Dicrotophos ......................................................................................................................
Diuron ..............................................................................................................................
Endothall ..........................................................................................................................
Epichlorohydrin ................................................................................................................
Erythromycin ....................................................................................................................
Ethylbenzene ...................................................................................................................
Ethylene glycol ................................................................................................................
Ethylene thiourea .............................................................................................................
Ethylurethane ...................................................................................................................
Etofenprox .......................................................................................................................
Fenoxaprop-P-ethyl .........................................................................................................
Flumetsulam ....................................................................................................................
Fomesafen sodium ..........................................................................................................
Fosetyl-Al (Aliette) ...........................................................................................................
Glufosinate ammonium ....................................................................................................
HCFC–22 .........................................................................................................................
Hexachlorobenzene .........................................................................................................
Hexachlorocyclopentadiene .............................................................................................
Hexane ............................................................................................................................
Hexythiazox .....................................................................................................................
Hydrazine .........................................................................................................................
Isoxaben ..........................................................................................................................
Lactofen ...........................................................................................................................
Lindane ............................................................................................................................
Methanol ..........................................................................................................................
Methyl tert-butyl ether ......................................................................................................
Metolachlor ethanesulfonic acid (ESA) ...........................................................................
Metolachlor oxanilic acid (OA) ........................................................................................
Nitrobenzene ...................................................................................................................
Nitroglycerin .....................................................................................................................
N-Methyl-2-pyrrolidone ....................................................................................................
N-Nitrosodimethylamine (NDMA) ....................................................................................
n-Propylbenzene ..............................................................................................................
o-Dichlorobenzene ...........................................................................................................
o-Toluidine .......................................................................................................................
Oxydemeton-methyl .........................................................................................................
Oxyfluorfen ......................................................................................................................
Paclobutrazol ...................................................................................................................
p-Dichlorobenzene ...........................................................................................................
Pentachlorophenol ...........................................................................................................
Perchlorate ......................................................................................................................
Perfluorooctane sulfonic acid (PFOS) .............................................................................
Perfluorooctanoic acid (PFOA) ........................................................................................
Picloram ...........................................................................................................................
Polychlorinated biphenyls ................................................................................................
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34256–82–1
187022–11–3
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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
25013–16–5
56–23–5
108–90–7
156–59–2
99129–21–2
74115–24–5
81777–89–1
56–72–4
420–04–2
66215–27–8
90823–38–4
103–23–1
75–09–2
141–66–2
330–54–1
145–73–3
106–89–8
114–07–8
100–41–4
107–21–1
96–45–7
51–79–6
80844–07–1
71283–80–2
98967–40–9
108731–70–0
39148–24–8
77182–82–2
75–45–6
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
1634–04–4
171118–09–5
152019–73–3
98–95–3
55–63–0
872–50–4
62–75–9
103–65–1
95–50–1
95–53–4
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
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Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices
TABLE 2—FINAL SECOND EDSP LIST OF CHEMICALS FOR TIER 1 SCREENING—Continued
Chemical name
CAS Reg No.
89. Profenofos .......................................................................................................................
90. Propionic acid ..................................................................................................................
91. Quinclorac ........................................................................................................................
92. Quinoline ..........................................................................................................................
93. Quizalofop-P-ethyl ...........................................................................................................
94. RDX .................................................................................................................................
95. sec-Butylbenzene ............................................................................................................
96. Styrene ............................................................................................................................
97. Terbufos ...........................................................................................................................
98. Terbufos sulfone ..............................................................................................................
99. Tetrachloroethylene .........................................................................................................
100. Thiophanate-methyl .......................................................................................................
101. Toluene diisocyanate .....................................................................................................
102. trans-1,2-Dichloroethylene .............................................................................................
103. Trichloroethylene ...........................................................................................................
104. Triflumizole ....................................................................................................................
105. Trinexapac-ethyl ............................................................................................................
106. Triphenyltin hydroxide (TPTH) ......................................................................................
107. Vinclozolin ......................................................................................................................
108. Xylenes (total) ................................................................................................................
109. Ziram ..............................................................................................................................
41198–08–7
79–09–4
84087–01–4
91–22–5
100646–51–3
121–82–4
135–98–8
100–42–5
13071–79–9
56070–16–7
127–18–4
23564–05–8
26471–62–5
156–60–5
79–01–6
68694–11–1
95266–40–3
76–87–9
50471–44–8
1330–20–7
137–30–4
Total ..................................................................................................................................................................
Dated: May 29, 2013.
James Jones,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
VI. References
mstockstill on DSK4VPTVN1PROD with NOTICES
The following is a list of the
documents that are specifically
referenced in this document. These
references are available at https://
www.regulations.gov.
[FR Doc. 2013–14232 Filed 6–13–13; 8:45 am]
BILLING CODE 6560–50–P
1. USEPA. 2010. Endocrine Disruptor
Screening Program; Second List of
Chemicals for Tier 1 Screening; Notice.
Federal Register, 75 FR 70248,
November 17, 2010.
2. USEPA. 1996. FFDCA section 408(p).
Available on-line at https://
epw.senate.gov/FDA_001.pdf.
3. USEPA. 1996. Amendments to the Safe
Drinking Water Act. Available on-line at:
https://water.epa.gov/lawsregs/guidance/
sdwa/text.cfm.
4. U.S. Congress. House Report 111–180.
Available at: https://www.gpo.gov/fdsys/
pkg/CRPT-111hrpt180/pdf/CRPT111hrpt180.pdf.
5. USEPA. 2009. Drinking Water
Contaminant Candidate List 3—Final;
Notice. Federal Register. Vol. 74. No
194. p. 51850. October 8, 2009.
6. USEPA. 2009. Final Contaminant
Candidate List 3 Chemicals: Identifying
the Universe, EPA 815–R–09–006.
August 2009.
7. USEPA. 2009. Final Contaminant
Candidate List 3 Chemicals: Screening to
a PCCL, EPA 815–R–05–007. August,
2009.
8. USEPA. 2009. Final Contaminant
Candidate List 3 Chemicals:
Classification of the PCCL to the CCL,
EPA 815–R–09–008. August, 2009.
List of Subjects
Environmental protection, Chemicals,
Drinking water, Endocrine disruptors,
Pesticides.
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ENVIRONMENTAL PROTECTION
AGENCY
[ER–FRL–9009–6]
Environmental Impacts Statements;
Notice of Availability
Responsible Agency: Office of Federal
Activities, General Information (202)
564–7146 or https://www.epa.gov/
compliance/nepa/.
Weekly receipt of Environmental Impact
Statements
Filed 06/03/2013 through 06/07/2013.
Pursuant to 40 CFR 1506.9.
Notice
Section 309(a) of the Clean Air Act
requires that EPA make public its
comments on EISs issued by other
Federal agencies. EPA’s comment letters
on EISs are available at: https://
www.epa.gov/compliance/nepa/
eisdata.html.
EIS No. 20130160, Final EIS, USFS, OR,
McKay Fuels and Vegetation
Management Project, Review Period
Ends: 07/15/2013, Contact: Marcy
Anderson 541–416–6463.
EIS No. 20130161, Draft EIS, USFS, MT,
East Reservoir Project, Comment
Period Ends: 07/29/2013, Contact:
Denise Beck 406–293–7773, ext. 7504.
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88
41
EIS No. 20130162, Final EIS, BLM, NM,
SunZia Southwest Transmission
Project, Proposed Resource
Management Plan Amendments,
Review Period Ends: 07/15/2013,
Contact: Adrian Garcia 505–954–
2199.
EIS No. 20130163, Draft EIS, FERC, AL,
Martin Dam Hydroelectric Project,
Relicensing, Comment Period Ends:
08/13/2013, Contact: Stephen Bowler
202–502–6861.
EIS No. 20130164, Revised Draft EIS,
USAF, FL, F–35 Beddown at Eglin Air
Force Base, Comment Period Ends:
07/29/2013, Contact: Mike Spaits
850–882–2836.
EIS No. 20130165, Draft EIS, BLM, SD,
South Dakota Resource Management
Plan, Comment Period Ends: 09/11/
2013, Contact: Mitch Iverson 605–
892–7008.
EIS No. 20130166, Final EIS, USFWS,
NiSource Multi-Species Habitat
Conservation Plan, Review Period
Ends: 07/15/2013, Contact: Thomas J.
Magnuson 612–713–5467.
EIS No. 20130167, Draft EIS, NOAA, MI,
Thunder Bay National Marine
Sanctuary, Boundary Expansion,
Comment Period Ends: 08/14/2013,
Contact: Jeff Gray 989–356–8805.
EIS No. 20130168, Final EIS, USACE,
CA, Feather River West Levee Project
Final 408 Permission, Review Period
Ends: 07/15/2013, Contact: Jeffery
Koschak 916–557–6994.
EIS No. 20130169, Final Supplement,
NRC, TN, Operation of Watts Bar
Nuclear Plant, Unit 2 NUREG–0498,
Supplement 2, Review Period Ends:
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]]>Agencies
[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35922-35928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14232]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2009-0477; FRL-9375-8]
Endocrine Disruptor Screening Program; Final Second List of
Chemicals and Substances for Tier 1 Screening
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This document announces the final second list of 109 chemicals
identified for Tier 1 screening under the Endocrine Disruptor Screening
Program (EDSP). The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to
develop a chemical screening program using appropriate validated test
systems and other scientifically relevant information to determine
whether certain substances may have hormonal effects.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Hannah Holsinger, Office of Water, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001 (MC-4607M); telephone number: (202) 564-0403,
email address: holsinger.hannah@epa.gov, or Pat West, Office of Science
Coordination and Policy, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001 (MC-7201M); telephone
number: (202) 564-1656, email address: west.pat@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email 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, or import chemicals (including pesticide chemicals)
that may be found in sources of drinking water; if you manufacture or
import chemicals that degrade to chemicals found in sources of drinking
water; or if you are, or may otherwise be, involved in the testing of
chemicals for potential endocrine effects. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
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.
B. How can I get copies of this document and other related information?
The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0477, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics
Docket (OPPT Docket), Environmental Protection Agency Docket Center
(EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280. Please review the visitor
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
II. Background
A. What action is the agency taking?
This document announces the final second list of 109 chemicals
identified for Tier 1 screening under the Endocrine Disruptor Screening
Program (EDSP). The EDSP is established under section 408(p) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), which requires EPA to
develop a chemical screening program using appropriate validated test
systems and other scientifically relevant information to determine
whether certain substances may have hormonal effects. After considering
comments received on the draft second list of chemicals and substances
published in the Federal Register notice of November 17, 2010 (75 FR
70248) (FRL-8848-7) (Ref. 1), EPA is announcing the final list of the
second group of chemicals that will be subject to screening based on
the approach described in the notice--``Endocrine Disruptor Screening
Program; Final Policies and Procedures for Screening Safe Drinking
Water Act (SDWA) Chemicals,'' published elsewhere in today's Federal
Register.
The EDSP consists of a two-tiered approach to screen and test
chemicals for potential endocrine disrupting effects. The purpose of
Tier 1 screening is to identify substances that have the potential to
interact with the endocrine system (specifically the estrogen,
androgen, or thyroid hormone systems) using a battery of assays.
Substances that have the potential to interact with estrogen, androgen
or thyroid systems may proceed to Tier 2, which is designed to identify
any adverse endocrine-related effects caused by the
[[Page 35923]]
substance, and establish a quantitative relationship between the dose
and that endocrine effect. This second list should not be construed as
a list of known or likely endocrine disruptors. Nothing in the approach
for generating the second list provides a basis to infer that by simply
being on this list these chemicals are suspected to interfere with the
endocrine systems of humans or other species, and it would be
inappropriate to do so. In a separate notice published elsewhere in
today's Federal Register, EPA describes other aspects of EDSP such as
the administrative procedures that EPA will use to require testing.
The second group of chemicals to be tested consists of chemicals
that section 408(p) of the FFDCA (Ref. 2) requires be screened, i.e.,
pesticide active ingredients and chemicals used as pesticide inert
ingredients (also known as other ingredients) and section 1457 of the
1996 amendment to the SDWA (Ref. 3). EPA developed this final list
using the approach outlined in the Federal Register notice announcing
the draft second list of chemicals and substances (Ref. 1). More
information on EPA's priority setting approach is available at https://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
This document does not describe other aspects of EDSP such as the
administrative procedures EPA generally intends to use to require
testing, the validated tests and battery that will be included in EDSP,
or the timeframe for requiring the testing or receiving the data. The
administrative procedures that EPA generally intends to use are
described in a separate notice published elsewhere in today's Federal
Register. The remaining topics will be addressed in separate notices
that will be subsequently published in the Federal Register.
B. What is the agency's authority for taking this action?
FFDCA section 408(p) 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)). Section 408(p)(3) 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 states 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.
III. History
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)). Unit II.B. describes the authority for listing a
chemical. As part of EDSP, EPA issues orders to collect certain test
data on selected chemical substances. In general, EPA intends to use
the data collected under EDSP, along with other information, to
determine if a pesticide chemical or other substances may pose a risk
to human health or the environment due to disruption of the endocrine
system. The determination that a chemical does or is not likely to have
the potential to interact with the endocrine system will be made on a
weight-of-evidence basis taking into account data from the Tier 1
assays and/or other scientifically relevant information. Chemicals that
go through Tier 1 screening and are found to have the potential to
interact with the estrogen, androgen, or thyroid hormone systems will
proceed to the next state of EDSP where EPA will determine which, if
any, of the Tier 2 tests are necessary based on available data. Tier 2
testing is designed to identify any adverse endocrine-related effects
caused by the substance, and establish a quantitative relationship
between the dose and that endocrine effect. Further information
regarding EDSP and requirements for Tier 1 and Tier 2 testing can be
found on the Agency's EDSP Web site, at https://www.epa.gov/endo/.
IV. Development of the Second EDSP List
The House Appropriations Committee report for EPA's FY 2010
appropriations (H.R. 2996, H. Rept. 111-180) (Ref. 4), 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
polybrominated diphenyl ethers, polychlorinated biphenyls,
perfluorocarbons (PFCs), plastics, bisphenol A, pharmaceuticals and
personal care products, and issue 25 orders per year for the testing of
these chemicals. This process also should allow for public input. In
response, EPA published a draft second list of chemicals for Tier 1
screening on November 17, 2010 and solicited public comments on the
list of chemicals. The development of the draft second list is
described at length in that Federal Register notice (Ref. 1).
EPA received comment letters from approximately 60 organizations or
individuals on the November 17, 2010 draft second EDSP list. These
organizations/individuals included a water-related association,
environmental advocacy groups, chemical industry, consumer and pet
advocacy groups, and consultants writing on behalf of the industry.
This notice summarizes major comments EPA received, along with the
Agency's response. A complete listing of public comments and EPA's
responses related to the draft second list of chemicals for Tier 1
screening are included in the document entitled ``Final Comment
Response Document for the Second Endocrine Disruptor Screening Program
List (Categorized Public Comments).'' The document is available in the
docket for this action under docket ID number EPA-HQ-OPPT-2009-0477.
A. SDWA 1457
Some commenters stated that EPA had not met the requirements of
SDWA 1457 when listing the draft second EDSP list. They stated that a
chemical's inclusion on the third Contaminant Candidate List (CCL3)
does not mean that the chemical meets SDWA 1457 requirements. SDWA 1457
states that ``the Administrator may provide for testing under the
screening program authorized by 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.'' SDWA section 1457 sets forth the criteria
for
[[Page 35924]]
the selection of substances for EDSP. Section 1457 does not require the
Agency to promulgate regulations further defining these criteria.
For the EDSP, EPA selected contaminants from the CCL3, for which
EPA had evaluated the nature of the occurrence and prevalence
information (Ref. 5), and selected contaminants from National Primary
Drinking Water Regulations (NPDWRs), which were designated by Congress
for regulation due to concerns about occurrence in drinking water and
adverse impacts on human health. The scientific basis for EPA's
selection of contaminants on the CCL3 also provides the basis for EPA's
determination that a chemical may be found in sources of drinking water
to which a substantial population may be exposed for the purposes of
SDWA section 1457.
B. Support for Contaminants Listed in the Draft Second List
The Agency received comments supporting the contaminants included
on the draft second EDSP list. One commenter stated that the draft
second EDSP list was an appropriate starting point since it was
developed from existing NPDWRs and the CCL3. Another commenter
acknowledged that many of the chemicals included on the draft second
EDSP list have already undergone a rigorous review within the Agency
for exposure potential in vulnerable populations and noted there is
incomplete toxicity data for the general population. The commenter
stated that EDSP will contribute important information about endocrine
disrupting potential of chemicals which have never been tested for
sensitive endpoints in estrogen, androgen, and thyroid hormone
disruption.
C. Exclusion or Inclusion of Contaminants
EPA received comments concerning contaminants that are no longer
manufactured or that have been cancelled (banned), indicating these
should be removed from the list. EPA also received comments related to
chemicals with physiochemical properties that would likely result in
test assay incompatibility issues. EPA agrees that contaminants derived
from chemicals that have been banned or are no longer manufactured
should be removed from the list. EPA has generally determined that it
would be reasonable to prioritize testing for those compounds which a
manufacturer, importer, or registrant is clearly identifiable and the
Agency could order these entities to conduct the testing. Chemicals
that have been banned or are no longer manufactured (or imported) do
not fit within this category. EPA also agrees that it would be
reasonable to exclude chemicals from the second list based on the
highly reactive physiochemical properties of the chemicals and test
assay incompatibility issues. The exclusion rationales for streamlining
the second EDSP list are discussed in the Federal Register notice for
the draft second list (Ref. 1).
Table 1 of this notice contains a list of chemicals that EPA
believes should be removed from the final second list because they are
no longer manufactured, are banned chemicals, or the chemicals have
physiological properties that make them highly reactive and
incompatible with the testing assays. Other chemicals remain on the
list as they are still in use and may be found in sources of drinking
water (see Unit IV.A. of this notice).
Other comments EPA received stated those chemicals with a maximum
contaminant level goal of zero should be removed. EPA recognizes that
it may not be possible to set more stringent levels for some of these
chemicals at this time. However, it is important to note that most of
the chemicals with maximum contaminant level goals of zero are based on
chronic health endpoints and compounds with endocrine disrupting
effects that can be subchronic. Also, it would be important to
understand whether a chemical might be an endocrine disruptor with
subchronic impacts since this may inform the Agency's risk assessment
and how best to address this contaminant from a regulatory standpoint.
In addition, if endocrine effects occur at a level lower than the
current maximum contaminant level, the Agency might consider whether
improvements in analytical feasibility, which would allow measurements
at the level of endocrine effects, have been developed since the
promulgation of the existing MCLs.
EPA also received comments stating that the Agency should have
included some chemicals (e.g., triclosan, alkylphenols and alkylphenol
polyethoxylates, bisphenol A, musk fragrances, and pharmaceutical
estrogens) with known or suspected endocrine disrupting effects on the
second list. When compiling the second EDSP list, EPA focused on
priority drinking water contaminants and pesticides previously
identified by EPA. These priority chemicals included the CCL3
chemicals, chemicals with NPDWRs, and registration review pesticides.
The basis for chemical selection is described in the Federal Register
notice for the draft second list (Ref. 1). While the chemicals
mentioned in the comments were not included on the current EDSP list,
they may be included on future EDSP lists. Several of the chemicals
suggested by commenters were evaluated as part of the CCL3 process but
did not make the final CCL3 for reasons that are outlined in EPA
supporting documents ``Final Contaminant Candidate List 3 Chemicals:
Identifying the Universe, Final Contaminant Candidate List 3 Chemicals:
Screening to a PCCL,'' and ``Final Contaminant Candidate List 3
Chemicals: PCCL to CCL'' (Refs. 6, 7, and 8).
As for the current approach for selecting chemicals for the second
EDSP list, EPA excluded chemicals that are hormones with confirmed
effects as stated in the Federal Register notice for the draft second
list (Ref. 1). EPA did not give weight to information on the potential
for a chemical to cause endocrine effects as criteria for listing as
the purpose of the second EDSP list is to identify substances that have
the potential to interact with the endocrine system using appropriate
validated test systems and other scientifically relevant information.
The final second EDSP list should neither be construed as a list of
known or likely endocrine disruptors nor characterized as such.
Some commenters also stated that naturally occurring contaminants
should be excluded from the draft second EDSP list. EPA sought and used
the best available information regarding all substances on the draft
second EDSP list, including those that have the potential to naturally
occur. Although EPA acknowledges that some substances on the list
(e.g., acetaldehyde, acrylamide, methanol, and perchlorate) can occur
naturally in the environment, this is not the only known pathway of
occurrence for these chemicals to enter into the environment. A basis
for chemical selection includes selecting substances that are known or
anticipated to occur in public drinking water. Anthropogenic pathways
for these chemicals to enter the environment are shown through data
from the Toxic Release Inventory (TRI), Chemical Update System/
Inventory Update Rule (CUS/IUR), and chemical manufacturing
information. Consequently, EPA does not believe that the fact that
these chemicals can occur naturally is sufficient reason to exclude the
manufacturers and importers of these chemicals from conducting the
necessary testing.
D. Pesticide Registration Review Issues
EPA received comments stating that pesticide active ingredients
should not be included on EDSP list and suggesting
[[Page 35925]]
that issuance of test orders should align with pesticide registration
review schedules.
The Agency is working toward integrating EDSP and the Registration
Review Program, such that the data gathering may be completed in a
coordinated manner under these two programs to permit a timely
registration review decision inclusive of EDSP and not rely on the
fixed chemical list approach for active ingredients. Ultimately, EPA
intends that chemicals scheduled for registration review may receive
EDSP test orders and the data submitted in response to those orders are
coordinated with the submission of data required under registration
review. The Agency may then review and evaluate the data submitted for
both programs in the same time frame, complete the risk assessment with
EDSP outcomes as appropriate, and likely conclude registration review
for a given chemical within the schedule, enhancing efficiency.
Currently, however, EPA does not have an information collection request
(ICR) clearance to issue orders to require EDSP testing generally for
registration review chemicals. While the ICR clearance process
continues, EPA continues to rely on the chemical list approach for the
fiscal year 2007/2008 registration review chemicals in an attempt to
begin to address EDSP testing for the early registration review
chemicals.
V. The Final Second List of Chemicals and Substances for Tier 1
Screening
A. Chemicals and Substances Removed From the Draft Second List for Tier
1 Screening
EPA removed 25 chemicals and substances from the draft second list
based on two of the criteria published in the November 17, 2010 issue
of the Federal Register, (Ref. 1):
1. Chemicals for which the manufacturer, importer or registrant
cannot be clearly identified (criterion two).
2. 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 (criterion five).
EPA reevaluated the draft second list of chemicals and substances based
on public comments and determined that sufficient data exist to remove
a total of 25 additional contaminants based on criterion two (n=21) and
criterion five (n=4). Table 1 presents an alphabetized list of 25
chemicals and substances EPA removed from the original list of 134
proposed for Tier 1 screening and provides the rationale for removal.
Although these chemicals have been removed from the second group of
chemicals and substances that EPA will screen, it is important to note
that the removal of these chemicals and substances does not imply that
the Agency has no interest in the potential for endocrine disruption
activity for these contaminants. At this time the Agency realizes that
there is some difficulty with collecting the information about
endocrine effects through EDSP because of the Agency's inability to
identify a manufacturer, importer, or registrant or because the
contaminant is incompatible with the testing assays.
Table 1--Chemicals Removed From Draft Second EDSP List
----------------------------------------------------------------------------------------------------------------
Chemical name CAS Reg No. SDWA PAI Rationale
----------------------------------------------------------------------------------------------------------------
1. 1, 2-Dibormo-3-chlorproprane 96-12-8 X ............... Pesticide not in use;
(DBCP). TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
2. 2, 4, 5-TP (Silvex)........... 93-72-1 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
3. Benzyl chloride............... 100-44-7 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
4. Chlordane..................... 57-74-9 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
5. Cumene hydroperoxide.......... 80-15-9 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
6. Dalapon....................... 75-99-0 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
7. Dimethipin.................... 55290-64-7 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
8. Dinoseb....................... 88-85-7 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
9. Endrin........................ 72-20-8 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
10. Ethylene dibromide (EDB)..... 106-93-4 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
11. Fenamiphos................... 22224-92-6 X X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
12. Fenarimol.................... 60168-88-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
13. Fenoxycarb................... 72490-01-8 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
[[Page 35926]]
14. Heptachlor................... 76-44-8 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
15. Heptachlor epoxide........... 1024-57-3 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
16. Methoxychlor................. 72-43-5 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
17. Molinate..................... 2212-67-1 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
18. Oxirane, methyl-............. 75-56-9 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
19. Propetamphos................. 31218-83-4 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
20. Pyridate..................... 55512-33-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
21. Sodium tetrathiocarbonate.... 7345-69-9 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
22. Sulfosate.................... 81591-81-3 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
23. Temephos..................... 3383-96-8 ............... X Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
24. Toxaphene.................... 8001-35-2 X ............... Pesticide not in use;
TRI and/or IUR
indicates importers or
manufacturers are
unlikely.
25. Triethylamine................ 121-44-8 X ............... Physiochemical
properties--highly
reactive; incompatible
with the testing
assays.
----------------------------------------------------------------------------------------------------------------
Endnotes--Table 1:
TRI contains information on toxic chemical releases from facilities that meet reporting criteria (for
most chemicals the thresholds are 25,000 pounds for manufacturing and processing and 10,000 pounds for use).
IUR contains site and manufacturing information for chemicals manufactured (including imported) in
amounts of 25,000 pounds or greater at a single site.
B. The Final Second List of Chemical and Substances for EDSP Tier 1
Screening
Table 2 presents an alphabetized list of the 109 chemicals and
substances included in the final second EDSP list of chemicals for Tier
1 screening. As in the draft second list, the final list includes
pesticides, two PFCs, and three pharmaceuticals (erythromycin,
nitroglycerin, and quinoline). The 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,
personal care products, and toxic substances. Because this list of
chemicals was selected on the basis of exposure potential only, it
should neither be construed as a list of known or likely endocrine
disruptors nor characterized as such.
Table 2--Final Second EDSP List of Chemicals for Tier 1 Screening
----------------------------------------------------------------------------------------------------------------
Chemical name CAS Reg No. SDWA PAI
----------------------------------------------------------------------------------------------------------------
1. 1,1,1,2-Tetrachloroethane............................... 630-20-6 X ...............
2. 1,1,1-Trichloroethane................................... 71-55-6 X ...............
3. 1,1,2-Trichloroethane................................... 79-00-5 X ...............
4. 1,1-Dichloroethane...................................... 75-34-3 X ...............
5. 1,1-Dichloroethylene.................................... 75-35-4 X ...............
6. 1,2,3-Trichloropropane.................................. 96-18-4 X ...............
7. 1,2,4-Trichlorobenzene.................................. 120-82-1 X ...............
8. 1,2-Dichloroethane...................................... 107-06-2 X ...............
9. 1,2-Dichloropropane..................................... 78-87-5 X ...............
10. 1,3-Dinitrobenzene..................................... 99-65-0 X ...............
11. 1,4-Dioxane............................................ 123-91-1 X ...............
12. 1-Butanol.............................................. 71-36-3 X ...............
13. 2-Methoxyethanol....................................... 109-86-4 X ...............
14. 2-Propen-1-ol.......................................... 107-18-6 X ...............
15. 4,4'-Methylenedianiline................................ 101-77-9 X ...............
16. Acetaldehyde........................................... 75-07-0 X ...............
[[Page 35927]]
17. Acetamide.............................................. 60-35-5 X ...............
18. Acetochlor............................................. 34256-82-1 X X
19. Acetochlor ethanesulfonic acid (ESA)................... 187022-11-3 X ...............
20. Acetochlor oxanilic acid (OA).......................... 194992-44-4 X ...............
21. Acrolein............................................... 107-02-8 X X
22. Acrylamide............................................. 79-06-1 X ...............
23. Alachlor............................................... 15972-60-8 X X
24. Alachlor ethanesulfonic acid (ESA)..................... 142363-53-9 X ...............
25. Alachlor oxanilic acid (OA)............................ 171262-17-2 X ...............
26. alpha-Hexachlorocyclohexane............................ 319-84-6 X ...............
27. Aniline................................................ 62-53-3 X ...............
28. Bensulide.............................................. 741-58-2 X X
29. Benzene................................................ 71-43-2 X ...............
30. Benzo(a)pyrene (PAHs).................................. 50-32-8 X ...............
31. Butylated hydroxyanisole............................... 25013-16-5 X ...............
32. Carbon tetrachloride................................... 56-23-5 X ...............
33. Chlorobenzene.......................................... 108-90-7 X ...............
34. cis-1,2-Dichloroethylene............................... 156-59-2 X ...............
35. Clethodim.............................................. 99129-21-2 X X
36. Clofentezine........................................... 74115-24-5 ............... X
37. Clomazone.............................................. 81777-89-1 ............... X
38. Coumaphos.............................................. 56-72-4 ............... X
39. Cyanamide.............................................. 420-04-2 ............... X
40. Cyromazine............................................. 66215-27-8 ............... X
41. Denatonium saccharide.................................. 90823-38-4 ............... X
42. Di(2-ethylhexyl) adipate............................... 103-23-1 X ...............
43. Dichloromethane........................................ 75-09-2 X ...............
44. Dicrotophos............................................ 141-66-2 X X
45. Diuron................................................. 330-54-1 X X
46. Endothall.............................................. 145-73-3 X X
47. Epichlorohydrin........................................ 106-89-8 X ...............
48. Erythromycin........................................... 114-07-8 X ...............
49. Ethylbenzene........................................... 100-41-4 X ...............
50. Ethylene glycol........................................ 107-21-1 X ...............
51. Ethylene thiourea...................................... 96-45-7 X ...............
52. Ethylurethane.......................................... 51-79-6 X ...............
53. Etofenprox............................................. 80844-07-1 ............... X
54. Fenoxaprop-P-ethyl..................................... 71283-80-2 ............... X
55. Flumetsulam............................................ 98967-40-9 ............... X
56. Fomesafen sodium....................................... 108731-70-0 ............... X
57. Fosetyl-Al (Aliette)................................... 39148-24-8 ............... X
58. Glufosinate ammonium................................... 77182-82-2 ............... X
59. HCFC-22................................................ 75-45-6 X ...............
60. Hexachlorobenzene...................................... 118-74-1 X ...............
61. Hexachlorocyclopentadiene.............................. 77-47-4 X ...............
62. Hexane................................................. 110-54-3 X ...............
63. Hexythiazox............................................ 78587-05-0 ............... X
64. Hydrazine.............................................. 302-01-2 X ...............
65. Isoxaben............................................... 82558-50-7 ............... X
66. Lactofen............................................... 77501-63-4 ............... X
67. Lindane................................................ 58-89-9 X ...............
68. Methanol............................................... 67-56-1 X ...............
69. Methyl tert-butyl ether................................ 1634-04-4 X ...............
70. Metolachlor ethanesulfonic acid (ESA).................. 171118-09-5 X ...............
71. Metolachlor oxanilic acid (OA)......................... 152019-73-3 X ...............
72. Nitrobenzene........................................... 98-95-3 X ...............
73. Nitroglycerin.......................................... 55-63-0 X ...............
74. N-Methyl-2-pyrrolidone................................. 872-50-4 X ...............
75. N-Nitrosodimethylamine (NDMA).......................... 62-75-9 X ...............
76. n-Propylbenzene........................................ 103-65-1 X ...............
77. o-Dichlorobenzene...................................... 95-50-1 X ...............
78. o-Toluidine............................................ 95-53-4 X ...............
79. Oxydemeton-methyl...................................... 301-12-2 X X
80. Oxyfluorfen............................................ 42874-03-3 X X
81. Paclobutrazol.......................................... 76738-62-0 ............... X
82. p-Dichlorobenzene...................................... 106-46-7 X X
83. Pentachlorophenol...................................... 87-86-5 X X
84. Perchlorate............................................ 14797-73-0 X ...............
85. Perfluorooctane sulfonic acid (PFOS)................... 1763-23-1 X ...............
86. Perfluorooctanoic acid (PFOA).......................... 335-67-1 X ...............
87. Picloram............................................... 1918-02-1 X X
88. Polychlorinated biphenyls.............................. 1336-36-3 X ...............
[[Page 35928]]
89. Profenofos............................................. 41198-08-7 X X
90. Propionic acid......................................... 79-09-4 ............... X
91. Quinclorac............................................. 84087-01-4 ............... X
92. Quinoline.............................................. 91-22-5 X ...............
93. Quizalofop-P-ethyl..................................... 100646-51-3 ............... X
94. RDX.................................................... 121-82-4 X ...............
95. sec-Butylbenzene....................................... 135-98-8 X ...............
96. Styrene................................................ 100-42-5 X ...............
97. Terbufos............................................... 13071-79-9 X X
98. Terbufos sulfone....................................... 56070-16-7 X ...............
99. Tetrachloroethylene.................................... 127-18-4 X ...............
100. Thiophanate-methyl.................................... 23564-05-8 X X
101. Toluene diisocyanate.................................. 26471-62-5 X ...............
102. trans-1,2-Dichloroethylene............................ 156-60-5 X ...............
103. Trichloroethylene..................................... 79-01-6 X ...............
104. Triflumizole.......................................... 68694-11-1 ............... X
105. Trinexapac-ethyl...................................... 95266-40-3 ............... X
106. Triphenyltin hydroxide (TPTH)......................... 76-87-9 X X
107. Vinclozolin........................................... 50471-44-8 X X
108. Xylenes (total)....................................... 1330-20-7 X X
109. Ziram................................................. 137-30-4 X X
----------------------------------------------------
Total..................................................................... 88 41
----------------------------------------------------------------------------------------------------------------
VI. References
The following is a list of the documents that are specifically
referenced in this document. These references are available at https://www.regulations.gov.
1. USEPA. 2010. Endocrine Disruptor Screening Program; Second List
of Chemicals for Tier 1 Screening; Notice. Federal Register, 75 FR
70248, November 17, 2010.
2. USEPA. 1996. FFDCA section 408(p). Available on-line at https://epw.senate.gov/FDA_001.pdf.
3. USEPA. 1996. Amendments to the Safe Drinking Water Act. Available
on-line at: https://water.epa.gov/lawsregs/guidance/sdwa/text.cfm.
4. U.S. Congress. House Report 111-180. Available at: https://www.gpo.gov/fdsys/pkg/CRPT-111hrpt180/pdf/CRPT-111hrpt180.pdf.
5. USEPA. 2009. Drinking Water Contaminant Candidate List 3--Final;
Notice. Federal Register. Vol. 74. No 194. p. 51850. October 8,
2009.
6. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Identifying the Universe, EPA 815-R-09-006. August 2009.
7. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Screening to a PCCL, EPA 815-R-05-007. August, 2009.
8. USEPA. 2009. Final Contaminant Candidate List 3 Chemicals:
Classification of the PCCL to the CCL, EPA 815-R-09-008. August,
2009.
List of Subjects
Environmental protection, Chemicals, Drinking water, Endocrine
disruptors, Pesticides.
Dated: May 29, 2013.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2013-14232 Filed 6-13-13; 8:45 am]
BILLING CODE 6560-50-P
