Hydrogen Sulfide; Community Right-to-Know Toxic Chemical Release Reporting, 64022-64037 [2011-23534]
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• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this rule does not have
Tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on Tribal governments or preempt
Tribal law.
B. Submission to Congress and the
Comptroller General
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by December 16, 2011. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action.
This action concerning Maryland’s
adoption of CTG standards for plastic
parts and business machines coatings
may not be challenged later in
proceedings to enforce its requirements.
(See section 307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: October 03, 2011.
W.C. Early,
Acting, Regional Administrator, Region III.
40 CFR part 52 is amended as follows:
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart V—Maryland
2. In § 52.1070, the table in paragraph
(c) is amended by revising the entry for
COMAR 26.11.19.07 and adding an
entry for COMAR 26.11.19.07–2 to read
as follows:
■
§ 52.1070
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Identification of plan.
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(c) * * *
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EPA-APPROVED REGULATIONS IN THE MARYLAND SIP
Code of Maryland
administrative
regulations (COMAR)
citation
State effective
date
Title/subject
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26.11.19
EPA approval date
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Volatile Organic Compounds from Specific Processes
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Additional explanation/
citation at 40 CFR
52.1100
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26.11.19.07 ...............
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Paper, Fabric, Film, and Foil Coating ...................
5/16/11
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10/17/11 [Insert page
number where the
document begins].
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Revisions to Section title
and Sections .07A
and .07C(3).
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26.11.19.07–2 ...........
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Plastic Parts and Business Machines Coating .....
5/16/11
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10/17/11 [Insert page
number where the
document begins].
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New Regulation.
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Lifting of Administrative Stay
for Hydrogen Sulfide.
ENVIRONMENTAL PROTECTION
AGENCY
ACTION:
40 CFR Part 372
[FR Doc. 2011–26638 Filed 10–14–11; 8:45 am]
*
SUMMARY:
BILLING CODE 6560–50–P
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[EPA–HQ–TRI–2009–0844; FRL–9463–5]
RIN 2025–AA27
Hydrogen Sulfide; Community Rightto-Know Toxic Chemical Release
Reporting
Environmental Protection
Agency (EPA).
AGENCY:
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EPA is announcing that it is
lifting the Administrative Stay of the
Emergency Planning and Community
Right-to-Know Act (EPCRA) section 313
toxic chemical release reporting
requirements for hydrogen sulfide
(Chemical Abstracts Service Number
(CAS No.) 7783–06–4). Hydrogen
sulfide was added to the EPCRA section
313 list of toxic chemicals in a final rule
published in the Federal Register on
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December 1, 1993. However, on August
22, 1994, EPA issued an Administrative
Stay of the reporting requirements for
hydrogen sulfide in order to evaluate
issues brought to the Agency’s attention
after promulgation of the final rule
concerning the human health effect
basis for the listing and the Agency’s
use of exposure analysis in EPCRA
section 313 listing decisions. Although
the final rule listing hydrogen sulfide
under section 313 of EPCRA remained
in force, the stay deferred the reporting
requirements for hydrogen sulfide while
EPA completed this further evaluation.
EPA completed its further evaluation of
additional information that has become
available since the stay was put in place
regarding the human health and
environmental effects of hydrogen
sulfide, and the Agency published a
position that the stay should be lifted in
the February 26, 2010, Federal Register
document ‘‘Intent to Consider Lifting
Administrative Stay; Opportunity for
Public Comment.’’ Based on EPA’s
further evaluation and the consideration
of the public comments received on the
notice of intent, EPA continues to
believe that the Administrative Stay
should be lifted. By this current action,
EPA is not revisiting the original listing
decision, which was accomplished by
final rule on December 1, 1993. Rather,
EPA is lifting the Administrative Stay of
the reporting requirements for hydrogen
sulfide.
DATES: This action is effective on
October 17, 2011, such that the first
reports on hydrogen sulfide will be due
on July 1, 2013 for reporting year 2012.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–HQ–TRI–2009–0844. All
documents in the docket are listed in
the https://www.regulations.gov index.
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, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in https://
www.regulations.gov or in hard copy at
the OEI Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. This Docket
Facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
64023
for the Public Reading Room is (202)
566–1744, and the telephone number for
the OEI Docket is (202) 566–1752.
FOR FURTHER INFORMATION CONTACT:
Daniel R. Bushman, Environmental
Analysis Division, Office of Information
Analysis and Access (2842T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone number: 202–566–
0743; fax number: 202–566–0677; email: bushman.daniel@epa.gov, for
specific information on this document.
For general information on EPCRA
section 313, contact the Emergency
Planning and Community Right-toKnow Hotline, toll free at (800) 424–
9346 or (703) 412–9810 in Virginia and
Alaska or toll free, TDD (800) 553–7672,
https://www.epa.gov/epaoswer/hotline/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or otherwise use hydrogen sulfide.
Potentially affected categories and
entities may include, but are not limited
to:
Category
Examples of potentially affected entities
Industry .........................
Facilities included in the following NAICS manufacturing codes (corresponding to SIC codes 20 through 39): 311*,
312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*,
111998*, 211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191,
511199, 512220, 512230*, 519130*, 541712*, or 811490*.
*Exceptions and/or limitations exist for these NAICS codes.
Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39):
212111, 212112, 212113 (correspond to SIC 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234,
212299 (correspond to SIC 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221119,
221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for
distribution in commerce) (correspond to SIC 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120
(Limited to facilities previously classified in SIC 5169, Chemicals and Allied Products, Not Elsewhere Classified); or
424710 (corresponds to SIC 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to facilities primarily
engaged in solvent recovery services on a contract or fee basis (previously classified under SIC 7389, Business
Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities regulated under the Resource
Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse Systems).
Federal facilities.
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Federal Government .....
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Some of the
entities listed in the table have
exemptions and/or limitations regarding
coverage, and other types of entities not
listed in the table could also be affected.
To determine whether your facility
would be affected by this action, you
should carefully examine the
applicability criteria in part 372 subpart
B of Title 40 of the Code of Federal
Regulations. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
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listed in the preceding FOR FURTHER
section.
INFORMATION CONTACT
II. Introduction
Section 313 of EPCRA, 42 U.S.C.
11023, requires certain facilities that
manufacture, process, or otherwise use
listed toxic chemicals in amounts above
reporting threshold levels to report their
environmental releases and other waste
management quantities of such
chemicals annually. These facilities
must also report pollution prevention
and recycling data for such chemicals,
pursuant to section 6607 of the
Pollution Prevention Act (PPA), 42
U.S.C. 13106. EPCRA section 313
established an initial list of toxic
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chemicals composed of more than 300
chemicals and 20 chemical categories.
EPCRA section 313(d) authorizes EPA
to add or delete chemicals from the list
and sets forth criteria for these actions.
Specifically, EPCRA section 313(d)(2)
states that EPA may add a chemical to
the list if ‘‘there is sufficient evidence to
establish any one’’ of the listing criteria.
Therefore, to add a chemical, EPA must
demonstrate that at least one criterion is
met, but need not determine whether
any other criterion is met. Conversely,
EPCRA section 313(d)(3) states that to
remove a chemical from the list, EPA
must determine that ‘‘there is not
sufficient evidence to establish any’’ of
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the Section 313(d)(2) criteria. Therefore,
to remove a chemical, EPA must
demonstrate that none of the criteria are
met. The EPCRA section 313(d)(2)
criteria are:
(A) The chemical is known to cause
or can reasonably be anticipated to
cause significant adverse acute human
health effects at concentration levels
that are reasonably likely to exist
beyond facility site boundaries as a
result of continuous, or frequently
recurring, releases.
(B) The chemical is known to cause or
can reasonably be anticipated to cause
in humans—
(i) Cancer or teratogenic effects, or
(ii) Serious or irreversible—
(I) Reproductive dysfunctions,
(II) Neurological disorders,
(III) Heritable genetic mutations, or
(IV) Other chronic health effects.
(C) The chemical is known to cause or
can be reasonably anticipated to cause,
because of
(i) Its toxicity,
(ii) Its toxicity and persistence in the
environment, or
(iii) Its toxicity and tendency to
bioaccumulate in the environment, a
significant adverse effect on the
environment of sufficient seriousness,
in the judgment of the Administrator, to
warrant reporting under this section.
EPA often refers to the section
313(d)(2)(A) criterion as the ‘‘acute
human health effects criterion;’’ the
section 313(d)(2)(B) criterion as the
‘‘chronic human health effects
criterion;’’ and the section 313(d)(2)(C)
criterion as the ‘‘environmental effects
criterion.’’
Under EPCRA section 313(e)(1), any
person may petition EPA to add
chemicals to or delete chemicals from
the list. EPA issued a statement of
petition policy and guidance in the
Federal Register of February 4, 1987 (52
FR 3479) to provide guidance regarding
the recommended content and format
for submitting petitions under EPCRA
section 313(e). EPA also issued
guidance in the Federal Register of May
23, 1991 (56 FR 23703) regarding the
recommended content of petitions to
delete individual members of the
section 313 metal compound categories.
In addition, EPA published in the
Federal Register of November 30, 1994
(59 FR 61432) a statement clarifying its
interpretation of the section 313(d)(2)
and (d)(3) criteria for modifying the
section 313 list of toxic chemicals.
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III. Background Information
A. What is the history of the listing of
hydrogen sulfide under EPCRA section
313?
In response to a petition from the
Natural Resources Defense Council and
the Governor of New York, hydrogen
sulfide, along with 20 other chemicals
and two chemical categories, was added
to the EPCRA section 313 list of toxic
chemicals as part of a 1993 final rule
(December 1, 1993, 58 FR 63500).
Hydrogen sulfide was listed under the
criteria of EPCRA section 313(d)(2)(B)
(chronic human health effects) based on
chronic neurotoxic effects in humans
and under EPCRA section 313(d)(2)(C)
(environmental effects) based on acute
aquatic toxicity. However, on August
22, 1994 (59 FR 43048), EPA issued an
Administrative Stay of the EPCRA
section 313 reporting requirements for
hydrogen sulfide. Although the final
rule listing hydrogen sulfide under
section 313 of EPCRA remained in force,
the stay deferred the reporting
requirements for hydrogen sulfide. On
February 26, 2010, EPA issued a
document in the Federal Register
entitled ‘‘Intent to Consider Lifting
Administrative Stay; Opportunity for
Public Comment’’ (75 FR 8889). That
document provided the public with the
opportunity to comment on EPA’s
review of the currently available data on
the human health and environmental
effects of hydrogen sulfide—
specifically, chronic respiratory effects,
chronic neurotoxic effects, and acute,
chronic and early-life stage aquatic
toxicity—and EPA’s belief that the
Administrative Stay should be lifted
based on that data.
B. What was the basis for the
administrative stay?
After the final rule was issued adding
hydrogen sulfide to the EPCRA section
313 list of toxic chemicals, some
members of the regulated community
expressed a concern that the ‘‘chronic
human health effects’’ basis for listing
hydrogen sulfide under EPCRA section
313(d)(2)(B) had changed between the
proposed rule (September 8, 1992, 57
FR 41020) and the final rule (December
1, 1993, 58 FR 63500), and that
commenters on the proposed rule
therefore did not have an opportunity to
comment on that individual basis for
the listing. Specifically, although the
Agency cited the same acute aquatic
toxicity as an ‘‘environmental effects’’
basis for the listing under EPCRA
section 313(d)(2)(C) in both the
proposed and final rules, the Agency
also cited chronic respiratory effects as
a ‘‘chronic human health effects’’ basis
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under EPCRA section 313(d)(2)(B) in the
proposed rule, but chronic neurotoxic
effects as a ‘‘chronic human health
effects’’ basis under that same provision
in the final rule. In addition, after
issuance of the final rule, some
members of the regulated community
expressed concern that EPA’s decision
not to include an exposure analysis in
deciding to list hydrogen sulfide on the
basis of chronic human health effects
was inconsistent with past Agency
practice.
Although EPA did not agree that it
had been inconsistent in its use of
exposure analyses, and notwithstanding
the fact that the listing decision was
appropriate based on the acute aquatic
toxicity finding alone under EPCRA
section 313(d)(2)(C), the Agency issued
an Administrative Stay of the reporting
requirements for hydrogen sulfide in
order to review the concerns raised after
issuance of the final rule by some
members of the regulated community.
C. What is EPA’s rationale for lifting the
administrative stay for hydrogen
sulfide?
EPA’s technical evaluation of
hydrogen sulfide, as discussed in detail
in the February 26, 2010 Federal
Register document (75 FR 8889), shows
that it can reasonably be anticipated to
cause chronic health effects in humans.
The chronic health effects have been
observed in laboratory animals at
concentrations as low as 28 milligrams
per cubic meter (mg/m3) (20 parts per
million (ppm)) for neurotoxicity and
41.7 mg/m3 (30 ppm) for upper
respiratory toxicity. In addition, EPA’s
technical evaluation of hydrogen sulfide
also shows that it can reasonably be
anticipated to cause, because of its
toxicity, significant adverse effects in
aquatic organisms. Examples of
hydrogen sulfide’s ecological toxicity
include acute toxicity (96-hour LC50
(i.e., the concentration that is lethal to
50% of test organisms)) values for
freshwater fish that ranged from 0.0149
milligrams per liter (mg/L) (fathead
minnow) to 0.0448 mg/L (bluegill),
indicating high aquatic toxicity.
Examples of hydrogen sulfide’s chronic
ecological toxicity include freshwater
fish values that ranged from a 6-week
lowest-observed-effect-concentration
(LOEC) (growth rate) of 0.0005 mg/L in
a tropical fish (Mystus nemurus) to a
430-day LOEC (final weight) of 0.009
mg/L for goldfish, also indicating high
aquatic toxicity.
Based on the above findings, EPA
believes that there is no basis for
continuing the Administrative Stay of
the reporting requirements for hydrogen
sulfide, and that the Administrative
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Stay should therefore be lifted. As an
aside, EPA notes also that it believes
that the above findings clearly
demonstrate the correctness of the
Agency’s final decision in December
1993 to list hydrogen sulfide on the
EPCRA section 313 toxic chemicals list
based on the listing criteria in EPCRA
sections 313(d)(2)(B) and (C).
Finally, in accordance with EPA’s
stated policy on the use of exposure
assessments (59 FR 61432), EPA does
not believe that an exposure assessment
is appropriate for determining whether
hydrogen sulfide meets the criteria of
EPCRA section 313(d)(2)(B) or (C), and
therefore the Administrative Stay
should not be continued for lack of an
exposure analysis. As EPA explained in
the Intent to Lift the Stay (and as
explained in Unit IV.A.1.c. of this
Notice):
sulfide in amounts above reporting
threshold levels must now comply with
the reporting requirements that have
been in place since hydrogen sulfide
was added to the EPCRA section 313 list
in 1993. The first reports on hydrogen
sulfide will be due on July 1, 2013 for
reporting year 2012.
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EPA has determined that hydrogen sulfide
can reasonably be anticipated to cause
serious or irreversible chronic human health
effects at relatively low doses and thus is
considered to have moderately high to high
chronic toxicity. EPA does not believe that it
is appropriate to consider exposure for
chemicals that are moderately high to highly
toxic based on a hazard assessment when
determining if a chemical can be listed for
chronic effects pursuant to EPCRA section
313(d)(2)(B) (see 59 FR 61432, 61433, 61440–
61442). Hydrogen sulfide has also been
determined to cause ecotoxicity at relatively
low concentrations, and thus is considered to
have high ecotoxicity. EPA believes that
chemicals that induce death or serious
adverse effects in aquatic organisms at
relatively low concentrations (i.e., they have
high ecotoxicity) have the potential to cause
significant changes in the population of fish
and other aquatic organisms, and can
therefore reasonably be anticipated to cause
a significant adverse effect on the
environment of sufficient seriousness to
warrant reporting. EPA does not believe that
it is required to consider exposure for
chemicals that have high ecotoxicity based
on a hazard assessment when determining if
a chemical can be listed for effects pursuant
to EPCRA section 313(d)(2)(C) (see 59 FR
61432, 61433, 61440–61442). (75 FR 8889,
8893 (Feb. 26, 2010)).
IV. What comments did EPA receive on
the intent to consider lifting the
administrative stay and what are EPA’s
responses to those comments?
EPA received fifteen comments on the
Federal Register document ‘‘Intent to
Consider Lifting Administrative Stay;
Opportunity for Public Comment’’ (75
FR 8889). The comments represented 6
individuals, 32 environmental groups,
one state agency, and 10 industry
groups. Environmental groups that
commented included the Food & Water
Watch, National Association of Clean
Water Agencies, Natural Resources
Defense Council, Waterkeeper Alliance
and one comment submitted by 28 other
environmental organizations. The
comments from the individuals,
environmental groups, and state agency
were supportive of EPA’s intent to lift
the Administrative Stay. Many of these
groups provided additional information
to support EPA’s action as well as
requesting other actions such as listing
additional industry sectors that have
significant releases of hydrogen sulfide.
The most extensive comments came
from the Hydrogen Sulfide Consortium,
whose members are: American Coke and
Coal Chemicals Institute, American
Forest and Paper Association, American
Petroleum Institute, Asphalt Institute,
Carbon Disulfide Coalition, Corn
Refiners Association, National
Petrochemical and Refiners Association,
and The Sulphur Institute. The most
significant opposing comments are
summarized and responded to below.
The complete set of comments and
EPA’s responses can be found in the
response to comment document in the
docket for this action (Ref. 1).
D. What is the purpose of this
document?
The purpose of this document is to
respond to the public comments
received on EPA’s February 26, 2010,
Federal Register document ‘‘Intent to
Consider Lifting Administrative Stay;
Opportunity for Public Comment’’ (75
FR 8889), and to give notice that EPA
is lifting the Administrative Stay of the
EPCRA section 313 toxic chemical
release reporting requirements for
hydrogen sulfide. With the lifting of this
stay, pursuant to Section 313 of EPCRA,
certain facilities that manufacture,
process, or otherwise use hydrogen
A. Comments From the Hydrogen
Sulfide Consortium
1. Scope of Comments. Commenters
claim that ‘‘EPA cannot properly limit
comments to whether or not EPA should
lift its Administrative Stay of EPCRA
section 313 reporting requirements,’’ but
rather must revisit the original listing
decision accomplished by final rule in
1993. In support of this argument,
commenters assert that: (1) EPA stated,
when it issued the Administrative Stay
in 1994, that it would revisit the original
listing decision; (2) EPA cited chronic
respiratory effects as one of the bases for
listing under EPCRA section
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313(d)(2)(B) in the proposed rule, but
chronic neurotoxic effects as a basis
under that same provision in the final
rule; (3) EPA adopted its current policy
regarding exposure analyses subsequent
to the 1993 listing of hydrogen sulfide;
and (4) EPA ‘‘must make a new listing
determination before it may lift [the
stay].’’
For the reasons stated below, EPA
disagrees with commenters that EPA
must revisit the original listing decision
in the context of EPA’s consideration of
lifting the Administrative Stay of the
EPCRA reporting requirements for
hydrogen sulfide. Based upon our
current review of the science, as
presented in EPA’s technical evaluation
of hydrogen sulfide, which is discussed
in detail in the February 26, 2010
Federal Register document (75 FR 8889)
and summarized in Unit III.C. of this
document, EPA has determined that
there is no need to re-visit the existing
listing determination. Before addressing
each of the commenter’s arguments in
turn, however, a brief reiteration of the
factual background is useful.
As described in detail below, EPCRA
section 313(d)(2) states that EPA may
add a chemical to the list if ‘‘there is
sufficient evidence to establish any one’’
(emphasis added) of the listing criteria
specified in section 313(d)(2). Therefore,
to add a chemical, EPA must
demonstrate that at least one criterion is
met, but need not determine whether
any other criterion is met.
EPA proposed to add hydrogen
sulfide to the EPCRA section 313 list of
toxic chemicals on September 8, 1992
(57 FR 41020) based on a determination
that there was sufficient evidence
establishing both chronic human health
effects per EPCRA section 313(d)(2)(B)
(specifically, chronic respiratory effects)
and environmental effects per EPCRA
section 313(d)(2)(C) (specifically, acute
aquatic toxicity). On December 1, 1993,
EPA promulgated a final rule adding
hydrogen sulfide to the EPCRA section
313 list of toxic chemicals (58 FR 63500)
(effective January 1, 1994). In the final
rule, the listing decision was based on
a determination that there was sufficient
evidence establishing environmental
effects per EPCRA section 313(d)(2)(C)
(specifically, the same acute aquatic
toxicity as identified in the proposed
rule) and chronic human health effects
per EPCRA section 313(d)(2)(B). In the
final rule, however, the chronic human
health effects finding was based on
chronic neurotoxic effects, instead of
chronic respiratory effects as stated in
the proposed rule.
After the final rule was issued adding
hydrogen sulfide to the EPCRA section
313 list, and notwithstanding the fact
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that the Agency cited the same acute
aquatic toxicity as an ‘‘environmental
effects’’ basis for the listing under
EPCRA section 313(d)(2)(C) in both the
proposed rule and the final rule, some
members of the regulated community
expressed a concern that the Agency
cited chronic respiratory effects as a
‘‘chronic human health effects’’ basis
under EPCRA section 313(d)(2)(B) in the
proposed rule, but chronic neurotoxic
effects as a ‘‘chronic human health
effects’’ basis under that same provision
in the final rule. In addition, after
issuance of the final rule, some
members of the regulated community
expressed concern that EPA’s decision
not to include an exposure analysis in
deciding to list hydrogen sulfide on the
basis of chronic human health effects
was inconsistent with past Agency
practice. As a result of these concerns,
some commenters threatened to bring
legal action challenging the final rule.
In response to the post-promulgation
comments and concerns raised by some
in the regulated community, and
notwithstanding the fact that the listing
decision was appropriate based on the
acute aquatic toxicity finding alone
under EPCRA section 313(d)(2)(C), EPA
issued an Administrative Stay of the
EPCRA section 313 reporting
requirements for hydrogen sulfide on
August 22, 1994 (59 FR 43048) in order
to review those post-promulgation
comments and concerns.
The stay issued on August 22, 1994
made clear that: ‘‘The effect of this stay
is to defer reporting on [hydrogen
sulfide] while the Agency reviews new
data and information made available
subsequent to the promulgation of the
final rule’’ (59 FR 43048 (Aug. 22, 1994)
(emphasis added)). As a result, while
the subsequent stay deferred reporting
requirements, the stay did not remove
hydrogen sulfide from the EPCRA
section 313 list or alter that final listing
determination, which remained in effect
as of January 1, 1994. The listing
determination was never
administratively or judicially
challenged.
On February 26, 2010, EPA issued a
notice announcing its ‘‘Intent to
Consider Lifting [the hydrogen sulfide]
Administrative Stay; Opportunity for
Public Comment.’’ 75 FR 8889
(hereinafter Intent to Lift the Stay). That
document stated: ‘‘The purpose of this
document is to provide the public with
the opportunity to comment on EPA’s
review of the currently available data on
the human health and environmental
effects of hydrogen sulfide * * * and
EPA’s belief that the Administrative
Stay should be lifted based on that
data* * *. In addition, this document
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addresses the concerns raised regarding
use of exposure analyses.’’ Id. at 8891.
The Intent to Lift the Stay notice clearly
explained: ‘‘By this current action, EPA
is not revisiting the original listing
decision, which was accomplished by
final rule on December 1, 1993. Rather,
EPA is merely presenting its rationale
for why the Administrative Stay of the
reporting requirements for hydrogen
sulfide should be lifted.’’ Id. at 8889
(emphasis added).
a. EPA Statements when Issuing the
Stay. Commenters first argue that EPA
cannot now limit comment to whether
or not to lift the stay because the Agency
stated, when it issued the
Administrative Stay in 1994, that it
intended, at some point in the future, to
‘‘seek comment on the Agency’s initial
determination for [hydrogen sulfide].’’
59 FR at 43049. Specifically, the
Administrative Stay stated:
[T]he Agency will be issuing a forthcoming
Federal Register notice which will seek
comment on the Agency’s initial
determination for [hydrogen sulfide], * * *
procedural issues concerning the initial final
rule, and generally, comments (and any
supporting data) on whether the Agency
should either propose to delete [hydrogen
sulfide] or affirm its initial determination and
dissolve today’s Administrative Stay. (59 FR
at 43049).
Hydrogen sulfide was listed under
section 313 of EPCRA by final rule on
December 1, 1993. The stay did not
remove hydrogen sulfide from the
EPCRA section 313 list or alter that final
listing determination. The 1993 listing
decision was appropriate based on the
acute aquatic toxicity finding alone
under EPCRA section 313(d)(2)(C),
which was included in both the
proposed and final rules and never
questioned. Therefore, EPA does not
believe it is necessary or appropriate to
revisit the 1993 final listing of hydrogen
sulfide in order to lift the stay of
reporting requirements.
Further, the Agency believes that its
action in taking comment on its intent
to lift the stay is substantially in accord
with the course of action it described in
issuing the stay in 1994. In the Intent to
Lift the Stay notice, the Agency
discussed and invited comment on the
data underlying its consideration of the
matter and EPA’s application of its
policy regarding exposure assessment to
the listing decision. As described in the
Intent to Lift the Stay notice, EPA’s
planned course of action arises out of
EPA’s review of the currently available
data, which clearly demonstrate both
chronic health effects in humans (upper
respiratory tract toxicity and
neurotoxicity) and significant adverse
effects in aquatic organisms (acute,
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chronic, and early life stage). Further,
EPA’s consideration of these effects is
fully consistent with its policy on
exposure assessment. Based on these
findings, EPA believes that there is no
basis for continuing the Administrative
Stay of the reporting requirements for
hydrogen sulfide, and that the
Administrative Stay should therefore be
lifted.
Moreover, these findings also
demonstrate that there is no basis to
consider delisting hydrogen sulfide.
EPCRA section 313(d)(3) states that to
remove a chemical from the list, EPA
must determine that ‘‘there is not
sufficient evidence to establish any’’ of
the Section 313(d)(2) criteria (emphasis
added). Therefore, to remove a
chemical, EPA must demonstrate that
none of the criteria are met. As EPA’s
review of the currently available data in
the context of its consideration of lifting
the Administrative Stay demonstrates,
EPA cannot show that none of the
criteria are met. Indeed, the Agency
believes that the only course available is
to dissolve the stay, which it is doing
through notice-and-comment, and
which is substantially in accord with at
least one of the alternative courses
anticipated in 1994.
Finally, to the extent that the
commenters are suggesting that EPA is
legally prohibited from now limiting
comment to the issue of whether or not
to lift the Administrative Stay based on
the statements in the preamble the
Agency made (excerpted above) when
issuing the Administrative Stay, EPA
respectfully notes that these preamble
statements do not create such a legal
obligation. See, e.g., Natural Resources
Defense Council v. EPA, 559 F.3d 561,
564–65 (D.C. Cir. 2009).
b. Proposed and Final Chronic
Human Health Effects. Second,
commenters argue that EPA cannot now
limit comment to whether or not to lift
the stay because EPA cited chronic
respiratory effects as one of the bases for
listing under EPCRA section
313(d)(2)(B) in the proposed rule, but
chronic neurotoxic effects as a basis
under that same provision in the final
rule.
EPCRA section 313(d) authorizes EPA
to add or delete chemicals from the list
and sets forth criteria for these actions.
The EPCRA section 313(d)(2) criteria
are:
(A) The chemical is known to cause or can
reasonably be anticipated to cause significant
adverse acute human health effects at
concentration levels that are reasonably
likely to exist beyond facility site boundaries
as a result of continuous, or frequently
recurring, releases.
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(B) The chemical is known to cause or can
reasonably be anticipated to cause in
humans—
(i) Cancer or teratogenic effects, or
(ii) Serious or irreversible—
(I) Reproductive dysfunctions,
(II) Neurological disorders,
(III) Heritable genetic mutations, or
(IV) Other chronic health effects.
(C) The chemical is known to cause or can
be reasonably anticipated to cause, because
of
(i) Its toxicity,
(ii) Its toxicity and persistence in the
environment, or
(iii) Its toxicity and tendency to
bioaccumulate in the environment,
a significant adverse effect on the
environment of sufficient seriousness, in the
judgment of the Administrator, to warrant
reporting under this section.
EPA often refers to the section
313(d)(2)(A) criterion as the ‘‘acute
human health effects criterion;’’ the
section 313(d)(2)(B) criterion as the
‘‘chronic human health effects
criterion;’’ and the section 313(d)(2)(C)
criterion as the ‘‘environmental effects
criterion.’’
While it is true that the Agency cited
chronic respiratory effects as a ‘‘chronic
human health effects’’ basis under
EPCRA section 313(d)(2)(B) in the
proposed rule, but chronic neurotoxic
effects as a ‘‘chronic human health
effects’’ basis under that same provision
in the final rule, it bears emphasizing
once again that the Agency also
separately cited the same acute aquatic
toxicity as an ‘‘environmental effects’’
basis for the listing under EPCRA
section 313(d)(2)(C) in both the
proposed and final rules. As a result,
and in light of the fact that EPCRA
section 313(d)(2) expressly allows EPA
to add a chemical to the list if ‘‘there is
sufficient evidence to establish any one’’
of the listing criteria (emphasis added),
the 1993 listing decision was
appropriate based on the acute aquatic
toxicity finding alone under EPCRA
section 313(d)(2)(C). That basis for the
listing was never questioned and was
and continues to be supported by the
data relied upon by EPA in determining
that the stay should be lifted. Any
procedural error that may have occurred
regarding the section 313(d)(2)(B)
‘‘chronic human health effects’’ finding
was harmless in light of the
unchallenged section 313(d)(2)(C)
‘‘environmental effects’’ finding
presented in both the proposed and
final rules. This analysis also played
directly into EPA’s decision to proceed
in the manner it has, as opposed to
rigidly following its stated intentions in
1994.
EPA is currently lifting the stay of
hydrogen sulfide reporting
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requirements—a substance that has been
and remains listed under EPCRA since
promulgation of the final rule on
December 1, 1993—based on EPA’s
review of the currently available data,
which clearly demonstrate both chronic
health effects in humans (upper
respiratory tract toxicity and
neurotoxicity) and significant adverse
effects in aquatic organisms (acute,
chronic, and early life stage). EPA is not
revisiting the original listing
determination, and comments on the
original listing decision are beyond the
scope of this action.
c. EPA’s Exposure Analysis Policy.
Third, commenters argue that EPA
cannot now limit comment to whether
or not to lift the stay because EPA
adopted its current policy regarding
exposure analysis subsequent to the
1993 listing of hydrogen sulfide.
EPA did not ‘‘adopt a new policy’’ on
its use of exposure analysis for listing
chemicals under EPCRA section 313
subsequent to the listing of hydrogen
sulfide in 1993. Instead, the Agency’s
then-existing position on the use of
exposure analyses in listing decisions
under EPCRA section 313 was presented
in a proposed rule in the Federal
Register of January 12, 1994 (59 FR
1788). That proposed rule provided the
public with the opportunity to comment
on the Agency’s then-existing
interpretation of the statutory listing
criteria as it relates to the use of
exposure considerations. After
considering the comments received,
EPA published in the Federal Register
of November 30, 1994 (59 FR 61432) a
‘‘chemical expansion’’ final rule,
including a statement clarifying its
interpretation of the statutory
requirements regarding how exposure is
considered in listing decisions.
Subsequent to that final rule, EPA’s
interpretation of the statutory listing
criteria as it relates to the consideration
of exposure was upheld in National
Oilseed Processors Ass’n. v. Browner,
924 F. Supp. 1193 (D.D.C. 1996), aff’d in
part & remanded in part, Troy Corp. v.
Browner, 120 F.3d 277 (D.C. Cir. 1997).
As stated in the chemical expansion
final rule:
Through this rulemaking, EPA is clarifying
its position regarding the use of hazard,
exposure, and risk in listing decisions under
EPCRA section 313. EPA will consider
exposure factors when making
determinations under section 313(d)(2)(A)
(acute human toxicity). In addition, EPA has
discretion to consider exposure factors where
appropriate for determinations under
sections 313(d)(2)(B) (chronic human
toxicity) and (C) (environmental toxicity),
and that there is a broader range of
circumstances in which exposure will be
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64027
considered under section 313(d)(2)(C) than
under (B).
EPA has reviewed its past listing decisions
in light of this clarification, and believes that
its prior listing determinations have been
consistent in the consideration of exposure in
31 of the 32 listing/delisting determinations
previous to this action* * *(59 FR 61442
(Nov. 30, 1994) (emphasis added)).
In Troy Corp. v. Browner, the DC
Circuit agreed with EPA, finding:
Were the EPA to abandon a long-held
exposure policy and take a new direction we
would, as urged, require a thorough
explanation of its reasons for doing so. Yet,
the EPA’s pronouncement in its preamble of
its exposure policy is not a change in course.
With one exception, the EPA has consistently
stated, as it does in this rulemaking, that it
will consider exposure under subsection (B)
only when the chemical was of ‘‘low to
moderately low’’ toxicity. * * * [T]he agency
has long maintained that it would consider
exposure under subheading (B) only for low
toxicity chemicals. The inorganic fluorides
petition was denied over ten years ago. Since
that time, the agency has made several dozen
listing and delisting decisions under EPCRA.
The inorganic fluorides case was the only
instance in which the agency articulated a
policy contrary to the one explicated in this
rulemaking. Under these circumstances we
cannot say that the agency has departed from
prior practice in a way that requires more
explanation than was provided. (Troy Corp.
v. Browner, 120 F.3d at 287 (emphasis added)
(citation omitted)).
Thus, EPA did not subsequently
adopt a new exposure policy as
Commenters suggest. Rather, the Agency
simply clarified the existing exposure
policy. Further, the 31 of 32 previous
cases, noted by the court in Troy Corp.,
in which the Agency had been
consistent with this exposure policy
included the listing of hydrogen sulfide.
Therefore, EPA had applied this same
exposure policy to the listing of
hydrogen sulfide, and need not, as
Commenters suggest, provide a new
notice and opportunity to comment on
the use of exposure analyses in listing
hydrogen sulfide under section 313 of
EPCRA.
As EPA explained in the Intent to Lift
the Stay:
EPA has determined that hydrogen sulfide
can reasonably be anticipated to cause
serious or irreversible chronic human health
effects at relatively low doses and thus is
considered to have moderately high to high
chronic toxicity. EPA does not believe that it
is appropriate to consider exposure for
chemicals that are moderately high to highly
toxic based on a hazard assessment when
determining if a chemical can be listed for
chronic effects pursuant to EPCRA section
313(d)(2)(B) (see 59 FR 61432, 61433, 61440–
61442). Hydrogen sulfide has also been
determined to cause ecotoxicity at relatively
low concentrations, and thus is considered to
have high ecotoxicity. EPA believes that
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chemicals that induce death or serious
adverse effects in aquatic organisms at
relatively low concentrations (i.e., they have
high ecotoxicity) have the potential to cause
significant changes in the population of fish
and other aquatic organisms, and can
therefore reasonably be anticipated to cause
a significant adverse effect on the
environment of sufficient seriousness to
warrant reporting. EPA does not believe that
it is required to consider exposure for
chemicals that have high ecotoxicity based
on a hazard assessment when determining if
a chemical can be listed for effects pursuant
to EPCRA section 313(d)(2)(C) (see 59 FR
61432, 61433, 61440–61442). (75 FR 8889,
8893 (Feb. 26, 2010)).
d. EPA Must Make a New Listing
Determination. Finally, Commenters
argue that EPA cannot now limit
comment to whether or not to lift the
stay because EPA ‘‘must make a new
listing determination before it may lift
[the stay].’’
This argument merely restates
Commenters’ first three arguments in
support of Commenters’ ultimate
position that EPA must revisit the 1993
listing decision. For the reasons already
discussed above, the Agency disagrees
with Commenters’ arguments.
2. Implementation of EPA’s Exposure
Policy. Commenters state that EPA may
not implement its policy on the use of
exposure analysis in EPCRA section 313
listing decisions in an arbitrary manner.
Commenters claim that EPA has not
identified the specific criteria it utilizes
in determining whether a substance
causes chronic human health effects at
relatively low doses or ecotoxicity at
relatively low concentrations.
Commenters noted that EPA stated in its
intent to lift the Administrative Stay
that it is applying the interpretation of
the statutory listing criteria and the
policy on the use of exposure analyses
adopted by the EPA in its November 30,
1994, final rule listing other substances.
Commenters cited EPA’s statements
from the rule that exposure
considerations are appropriate in
making listing determinations under
EPCRA section 313(d)(2)(B) for
chemicals with low to moderately low
toxicity based on hazard assessment and
under EPCRA section 313(d)(2)(C) for
chemicals that are low or moderately
ecotoxic. Commenters claim that they
were unable to identify or locate in the
docket for this action any objective
criteria that EPA uses in making a
determination of whether a substance
may cause ‘‘serious or irreversible
chronic health effects’’ or has ‘‘low to
moderately low toxicity.’’ Commenters
state that they were unable to find any
explanation of the criteria that EPA uses
in deciding whether a substance has
‘‘low to moderately low ecotoxicity.’’
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Commenters noted that EPA stated that
its interpretation of the statutory listing
criteria that supports the 1994 policy
statement was sustained during
subsequent judicial review.
Commenters state that even if EPA
has discretion to select a policy
concerning the circumstances in which
exposure analysis will be part of the
EPCRA section 313(d)(2) listing
decision, it does not mean the EPA has
unfettered discretion to apply that
policy in an arbitrary manner.
Commenters state that if EPA is to have
a rational policy that can be applied in
a fair and equitable manner, the
scientists conducting a hazard
assessment under EPCRA section
313(d)(2) should not be permitted to
make qualitative judgments concerning
potential toxicity in the absence of
objective criteria or guidance
concerning what these terms mean.
However, as discussed below, this is
precisely the question at issue in
National Oilseed Processors Ass’n. v.
Browner, 924 F. Supp. 1193 (D.D.C.
1996), aff’d in part & remanded in part,
Troy Corp. v. Browner, 120 F.3d 277
(D.C. Cir. 1997), where those Courts
held that EPA’s exposure analysis
policy, including the determination of
when a toxic chemical has ‘‘moderately
high to high toxicity’’ based on adverse
effects at ‘‘low’’ or ‘‘moderate’’ dose
levels and thus does not require an
exposure analysis in order to be listed,
was not arbitrary or capricious.
EPA has identified the criteria that it
uses in making a determination of
whether a substance that may cause
‘‘serious or irreversible chronic health
effects’’ has ‘‘low to moderately low
toxicity,’’ and has not applied its policy
on the use of exposure analysis in
EPCRA section 313 listing
determinations in an arbitrary manner.
To the contrary, in the preamble to the
1994 chemical expansion final rule,
EPA explained that two types of
chemicals are considered to exhibit
moderately high to high toxicity:
• Where a review of the scientific
data provides a high level of confidence
that the chemical causes an adverse
effect at relatively low dose levels, and
• Where a review of the scientific
data indicates that the chemical will
cause various adverse effects at
moderate dose levels.
(59 FR 61432, 61433 (Nov. 30, 1994).
Thus, EPA has in fact articulated
criteria for its determination whether or
not exposure considerations will be
taken into account in its chemical
listing decisions.
More specifically, EPA has provided
guidance concerning how it evaluates
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chemicals to determine whether they
meet the EPCRA section 313 listing
criteria, including information on the
factors EPA considers in determining
whether a chemical is sufficiently toxic
that exposure need not be considered in
the listing decision. The specific criteria
EPA uses to determine whether a
chemical has moderately high or high
toxicity, and thus does not have low to
moderately low toxicity, were explained
in detail in the 1994 chemical
expansion rule:
3. Hazard evaluation. After completing the
screening phase, EPA conducted a thorough
hazard assessment for each of the addition
candidates that resulted from the above
analyses and determined based on the
weight-of-the evidence if there was sufficient
evidence to establish that the candidate
chemical met the statutory criteria for
addition to EPCRA section 313. To make this
determination, EPA senior scientists
reviewed readily available toxicity
information on each chemical for each of the
following effect areas: acute human health
effects; cancer; other chronic human effects;
and environmental effects. In addition, EPA
reviewed, where appropriate, information on
the environmental fate of the chemical.
The hazard assessment was conducted in
accordance with relevant EPA guidelines for
each adverse human health or environmental
effect (e.g., the appropriate guidelines for
hazard evaluation of chemical carcinogens
and for the type of evidence required to
substantiate a determination of
carcinogenicity are the Assessment
Guidelines for Carcinogen Risk (Ref. 4)).
During this assessment the number, severity,
and significance of the effects induced by the
chemical, the dose level causing the effect,
and the quality and quantity of the available
data, including the nature of the data (e.g.,
human epidemiological, laboratory animal,
field or workplace studies) and confidence
level in the existing data base, were all
considered. Where a careful review of the
scientific data for a particular chemical
results in a high level of confidence that the
chemical causes an adverse effect at
relatively low dose levels, EPA believes that
this evidence is sufficient for listing the
chemical under section 313. EPA also
believes that where a review of the scientific
data indicates that the chemical will cause
various adverse effects at moderate dose
levels, the total weight-of-the-evidence
indicates that there is sufficient evidence for
listing the chemical under EPCRA section
313. EPA believes that both types of
chemicals described above exhibit
moderately high to high toxicity based on a
hazard assessment.
EPA also conducted an analysis of
exposure for each chemical or chemical
category proposed for listing under EPCRA
section 313(d)(2)(A) (i.e., based on adverse
acute human health effects), and, where
appropriate, under section 313(d)(2)(C) (i.e.,
based on adverse ecological effects). For
chemicals listed under EPCRA section
313(d)(2)(A), this analysis included estimated
concentrations of the chemical at or beyond
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the facility site boundary through the use of
estimated releases and modeling techniques.
EPA did not conduct an analysis of exposure
for the chemicals proposed for listing under
section 313(d)(2)(B) because these chemicals
exhibit moderately high to high toxicity
based on a hazard assessment (see Unit IV.B.
for a discussion of the use of exposure). As
discussed more thoroughly in Unit IV.B. of
this preamble, EPA does not believe that it
is appropriate to factor exposure into the
listing decisions for the chemicals being
listed pursuant to section 313(d)(2)(B) in this
rulemaking.
Following a review and analysis of the
information available about each chemical in
this final rule (including information
provided through public comment) by senior
Agency scientists, the Agency concludes that
for each of the chemicals listed one or more
of the EPCRA section 313 listing criteria are
met. Moreover, the adverse effects associated
with each of the chemicals being listed today
are serious and significant. In some cases the
effects are extreme, such as cancer or death.
In others, the effects are serious and lasting,
including, for example, impairment of a
fetus’ or an offspring’s physical development,
neurological effects inhibiting motor abilities
or mental processes or impairing the ability
to reproduce, or the sustainability of a fragile
ecosystem such as an estuary. For a number
of chemicals in the final rule, there is more
than one adverse effect.
It is important to understand that although
an adverse effect is known or can be
reasonably anticipated to be caused by a
chemical on the section 313 list, a release of
a chemical into a community does not
necessarily mean that the effect will occur.
Exposure and dose are also important factors
in determining whether an adverse effect
occurs and how serious the manifestation
will be. The listing of a chemical on the
section 313 list does not mean that a
particular community will experience these
adverse effects. Instead the purpose for
listing a chemical is to ensure that the public
gets information about releases of such
chemicals. Thus, EPA believes that for
chemicals that typically do not affect solely
one or two species but rather affect changes
across a whole ecosystem and for which
there is well-documented evidence
supporting the adverse effects, that their
addition to the EPCRA section 313 list is
warranted even though the severity of the
adverse effects that they induce will be
dependent upon site-specific characteristics.
Once EPA makes release data available
through TRI, the community may then make
its own determination on the importance of
these releases (and their potential adverse
effects). (59 FR at 61433, 11/30/1994
(emphasis added)).
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EPA went on to state in the chemical
expansion rule that:
Through this rulemaking, EPA is clarifying
its position regarding the use of hazard,
exposure, and risk in listing decisions under
EPCRA section 313. EPA will consider
exposure factors when making
determinations under section 313(d)(2)(A)
(acute human toxicity). In addition, EPA has
discretion to consider exposure factors where
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appropriate for determinations under
sections 313(d)(2)(B) (chronic human
toxicity) and (C) (environmental toxicity),
and that there is a broader range of
circumstances in which exposure will be
considered under section 313(d)(2)(C) than
under (B).
EPA has reviewed its past listing decisions
in light of this clarification, and believes that
its prior listing determinations have been
consistent in the consideration of exposure in
31 of the 32 listing/delisting determinations
previous to this action, including a number
of deletions of low toxicity chemicals that
Congress placed on the initial EPCRA section
313 list. EPA is currently reviewing the one
exception, inorganic fluorides, to determine
if additional action is warranted. EPA will
continue to evaluate petitions according to
this clarification and will delete chemicals
that do not meet the statutory criteria. (59 FR
at 61442, 11/30/1994).
EPA’s exposure analysis policy, as set
forth in the chemical expansion Final
Rule, was judicially challenged in
National Oilseed Producers Ass’n v.
Browner, 924 F. Supp. 1193 (D.D.C.
1996). There, the plaintiffs presented
precisely the same argument that the
Hydrogen Sulfide Consortium now
raises. In National Oilseed, the court
stated that ‘‘Plaintiffs * * * claim that
EPA has not adequately explained when
it will consider exposure under Section
313(d)(2)(B).’’ National Oilseed, 924 F.
Supp. at 1203. The court squarely
rejected that argument, holding:
The Agency argues generally that, in the
exercise of its discretion, it has elected to
consider exposure only in limited
circumstances. Specifically, when EPA’s
hazard assessment shows that a chemical
exhibits only low or moderately low toxicity,
EPA will consider the potential for exposure
in making a listing decision. Conversely,
where EPA’s hazard assessment reveals that
a chemical’s toxicity is high or moderately
high, EPA does not consider exposure, and
will list the chemical based solely on its toxic
effect.
*
*
*
*
*
Moreover, EPA asserts that it explained
adequately on the record that it chose to not
consider exposure in this rulemaking because
all of the chemicals proposed for listing
under Section 313(d)(2)(B) were of ‘‘high to
moderately-high’’ toxicity and therefore
consideration of exposure was not
appropriate.
After consideration of the extensive
arguments on both sides of this issue, the
Court concludes that the Agency did not act
arbitrarily and capriciously in declining to
consider exposure in the listing decisions for
this rulemaking. * * * While a more clearly
and fully articulated policy would be
preferable, the Court cannot conclude that
EPA was unreasonable in exercising its
discretion by continuing to exclude
consideration of exposure when chemicals
are of high to moderately-high toxicity.
*
*
*
*
*
What is significant is that EPA stated what
its policy for consideration of exposure
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64029
would be, and then described its application
to the chemicals considered in this
rulemaking.
Because EPA’s decision to not consider
exposure in this rulemaking was consistent
with its policy of using exposure data only
in particular circumstances, i.e., where
chemicals are of low toxicity, the Court
concludes that the Agency was not arbitrary
and capricious.
National Oilseed, 924 F. Supp. at
1203–04 (citations and footnotes
omitted).
On appeal to the U.S. Court of
Appeals for the D.C. Circuit, the
plaintiffs again raised this same
argument. There, the court stated:
‘‘* * * [Plaintiffs] argue that the EPA
abused its discretion and acted
arbitrarily and capriciously by failing to
establish criteria for the consideration of
exposure * * *.’’ Troy Corp. v.
Browner, 120 F.3d 277, 282 (D.C. Cir.
1997). On this point, the D.C. Circuit
rejected the plaintiffs’ argument and
affirmed the judgment of the D.C.
District Court in National Oilseed. Troy
Corp., 120 F.3d at 293.
Just as EPA did in the 1994 chemical
expansion rule and other previous
listing decisions, upheld by the Courts
in National Oilseed and Troy Corp.—
including application of the Agency’s
exposure analysis policy in conducting
such hazard assessments—EPA
conducted a hazard assessment of the
human health and ecological effects of
hydrogen sulfide, upon which the
determinations that hydrogen sulfide
has moderately high to high human
toxicity were based. Based on the data
from the hazard assessment, as
presented in the Federal Register notice
and supporting documents, EPA
determined that hydrogen sulfide has
moderately high to high toxicity to
humans and is highly toxic to aquatic
organisms. EPA discussed these
determinations in detail in the notice of
Intent to Lift the Stay in the Federal
Register (75 FR 8889, 2/26/2010).
Human health toxicity was discussed in
detail beginning on page 8891, with
references, and ecological effects were
discussed in detail beginning on page
8893, with references.
In the section of the Federal Register
document that discussed the rationale
for lifting the stay, EPA provided the
following summary of the hazard data:
EPA’s technical evaluation of hydrogen
sulfide shows that it can reasonably be
anticipated to cause chronic health effects in
humans. The chronic health effects have
been observed in laboratory animals at
concentrations as low as 28 mg/m3 (20 ppm)
and 41.7 mg/m3 (30 ppm). In addition, EPA’s
technical evaluation of hydrogen sulfide also
shows that it can reasonably be anticipated
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to cause, because of its toxicity, significant
adverse effects in aquatic organisms.
Examples of hydrogen sulfide’s ecological
toxicity include acute toxicity (96-hour LC50)
values for freshwater fish that ranged from
0.0149 mg/L (fathead minnow) to 0.0448 mg/
L (bluegill), indicating high aquatic toxicity.
Examples of hydrogen sulfide’s chronic
ecological toxicity include freshwater fish
values that ranged from a 6-week LOEC
(growth rate) of 0.0005 mg/L in a tropical fish
(Mystus nemurus) to a 430-day LOEC (final
weight) of 0.009 mg/L for goldfish, also
indicating high aquatic toxicity. (75 FR 8893,
2/26/2010).
As the language above clearly shows,
EPA did identify the information and
the rationale for why hydrogen sulfide
was determined to have moderately
high to high human toxicity and high
ecotoxicity.
3. EPA’s Rationale for Hydrogen
Sulfide’s Toxicity Level. Commenters
claim that EPA has not given its
rationale for why hydrogen sulfide
causes chronic human health effects at
relatively low levels and ecotoxicity at
relatively low concentrations.
Commenters contend that EPA has not
provided any rationale for the
determinations that no exposure
assessment is needed for hydrogen
sulfide. Commenters noted that EPA
provided a description of the chronic
human health effects and ecological
toxicity of hydrogen sulfide.
Commenters also noted that EPA
asserted that it had made the requisite
determinations concerning the relative
magnitude of the toxicity of hydrogen
sulfide for both human health and
ecological effects. Commenters contend,
however, that EPA’s statements are
wholly conclusory and that the docket
does not appear to contain any
explanations of the relation between the
hazard assessments prepared by EPA
scientists and these determinations.
Commenters state that they do not
believe that the effect levels cited by
EPA will be caused by the releases
reportable under EPCRA section 313.
Commenters state that they believe that
the effect levels cited by EPA as
‘‘relatively low’’ are actually very high.
Commenters stated that the chronic
health effect levels cited by EPA are
2,000 to 3,000 times greater than the
odor detection threshold (10 parts per
billion (ppb)) for hydrogen sulfide.
Commenters claim that while releases
may result in ambient hydrogen sulfide
concentrations that exceed the odor
detection threshold, the concentrations
will always be far below the lowest
levels for chronic effects in animals
cited by EPA. Commenters cited a 1990
EPA study on oil and natural gas
extraction and a 1999 Public Health
Service study for one city near hydrogen
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sulfide sources as evidence that
hydrogen sulfide levels are low.
Commenters also cited established state
air standards that range from 83 to 200
ppb noting that these are 100 to 150
times less than the lowest levels EPA
cited for chronic effects in animals.
In discussing the data EPA cited as
supporting its evaluation that hydrogen
sulfide is toxic to aquatic organisms at
relatively low concentrations, the
commenters stated that while the levels
may seem relatively low in the abstract,
they believe they are actually quite high
when viewed in the context of data that
clearly establish that hydrogen sulfide
will rapidly oxidize to less toxic
chemical forms when released to surface
waters. Commenters cited the EPA
Water Quality Criteria Gold Book as
support for their position:
The fact that H2S is oxidized in wellaerated water by natural biological systems to
sulfates or is biologically oxidized to
elemental sulfur has caused investigators to
minimize the toxic effects of H2S on fish and
other aquatic life. (EPA Gold Book, May 1,
1986, page 268 (Ref. 2)).
As discussed in the previous
response, EPA has provided guidance
on how it determines whether a
chemical has moderately high to high
human toxicity and high ecotoxicity. In
its notice of Intent to Lift the Stay, EPA
provided a detailed hazard assessment
of both the human health effects and the
ecological effects of hydrogen sulfide.
This assessment included both the
effects caused by hydrogen sulfide and
the doses/concentrations that caused
those effects. This information was
discussed in the Federal Register (75 FR
8889, 2/26/2010), and the details were
contained in the hazard assessments
and other references cited by EPA.
Specifically, at 75 FR 8889, 8891–8893
(Feb. 26, 2010), EPA’s lengthy and
detailed technical review of hydrogen
sulfide (Part IV. of the Federal Register
notice, entitled ‘‘What is EPA’s
Technical Review of Hydrogen
Sulfide?’’), including references, can be
found (and need not be reiterated here).
EPA then concluded, based on the
hazard assessment:
EPA has determined that hydrogen sulfide
can reasonably be anticipated to cause
serious or irreversible chronic human health
effects at relatively low doses and thus is
considered to have moderately high to high
chronic toxicity * * *. Hydrogen sulfide has
also been determined to cause ecotoxicity at
relatively low concentrations, and thus is
considered to have high ecotoxicity. EPA
believes that chemicals that induce death or
serious adverse effects in aquatic organisms
at relatively low concentrations (i.e., they
have high ecotoxicity) have the potential to
cause significant changes in the population
of fish and other aquatic organisms, and can
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therefore reasonably be anticipated to cause
a significant adverse effect on the
environment of sufficient seriousness to
warrant reporting. (75 FR 8893, 2/26/2010).
In the section of the Federal Register
document that discussed the rationale
for lifting the stay, EPA provided the
following summary of the hazard data:
EPA’s technical evaluation of hydrogen
sulfide shows that it can reasonably be
anticipated to cause chronic health effects in
humans. The chronic health effects have
been observed in laboratory animals at
concentrations as low as 28 mg/m3 (20 ppm)
and 41.7 mg/m3 (30 ppm). In addition, EPA’s
technical evaluation of hydrogen sulfide also
shows that it can reasonably be anticipated
to cause, because of its toxicity, significant
adverse effects in aquatic organisms.
Examples of hydrogen sulfide’s ecological
toxicity include acute toxicity (96-hour LC50)
values for freshwater fish that ranged from
0.0149 mg/L (fathead minnow) to 0.0448 mg/
L (bluegill), indicating high aquatic toxicity.
Examples of hydrogen sulfide’s chronic
ecological toxicity include freshwater fish
values that ranged from a 6-week LOEC
(growth rate) of 0.0005 mg/L in a tropical fish
(Mystus nemurus) to a 430-day LOEC (final
weight) of 0.009 mg/L for goldfish, also
indicating high aquatic toxicity. (75 FR 8893,
2/26/2010).
The above determinations are based
on the human health effects and
ecological effects caused by hydrogen
sulfide and the doses/concentrations
that caused those effects. EPA clearly
stated why the hazard assessment
supports a finding of moderately high to
high human toxicity and high
ecotoxicity. Therefore, EPA has clearly
stated how the hazard assessment data
supports a conclusion that hydrogen
sulfide has moderately high to high
human toxicity and high ecological
toxicity.
Regarding the information that the
commenter provided on previous
exposure assessments, air standards,
etc., none of that information is relevant
to a determination that hydrogen sulfide
has moderately high to high human
toxicity or high ecological toxicity. The
toxicity of a chemical is separate from
whether there are exposures from
facility releases of that chemical or not.
In addition, the information provided by
the commenter does not demonstrate
that releases of hydrogen sulfide could
not reach a level of concern from all the
types of facilities that report under
EPCRA section 313. EPA notes that the
examples of the very low air standards
for hydrogen sulfide of 83–200 parts per
billion support EPA’s determination
that hydrogen sulfide is highly toxic.
The commenter’s statement that the
cited toxic effects of hydrogen sulfide
are 2,000 to 3,000 times greater than the
odor detection threshold for hydrogen
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sulfide of 10 ppb is not a basis for
discounting the toxic effects of
hydrogen sulfide. As EPA has stated:
Recent reviews of the health hazards
associated with H2S exposure and
subsequent treatment include Milby and
Baselt (1999a) and Guidotti (1996). Earlier
reviews of the health effects were provided
by Glass (1990), Reiffenstein et al. (1992),
and Mehlman (1994). Exposure to H2S has
been reported to be an important cause of
morbidity and mortality in the workplace
(Snyder et al., 1995) and olfactory
dysfunction (Hirsch and Zavala, 1999). These
reviews indicate that the typical ‘‘rotten-egg
odor’’ of H2S is an inadequate warning
indicator of exposure since levels in the
range of 100–200 ppm (140–280 mg/m3) can
lead to loss of smell followed by olfactory
paralysis (Reiffenstein et al., 1992) (IRIS,
2003, page 10 (Ref. 3)).
In addition, simply because someone
can smell hydrogen sulfide does not
mean they will automatically remove
themselves from that exposure.
Individuals that are frequently exposed
to hydrogen sulfide may become less
sensitive to the smell and, as indicated
in the IRIS assessment, it is possible to
have loss of smell from hydrogen sulfide
exposure.
Commenters further state that:
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EPA bases its evaluation that H2S is
ecotoxic at ‘‘relatively low concentrations’’
exclusively on potential effects on aquatic
life, noting that toxicity values for aquatic
species include ‘‘numerous values that are
well below 1 milligram per liter (mg/L).’’
While the levels cited by EPA may seem
‘‘relatively low’’ in the abstract, they are
actually quite high when viewed in the
context of data that clearly establish that H2S
will be rapidly oxidized to less toxic
chemical forms when released to surface
waters. The EPA Water Quality Criteria Gold
Book makes a similar observation:
The fact that H2S is oxidized in wellaerated water by natural biological systems to
sulfates or is biologically oxidized to
elemental sulfur has caused investigators to
minimize the toxic effects of H2S on fish and
other aquatic life.
(Footnotes omitted)
The quote from the water quality
criteria document that ‘‘[t]he fact that
H2S is oxidized in well-aerated water by
natural biological systems to sulfates or
is biologically oxidized to elemental
sulfur has caused investigators to
minimize the toxic effects of H2S on fish
and other aquatic life’’ is from the
introductory paragraph of the water
quality criteria for hydrogen sulfide.
This statement simply explains what
has caused some investigators in the
past to minimize the toxic effects of
hydrogen sulfide. However, in the
rationale section, the document goes on
to discuss the toxicity of hydrogen
sulfide to aquatic life in detail and does
not dismiss the potential impacts
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hydrogen sulfide may have on aquatic
life. In fact, the document presents the
rationale for setting a water quality
criterion of just 2 micrograms per liter
(mg/L) undissociated hydrogen sulfide
for fish and other aquatic life in both
fresh and marine water. Concerning
oxidation, the EPA Gold Book states:
hydrogen sulfide and discussed the
topic in its hazard assessment on page
8 and again on page 17 (Ref. 4).
However, the fact that hydrogen sulfide
can be oxidized under certain
environmental conditions does not
mean that it is not highly toxic. As was
cited above, the EPA Gold Book stated:
The degree of hazard exhibited by sulfide
to aquatic animal life is dependent on the
temperature, pH, and dissolved oxygen. At
lower pH values a greater proportion is in the
form of the toxic undissociated H2S. In
winter when the pH is neutral or below or
when dissolved oxygen levels are low but not
lethal to fish, the hazard from sulfide is
exacerbated. (EPA Gold Book, May 1, 1986,
page 268, (Ref. 2)).
The degree of hazard exhibited by sulfide
to aquatic animal life is dependent on the
temperature, pH, and dissolved oxygen. At
lower pH values a greater proportion is in the
form of the toxic undissociated H2S. In
winter when the pH is neutral or below or
when dissolved oxygen levels are low but not
lethal to fish, the hazard from sulfide is
exacerbated. (EPA Gold Book, May 1, 1986,
page 268 (Ref. 2)).
The criteria document also states that:
If hydrogen sulfide were rapidly
oxidized to harmless chemicals under
all environmental conditions, then that
would have an impact on EPA’s
assessment, but that is certainly not the
case. How much damage a particular
release of hydrogen sulfide will cause
can depend on a number of factors
including the amount of the release,
whether the release is continuous or
infrequent, the pH of the water, the
temperature of the water, the type of
water (fresh or seawater), the time of
year, velocity of the body of water, etc.
These factors would be considered in
site-specific exposure and risk
assessments. While hydrogen sulfide
may be oxidized under certain
environmental conditions, there are
many common environmental
conditions under which oxidation will
not be significant and thus will not
lessen the impact of a release of
hydrogen sulfide. As the aquatic toxicity
data shows, hydrogen sulfide is toxic to
many different aquatic species and at
several stages of life with some toxicity
values at or below one part in a billion.
Thus, it takes very little hydrogen
sulfide to have an impact on aquatic
life. Even under favorable oxidation
conditions, the experimental half-life of
hydrogen sulfide is 50 hours in fresh
water and 26 hours in seawater.
Considering how low the 48 and 96
hour LC50 values are for hydrogen
sulfide, hydrogen sulfide toxicity is still
a concern even under favorable
oxidation conditions. The potential
oxidation of hydrogen sulfide does not
lessen the inherent toxicity of hydrogen
sulfide.
EPA notes that, other than the single
quote from the water quality criteria
document and two references
concerning oxidation of hydrogen
sulfide in water, the commenters have
not questioned or tried to refute in any
way the aquatic toxicity information
provided in EPA’s hazard assessment.
The summary table of the aquatic
Many past data on the toxicity of hydrogen
sulfide to fish and other aquatic life have
been based on extremely short exposure
periods. Consequently, these early data have
indicated that concentrations between 0.3
and 0.4 mg/L permit fish to survive (Van
Horn 1958, Boon and Follie 1967, Theede et
al., 1969). Recent long-term data, both in
field situations and under controlled
laboratory conditions, demonstrate hydrogen
sulfide toxicity at lower concentrations. (EPA
Gold Book, May 1, 1986, page 268, (Ref. 2)).
and concludes that:
Available data indicate that water
containing concentrations of 2.0 mg/L
undissociated H2S would not be hazardous to
most fish and other aquatic wildlife, but
concentrations in excess of 2.0 mg/L would
constitute a long-term hazard.’’ (EPA Gold
Book, May 1, 1986, page 270 (emphasis
added) (Ref. 2)).
The conclusion that a concentration of
hydrogen sulfide in excess of just 2.0
mg/L would constitute a long-term
hazard to aquatic life supports a
determination that hydrogen sulfide is
clearly highly toxic and a potential
hazard to aquatic life despite its fate
under certain environmental conditions.
If hydrogen sulfide were not highly
toxic to fish and other aquatic life, then
there would be no need for such a very
low water quality criteria value.
Regarding the two references cited by
the commenters concerning oxidation of
hydrogen sulfide in seawater and
aqueous solutions (i.e., Millero, F.J.,
Hubinger, Fernandez and Garnett
(1987). Oxidation of H2S in Seawater as
a Function of Temperature, pH and
Ionic Strength. Env. Sci. Tech. 21:439–
443; Obrien, D.J. and Birkner, F.B.
(1977). Kinetics of Oxygenation of
Reduced Sulfur Species in Aqueous
Solutions. Env. Sci. Tech. 11:1114–
1120.), the Millero reference was cited
in EPA’s hazard assessment (page 8) and
the Obrien reference was cited in the
Millero reference (Ref. 4). EPA is thus
familiar with the issue of oxidation of
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toxicity values presented in the hazard
assessment provided over 90 toxicity
values from more than a dozen sources.
The commenters did not provide any
specific comments on why those data
should not be considered sufficient to
support EPA’s conclusions.
With regard to the commenters’
statements concerning criteria or
guidance for determining whether a
chemical has moderately high to high
human toxicity or high ecological
toxicity, it appears that the commenters
may have been looking for some type of
numerical cutoffs. The comments
regarding criteria or guidance for
determining whether a chemical has
moderately high to high human toxicity
or high ecological toxicity have been
addressed in EPA’s other responses to
the commenters. With regard to possible
numerical cutoffs, EPA does not agree
that numerical cutoffs should be or need
to be established in order to determine
whether a chemical has moderately high
to high human toxicity or high
ecological toxicity. As EPA explained in
the chemical expansion rule in 1994:
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The hazard assessment was conducted in
accordance with relevant EPA guidelines for
each adverse human health or environmental
effect (e.g., the appropriate guidelines for
hazard evaluation of chemical carcinogens
and for the type of evidence required to
substantiate a determination of
carcinogenicity are the Assessment
Guidelines for Carcinogen Risk (Ref. 4)).
During this assessment the number, severity,
and significance of the effects induced by the
chemical, the dose level causing the effect,
and the quality and quantity of the available
data, including the nature of the data (e.g.,
human epidemiological, laboratory animal,
field or workplace studies) and confidence
level in the existing data base, were all
considered. Where a careful review of the
scientific data for a particular chemical
results in a high level of confidence that the
chemical causes an adverse effect at
relatively low dose levels, EPA believes that
this evidence is sufficient for listing the
chemical under section 313. EPA also
believes that where a review of the scientific
data indicates that the chemical will cause
various adverse effects at moderate dose
levels, the total weight-of-the-evidence
indicates that there is sufficient evidence for
listing the chemical under EPCRA section
313. EPA believes that both types of
chemicals described above exhibit
moderately high to high toxicity based on a
hazard assessment. (59 FR 61433, 11/30/
1994).
EPA provided a hazard assessment
that presented the information used to
support the finding that hydrogen
sulfide has moderately high to high
human toxicity and high ecotoxicity. As
in the 1994 rulemaking, and subsequent
rulemakings, the data presented in the
hazard assessments addressed issues
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such as the number, severity, and
significance of the effects induced by
the chemical, the dose level causing the
effect, and the quality and quantity of
the available data, including the nature
of the data (e.g., human
epidemiological, laboratory animal,
field or workplace studies) and
confidence level in the existing data
base. All commenters had the
opportunity to comment on whether
these data support EPA’s determinations
regarding the toxicity of hydrogen
sulfide in response to EPA’s notice of
Intent to Lift the Stay of the reporting
requirements for hydrogen sulfide.
Establishing a numerical cutoff would
limit EPA’s ability to consider other
factors that might increase or decrease
the concern for the toxicity of a
chemical. For example, if one chemical
causes one serious effect at 100
milligrams per kilogram per day (mg/kg/
day) and another chemical causes
multiple serious effects across multiple
organ systems but at 300 mg/kg/day it
would not make sense to discount the
latter if there were some arbitrary
numerical cutoff of 200 mg/kg/day. EPA
does not believe that would be the
correct way to evaluate chemicals for
listing. Rather, EPA considers all of the
toxicity data, including the doses/
concentrations causing the toxic effects,
in making determinations about the
toxicity of a chemical. EPA provided
this information in the hazard
assessment for hydrogen sulfide and
provided its rationale for lifting the stay
based on this information.
While EPA has not set numerical
cutoffs, a quick review of the chemicals
included in the 1994 chemical
expansion rule (59 FR 61432, 11/30/
1994), the persistent, bioaccumulative,
and toxic (PBT) chemicals rule (64 FR
693, 1/5/1999), and other actions shows
that the doses and concentrations that
cause adverse effects for hydrogen
sulfide are well within those of
chemicals that EPA has previously
determined to have moderately high to
high human toxicity and high
ecotoxicity. In fact, with regard to
ecotoxicity, some of the levels at which
hydrogen sulfide causes toxicity are
among the lowest that EPA has
evaluated. Even if EPA were to establish
numerical cutoffs, based on EPA’s
previous listing determinations the
levels at which hydrogen sulfide causes
toxicity would be well below any such
numerical cutoffs.
With regard to the phrase ‘‘relatively
low doses,’’ this simply refers to doses
that are low relative to the body burden
they impose. Dose levels are most often
measured as (or converted into) the
units milligrams per kilogram per day
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(mg/kg/day) where kilogram refers to
each kilogram of body weight. As noted
above, EPA has explained that in
determining whether a chemical has
moderately high to high chronic toxicity
the dose levels causing the effects along
with the number and severity of the
adverse effects are considered (59 FR
61433, 1/30/1994). While EPA has not
set a numerical cutoff for a relatively
low dose, it has provided numerous
examples of the dose levels that EPA
considers to be relatively low as well as
dose levels that EPA considers to be
relatively high. The 1994 chemical
expansion rule alone contains over 200
examples of relatively low doses (59 FR
1788, 1/12/1994). Doses in that rule that
were considered relatively low were
generally at or below 100 mg/kg/day.
EPA has also identified, through
numerous actions, dose levels that are
considered to be high or relatively high.
Such dose levels are typically at or
above 500 mg/kg/day, with most
examples being in excess of 1,000 mg/
kg/day or more (see for example: 59 FR
49888, 9/30/1994; 60 FR 46076, 9/5/
1995, and 64 FR 8769, 2/23/1999). Even
in the rulemaking that added hydrogen
sulfide to the TRI list, EPA identified
doses of 600 and 1,000 mg/kg/day as
‘‘relatively high doses’’ (57 FR 41020,
9/8/1992). These ‘‘relatively high doses’’
were cited by EPA in the determinations
that b-chloronapthalene and isobutyl
alcohol were not sufficiently toxic to be
added to the EPCRA section 313 list (57
FR 41033, 9/8/1992). These dose levels
are significantly higher than the less
than 15 mg/kg/day doses (converted
from 20–30 ppm) that EPA has cited as
being relatively low for hydrogen
sulfide. While EPA has not set a
numerical cutoff for relatively low
doses, the Agency has provided,
through the listing and delisting of
chemicals, substantial guidance for this
terminology.
As EPA has noted, low dose alone is
not the only consideration in
determining whether a chemical has
moderately high to high toxicity and
thus should be listed on hazard alone:
Where a careful review of the scientific
data for a particular chemical results in a
high level of confidence that the chemical
causes an adverse effect at relatively low
dose levels, EPA believes that this evidence
is sufficient for listing the chemical under
section 313. EPA also believes that where a
review of the scientific data indicates that the
chemical will cause various adverse effects at
moderate dose levels, the total weight-of- theevidence indicates that there is sufficient
evidence for listing the chemical under
EPCRA section 313. EPA believes that both
types of chemicals described above exhibit
moderately high to high toxicity based on a
hazard assessment. (59 FR 61433, 1/30/1994).
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An example of this concept is the listing
of triphenyltin chloride. This chemical
was cited by EPA as causing significant
reproductive toxicity, including adverse
effects on the testes, epididymis, sperm
duct, prostate gland, seminal vesicle,
Cowper’s gland, and accessory glands,
at an oral dose of 380 mg/kg over 19
days. While the dose level was more
moderate, EPA determined that the
severity and number of effects were
sufficient for listing (59 FR 1843, 1/12/
1994). This is the kind of flexibility
regarding dose levels that is required
when making determinations about the
toxicity of chemicals, and is consistent
with the exposure policy EPA has
established for EPCRA section 313
determinations.
Regarding the phrase ‘‘relatively low
concentrations’’ used in the assessment
of ecological toxicity, this is similar to
the ‘‘relatively low dose’’ terminology in
that it focuses on concentrations that
result in low doses to the organisms.
Data for aquatic organisms is the most
commonly cited data and typically has
the units of milligrams per liter (mg/L).
As EPA has stated, exposure
assessments are not used to list a
chemical for ecological effects if it has
high toxicity. Based on concentration,
EPA has typically limited its
consideration of highly toxic to those
chemicals that cause acute effects at
about 1 mg/L or less and chronic effects
at 0.1 mg/L or less (see for example: 57
FR 41020, 9/8/1992 and 59 FR 1788, 1/
12/1994). Since the statutory criteria of
EPCRA section 313(d)(2)(C) also
includes consideration of persistence
and bioaccumulation, EPA has
considered somewhat higher
concentrations as highly toxic for
chemicals with those characteristics (64
FR 696, 1/5/1999). As with chronic
human health effects, EPA has not set a
numerical cut off for relatively low
concentrations, but has provided,
through the listing and delisting of
chemicals, substantial guidance for this
terminology.
EPA notes that other programs within
the Agency that have numerical cutoffs
for aquatic organisms have set
numerical cutoffs that are consistent
with the kind of toxicity concentrations
that EPA has identified as being highly
toxic in EPCRA section 313 evaluations.
For example, the Office of Pesticide
Programs cites the following:
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ECOTOXICITY CATEGORIES FOR TERRESTRIAL AND AQUATIC ORGANISMS
Concentration
(ppm)
Toxicity category
Aquatic Organisms: Acute
< 0.1 ..............
0.1–1 .............
>1–10 ............
>10–100 ........
> 100 .............
very highly toxic.
highly toxic.
moderately toxic.
slightly toxic.
practically nontoxic.
(https://www.epa.gov/oppefed1/ecorisk_ders/
toera_analysis_eco.htm#Ecotox).
Under the above numerical cutoffs, not
only would hydrogen sulfide be
considered highly toxic, but most of the
available data would support a
classification of very highly toxic.
4. Qualitative Judgment on Exposure
Levels. Commenters stated that the lack
of any objective rationale for EPA’s
determination that hydrogen sulfide
causes health and ecological effects at
relatively low levels suggests that EPA
made a qualitative judgment about the
magnitude of the potential exposure
without preparing any supporting
exposure analysis. Commenters restated
their position that EPA has not provided
any objective criteria for its
determination that hydrogen sulfide
causes human health effects and
ecological effects at relatively low
levels. Commenters assert that one
possibility is that EPA scientists have
simply made a qualitative judgment
concerning the plausibility that
hydrogen sulfide exposure might occur
at the levels in question. Commenters
stated that such a judgment would be
intrinsically arbitrary when it is
possible to do a proper and defensible
exposure analysis. Commenters claim
that if an exposure analysis were
conducted they are confident it would
show that exposure levels are below the
levels that EPA has identified for human
health effects and ecological effects.
As discussed in a previous response
to this commenter, EPA has provided
the information it used to determine
that hydrogen sulfide has moderately
high to high human toxicity and high
ecotoxicity and has explained the
methodology by which EPA makes such
determinations. Therefore, EPA
disagrees with the commenter’s
statement that EPA did not provide an
objective rationale for its
determinations.
Commenter asserts that:
One possibility is that EPA scientists have
simply made a qualitative judgment
concerning the plausibility that H2S exposure
might occur at the levels in question. Such
a judgment would be intrinsically arbitrary
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when it is possible to do a proper and
defensible exposure analysis.
There is nothing in the materials that
EPA has provided that even suggests
that EPA made a qualitative judgment
about hydrogen sulfide exposure levels.
The determination as to whether or not
a chemical has moderately high to high
human toxicity or high ecotoxicity is
separate from any consideration of
potential exposures. EPA did not
consider or evaluate the potential
exposures to hydrogen sulfide in
making its finding that hydrogen sulfide
has moderately high to high toxicity to
humans and is highly toxic to aquatic
organisms. The toxicity of a chemical is
an intrinsic property of the chemical
that is established by determining what
exposure level (i.e., dose) causes
adverse effects through appropriately
conducted toxicological studies; it is not
based on releases that occur at facilities.
Consideration of the level of exposure
from releases occurring at facilities is
part of a risk assessment, not a hazard
assessment. Unlike the intrinsic toxicity
of a chemical, exposure levels can
change depending on many factors such
as release quantities, type of release,
changes in weather patterns, etc. As
EPA has stated:
It is important to understand that although
an adverse effect is known or can be
reasonably anticipated to be caused by a
chemical on the section 313 list, a release of
a chemical into a community does not
necessarily mean that the effect will occur.
Exposure and dose are also important factors
in determining whether an adverse effect
occurs and how serious the manifestation
will be. The listing of a chemical on the
section 313 list does not mean that a
particular community will experience these
adverse effects. Instead the purpose for
listing a chemical is to ensure that the public
gets information about releases of such
chemicals. Thus, EPA believes that for
chemicals that typically do not affect solely
one or two species but rather affect changes
across a whole ecosystem and for which
there is well-documented evidence
supporting the adverse effects, that their
addition to the EPCRA section 313 list is
warranted even though the severity of the
adverse effects that they induce will be
dependent upon site-specific characteristics.
Once EPA makes release data available
through TRI, the community may then make
its own determination on the importance of
these releases (and their potential adverse
effects). (59 FR 61433, 11/30/1994).
In upholding EPA’s interpretation of
EPCRA section 313 listing decisions as
it relates to the use of exposure, the U.S.
Court of Appeals for the District of
Columbia itself provided a very good
example of the difference between the
toxicity of a chemical and exposure to
that chemical:
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It is not the case that the congressional
language mandating listing of a chemical that
‘is known to cause or can reasonably be
anticipated to cause in humans’ the
enumerated adverse effects unambiguously
incorporates the likelihood of contact
between humans and the chemical. A simple
analogy quickly refutes NPG’s argument that
the language is unambiguous. Consider a
herpetologist and a student contemplating a
reptile imprisoned in a glass cage. The
student asks, ‘Can that snake’s bite
reasonably be anticipated to cause death in
humans?’ The scientist replies, ‘Yes.’ The
scientist is not commenting on the likelihood
of the serpent’s escape, only the toxicity of
its venom. Concededly, his answer could be
taken to mean, ‘Yes, it is likely that this
creature will escape, bite someone, and kill
them.’ But that is certainly not the
unambiguous purport of his words. Even so
is the statutory language of Congress. It is
conceivable that Congress may have
contemplated release in its phrasing of the
standard, but that is certainly not
unambiguously the case. (Troy Corp. v.
Browner, 120 F.3d 277, 285 (D.C. Cir. 1997)).
The example of a venomous snake in
a glass cage provides a perfect
illustration of the difference between
exposure and toxicity. Just as the
containment of the venomous snake in
a glass cage does not change the fact that
the snake’s venom is highly toxic, lack
of exposure does not lessen the intrinsic
toxicity of a chemical. Lack of exposure
addresses the issue of the level of risk,
not the level of toxicity.
5. Use of Best Available Science.
Commenters claim that EPA did not
properly consider the best available
scientific evidence concerning hydrogen
sulfide toxicity and exposure.
Commenters cited one clinical study of
potential neurological effects of
hydrogen sulfide exposure in humans
that EPA did not consider. Commenters
stated that in the Fieldler et al. study
(Ref. 5), 74 healthy male and female
volunteers participated in a clinical
study designed to evaluate
neurobehavioral effects of 2-hour
controlled chamber exposures to
hydrogen sulfide. Commenters state that
neurobehavioral effects were evaluated
using a battery of established tests
immediately prior to, and immediately
following, exposure to 0.05, 0.5, and 5.0
ppm hydrogen sulfide in separate
sessions approximately one week apart.
Commenters state that the sequence of
exposures was randomly assigned to
each subject and that the investigators
reported that no significant changes
were found between pre- and postexposure performance, and that no
dose-response was found in any of the
neurobehavioral or neurosensory data
sets. Commenters contend that although
the exposures studied in the Fiedler et
al. study did not constitute chronic
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exposure, the study is highly relevant in
establishing the levels at which humans
might experience neurological effects
from hydrogen sulfide exposure.
Commenters claim that the
neurobehavioral endpoints that were
evaluated in this study are likely to be
much more effective in capturing subtle
neurological impairments that could not
be detected in animal studies.
Commenters provided an additional
primary literature resource for the
evaluation of hydrogen sulfide human
health effects. However, the commenters
mistakenly reported no significant
changes between pre- and post-exposure
performance. This is inaccurate as the
authors identified significant
impairment of verbal learning in all
exposure groups (p ≤ 0.0003). Although
the response was not dose dependent,
the authors offer several explanations
for this finding including a threshold
effect for hydrogen sulfide as low as
0.05 ppm.
EPA’s Federal Register notice of
Intent to Lift the Stay of the hydrogen
sulfide reporting requirements
specifically states that the human health
concern for hydrogen sulfide is chronic
human health effects (both upper
respiratory and neurotoxic effects) (75
FR 8893, February 26, 2010). As the
commenters correctly pointed out, the
Fiedler et al. study ‘‘Sensory and
Cognitive Effects of Acute Exposure to
Hydrogen Sulfide’’ evaluated only acute
exposures—not chronic exposures. The
study evaluated subjects exposed to
hydrogen sulfide for ≤2 hours.
Therefore, the study in question is not
relevant to the chronic human health
effects or the environmental effects that
form the basis of EPA’s cited concerns
for hydrogen sulfide.
While the Fiedler et al. study may be
relevant in establishing the levels at
which humans might experience
neurological effects from acute
hydrogen sulfide exposure, the Agency
does not support the extension to
chronic neurological effects. The Fiedler
et al. study was designed to evaluate
cognitive endpoints shown to be
responsive in acute studies. As detailed
in the Federal Register (75 FR 8891,
February 26, 2010), hydrogen sulfide
neurotoxicity is thought to occur due to
hypoxia induced neuronal cell death.
This pathology would not be evidenced
in the short-term human study
conducted by Fiedler et al. because the
exposures were acute not chronic.
Therefore, we would also conclude that
the neurobehavioral endpoints that were
used in the Fiedler et al. study are not,
as the commenters suggest, ‘‘likely to be
much more effective in capturing subtle
neurological impairments that could not
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be detected in animal studies’’ since the
effects of chronic exposure would not be
observed. The ability to sacrifice
animals to study neurotransmitters and
brain chemistry provides information
that is not available in human studies.
These types of studies provide powerful
quantitative data, as evidenced in
Skrajny et al. (Ref. 6).
It should also be noted that the
hydrogen sulfide inhalation exposure in
the Fiedler et al. study ranged from 0.05
to 5.0 ppm. This is far below the lowest
observed adverse effect levels (LOAELs)
seen in the animal studies of
neurotoxicity cited in EPA’s notice of
Intent to Lift the Stay and support
materials. The Fiedler et al. study may
indicate that hydrogen sulfide can cause
adverse effects in humans at exposure
levels (at least acute exposure levels)
much lower than previously expected.
6. New Hydrogen Sulfide Dosimetry
Data. Commenters state that EPA has
not considered new information on
tissue dosimetry in determining the no
observed adverse effect levels for
chronic inhalation exposure to
hydrogen sulfide. Commenters cited two
studies that, in combination with the
Fiedler et al. study, they contend
demonstrate that the chronic human
health effects are not likely at hydrogen
sulfide concentrations of 5 ppm or
below. Commenters cited the 2006
Schroeter et al. study (Ref. 7), in which
the authors used computational fluid
dynamics (CFD) modeling to
quantitatively correlate hydrogen
sulfide tissue dosimetry in rat and
human nasal passages. Commenters
state that assuming that equivalent
hydrogen sulfide flux values will induce
similar responses in the olfactory
regions of rats and humans, the no
observed adverse effect level-human
equivalent concentration (NOAEL–HEC)
was estimated to be 5 ppm. Commenters
also cited a 2010 Schroeter et al. study
(Ref. 8) in which the authors
investigated interhuman variability of
hydrogen sulfide nasal dosimetry using
anatomically accurate CFD models of
the nasal passages of five adults and two
children generated from magnetic
resonance imaging (MRI) or computed
tomography (CT) scan data. Commenters
state that using allometrically
equivalent breathing rates, the authors
simulated steady-state inspiratory
airflow and hydrogen sulfide uptake.
Approximate locations of olfactory
epithelium were mapped in each model
to compare air : tissue flux in the
olfactory region among individuals. The
fraction of total airflow to the olfactory
region ranged from 2 percent to 16
percent. Despite this wide range in
olfactory airflow, hydrogen sulfide
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dosimetry in the olfactory region was
predicted to be similar among
individuals. Differences in the 99th
percentile and average flux values were
< 1.2-fold at inhaled concentrations of 1,
5, and 10 ppm. Commenters contend
that these preliminary results suggest
that differences in nasal anatomy and
ventilation among adults and children
do not have a significant effect on
hydrogen sulfide dosimetry in the
olfactory region.
The Agency would like to thank the
commenters for bringing additional
primary research studies to our
attention, enabling us to make decisions
using all available resources. EPA agrees
with the commenters in regard to
consideration of the dosimetry
information presented in both papers by
Schroeter et al. This type of
pharmacokinetic modeling and the
results presented represent the current
state-of-the-science for inhalation
dosimetry and are being reviewed by
EPA for its utility in addressing our
current reference concentration (RfC)
derivation methods (see https://
cfpub.epa.gov/ncea/cfm/
recordisplay.cfm?deid=212131).
However, it is important to note that the
purpose of the papers by Schroeter et al.
was to provide a model-based NOAEL–
HEC (5 ppm), not an alternative final
RfC which incorporates the application
of uncertainty factors. Thus, the only
part of the EPA’s methods in deriving a
value that is addressed is the calculation
of an HEC extrapolated from animal
data. No judgment is made by these
authors that 5 ppm represents a
replacement or alternative RfC or serves
to replace or reduce the application of
uncertainty factors. EPA’s human health
hazard assessment for hydrogen sulfide
is based on the Agency’s current IRIS
toxicological profile (Ref. 3), and while
this new dosimetry information and
resulting NOAEL–HEC might be
considered in a revaluation of the
current RfC, it does not impact EPA’s
assessment of the potential for hydrogen
sulfide to cause chronic toxicity.
The Agency does not concur with the
commenter’s conclusion that the Fiedler
and Shroeter studies demonstrate that
chronic human health effects are not
likely at hydrogen sulfide
concentrations of 5 ppm or below. As
noted, the Fiedler study addresses
solely acute exposures and is not
relevant to chronic effects. Further, the
Schroeter reports only provide data for
use in calculating the NOEAL–HEC
based on pharmacokinetic modeling.
Therefore, the commenter’s conclusions
regarding chronic human health effects
of hydrogen sulfide are not supported
by the studies presented.
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7. No Need for TRI Reporting.
Commenters contend that there is no
need to include hydrogen sulfide on the
Toxics Release Inventory. Commenters
restated their claim that emissions of
hydrogen sulfide reported under EPCRA
section 313 cannot be reasonably
anticipated to cause any of the chronic
health effects covered by EPCRA section
313(d)(2)(B). Commenters state that
although accidental releases of
hydrogen sulfide can result in serious
adverse effects, such releases are subject
to the emergency notification
requirements of EPCRA section 304 and
by the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) section 103. Commenters
state that such accidental releases are
expressly regulated pursuant to Clean
Air Act (CAA) Section 112(r) and
hydrogen sulfide is among the
substances that were specifically
identified for such regulation by
Congress in Section 112(r). Commenters
also claim that since there is no
evidence that suggests that routine
releases of hydrogen sulfide pose any
risk, nothing would be achieved by
adding reporting requirements under
EPCRA section 313. Commenters
contend that since emissions of
hydrogen sulfide that would typically
be reported under EPCRA Section 313
are irrelevant to potential chronic health
effects of the type addressed by EPCRA
Section 313(d)(2)(B), and accidental
releases of hydrogen sulfide that might
be expected to present a potential
hazard are well regulated, reporting
under EPCRA Section 313 serves no
purpose. Commenters claim that even if
EPA has properly determined that
hydrogen sulfide has ‘‘moderately high
to high chronic toxicity,’’ EPA is not
required to list hydrogen sulfide in
these circumstances.
Commenters state that in announcing
its policy concerning use of exposure
analyses in listing determinations under
EPCRA Section 313(d)(2), EPA stated:
The statute is silent on the issue of
exposure considerations for the section
313(d)(2)(B) and (C) criteria. The language of
section 313 does not prohibit EPA from
considering exposure factors when making a
finding under either section 313(d)(2)(B) or
section 313(d)(2)(C) (59 FR 61441–61442).
Commenters state that the reviewing
court that reviewed this construction
expressly affirmed this conclusion,
stating that ‘‘chemicals of moderate or
high toxicity are not necessarily added
[to the list] because of it.’’ Troy Corp. v.
Browner, 120 F.3d at 287.
Commenters claim that EPA has not
cited any adverse consequence from the
Administrative Stay of reporting
requirements under EPCRA Section 313
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64035
that has been in place for over 15 years
and that EPA should exercise its
discretion to consider exposure factors
in making a new listing determination
for hydrogen sulfide and then rescind
its prior listing determination.
As EPA stated in response to the
commenter’s previous comments on the
releases of hydrogen sulfide, EPA does
not agree that the commenters have
shown that releases of hydrogen sulfide
will not cause the kinds of health and
environmental effects that EPA cited as
support for listing hydrogen sulfide.
Most importantly, EPA is not required
to show that the effects that hydrogen
sulfide can cause are actually occurring
in order to list it on EPCRA section 313.
EPA notes that other commenters have
provided comments alleging that they
have experienced adverse health effects
from hydrogen sulfide releases (see for
example: EPA–HQ–TRI–2009–0844–
0076, EPA–HQ–TRI–2009–0844–0081 in
the docket for this action).
Regarding the fact that accidental
releases of hydrogen sulfide that may
cause serious adverse health effects
including death are covered by other
statutes, this has no impact on the
listing of a chemical under EPCRA
section 313. Listing of a chemical under
EPCRA section 313 is separate and apart
from any other regulatory actions.
EPCRA section 313 is focused on a
community’s right-to-know about
releases of toxic chemicals, not
emergency reporting requirements for
industrial accidents.
With regard to the commenter’s
statements that listing hydrogen sulfide
on EPCRA section 313 serves no
purpose, the Agency disagrees. As EPA
has stated:
It is important to understand that although
an adverse effect is known or can be
reasonably anticipated to be caused by a
chemical on the section 313 list, a release of
a chemical into a community does not
necessarily mean that the effect will occur.
Exposure and dose are also important factors
in determining whether an adverse effect
occurs and how serious the manifestation
will be. The listing of a chemical on the
section 313 list does not mean that a
particular community will experience these
adverse effects. Instead the purpose for
listing a chemical is to ensure that the public
gets information about releases of such
chemicals. Thus, EPA believes that for
chemicals that typically do not affect solely
one or two species but rather affect changes
across a whole ecosystem and for which
there is well-documented evidence
supporting the adverse effects, that their
addition to the EPCRA section 313 list is
warranted even though the severity of the
adverse effects that they induce will be
dependent upon site-specific characteristics.
Once EPA makes release data available
through TRI, the community may then make
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its own determination on the importance of
these releases (and their potential adverse
effects). (59 FR 61433, 11/30/1994 (emphasis
added)).
Listing a chemical under EPCRA
section 313 allows the public and
governments to track and assess the
impacts of chemical releases and make
determinations as to whether or not a
risk exists. Without release data, the
public is limited in its ability to
determine whether or not releases of a
toxic chemical are impacting their
health and/or environment. Even if
releases are low and no adverse impacts
are expected, that information is still of
value to the public.
The listing of hydrogen sulfide on
EPCRA section 313 is consistent with
EPA’s stated policy on the use of
exposure assessments, which does not
include the use of exposure for
chemicals such as hydrogen sulfide that
have moderately high to high human
toxicity and high ecotoxicity. The
commenter suggests that EPA should
exercise its discretion with regard to the
consideration of exposure, citing Troy
Corp v. Browner for the proposition that
‘‘chemicals of moderate or high toxicity
are not necessarily added [to the list]
because of it.’’ Placed in greater context,
that quotation is as follows:
The EPA’s exposure policy merely
informed the public that the agency would
exercise its discretion by considering
exposure only for low toxicity chemicals.
The EPA did not thereby curtail this
discretion; it did nothing more than clarify
its own position. The policy does not impose
rights or obligations or bind the agency to a
particular result. Chemicals of low toxicity
may be added despite the policy, just as
chemicals of moderate or high toxicity are
not necessarily added because of it. (Troy
Corp. v. Browner, 120 F.3d at 287).
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As the DC Circuit noted, EPA stated
that it would exercise its discretion by
considering exposure only for low
toxicity chemicals. If EPA were to
consider exposure for hydrogen sulfide
it would be inconsistent with the
Agency’s stated policy on the use of
exposure assessments in EPCRA section
313 listing decisions. While EPA does
have discretion to deviate from its
policy, the Agency does not believe that
there is any reason to consider exposure
in its listing decision for hydrogen
sulfide and thus has no reason to
deviate from its stated exposure policy.
B. Comments From the National
Renderers Association
The commenter stated that they do
not support listing hydrogen sulfide
emissions from rendering plants under
EPCRA section 313 because of what
they claim are extremely low levels of
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hydrogen sulfide potentially emitted
from such facilities. The commenter
stated that they agreed with EPA that, at
certain concentration levels, exposure to
hydrogen sulfide can cause significant
adverse acute and chronic human health
effects and adverse impacts to the
environment. The commenters contend
that these potentially harmful
concentrations are well understood,
published, and regulated under the
Occupational Safety and Health
Administration (OSHA) and the
National Institute for Occupational
Safety and Health (NIOSH) standards
with which their facilities comply. The
commenter stated that there are safe
levels of hydrogen sulfide exposure and
that the fence-line concentration of
hydrogen sulfide at a typical rendering
plant would be expected to be well
below these safe levels. The commenter
recommended that EPA take into
account the ‘‘concentration levels that
are reasonably likely to exist beyond
facility site boundaries as a result of
continuous, or frequently recurring,
releases,’’ as required under EPCRA
section 313(d)(2)(A), and exempt the
reporting of hydrogen sulfide as a byproduct of rendering operations.
The commenter provided information
on the natural sources of hydrogen
sulfide and information that hydrogen
sulfide degrades rapidly in the
environment. The commenter stated
that the typical rendering plant might
emit roughly 400 pounds of hydrogen
sulfide per year. The commenter stated
that hydrogen sulfide can be found in
very low concentrations throughout the
rendering industry supply and
processing chain as a by-product related
to the recycling, collecting, handling
and processing of animal byproduct and
used cooking oil. The commenter claims
that hydrogen sulfide releases in the
rendering facility workplace
environment tend to be fugitive in
nature, inconsistent in concentration,
and irregularly present. The commenter
stated that the presence of hydrogen
sulfide, if any, depends on the age of the
raw materials, moisture content,
temperature, state of anaerobic bacterial
decay, and other factors. The
commenter claimed that ‘‘[h]ydrogen
sulfide concentration emissions from a
typical rendering plant likely result in
air concentrations off-site that would be
several orders of magnitude below
concentrations that are potentially
hazardous to human health and the
environment.’’ The commenter claims
that as a result of these characteristics,
the hydrogen sulfide that may be
present in a rendering facility is not
likely to reach site boundaries at any
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measurable or reliably quantifiable
concentration. The commenters claim
that through their years of studying
potential hydrogen sulfide emissions in
rendering operations, they know that it
is difficult to quantify and report the
low levels of emissions that may occur
at their facilities. The commenter
suggested that the addition of hydrogen
sulfide to TRI listing must, at a
minimum, allow for no TRI
requirements for de minimums sources
such as facilities in the rendering
supply and processing chain.
As EPA discussed in the Notice of
Intent to Lift the Stay (75 FR 8893, 8889,
February 26, 2010), exposure
consideration is not appropriate for
chemicals that have moderately high to
high chronic human health toxicity or
high environmental toxicity. Hydrogen
sulfide meets both of these criteria,
therefore exposure (or the potential for
exposure) is not a factor in the listing
decision. Regarding EPCRA section
313(d)(2)(A), hydrogen sulfide is not
listed under that criteria, but rather the
criteria of EPCRA sections 313(d)(2)(B)
and (C).
It is well known that hydrogen sulfide
is a byproduct of the rendering process
(Ref. 9). EPA has published emission
factors for at least one stage of the
rendering process (Ref. 10). The
commenter believes that reporting
would be difficult for hydrogen sulfide,
yet they provide an estimate of 400
pounds of releases per year, thus it
appears that these facilities could make
at least a reasonable estimate of releases
as required under EPCRA section 313.
EPA notes that rendering plants must
already report their release of ammonia,
another gas with variations in
production and release. Regarding
whether or not ‘‘emissions from a
typical rendering plant likely result in
air concentrations off-site that would be
several orders of magnitude below
concentrations that are potentially
hazardous to human health and the
environment,’’ unless the release data is
made available the local communities
and governments will not be able to
confirm this conclusion. EPCRA section
313 contains no provisions for de
minimis sources other than the fact that
facilities must exceed the reporting
thresholds (25,000 pounds for
manufacture and processing and 10,000
pounds for otherwise use). It appears
that rendering plants do not use
hydrogen sulfide, thus they would have
to manufacture or process 25,000
pounds before they would have to file
a report.
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C. Comments From the American Meat
Institute
The commenters stated that they agree
with the comments submitted by the
National Renderers Association. The
commenter stated that in their members’
plants hydrogen sulfide is released
primarily in rendering and waste
treatment processes and that the
releases are fugitive, can be widespread
and are in concentrations that are
irregular and inconsistent. The
commenter stated that to comply with
EPCRA Section 313, their members will
have to estimate their releases to
determine if the reporting thresholds are
met. The commenter claimed that
because of the ephemeral nature of the
releases, standard field and even more
sophisticated laboratory grade
measurement devices are inadequate
and unreliable. The commenter claimed
that the releases disperse rapidly,
resulting in concentrations below the
measurement capability of some devices
and, regardless of the measurement
device, the measurements are not easily
replicated. The commenter stated that
meat packing and processing plants do
not have a reliable method for
determining compliance. The
commenter stated that because of this
they have significant concerns regarding
how to implement EPCRA section 313
with respect to hydrogen sulfide and
contend EPA should consider such
practical issues before lifting the stay.
EPA notes that the ability of any one
particular industry to be able to report
releases is not a factor in determining
whether a chemical meets the EPCRA
section 313 listing criteria. It is well
known that hydrogen sulfide is a
byproduct of the rendering process (Ref.
9). EPA has published emission factors
for at least one stage of the rendering
process (Ref. 10). The commenter
believes that reporting would be
difficult for hydrogen sulfide, yet the
National Renderers Association
provided an estimate of 400 pounds of
releases per year, thus it appears that
these facilities could make at least a
reasonable estimate of releases as
required under EPCRA section 313. EPA
notes that rendering plants as well as
meat packing and processing plants
must already report their release of
ammonia, another gas that is also likely
to have variations in production and
release as it is also produced from the
decay of organic matter. While EPA
would like to collect the most accurate
information possible, EPCRA section
313 only requires that facilities report a
reasonable estimate of releases. EPA
sees no reason why meat packing and
processing plants should not be able to
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make at least reasonable estimates of the
amounts of hydrogen sulfide
manufactured and released.
VI. What are the references cited in this
document?
EPA has established an official public
docket for this action under Docket ID
No. EPA–HQ–TRI–2009–0844. The
public docket includes information
considered by EPA in developing this
action, including the documents listed
below, which are electronically or
physically located in the docket. In
addition, interested parties should
consult documents that are referenced
in the documents that EPA has placed
in the docket, regardless of whether
these referenced documents are
electronically or physically located in
the docket. For assistance in locating
documents that are referenced in
documents that EPA has placed in the
docket, but that are not electronically or
physically located in the docket, please
consult the person listed in the above
FOR FURTHER INFORMATION CONTACT
section.
1. USEPA, OEI. Response to Comments
Received on the February 26, 2010,
Federal Register Document (75 FR 8889):
Hydrogen Sulfide; Community Right-toKnow Toxic Chemical Release Reporting;
Intent to consider lifting the
administrative stay; opportunity for
public comment. U.S. Environmental
Protection Agency, Office of
Environmental Information, Office of
Information Analysis and Access. July
21, 2011.
2. USEPA, Office of Water Regulations and
Standards, Quality Criteria for Water,
EPA 440/5–86–001 (May 1, 1986) (EPA
Gold Book), page 268.
3. U.S. Environmental Protection Agency.
‘‘Toxicological Review of Hydrogen
sulfide, (CAS No. 7783–06–4), In
Support of Summary Information on the
Integrated Risk Information System.’’
Washington, DC: Integrated Risk
Information System. U.S. Environmental
Protection Agency. June, 2003. https://
www.epa.gov/ncea/iris/toxreviews/0061tr.pdf. Integrated Risk Information
Summary for Hydrogen Sulfide available
at: https://www.epa.gov/ncea/iris/subst/
0061.htm.
4. U.S. Environmental Protection Agency,
Technical Review of Hydrogen Sulfide:
Chemistry, Environmental Fate and
Ecological Toxicity, CAS Registry
Number 7783–06–4; Office of
Environmental Information, Office of
Information Access and Analysis,
Environmental Analysis Division,
Analytical Support Branch; June 22,
2009.
5. Fiedler N., Kipen H., Ohman-Strickland P.,
Zhang J., Weisel C., Laumbach R., KellyMcNeil K., Olejeme K., and Lioy P.,
‘‘Sensory and Cognitive Effects of Acute
Exposure to Hydrogen Sulfide.’’ Env.
PO 00000
Frm 00037
Fmt 4700
Sfmt 9990
64037
Health Persp. v. 116(1), (2008), pp. 78–
85.
6. Skrajny, B., Hannah, R.S., Roth, S.H., ‘‘Low
concentrations of hydrogen sulphide
alter monoamine levels in the
developing rat central nervous system.’’
Can. J. Physiol. Pharmacol. v. 70(11),
(1992), pp. 1515–1518.
7. Schroeter J.D., Kimbell J.S., Andersen
M.E., and Dorman D.C., ‘‘Use of a
pharmacokinetic-driven computational
fluid dynamics model to predict nasal
extraction of hydrogen sulfide in rats and
humans.’’ Toxicol. Sci. v. 94(2), (2006),
pp. 359–367.
8. Schroeter J.D., Garcia G.J. M., and Kimbell,
J.S., ‘‘A computational fluid dynamics
approach to assess interhuman
variability in hydrogen sulfide nasal
dosimetry.’’ Inhalation Toxicol. v. 22(4),
(2010), pp. 277–286.
9. Emission Factor Documentation for AP–42
Section 9.5.3 Meat Rendering Plants
Final Report. Prepared by Midwest
Research Institute (MRI) for the Office of
Air Quality Planning and Standards
(OAQPS), U. S. Environmental
Protection Agency (EPA), under EPA
Contract No. 68–D2–0159. September
1995.
10. AP 42, Fifth Edition, January 1995.
Compilation of Air Pollutant Emission
Factors, Volume I: Stationary Point and
Area Sources. Chapter 9: Food and
Agricultural Industries section 9.5.3
Meat Rendering Plants. Office of Air
Quality Planning and Standards
(OAQPS), Office of Air and Radiation,
U.S. Environmental Protection Agency
(EPA).
List of Subjects in 40 CFR Part 372
Environmental protection,
Community right-to-know, Reporting
and recordkeeping requirements, and
Toxic chemicals.
Dated: September 8, 2011.
Lisa P. Jackson,
Administrator.
Therefore, 40 CFR part 372 is
amended as follows:
PART 372—[AMENDED]
1. The authority citation for part 372
continues to read as follows:
■
Authority: 42 U.S.C. 11023 and 11048.
§ 372.65
[Amended]
2. Section 372.65 is amended by
lifting the stay on hydrogen sulfide and
methyl mercaptan entries and all related
dates under paragraph (a) and under
paragraph (b), lifting the stay on the
entries for CAS Nos. 74–93–1 and 7783–
06–04 and all related dates.
■
[FR Doc. 2011–23534 Filed 10–14–11; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\17OCR1.SGM
17OCR1
Agencies
[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Rules and Regulations]
[Pages 64022-64037]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23534]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[EPA-HQ-TRI-2009-0844; FRL-9463-5]
RIN 2025-AA27
Hydrogen Sulfide; Community Right-to-Know Toxic Chemical Release
Reporting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Lifting of Administrative Stay for Hydrogen Sulfide.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing that it is lifting the Administrative Stay
of the Emergency Planning and Community Right-to-Know Act (EPCRA)
section 313 toxic chemical release reporting requirements for hydrogen
sulfide (Chemical Abstracts Service Number (CAS No.) 7783-06-4).
Hydrogen sulfide was added to the EPCRA section 313 list of toxic
chemicals in a final rule published in the Federal Register on
[[Page 64023]]
December 1, 1993. However, on August 22, 1994, EPA issued an
Administrative Stay of the reporting requirements for hydrogen sulfide
in order to evaluate issues brought to the Agency's attention after
promulgation of the final rule concerning the human health effect basis
for the listing and the Agency's use of exposure analysis in EPCRA
section 313 listing decisions. Although the final rule listing hydrogen
sulfide under section 313 of EPCRA remained in force, the stay deferred
the reporting requirements for hydrogen sulfide while EPA completed
this further evaluation. EPA completed its further evaluation of
additional information that has become available since the stay was put
in place regarding the human health and environmental effects of
hydrogen sulfide, and the Agency published a position that the stay
should be lifted in the February 26, 2010, Federal Register document
``Intent to Consider Lifting Administrative Stay; Opportunity for
Public Comment.'' Based on EPA's further evaluation and the
consideration of the public comments received on the notice of intent,
EPA continues to believe that the Administrative Stay should be lifted.
By this current action, EPA is not revisiting the original listing
decision, which was accomplished by final rule on December 1, 1993.
Rather, EPA is lifting the Administrative Stay of the reporting
requirements for hydrogen sulfide.
DATES: This action is effective on October 17, 2011, such that the
first reports on hydrogen sulfide will be due on July 1, 2013 for
reporting year 2012.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-TRI-2009-0844. All documents in the docket are listed in the
https://www.regulations.gov index. 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, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in https://www.regulations.gov or in hard copy at the OEI Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
This Docket Facility 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
OEI Docket is (202) 566-1752.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Environmental
Analysis Division, Office of Information Analysis and Access (2842T),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 202-566-0743; fax number: 202-
566-0677; e-mail: bushman.daniel@epa.gov, for specific information on
this document. For general information on EPCRA section 313, contact
the Emergency Planning and Community Right-to-Know Hotline, toll free
at (800) 424-9346 or (703) 412-9810 in Virginia and Alaska or toll
free, TDD (800) 553-7672, https://www.epa.gov/epaoswer/hotline/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or otherwise use hydrogen sulfide. Potentially affected
categories and entities may include, but are not limited to:
----------------------------------------------------------------------------------------------------------------
Category Examples of potentially affected entities
----------------------------------------------------------------------------------------------------------------
Industry.................................... Facilities included in the following NAICS manufacturing codes
(corresponding to SIC codes 20 through 39): 311*, 312*, 313*,
314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332,
333, 334*, 335*, 336, 337*, 339*, 111998*, 211112*, 212324*,
212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130,
511140*, 511191, 511199, 512220, 512230*, 519130*, 541712*, or
811490*.
*Exceptions and/or limitations exist for these NAICS codes.
Facilities included in the following NAICS codes (corresponding to
SIC codes other than SIC codes 20 through 39): 212111, 212112,
212113 (correspond to SIC 12, Coal Mining (except 1241)); or
212221, 212222, 212231, 212234, 212299 (correspond to SIC 10,
Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112,
221113, 221119, 221121, 221122, 221330 (Limited to facilities
that combust coal and/or oil for the purpose of generating power
for distribution in commerce) (correspond to SIC 4911, 4931, and
4939, Electric Utilities); or 424690, 425110, 425120 (Limited to
facilities previously classified in SIC 5169, Chemicals and
Allied Products, Not Elsewhere Classified); or 424710
(corresponds to SIC 5171, Petroleum Bulk Terminals and Plants);
or 562112 (Limited to facilities primarily engaged in solvent
recovery services on a contract or fee basis (previously
classified under SIC 7389, Business Services, NEC)); or 562211,
562212, 562213, 562219, 562920 (Limited to facilities regulated
under the Resource Conservation and Recovery Act, subtitle C, 42
U.S.C. 6921 et seq.) (correspond to SIC 4953, Refuse Systems).
Federal Government.......................... Federal facilities.
----------------------------------------------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Some of the entities listed in the table have exemptions and/or
limitations regarding coverage, and other types of entities not listed
in the table could also be affected. To determine whether your facility
would be affected by this action, you should carefully examine the
applicability criteria in part 372 subpart B of Title 40 of the Code of
Federal Regulations. If you have questions regarding the applicability
of this action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.
II. Introduction
Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities
that manufacture, process, or otherwise use listed toxic chemicals in
amounts above reporting threshold levels to report their environmental
releases and other waste management quantities of such chemicals
annually. These facilities must also report pollution prevention and
recycling data for such chemicals, pursuant to section 6607 of the
Pollution Prevention Act (PPA), 42 U.S.C. 13106. EPCRA section 313
established an initial list of toxic chemicals composed of more than
300 chemicals and 20 chemical categories.
EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets forth criteria for these actions. Specifically, EPCRA
section 313(d)(2) states that EPA may add a chemical to the list if
``there is sufficient evidence to establish any one'' of the listing
criteria. Therefore, to add a chemical, EPA must demonstrate that at
least one criterion is met, but need not determine whether any other
criterion is met. Conversely, EPCRA section 313(d)(3) states that to
remove a chemical from the list, EPA must determine that ``there is not
sufficient evidence to establish any'' of
[[Page 64024]]
the Section 313(d)(2) criteria. Therefore, to remove a chemical, EPA
must demonstrate that none of the criteria are met. The EPCRA section
313(d)(2) criteria are:
(A) The chemical is known to cause or can reasonably be anticipated
to cause significant adverse acute human health effects at
concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
(B) The chemical is known to cause or can reasonably be anticipated
to cause in humans--
(i) Cancer or teratogenic effects, or
(ii) Serious or irreversible--
(I) Reproductive dysfunctions,
(II) Neurological disorders,
(III) Heritable genetic mutations, or
(IV) Other chronic health effects.
(C) The chemical is known to cause or can be reasonably anticipated
to cause, because of
(i) Its toxicity,
(ii) Its toxicity and persistence in the environment, or
(iii) Its toxicity and tendency to bioaccumulate in the
environment, a significant adverse effect on the environment of
sufficient seriousness, in the judgment of the Administrator, to
warrant reporting under this section.
EPA often refers to the section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the section 313(d)(2)(B)
criterion as the ``chronic human health effects criterion;'' and the
section 313(d)(2)(C) criterion as the ``environmental effects
criterion.''
Under EPCRA section 313(e)(1), any person may petition EPA to add
chemicals to or delete chemicals from the list. EPA issued a statement
of petition policy and guidance in the Federal Register of February 4,
1987 (52 FR 3479) to provide guidance regarding the recommended content
and format for submitting petitions under EPCRA section 313(e). EPA
also issued guidance in the Federal Register of May 23, 1991 (56 FR
23703) regarding the recommended content of petitions to delete
individual members of the section 313 metal compound categories. In
addition, EPA published in the Federal Register of November 30, 1994
(59 FR 61432) a statement clarifying its interpretation of the section
313(d)(2) and (d)(3) criteria for modifying the section 313 list of
toxic chemicals.
III. Background Information
A. What is the history of the listing of hydrogen sulfide under EPCRA
section 313?
In response to a petition from the Natural Resources Defense
Council and the Governor of New York, hydrogen sulfide, along with 20
other chemicals and two chemical categories, was added to the EPCRA
section 313 list of toxic chemicals as part of a 1993 final rule
(December 1, 1993, 58 FR 63500). Hydrogen sulfide was listed under the
criteria of EPCRA section 313(d)(2)(B) (chronic human health effects)
based on chronic neurotoxic effects in humans and under EPCRA section
313(d)(2)(C) (environmental effects) based on acute aquatic toxicity.
However, on August 22, 1994 (59 FR 43048), EPA issued an Administrative
Stay of the EPCRA section 313 reporting requirements for hydrogen
sulfide. Although the final rule listing hydrogen sulfide under section
313 of EPCRA remained in force, the stay deferred the reporting
requirements for hydrogen sulfide. On February 26, 2010, EPA issued a
document in the Federal Register entitled ``Intent to Consider Lifting
Administrative Stay; Opportunity for Public Comment'' (75 FR 8889).
That document provided the public with the opportunity to comment on
EPA's review of the currently available data on the human health and
environmental effects of hydrogen sulfide--specifically, chronic
respiratory effects, chronic neurotoxic effects, and acute, chronic and
early-life stage aquatic toxicity--and EPA's belief that the
Administrative Stay should be lifted based on that data.
B. What was the basis for the administrative stay?
After the final rule was issued adding hydrogen sulfide to the
EPCRA section 313 list of toxic chemicals, some members of the
regulated community expressed a concern that the ``chronic human health
effects'' basis for listing hydrogen sulfide under EPCRA section
313(d)(2)(B) had changed between the proposed rule (September 8, 1992,
57 FR 41020) and the final rule (December 1, 1993, 58 FR 63500), and
that commenters on the proposed rule therefore did not have an
opportunity to comment on that individual basis for the listing.
Specifically, although the Agency cited the same acute aquatic toxicity
as an ``environmental effects'' basis for the listing under EPCRA
section 313(d)(2)(C) in both the proposed and final rules, the Agency
also cited chronic respiratory effects as a ``chronic human health
effects'' basis under EPCRA section 313(d)(2)(B) in the proposed rule,
but chronic neurotoxic effects as a ``chronic human health effects''
basis under that same provision in the final rule. In addition, after
issuance of the final rule, some members of the regulated community
expressed concern that EPA's decision not to include an exposure
analysis in deciding to list hydrogen sulfide on the basis of chronic
human health effects was inconsistent with past Agency practice.
Although EPA did not agree that it had been inconsistent in its use
of exposure analyses, and notwithstanding the fact that the listing
decision was appropriate based on the acute aquatic toxicity finding
alone under EPCRA section 313(d)(2)(C), the Agency issued an
Administrative Stay of the reporting requirements for hydrogen sulfide
in order to review the concerns raised after issuance of the final rule
by some members of the regulated community.
C. What is EPA's rationale for lifting the administrative stay for
hydrogen sulfide?
EPA's technical evaluation of hydrogen sulfide, as discussed in
detail in the February 26, 2010 Federal Register document (75 FR 8889),
shows that it can reasonably be anticipated to cause chronic health
effects in humans. The chronic health effects have been observed in
laboratory animals at concentrations as low as 28 milligrams per cubic
meter (mg/m\3\) (20 parts per million (ppm)) for neurotoxicity and 41.7
mg/m\3\ (30 ppm) for upper respiratory toxicity. In addition, EPA's
technical evaluation of hydrogen sulfide also shows that it can
reasonably be anticipated to cause, because of its toxicity,
significant adverse effects in aquatic organisms. Examples of hydrogen
sulfide's ecological toxicity include acute toxicity (96-hour
LC50 (i.e., the concentration that is lethal to 50% of test
organisms)) values for freshwater fish that ranged from 0.0149
milligrams per liter (mg/L) (fathead minnow) to 0.0448 mg/L (bluegill),
indicating high aquatic toxicity. Examples of hydrogen sulfide's
chronic ecological toxicity include freshwater fish values that ranged
from a 6-week lowest-observed-effect-concentration (LOEC) (growth rate)
of 0.0005 mg/L in a tropical fish (Mystus nemurus) to a 430-day LOEC
(final weight) of 0.009 mg/L for goldfish, also indicating high aquatic
toxicity.
Based on the above findings, EPA believes that there is no basis
for continuing the Administrative Stay of the reporting requirements
for hydrogen sulfide, and that the Administrative
[[Page 64025]]
Stay should therefore be lifted. As an aside, EPA notes also that it
believes that the above findings clearly demonstrate the correctness of
the Agency's final decision in December 1993 to list hydrogen sulfide
on the EPCRA section 313 toxic chemicals list based on the listing
criteria in EPCRA sections 313(d)(2)(B) and (C).
Finally, in accordance with EPA's stated policy on the use of
exposure assessments (59 FR 61432), EPA does not believe that an
exposure assessment is appropriate for determining whether hydrogen
sulfide meets the criteria of EPCRA section 313(d)(2)(B) or (C), and
therefore the Administrative Stay should not be continued for lack of
an exposure analysis. As EPA explained in the Intent to Lift the Stay
(and as explained in Unit IV.A.1.c. of this Notice):
EPA has determined that hydrogen sulfide can reasonably be
anticipated to cause serious or irreversible chronic human health
effects at relatively low doses and thus is considered to have
moderately high to high chronic toxicity. EPA does not believe that
it is appropriate to consider exposure for chemicals that are
moderately high to highly toxic based on a hazard assessment when
determining if a chemical can be listed for chronic effects pursuant
to EPCRA section 313(d)(2)(B) (see 59 FR 61432, 61433, 61440-61442).
Hydrogen sulfide has also been determined to cause ecotoxicity at
relatively low concentrations, and thus is considered to have high
ecotoxicity. EPA believes that chemicals that induce death or
serious adverse effects in aquatic organisms at relatively low
concentrations (i.e., they have high ecotoxicity) have the potential
to cause significant changes in the population of fish and other
aquatic organisms, and can therefore reasonably be anticipated to
cause a significant adverse effect on the environment of sufficient
seriousness to warrant reporting. EPA does not believe that it is
required to consider exposure for chemicals that have high
ecotoxicity based on a hazard assessment when determining if a
chemical can be listed for effects pursuant to EPCRA section
313(d)(2)(C) (see 59 FR 61432, 61433, 61440-61442). (75 FR 8889,
8893 (Feb. 26, 2010)).
D. What is the purpose of this document?
The purpose of this document is to respond to the public comments
received on EPA's February 26, 2010, Federal Register document ``Intent
to Consider Lifting Administrative Stay; Opportunity for Public
Comment'' (75 FR 8889), and to give notice that EPA is lifting the
Administrative Stay of the EPCRA section 313 toxic chemical release
reporting requirements for hydrogen sulfide. With the lifting of this
stay, pursuant to Section 313 of EPCRA, certain facilities that
manufacture, process, or otherwise use hydrogen sulfide in amounts
above reporting threshold levels must now comply with the reporting
requirements that have been in place since hydrogen sulfide was added
to the EPCRA section 313 list in 1993. The first reports on hydrogen
sulfide will be due on July 1, 2013 for reporting year 2012.
IV. What comments did EPA receive on the intent to consider lifting the
administrative stay and what are EPA's responses to those comments?
EPA received fifteen comments on the Federal Register document
``Intent to Consider Lifting Administrative Stay; Opportunity for
Public Comment'' (75 FR 8889). The comments represented 6 individuals,
32 environmental groups, one state agency, and 10 industry groups.
Environmental groups that commented included the Food & Water Watch,
National Association of Clean Water Agencies, Natural Resources Defense
Council, Waterkeeper Alliance and one comment submitted by 28 other
environmental organizations. The comments from the individuals,
environmental groups, and state agency were supportive of EPA's intent
to lift the Administrative Stay. Many of these groups provided
additional information to support EPA's action as well as requesting
other actions such as listing additional industry sectors that have
significant releases of hydrogen sulfide. The most extensive comments
came from the Hydrogen Sulfide Consortium, whose members are: American
Coke and Coal Chemicals Institute, American Forest and Paper
Association, American Petroleum Institute, Asphalt Institute, Carbon
Disulfide Coalition, Corn Refiners Association, National Petrochemical
and Refiners Association, and The Sulphur Institute. The most
significant opposing comments are summarized and responded to below.
The complete set of comments and EPA's responses can be found in the
response to comment document in the docket for this action (Ref. 1).
A. Comments From the Hydrogen Sulfide Consortium
1. Scope of Comments. Commenters claim that ``EPA cannot properly
limit comments to whether or not EPA should lift its Administrative
Stay of EPCRA section 313 reporting requirements,'' but rather must
revisit the original listing decision accomplished by final rule in
1993. In support of this argument, commenters assert that: (1) EPA
stated, when it issued the Administrative Stay in 1994, that it would
revisit the original listing decision; (2) EPA cited chronic
respiratory effects as one of the bases for listing under EPCRA section
313(d)(2)(B) in the proposed rule, but chronic neurotoxic effects as a
basis under that same provision in the final rule; (3) EPA adopted its
current policy regarding exposure analyses subsequent to the 1993
listing of hydrogen sulfide; and (4) EPA ``must make a new listing
determination before it may lift [the stay].''
For the reasons stated below, EPA disagrees with commenters that
EPA must revisit the original listing decision in the context of EPA's
consideration of lifting the Administrative Stay of the EPCRA reporting
requirements for hydrogen sulfide. Based upon our current review of the
science, as presented in EPA's technical evaluation of hydrogen
sulfide, which is discussed in detail in the February 26, 2010 Federal
Register document (75 FR 8889) and summarized in Unit III.C. of this
document, EPA has determined that there is no need to re-visit the
existing listing determination. Before addressing each of the
commenter's arguments in turn, however, a brief reiteration of the
factual background is useful.
As described in detail below, EPCRA section 313(d)(2) states that
EPA may add a chemical to the list if ``there is sufficient evidence to
establish any one'' (emphasis added) of the listing criteria specified
in section 313(d)(2). Therefore, to add a chemical, EPA must
demonstrate that at least one criterion is met, but need not determine
whether any other criterion is met.
EPA proposed to add hydrogen sulfide to the EPCRA section 313 list
of toxic chemicals on September 8, 1992 (57 FR 41020) based on a
determination that there was sufficient evidence establishing both
chronic human health effects per EPCRA section 313(d)(2)(B)
(specifically, chronic respiratory effects) and environmental effects
per EPCRA section 313(d)(2)(C) (specifically, acute aquatic toxicity).
On December 1, 1993, EPA promulgated a final rule adding hydrogen
sulfide to the EPCRA section 313 list of toxic chemicals (58 FR 63500)
(effective January 1, 1994). In the final rule, the listing decision
was based on a determination that there was sufficient evidence
establishing environmental effects per EPCRA section 313(d)(2)(C)
(specifically, the same acute aquatic toxicity as identified in the
proposed rule) and chronic human health effects per EPCRA section
313(d)(2)(B). In the final rule, however, the chronic human health
effects finding was based on chronic neurotoxic effects, instead of
chronic respiratory effects as stated in the proposed rule.
After the final rule was issued adding hydrogen sulfide to the
EPCRA section 313 list, and notwithstanding the fact
[[Page 64026]]
that the Agency cited the same acute aquatic toxicity as an
``environmental effects'' basis for the listing under EPCRA section
313(d)(2)(C) in both the proposed rule and the final rule, some members
of the regulated community expressed a concern that the Agency cited
chronic respiratory effects as a ``chronic human health effects'' basis
under EPCRA section 313(d)(2)(B) in the proposed rule, but chronic
neurotoxic effects as a ``chronic human health effects'' basis under
that same provision in the final rule. In addition, after issuance of
the final rule, some members of the regulated community expressed
concern that EPA's decision not to include an exposure analysis in
deciding to list hydrogen sulfide on the basis of chronic human health
effects was inconsistent with past Agency practice. As a result of
these concerns, some commenters threatened to bring legal action
challenging the final rule.
In response to the post-promulgation comments and concerns raised
by some in the regulated community, and notwithstanding the fact that
the listing decision was appropriate based on the acute aquatic
toxicity finding alone under EPCRA section 313(d)(2)(C), EPA issued an
Administrative Stay of the EPCRA section 313 reporting requirements for
hydrogen sulfide on August 22, 1994 (59 FR 43048) in order to review
those post-promulgation comments and concerns.
The stay issued on August 22, 1994 made clear that: ``The effect of
this stay is to defer reporting on [hydrogen sulfide] while the Agency
reviews new data and information made available subsequent to the
promulgation of the final rule'' (59 FR 43048 (Aug. 22, 1994) (emphasis
added)). As a result, while the subsequent stay deferred reporting
requirements, the stay did not remove hydrogen sulfide from the EPCRA
section 313 list or alter that final listing determination, which
remained in effect as of January 1, 1994. The listing determination was
never administratively or judicially challenged.
On February 26, 2010, EPA issued a notice announcing its ``Intent
to Consider Lifting [the hydrogen sulfide] Administrative Stay;
Opportunity for Public Comment.'' 75 FR 8889 (hereinafter Intent to
Lift the Stay). That document stated: ``The purpose of this document is
to provide the public with the opportunity to comment on EPA's review
of the currently available data on the human health and environmental
effects of hydrogen sulfide * * * and EPA's belief that the
Administrative Stay should be lifted based on that data* * *. In
addition, this document addresses the concerns raised regarding use of
exposure analyses.'' Id. at 8891. The Intent to Lift the Stay notice
clearly explained: ``By this current action, EPA is not revisiting the
original listing decision, which was accomplished by final rule on
December 1, 1993. Rather, EPA is merely presenting its rationale for
why the Administrative Stay of the reporting requirements for hydrogen
sulfide should be lifted.'' Id. at 8889 (emphasis added).
a. EPA Statements when Issuing the Stay. Commenters first argue
that EPA cannot now limit comment to whether or not to lift the stay
because the Agency stated, when it issued the Administrative Stay in
1994, that it intended, at some point in the future, to ``seek comment
on the Agency's initial determination for [hydrogen sulfide].'' 59 FR
at 43049. Specifically, the Administrative Stay stated:
[T]he Agency will be issuing a forthcoming Federal Register
notice which will seek comment on the Agency's initial determination
for [hydrogen sulfide], * * * procedural issues concerning the
initial final rule, and generally, comments (and any supporting
data) on whether the Agency should either propose to delete
[hydrogen sulfide] or affirm its initial determination and dissolve
today's Administrative Stay. (59 FR at 43049).
Hydrogen sulfide was listed under section 313 of EPCRA by final
rule on December 1, 1993. The stay did not remove hydrogen sulfide from
the EPCRA section 313 list or alter that final listing determination.
The 1993 listing decision was appropriate based on the acute aquatic
toxicity finding alone under EPCRA section 313(d)(2)(C), which was
included in both the proposed and final rules and never questioned.
Therefore, EPA does not believe it is necessary or appropriate to
revisit the 1993 final listing of hydrogen sulfide in order to lift the
stay of reporting requirements.
Further, the Agency believes that its action in taking comment on
its intent to lift the stay is substantially in accord with the course
of action it described in issuing the stay in 1994. In the Intent to
Lift the Stay notice, the Agency discussed and invited comment on the
data underlying its consideration of the matter and EPA's application
of its policy regarding exposure assessment to the listing decision. As
described in the Intent to Lift the Stay notice, EPA's planned course
of action arises out of EPA's review of the currently available data,
which clearly demonstrate both chronic health effects in humans (upper
respiratory tract toxicity and neurotoxicity) and significant adverse
effects in aquatic organisms (acute, chronic, and early life stage).
Further, EPA's consideration of these effects is fully consistent with
its policy on exposure assessment. Based on these findings, EPA
believes that there is no basis for continuing the Administrative Stay
of the reporting requirements for hydrogen sulfide, and that the
Administrative Stay should therefore be lifted.
Moreover, these findings also demonstrate that there is no basis to
consider delisting hydrogen sulfide. EPCRA section 313(d)(3) states
that to remove a chemical from the list, EPA must determine that
``there is not sufficient evidence to establish any'' of the Section
313(d)(2) criteria (emphasis added). Therefore, to remove a chemical,
EPA must demonstrate that none of the criteria are met. As EPA's review
of the currently available data in the context of its consideration of
lifting the Administrative Stay demonstrates, EPA cannot show that none
of the criteria are met. Indeed, the Agency believes that the only
course available is to dissolve the stay, which it is doing through
notice-and-comment, and which is substantially in accord with at least
one of the alternative courses anticipated in 1994.
Finally, to the extent that the commenters are suggesting that EPA
is legally prohibited from now limiting comment to the issue of whether
or not to lift the Administrative Stay based on the statements in the
preamble the Agency made (excerpted above) when issuing the
Administrative Stay, EPA respectfully notes that these preamble
statements do not create such a legal obligation. See, e.g., Natural
Resources Defense Council v. EPA, 559 F.3d 561, 564-65 (D.C. Cir.
2009).
b. Proposed and Final Chronic Human Health Effects. Second,
commenters argue that EPA cannot now limit comment to whether or not to
lift the stay because EPA cited chronic respiratory effects as one of
the bases for listing under EPCRA section 313(d)(2)(B) in the proposed
rule, but chronic neurotoxic effects as a basis under that same
provision in the final rule.
EPCRA section 313(d) authorizes EPA to add or delete chemicals from
the list and sets forth criteria for these actions. The EPCRA section
313(d)(2) criteria are:
(A) The chemical is known to cause or can reasonably be
anticipated to cause significant adverse acute human health effects
at concentration levels that are reasonably likely to exist beyond
facility site boundaries as a result of continuous, or frequently
recurring, releases.
[[Page 64027]]
(B) The chemical is known to cause or can reasonably be
anticipated to cause in humans--
(i) Cancer or teratogenic effects, or
(ii) Serious or irreversible--
(I) Reproductive dysfunctions,
(II) Neurological disorders,
(III) Heritable genetic mutations, or
(IV) Other chronic health effects.
(C) The chemical is known to cause or can be reasonably
anticipated to cause, because of
(i) Its toxicity,
(ii) Its toxicity and persistence in the environment, or
(iii) Its toxicity and tendency to bioaccumulate in the
environment,
a significant adverse effect on the environment of sufficient
seriousness, in the judgment of the Administrator, to warrant
reporting under this section.
EPA often refers to the section 313(d)(2)(A) criterion as the
``acute human health effects criterion;'' the section 313(d)(2)(B)
criterion as the ``chronic human health effects criterion;'' and the
section 313(d)(2)(C) criterion as the ``environmental effects
criterion.''
While it is true that the Agency cited chronic respiratory effects
as a ``chronic human health effects'' basis under EPCRA section
313(d)(2)(B) in the proposed rule, but chronic neurotoxic effects as a
``chronic human health effects'' basis under that same provision in the
final rule, it bears emphasizing once again that the Agency also
separately cited the same acute aquatic toxicity as an ``environmental
effects'' basis for the listing under EPCRA section 313(d)(2)(C) in
both the proposed and final rules. As a result, and in light of the
fact that EPCRA section 313(d)(2) expressly allows EPA to add a
chemical to the list if ``there is sufficient evidence to establish any
one'' of the listing criteria (emphasis added), the 1993 listing
decision was appropriate based on the acute aquatic toxicity finding
alone under EPCRA section 313(d)(2)(C). That basis for the listing was
never questioned and was and continues to be supported by the data
relied upon by EPA in determining that the stay should be lifted. Any
procedural error that may have occurred regarding the section
313(d)(2)(B) ``chronic human health effects'' finding was harmless in
light of the unchallenged section 313(d)(2)(C) ``environmental
effects'' finding presented in both the proposed and final rules. This
analysis also played directly into EPA's decision to proceed in the
manner it has, as opposed to rigidly following its stated intentions in
1994.
EPA is currently lifting the stay of hydrogen sulfide reporting
requirements--a substance that has been and remains listed under EPCRA
since promulgation of the final rule on December 1, 1993--based on
EPA's review of the currently available data, which clearly demonstrate
both chronic health effects in humans (upper respiratory tract toxicity
and neurotoxicity) and significant adverse effects in aquatic organisms
(acute, chronic, and early life stage). EPA is not revisiting the
original listing determination, and comments on the original listing
decision are beyond the scope of this action.
c. EPA's Exposure Analysis Policy. Third, commenters argue that EPA
cannot now limit comment to whether or not to lift the stay because EPA
adopted its current policy regarding exposure analysis subsequent to
the 1993 listing of hydrogen sulfide.
EPA did not ``adopt a new policy'' on its use of exposure analysis
for listing chemicals under EPCRA section 313 subsequent to the listing
of hydrogen sulfide in 1993. Instead, the Agency's then-existing
position on the use of exposure analyses in listing decisions under
EPCRA section 313 was presented in a proposed rule in the Federal
Register of January 12, 1994 (59 FR 1788). That proposed rule provided
the public with the opportunity to comment on the Agency's then-
existing interpretation of the statutory listing criteria as it relates
to the use of exposure considerations. After considering the comments
received, EPA published in the Federal Register of November 30, 1994
(59 FR 61432) a ``chemical expansion'' final rule, including a
statement clarifying its interpretation of the statutory requirements
regarding how exposure is considered in listing decisions. Subsequent
to that final rule, EPA's interpretation of the statutory listing
criteria as it relates to the consideration of exposure was upheld in
National Oilseed Processors Ass'n. v. Browner, 924 F. Supp. 1193
(D.D.C. 1996), aff'd in part & remanded in part, Troy Corp. v. Browner,
120 F.3d 277 (D.C. Cir. 1997).
As stated in the chemical expansion final rule:
Through this rulemaking, EPA is clarifying its position
regarding the use of hazard, exposure, and risk in listing decisions
under EPCRA section 313. EPA will consider exposure factors when
making determinations under section 313(d)(2)(A) (acute human
toxicity). In addition, EPA has discretion to consider exposure
factors where appropriate for determinations under sections
313(d)(2)(B) (chronic human toxicity) and (C) (environmental
toxicity), and that there is a broader range of circumstances in
which exposure will be considered under section 313(d)(2)(C) than
under (B).
EPA has reviewed its past listing decisions in light of this
clarification, and believes that its prior listing determinations
have been consistent in the consideration of exposure in 31 of the
32 listing/delisting determinations previous to this action* * *(59
FR 61442 (Nov. 30, 1994) (emphasis added)).
In Troy Corp. v. Browner, the DC Circuit agreed with EPA, finding:
Were the EPA to abandon a long-held exposure policy and take a
new direction we would, as urged, require a thorough explanation of
its reasons for doing so. Yet, the EPA's pronouncement in its
preamble of its exposure policy is not a change in course. With one
exception, the EPA has consistently stated, as it does in this
rulemaking, that it will consider exposure under subsection (B) only
when the chemical was of ``low to moderately low'' toxicity. * * *
[T]he agency has long maintained that it would consider exposure
under subheading (B) only for low toxicity chemicals. The inorganic
fluorides petition was denied over ten years ago. Since that time,
the agency has made several dozen listing and delisting decisions
under EPCRA. The inorganic fluorides case was the only instance in
which the agency articulated a policy contrary to the one explicated
in this rulemaking. Under these circumstances we cannot say that the
agency has departed from prior practice in a way that requires more
explanation than was provided. (Troy Corp. v. Browner, 120 F.3d at
287 (emphasis added) (citation omitted)).
Thus, EPA did not subsequently adopt a new exposure policy as
Commenters suggest. Rather, the Agency simply clarified the existing
exposure policy. Further, the 31 of 32 previous cases, noted by the
court in Troy Corp., in which the Agency had been consistent with this
exposure policy included the listing of hydrogen sulfide. Therefore,
EPA had applied this same exposure policy to the listing of hydrogen
sulfide, and need not, as Commenters suggest, provide a new notice and
opportunity to comment on the use of exposure analyses in listing
hydrogen sulfide under section 313 of EPCRA.
As EPA explained in the Intent to Lift the Stay:
EPA has determined that hydrogen sulfide can reasonably be
anticipated to cause serious or irreversible chronic human health
effects at relatively low doses and thus is considered to have
moderately high to high chronic toxicity. EPA does not believe that
it is appropriate to consider exposure for chemicals that are
moderately high to highly toxic based on a hazard assessment when
determining if a chemical can be listed for chronic effects pursuant
to EPCRA section 313(d)(2)(B) (see 59 FR 61432, 61433, 61440-61442).
Hydrogen sulfide has also been determined to cause ecotoxicity at
relatively low concentrations, and thus is considered to have high
ecotoxicity. EPA believes that
[[Page 64028]]
chemicals that induce death or serious adverse effects in aquatic
organisms at relatively low concentrations (i.e., they have high
ecotoxicity) have the potential to cause significant changes in the
population of fish and other aquatic organisms, and can therefore
reasonably be anticipated to cause a significant adverse effect on
the environment of sufficient seriousness to warrant reporting. EPA
does not believe that it is required to consider exposure for
chemicals that have high ecotoxicity based on a hazard assessment
when determining if a chemical can be listed for effects pursuant to
EPCRA section 313(d)(2)(C) (see 59 FR 61432, 61433, 61440-61442).
(75 FR 8889, 8893 (Feb. 26, 2010)).
d. EPA Must Make a New Listing Determination. Finally, Commenters
argue that EPA cannot now limit comment to whether or not to lift the
stay because EPA ``must make a new listing determination before it may
lift [the stay].''
This argument merely restates Commenters' first three arguments in
support of Commenters' ultimate position that EPA must revisit the 1993
listing decision. For the reasons already discussed above, the Agency
disagrees with Commenters' arguments.
2. Implementation of EPA's Exposure Policy. Commenters state that
EPA may not implement its policy on the use of exposure analysis in
EPCRA section 313 listing decisions in an arbitrary manner. Commenters
claim that EPA has not identified the specific criteria it utilizes in
determining whether a substance causes chronic human health effects at
relatively low doses or ecotoxicity at relatively low concentrations.
Commenters noted that EPA stated in its intent to lift the
Administrative Stay that it is applying the interpretation of the
statutory listing criteria and the policy on the use of exposure
analyses adopted by the EPA in its November 30, 1994, final rule
listing other substances. Commenters cited EPA's statements from the
rule that exposure considerations are appropriate in making listing
determinations under EPCRA section 313(d)(2)(B) for chemicals with low
to moderately low toxicity based on hazard assessment and under EPCRA
section 313(d)(2)(C) for chemicals that are low or moderately ecotoxic.
Commenters claim that they were unable to identify or locate in the
docket for this action any objective criteria that EPA uses in making a
determination of whether a substance may cause ``serious or
irreversible chronic health effects'' or has ``low to moderately low
toxicity.'' Commenters state that they were unable to find any
explanation of the criteria that EPA uses in deciding whether a
substance has ``low to moderately low ecotoxicity.'' Commenters noted
that EPA stated that its interpretation of the statutory listing
criteria that supports the 1994 policy statement was sustained during
subsequent judicial review.
Commenters state that even if EPA has discretion to select a policy
concerning the circumstances in which exposure analysis will be part of
the EPCRA section 313(d)(2) listing decision, it does not mean the EPA
has unfettered discretion to apply that policy in an arbitrary manner.
Commenters state that if EPA is to have a rational policy that can be
applied in a fair and equitable manner, the scientists conducting a
hazard assessment under EPCRA section 313(d)(2) should not be permitted
to make qualitative judgments concerning potential toxicity in the
absence of objective criteria or guidance concerning what these terms
mean. However, as discussed below, this is precisely the question at
issue in National Oilseed Processors Ass'n. v. Browner, 924 F. Supp.
1193 (D.D.C. 1996), aff'd in part & remanded in part, Troy Corp. v.
Browner, 120 F.3d 277 (D.C. Cir. 1997), where those Courts held that
EPA's exposure analysis policy, including the determination of when a
toxic chemical has ``moderately high to high toxicity'' based on
adverse effects at ``low'' or ``moderate'' dose levels and thus does
not require an exposure analysis in order to be listed, was not
arbitrary or capricious.
EPA has identified the criteria that it uses in making a
determination of whether a substance that may cause ``serious or
irreversible chronic health effects'' has ``low to moderately low
toxicity,'' and has not applied its policy on the use of exposure
analysis in EPCRA section 313 listing determinations in an arbitrary
manner. To the contrary, in the preamble to the 1994 chemical expansion
final rule, EPA explained that two types of chemicals are considered to
exhibit moderately high to high toxicity:
Where a review of the scientific data provides a high
level of confidence that the chemical causes an adverse effect at
relatively low dose levels, and
Where a review of the scientific data indicates that the
chemical will cause various adverse effects at moderate dose levels.
(59 FR 61432, 61433 (Nov. 30, 1994).
Thus, EPA has in fact articulated criteria for its determination
whether or not exposure considerations will be taken into account in
its chemical listing decisions.
More specifically, EPA has provided guidance concerning how it
evaluates chemicals to determine whether they meet the EPCRA section
313 listing criteria, including information on the factors EPA
considers in determining whether a chemical is sufficiently toxic that
exposure need not be considered in the listing decision. The specific
criteria EPA uses to determine whether a chemical has moderately high
or high toxicity, and thus does not have low to moderately low
toxicity, were explained in detail in the 1994 chemical expansion rule:
3. Hazard evaluation. After completing the screening phase, EPA
conducted a thorough hazard assessment for each of the addition
candidates that resulted from the above analyses and determined
based on the weight-of-the evidence if there was sufficient evidence
to establish that the candidate chemical met the statutory criteria
for addition to EPCRA section 313. To make this determination, EPA
senior scientists reviewed readily available toxicity information on
each chemical for each of the following effect areas: acute human
health effects; cancer; other chronic human effects; and
environmental effects. In addition, EPA reviewed, where appropriate,
information on the environmental fate of the chemical.
The hazard assessment was conducted in accordance with relevant
EPA guidelines for each adverse human health or environmental effect
(e.g., the appropriate guidelines for hazard evaluation of chemical
carcinogens and for the type of evidence required to substantiate a
determination of carcinogenicity are the Assessment Guidelines for
Carcinogen Risk (Ref. 4)). During this assessment the number,
severity, and significance of the effects induced by the chemical,
the dose level causing the effect, and the quality and quantity of
the available data, including the nature of the data (e.g., human
epidemiological, laboratory animal, field or workplace studies) and
confidence level in the existing data base, were all considered.
Where a careful review of the scientific data for a particular
chemical results in a high level of confidence that the chemical
causes an adverse effect at relatively low dose levels, EPA believes
that this evidence is sufficient for listing the chemical under
section 313. EPA also believes that where a review of the scientific
data indicates that the chemical will cause various adverse effects
at moderate dose levels, the total weight-of-the-evidence indicates
that there is sufficient evidence for listing the chemical under
EPCRA section 313. EPA believes that both types of chemicals
described above exhibit moderately high to high toxicity based on a
hazard assessment.
EPA also conducted an analysis of exposure for each chemical or
chemical category proposed for listing under EPCRA section
313(d)(2)(A) (i.e., based on adverse acute human health effects),
and, where appropriate, under section 313(d)(2)(C) (i.e., based on
adverse ecological effects). For chemicals listed under EPCRA
section 313(d)(2)(A), this analysis included estimated
concentrations of the chemical at or beyond
[[Page 64029]]
the facility site boundary through the use of estimated releases and
modeling techniques. EPA did not conduct an analysis of exposure for
the chemicals proposed for listing under section 313(d)(2)(B)
because these chemicals exhibit moderately high to high toxicity
based on a hazard assessment (see Unit IV.B. for a discussion of the
use of exposure). As discussed more thoroughly in Unit IV.B. of this
preamble, EPA does not believe that it is appropriate to factor
exposure into the listing decisions for the chemicals being listed
pursuant to section 313(d)(2)(B) in this rulemaking.
Following a review and analysis of the information available
about each chemical in this final rule (including information
provided through public comment) by senior Agency scientists, the
Agency concludes that for each of the chemicals listed one or more
of the EPCRA section 313 listing criteria are met. Moreover, the
adverse effects associated with each of the chemicals being listed
today are serious and significant. In some cases the effects are
extreme, such as cancer or death. In others, the effects are serious
and lasting, including, for example, impairment of a fetus' or an
offspring's physical development, neurological effects inhibiting
motor abilities or mental processes or impairing the ability to
reproduce, or the sustainability of a fragile ecosystem such as an
estuary. For a number of chemicals in the final rule, there is more
than one adverse effect.
It is important to understand that although an adverse effect is
known or can be reasonably anticipated to be caused by a chemical on
the section 313 list, a release of a chemical into a community does
not necessarily mean that the effect will occur. Exposure and dose
are also important factors in determining whether an adverse effect
occurs and how serious the manifestation will be. The listing of a
chemical on the section 313 list does not mean that a particular
community will experience these adverse effects. Instead the purpose
for listing a chemical is to ensure that the public gets information
about releases of such chemicals. Thus, EPA believes that for
chemicals that typically do not affect solely one or two species but
rather affect changes across a whole ecosystem and for which there
is well-documented evidence supporting the adverse effects, that
their addition to the EPCRA section 313 list is warranted even
though the severity of the adverse effects that they induce will be
dependent upon site-specific characteristics. Once EPA makes release
data available through TRI, the community may then make its own
determination on the importance of these releases (and their
potential adverse effects). (59 FR at 61433, 11/30/1994 (emphasis
added)).
EPA went on to state in the chemical expansion rule that:
Through this rulemaking, EPA is clarifying its position
regarding the use of hazard, exposure, and risk in listing decisions
under EPCRA section 313. EPA will consider exposure factors when
making determinations under section 313(d)(2)(A) (acute human
toxicity). In addition, EPA has discretion to consider exposure
factors where appropriate for determinations under sections
313(d)(2)(B) (chronic human toxicity) and (C) (environmental
toxicity), and that there is a broader range of circumstances in
which exposure will be considered under section 313(d)(2)(C) than
under (B).
EPA has reviewed its past listing decisions in light of this
clarification, and believes that its prior listing determinations
have been consistent in the consideration of exposure in 31 of the
32 listing/delisting determinations previous to this action,
including a number of deletions of low toxicity chemicals that
Congress placed on the initial EPCRA section 313 list. EPA is
currently reviewing the one exception, inorganic fluorides, to
determine if additional action is warranted. EPA will continue to
evaluate petitions according to this clarification and will delete
chemicals that do not meet the statutory criteria. (59 FR at 61442,
11/30/1994).
EPA's exposure analysis policy, as set forth in the chemical
expansion Final Rule, was judicially challenged in National Oilseed
Producers Ass'n v. Browner, 924 F. Supp. 1193 (D.D.C. 1996). There, the
plaintiffs presented precisely the same argument that the Hydrogen
Sulfide Consortium now raises. In National Oilseed, the court stated
that ``Plaintiffs * * * claim that EPA has not adequately explained
when it will consider exposure under Section 313(d)(2)(B).'' National
Oilseed, 924 F. Supp. at 1203. The court squarely rejected that
argument, holding:
The Agency argues generally that, in the exercise of its
discretion, it has elected to consider exposure only in limited
circumstances. Specifically, when EPA's hazard assessment shows that
a chemical exhibits only low or moderately low toxicity, EPA will
consider the potential for exposure in making a listing decision.
Conversely, where EPA's hazard assessment reveals that a chemical's
toxicity is high or moderately high, EPA does not consider exposure,
and will list the chemical based solely on its toxic effect.
* * * * *
Moreover, EPA asserts that it explained adequately on the record
that it chose to not consider exposure in this rulemaking because
all of the chemicals proposed for listing under Section 313(d)(2)(B)
were of ``high to moderately-high'' toxicity and therefore
consideration of exposure was not appropriate.
After consideration of the extensive arguments on both sides of
this issue, the Court concludes that the Agency did not act
arbitrarily and capriciously in declining to consider exposure in
the listing decisions for this rulemaking. * * * While a more
clearly and fully articulated policy would be preferable, the Court
cannot conclude that EPA was unreasonable in exercising its
discretion by continuing to exclude consideration of exposure when
chemicals are of high to moderately-high toxicity.
* * * * *
What is significant is that EPA stated what its policy for
consideration of exposure would be, and then described its
application to the chemicals considered in this rulemaking.
Because EPA's decision to not consider exposure in this
rulemaking was consistent with its policy of using exposure data
only in particular circumstances, i.e., where chemicals are of low
toxicity, the Court concludes that the Agency was not arbitrary and
capricious.
National Oilseed, 924 F. Supp. at 1203-04 (citations and footnotes
omitted).
On appeal to the U.S. Court of Appeals for the D.C. Circuit, the
plaintiffs again raised this same argument. There, the court stated:
``* * * [Plaintiffs] argue that the EPA abused its discretion and acted
arbitrarily and capriciously by failing to establish criteria for the
consideration of exposure * * *.'' Troy Corp. v. Browner, 120 F.3d 277,
282 (D.C. Cir. 1997). On this point, the D.C. Circuit rejected the
plaintiffs' argument and affirmed the judgment of the D.C. District
Court in National Oilseed. Troy Corp., 120 F.3d at 293.
Just as EPA did in the 1994 chemical expansion rule and other
previous listing decisions, upheld by the Courts in National Oilseed
and Troy Corp.--including application of the Agency's exposure analysis
policy in conducting such hazard assessments--EPA conducted a hazard
assessment of the human health and ecological effects of hydrogen
sulfide, upon which the determinations that hydrogen sulfide has
moderately high to high human toxicity were based. Based on the data
from the hazard assessment, as presented in the Federal Register notice
and supporting documents, EPA determined that hydrogen sulfide has
moderately high to high toxicity to humans and is highly toxic to
aquatic organisms. EPA discussed these determinations in detail in the
notice of Intent to Lift the Stay in the Federal Register (75 FR 8889,
2/26/2010). Human health toxicity was discussed in detail beginning on
page 8891, with references, and ecological effects were discussed in
detail beginning on page 8893, with references.
In the section of the Federal Register document that discussed the
rationale for lifting the stay, EPA provided the following summary of
the hazard data:
EPA's technical evaluation of hydrogen sulfide shows that it can
reasonably be anticipated to cause chronic health effects in humans.
The chronic health effects have been observed in laboratory animals
at concentrations as low as 28 mg/m\3\ (20 ppm) and 41.7 mg/m\3\ (30
ppm). In addition, EPA's technical evaluation of hydrogen sulfide
also shows that it can reasonably be anticipated
[[Page 64030]]
to cause, because of its toxicity, significant adverse effects in
aquatic organisms. Examples of hydrogen sulfide's ecological
toxicity include acute toxicity (96-hour LC50) values for
freshwater fish that ranged from 0.0149 mg/L (fathead minnow) to
0.0448 mg/L (bluegill), indicating high aquatic toxicity. Examples
of hydrogen sulfide's chronic ecological toxicity include freshwater
fish values that ranged from a 6-week LOEC (growth rate) of 0.0005
mg/L in a tropical fish (Mystus nemurus) to a 430-day LOEC (final
weight) of 0.009 mg/L for goldfish, also indicating high aquatic
toxicity. (75 FR 8893, 2/26/2010).
As the language above clearly shows, EPA did identify the
information and the rationale for why hydrogen sulfide was determined
to have moderately high to high human toxicity and high ecotoxicity.
3. EPA's Rationale for Hydrogen Sulfide's Toxicity Level.
Commenters claim that EPA has not given its rationale for why hydrogen
sulfide causes chronic human health effects at relatively low levels
and ecotoxicity at relatively low concentrations. Commenters contend
that EPA has not provided any rationale for the determinations that no
exposure assessment is needed for hydrogen sulfide. Commenters noted
that EPA provided a description of the chronic human health effects and
ecological toxicity of hydrogen sulfide. Commenters also noted that EPA
asserted that it had made the requisite determinations concerning the
relative magnitude of the toxicity of hydrogen sulfide for both human
health and ecological effects. Commenters contend, however, that EPA's
statements are wholly conclusory and that the docket does not appear to
contain any explanations of the relation between the hazard assessments
prepared by EPA scientists and these determinations. Commenters state
that they do not believe that the effect levels cited by EPA will be
caused by the releases reportable under EPCRA section 313. Commenters
state that they believe that the effect levels cited by EPA as
``relatively low'' are actually very high. Commenters stated that the
chronic health effect levels cited by EPA are 2,000 to 3,000 times
greater than the odor detection threshold (10 parts per billion (ppb))
for hydrogen sulfide. Commenters claim that while releases may result
in ambient hydrogen sulfide concentrations that exceed the odor
detection threshold, the concentrations will always be far below the
lowest levels for chronic effects in animals cited by EPA. Commenters
cited a 1990 EPA study on oil and natural gas extraction and a 1999
Public Health Service study for one city near hydrogen sulfide sources
as evidence that hydrogen sulfide levels are low. Commenters also cited
established state air standards that range from 83 to 200 ppb noting
that these are 100 to 150 times less than the lowest levels EPA cited
for chronic effects in animals.
In discussing the data EPA cited as supporting its evaluation that
hydrogen sulfide is toxic to aquatic organisms at relatively low
concentrations, the commenters stated that while the levels may seem
relatively low in the abstract, they believe they are actually quite
high when viewed in the context of data that clearly establish that
hydrogen sulfide will rapidly oxidize to less toxic chemical forms when
released to surface waters. Commenters cited the EPA Water Quality
Criteria Gold Book as support for their position:
The fact that H2S is oxidized in well-aerated water
by natural biological systems to sulfates or is biologically
oxidized to elemental sulfur has caused investigators to minimize
the toxic effects of H2S on fish and other aquatic life.
(EPA Gold Book, May 1, 1986, page 268 (Ref. 2)).
As discussed in the previous response, EPA has provided guidance on
how it determines whether a chemical has moderately high to high human
toxicity and high ecotoxicity. In its notice of Intent to Lift the
Stay, EPA provided a detailed hazard assessment of both the human
health effects and the ecological effects of hydrogen sulfide. This
assessment included both the effects caused by hydrogen sulfide and the
doses/concentrations that caused those effects. This information was
discussed in the Federal Register (75 FR 8889, 2/26/2010), and the
details were contained in the hazard assessments and other references
cited by EPA. Specifically, at 75 FR 8889, 8891-8893 (Feb. 26, 2010),
EPA's lengthy and detailed technical review of hydrogen sulfide (Part
IV. of the Federal Register notice, entitled ``What is EPA's Technical
Review of Hydrogen Sulfide?''), including references, can be found (and
need not be reiterated here). EPA then concluded, based on the hazard
assessment:
EPA has determined that hydrogen sulfide can reasonably be
anticipated to cause serious or irreversible chronic human health
effects at relatively low doses and thus is considered to have
moderately high to high chronic toxicity * * *. Hydrogen sulfide has
also been determined to cause ecotoxicity at relatively low
concentrations, and thus is considered to have high ecotoxicity. EPA
believes that chemicals that induce death or serious adverse effects
in aquatic organisms at relatively low concentrations (i.e., they
have high ecotoxicity) have the potential to cause significant
changes in the population of fish and other aquatic organisms, and
can therefore reasonably be anticipated to cause a significant
adverse effect on the environment of sufficient seriousness to
warrant reporting. (75 FR 8893, 2/26/2010).
In the section of the Federal Register document that discussed the
rationale for lifting the stay, EPA provided the following summary of
the hazard data:
EPA's technical evaluation of hydrogen sulfide shows that it can
reasonably be anticipated to cause chronic health effects in humans.
The chronic health effects have been observed in laboratory animals
at concentrations as low as 28 mg/m\3\ (20 ppm) and 41.7 mg/m\3\ (30
ppm). In addition, EPA's technical evaluation of hydrogen sulfide
also shows that it can reasonably be anticipated to cause, because
of its toxicity, significant adverse effects in aquatic organisms.
Examples of hydrogen sulfide's ecological toxicity include acute
toxicity (96-hour LC50) values for freshwater fish that
ranged from 0.0149 mg/L (fathead minnow) to 0.0448 mg/L (bluegill),
indicating high aquatic toxicity. Examples of hydrogen sulfide's
chronic ecological toxicity include freshwater fish values that
ranged from a 6-week LOEC (growth rate) of 0.0005 mg/L in a tropical
fish (Mystus nemurus) to a 430-day LOEC (final weight) of 0.009 mg/L
for goldfish, also indicating high aquatic toxicity. (75 FR 8893, 2/
26/2010).
The above determinations are based on the human health effects and
ecological effects caused by hydrogen sulfide and the doses/
concentrations that caused those effects. EPA clearly stated why the
hazard assessment supports a finding of moderately high to high human
toxicity and high ecotoxicity. Therefore, EPA has clearly stated how
the hazard assessment data supports a conclusion that hydrogen sulfide
has moderately high to high human toxicity and high ecological
toxicity.
Regarding the information that the commenter provided on previous
exposure assessments, air standards, etc., none of that information is
relevant to a determination that hydrogen sulfide has mod