Emergency Planning and Notification; Emergency Planning and List of Extremely Hazardous Substances and Threshold Planning Quantities, 21299-21311 [2011-9096]
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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Proposed Rules
21299
TABLE—EUP MICROBIAL PRODUCT ANALYSIS DATA REQUIREMENTS
Guideline No.
Test substance
All use
patterns
Data requirement
Test notes
MP
EP
R
R
R
MP
TGAI and MP
TGAI
EP
TGAI and EP
TGAI
..........................
1, 2
3
R
TGAI and MP
TGAI and EP
2
TGAI and MP
MP
TGAI and EP
EP
2, 4
..........................
R
R
R
R
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
..........................
..........................
..........................
..........................
R
R
R
R
R
R
TGAI and MP
MP
MP
TGAI
MP
TGAI
TGAI and EP
EP
EP
TGAI
EP
TGAI
..........................
5
6
..........................
7
..........................
Product Chemistry and Composition
885.1100 ........
885.1200 ........
885.1250 ........
885.1300 ........
Product identity ............................................................................
Manufacturing process ................................................................
Deposition of a sample in a nationally recognized culture collection.
Discussion of formation of unintentional ingredients ...................
Analysis and Certified Limits
885.1400 ........
885.1500 ........
Analysis of samples .....................................................................
Certification of limits ....................................................................
R
R
Physical and Chemical Characteristics
830.6302
830.6303
830.6304
830.6313
........
........
........
........
830.6317
830.6319
830.6320
830.7000
830.7100
830.7300
........
........
........
........
........
........
Color ............................................................................................
Physical state ...............................................................................
Odor .............................................................................................
Stability to normal and elevated temperatures, metals and
metal ions.
Storage stability ...........................................................................
Miscibility ......................................................................................
Corrosion characteristics .............................................................
pH ................................................................................................
Viscosity .......................................................................................
Density/relative density/bulk density (specific gravity) ................
(d) * * *
3. Required for each isolate of a
microbial pesticide. New isolates must
be deposited with an agreement to
ensure that the sample will be
maintained and will not be discarded
for the duration of the associated
experimental use permit(s).
*
*
*
*
*
[FR Doc. 2011–9191 Filed 4–14–11; 8:45 am]
BILLING CODE 6560–50–P
The public hearing originally
scheduled for April 13, 2011 at 9 a.m.
has been cancelled.
DATES:
FOR FURTHER INFORMATION CONTACT:
Katherine Griffith, U. S. Environmental
Protection Agency, Region 10, 1200
Sixth Avenue, Suite 900, Mail Stop:
OCE–082, Seattle, WA 98101, phone
number: (206) 553–2901, e-mail:
griffith.katherine@epa.gov.
A notice
of proposed rulemaking and a notice of
public hearing that appeared in the
Federal Register on Wednesday, March
2, 2011 (76 FR 11404) announced that
a public hearing was scheduled for
April 13, 2011, at 9 a.m. at the United
States Environmental Protection
Agency, 805 SW. Broadway, Suite 500,
Portland, Oregon 97205.
The public comment period for the
proposed rulemaking expired on April
1, 2011. The notice of proposed
rulemaking and notice of public hearing
instructed those interested in testifying
at the public hearing to submit a
request. As of Monday, April 4, 2011, no
one has requested to speak. Therefore,
the public hearing scheduled for April
13, 2011, is cancelled.
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 281
[EPA–R10–UST–2011–0097; FRL–9296–1]
Oregon: Tentative Approval of State
Underground Storage Tank Program:
Public Hearing Cancellation
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; cancellation of
notice of public hearing.
AGENCY:
This document cancels a
public hearing on a proposed
rulemaking relating to the State of
Oregon’s application for final approval
of its Underground Storage Tank (UST)
Program under Subtitle I of the Resource
Conservation and Recovery Act (RCRA).
The Environmental Protection Agency
did not receive any comments or a
request for a public hearing.
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SUMMARY:
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Dated: April 8, 2011.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2011–9184 Filed 4–14–11; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 355
[EPA–HQ–SFUND–2010–0586; FRL–9295–6]
RIN 2050–AF08
Emergency Planning and Notification;
Emergency Planning and List of
Extremely Hazardous Substances and
Threshold Planning Quantities
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to revise the
manner by which the regulated
community would apply the threshold
planning quantities (TPQs) for those
extremely hazardous substances (EHSs)
that are non-reactive solid chemicals in
solution form. Specifically, facilities
with a solid EHS in solution would be
subject to the Emergency Planning
requirements if the amount of the solid
chemical on-site, when multiplied by
0.2, equaled or exceeded the lower
published TPQ, based on data that
shows less potential for the solid
chemical in solution to remain airborne
in the event of an accidental release.
Previously, EPA assumed that 100% of
the chemical could become airborne in
the event of an accidental release.
DATES: Comments must be submitted on
or before June 14, 2011.
SUMMARY:
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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Proposed Rules
Submit your comments,
identified by Docket ID No. EPA–HQ–
SFUND–2010–0586, by one of the
following methods:
• https://www.regulations.gov: Follow
the online instructions for submitting
comments.
• E-mail: superfund.docket@epa.gov.
• Fax: (202) 566–9744.
• Mail: Superfund Docket,
Environmental Protection Agency, Mail
code: [2822T], 1200 Pennsylvania Ave.,
NW., Washington, DC 20460.
• Hand Delivery: EPA West, Room
3334, 1301 Constitution Ave., NW.,
Washington, DC. Such deliveries are
only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–SFUND–2010–
0586. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
For additional instructions on
submitting comments, go to Section I.B
of the SUPPLEMENTARY INFORMATION
section of this document.
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ADDRESSES:
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Docket: 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 https://
www.regulations.gov/or in hard copy at
the Superfund Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the Superfund Docket is
(202) 566–0276.
FOR FURTHER INFORMATION CONTACT:
Kathy Franklin, Office of Emergency
Management, Mail Code 5104A, U.S.
Environmental Protection Agency, 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460–0002; telephone
number: (202) 564–7987; fax number:
(202) 564–2625; e-mail address:
franklin.kathy@epa.gov. You may also
contact the Superfund, TRI, EPCRA,
RMP and Oil Information Center at (800)
424–9346 or (703) 412–9810 (in the
Washington, DC metropolitan area). The
Telecommunications Device for the Deaf
(TDD) number is (800) 553–7672 or
(703) 412–3323 (in the Washington, DC
metropolitan area). You may wish to
visit the Office of Emergency
Management (OEM) Internet site at
www.epa.gov/emergencies/content/
epcra.
SUPPLEMENTARY INFORMATION: Here are
the contents of today’s preamble.
I. General Information
A. Who is affected by this proposed rule?
B. What should I consider as I prepare my
comments for EPA?
C. What is the statutory authority for this
proposed rule?
D. What is the background for this
proposed rule?
II. Summary of This Action
A. What is the scope of this proposed rule?
B. What is EPA’s rationale for proposing
the TPQ changes?
C. What alternative approaches were
considered?
D. What are the peer review results?
E. What are the economic impacts of the
TPQ changes?
III. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
H. Executive Order 13211: Energy Effects
I. National Technology Transfer and
Advancement Act (‘‘NTAA’’)
J. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
I. General Information
A. Who is affected by this proposed
rule?
Entities that would be affected by this
proposed rule are those organizations
and facilities subject to section 302 of
the Emergency Planning and
Community Right-to-Know Act (EPCRA)
and its implementing regulations found
in 40 CFR part 355, subpart B—
Emergency Planning. To determine
whether your facility is affected by this
action, you should carefully examine
the applicability provisions at 40 CFR
part 355. 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.
B. What should I consider as I prepare
my comments for EPA?
Tips for Preparing Your Comments.
When submitting comments remember
to:
• Identify the rulemaking by docket
number and other identifying
information (subject heading, Federal
Register date and page number).
• Follow directions—The Agency
may ask you to respond to specific
questions or organize comments by
referencing a Code of Federal
Regulations (CFR) part or section
number.
• Explain why you agree or disagree,
suggest alternatives, and substitute
language for your requested changes.
• Describe any assumptions and
provide any technical information and/
or data that you used.
• If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
• Provide specific examples to
illustrate your concerns, and suggest
alternatives.
• Explain your views as clearly as
possible.
• Make sure to submit your
comments by the comment period
deadline identified.
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C. What is the statutory authority for
this proposed rule?
This proposed rule is being issued
under the Emergency Planning and
Community Right-to-Know Act of 1986
(EPCRA), which was enacted as Title III
of the Superfund Amendments and
Reauthorization Act of 1986 (Pub. L. 99–
499), (SARA). The Agency relies on
EPCRA section 328 for general
rulemaking authority.
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D. What is the background of this
proposed rule?
Title III of SARA (EPCRA) establishes
authorities for emergency planning and
preparedness, emergency release
notification reporting, community rightto-know reporting, and toxic chemical
release reporting. It is intended to
encourage state and local planning for,
and response to releases of, hazardous
substances and to provide the public,
local governments, fire departments,
and other emergency officials with
information concerning potential
chemical hazards present in their
communities. The implementing
regulations for emergency planning,
emergency release notification and the
chemicals subject to these regulations
(extremely hazardous substances
(EHSs)) are codified in 40 CFR part 355.
The implementing regulations for
community right-to-know reporting (or
hazardous chemical reporting) are
codified in 40 CFR part 370.
Subtitle A of EPCRA establishes the
framework for local emergency
planning. The statute requires that EPA
publish a list of EHSs. The EHSs list
was established by EPA to identify
chemical substances which could cause
serious irreversible health effects from
accidental releases (52 FR 13378). The
Agency was also directed to establish
threshold planning quantities (TPQs) for
each extremely hazardous substance.
Under EPCRA section 302, a facility
which has an EHS in excess of its TPQ
on-site must notify the State Emergency
Response Commission (SERC) and Local
Emergency Planning Committee (LEPC),
as well as participate in local emergency
planning activities. Under EPCRA
section 304, the facility owner or
operator must report accidental releases
of EHSs and hazardous substances listed
under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) listed in 40 CFR 302.4 in
excess of the reportable quantity (RQ) to
the LEPC and SERC. Under EPCRA
section 311 and 312, facilities which
have a hazardous chemical defined
under the Hazard Communication
Standards (HCS) of the Occupational
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Safety and Health Act (OSHA) at or
above 10,000 pounds or an EHS at or
above its TPQ or 500 pounds, whichever
is lower, are required to submit an
Emergency and Hazardous Chemical
Inventory form and Material Safety Data
Sheet (MSDS) for that chemical to their
SERC, LEPC and local fire department.
The purpose of the EHSs list is to
focus initial efforts in the development
of state and local contingency plans.
Inclusion of a chemical on the EHSs list
does not mean state or local
communities should ban or otherwise
restrict use of a listed chemical. Rather,
such identification indicates a need for
the community to undertake a program
to investigate and evaluate the potential
for accidental exposure associated with
the production, storage or handling of
the chemical at a particular site and
develop a chemical emergency response
plan around those risks.
1. Regulatory Background
The list of EHSs and their TPQs are
codified in 40 CFR part 355,
Appendices A & B. EPA first published
the EHSs list and TPQs along with the
methodology for determining TPQs as
an interim final rule on November 17,
1986 (51 FR 41570). In the final rule of
April 22, 1987 (52 FR 13378), EPA made
a number of revisions. Among other
things, the final rule republished the
EHSs list, added four new chemicals
and revised the methodology for some
TPQs. The final rule also defined TPQs
for EHS solids in solution, based on
comments on the interim final rule.
Details of the methodology used in
determining whether to list a substance
as an EHS and deriving the TPQs are
found in the November 1986 and April
1987 Federal Register notices and in the
technical support documents in the
rulemaking record (‘‘Threshold Planning
Quantities Technical Support
Document’’; ‘‘Chemicals That Were
Assigned Threshold Planning Quantities
Different From the Calculated Index
Value’’; ‘‘Reactive Solids Whose
Threshold Planning Quantities Should
Be Less than 10,000 Pounds’’; ‘‘Changes
Made to Threshold Planning Quantities
Between Proposed Rule and Final Rule’’:
all dated April 7, 1987, and ‘‘Technical
Support Document for Determination of
Levels of Concern,’’ November 11, 1986).
These documents are found in the
docket for this rulemaking.
EPA has since amended the EHSs list
and deleted 51 chemicals. Ten
chemicals were deleted based on the
request of petitioners and the remaining
41 chemicals were deleted as a result of
Agency review. The chemicals were
deleted because they did not meet the
toxicity criteria for the list and/or were
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21301
originally listed in error. Petitions
requesting deletion of two chemicals,
paraquat dichloride (which is discussed
below) and isophorone diisocyante have
been denied. Isophorone diisocyanate
was not deleted from the EHSs list
because its inhalation toxicity met the
EHSs listing criteria.
EPA has also changed the TPQs for
some of the EHSs. In the April 22, 1987
final rule, EPA reduced the TPQs for 36
substances, while it raised the TPQs for
12 substances based on updated acute
toxicity data. Since then, EPA has
lowered the TPQ for muscimol because
of a typographical error in a prior
rulemaking; EPA has raised the TPQ for
isophorone diisocyanate because it was
mistakenly based on a physical state of
reactive solid, when it is actually a
liquid; and EPA has denied a petition to
raise the TPQs for azinphos methyl and
fenamiphos.
After a final rule was published on
November 3, 2008 (73 FR 65452) which
revised the footnotes to Appendix A and
B, EPA found some printing errors in
the Appendix A and B tables of the CFR
affecting 11 EHS listings. This
November 3, 2008 rule did not add,
delete or revise any of the EHS names,
RQs or TPQs. For the eleven EHSs
listings, their RQ and TPQ values are
correct, but just appear under the wrong
column heading in the table and one
EHS chemical name mistakenly appears
in CAS No. column. The errors do not
appear in the November 3, 2008 FR
notice, but only in the 2009 and 2010
versions of the CFR. These errors to the
CFR will be corrected in a future effort.
2. Petition for Paraquat Dichloride
Paraquat dichloride was originally
listed as paraquat with a CAS No. 1910–
42–5 on the final EHSs list. The lower
TPQ was set at 10 pounds for paraquat
dichloride with a particle size less than
100 microns in diameter, in molten form
or as a solid in solution. The higher TPQ
was set at 10,000 pounds for a particle
size equal to or greater than 100 microns
in diameter. ICI Americas submitted a
petition in October 1989 that requested
the Agency to remove paraquat from the
EHSs list or alternatively, revise the
TPQ. The TPQ for paraquat was based
on an Immediately Dangerous to Life
and Health (IDLH) value of 1.5
milligrams per cubic meter (mg/m3).
The petitioner requested that EPA base
the TPQ on the LD50 or LC50 test results
rather than the IDLH level. LD50 is the
median lethal dose via dermal exposure
or ingestion, defined as the dose at
which 50 percent of the test animals
died during exposure. LC50 is the
median lethal concentration, defined as
the concentration level at which 50
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percent of the test animals died when
exposed by inhalation within the stated
study time. ICI Americas also noted that
the CAS No. 1910–42–5 represented the
chemical paraquat dichloride, not the
paraquat cation, which can form many
different salts.
On October 12, 1994 (59 FR 51816),
EPA denied the petition to delete
paraquat or modify the TPQ, but
changed the listed chemical name from
paraquat to paraquat dichloride. The
oral toxicity for paraquat dichloride met
the listing criteria based on the paraquat
ion only, but did not meet the listing
criteria based on total paraquat
dichloride weight. Therefore, EPA
changed the basis of the listing from an
oral LD50 of 22 milligrams paraquat ion
per kg of body weight (mg/kg) to an
inhalation LC50 of 0.00138 milligrams
paraquat dichloride per liter of air (mg/
L). Because this inhalation toxicity met
the EHSs listing criteria, paraquat
dichloride was not deleted from the
EHSs list. Further explanation of EPA’s
rationale for denying the petition can be
found in the October 12, 1994 final rule
(59 FR 51816).
3. Zeneca’s Request To Reconsider the
Paraquat Dichloride Petition
In November 1999, Zeneca (formerly
ICI Americas) requested that EPA
reconsider either removing paraquat
dichloride from the EHSs list or raising
its TPQ. Zeneca claimed that the form
of the chemical used in inhalation
toxicity tests (temporarily atomized
powder under laboratory conditions) is
not relevant data to use for listing
paraquat dichloride. Zeneca believed
that it was highly unlikely that
inhalable particles or vapors of paraquat
dichloride could become airborne
during an accidental release. Zeneca did
not agree with the rationale EPA used to
assign a TPQ of 10 pounds to paraquat
dichloride, which is only manufactured,
processed and used in solution form.
Zeneca claimed that EPA did not
explain why a greater potential for
airborne dispersion for solids in
solution exists as opposed to liquid
chemicals.
On October 11, 2000, Syngenta
(formerly Zeneca) filed an action in U.S.
District Court for the District of
Columbia under the Administrative
Procedures Act seeking judicial review
of EPA’s decisions regarding paraquat
dichloride. In this complaint, Syngenta
requested EPA to either delete paraquat
dichloride from the EHSs list or raise its
TPQ. On January 23, 2003, EPA filed a
Motion for Voluntary Remand in order
to reconsider the petition. The court
granted EPA’s motion and dismissed
Syngenta’s complaint on January 31,
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2003. By order of February 24, 2003, the
court denied Syngenta’s Motion to
Amend Judgment. EPA again reviewed
the request to delete paraquat dichloride
and/or to raise its TPQ. In a November
21, 2003 letter to the petitioner, EPA
reaffirmed its denial to delete paraquat
dichloride from the EHSs list. EPA
concluded that the acute toxicity of
paraquat dichloride meets the criteria
for listing it as an EHS chemical. In the
same letter to the petitioner, however,
EPA agreed to consider a revision to the
TPQ for paraquat dichloride in the
context of a proposed rule to amend the
TPQ for all EHS chemicals handled as
solids in solution. This letter is in the
docket for today’s rulemaking.
II. Summary of This Action
A. What is the scope of this proposed
rule?
The scope of this proposed rule is to
revise the manner by which the
regulated community would apply the
TPQ for EHS chemicals that are handled
as solids in solution. There are 157 EHS
chemicals that are non-reactive solids at
ambient temperature, which could
potentially be affected by this change, if
they are handled by facilities in a
solution form. The affected chemicals
are identified in Appendix C in the
‘‘Technical Support Document for
Revised TPQ Method for Solids in
Solution,’’ which is in the Docket to this
rulemaking. These 157 chemicals
appear with two TPQs, (the higher TPQ
is 10,000 pounds) in Appendix A and B
of 40 CFR part 355. However, this
change will not apply to the 12 solid
EHS chemicals that are reactive solids
(noted by footnote ‘‘a’’ in Appendix A
and B of 40 CFR part 355). Reactive
solids are highly reactive with air or
water or are explosive. Because of this,
they are more likely than other solids to
be dispersed into the air due to the
energy or heat created when they react.
Other reactive solids form toxic gases
when they react with air or water. The
explanation for not assigning a 10,000
pound TPQ to each of the reactive solids
is discussed in the document, ‘‘Reactive
Solids Whose Threshold Planning
Quantities Should Be Less Than 10,000
Pounds,’’ April 7, 1987, which can be
found in the docket to this rulemaking.
Additionally, the proposed
methodology of applying TPQs for
solids in solution does not affect the
reporting requirements for Sections 311
and 312 of EPCRA (40 CFR part 370).
Specifically, emergency planning
notification under Section 302 helps
LEPCs identify those facilities whose
accidental releases pose risks to the
surrounding community so they can
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develop emergency plans that identify
the location and number of affected
populations, evacuation or shelter-inplace procedures, etc. On the other
hand, Sections 311 and 312 require
submission of MSDSs and an on-site
inventory of hazardous chemicals to
help emergency responders assess how
to respond to an emergency release or
fire. Responders need the amounts,
manner of storage and locations of the
chemical on-site, not only the amount
released off-site. They need information
on the chemical and physical
properties, hazard ratings, toxicity
information and incompatibilities of the
chemical, as well as measures needed to
contain the spill or fire at the facility.
They need to know what type of
protective equipment is needed to
protect them from exposure, not only
airborne, but dermal.
Solid EHSs (except reactive solids)
have a 10,000 pound TPQ or a specified
lower TPQ for certain forms. For
purposes of complying with the
emergency planning notification
requirements of Section 302 of EPCRA,
EPA is proposing that facilities multiply
the amount of EHS chemical handled as
a solid in solution on-site by 0.2 and
then determine if this amount equals or
exceeds the established lower TPQ. If
the amount of the solid EHS in solution
on-site multiplied by 0.2 does not equal
or exceed the lower TPQ for that solid
EHS, then the facility is not subject to
the EPCRA Section 302 emergency
planning notification requirements for
that substance. This amount includes
only the weight of the chemical and not
the solvent or other chemicals in
solution. The amount of solid in
solution may be determined by
multiplying the weight percent of the
solid in solution in a particular
container by the weight of the solution.
Solutions include aqueous or organic
solutions, slurries, viscous solutions,
suspensions, emulsions, and pastes. The
revised TPQ methodology for solids in
solution is similar to the use of the TPQ
for EHS chemicals that are molten
solids.1
The emergency release notification
requirements under EPCRA Section 304
are not affected by this proposal.
Section 304 requires facilities to notify
the community emergency coordinator
for the LEPC of any area likely to be
affected by the release and the SERC of
any area likely to be affected by the
release (defined in 40 CFR 355.42) at or
above the reportable quantity (RQ) of
1 The TPQ for EHSs that are in a molten form onsite is calculated by multiplying the weight of the
chemical by 0.3 to determine if the lower TPQ is
met or exceeded.
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any EHS or CERCLA hazardous
substance. The RQ is not the same as the
TPQ. TPQs are based on acute
mammalian toxicity and potential for
airborne dispersion. RQs, on the other
hand, are developed using several
criteria, including aquatic toxicity,
mammalian toxicity, ignitability,
reactivity, chronic toxicity, potential
carcinogenicity, biodegradation,
hydrolysis, and photolysis (50 FR
13468, April 4, 1985).
As an example, a facility has 4,000
pounds of a solution of 37% by weight
paraquat dichloride on-site. Therefore,
this solution contains 1,480 pounds of
paraquat dichloride (0.37 × 4,000
pounds). The facility would multiply
1,480 pounds by 0.2 which equals 296
pounds. This amount is then compared
to the TPQ for paraquat dichloride,
which is 10 pounds. Because this
amount exceeds the 10 pound TPQ, the
facility is required to comply with the
emergency notification requirements of
Section 302 of EPCRA. As another
example, a facility has 10 gallons of a
solution of 37% by weight paraquat
dichloride on-site. The density of the
solution is 9.33 pounds per gallon.
Therefore, this solution contains 34.5
pounds of paraquat dichloride (10 gal ×
9.33 lb/gal × 0.37). The facility would
multiply 34.5 pounds by 0.2 which
equals 6.9 pounds. This amount is then
compared to the TPQ for paraquat
dichloride, which is 10 pounds. Because
this amount is less than the 10 pound
TPQ, the facility is not required to
comply with the emergency notification
requirements of Section 302 of EPCRA.
Facilities that handle both the
powdered and solution forms of a
particular solid EHS will have to
consider the quantities of each form and
the particle size to determine whether
they exceed a TPQ. Below are several
examples of how to apply the revised
TPQ methods in various cases.2
Solid in solution exceed lower TPQ,
powder below 10,000 pounds. A facility
has 5,000 pounds of a pure EHS powder
form on-site which is less than the
10,000 pound TPQ. However, they have
1,000 gallons of a 35% by weight EHS
solid in solution with a density of 9
pounds per gallon. The amount of solids
in solution on-site is 3,150 pounds
(1000 gallons × 9 pounds per gallon ×
0.35). Multiplying the 3,150 pounds of
solid in solution by 0.2 equates to 630
pounds, which exceeds the lower TPQ
of 500 pounds. Thus, the facility must
report under Section 302 of EPCRA
based on exceeding the lower TPQ for
the solid in solution form.
2 For these examples, the EHS is not paraquat
dichloride, but an unspecified solid EHS.
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Solid in solution below lower TPQ,
powder exceeds 10,000 pounds. A
facility has 11,000 pounds of a pure
EHS solid powder on-site which is more
than the 10,000 pound TPQ. They also
have 2,000 gallons of a 10% by weight
EHS solid in solution with a density of
9 pounds per gallon. The amount of
solids in solution on-site is 1,800
pounds (2,000 gallons × 9 pounds per
gallon × 0.10). Multiplying the 1,800
pounds of solid in solution by 0.2
equates to 360 pounds, which is less
than the lower TPQ of 500 pounds.
Thus, the facility must report under
Section 302 of EPCRA based on
exceeding the 10,000 pound TPQ for the
solid in powder form.
Solid in solution below lower TPQ,
powder below 10,000 pounds. A facility
has 5,000 pounds of a pure EHS solid
powder which is less than the 10,000
pound TPQ. They also have 1,500
gallons of a 15% by weight EHS solid
in solution with a density of 9 pounds
per gallon. The amount of solids in
solution on-site is 2,025 pounds (1.500
gallons × 9 pounds per gallon × 0.15).
Multiplying the 2,025 pounds of solid in
solution by 0.2 equates to 405 pounds,
which is less than the lower TPQ of 500
pounds. Thus, the facility is not
required to report under Section 302 of
EPCRA because it does not exceed the
lower 500 pound TPQ for the solid in
solution form or the 10,000 pound TPQ
for the powder with particle size greater
than 100 microns.
Powdered product less than 100
microns, processed into solution. If the
same amounts of solid EHS were
involved as the same scenarios above,
except the powder has a particle size of
less than 100 microns, then the lower
500 pound TPQ would apply to the
powder instead of the 10,000 pounds. If
either the amount of powder or solid in
solution exceeds the lower TPQ, the
facility would be required to report
under Section 302 of EPCRA.
EPA is proposing this change based
on data in the literature that shows the
original assumption of 100% potential
airborne release for solids in solution is
inappropriate because it appears to
overestimate the amount of chemical
that would remain airborne after release.
Review of the literature for accidental
releases of liquid aerosols suggests a
new methodology for applying the TPQs
for solids in solution is warranted. The
data shows that no more than 20% of
the release is expected to remain
airborne. More detailed discussion can
be found in Section II.B.4.a of this
preamble and in the technical support
document in the docket to this proposed
rule.
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EPA’s revised TPQ methodology for
EHS solids in solution and supporting
data was peer reviewed and the
technical support document was revised
based on peer review comments. The
results of the peer review and response
to peer review comments are found in
a separate document, ‘‘Peer Review of
Technical Support Document for
Revised TPQ Method for EHS Solids in
Solution,’’ which is available in the
docket to this rulemaking. A summary
of the peer reviewer’s comments and
EPA responses to them are presented in
Section II.D of this preamble.
B. What is EPA’s rationale for the TPQ
changes?
1. Development of Existing TPQs
The TPQs were initially assigned
based on a ranking scheme using a Level
of Concern (LOC) based on acute
toxicity and the potential for airborne
dispersion. The TPQ methodology is
described in detail in the ‘‘Threshold
Planning Quantities Technical Support
Document’’ dated April 7, 1987, which
can be found in the docket for this
rulemaking. For each chemical, a
ranking index was calculated which
equaled the LOC divided by an air
dispersion factor (V). For gases, V = 1,
while for liquids, V was based on a
volatilization model using the molecular
weight and boiling point of the
chemical.
Solid EHS chemicals with a particle
size less than 100 microns in diameter,
molten solids, solids in solution, and
solids with a National Fire Protection
Association (NFPA) reactivity rating of
2, 3, or 4 were assigned a V equal to 1.
If the EHS solid does not have a particle
size less than 100 microns, is not molten
or handled in solution form, and does
not have an NFPA reactivity rating of 2,
3, or 4, then the EHS chemical was
assigned a TPQ of 10,000 pounds,
which corresponds to the highest index
value. Solids with an NFPA reactivity
rating of 2, 3, or 4 are noted with
footnote ‘‘b’’ in the EHSs list.
Between one and 10,000 pounds,
chemicals were assigned to the
intermediate TPQ categories of 10, 100,
500 or 1,000 pounds based on the order
of magnitude ranges of the index values.
Also, for solids in molten form, before
applying the TPQ, the amount of
chemical on-site at any time is
multiplied by an adjustment factor of
0.3 to conservatively account for the
maximum volatilization of the spilled
molten substance that is likely to take
place.
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2. Petitioner’s Arguments for Changing
Paraquat Dichloride’s TPQ
In their complaint, Syngenta did not
agree with EPA’s rationale to assign a
lower TPQ of 10 pounds to paraquat
dichloride, which is only manufactured,
processed and used in solution form.
Syngenta claimed that EPA did not
explain why it assumed a greater
potential for airborne dispersion for
solids in solution as opposed to liquid
chemicals. In addition, Syngenta argued
that Paraquat Dichloride solution is
basically a non-volatile salt dissolved in
water, and that the physical and
chemical characteristics of many solids
like paraquat dichloride limit their
capacity to become airborne. Pure
paraquat dichloride has a very low
vapor pressure and decomposes at about
340° Celsius (C) before it reaches a
boiling point. Syngenta further argued
that using a liquid volatilization model
to set a TPQ for paraquat dichloride is
inappropriate.3 Moreover, Syngenta
stated that ‘‘the laws of physics preclude
the possibility of a release of paraquat
dichloride becoming completely
airborne. Regardless of the emergency
release scenario (extreme temperature,
explosion, etc.), the amount to become
airborne would not only be less than
100%, it would be virtually zero.’’
Syngenta also stated that although
paraquat dichloride can be temporarily
atomized under laboratory conditions
for testing animals, they do not believe
that inhalable particles or vapors of
paraquat dichloride can become
airborne during an accidental release.
In discussions with EPA, Syngenta
also raised the issue of aerosol size as
a factor to be considered in developing
the TPQ methodology for EHS solids in
solution.
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3. Basis for Existing Solids in Solution
TPQs
In the April 7, 1987 ‘‘Threshold
Planning Quantities Technical Support
Document’’ (page 27), EPA noted that
‘‘solids may also be handled in solution
and molten form and could potentially
follow a liquid release scenario.
However, even at molten temperatures,
significant amounts of vapor are not
likely to be generated.’’ On page 24 of
the same technical support document,
when discussing liquid releases, EPA
assumed that a spill of a liquid could
occur as a result of an accidental
situation that involves heat (e.g. fire,
3 EPA agrees with the petitioner that using the
liquid volatilization model to set a TPQ for paraquat
dichloride, whether handled as a pure chemical or
in solution, is inappropriate. However, the TPQ for
paraquat dichloride was not set using the
volatilization method.
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exothermic runaway reaction, or
reactions with air or water).
More specifically, when a solid
chemical is in solution form, the
solution can behave like a liquid during
an accidental release and be dispersed
into the air due to overheating,
overpressure or anything that can cause
a loss of containment from a vessel or
piece of equipment. An accident
involving a release of energy could
create a liquid aerosol type of release
into the air. Such liquid aerosol
droplets, if small enough, can be
dispersed into the air and remain
airborne beyond the facility boundary,
resulting in EHS exposure to the
surrounding community. Environmental
conditions and the properties of the
specific chemical will dictate the
behavior and dispersion of the chemical
after a release or spill has occurred. For
example, the solvent can evaporate from
solution (especially at higher
temperature) and small particulates of
solid remaining after evaporation of the
solvent can potentially be carried offsite. EPA recognized that the solid EHS
(dissolved or suspended in a liquid
solution) will not be dispersed into the
air based on volatilization of the solid,
but because of the energy released from
the accident, or by wind.
At the time of the April 1987
rulemaking, EPA did not have sufficient
information to determine how much of
the solid EHS in solution could be
dispersed airborne off-site and
conservatively used V=1 for this release
scenario. Furthermore, although
paraquat dichloride decomposes at a
temperature of 340° C (644° Fahrenheit,
F), EPA believed that accidents
involving aerosol releases of paraquat
dichloride solution could potentially
occur at temperatures less than 340° C.
Boiling solutions containing nonvolatile solids result in vaporization of
the solvent, but not the solid. However,
the turbulence of boiling the solution
can entrain liquid aerosol droplets
containing the solid into the air.
4. Airborne Dispersion of Solids in
Solution.
Based on more recent information,
EPA has re-evaluated the assumption of
100% airborne releases when setting the
TPQ for solids in solution, not just for
paraquat dichloride solution, but for all
EHS solids in solution, except for the 12
solid EHS chemicals that are reactive
solids.
a. Liquid Aerosol Release Data
EPA reviewed data in the literature on
releases of aerosols to evaluate their
potential use for revising the application
of the TPQs for EHS solids in solution.
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EPA was specifically looking for data on
how much of a solution containing a
dissolved or suspended solid would
remain airborne after an accidental
release. One problem encountered in
reviewing the literature was some
studies only involved chemicals that are
pure liquids and which have vapor
pressures much higher than solid
chemicals. That data would likely not
represent the release and dispersion of
a solid chemical that normally has a
very low vapor pressure. However, the
U.S. Department of Energy (USDOE)
used experimental liquid aerosol release
data involving metal salt solutions to
estimate the Airborne Release Fraction
(ARF) of metal salt solutions for a wide
variety of release scenarios. This
information was collected in a 1994
report, which is available in the docket
to this rulemaking.4 Many of the USDOE
scenarios had very low ARFs; EPA
considered the scenarios with higher
release potential to best serve the
purposes of emergency planning. Also,
scenarios which required hypothetical
input data to compute the ARF were not
used. When median and bounding
(maximum) values of ARFs were
provided for a scenario, EPA used the
maximum ARF in order to be
conservative and cover the worst case
scenario. EPA summarized the data
from those DOE aerosol release
scenarios with the highest (ARFs) in the
table below. (The ARF values, release
scenarios from the USDOE report and
other data are discussed in greater detail
in the technical support document for
this rulemaking, which is available in
the docket to this rulemaking.) From
this data, EPA determined that a worst
case estimate of the ARF for a solution
containing non-volatile solids would be
0.2. This particular ARF is based on the
scenarios of an aqueous solution or air
dried salts under gasoline fire on a
metal surface. The airborne fractions
from the USDOE report generally
contained aerosol sizes less than or
equal to 100 microns. Droplets larger
than 100 microns in diameter are
expected to fall out before they reach a
community outside a facility.
Aerosol release scenario
Thermal Stress from Boiling .........
Maximum
airborne
release
fraction
(ARF)
0.002
4 USDOE. 1994. DOE Handbook, Airborne Release
Fractions/Rates and Respirable Fractions for
Nonreactor Nuclear Facilities. December 1994. US
Department of Energy, Washington, DC 20585 DOE–
HDBK–3010–94. Volume 1—Analysis of
Experimental Data and Volume II—Appendices.
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special grants from some of the CCPS
sponsors and from the USEPA and
Aerosol release scenario
USDOE. The experimental superheated
liquid release data was developed,
documented, peer reviewed and, where
necessary, corrected. The Vapor Cloud
High Pressure Venting Below LiqModeling Subcommittee contracted a
uid Level ....................................
0.12
Pressure Venting Above the Liqreview of the fundamental basis for the
uid Level ....................................
0.002 RELEASE model and to make model
Superheated Liquid Temp ≥ 50 °C
improvements to reconcile the
and ≤ 100 °C .............................
0.1
cyclohexane, chlorine and methylamine
Superheated Liquid Temp ≤ 50 °C
0.01
test data. The results of the model
Burning Organic Layer Over
development and the experimental field
Aqueous Solution ......................
0.1
data used was published in 1999 in a
Aqueous Solution or Dry Salt
CCPS concept book ‘‘RELEASE: A Model
Under Gasoline Fire on Metal ..
0.2
with Data to Predict Aerosol Rainout in
Aerodynamic Entrainment and
Re-Suspension ..........................
0.1
Accidental Releases’’ by David W.
Johnson and John L. Woodward.
Using the highest airborne release
EPA did not use the aerosol release
fraction rather than an average result of
fraction from the CCPS data because
the scenarios is consistent with the
these liquids did not contain any solid
intent of the emergency planning
material in solution. Specifically, the
program to plan for a reasonable worst
reported airborne release fraction for
case scenario. This data is a good
water varied from 0.03 to 0.54 and for
surrogate to use to predict the maximum cyclohexane varied from 0.36 to 0.94.
potential aerosol release fraction of EHS Cyclohexane with a vapor pressure of 95
solids in solution in the event of an
millimeters (mm) mercury (Hg) is more
accidental release. Water is probably the volatile than water with its vapor
most common solvent that would be
pressure of 24 mm Hg. It is not a good
used with most of the EHS solids,
comparison to use aerosol release
whether they are dissolved, suspended
fractions of volatile liquids to estimate
or emulsified in water. Many of the EHS the aerosol release fractions of a solid in
solids are pesticides and pesticides are
solution because solids generally are not
commonly applied as water solutions or very volatile. The water aerosol data
emulsions.
might be a close surrogate for estimating
EPA also looked at experimental data
a release of an aqueous solution of the
collected by the Center for Chemical
solid, but it does not have the important
Process Safety (CCPS) for aerosol
constituent of a dissolved solid, which
releases of water and cyclohexane.
might influence the amount of aerosol
CCPS, a directorate of the American
remaining entrained in the air.
Institute of Chemical Engineers
However, the CCPS data for water
(AICHE), was established in 1985 to
supports EPA’s belief that assuming a
develop and disseminate technical
100% airborne liquid aerosol release is
information for use in the prevention of inappropriate because the water aerosol
major chemical process incidents. CCPS fractions measured in the experiments
develops and publishes guidelines,
were less than one. CCPS also had
conducts seminars, symposia, training
experimental release data for CFC–11
programs and meetings on chemical
and chlorine (both gases) and
process-safety matters; CCPS also
methylamine (a highly volatile chemical
cooperates with other organizations,
with a vapor pressure of 300 mg Hg), but
both internationally and domestically,
EPA did not consider this data for use
to promote process safety. CCPS’s
as a good analogy because of their high
activities are supported by funding and
volatility and they did not contain any
expertise from over 100 entities
solids.
including, industry, consulting firms
USDOE was interested in applying the
and governmental organizations. USEPA experimental aerosol release data to
is a member of this organization.
estimate airborne fractions of liquid
In 1989, the CCPS Vapor Cloud
aerosol releases that were below
Modeling Subcommittee began an
respirable size, which they defined as
‘‘Aerosol Project’’ to meet some of the
particles of 10 micron Aerodynamic
research objectives proposed to the U.S. Equivalent Diameter (AED) or less. By
National Vapor Cloud Research
USDOE’s definition, respirable size
Committee, which included developing particles are those that can be
a superheated liquid release model and
transported through the air and inhaled
developing experimental data to
into the human respiratory system.
validate the model. The experimental
For purposes of establishing TPQs,
field data was the result of field
EPA chose a distance of 100 meters (330
controlled-release experimentation by
feet) to represent the distance from a
CCPS with financial assistance by
source inside a chemical facility to the
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Maximum
airborne
release
fraction
(ARF)
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21305
point where the community might be
exposed. This decision was based on
data indicating that a particle size
greater than 100 microns is not likely to
be deposited more than 100 meters from
the source (‘‘Threshold Planning
Quantities Technical Support
Document,’’ USEPA April 7, 1987,
Public Docket 300PQ, Document No.
300PQ–2–21). The 100-micron cutoff is
also consistent with CERCLA
regulations (for reportable quantities)
which also uses a 100 micron particle
size for powdered materials.
Most of the USDOE experimental
aerosol release data had median aerosol
diameters of less than 100 microns. This
size is consistent with what EPA
believes is the size of aerosols to which
the community could be exposed. On
the other hand, the water and
cyclohexane aerosol release data
compiled by CCPS had much larger
mean aerosol diameter sizes, generally
over 100 microns. For the reasons
already discussed and because it is
likely that aerosol releases with
diameters larger than 100 microns will
fall out of the air before they reach a
community, the water and cylcohexane
aerosol release fractions were not used
in determining the TPQs for solids in
solution.
b. Liquid and Solution TPQ Comparison
Pure EHS liquids could also be
released accidentally as aerosols via the
same catastrophic scenarios
(overpressure, superheating). It could be
argued that perhaps the TPQ method for
solids in solution could also apply to
liquids. However, this goes against the
ranking used for setting TPQs based on
the extent of airborne releases by
physical state as being high for gases,
less for liquids and even less for solids
in solution. Currently, the release
scenario used for developing the liquid
TPQs considers a spill of the liquid due
to a loss of containment. The liquid then
escapes into the air by volatilization. An
airborne release of solids in solution
will require more than a failure of
containment to have appreciable
airborne dispersion. An energy source,
such as overpressure or high
temperature would be required to
disperse the solution into the air and
create aerosol droplets. Not all of the
droplets will stay airborne (unlike
volatilized vapors) and affect the
community, whose exposure depends
on droplet size and distance from the
facility fence line.
If one assumes that there is an equal
potential for airborne releases for gases,
liquids, small particulate solids and
solids in solution, then the TPQ ranking
scheme would change radically and rely
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almost entirely on the toxicity of the
chemical. However, EPA believes that
airborne dispersibility is a critical factor
in determining TPQs. Limited state and
local resources should be focused on
those EHS chemicals that can
potentially cause the greatest harm and
less on those that might be toxic, but
less likely to be released to the air and
carried beyond the facility boundary.
As a hypothetical scenario, EPA
determined if the current TPQ method
for liquids gives more conservative (or
at least as conservative) TPQs (lower
thresholds) as compared to the proposed
TPQ methodology for solids in solution.
To do this, EPA estimated the TPQs for
liquids by assuming that V = 1, and then
divided it by 0.2 (based on an expected
20% maximum airborne dispersion) to
determine the amount of EHS on-site
that would trigger emergency planning
notification. These amounts or ‘‘effective
TPQs’’ were then compared to the
current listed TPQs for liquids. For 116
of the 163 EHS liquids, the current
TPQs for liquids based on volatilization
were equal to or lower than the new
effective TPQs based on aerosolization.
Most of the other 47 liquids had current
TPQs that were about twice the effective
TPQ. This comparison with a table of
results for the EHS liquids is discussed
in the technical support document for
this rulemaking. Based on this analysis,
EPA believes that using the
volatilization model to establish V for
liquid TPQs is still appropriate. The
spilled liquid using a boiling point
scenario is probably the most prevalent
worst-case scenario that is reasonable to
use for establishing TPQs for liquids.
Further examination of the 47 liquid
chemicals was undertaken to see why
these had TPQs greater than the
effective TPQs—that is, about twice the
effective TPQ. Many of these liquids
had effective TPQ values of 5, 50 and
5,000 pounds. However, there are no
TPQs of 5, 50 or 5,000 pounds. Rather,
the use of order of magnitude index
ranges assigned to various TPQ levels
resulted in assigned TPQ values of 1, 10,
100, 500, 1,000 and 10,000 pounds.
Thus, where the effective TPQs are
either 5, 50, or 5,000 pounds, the
comparison of a current TPQ versus an
effective TPQ may not be valid. More
discussion on this can be found in the
technical support document.
C. What alternative approaches were
considered?
Given the data in the literature
available on aerosol releases of solids in
solution, EPA considered various
alternative approaches. One alternative
was using an index ranking method
with an assigned V similar to the
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original method of assigning TPQs.
Another alternative was to apply the
ARF to the existing lower TPQ for solids
to develop a new TPQ for solids in
solution for each solid EHS. A third
alternative was similar to the approach
of multiplying the maximum ARF by
the amount on-site, except that the ARF
would only represent aerosol sizes less
than respirable size. Below we discuss
these alternatives, as well as the basis
for not selecting them.
1. Index Ranking Method With V Less
Than 1
This alternative would establish TPQs
using a ranking approach based on each
chemical’s physical state, acute toxicity
and, the potential for the chemical to
become airborne (V). For this
alternative, V would be set to 0.2 for
EHS solids in solution.
For the original development of the
TPQs, the ranking index was defined as
the LOC divided by V, where V was set
equal to 1 for gases and solids in
powder form with a particle size less
than 100 microns, molten solids and
solids in solution. For liquid EHSs, V
(the potential to become airborne)
depended upon the property of
volatility (evaporation of liquid into the
gas phase). In the development of V for
use in setting TPQs for liquids, V
represented the mass per time evolved
to the air per mass of the spill. This is
explained in further detail in the April
1987 ‘‘Threshold Planning Quantities
Technical Support Document’’ available
in the docket.
Most of the values for V for liquids are
approximately 0.1 (see Appendix B in
the ‘‘Technical Support Document for
Revising TPQ Method for Solids in
Solution’’ for this rule). Using a higher
V equal to 0.2 for solids in solution
implies that in the event of an
accidental release, more of the solution
would become airborne than if it were
volatilized from a liquid spill. Even if a
liquid were accidentally released via
aerosol form, the volatility of the liquid
chemical will increase the fraction that
remains dispersed in the air. Therefore,
it would not be a fair representation to
have a solid in solution with a V higher
than that used for a volatile liquid. Also,
because there are different mechanisms
involved in the two types of releases, it
may not be comparable to use the 0.2 as
a substitute for V for solids in solution.
2. Existing TPQ and Aerosol Release
Fraction
Another alternative is to apply the
ARF to the existing lower TPQ for solids
to develop a new TPQ. For example, the
lower TPQ for paraquat dichloride is 10
pounds. Dividing 10 pounds by 0.2, the
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maximum expected aerosol release
fraction for a solution would result in a
new TPQ of 50 pounds for paraquat
dichloride in solution form. For each of
the 157 non-reactive solids on the EHSs
list, a new TPQ for the solution form of
the EHS solid could be determined and
listed. However, for each solid nonreactive chemical, there are already two
TPQs, one developed based on the
ranking index methodology of (Index =
Level of Concern/V) and one based on
the default TPQ of 10,000 pounds for
non-molten, non-reactive, non-solution
solids with a particle size equal to or
greater than 100 microns. Including a
third set of TPQs for EHS solids in
solution could be confusing to the
regulated community. Thus, EPA
believes that using the existing lower
TPQ for solids and comparing that to
the product of the amount on-site
multiplied by 0.2 is a better approach,
and similar to the approach used for the
molten solids form.
3. Using ARF Limited to Smaller
Aerosol Sizes
Another approach considered is
similar to the proposed approach of
multiplying the maximum ARF by the
amount on-site, except that the ARF
would only represent the fraction of
aerosols with particles less than
respirable size. Through discussions
with the petitioner and EPA’s November
2003 response to the petition, EPA has
considered whether aerosol size should
be used as a factor in developing new
TPQs for solids in solution. A
consultant for Syngenta believes that
EPA should only consider the
dispersion of aerosols with particle sizes
less than or equal to 4 microns because
these smaller aerosols are the size that
can enter the lung and because the
inhalation toxicity tests used for the
basis of the EHSs listing only used very
small particles.
This approach would require
sufficient data on the aerosol size
distribution for each release scenario to
develop a new ARF that would include
only aerosols of 4 microns and lower.
The ARFs currently cited for the
scenarios used for the preferred
approach include aerosol sizes of 100
microns and lower. For some of the
USDOE accident scenarios, it is possible
to recalculate the airborne aerosol
fractions using the raw experimental
data to include only aerosols less than
or equal to 4 microns in diameter. This
results in smaller airborne release
fractions.
EPA does not believe this approach
should be used for a number of reasons,
including:
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• Inhalation toxicity tests are
designed to use small particles to ensure
that the lung is exposed. However, EPA
is not using the inhalation toxicity for
risk assessment, but only as a screening
tool.
• Although the EHSs listing for
paraquat dichloride is based on
inhalation toxicity, EPA also has
concerns regarding dermal and
ingestion exposure via swallowing for
the larger aerosols.
• Solvent evaporation from larger
aerosols can also create smaller aerosols
which can enter the lung.
Each of these is discussed below.
jlentini on DSKJ8SOYB1PROD with PROPOSALS
a. Aerosol Size in Toxicity Tests
Aerosols may be defined as a
suspension of solid or liquid particles in
air. Inhalation acute toxicity tests are
purposely designed with very small
diameter particles in order to ensure
that particles are small enough to enter
the rodent’s lungs and test the toxicity
in the lungs. Larger particles may not
enter deep areas of the lungs and thus,
test results may be misinterpreted if
little inhalation toxicity is shown. EPA
is not attempting to use the airborne
aerosol fraction for purposes of risk
assessment, but only as a tool to set
screening levels for the amount of
chemicals on-site which may potentially
cause harm if accidentally released.
Also, the size of the aerosols used in an
animal laboratory test cannot be
assumed to be the same as those that
people may be exposed to during an
accidental release.
b. Particle Size and Exposure
Inhalable size particles enter the
respiratory tract, including the head
airways and are generally equal to or
less than 100 microns. Thoracic size
particles (generally equal to or less than
10 microns) travel past the larynx and
reach the lung airways and the gasexchange regions of the lung. Respirable
size particles (generally less than or
equal to 4 microns) are a subset of
thoracic particles that are more likely to
reach the gas-exchange region of the
lung.5
Most particles that enter the upper
airways are trapped in mucous that
moves to the throat and is swallowed
within a few hours. Thus, instead of
inhalation exposure deep in the lungs,
exposure to larger particles of chemicals
may occur through dermal exposure to
5 USEPA. October 2004. Air Quality Criteria for
Particulate Matter. Vol I, Chapter 2 and Volume II,
Chapter 6. U.S. Environmental Protection Agency,
Office of Research and Development, National
Center for Environmental Assessment. Research
Triangle Park, NC. EPA/600/P–00/002aF and EPA/
600/P–00/002bF
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mucous membranes or ingestion
exposure through swallowing.
Emergency planning for EHS chemicals
is not limited to inhalation exposure
only, although many of the EHS
chemical listings are based on studies
which meet the EHSs listing criteria for
inhalation toxicity. Although airborne
exposure is the most likely route of
exposure, it is not the only route of
exposure. In the event of an accidental
release, EPA is concerned about all
routes of exposure (inhalation, dermal
and ingestion) to the community. Thus,
exposure to larger size aerosols (e.g.
those above 4 or 10 microns) by any
route, such as through the skin or
mucous membranes) should not be
ignored when setting TPQs.
c. Solvent Evaporation From Aerosols
Even after liquid aerosol droplets are
released, some of the solvent may
evaporate in the air. This would result
in even smaller size aerosols or solid
EHS particulates in the air to which a
community would be exposed. One
concern is that droplets of size greater
than 100 microns could settle quickly,
dry into a smaller particle size and then
become airborne again (re-suspension).
In the event of an accidental release, the
responsible party should clean up
chemicals deposited on the facility
grounds before additional exposure to
the community would take place. The
USDOE report did include data on resuspension of particulates from soil
after an aerosol release. However, the
amount re-suspended did not add much
to the reasonable worst case aerosol
release fraction of 0.2. This scenario is
explained further in the technical
support document for this rule.
D. What are the peer review results?
EPA’s revised TPQ methodology for
EHS solids in solution and supporting
data was peer reviewed and the
technical support document was revised
based on the peer review comments.
The description of the peer review
process, the results of the peer review
and EPA’s response to the peer review
comments are found in a separate
document, ‘‘Peer Review of Technical
Support Document for Revised TPQ
Method for EHS Solids in Solution,’’
which is available in the docket to this
rulemaking. Below are the questions
posed to the peer reviewers, a summary
of the peer reviewers’ comments and
EPA’s responses.
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1. Based on your reading and analysis
of the information provided, do you find
the revised TPQ method to be logical
with a sound scientific basis?
Two of the three reviewers agreed that
the revised TPQ method was logical
with a sound scientific basis using the
USDOE experimental aerosol release
data. However, one reviewer thought the
revised TPQ method may not be based
on the most sound science because the
LOC is based on Immediately Dangerous
to Health and Life values (IDLH) and
animal lethality data that he believes
may not be appropriate. Nonetheless,
this reviewer did think that a cursory
review of the effective TPQ list
(Appendix B in technical support
document) appears to have
appropriately listed the ranking of
chemicals by potential hazard to the
public.
EPA recognizes that use of the IDLH
was an imperfect measure for
determining the LOC, but believes the
approach provides a consistent relative
ranking of the EHS. Where animal
lethality data were substituted, safety
factors were applied to the data to
estimate the LOC. Human data were
taken into account for some chemicals,
such as chemical warfare agents, and
adjustments were made to the TPQ
initially based on index values. EPA
realizes that better data are being
developed that could be used for the
LOC (such as AEGLs—Acute Exposure
Guideline Levels). However, a reevaluation of the LOC for all EHS
chemicals would best be undertaken by
a separate rulemaking effort, given the
extent and complexity of this issue.
2. Is the writing clear and concise? Has
EPA provided the right level of detail?
Is the method understandable? Are the
results clearly presented?
Two of the three reviewers thought
that the revised method was not clear
and understandable and suggested
improvements. For example, it was
recommended that EPA clarify the
definition of a solution, as well as
include a flowchart of the method or a
graph to help describe the approach.
EPA agrees that improvements were
needed in order to present the
information in a better way for the
regulated community to understand and
apply, and the revised technical support
document addresses those concerns.
Thus, additional supporting background
information, discussion about the
development of TPQs, and examples
and calculations of how to apply the
TPQs for EHS solids in solution have
been added to the technical support
document and has been further
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jlentini on DSKJ8SOYB1PROD with PROPOSALS
explained in the preamble to the
proposed rule. The proposed rule,
which was not provided to the peer
reviewers, is written more clearly and is
less technical than the materials given
to the peer reviewers to review.
One reviewer thought that EPA had
provided the right amount of detail, and
thought the method is understandable,
and the text is for the most part
readable. However, the reviewer had
several clarifications and corrections he
thought EPA should make. These
clarifications have been made to the
technical support document, including
improving a description of background
on TPQ development, clarifying some
terms used in the document, and adding
some references and other editorial
comments.
This same reviewer thought the
argument against the alternative
approach of using V=0.2 for developing
TPQ for solids in solutions was not that
convincing. EPA has revised the
discussion of this alternative approach
by stating that EPA believes that this
approach would result in TPQs that
would be too low as compared to TPQs
for liquids of similar toxicity because
most of the liquids have approximately
V=0.1. EPA believes that liquids have a
higher potential for airborne dispersion
because of their inherently higher
volatility. Also, the mechanism for
airborne dispersion for liquids using the
spill model is volatilization, whereas
solids in solution will be dispersed via
aerosolization, so using V=0.2 for
solutions may be not comparable.
3. Is the revised method consistent with
the overall approach used for setting
TPQs for other EHS chemicals?
All three reviewers thought that the
revised method was fairly consistent
with the approach used for setting other
TPQs. However, one reviewer thought
that EPA should consider lowering the
TPQs for 46 of 163 EHS liquids based
on the comparison of using the revised
TPQ method versus the current method.
EPA believes that using a V of 0.2 to
recalculate the TPQ indexes would
result in conservatively low TPQs for
solids in solution as compared to
liquids of the same toxicity. Given that
volatilization requires only the loss of
containment of a chemical, whereas
aerosolization requires the loss of
containment and usually an energy
release, EPA believes the higher
potential for airborne dispersion should
be assigned to liquids as compared to a
non-volatile solid in solution. Because
there are different mechanisms
(volatilization versus aerosolization)
involved in the two types of releases, it
may not be comparable to use 0.2 as a
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substitute for V for solids in solution.
Based on the comments, EPA has
revised the discussion in the preamble
to the rule and Section VI.A—Use
Original Ranking Method to Develop
New TPQs of the document, ‘‘Technical
Support Document for Revised TPQ
Method for EHS Solids in Solution.’’
EPA has also provided a more logical
and clearer explanation for TPQs for
different forms in Appendix A:
Assigning Threshold Planning
Quantities (TPQs) for Extremely
Hazardous Substances, in the above
document.
4. Is the revised method sufficiently
protective for fulfilling accident
prevention purposes of section 302 of
EPCRA?
The reviewers all agreed that the
method was sufficiently conservative to
fulfill the accident prevention purposes
of section 302 of EPCRA.
5. Is the revised method presented in a
straightforward and uncomplicated way
for the regulated community to
understand and apply?
One reviewer thought that the revised
method is not particularly
straightforward and uncomplicated and
that the regulated community will have
difficulty understanding and applying
it. Another reviewer suggested that
examples be provided of how to apply
the method when both powdered and
solution form of a solid EHS is on-site.
One reviewer thought a flow chart might
be helpful to summarize the TPQ
approach for the full spectrum of
chemical forms.
To address these concerns, EPA has
provided in the technical support
document and the preamble to the
proposed rule, a number of examples of
how to apply the new TPQ method for
solids in solution.
6. Are you aware of any other
approaches or significant data/studies
that are relevant and should be included
or referenced in this document? Please
explain
The reviewers were not able to
provide any other approaches or data
that should be used to revise the TPQ
method for solids in solution, although
one did provide other recommendations
regarding the EHS chemical listing
process and the toxicity values used for
TPQs. Some of these comments address
issues that are outside the scope of the
current effort, which focuses only on
TPQs for solids in solution.
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7. Please Provide Any Other Suggestions
You May Have About How To
Strengthen the Document
To address other comments and
concerns of the reviewers, EPA has
clarified that the 12 reactive EHS solids
are not subject to the revised TPQ
method for solids in solution. EPA has
also added several technical references
as suggested into the technical support
document.
E. What are the economic impacts of the
TPQ changes?
Currently, facilities, who have an EHS
present in an amount equal to or greater
than the EHS’s TPQ, are required to:
• Notify the SERC and LEPC that the
facility is subject to emergency planning
notification.
• Notify the SERC and LEPC of a
facility representative to participate in
the local emergency planning process.
• Notify the LEPC of any relevant
facility changes that affect emergency
planning.
• Provide the LEPC with the
necessary information for developing a
local emergency plan, as requested.
For facilities with an EHS that exists
as solids in solution, emergency
planning notification is required if the
amount of solids by weight meets or
exceeds the lower published TPQ for
that chemical. Solid EHSs have another
higher TPQ of 10,000 pounds that
applies only if the EHS is not in
solution, has a particle size equal to or
greater than 100 microns, is not molten
and does not have an NFPA reactivity
rating of 2, 3, or 4.
The proposed rule would subject
facilities with an EHS solid in solution
to the emergency planning requirements
if the amount of solid chemical on-site,
when multiplied by 0.2, equals or
exceeds the lower published TPQ. The
effect would be to allow facilities to
have up to five times larger amounts of
EHS solids in solution on-site than
before without being subject to the
above emergency planning
requirements.
Facilities who already had EHS solids
in solution on-site above the TPQ and
who have already (or should have
already) completed emergency planning
notification should notify their LEPC if
they no longer exceed the TPQ as a
result of this rulemaking. Section
303(d)(2) of EPCRA requires facilities to
promptly provide to their LEPC any
changes relevant to emergency
planning. Regulations at 40 CFR 355.21
clarify that relevant changes to
emergency planning should be reported
within 30 days. EPA expects that this
notification will be a minimal burden.
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The emergency planning notification
requirement is not required annually.
Facilities, who are handling an EHS
solid in solution for the first time, may
benefit from the changes. However, if
they have other EHSs on-site which
trigger the reporting requirements, they
would still have to make the necessary
notifications.
EPA believes that the changes
proposed by this rule can benefit SERCs
and LEPCs to better focus their limited
resources on those amounts of EHS
chemicals that will potentially cause the
greatest harm and to spend fewer
resources on those that pose less harm,
when released. The EHSs list has a total
of 355 chemicals, of which 157 are nonreactive solids. This proposed rule
applies only to those 157 non-reactive
solids and only when they exist in
solution form. While the Agency does
not collect information to quantify the
number of facilities that may be
impacted by this rule, we suspect it will
likely be a minimal number of facilities
that are impacted since we believe that
many of these facilities handle other
EHS chemicals that will trigger the
emergency planning requirements.
However, the Agency solicits comment
and data on the number of facilities that
may be impacted, and the extent of the
impact.
jlentini on DSKJ8SOYB1PROD with PROPOSALS
III. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866 (58 FR
51735, October 4, 1993), this action is a
‘‘significant regulatory action’’ because it
raises novel policy issues arising out of
litigation on the listing of paraquat
dichloride as an EHS. EPA has decided
to modify the manner by which the TPQ
is applied for paraquat dichloride, as
well as any other EHS that exists as a
non-reactive solid in solution.
Specifically, facilities with a nonreactive solid EHS in solution would be
subject to the Emergency Planning
requirements of 40 CFR part 355,
subpart B—Emergency Planning only if
the amount of non-reactive EHS solids
in solution on-site multiplied by 0.2
equals or exceeds the lower published
TPQ. Accordingly, EPA submitted this
action to the Office of Management and
Budget for review under Executive
Order 12866 and any changes made in
response to OMB recommendations
have been documented in the docket for
this action.
The proposed regulation will not have
an annual effect on the economy of $100
million or more or adversely affect in a
material way the economy, a sector of
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the economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local, or tribal
governments or communities.
B. Paperwork Reduction Act
This proposed rule does not impose
any new information collection burden.
Rather, this proposed rule, in effect,
raises the amount of chemical on-site
required before triggering emergency
planning reporting under 40 CFR part
355 for EHS non-reactive solids in
solution. Facilities with this form of
EHS chemical would have already (or
should have already) reported their
presence to their SERC and LEPC and
identified a Facility Emergency
Coordinator and necessary information
for development of a local emergency
plan to their LEPC. If as a result of this
rulemaking, facilities find that they have
an EHS solid in solution on-site which
no longer equals or exceeds the TPQ,
the facility should notify their LEPC.
Section 303(d)(2) of EPCRA requires
facilities to promptly provide to their
LEPC any changes relevant to
emergency planning. Regulations at 40
CFR 355.21 clarify that relevant changes
to emergency planning should be
reported within 30 days. EPA expects
that this notification will be a minimal
burden. The emergency planning
notification requirement is not required
annually. There may be a slight burden
reduction for facilities who are reporting
EHS non-reactive solids in solution for
the first time under the Section 302
requirements.
The Office of Management and Budget
(OMB) has previously approved the
information collection requirements
contained in the existing regulations at
40 CFR part 355 under the provisions of
the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB
control number 2050–0092, EPA ICR
number 1395.07. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
For purposes of assessing the impacts
of today’s proposed rule on small
entities, small entity is defined as: (1) A
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small business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
a small organization that is any not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today’s proposed rule on
small entities, I certify that this action
will not have a significant economic
impact on a substantial number of small
entities. In determining whether a rule
has a significant economic impact on a
substantial number of small entities, the
impact of concern is any significant
adverse economic impact on small
entities, since the primary purpose of
the regulatory flexibility analyses is to
identify and address regulatory
alternatives ‘‘which minimize any
significant economic impact of the rule
on small entities.’’ 5 USC 603 and 604.
Thus, an agency may certify that a rule
will not have a significant economic
impact on a substantial number of small
entities if the rule relieves regulatory
burden, or otherwise has a positive
economic effect on all of the small
entities subject to the rule.
This proposed rule changes the
manner by which facilities apply the
TPQs for those EHSs that are solid
chemicals in solution form. Specifically,
facilities with a non-reactive solid EHS
in solution would be subject to the
Emergency Planning requirements of 40
CFR part 355, subpart B—Emergency
Planning only if the amount of nonreactive EHS solids in solution on-site,
multiplied by 0.2 equals or exceeds the
lower published TPQ. We have
therefore concluded that today’s
proposed rule will relieve regulatory
burden for some affected small entities.
We continue to be interested in the
potential impacts of the proposed rule
on small entities and welcome
comments on issues related to such
impacts.
D. Unfunded Mandates Reform Act
This action contains no Federal
mandates under the provisions of Title
II of the Unfunded Mandates Reform
Act of 1995 (UMRA), 2 U.S.C. 1532–
1538 for state, local, or tribal
governments or the private sector. This
proposed rule does not impose any new
requirements on state, local or tribal
governments. Facilities currently with
EHS non-reactive solids in solution onsite have already (or should have
already) reported these chemicals to
their SERC and LEPC and identified a
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Facility Emergency Coordinator and the
necessary information for developing an
emergency plan to their LEPC. We
expect that this proposed action will
neither increase nor decrease the
requirements for SERCs or LEPCs.
Therefore, this action is not subject to
the requirements of sections 202 or 205
of the UMRA.
This action is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that might significantly or
uniquely affect small governments. This
proposed action does not impose any
new requirements on state, local or
tribal governments.
jlentini on DSKJ8SOYB1PROD with PROPOSALS
E. Executive Order 13132: Federalism
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132.
This proposed rule would reduce the
reporting burden on any facilities that
would have an EHS non-reactive solid
in solution on-site for the first time and
could be subject to the emergency
planning requirements for that chemical
under 40 CFR part 355, subpart B—
Emergency Planning. We also expect
that this proposed action will neither
increase nor decrease the requirements
for SERCs or LEPCs. This rule does not
impose any requirements on state or
local governments. Thus, Executive
Order 13132 does not apply to this
action.
In the spirit of Executive Order 13132
and consistent with EPA policy to
promote communications between EPA
and state and local governments, EPA
specifically solicits comment on this
proposed action from state and local
officials.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications, as specified in Executive
Order 13175, (65 FR 67249, November
9, 2000). This proposed rule would
reduce reporting burden on any
facilities that would have an EHS nonreactive solid in solution on-site for the
first time and could be subject to the
emergency planning requirements for
that chemical under 40 CFR part 355,
subpart B—Emergency Planning. This
action also does not impose any new
requirements on tribal governments.
Thus, Executive Order 13175 does not
apply to this action.
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G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997) because it is not economically
significant as defined in Executive
Order 12866 and because the Agency
does not believe the environmental
health or safety risks addressed by this
action present a disproportionate risk to
children. This proposed rule would
reduce reporting burden on any
facilities that would have an EHS nonreactive solid in solution on-site for the
first time and could be subject to the
emergency planning requirements for
that chemical under 40 CFR part 355,
subpart B—Emergency Planning.
H. Executive Order 13211: Energy
Effects
This action is not a ‘‘significant energy
action’’ as defined in Executive Order
13211 (66 FR 28355, May 22, 2001),
because it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy. Rather,
this proposed rule would reduce
reporting burden on any facilities that
would have an EHS non-reactive solid
in solution on-site for the first time and
could be subject to the emergency
planning requirements for that chemical
under 40 CFR part 355, subpart B—
Emergency Planning.
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless doing so would be inconsistent
with applicable law or would otherwise
be impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations of
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This proposed rule does not involve
technical standards. Therefore, EPA
does not consider the use of any
voluntary consensus standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629 (February 16, 1994)) establishes
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federal executive policy on
environmental justice. Its main
provision directs federal agencies, to the
greatest extent practicable and
permitted by law, to make
environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA has determined that this
proposed rule does not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations
because it does not affect the level of
protection provided to human health or
the environment. That is, based on new
information and data, the Agency
believes that amounts of EHS nonreactive solids in solution that would
remain airborne from a potential release
into the environment from an accident
would be lower than previously
considered, and thus, would have less
impact on the local community. This in
turn will allow SERCs and LEPCs to
better focus their limited resources on
the amounts of EHS chemicals that will
potentially cause the greatest harm,
including those affecting minority or
low-income populations and to spend
fewer resources on those that pose less
harm, when released.
List of Subjects in 40 CFR Part 355
Environmental protection, Air
pollution control, Chemicals, Disaster
assistance, Hazardous substances,
Hazardous waste, Intergovernmental
relations, Natural resources, Penalties,
Reporting and recordkeeping
requirements, Superfund, Water
pollution control, Water supply.
Dated: April 8, 2011.
Lisa P. Jackson,
Administrator.
For the reasons set out in the
preamble, title 40, chapter I of the Code
of Federal Regulations is proposed to be
amended as follows:
PART 355—EMERGENCY PLANNING
AND NOTIFICATION
1. The authority citation for part 355
continues to read as follows:
Authority: Sections 302, 303, 304, 325,
327, 328, and 329 of the Emergency Planning
and Community Right-to-Know Act of 1986
(EPCRA) (42 U.S.C. 11002, 11003, 11004,
11045, 11047, 11048, and 11049).
2. Section 355.16 is amended by
revising paragraph (b) to read as follows:
E:\FR\FM\15APP1.SGM
15APP1
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Proposed Rules
§ 355.16 How do I determine the quantity
of extremely hazardous substances present
for certain forms of solids?
*
*
*
*
*
(b) Solids in solution. Multiply the
weight percent of non-reactive solids in
solution in a particular container by the
total weight of solution in the container.
Then multiply by 0.2.
*
*
*
*
*
3. Section 355.61 is amended by
adding in alphabetical order the
definition of ‘‘Solution’’ to read as
follows:
§ 355.61 How are key words in this part
defined?
*
*
*
*
*
Solution means any aqueous or
organic solutions, slurries, viscous
solutions, suspensions, emulsions, or
pastes.
*
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[FR Doc. 2011–9096 Filed 4–14–11; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 441
[CMS–2296–P]
RIN 0938–AP61
Medicaid Program; Home and
Community-Based Services (HCBS)
Waivers
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
revise the regulations implementing
Medicaid home and community-based
services (HCBS) waivers under section
1915(c) of the Social Security Act by
providing States the option to combine
the existing three waiver targeting
groups as identified in § 441.301. In
addition, we are proposing other
changes to the HCBS waiver provisions
to convey expectations regarding
person-centered plans of care, to
provide characteristics of settings that
are not home and community-based, to
clarify the timing of amendments and
public input requirements when States
propose modifications to HCBS waiver
programs and service rates, and to
describe the additional strategies
available to CMS to ensure State
compliance with the statutory
provisions of section 1915(c) of the Act.
DATES: To be assured consideration,
comments must be received at one of
jlentini on DSKJ8SOYB1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:22 Apr 14, 2011
Jkt 223001
the addresses provided below, no later
than 5 p.m. on June 14, 2011.
ADDRESSES: In commenting, please refer
to file code CMS–22296–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the instructions under the ‘‘More Search
Options’’ tab.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–2296–P, P.O. Box 8016, Baltimore,
MD 21244–1850.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–2296–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses
indicated as appropriate for hand or
PO 00000
Frm 00056
Fmt 4702
Sfmt 4702
21311
courier delivery may be delayed and
received after the comment period.
FOR FURTHER INFORMATION CONTACT:
Kathryn Poisal, (410) 786–5940.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
Section 1915(c) of the Social Security
Act (the Act) authorizes the Secretary of
Health and Human Services to waive
certain Medicaid statutory requirements
so that a State may offer Home and
Community-Based Services (HCBS) to
State-specified group(s) of Medicaid
beneficiaries who otherwise would
require services at an institutional level
of care. This provision was added to the
Act by the Omnibus Budget and
Reconciliation Act of 1981 (Pub. L. 97–
35, enacted August 13, 1981) (OBRA’81)
(with a number of subsequent
amendments). Regulations were
published to effectuate this statutory
provision, with final regulations issued
on July 25, 1994 (59 FR 37719). In the
June 22, 2009 Federal Register (74 FR
29453), we published the Medicaid
Program; Home and Community-Based
Services (HCBS) advance notice of
proposed rulemaking (ANPRM) that
proposed to initiate rulemaking on a
number of areas within the section
1915(c) program. We received 313
comments (which can be accessed at
https://www.regulations.gov/) and held
teleconferences with stakeholders. The
correspondence included comments
from States, health care and community
support providers and associations,
consumer groups, and social workers,
and others. In the following sections, we
discuss comments relating to questions
E:\FR\FM\15APP1.SGM
15APP1
Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Proposed Rules]
[Pages 21299-21311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9096]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 355
[EPA-HQ-SFUND-2010-0586; FRL-9295-6]
RIN 2050-AF08
Emergency Planning and Notification; Emergency Planning and List
of Extremely Hazardous Substances and Threshold Planning Quantities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revise the manner by which the regulated
community would apply the threshold planning quantities (TPQs) for
those extremely hazardous substances (EHSs) that are non-reactive solid
chemicals in solution form. Specifically, facilities with a solid EHS
in solution would be subject to the Emergency Planning requirements if
the amount of the solid chemical on-site, when multiplied by 0.2,
equaled or exceeded the lower published TPQ, based on data that shows
less potential for the solid chemical in solution to remain airborne in
the event of an accidental release. Previously, EPA assumed that 100%
of the chemical could become airborne in the event of an accidental
release.
DATES: Comments must be submitted on or before June 14, 2011.
[[Page 21300]]
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2010-0586, by one of the following methods:
https://www.regulations.gov: Follow the online instructions
for submitting comments.
E-mail: superfund.docket@epa.gov.
Fax: (202) 566-9744.
Mail: Superfund Docket, Environmental Protection Agency,
Mail code: [2822T], 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2010-0586. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or e-mail. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through https://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at https://www.epa.gov/epahome/dockets.htm. For additional instructions on submitting
comments, go to Section I.B of the SUPPLEMENTARY INFORMATION section of
this document.
Docket: 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
https://www.regulations.gov/or in hard copy at the Superfund Docket,
EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
Superfund Docket is (202) 566-0276.
FOR FURTHER INFORMATION CONTACT: Kathy Franklin, Office of Emergency
Management, Mail Code 5104A, U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460-0002; telephone number:
(202) 564-7987; fax number: (202) 564-2625; e-mail address:
franklin.kathy@epa.gov. You may also contact the Superfund, TRI, EPCRA,
RMP and Oil Information Center at (800) 424-9346 or (703) 412-9810 (in
the Washington, DC metropolitan area). The Telecommunications Device
for the Deaf (TDD) number is (800) 553-7672 or (703) 412-3323 (in the
Washington, DC metropolitan area). You may wish to visit the Office of
Emergency Management (OEM) Internet site at www.epa.gov/emergencies/content/epcra.
SUPPLEMENTARY INFORMATION: Here are the contents of today's preamble.
I. General Information
A. Who is affected by this proposed rule?
B. What should I consider as I prepare my comments for EPA?
C. What is the statutory authority for this proposed rule?
D. What is the background for this proposed rule?
II. Summary of This Action
A. What is the scope of this proposed rule?
B. What is EPA's rationale for proposing the TPQ changes?
C. What alternative approaches were considered?
D. What are the peer review results?
E. What are the economic impacts of the TPQ changes?
III. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Energy Effects
I. National Technology Transfer and Advancement Act (``NTAA'')
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
I. General Information
A. Who is affected by this proposed rule?
Entities that would be affected by this proposed rule are those
organizations and facilities subject to section 302 of the Emergency
Planning and Community Right-to-Know Act (EPCRA) and its implementing
regulations found in 40 CFR part 355, subpart B--Emergency Planning. To
determine whether your facility is affected by this action, you should
carefully examine the applicability provisions at 40 CFR part 355. 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.
B. What should I consider as I prepare my comments for EPA?
Tips for Preparing Your Comments. When submitting comments remember
to:
Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
Describe any assumptions and provide any technical
information and/or data that you used.
If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible.
Make sure to submit your comments by the comment period
deadline identified.
[[Page 21301]]
C. What is the statutory authority for this proposed rule?
This proposed rule is being issued under the Emergency Planning and
Community Right-to-Know Act of 1986 (EPCRA), which was enacted as Title
III of the Superfund Amendments and Reauthorization Act of 1986 (Pub.
L. 99-499), (SARA). The Agency relies on EPCRA section 328 for general
rulemaking authority.
D. What is the background of this proposed rule?
Title III of SARA (EPCRA) establishes authorities for emergency
planning and preparedness, emergency release notification reporting,
community right-to-know reporting, and toxic chemical release
reporting. It is intended to encourage state and local planning for,
and response to releases of, hazardous substances and to provide the
public, local governments, fire departments, and other emergency
officials with information concerning potential chemical hazards
present in their communities. The implementing regulations for
emergency planning, emergency release notification and the chemicals
subject to these regulations (extremely hazardous substances (EHSs))
are codified in 40 CFR part 355. The implementing regulations for
community right-to-know reporting (or hazardous chemical reporting) are
codified in 40 CFR part 370.
Subtitle A of EPCRA establishes the framework for local emergency
planning. The statute requires that EPA publish a list of EHSs. The
EHSs list was established by EPA to identify chemical substances which
could cause serious irreversible health effects from accidental
releases (52 FR 13378). The Agency was also directed to establish
threshold planning quantities (TPQs) for each extremely hazardous
substance.
Under EPCRA section 302, a facility which has an EHS in excess of
its TPQ on-site must notify the State Emergency Response Commission
(SERC) and Local Emergency Planning Committee (LEPC), as well as
participate in local emergency planning activities. Under EPCRA section
304, the facility owner or operator must report accidental releases of
EHSs and hazardous substances listed under the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) listed
in 40 CFR 302.4 in excess of the reportable quantity (RQ) to the LEPC
and SERC. Under EPCRA section 311 and 312, facilities which have a
hazardous chemical defined under the Hazard Communication Standards
(HCS) of the Occupational Safety and Health Act (OSHA) at or above
10,000 pounds or an EHS at or above its TPQ or 500 pounds, whichever is
lower, are required to submit an Emergency and Hazardous Chemical
Inventory form and Material Safety Data Sheet (MSDS) for that chemical
to their SERC, LEPC and local fire department.
The purpose of the EHSs list is to focus initial efforts in the
development of state and local contingency plans. Inclusion of a
chemical on the EHSs list does not mean state or local communities
should ban or otherwise restrict use of a listed chemical. Rather, such
identification indicates a need for the community to undertake a
program to investigate and evaluate the potential for accidental
exposure associated with the production, storage or handling of the
chemical at a particular site and develop a chemical emergency response
plan around those risks.
1. Regulatory Background
The list of EHSs and their TPQs are codified in 40 CFR part 355,
Appendices A & B. EPA first published the EHSs list and TPQs along with
the methodology for determining TPQs as an interim final rule on
November 17, 1986 (51 FR 41570). In the final rule of April 22, 1987
(52 FR 13378), EPA made a number of revisions. Among other things, the
final rule republished the EHSs list, added four new chemicals and
revised the methodology for some TPQs. The final rule also defined TPQs
for EHS solids in solution, based on comments on the interim final
rule. Details of the methodology used in determining whether to list a
substance as an EHS and deriving the TPQs are found in the November
1986 and April 1987 Federal Register notices and in the technical
support documents in the rulemaking record (``Threshold Planning
Quantities Technical Support Document''; ``Chemicals That Were Assigned
Threshold Planning Quantities Different From the Calculated Index
Value''; ``Reactive Solids Whose Threshold Planning Quantities Should
Be Less than 10,000 Pounds''; ``Changes Made to Threshold Planning
Quantities Between Proposed Rule and Final Rule'': all dated April 7,
1987, and ``Technical Support Document for Determination of Levels of
Concern,'' November 11, 1986). These documents are found in the docket
for this rulemaking.
EPA has since amended the EHSs list and deleted 51 chemicals. Ten
chemicals were deleted based on the request of petitioners and the
remaining 41 chemicals were deleted as a result of Agency review. The
chemicals were deleted because they did not meet the toxicity criteria
for the list and/or were originally listed in error. Petitions
requesting deletion of two chemicals, paraquat dichloride (which is
discussed below) and isophorone diisocyante have been denied.
Isophorone diisocyanate was not deleted from the EHSs list because its
inhalation toxicity met the EHSs listing criteria.
EPA has also changed the TPQs for some of the EHSs. In the April
22, 1987 final rule, EPA reduced the TPQs for 36 substances, while it
raised the TPQs for 12 substances based on updated acute toxicity data.
Since then, EPA has lowered the TPQ for muscimol because of a
typographical error in a prior rulemaking; EPA has raised the TPQ for
isophorone diisocyanate because it was mistakenly based on a physical
state of reactive solid, when it is actually a liquid; and EPA has
denied a petition to raise the TPQs for azinphos methyl and fenamiphos.
After a final rule was published on November 3, 2008 (73 FR 65452)
which revised the footnotes to Appendix A and B, EPA found some
printing errors in the Appendix A and B tables of the CFR affecting 11
EHS listings. This November 3, 2008 rule did not add, delete or revise
any of the EHS names, RQs or TPQs. For the eleven EHSs listings, their
RQ and TPQ values are correct, but just appear under the wrong column
heading in the table and one EHS chemical name mistakenly appears in
CAS No. column. The errors do not appear in the November 3, 2008 FR
notice, but only in the 2009 and 2010 versions of the CFR. These errors
to the CFR will be corrected in a future effort.
2. Petition for Paraquat Dichloride
Paraquat dichloride was originally listed as paraquat with a CAS
No. 1910-42-5 on the final EHSs list. The lower TPQ was set at 10
pounds for paraquat dichloride with a particle size less than 100
microns in diameter, in molten form or as a solid in solution. The
higher TPQ was set at 10,000 pounds for a particle size equal to or
greater than 100 microns in diameter. ICI Americas submitted a petition
in October 1989 that requested the Agency to remove paraquat from the
EHSs list or alternatively, revise the TPQ. The TPQ for paraquat was
based on an Immediately Dangerous to Life and Health (IDLH) value of
1.5 milligrams per cubic meter (mg/m\3\). The petitioner requested that
EPA base the TPQ on the LD50 or LC50 test results
rather than the IDLH level. LD50 is the median lethal dose
via dermal exposure or ingestion, defined as the dose at which 50
percent of the test animals died during exposure. LC50 is
the median lethal concentration, defined as the concentration level at
which 50
[[Page 21302]]
percent of the test animals died when exposed by inhalation within the
stated study time. ICI Americas also noted that the CAS No. 1910-42-5
represented the chemical paraquat dichloride, not the paraquat cation,
which can form many different salts.
On October 12, 1994 (59 FR 51816), EPA denied the petition to
delete paraquat or modify the TPQ, but changed the listed chemical name
from paraquat to paraquat dichloride. The oral toxicity for paraquat
dichloride met the listing criteria based on the paraquat ion only, but
did not meet the listing criteria based on total paraquat dichloride
weight. Therefore, EPA changed the basis of the listing from an oral
LD50 of 22 milligrams paraquat ion per kg of body weight
(mg/kg) to an inhalation LC50 of 0.00138 milligrams paraquat
dichloride per liter of air (mg/L). Because this inhalation toxicity
met the EHSs listing criteria, paraquat dichloride was not deleted from
the EHSs list. Further explanation of EPA's rationale for denying the
petition can be found in the October 12, 1994 final rule (59 FR 51816).
3. Zeneca's Request To Reconsider the Paraquat Dichloride Petition
In November 1999, Zeneca (formerly ICI Americas) requested that EPA
reconsider either removing paraquat dichloride from the EHSs list or
raising its TPQ. Zeneca claimed that the form of the chemical used in
inhalation toxicity tests (temporarily atomized powder under laboratory
conditions) is not relevant data to use for listing paraquat
dichloride. Zeneca believed that it was highly unlikely that inhalable
particles or vapors of paraquat dichloride could become airborne during
an accidental release. Zeneca did not agree with the rationale EPA used
to assign a TPQ of 10 pounds to paraquat dichloride, which is only
manufactured, processed and used in solution form. Zeneca claimed that
EPA did not explain why a greater potential for airborne dispersion for
solids in solution exists as opposed to liquid chemicals.
On October 11, 2000, Syngenta (formerly Zeneca) filed an action in
U.S. District Court for the District of Columbia under the
Administrative Procedures Act seeking judicial review of EPA's
decisions regarding paraquat dichloride. In this complaint, Syngenta
requested EPA to either delete paraquat dichloride from the EHSs list
or raise its TPQ. On January 23, 2003, EPA filed a Motion for Voluntary
Remand in order to reconsider the petition. The court granted EPA's
motion and dismissed Syngenta's complaint on January 31, 2003. By order
of February 24, 2003, the court denied Syngenta's Motion to Amend
Judgment. EPA again reviewed the request to delete paraquat dichloride
and/or to raise its TPQ. In a November 21, 2003 letter to the
petitioner, EPA reaffirmed its denial to delete paraquat dichloride
from the EHSs list. EPA concluded that the acute toxicity of paraquat
dichloride meets the criteria for listing it as an EHS chemical. In the
same letter to the petitioner, however, EPA agreed to consider a
revision to the TPQ for paraquat dichloride in the context of a
proposed rule to amend the TPQ for all EHS chemicals handled as solids
in solution. This letter is in the docket for today's rulemaking.
II. Summary of This Action
A. What is the scope of this proposed rule?
The scope of this proposed rule is to revise the manner by which
the regulated community would apply the TPQ for EHS chemicals that are
handled as solids in solution. There are 157 EHS chemicals that are
non-reactive solids at ambient temperature, which could potentially be
affected by this change, if they are handled by facilities in a
solution form. The affected chemicals are identified in Appendix C in
the ``Technical Support Document for Revised TPQ Method for Solids in
Solution,'' which is in the Docket to this rulemaking. These 157
chemicals appear with two TPQs, (the higher TPQ is 10,000 pounds) in
Appendix A and B of 40 CFR part 355. However, this change will not
apply to the 12 solid EHS chemicals that are reactive solids (noted by
footnote ``a'' in Appendix A and B of 40 CFR part 355). Reactive solids
are highly reactive with air or water or are explosive. Because of
this, they are more likely than other solids to be dispersed into the
air due to the energy or heat created when they react. Other reactive
solids form toxic gases when they react with air or water. The
explanation for not assigning a 10,000 pound TPQ to each of the
reactive solids is discussed in the document, ``Reactive Solids Whose
Threshold Planning Quantities Should Be Less Than 10,000 Pounds,''
April 7, 1987, which can be found in the docket to this rulemaking.
Additionally, the proposed methodology of applying TPQs for solids
in solution does not affect the reporting requirements for Sections 311
and 312 of EPCRA (40 CFR part 370). Specifically, emergency planning
notification under Section 302 helps LEPCs identify those facilities
whose accidental releases pose risks to the surrounding community so
they can develop emergency plans that identify the location and number
of affected populations, evacuation or shelter-in-place procedures,
etc. On the other hand, Sections 311 and 312 require submission of
MSDSs and an on-site inventory of hazardous chemicals to help emergency
responders assess how to respond to an emergency release or fire.
Responders need the amounts, manner of storage and locations of the
chemical on-site, not only the amount released off-site. They need
information on the chemical and physical properties, hazard ratings,
toxicity information and incompatibilities of the chemical, as well as
measures needed to contain the spill or fire at the facility. They need
to know what type of protective equipment is needed to protect them
from exposure, not only airborne, but dermal.
Solid EHSs (except reactive solids) have a 10,000 pound TPQ or a
specified lower TPQ for certain forms. For purposes of complying with
the emergency planning notification requirements of Section 302 of
EPCRA, EPA is proposing that facilities multiply the amount of EHS
chemical handled as a solid in solution on-site by 0.2 and then
determine if this amount equals or exceeds the established lower TPQ.
If the amount of the solid EHS in solution on-site multiplied by 0.2
does not equal or exceed the lower TPQ for that solid EHS, then the
facility is not subject to the EPCRA Section 302 emergency planning
notification requirements for that substance. This amount includes only
the weight of the chemical and not the solvent or other chemicals in
solution. The amount of solid in solution may be determined by
multiplying the weight percent of the solid in solution in a particular
container by the weight of the solution. Solutions include aqueous or
organic solutions, slurries, viscous solutions, suspensions, emulsions,
and pastes. The revised TPQ methodology for solids in solution is
similar to the use of the TPQ for EHS chemicals that are molten
solids.\1\
---------------------------------------------------------------------------
\1\ The TPQ for EHSs that are in a molten form on-site is
calculated by multiplying the weight of the chemical by 0.3 to
determine if the lower TPQ is met or exceeded.
---------------------------------------------------------------------------
The emergency release notification requirements under EPCRA Section
304 are not affected by this proposal. Section 304 requires facilities
to notify the community emergency coordinator for the LEPC of any area
likely to be affected by the release and the SERC of any area likely to
be affected by the release (defined in 40 CFR 355.42) at or above the
reportable quantity (RQ) of
[[Page 21303]]
any EHS or CERCLA hazardous substance. The RQ is not the same as the
TPQ. TPQs are based on acute mammalian toxicity and potential for
airborne dispersion. RQs, on the other hand, are developed using
several criteria, including aquatic toxicity, mammalian toxicity,
ignitability, reactivity, chronic toxicity, potential carcinogenicity,
biodegradation, hydrolysis, and photolysis (50 FR 13468, April 4,
1985).
As an example, a facility has 4,000 pounds of a solution of 37% by
weight paraquat dichloride on-site. Therefore, this solution contains
1,480 pounds of paraquat dichloride (0.37 x 4,000 pounds). The facility
would multiply 1,480 pounds by 0.2 which equals 296 pounds. This amount
is then compared to the TPQ for paraquat dichloride, which is 10
pounds. Because this amount exceeds the 10 pound TPQ, the facility is
required to comply with the emergency notification requirements of
Section 302 of EPCRA. As another example, a facility has 10 gallons of
a solution of 37% by weight paraquat dichloride on-site. The density of
the solution is 9.33 pounds per gallon. Therefore, this solution
contains 34.5 pounds of paraquat dichloride (10 gal x 9.33 lb/gal x
0.37). The facility would multiply 34.5 pounds by 0.2 which equals 6.9
pounds. This amount is then compared to the TPQ for paraquat
dichloride, which is 10 pounds. Because this amount is less than the 10
pound TPQ, the facility is not required to comply with the emergency
notification requirements of Section 302 of EPCRA.
Facilities that handle both the powdered and solution forms of a
particular solid EHS will have to consider the quantities of each form
and the particle size to determine whether they exceed a TPQ. Below are
several examples of how to apply the revised TPQ methods in various
cases.\2\
---------------------------------------------------------------------------
\2\ For these examples, the EHS is not paraquat dichloride, but
an unspecified solid EHS.
---------------------------------------------------------------------------
Solid in solution exceed lower TPQ, powder below 10,000 pounds. A
facility has 5,000 pounds of a pure EHS powder form on-site which is
less than the 10,000 pound TPQ. However, they have 1,000 gallons of a
35% by weight EHS solid in solution with a density of 9 pounds per
gallon. The amount of solids in solution on-site is 3,150 pounds (1000
gallons x 9 pounds per gallon x 0.35). Multiplying the 3,150 pounds of
solid in solution by 0.2 equates to 630 pounds, which exceeds the lower
TPQ of 500 pounds. Thus, the facility must report under Section 302 of
EPCRA based on exceeding the lower TPQ for the solid in solution form.
Solid in solution below lower TPQ, powder exceeds 10,000 pounds. A
facility has 11,000 pounds of a pure EHS solid powder on-site which is
more than the 10,000 pound TPQ. They also have 2,000 gallons of a 10%
by weight EHS solid in solution with a density of 9 pounds per gallon.
The amount of solids in solution on-site is 1,800 pounds (2,000 gallons
x 9 pounds per gallon x 0.10). Multiplying the 1,800 pounds of solid in
solution by 0.2 equates to 360 pounds, which is less than the lower TPQ
of 500 pounds. Thus, the facility must report under Section 302 of
EPCRA based on exceeding the 10,000 pound TPQ for the solid in powder
form.
Solid in solution below lower TPQ, powder below 10,000 pounds. A
facility has 5,000 pounds of a pure EHS solid powder which is less than
the 10,000 pound TPQ. They also have 1,500 gallons of a 15% by weight
EHS solid in solution with a density of 9 pounds per gallon. The amount
of solids in solution on-site is 2,025 pounds (1.500 gallons x 9 pounds
per gallon x 0.15). Multiplying the 2,025 pounds of solid in solution
by 0.2 equates to 405 pounds, which is less than the lower TPQ of 500
pounds. Thus, the facility is not required to report under Section 302
of EPCRA because it does not exceed the lower 500 pound TPQ for the
solid in solution form or the 10,000 pound TPQ for the powder with
particle size greater than 100 microns.
Powdered product less than 100 microns, processed into solution. If
the same amounts of solid EHS were involved as the same scenarios
above, except the powder has a particle size of less than 100 microns,
then the lower 500 pound TPQ would apply to the powder instead of the
10,000 pounds. If either the amount of powder or solid in solution
exceeds the lower TPQ, the facility would be required to report under
Section 302 of EPCRA.
EPA is proposing this change based on data in the literature that
shows the original assumption of 100% potential airborne release for
solids in solution is inappropriate because it appears to overestimate
the amount of chemical that would remain airborne after release. Review
of the literature for accidental releases of liquid aerosols suggests a
new methodology for applying the TPQs for solids in solution is
warranted. The data shows that no more than 20% of the release is
expected to remain airborne. More detailed discussion can be found in
Section II.B.4.a of this preamble and in the technical support document
in the docket to this proposed rule.
EPA's revised TPQ methodology for EHS solids in solution and
supporting data was peer reviewed and the technical support document
was revised based on peer review comments. The results of the peer
review and response to peer review comments are found in a separate
document, ``Peer Review of Technical Support Document for Revised TPQ
Method for EHS Solids in Solution,'' which is available in the docket
to this rulemaking. A summary of the peer reviewer's comments and EPA
responses to them are presented in Section II.D of this preamble.
B. What is EPA's rationale for the TPQ changes?
1. Development of Existing TPQs
The TPQs were initially assigned based on a ranking scheme using a
Level of Concern (LOC) based on acute toxicity and the potential for
airborne dispersion. The TPQ methodology is described in detail in the
``Threshold Planning Quantities Technical Support Document'' dated
April 7, 1987, which can be found in the docket for this rulemaking.
For each chemical, a ranking index was calculated which equaled the LOC
divided by an air dispersion factor (V). For gases, V = 1, while for
liquids, V was based on a volatilization model using the molecular
weight and boiling point of the chemical.
Solid EHS chemicals with a particle size less than 100 microns in
diameter, molten solids, solids in solution, and solids with a National
Fire Protection Association (NFPA) reactivity rating of 2, 3, or 4 were
assigned a V equal to 1. If the EHS solid does not have a particle size
less than 100 microns, is not molten or handled in solution form, and
does not have an NFPA reactivity rating of 2, 3, or 4, then the EHS
chemical was assigned a TPQ of 10,000 pounds, which corresponds to the
highest index value. Solids with an NFPA reactivity rating of 2, 3, or
4 are noted with footnote ``b'' in the EHSs list.
Between one and 10,000 pounds, chemicals were assigned to the
intermediate TPQ categories of 10, 100, 500 or 1,000 pounds based on
the order of magnitude ranges of the index values. Also, for solids in
molten form, before applying the TPQ, the amount of chemical on-site at
any time is multiplied by an adjustment factor of 0.3 to conservatively
account for the maximum volatilization of the spilled molten substance
that is likely to take place.
[[Page 21304]]
2. Petitioner's Arguments for Changing Paraquat Dichloride's TPQ
In their complaint, Syngenta did not agree with EPA's rationale to
assign a lower TPQ of 10 pounds to paraquat dichloride, which is only
manufactured, processed and used in solution form. Syngenta claimed
that EPA did not explain why it assumed a greater potential for
airborne dispersion for solids in solution as opposed to liquid
chemicals. In addition, Syngenta argued that Paraquat Dichloride
solution is basically a non-volatile salt dissolved in water, and that
the physical and chemical characteristics of many solids like paraquat
dichloride limit their capacity to become airborne. Pure paraquat
dichloride has a very low vapor pressure and decomposes at about
340[deg] Celsius (C) before it reaches a boiling point. Syngenta
further argued that using a liquid volatilization model to set a TPQ
for paraquat dichloride is inappropriate.\3\ Moreover, Syngenta stated
that ``the laws of physics preclude the possibility of a release of
paraquat dichloride becoming completely airborne. Regardless of the
emergency release scenario (extreme temperature, explosion, etc.), the
amount to become airborne would not only be less than 100%, it would be
virtually zero.'' Syngenta also stated that although paraquat
dichloride can be temporarily atomized under laboratory conditions for
testing animals, they do not believe that inhalable particles or vapors
of paraquat dichloride can become airborne during an accidental
release.
---------------------------------------------------------------------------
\3\ EPA agrees with the petitioner that using the liquid
volatilization model to set a TPQ for paraquat dichloride, whether
handled as a pure chemical or in solution, is inappropriate.
However, the TPQ for paraquat dichloride was not set using the
volatilization method.
---------------------------------------------------------------------------
In discussions with EPA, Syngenta also raised the issue of aerosol
size as a factor to be considered in developing the TPQ methodology for
EHS solids in solution.
3. Basis for Existing Solids in Solution TPQs
In the April 7, 1987 ``Threshold Planning Quantities Technical
Support Document'' (page 27), EPA noted that ``solids may also be
handled in solution and molten form and could potentially follow a
liquid release scenario. However, even at molten temperatures,
significant amounts of vapor are not likely to be generated.'' On page
24 of the same technical support document, when discussing liquid
releases, EPA assumed that a spill of a liquid could occur as a result
of an accidental situation that involves heat (e.g. fire, exothermic
runaway reaction, or reactions with air or water).
More specifically, when a solid chemical is in solution form, the
solution can behave like a liquid during an accidental release and be
dispersed into the air due to overheating, overpressure or anything
that can cause a loss of containment from a vessel or piece of
equipment. An accident involving a release of energy could create a
liquid aerosol type of release into the air. Such liquid aerosol
droplets, if small enough, can be dispersed into the air and remain
airborne beyond the facility boundary, resulting in EHS exposure to the
surrounding community. Environmental conditions and the properties of
the specific chemical will dictate the behavior and dispersion of the
chemical after a release or spill has occurred. For example, the
solvent can evaporate from solution (especially at higher temperature)
and small particulates of solid remaining after evaporation of the
solvent can potentially be carried off-site. EPA recognized that the
solid EHS (dissolved or suspended in a liquid solution) will not be
dispersed into the air based on volatilization of the solid, but
because of the energy released from the accident, or by wind.
At the time of the April 1987 rulemaking, EPA did not have
sufficient information to determine how much of the solid EHS in
solution could be dispersed airborne off-site and conservatively used
V=1 for this release scenario. Furthermore, although paraquat
dichloride decomposes at a temperature of 340[deg] C (644[deg]
Fahrenheit, F), EPA believed that accidents involving aerosol releases
of paraquat dichloride solution could potentially occur at temperatures
less than 340[deg] C. Boiling solutions containing non-volatile solids
result in vaporization of the solvent, but not the solid. However, the
turbulence of boiling the solution can entrain liquid aerosol droplets
containing the solid into the air.
4. Airborne Dispersion of Solids in Solution.
Based on more recent information, EPA has re-evaluated the
assumption of 100% airborne releases when setting the TPQ for solids in
solution, not just for paraquat dichloride solution, but for all EHS
solids in solution, except for the 12 solid EHS chemicals that are
reactive solids.
a. Liquid Aerosol Release Data
EPA reviewed data in the literature on releases of aerosols to
evaluate their potential use for revising the application of the TPQs
for EHS solids in solution. EPA was specifically looking for data on
how much of a solution containing a dissolved or suspended solid would
remain airborne after an accidental release. One problem encountered in
reviewing the literature was some studies only involved chemicals that
are pure liquids and which have vapor pressures much higher than solid
chemicals. That data would likely not represent the release and
dispersion of a solid chemical that normally has a very low vapor
pressure. However, the U.S. Department of Energy (USDOE) used
experimental liquid aerosol release data involving metal salt solutions
to estimate the Airborne Release Fraction (ARF) of metal salt solutions
for a wide variety of release scenarios. This information was collected
in a 1994 report, which is available in the docket to this
rulemaking.\4\ Many of the USDOE scenarios had very low ARFs; EPA
considered the scenarios with higher release potential to best serve
the purposes of emergency planning. Also, scenarios which required
hypothetical input data to compute the ARF were not used. When median
and bounding (maximum) values of ARFs were provided for a scenario, EPA
used the maximum ARF in order to be conservative and cover the worst
case scenario. EPA summarized the data from those DOE aerosol release
scenarios with the highest (ARFs) in the table below. (The ARF values,
release scenarios from the USDOE report and other data are discussed in
greater detail in the technical support document for this rulemaking,
which is available in the docket to this rulemaking.) From this data,
EPA determined that a worst case estimate of the ARF for a solution
containing non-volatile solids would be 0.2. This particular ARF is
based on the scenarios of an aqueous solution or air dried salts under
gasoline fire on a metal surface. The airborne fractions from the USDOE
report generally contained aerosol sizes less than or equal to 100
microns. Droplets larger than 100 microns in diameter are expected to
fall out before they reach a community outside a facility.
---------------------------------------------------------------------------
\4\ USDOE. 1994. DOE Handbook, Airborne Release Fractions/Rates
and Respirable Fractions for Nonreactor Nuclear Facilities. December
1994. US Department of Energy, Washington, DC 20585 DOE-HDBK-3010-
94. Volume 1--Analysis of Experimental Data and Volume II--
Appendices.
------------------------------------------------------------------------
Maximum
airborne
Aerosol release scenario release
fraction
(ARF)
------------------------------------------------------------------------
Thermal Stress from Boiling.................................. 0.002
[[Page 21305]]
High Pressure Venting Below Liquid Level..................... 0.12
Pressure Venting Above the Liquid Level...................... 0.002
Superheated Liquid Temp >= 50 [deg]C and <= 100 [deg]C....... 0.1
Superheated Liquid Temp <= 50 [deg]C......................... 0.01
Burning Organic Layer Over Aqueous Solution.................. 0.1
Aqueous Solution or Dry Salt Under Gasoline Fire on Metal.... 0.2
Aerodynamic Entrainment and Re-Suspension.................... 0.1
------------------------------------------------------------------------
Using the highest airborne release fraction rather than an average
result of the scenarios is consistent with the intent of the emergency
planning program to plan for a reasonable worst case scenario. This
data is a good surrogate to use to predict the maximum potential
aerosol release fraction of EHS solids in solution in the event of an
accidental release. Water is probably the most common solvent that
would be used with most of the EHS solids, whether they are dissolved,
suspended or emulsified in water. Many of the EHS solids are pesticides
and pesticides are commonly applied as water solutions or emulsions.
EPA also looked at experimental data collected by the Center for
Chemical Process Safety (CCPS) for aerosol releases of water and
cyclohexane. CCPS, a directorate of the American Institute of Chemical
Engineers (AICHE), was established in 1985 to develop and disseminate
technical information for use in the prevention of major chemical
process incidents. CCPS develops and publishes guidelines, conducts
seminars, symposia, training programs and meetings on chemical process-
safety matters; CCPS also cooperates with other organizations, both
internationally and domestically, to promote process safety. CCPS's
activities are supported by funding and expertise from over 100
entities including, industry, consulting firms and governmental
organizations. USEPA is a member of this organization.
In 1989, the CCPS Vapor Cloud Modeling Subcommittee began an
``Aerosol Project'' to meet some of the research objectives proposed to
the U.S. National Vapor Cloud Research Committee, which included
developing a superheated liquid release model and developing
experimental data to validate the model. The experimental field data
was the result of field controlled-release experimentation by CCPS with
financial assistance by special grants from some of the CCPS sponsors
and from the USEPA and USDOE. The experimental superheated liquid
release data was developed, documented, peer reviewed and, where
necessary, corrected. The Vapor Cloud Modeling Subcommittee contracted
a review of the fundamental basis for the RELEASE model and to make
model improvements to reconcile the cyclohexane, chlorine and
methylamine test data. The results of the model development and the
experimental field data used was published in 1999 in a CCPS concept
book ``RELEASE: A Model with Data to Predict Aerosol Rainout in
Accidental Releases'' by David W. Johnson and John L. Woodward.
EPA did not use the aerosol release fraction from the CCPS data
because these liquids did not contain any solid material in solution.
Specifically, the reported airborne release fraction for water varied
from 0.03 to 0.54 and for cyclohexane varied from 0.36 to 0.94.
Cyclohexane with a vapor pressure of 95 millimeters (mm) mercury (Hg)
is more volatile than water with its vapor pressure of 24 mm Hg. It is
not a good comparison to use aerosol release fractions of volatile
liquids to estimate the aerosol release fractions of a solid in
solution because solids generally are not very volatile. The water
aerosol data might be a close surrogate for estimating a release of an
aqueous solution of the solid, but it does not have the important
constituent of a dissolved solid, which might influence the amount of
aerosol remaining entrained in the air. However, the CCPS data for
water supports EPA's belief that assuming a 100% airborne liquid
aerosol release is inappropriate because the water aerosol fractions
measured in the experiments were less than one. CCPS also had
experimental release data for CFC-11 and chlorine (both gases) and
methylamine (a highly volatile chemical with a vapor pressure of 300 mg
Hg), but EPA did not consider this data for use as a good analogy
because of their high volatility and they did not contain any solids.
USDOE was interested in applying the experimental aerosol release
data to estimate airborne fractions of liquid aerosol releases that
were below respirable size, which they defined as particles of 10
micron Aerodynamic Equivalent Diameter (AED) or less. By USDOE's
definition, respirable size particles are those that can be transported
through the air and inhaled into the human respiratory system.
For purposes of establishing TPQs, EPA chose a distance of 100
meters (330 feet) to represent the distance from a source inside a
chemical facility to the point where the community might be exposed.
This decision was based on data indicating that a particle size greater
than 100 microns is not likely to be deposited more than 100 meters
from the source (``Threshold Planning Quantities Technical Support
Document,'' USEPA April 7, 1987, Public Docket 300PQ, Document No.
300PQ-2-21). The 100-micron cutoff is also consistent with CERCLA
regulations (for reportable quantities) which also uses a 100 micron
particle size for powdered materials.
Most of the USDOE experimental aerosol release data had median
aerosol diameters of less than 100 microns. This size is consistent
with what EPA believes is the size of aerosols to which the community
could be exposed. On the other hand, the water and cyclohexane aerosol
release data compiled by CCPS had much larger mean aerosol diameter
sizes, generally over 100 microns. For the reasons already discussed
and because it is likely that aerosol releases with diameters larger
than 100 microns will fall out of the air before they reach a
community, the water and cylcohexane aerosol release fractions were not
used in determining the TPQs for solids in solution.
b. Liquid and Solution TPQ Comparison
Pure EHS liquids could also be released accidentally as aerosols
via the same catastrophic scenarios (overpressure, superheating). It
could be argued that perhaps the TPQ method for solids in solution
could also apply to liquids. However, this goes against the ranking
used for setting TPQs based on the extent of airborne releases by
physical state as being high for gases, less for liquids and even less
for solids in solution. Currently, the release scenario used for
developing the liquid TPQs considers a spill of the liquid due to a
loss of containment. The liquid then escapes into the air by
volatilization. An airborne release of solids in solution will require
more than a failure of containment to have appreciable airborne
dispersion. An energy source, such as overpressure or high temperature
would be required to disperse the solution into the air and create
aerosol droplets. Not all of the droplets will stay airborne (unlike
volatilized vapors) and affect the community, whose exposure depends on
droplet size and distance from the facility fence line.
If one assumes that there is an equal potential for airborne
releases for gases, liquids, small particulate solids and solids in
solution, then the TPQ ranking scheme would change radically and rely
[[Page 21306]]
almost entirely on the toxicity of the chemical. However, EPA believes
that airborne dispersibility is a critical factor in determining TPQs.
Limited state and local resources should be focused on those EHS
chemicals that can potentially cause the greatest harm and less on
those that might be toxic, but less likely to be released to the air
and carried beyond the facility boundary.
As a hypothetical scenario, EPA determined if the current TPQ
method for liquids gives more conservative (or at least as
conservative) TPQs (lower thresholds) as compared to the proposed TPQ
methodology for solids in solution. To do this, EPA estimated the TPQs
for liquids by assuming that V = 1, and then divided it by 0.2 (based
on an expected 20% maximum airborne dispersion) to determine the amount
of EHS on-site that would trigger emergency planning notification.
These amounts or ``effective TPQs'' were then compared to the current
listed TPQs for liquids. For 116 of the 163 EHS liquids, the current
TPQs for liquids based on volatilization were equal to or lower than
the new effective TPQs based on aerosolization. Most of the other 47
liquids had current TPQs that were about twice the effective TPQ. This
comparison with a table of results for the EHS liquids is discussed in
the technical support document for this rulemaking. Based on this
analysis, EPA believes that using the volatilization model to establish
V for liquid TPQs is still appropriate. The spilled liquid using a
boiling point scenario is probably the most prevalent worst-case
scenario that is reasonable to use for establishing TPQs for liquids.
Further examination of the 47 liquid chemicals was undertaken to
see why these had TPQs greater than the effective TPQs--that is, about
twice the effective TPQ. Many of these liquids had effective TPQ values
of 5, 50 and 5,000 pounds. However, there are no TPQs of 5, 50 or 5,000
pounds. Rather, the use of order of magnitude index ranges assigned to
various TPQ levels resulted in assigned TPQ values of 1, 10, 100, 500,
1,000 and 10,000 pounds. Thus, where the effective TPQs are either 5,
50, or 5,000 pounds, the comparison of a current TPQ versus an
effective TPQ may not be valid. More discussion on this can be found in
the technical support document.
C. What alternative approaches were considered?
Given the data in the literature available on aerosol releases of
solids in solution, EPA considered various alternative approaches. One
alternative was using an index ranking method with an assigned V
similar to the original method of assigning TPQs. Another alternative
was to apply the ARF to the existing lower TPQ for solids to develop a
new TPQ for solids in solution for each solid EHS. A third alternative
was similar to the approach of multiplying the maximum ARF by the
amount on-site, except that the ARF would only represent aerosol sizes
less than respirable size. Below we discuss these alternatives, as well
as the basis for not selecting them.
1. Index Ranking Method With V Less Than 1
This alternative would establish TPQs using a ranking approach
based on each chemical's physical state, acute toxicity and, the
potential for the chemical to become airborne (V). For this
alternative, V would be set to 0.2 for EHS solids in solution.
For the original development of the TPQs, the ranking index was
defined as the LOC divided by V, where V was set equal to 1 for gases
and solids in powder form with a particle size less than 100 microns,
molten solids and solids in solution. For liquid EHSs, V (the potential
to become airborne) depended upon the property of volatility
(evaporation of liquid into the gas phase). In the development of V for
use in setting TPQs for liquids, V represented the mass per time
evolved to the air per mass of the spill. This is explained in further
detail in the April 1987 ``Threshold Planning Quantities Technical
Support Document'' available in the docket.
Most of the values for V for liquids are approximately 0.1 (see
Appendix B in the ``Technical Support Document for Revising TPQ Method
for Solids in Solution'' for this rule). Using a higher V equal to 0.2
for solids in solution implies that in the event of an accidental
release, more of the solution would become airborne than if it were
volatilized from a liquid spill. Even if a liquid were accidentally
released via aerosol form, the volatility of the liquid chemical will
increase the fraction that remains dispersed in the air. Therefore, it
would not be a fair representation to have a solid in solution with a V
higher than that used for a volatile liquid. Also, because there are
different mechanisms involved in the two types of releases, it may not
be comparable to use the 0.2 as a substitute for V for solids in
solution.
2. Existing TPQ and Aerosol Release Fraction
Another alternative is to apply the ARF to the existing lower TPQ
for solids to develop a new TPQ. For example, the lower TPQ for
paraquat dichloride is 10 pounds. Dividing 10 pounds by 0.2, the
maximum expected aerosol release fraction for a solution would result
in a new TPQ of 50 pounds for paraquat dichloride in solution form. For
each of the 157 non-reactive solids on the EHSs list, a new TPQ for the
solution form of the EHS solid could be determined and listed. However,
for each solid non-reactive chemical, there are already two TPQs, one
developed based on the ranking index methodology of (Index = Level of
Concern/V) and one based on the default TPQ of 10,000 pounds for non-
molten, non-reactive, non-solution solids with a particle size equal to
or greater than 100 microns. Including a third set of TPQs for EHS
solids in solution could be confusing to the regulated community. Thus,
EPA believes that using the existing lower TPQ for solids and comparing
that to the product of the amount on-site multiplied by 0.2 is a better
approach, and similar to the approach used for the molten solids form.
3. Using ARF Limited to Smaller Aerosol Sizes
Another approach considered is similar to the proposed approach of
multiplying the maximum ARF by the amount on-site, except that the ARF
would only represent the fraction of aerosols with particles less than
respirable size. Through discussions with the petitioner and EPA's
November 2003 response to the petition, EPA has considered whether
aerosol size should be used as a factor in developing new TPQs for
solids in solution. A consultant for Syngenta believes that EPA should
only consider the dispersion of aerosols with particle sizes less than
or equal to 4 microns because these smaller aerosols are the size that
can enter the lung and because the inhalation toxicity tests used for
the basis of the EHSs listing only used very small particles.
This approach would require sufficient data on the aerosol size
distribution for each release scenario to develop a new ARF that would
include only aerosols of 4 microns and lower. The ARFs currently cited
for the scenarios used for the preferred approach include aerosol sizes
of 100 microns and lower. For some of the USDOE accident scenarios, it
is possible to recalculate the airborne aerosol fractions using the raw
experimental data to include only aerosols less than or equal to 4
microns in diameter. This results in smaller airborne release
fractions.
EPA does not believe this approach should be used for a number of
reasons, including:
[[Page 21307]]
Inhalation toxicity tests are designed to use small
particles to ensure that the lung is exposed. However, EPA is not using
the inhalation toxicity for risk assessment, but only as a screening
tool.
Although the EHSs listing for paraquat dichloride is based
on inhalation toxicity, EPA also has concerns regarding dermal and
ingestion exposure via swallowing for the larger aerosols.
Solvent evaporation from larger aerosols can also create
smaller aerosols which can enter the lung.
Each of these is discussed below.
a. Aerosol Size in Toxicity Tests
Aerosols may be defined as a suspension of solid or liquid
particles in air. Inhalation acute toxicity tests are purposely
designed with very small diameter particles in order to ensure that
particles are small enough to enter the rodent's lungs and test the
toxicity in the lungs. Larger particles may not enter deep areas of the
lungs and thus, test results may be misinterpreted if little inhalation
toxicity is shown. EPA is not attempting to use the airborne aerosol
fraction for purposes of risk assessment, but only as a tool to set
screening levels for the amount of chemicals on-site which may
potentially cause harm if accidentally released. Also, the size of the
aerosols used in an animal laboratory test cannot be assumed to be the
same as those that people may be exposed to during an accidental
release.
b. Particle Size and Exposure
Inhalable size particles enter the respiratory tract, including the
head airways and are generally equal to or less than 100 microns.
Thoracic size particles (generally equal to or less than 10 microns)
travel past the larynx and reach the lung airways and the gas-exchange
regions of the lung. Respirable size particles (generally less than or
equal to 4 microns) are a subset of thoracic particles that are more
likely to reach the gas-exchange region of the lung.\5\
---------------------------------------------------------------------------
\5\ USEPA. October 2004. Air Quality Criteria for Particulate
Matter. Vol I, Chapter 2 and Volume II, Chapter 6. U.S.
Environmental Protection Agency, Office of Research and Development,
National Center for Environmental Assessment. Research Triangle
Park, NC. EPA/600/P-00/002aF and EPA/600/P-00/002bF
---------------------------------------------------------------------------
Most particles that enter the upper airways are trapped in mucous
that moves to the throat and is swallowed within a few hours. Thus,
instead of inhalation exposure deep in the lungs, exposure to larger
particles of chemicals may occur through dermal exposure to mucous
membranes or ingestion exposure through swallowing. Emergency planning
for EHS chemicals is not limited to inhalation exposure only, although
many of the EHS chemical listings are based on studies which meet the
EHSs listing criteria for inhalation toxicity. Although airborne
exposure is the most likely route of exposure, it is not the only route
of exposure. In the event of an accidental release, EPA is concerned
about all routes of exposure (inhalation, dermal and ingestion) to the
community. Thus, exposure to larger size aerosols (e.g. those above 4
or 10 microns) by any route, such as through the skin or mucous
membranes) should not be ignored when setting TPQs.
c. Solvent Evaporation From Aerosols
Even after liquid aerosol droplets are released, some of the
solvent may evaporate in the air. This would result in even smaller
size aerosols or solid EHS particulates in the air to which a community
would be exposed. One concern is that droplets of size greater than 100
microns could settle quickly, dry into a smaller particle size and then
become airborne again (re-suspension). In the event of an accidental
release, the responsible party should clean up chemicals deposited on
the facility grounds before additional exposure to the community would
take place. The USDOE report did include data on re-suspension of
particulates from soil after an aerosol release. However, the amount
re-suspended did not add much to the reasonable worst case aerosol
release fraction of 0.2. This scenario is explained further in the
technical support document for this rule.
D. What are the peer review results?
EPA's revised TPQ methodology for EHS solids in solution and
supporting data was peer reviewed and the technical support document
was revised based on the peer review comments. The description of the
peer review process, the results of the peer review and EPA's response
to the peer review comments are found in a separate document, ``Peer
Review of Technical Support Document for Revised TPQ Method for EHS
Solids in Solution,'' which is available in the docket to this
rulemaking. Below are the questions posed to the peer reviewers, a
summary of the peer reviewers' comments and EPA's responses.
1. Based on your reading and analysis of the information provided, do
you find the revised TPQ method to be logical with a sound scientific
basis?
Two of the three reviewers agreed that the revised TPQ method was
logical with a sound scientific basis using the USDOE experimental
aerosol release data. However, one reviewer thought the revised TPQ
method may not be based on the most sound science because the LOC is
based on Immediately Dangerous to Health and Life values (IDLH) and
animal lethality data that he believes may not be appropriate.
Nonetheless, this reviewer did think that a cursory review of the
effective TPQ list (Appendix B in technical support document) appears
to have appropriately listed the ranking of chemicals by potential
hazard to the public.
EPA recognizes that use of the IDLH was an imperfect measure for
determining the LOC, but believes the approach provides a consistent
relative ranking of the EHS. Where animal lethality data were
substituted, safety factors were applied to the data to estimate the
LOC. Human data were taken into account for some chemicals, such as
chemical warfare agents, and adjustments were made to the TPQ initially
based on index values. EPA realizes that better data are being
developed that could be used for the LOC (such as AEGLs--Acute Exposure
Guideline Levels). However, a re-evaluation of the LOC for all EHS
chemicals would best be undertaken by a separate rulemaking effort,
given the extent and complexity of this issue.
2. Is the writing clear and concise? Has EPA provided the right level
of detail? Is the method understandable? Are the results clearly
presented?
Two of the three reviewers thought that the revised method was not
clear and understandable and suggested improvements. For example, it
was recommended that EPA clarify the definition of a solution, as well
as include a flowchart of the method or a graph to help describe the
approach.
EPA agrees that improvements were needed in order to present the
information in a better way for the regulated community to understand
and apply, and the revised technical support document addresses those
concerns. Thus, additional supporting background information,
discussion about the development of TPQs, and examples and calculations
of how to apply the TPQs for EHS solids in solution have been added to
the technical support document and has been further
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explained in the preamble to the proposed rule. The proposed rule,
which was not provided to the peer reviewers, is written more clearly
and is less technical than the materials given to the peer reviewers to
review.
One reviewer thought that EPA had provided the right amount of
detail, and thought the method is understandable, and the text is for
the most part readable. However, the reviewer had several
clarifications and corrections he thought EPA should make. These
clarifications have been made to the technical support document,
including improving a description of background on TPQ development,
clarifying some terms used in the document, and adding some references
and other editorial comments.
This same reviewer thought the argument against the alternative
approach of using V=0.2 for developing TPQ for solids in solutions was
not that convincing. EPA has revised the discussion of this alternative
approach by stating that EPA believes that this approach would result
in TPQs that would be too low as compared to TPQs for liquids of
similar toxicity because most of the liquids have approximately V=0.1.
EPA believes that liquids have a higher potential for airborne
dispersion because of their inherently higher volatility. Also, the
mechanism for airborne dispersion for liquids using the spill model is
volatilization, whereas solids in solution will be dispersed via
aerosolization, so using V=0.2 for solutions may be not comparable.
3. Is the revised method consistent with the overall approach used for
setting TPQs for other EHS chemicals?
All three reviewers thought that the revised method was fairly
consistent with the approach used for setting other TPQs. However, one
reviewer thought that EPA should consider lowering the TPQs for 46 of
163 EHS liquids based on the comparison of using the revised TPQ method
versus the current method. EPA believes that using a V of 0.2 to
recalculate the TPQ indexes would result in conservatively low TPQs for
solids in solution as compared to liquids of the same toxicity. Given
that volatilization requires only the loss of containment of a
chemical, whereas aerosolization requires the loss of containment and
usually an energy release, EPA believes the higher potential for
airborne dispersion should be assigned to liquids as compared to a non-
volatile solid in solution. Because there are different mechanisms
(volatilization versus aerosolization) involved in the two types of
releases, it may not be comparable to use 0.2 as a substitute for V for
solids in solution. Based on the comments, EPA has revised the
discussion in the preamble to the rule and Section VI.A--Use Orig