[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Proposed Rules]
[Pages 21299-21311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9096]
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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
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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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:
http://www.regulations.gov: Follow the online instructions
for submitting comments.
E-mail: [email protected].
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
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://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 http://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 http://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 http://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
http://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:
[email protected]. 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\
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\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.
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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\
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\2\ For these examples, the EHS is not paraquat dichloride, but
an unspecified solid EHS.
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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.
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\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
[[Page 21308]]
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 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.
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.
[[Page 21309]]
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
non-reactive 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.
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 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 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 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 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-for-profit 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 non-reactive
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 on-site have already (or should have
already) reported these chemicals to their SERC and LEPC and identified
a
[[Page 21310]]
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.
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 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. This action also
does not impose any new requirements on tribal governments. Thus,
Executive Order 13175 does not apply to this action.
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 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.
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 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 non-reactive 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:
[[Page 21311]]
Sec. 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:
Sec. 355.61 How are key words in this part defined?
* * * * *
Solution means any aqueous or organic solutions, slurries, viscous
solutions, suspensions, emulsions, or pastes.
* * * * *
[FR Doc. 2011-9096 Filed 4-14-11; 8:45 am]
BILLING CODE 6560-50-P