[Federal Register Volume 59, Number 196 (Wednesday, October 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25196]
[[Page Unknown]]
[Federal Register: October 12, 1994]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 355
Superfund Program;
Extremely Hazardous Substance List; Proposed Rule
and Final Rule Correction
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 355
[FRL-5088-8]
RIN 2050-AD50
Extremely Hazardous Substance List
AGENCY: U.S. Environmental Protection Agency (EPA).
ACTION: Proposed rule; denial of petitions.
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SUMMARY: EPA is responding to several citizens' petitions requesting
the Agency to revise the list of ``extremely hazardous substances''
published under section 302 of the Emergency Planning and Community
Right-to-Know Act of 1986 (EPCRA). EPA is proposing a rule to delete
from the extremely hazardous substance list phosphorous pentoxide,
dithlycarbamazine citrate, fenitrothion and tellurium, and to revise
the threshold planning quantity for isophorone diisocyanate from 100 to
1,000 pounds. EPA is denying petitions requesting deletion from the EHS
list of paraquat and isophorone diisocyanate. The Agency is also
denying a petition that requests revision of the threshold planning
quantities for azinphos-methyl and fenamiphos.
DATES: Comments must be submitted on or before December 12, 1994.
ADDRESSES: Written comments should be submitted to: Superfund Docket
Clerk, Attention: Docket Number 300PQ-R2, Room 2615 Mall, U.S.
Environmental Protection Agency, Mail Stop 5201, 401 M Street, SW,
Washington, DC 20460.
Copies of materials relevant to the rulemaking are contained in the
Superfund Docket, Room 2615 Mall, U.S. Environmental Protection Agency,
401 M Street, SW, Washington, DC 20460. The technical background
document relevant to the rulemaking is available in the docket. As
provided in 40 CFR Part 2, a reasonable fee may be charged for copying
services.
FOR FURTHER INFORMATION CONTACT: John Ferris, Chemical Emergency
Preparedness and Prevention Office, OS-120, U.S. EPA, 401 M Street SW,
Washington, DC 20460. The Emergency Planning and Community Right-to-
Know Information Hotline can also be contacted for further information
at 1-800-535-0202, in Washington, DC and Alaska at 1-703-412-9877.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Statutory Authority
This proposed rule is issued under sections 302 and 328 of the
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA).
B. Background
On October 17, 1986, the President signed into law the Superfund
Amendments and Reauthorization Act of 1986 (``SARA''). Pub. L. 99-499
(1986). Title III of SARA established a program designed to require
state and local planning and preparedness for spills or releases of
hazardous substances and to provide the public and local governments
with information concerning potential chemical hazards in their
communities. This program is codified as the Emergency Planning and
Community Right-to-Know Act of 1986 (EPCRA), 42 U.S.C. 11001-11050.
Subtitle A of EPCRA establishes the framework for local emergency
planning. The Statute required that EPA publish the Agency's list of
``extremely hazardous substances'' (``EHSs''). This had previously been
published in November, 1985, by the EPA Administrator in Appendix A of
the ``Chemical Emergency Preparedness Program Interim Guidance'' (CEPP
Guidance), as the list of acutely toxic chemicals. The Agency was also
directed to establish ``threshold planning quantities'' (``TPQs'') for
each extremely hazardous substance. Under section 302, a facility which
has present an EHS in excess of its threshold planning quantity must
notify the State emergency response commission and local emergency
planning committee as well as participate in local emergency planning
activities.
The purpose of the extremely hazardous substance list is to focus
initial efforts in the development of State and local contingency
plans. It is not intended to be a complete list of all chemicals that
could potentially be hazardous to a community. The identification of a
chemical that meets the EHS criteria does not in itself indicate the
potential for serious effects in any release, accidental or routine.
Thus, inclusion on the EHS list is not meant as a signal to state or
local communities to 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. EPA also
encourages communities to go beyond the EHS list when evaluating the
hazards of facilities in their community, in that facilities handling
chemicals not on the EHS list could be as hazardous as those handling
EHSs.
To date, 46 chemicals have been delisted from the EHS list in
previous rulemakings because they did not meet the toxicity criteria
for the list and were originally listed under section 302 in error.
1. Regulatory Background
The list of extremely hazardous substances and their threshold
planning quantities is codified in EPA regulations at volume 40 of the
Code of Federal Regulations, part 355, appendices A and B (40 CFR, Part
355, Apps. A & B). EPA's explanation for the methodologies used to
determine whether to list a substance as an extremely hazardous
substance and for deriving the threshold planning quantities is found
in preambles to the Federal Register notices which promulgated these
rules. The relevant notices were published in the Federal Register on
November 17, 1986 (51 FR 41570-41592), and April 22, 1987 (52 FR 13378-
13410).
In the November 17, 1986 notice EPA, as required by EPCRA section
302, promulgated an interim final rule which, among other things,
included a list of extremely hazardous substances and established their
threshold planning quantities. While the interim final rule established
enforceable requirements, the Agency simultaneously solicited public
comments, as explained in a Federal Register notice issued on the same
day (51 FR 41953-54).
EPA received public comment on the interim final rule and issued a
final rule on April 22, 1987, which responded in its preamble to the
public comments. The April 1987 final rule made a number of revisions
to the interim final rule. Among other things, the April 1987 rule
republished the extremely hazardous substance list, with the addition
of four new chemicals, and revised the methodology for determining some
threshold planning quantities (52 FR 13381).
Details of the methodology used to determine whether to list a
substance as an extremely hazardous substance and for deriving the
threshold planning quantities are found in the November 1986 notice at
51 FR 41573-41579 and 41580 (Attachment 1), in the April 1987 notice at
52 FR 13387-13392, and in technical support documents in the rulemaking
records.
2. Summary of petitions
In this notice EPA is responding to seven petitions requesting
action on substances listed as extremely hazardous substances. EPA
received petitions from the Elemental Phosphorus Ad Hoc Solid Waste
Group to delist phosphorus pentoxide (CAS #1314-56-3); from SmithKline
Beecham to delist diethylcarbamazine citrate (CAS #1642-54-2); from
Sumitomo Chemical America, Inc., to delist fenitrothion (CAS #122-14-
5); from ICI America's, Inc. to delist or change the threshold planning
quantity for paraquat (CAS #1910-42-5); from Huls America, Inc., to
delist isophorone diisocyanate (CAS #4098-71-9); and from the Selenium
Tellurium Development Association (STDA) to delist tellurium (CAS
#13494-80-9). EPA also received a petition from Miles, Inc. requesting
that the threshold planning quantities for azinphos-methyl (CAS #86-50-
0) and fenamiphos (CAS #22224-92-6) be increased from the current 100
pounds to 10,000 pounds.
Today's notice proposes a rule to amend 40 CFR, part 355
(Appendices A and B), to delist phosphorus pentoxide,
diethylcarbamazine citrate, fenitrothion and tellurium from the list of
extremely hazardous substances and to revise the threshold planning
quantity for isophorone diisocyanate from 100 pounds to 1,000 pounds.
EPA is denying the requests to delist paraquat and isophorone
diisocyanate and the request to change the threshold planning
quantities for azinphos-methyl and fenamiphos. These decisions
constitute final agency action.
II. Proposed Modifications
EPA is proposing to remove the four chemicals noted above from the
extremely hazardous substance list because review of the available
toxicity data shows they do not meet the listing criteria. EPA believes
these four chemicals were incorrectly listed.
EPA is proposing to revise the threshold planning quantity for
isophorone diisocyanate from 100 to 1,000 pounds, based upon the
Agency's own review of the physical and chemical properties of the
chemical, even though revision of the threshold planning quantity was
not requested in the petition.
Phosphorus pentoxide was listed on the basis of an abstract of a
study of smoke from burning red phosphorus that gave LC50 values
for guinea pigs of 0.061 mg/liter/1 hour and for mice of 0.271 mg/
liter/1 hour (Ballantyne (1981)). An LC50 is the air concentration
dose at which half the animals studied die. As explained in the
November 17, 1986 (51 FR 41574), Federal Register notice, EPA listed a
substance as an extremely hazardous substance if inhalation studies
showed an LC50 value in tests of the most sensitive mammalian
species of less than 0.5
mg/l over a period of exposure of eight hours or less.
As noted above, the Agency listed phosphorus pentoxide based upon
an abstract (Ballantyne (1981)). The Agency now believes that this
abstract should not be used as the basis for listing. The title of the
abstract reported the toxicity of phosphorus pentoxide smoke. However,
the study was actually performed using the smoke generated by burning
red phosphorus. In burning red phosphorus, two studies (Tarnov (1980)
and Burton et. al (1982)) have shown that the major product is
phosphorus pentoxide. However, the Ballantyne abstract does not
establish that the toxicity found was attributable to the phosphorous
pentoxide in the smoke, or other chemicals in lower concentrations.
Since there is no conclusive evidence to suggest that the animals in
Ballantyne's study were primarily exposed to phosphorus pentoxide, the
available data from Ballantyne's findings are insufficient to prove or
disprove that the LC50 values in guinea pigs and mice satisfy the
criteria for listing phosphorous pentoxide on the EHS list.
Information submitted by the Elemental Phosphorus Ad Hoc Solid
Waste Group showed that the direct tests on phosphorous pentoxide show
an LC50 value higher than the criteria for listing. In an
unpublished Monsanto report (1987), rats were exposed to aerosolized
phosphorous pentoxide for 4 hours, at levels up to 0.99 mg/liter. (It
should be noted that although the analytical standards used in the
analysis conducted for this study were phosphorous pentoxide, no
information was obtained regarding the actual chemical species present
in the chamber atmosphere.)
This is the only available study in the literature that provides
direct evidence of the toxic potential of phosphorous pentoxide. The
LC50 for phosphorous pentoxide was found to be greater than 0.99
mg/liter, which does not meet the criteria for listing for listing
substances as an extremely hazardous substance. Since the Agency now
believes that the abstract used as the basis for listing is invalid
(the Agency was unable to obtain the actual report) and the only direct
studies available to the Agency show that phosphorus pentoxide does not
meet the listing criteria, the Agency is proposing to remove the
chemical from the EHS list.
Diethylcarbamazine citrate was listed on the basis of a report in a
Russian data compilation showing an LC50 inhalation value of 0.309
mg/liter/4 hours in rats. The citation number listed in the United
Nations sponsored translation is incorrect, and additional details
about the original study are unavailable. Methods used for this
inhalation toxicity study could not be found to determine if they meet
international standards, therefore, the toxicity values could not be
verified.
An inhalation study sponsored by SmithKline Beecham indicated that
a 1-hour exposure of rats to Diethylcarbamazine citrate at
concentration of 1.63 mg per liter or 2.38 mg per liter produced no
fatalities. Since the only studies available to EPA show that this
chemical does not meet the listing criteria for inhalation (LC50
less than 0.5 mg per liter), the Agency is proposing to remove it from
the EHS list.
Fenitrothion was initially listed because it appeared to meet the
extremely hazardous substance criteria, based upon a study showing an
LC50 of 0.378 mg/liter/4 hours (NIOSH/RTECS 1985). The delisting
petition charged that this study was deficient in that the material
tested contained a toxic impurity of unknown potency, and that the
study overestimated the toxicity of fenitrothion itself, because the
test material contained surfactants that would have made the test
animal's skin and cell membranes more permeable to the test substance.
Examination of a study submitted by the petitioner (Kohda et. al
(1986)) reports an LC50 of above 2.210 mg/liter. In studying the
report provided by the petitioner, the Agency agrees that the data by
which the listing is based may have been in error for the reasons
stated by the petitioner. Since the only other study available to the
Agency shows that fenitrothion does not meet the listing criteria, EPA
is proposing to remove this substance from the EHS list.
Tellurium metal was listed on the basis of a study (Lenchenko and
Plotko (1969)) which reported an LD50 (median lethal dose, the
dose that killed 50 percent of the test animals) oral toxicity of 20
mg/kg of body weight. As explained in the November 17, 1986 (51 FR
41574) Federal Register notice, EPA listed a substance as an extremely
hazardous substance if oral studies showed an LD50 of less than or
equal to 25 mg per kilogram (kg) of body weight. The petitioner brought
to the Agency's attention that the study was actually on sodium
tellurate (CAS #10102-20-2; already listed as an EHS) and not on
tellurium metal. The petitioner also provided a study (Prinsen (1991))
which showed an LD50 for tellurium metal in excess of 5000 mg/kg.
Based upon this information, the Agency is proposing to remove
tellurium from the EHS listing while maintaining the listing for sodium
tellurate.
The Agency requests comments on whether it should proceed to delist
these four chemicals based upon this information or any additional
information submitted by commenters relating to whether these chemicals
meet the section 302 listing criteria.
HULs America, Inc. submitted a petition to delist isophorone
diisocyanate (IPDI). EPA is denying the petition to delist because IPDI
meets the criteria for listing, as discussed in the next Unit on
Petition Denials. However, in considering this petition, EPA noted that
the threshold planning quantity had been determined based on IPDI's
being a reactive solid at standard temperatures, when in fact it is a
liquid and not highly reactive. Accordingly, EPA is proposing to change
the threshold planning quantity for IPDI based on the methodology for
determining threshold planning quantities for liquids instead of the
methodology for reactive solids.
EPA's methodology for establishing threshold planning quantities
for liquids, once it is determined that the substance meets the listing
criteria, consists of initially determining the maximum short term
exposure concentration in air that would not lead to serious
irreversible health effects in the general population when exposed to
the substance for relatively short duration. This is the so-called
``level of concern.'' (See the Threshold Planning Quantities Technical
Support Document, April 7, 1987.)
There are two ways to determine a ``level of concern.'' If it is
available for a chemical, EPA may use the Immediately Dangerous to Life
and Health (IDLH) level established by the National Institute for
Occupational Safety and Health (NIOSH). This is the maximum
concentration of a substance in air to which a healthy worker can be
exposed for 30 minutes and escape without suffering irreversible health
effects or impairing symptoms.
If the IDLH value is not available, as is the case for most of the
EHSs, the EPA uses an IDLH equivalent value using available toxicity
data with an adjustment factor to estimate the IDLH value. For the
initial TPQ for IPDI the LC50 of 0.12 mg/l over a 4 hour exposure
period was multiplied by 0.1 to estimate the IDLH value.
The level of concern is then divided by a factor ``V'' which
represents the extent to which the material can volatilize and become
airborne and dispersed. This is explained in the November 17, 1986
Federal Register notice at 51 FR 41577. For liquids this involves
knowing the molecular weight and vapor pressure. The derivation of the
factor ``V'' for liquids is explained in Appendix 1 of the November 17,
1986 Federal Register notice for the interim final rule (51 FR 41580).
The final threshold planning quantity is then determined from a set
of index values. The index values and their corresponding threshold
planning quantities are found in the threshold planning quantity
technical support document. Applying this methodology to IPDI gives it
a threshold planning quantity of 1000 pounds. The calculations for this
determination are found in the administrative record for this petition.
EPA is, thus, proposing to raise the threshold planning quantity for
IPDI from 100 to 1000 pounds.
III. Petition Denials
EPA is denying the petition of ICI Americas with respect to
paraquat. The petitioner requests the Agency to remove paraquat from
the extremely hazardous substance list or, in the alternative, to
revise the threshold planning quantity.
Petitioner notes that the ``paraquat'' on the EHS list is actually
paraquat dichloride since, strictly speaking, paraquat is a divalent
cation which can form many different salts, and paraquat dichloride is
the only commercially available paraquat salt in the United States.
Further, the Chemical Abstract Service (CAS) number identified on the
EHS list is the number for paraquat dichloride. Petitioner bases its
request to delist paraquat (dichloride) on the fact that the only
studies that show LD50 or LC50 tests below the Agency
criteria for listing are tests on either the pure solid form of the
chemical or the highly concentrated form of the solution. Petitioner
claims that the toxicity for any commercially available form is much
lower than the EHS listing criteria and that tests showing high
toxicity are of no practical importance.
EPA agrees with petitioner that paraquat dichloride is the
appropriate listed chemical. To clear any confusion that may result
from the conflict between the paraquat listing and the CAS number, EPA
is making a technical amendment to the EHS listing in 40 CFR Part 355
by substituting the term paraquat dichloride for paraquat (published
elsewhere in this issue of the Federal Register). All indications from
the petition are that the public has been complying with the
regulations under the assumption that ``paraquat'' refers to the
paraquat dichloride product.
EPA disagrees with petitioner that paraquat dichloride should be
removed from the EHS list because only highly concentrated forms show
high toxicity. Paraquat dichloride qualifies as an EHS because some
form of it shows high toxicity that exceeds the Agency's criteria. This
is the case for many animal tests used to determine toxicity for
regulatory purposes. Animals may be dosed in concentrated forms or at
very high levels to determine toxicity. The dose in the studies may be
much higher than any found in actual practice. In the case of LD50
or LC50 tests, half the animals die. If these tests show 50
percent mortality at a relatively low dose, they at least raise
concerns that qualify for listing. Smaller numbers of subjects may be
affected at much lower doses, but that does not eliminate any concern
for the tested chemical. Paraquat dichloride is listed because it is
grouped with those chemicals that exceed Agency criteria in some form.
The basis for listing paraquat was a study (Murray and Gibson,
1972) which showed a formulation containing paraquat dichloride as
having an oral (guinea pig) LD50 value of 22 mg/kg. Although the
toxicity of the paraquat dichloride formulation is caused solely by the
paraquat ion, based on the LD50 of 22mg/kg for paraquat ion, ICI
estimated an oral LD50 value of 30.4 mg/kg for paraquat dichloride
which does not meet the EHS criteria. ICI sponsored two acute
inhalation studies in rats (ICI, 1989). The studies resulted in an
LC50 value of .001 mg/liter for the paraquat ion, which can be
estimated for paraquat dichloride to be an LC50 of .00138 mg/
liter. This value would meet the EHS criteria for listing of 0.5 mg/
liter as noted above. EPA is changing the basis for listing value from
oral LD50 of 22 mg/kg for paraquat ion to inhalation LC50 of
0.00138 mg/liter for paraquat dichloride.
Petitioner, alternatively, requests that the threshold planning
quantity for paraquat dichloride should be higher than the current
amount of 10 pounds. The threshold planning quantity for paraquat is 10
pounds for the chemical in finely powdered form (particle size under
100 microns), in molten form, or in solution. For paraquat in solid
form with particle size greater than 100 microns the threshold planning
quantity is 10,000 pounds. EPA's reasoning for determining these levels
is found in the November 17, 1986 interim final rule notice at 51 FR
41575-76 and 41577, as amended by the April 22, 1987 final rule notice
at 52 FR 13390. A summary of that reasoning follows.
The paraquat listed, essentially the dichloride salt, is a solid in
solution. There is available for paraquat an IDLH level of 1.5
milligrams per cubic meter (mg/m\3\). This converts to an Index Value
of .0015, which results in a threshold planning quantity of 10 pounds.
While the November, 1986 notice for the interim final EHS listing rule
applied this calculation to all solids, the April 22, 1987, notice (52
FR 13390-91) modified this by applying this calculation to solids only
if they have a particle size less than 100 microns, if they are handled
in solution or molten form, or if they have a high rating for
reactivity. For particle sizes over 100 microns, the threshold planning
quantity is 10,000 pounds. Paraquat dichloride, therefore, has two
threshold planning quantities depending on its particle size and
whether it is used in solution.
The petitioner requests that the Agency base the level of concern
for paraquat dichloride on the LD50 or LC50 tests rather than
the IDLH. EPA disagrees. The IDLH, while it has flaws, is the best
available measure for determining a level of concern because it is
based on actual human data. When an IDLH is available, EPA declines to
use conversion factors, as it does for those substances for which IDLH
values are not available (see 51 FR 41576), because these factors are
even rougher measurements.
NIOSH lists the two chemicals (paraquat and paraquat dichloride) as
synonyms (NIOSH/RTECS 1983 Synonyms, Volume 1, p. 719); therefore, the
Agency considers the ionic form of paraquat as the dichloride salt in a
solution. Since the IDLH value applies to both the salt and the
solution, EPA has decided not to remove the chemical from the EHS list
or modify the TPQ.
The paraquat ion is reportable as a solution (or mixture) of
paraquat dichloride and a carrier (for example, water). For threshold
purposes, the facility only needs to consider the weight percent of
paraquat dichloride that was placed in the solution.
Miles, Inc., has submitted a petition requesting that the 10,000-
pound TPQ apply to azinphos-methyl and fenamiphos in the Miles products
Guthion 2L and Nemacur 3. Both of these chemicals have TPQs of 10
pounds that apply when the chemicals are in finely powdered form, in
molten form, or in solution, as calculated using the same methodology
applied to paraquat dichloride. The 10,000-pound TPQ applies to the
solid form with particle size greater than 100 microns. The petitioner
submits that both of these compounds are ``waxy, amorphous solids with
low melting points and their technical grade materials used for
production are generally liquid at summer temperatures.'' The
petitioner stated that the TPQ for the chemicals should be based upon
their being liquids using the methodology described for IPDI, above, in
unit II. This would raise the TPQ to 10,000 pounds.
EPA disagrees. The Farm Chemicals Handbook (1984 p. C161) lists
fenamiphos as a brown, waxy solid. The Hawley handbook (1981) lists
azinphos-methyl as a brown waxy solid as well. Since these references,
used as background to the listing, show these chemicals as solids, the
EPA considers the chemicals as solids as well. They would be near the
melting point but never quite reach it. Molten solids are not treated
as liquids under the TPQ methodology, because the solids have to be
raised above standard temperature in order to become molten. Since EPA
has no way of knowing at what temperatures facilities have the molten
solids (to determine volatilization), EPA chose to consider solids
different from chemicals that are liquid at standard temperatures.
Instead, EPA accounts for solids that become liquids (molten form)
with the two tiered threshold. When handled in molten form, the TPQ for
these chemicals would be 10 pounds because of the possibility of
volatilization. However, even in molten form, significant amounts of
vapor are not likely to be generated. The Agency examined the fraction
of volatilization expected for the solids on the list and found that it
ranges from 0.3 to 0.008 pounds/minute per pound spilled (see Threshold
Planning Quantities, Technical Support Document, April 7, 1987, page
27). Since data were not available for all solids and to be
conservative, the Agency chose to incorporate the 0.3 fraction into the
reporting requirements. If a facility is handling the solid in molten
form, the amount molten should be multiplied by 0.3 to obtain the
actual amount to be compared to the threshold planning quantity for
reporting (see 40 CFR 355.30(e)(iv)).
HULs America Inc. submitted a petition to delist isophorone
diisocyanate (IPDI). IPDI had been listed because it met the criteria
for extremely hazardous substance listing, on the basis of two aerosol
inhalation-toxicity studies in rats. The 4 hour LC50 is .26 mg per
liter, which is less than the LC50 of 0.5 mg/liter which qualifies
it as an extremely hazardous substance under Agency criteria (51 FR
41574). The delisting petition made the following points. This material
is manufactured in a closed system that does not use high pressure, and
contends that unusual measures are required to generate test
atmospheres containing IPDI for toxicity testing. If the substance is
aerosolized, particles would be expected to precipitate out of the air.
The material is not volatile under normal conditions. It does not react
rapidly with water to generate heat that might cause volatilization.
The low vapor pressure led the Department of Transportation to remove
IPDI from its list of materials that are toxic by inhalation, according
to the petition.
EPA disagrees. Petitioner's argument is essentially that the test
used to determine acute toxicity subjects the animals to extreme
conditions not likely to be found in reality. This, however, is the
case for many animal tests used to determine toxicity for regulatory
purposes. In fact, a similar case can be made for most LD50 or
LC50 tests, since the levels at which animals are dosed are far
higher than would be delivered in actual conditions. The fact is that
IPDI is toxic at low levels, based on an LC50, compared to other
chemicals regardless of the conditions of the chemical during the test.
This qualifies the chemical for listing.
Extrapolations from the extreme conditions of testing may then be
used to determine regulatory levels. For example, to determine a level
of concern for chemicals on the EHS list in calculating threshold
planning quantities, as noted above, EPA applies a conversion factor to
the acute toxicity tests. Conversion factors may range from one-tenth
to one-hundredth of the levels found in the acute toxicity tests. This
is explained in the November 17, 1986 Interim Final Rule preamble at 51
FR 41576. For listing purposes, however, conditions of testing are not
generally relevant.
EPA, however, as noted above, has taken into account physical/
chemical properties of IPDI in proposing to revise the TPQ.
EPA believes that the data used to list paraquat, azinphos-methyl,
fenamiphos and isophorone diisocyanate is sound and that the denial of
these petitions is consistent with the listing criteria and TPQ
methodology. At this time, the Agency is not planning to modify the
listing criteria nor the TPQ methodology. The Agency however, will
accept any comments on additional criteria which can be used to
increase the usefulness of the EHS list and the TPQ methodology.
In the consideration of these petitions, HULs America brought to
the Agency's attention that there may be at least three competing
products with toxicity and physical/chemical properties very similar to
IPDI and, therefore should be treated the same. Huls maintains none of
the chemicals should be listed. EPA is requesting information on other
chemicals, currently not listed, for which toxicity meets the criteria,
and which therefore warrant listing. At this time, EPA is not proposing
to increase the number of chemicals on the EHS list; however, in the
future it will propose to list chemicals with toxicity information
showing that they warrant listing.
The reader should note that the Agency is making several technical
corrections to the 40 CFR part 355 elsewhere in this issue of the
Federal Register. As mentioned earlier in this preamble, the listing of
``paraquat'' is being corrected to read ``paraquat dichloride.''
``Phenylthiourma'' in 40 CFR part 355, appendix A should read
``phenylthiourea. ``The listing of hydrogen chloride in 40 CFR part
355, appendix B should read ``hydrogen chloride (gas only).''
``Quabain'' in 40 CFR part 355, appendix B should read ``ouabain.''
IV. Regulatory Analyses
A. Executive Order 12866
Under Executive Order 12866, [58 FR 51735 (October 4, 1993)] the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) 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;
(2) create a serious inconsistency or otherwise interfere with
an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements,
grants, user fees, or lean programs or the rights and obligations or
recipients thereof; or
(4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
B. Regulatory Flexibility Analysis
Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.,
whenever an agency is required to publish a notice of rulemaking for
any proposed or final rule, it must prepare and make available for
public comment a regulatory flexibility analysis that describes the
effect of the rule on small entities (i.e., small businesses, small
organizations, and small governmental jurisdictions). This analysis is
unnecessary, however, if the agency's administrator certifies that the
rule will not have a significant economic effect on a substantial
number of small entities.
EPA has examined the rule's potential effects on small entities as
required by the Regulatory Flexibility Act. It has determined this rule
will have no adverse effect on small entities because it reduces the
number of chemicals which would potentially make businesses subject to
the reporting requirements. Therefore, I certify that today's proposed
rule will not have a significant economic effect on a substantial
number of small entities.
C. Paperwork Reduction Act
This rule relieves facilities from having to report the presence of
these four chemicals to the State Emergency Response Commissions and
Local Emergency Planning Committees. If these facilities have no other
Extremely Hazardous Substances, they will no longer be required to
participate in the emergency planning process required by the statute.
Therefore, there are no information collection requirements for OMB to
review under the provisions of the Paperwork Reduction Act of 1980, 44
U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 355
Environmental Protection, Air pollution control, Chemicals,
Chemical accident prevention, Chemical emergency preparedness,
Community emergency response plan, Community right-to-know, Contingency
planning, Disaster assistance, Extremely hazardous substances,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Penalties, Reportable quantity, Reporting and
recordkeeping requirements, Superfund, Threshold planning quantity,
Water pollution control, and Water supply.
Dated: September 30, 1994.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, part 355 of title 40 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: 42 U.S.C. 11002, 11004, and 11048.
Appendix A to Part 355--[Amended]
2. Appendix A to part 355 is proposed to be amended by removing
``e'' from the notes column and changing the threshold planning
quantity to 1,000 pounds for Isophorone Diisocyanate, CAS No. 4098-71-
9. Appendix A to part 355 is further proposed to be amended by removing
the following entries:
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
1642-54-2.......................... Diethylcarbamazine Citrate.
122-14-5........................... Fenitrothion.
1314-56-3.......................... Phosphorus Pentoxide.
13494-80-9......................... Tellurium.
------------------------------------------------------------------------
Appendix B to Part 355--[Amended]
3. Appendix B to part 355 is proposed to be amended by removing
``e'' from the notes column and changing the threshold planning
quantity to 1,000 pounds for Isophorone Diisocyanate, CAS No. 4098-71-
9. Appendix B to part 355 is further proposed to be amended by removing
the following entries:
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
122-14-5........................... Fenitrothion.
1314-56-3.......................... Phosphorus Pentoxide.
1642-54-2.......................... Diethylcarbamazine Citrate.
13494-80-9......................... Tellurium.
------------------------------------------------------------------------
[FR Doc. 94-25196 Filed 10-11-94; 8:45 am]
BILLING CODE 6560-50-P