[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]


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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.

-----------------------------------------------------------------------

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